Influence of sodium/glucose cotransporter-2 inhibitors on the incidence of acute kidney injury: a meta-analysis.

Background: Sodium/glucose cotransporter-2 inhibitors (SGLT2i) are associated with cardiovascular benefits. The aim of this systematic review and meta-analysis is to summarize the influence of SGLT2i on the incidence of acute kidney injury (AKI), and to ascertain whether it is affected by confounding variables such as age, baseline renal function and concurrent use of renin-angiotensin-aldosterone system inhibitors (RAASi) or mineralocorticoid receptor antagonists (MRA). Methods: PubMed, Embase, and Cochrane Library databases were searched for randomized controlled trials comparing the influence of SGLT2i versus placebo/blank treatment on AKI in the adult population. A fixed-effect model was used if the heterogeneity was not significant; otherwise, a randomized-effect model was used. Results: Eighteen studies comprising 98,989 patients were included. Compared with placebo/blank treatment, treatment with SGLT2i significantly reduced the risk of AKI (risk ratio [RR]: 0.78, 95% confidence interval [CI]: 0.71 to 0.84, p < 0.001; I 2 = 0%). Subgroup analysis suggested consistent results in patients with diabetes, chronic kidney disease, and heart failure (for subgroup difference, p = 0.32). Finally, univariate meta-regression suggested that the influence of SGLT2i on the risk of AKI was not significantly modified by variables such as age (coefficient: 0.011, p = 0.39), baseline estimated glomerular filtration rate (coefficient: -0.0042, p = 0.13) or concomitant use of RAASi (coefficient: 0.0041, p = 0.49) or MRA (coefficient: -0.0020, p = 0.34). Conclusion: SGLT2i may be effective in reducing the risk of AKI, and the effect might not be modified by age, baseline renal function and concurrent use of RAASi or MRA.

Prophylactic Mesh Reinforcement for Non-Midline Incisions: A Systematic Review.

Background: Many abdominal-pelvic surgeries utilize incisions not along the linea alba, such as transverse, laparoscopic, ostomy reversal, or ostomy formation incisions. The prevalence of ventral incisional hernias (VIH) at these sites and the efficacy of prophylactic mesh in preventing VIH remains unclear. Methods: PubMed, Embase, Scopus, and Cochrane databases were systematically reviewed from inception to September 2022. We included published randomized controlled trials (RCTs) that compared prophylactic mesh reinforcement versus no mesh. The primary outcome was the incidence of VIH at postoperative follow-up equal to or greater than 24 months. Secondary outcomes included surgical site infection (SSI) and surgical site occurrence (SSO). Results: Of 3186 screened articles, only 3 RCTs with at least an 80% 2-year follow-up, encompassing a total of 901 patients, were included for analysis of non-midline VIH. Fifteen additional RCTs were included for analysis of secondary outcomes. The rate of parastomal hernias with prophylactic mesh was 21%, while it ranged from 44%-64% in the control group. The rate of incisional hernia after ostomy reversal with prophylactic mesh was 10%, and 16% in the control group. No clear evidence of a difference was found in rates of SSI or SSO between groups. Conclusion: There is limited evidence on the role of prophylactic mesh in preventing non-midline VIH. More studies at low risk for bias are needed to elucidate the balance of the long-term risks and benefits of prophylactic mesh for non-midline incisions.

Are Orthopaedic Clinical Trials Linguistically and Culturally Diverse? A Systematic Review.

Purpose: Underrepresentation and misrepresentation of historically underrepresented populations in randomized controlled trials (RCTs) may have implications for the validity of research results and their application for diverse populations. To evaluate the representation of historically linguistically, racially, and ethnically underrepresented participants in orthopaedic randomized controlled trials (RCTs) and to assess the use of translated and culturally adapted patient reported outcome measures (PROMs). Methods: Separate and comprehensive literature searches of PubMed, Web of Science, and Embase databases were performed to identify RCTs utilizing PROMs between the years 2012 - 2022 among the top five highest 5-year impact factor orthopaedic journals according to the 2021 Journal Citation Reports database. The primary outcomes of interest included reporting of linguistic, racial and ethnic demographic characteristics of trial participants and the utilization of translated PROMs. The methodological quality of each clinical trial was assessed using the Jadad Criteria. Results: 230 RCTs met inclusion criteria. The language of participants was reported in 14% of trials and in 17% of trials when searching both the published text and clinical trial registration information. In addition, race and/or ethnicity was reported in 11% of trials, and the use of translated PROMs was reported in 7% of trials. Among the six multinational studies, none reported the language of the study population nor the use of translated PROMs. Notably, four studies (2%) reported utilizing culturally adapted PROMs. The average Jadad score was 3.07. Conclusion: Participant language, race, and ethnicity are infrequently reported in orthopaedic clinical trials, potentially limiting the application and interpretation of study results. Similarly, the linguistic and cultural adaptation of PROMs utilized are often not reported, which also limits interpretations of the validity and generalizability of orthopedic study results. Researchers and journals should promote standard reporting of demographic data and methods of PROM adaptation to ensure results are generalizable to diverse patient populations. Level of Evidence: III.

The Efficacy of Montelukast in Reducing the Risk of Warning Signs and Subsequent Dengue Shock Syndrome in Adult Dengue Fever Patients.

BACKGROUND: Dengue fever continues to pose significant health challenges globally, with recent outbreaks in Bihar, India, prompting a search for effective therapeutic interventions. This study assesses the effectiveness of Montelukast, traditionally used for asthma, in mitigating the severity of dengue fever symptoms and its progression to dengue shock syndrome (DSS). OBJECTIVE: To evaluate the impact of Montelukast on the prevalence of dengue warning signs and the incidence of DSS in adult patients. METHODS: A prospective observational study was conducted at the Indira Gandhi Institute of Medical Sciences (IGIMS), Patna, India, from August 2022 to October 2023, enrolling 500 patients diagnosed with dengue fever. Participants were divided into two groups. About 250 were treated with Montelukast and 250 received standard care. Outcomes measured included the incidence of warning signs, DSS, length of hospital stay, and 30-day mortality. RESULTS: The Montelukast group exhibited a 24% lower prevalence of dengue warning signs compared to the control group, with 90 out of 250 patients (36%) in the Montelukast group versus 150 out of 250 patients (60%) in the control group (p < 0.001). The incidence of DSS was significantly reduced in the Montelukast group, with 4 out of 250 patients (1.6%) compared to 21 out of 250 patients (8.4%) in the control group (odds ratio: 0.178, p < 0.001). Furthermore, Montelukast users experienced shorter hospital stays (average 4.52 days vs. 6.54 days, T-statistic: -7.59, p = 1.58×10-13) and a reduced 30-day mortality rate, with 5 out of 250 patients (2%) in the Montelukast group versus 12 out of 250 patients (5%) in the control group (p < 0.03). CONCLUSION: Montelukast significantly lowers the incidence of dengue warning signs and DSS, shortens hospital stays, and decreases mortality rates among dengue patients, supporting its potential integration into existing dengue treatment protocols. This study highlights the need for further clinical trials to confirm these findings and fully understand the therapeutic mechanisms of Montelukast in dengue management.

Efficacy and Safety of Adding Ketamine to Lidocaine in Intravenous Regional Anesthesia: A Meta-analysis of Randomized Controlled Trials.

PURPOSE: To systematically evaluate the efficacy and safety of adding ketamine (K) to lidocaine (L) for intravenous regional anesthesia (IVRA). DESIGN: A systematic review and meta-analysis. METHODS: A comprehensive search of the Cochrane library, Embase, PubMed, Web of Science, and ProQuest databases, and the Google Scholar search engine was conducted from inception to March 2023. All retrieved articles were imported into Endnote X20 software and independently screened by two researchers according to predetermined inclusion and exclusion criteria. The data were analyzed using Revman 5.4 software and the assessed outcomes included the time of sensory and motor block onset, time of sensory and motor block recovery, fentanyl consumption, time of tourniquet pain onset, intraoperative and postoperative visual analog scale scores, and complications. FINDINGS: A total of 532 patients from 11 randomized controlled trials were included in the meta-analysis. The results showed that the time of sensory (P < .00001) and motor block onset (P < .00001) were shorter in the L + K group than in the L-only group. The time of sensory (P = .01) and motor block recovery (P = .006) and time of tourniquet pain onset (P < .00001) were longer in the L + K group than in the L-only group. There was a significant reduction in fentanyl consumption (P = .0002) in the L + K group compared to the L-only group. Moreover, the visual analog scale scores in the L + K group were significantly lower than the L-only group 10 minutes (P = .04), 20 minutes (P = .0004), 30 minutes (P < .00001), and 40 minutes (P < .0001) after tourniquet inflation, and 5 minutes (P < .00001), 15 minutes (P = .04), 30 minutes (P = .008), 1 hour (P = .002), 2 hours (P < .00001), and 4 hours (P < .00001) after tourniquet deflation. There was no evidence that the use of K as an adjuvant in IVRA increased adverse effects. CONCLUSIONS: The addition of K to L in IVRA shortened the onset time, prolonged the block time, and reduced intraoperative and postoperative pain without increasing complications.

[Head-to-head studies on connective tissue diseases and vasculitides]. / Head-to-Head-Studien bei Kollagenosen und Vaskulitiden.

Head-to-head (H2H) studies enable the direct comparison of several alternative therapeutic approaches and thus provide the evidence-based foundation for the relative position of one treatment as compared to others for a specific indication. These trials constitute an important addition to placebo-controlled clinical trials. Among the controlled clinical trials not performed by the pharmaceutical industry, there are a relevant number of H2H trials for connective tissue diseases (CTDs) and vasculitides, particularly for systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). This article encompasses a review of the H2H trials for CTDs and vasculitides and discusses their relevance for current treatment algorithms. For SLE the H2H trials were predominantly performed for the treatment of lupus nephritis, demonstrating the impact of low-dose cyclophosphamide and mycophenolate as well as azathioprine for maintenance therapy. In recent H2H trials rituximab could be established as induction and maintenance therapy for AAV, which has now been incorporated into current treatment guidelines. Further comparative trials will be necessary in order to select the most effective and safest treatment for every patient, in the sense of personalized medicine.

Extracorporeal cardiopulmonary resuscitation versus standard treatment for refractory out-of-hospital cardiac arrest: a Bayesian meta-analysis.

BACKGROUND: The outcomes of several randomized trials on extracorporeal cardiopulmonary resuscitation (ECPR) in patients with refractory out-of-hospital cardiac arrest were examined using frequentist methods, resulting in a dichotomous interpretation of results based on p-values rather than in the probability of clinically relevant treatment effects. To determine such a probability of a clinically relevant ECPR-based treatment effect on neurological outcomes, the authors of these trials performed a Bayesian meta-analysis of the totality of randomized ECPR evidence. METHODS: A systematic search was applied to three electronic databases. Randomized trials that compared ECPR-based treatment with conventional CPR for refractory out-of-hospital cardiac arrest were included. The study was preregistered in INPLASY (INPLASY2023120060). The primary Bayesian hierarchical meta-analysis estimated the difference in 6-month neurologically favorable survival in patients with all rhythms, and a secondary analysis assessed this difference in patients with shockable rhythms (Bayesian hierarchical random-effects model). Primary Bayesian analyses were performed under vague priors. Outcomes were formulated as estimated median relative risks, mean absolute risk differences, and numbers needed to treat with corresponding 95% credible intervals (CrIs). The posterior probabilities of various clinically relevant absolute risk difference thresholds were estimated. RESULTS: Three randomized trials were included in the analysis (ECPR, n = 209 patients; conventional CPR, n = 211 patients). The estimated median relative risk of ECPR for 6-month neurologically favorable survival was 1.47 (95%CrI 0.73-3.32) with a mean absolute risk difference of 8.7% (- 5.0; 42.7%) in patients with all rhythms, and the median relative risk was 1.54 (95%CrI 0.79-3.71) with a mean absolute risk difference of 10.8% (95%CrI - 4.2; 73.9%) in patients with shockable rhythms. The posterior probabilities of an absolute risk difference > 0% and > 5% were 91.0% and 71.1% in patients with all rhythms and 92.4% and 75.8% in patients with shockable rhythms, respectively. CONCLUSION: The current Bayesian meta-analysis found a 71.1% and 75.8% posterior probability of a clinically relevant ECPR-based treatment effect on 6-month neurologically favorable survival in patients with all rhythms and shockable rhythms. These results must be interpreted within the context of the reported credible intervals and varying designs of the randomized trials. REGISTRATION: INPLASY (INPLASY2023120060, December 14th, 2023, https://doi.org/10.37766/inplasy2023.12.0060 ).

Evaluating research waste and traits among randomized controlled trials of scars over the past 20 years: a cross-sectional study.

PURPOSE: To analyze the changes in the characteristics of randomized controlled trials (RCTs) in the field of scarring over the last two decades, unveil the components of research waste (RW) within these RCTs, and identify targets for improvement. METHODS: A search was conducted on ClinicalTrials.gov for RCTs registered from January 2000 to December 2023, using "scar" as the keyword. The search was carried out in January 2024. RESULTS: 391 RCTs were included in this analysis. The global registration of RCTs in scarring has exhibited a consistent increase annually, with the proportion in Asia gradually rising, while the shares in North America and Europe have demonstrated a declining trend. In the analysis of RW, 232 RCTs were included, of which 96 (41.4%) have been published. Among the published RCTs, 56 (58.3%) were evaluated to have sufficient reporting, while 47 RCTs (48.9%) were identified as having avoidable design flaws. Ultimately, 183 RCTs (78.9%) exhibited at least one form of RW. Multicenter design (OR: 3.324, 95%CI: 1.385-7.975, P = 0.018), non-pharmacological interventions (OR: 2.61, 95%CI: 1.253-5.435, P = 0.010), the absence of external funding (OR: 0.325, 95%CI: 0.144-0.732, P = 0.031), and participant numbers exceeding 50 (OR: 3.269, 95%CI: 1.573-6.794, P = 0.002) were identified as independent protective factors against waste. CONCLUSIONS: This study delineates the changes in the characteristics of scar RCTs globally over the past two decades, uncovering a substantial burden of RW in scarring research. It provides an evidential reference for more rational planning of future scar-related RCTs and for minimizing RW.

A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial.

BACKGROUND: Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment. METHOD: The NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site. DISCUSSION: We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe. TRIAL REGISTRATION: ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up. How to search: ( https://ctri.nic.in/Clinicaltrials/advsearch.php -use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC).

Non-surgical vs. surgical treatment of distal radius fractures: a meta-analysis of randomized controlled trials.

PURPOSE: To compare the clinical outcomes between nonsurgical and surgical treatment of distal radius fracture. METHODS: We performed a systematic literature search by using multiple databases, including Medline, PubMed, and Cochrane. All databases were searched from the earliest records through February 2023. The study compared nonsurgical versus surgical treatment of distal radius fractures and included only randomized controlled trials (RCTS). RESULTS: There were seventeen randomized controlled trials retrieved. A total of 1730 patients were included: 862 in the nonsurgical group and 868 in the surgical group. The results showed a significant reduction in DASH score with surgical treatment (WMD 3.98, 95% CI (2.00, 5.95), P < 0.001). And in grip strength (%), the results showed a significant improvement in surgical treatment compared with non-surgical treatment (WMD - 6.60, 95% CI (-11.61, -1.60), P = 0.01). There was significant difference in radial inclination, radial length, volar title, range of wrist pronation, range of wrist supination. However, no difference in radial deviation, ulnar deviation, ulnar variance, range of wrist extension and range of wrist flexion was observed. CONCLUSIONS: The results of this meta-analysis suggest that some patients with surgical treatment of distal radius fractures not only improved the grip strength (%), decreased the DASH score, but also improved the range of wrist pronation and the range of wrist supination compared with nonsurgical treatment. Based on the present meta-analysis, we suggest that some patients with surgical treatment might be more effective in patients with distal radius fracture.

Adverse events profile associated with intermittent fasting in adults with overweight or obesity: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: There is little evidence to comprehensively summarize the adverse events (AEs) profile of intermittent fasting (IF) despite its widespread use in patients with overweight or obesity. METHODS: We searched the main electronic databases and registry websites to identify eligible randomized controlled trials (RCTs) comparing IF versus control groups. A direct meta-analysis using a fixed-effect model was conducted to pool the risk differences regarding common AEs and dropouts. Study quality was assessed by using the Jadad scale. Pre-specified subgroup and sensitivity analyses were conducted to explore potential heterogeneity. RESULTS: A total of 15 RCTs involving 1,365 adult individuals were included. Findings did not show a significant difference between IF and Control in risk rate of fatigue [0%, 95% confidence interval (CI), -1% to 2%; P = 0.61], headache [0%, 95%CI: -1% to 2%; P = 0.86] and dropout [1%, 95%CI: -2% to 4%; P = 0.51]. However, a numerically higher risk of dizziness was noted among the IF alone subgroup with non-early time restricted eating [3%, 95%CI: -0% to 6%; P = 0.08]. CONCLUSIONS: This meta-analysis suggested that IF was not associated with a greater risk of AEs in adult patients affected by overweight or obesity. Additional large-scale RCTs stratified by key confounders and designed to evaluate the long-term effects of various IF regimens are needed to ascertain these AEs profile.

A phase 2b double-blind placebo-controlled randomized clinical trial of SB-061, an aggrecan mimetic, in patients with symptomatic knee osteoarthritis.

OBJECTIVES: To evaluate the efficacy and safety of intra-articular injections of a novel aggrecan mimetic, SB-061, in subjects with knee osteoarthritis (OA). METHODS: This was a randomized, placebo-controlled, double-blind phase II study comparing intra-articular injections of SB-061 with placebo (isotonic saline) for 52 weeks, administered at baseline, Wk 16, and Wk 32. Eligible subjects had a KL grade of 2 or 3 on X-ray of the target knee and a Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain score ≥20 out of 50 at screening and baseline visits. Subjects having any other knee condition were excluded. Use of analgesics was prohibited, except for rescue medication. The primary endpoint was change from baseline (CFB) in WOMAC pain at Week 8. Secondary endpoints were CFB in WOMAC function and total, ICOAP, Patient Global Assessment, and 20-meter walk test. Exploratory endpoints included structural CFB in magnetic resonance imaging entities. RESULTS: A total of 288 subjects were randomized to SB-061 (n = 145) or placebo (n = 143), and 252 (87.5%) completed injections. The groups were comparable at baseline. The primary endpoint was not met, as no significant difference in the CFB of the WOMAC pain score at Week 8 between groups was observed, nor at any other time point during the study. Similarly, neither of the secondary or exploratory endpoints indicated any significant difference between groups. The frequency and type of adverse events were similar between groups. SB-061 was well-tolerated. CONCLUSION: Intra-articular injections of SB-061 administered at baseline, Week 16, and Week 32, over one year in subjects with knee OA, were safe but did not show any statistically significant effect on knee pain nor on other symptomatic or structural entities compared to placebo. TRIAL REGISTRATION NUMBER EUDRACT NO: 2019-004515-31.

Telemedicine in Improving Glycemic Control Among Children and Adolescents With Type 1 Diabetes Mellitus: Systematic Review and Meta-Analysis.

BACKGROUND: Type 1 diabetes mellitus (T1DM) is the most common chronic autoimmune disease among children and adolescents. Telemedicine has been widely used in the field of chronic disease management and can benefit patients with T1DM. However, existing studies lack high-level evidence related to the effectiveness of telemedicine for glycemic control in children and adolescents with T1DM. OBJECTIVE: This study aims to systematically review the evidence on the effectiveness of telemedicine interventions compared with usual care on glycemic control among children and adolescents with T1DM. METHODS: In this systematic review and meta-analysis, we searched PubMed, Cochrane Library, Embase, Web of Science (all databases), and CINAHL Complete from database inception to May 2023. We included randomized controlled trials (RCTs) that evaluated the effectiveness of a telemedicine intervention on glycemic control in children and adolescents with T1DM. In total, 2 independent reviewers performed the study selection and data extraction. Study quality was assessed using the Cochrane Risk of Bias 2 tool. Our primary outcome was glycated hemoglobin (HbA1c) levels. Secondary outcomes were quality of life, self-monitoring of blood glucose, the incidence of hypoglycemia, and cost-effectiveness. A random-effects model was used for this meta-analysis. RESULTS: Overall, 20 RCTs (1704 participants from 12 countries) were included in the meta-analysis. Only 5% (1/20) of the studies were at high risk of bias. Compared to usual care, telemedicine was found to reduce HbA1c levels by 0.22 (95% CI -0.33 to -0.10; P<.001; I2=35%). There was an improvement in self-monitoring of blood glucose (mean difference [MD] 0.54, 95% CI -0.72 to 1.80; P=.40; I2=67.8%) and the incidence of hypoglycemia (MD -0.15, 95% CI -0.57 to 0.27; P=.49; I2=70.7%), although this was not statistically significant. Moreover, telemedicine had no convincing effect on the Diabetes Quality of Life for Youth score (impact of diabetes: P=.59; worries about diabetes: P=.71; satisfaction with diabetes: P=.68), but there was a statistically significant improvement in non-youth-specific quality of life (MD -0.24, 95% CI -0.45 to -0.02; P=.04; I2=0%). Subgroup analyses revealed that the effect of telemedicine on HbA1c levels appeared to be greater in studies involving children (MD -0.41, 95% CI -0.62 to -0.20; P<.001), studies that lasted <6 months (MD -0.32, 95% CI -0.48 to -0.17; P<.001), studies where providers used smartphone apps to communicate with patients (MD -0.37, 95% CI -0.53 to -0.21; P<.001), and studies with medication dose adjustment (MD -0.25, 95% CI -0.37 to -0.12; P<.001). CONCLUSIONS: Telemedicine can reduce HbA1c levels and improve quality of life in children and adolescents with T1DM. Telemedicine should be regarded as a useful supplement to usual care to control HbA1c levels and a potentially cost-effective mode. Meanwhile, researchers should develop higher-quality RCTs using large samples that focus on hard clinical outcomes, cost-effectiveness, and quality of life.

A meta-analysis of randomized controlled trials evaluating the effectiveness of fecal microbiota transplantation for patients with irritable bowel syndrome.

OBJECTIVE: Multiple randomized controlled trials (RCTs) have investigated the efficacy of fecal microbiota transplantation (FMT) for irritable bowel syndrome (IBS), but have yielded inconsistent results. We updated the short-term and long-term efficacy of FMT in treating IBS, and performed a first-of-its-kind exploration of the relationship between gut microbiota and emotions. METHODS: We conducted a comprehensive search of PubMed, Embase, Web of Science, and the Cochrane Library using various search strategies to identify all eligible studies. The inclusion criteria for data extraction were randomized controlled trials (RCTs) that investigated the efficacy of fecal microbiota transplantation (FMT) compared to placebo in adult patients (≥ 18 years old) with irritable bowel syndrome (IBS). A meta-analysis was then performed to assess the summary relative risk (RR) and corresponding 95% confidence intervals (CIs). RESULTS: Out of 3,065 potentially relevant records, a total of 10 randomized controlled trials (RCTs) involving 573 subjects met the eligibility criteria for inclusion in the meta-analysis. The meta-analyses revealed no significant differences in short-term (12 weeks) (RR 0.20, 95% CI -0.04 to 0.44), long-term (52 weeks) global improvement (RR 1.38, 95% CI 0.87 to 2.21), besides short-term (12 weeks) (SMD - 48.16, 95% CI -102.13 to 5.81, I2 = 90%) and long-term (24 weeks) (SMD 2.16, 95% CI -60.52 to 64.83, I2 = 68%) IBS-SSS. There was statistically significant difference in short-term improvement of IBS-QoL (SMD 10.11, 95% CI 0.71 to 19.51, I2 = 82%), although there was a high risk of bias. In terms of long-term improvement (24 weeks and 54 weeks), there were no significant differences between the FMT and placebo groups (SMD 7.56, 95% CI 1.60 to 13.52, I2 = 0%; SMD 6.62, 95% CI -0.85 to 14.08, I2 = 0%). Sensitivity analysis indicated that there were visible significant effects observed when the criteria were based on Rome IV criteria (RR 16.48, 95% CI 7.22 to 37.62) and Gastroscopy (RR 3.25, 95%CI 2.37 to 4.47), Colonoscopy (RR 1.42, 95% CI 0.98 to 2.05). when using mixed stool FMT based on data from two RCTs, no significant difference was observed (RR 0.94, 95% CI 0.66 to -1.34). The remission of depression exhibited no significant difference between the FMT and placebo groups at the 12-week mark (SMD - 0.26, 95% CI -3.09 to 2.58), and at 24 weeks (SMD - 2.26, 95% CI -12.96 to 8.45). Furthermore, major adverse events associated with FMT were transient and self-limiting. DISCUSSION: Based on the available randomized controlled trials (RCTs), the current evidence does not support the efficacy of FMT in improving global IBS symptoms in the long term. The differential results observed in subgroup analyses raise questions about the accurate identification of suitable populations for FMT. Further investigation is needed to better understand the reasons behind these inconsistent findings and to determine the true potential of FMT as a treatment for IBS.

Effect of dipeptidyl peptidase-4 inhibitors on tumor necrosis factor alpha levels in patients with type 2 diabetes mellitus.

AIMS: Dipeptidyl peptidase-4 inhibitors (DPP-4i) served as oral antidiabetic agents for treatment of type 2 diabetes mellitus (T2DM). Although an action on glucose homeostasis was identified, no well-rounded illustration had been established on the changes of tumor necrosis factor alpha (TNF-alpha) levels during DPP-4i treatment. This study aimed to explore the anti-inflammatory effect of DPP-4i on TNF-alpha in patients with T2DM. METHODS: PubMed, Embase and Cochrane Library were systematically searched from inception to May 31, 2024. Randomized controlled trials exploring the impact of DPP-4i on TNF-alpha levels were identified. Risk of bias was assessed according to the Cochrane criteria. A fixed or random-effects model was selected to pool estimate on whether the heterogeneity was present. Subgroup analysis were performed to explore the potential factors that influenced heterogeneity. Related meta-analysis was conducted with the software of Revman 5.3 and STATA 12.0. RESULTS: Eleven trials involving 884 participants with T2DM were included. Pooled estimates suggested that DPP-4i did not significantly modulate TNF-alpha levels (WMD, - 0.70, 95% CI - 1.94 to 0.53, P = 0.26) in T2DM. DPP-4i produced a significant effect on TNF-alpha (WMD, - 4.50 pg/mL, 95% CI - 4.68 to - 4.32, P < 0.00001) when compared to placebo, and a comparable effect was demonstrated on TNF-alpha (WMD, 0.10 pg/mL, 95% CI - 0.11 to 0.30, P = 0.35) in comparison with active agents. Estimate was stable according to the sensitivity test. Subgroup analysis revealed that heterogeneity might not correlate with baseline glycated hemoglobin (HbA1c), age or treatment duration. CONCLUSIONS: A significant effect of DPP-4i on TNF-alpha levels was present in T2DM when compared to placebo. Administration of DPP-4i produced no significant effect on TNF-alpha in comparison with active comparators. Further studies with large samples should be performed to illustrate the impact of DPP-4i on TNF-alpha levels in T2DM. Trial registration International Prospective Register for Systematic Review (PROSPERO) number: CRD42020185479.

The Role of Community Engagement in Successful Recruitment of Research Participants During the COVID-19 Pandemic.

Background: Our research team was in the process of recruiting American Indian and Alaska Native (AIAN) women for a community-based intervention to prevent alcohol-exposed pregnancy when the COVID-19 pandemic began. Safety measures adopted at the tribal, state, and national level required us to rethink and revise study protocols. We followed the principles of community-based participatory research, especially community engagement. The goal of this article is to report the recommendations from local AIAN field staff and the community advisory board that enabled us to exceed our prepandemic recruitment goal. Methods: First, we developed a list of major adaptations and mapped each one onto our recruitment timeline to assess its effect on subsequent enrollment. Second, we surveyed the two AIAN field staff who led recruitment and an administrative staffer at the study site and conducted a qualitative analysis of their responses. Results: Our revised project timeline presents the major adaptations that led to our successful recruitment, as verified by qualitative data from field staff. These adaptations included expanding our social media presence, expanding recruitment to a nearby urban site, implementing a "refer a friend" program, and recruiting through local media outlets. Most important was having local AIAN staff who cultivated a nonjudgmental space for potential participants to talk about sensitive topics. Discussion: We not only met our prepandemic recruitment goal but exceeded it by 16.6%. The input of our community advisory board and the efforts of community-based staff were essential in achieving success during the unprecedented conditions of the COVID-19 pandemic.

Acupuncture and moxibustion treatment for breast cancer-related lymphoedema： a systematic review and Meta-analysis. / é’ˆç¸æ²»ç–—ä¹³è ºç™Œæ·‹å·´æ°´è‚¿çš„ç³»ç»Ÿè¯„ä»·å’ŒMeta分析.

OBJECTIVES: To evaluate the efficacy of acupuncture in treating breast cancer-related lymphedema (BCRL) by using systematic review and Meta analysis method. METHODS: Searching CNKI, Wanfang Data Knowledge Service Platform, VIP Chinese Journal Service Platform, Chinese Biomedical Literature Database, PubMed, Cochrane Library, Embase and Web of Science, the randomized controlled trials (RCTs) literature of acupuncture for BCRL was collected from the establishment of the databases to October 1st, 2023. After data extraction and risk of bias evaluation of the included literature, Meta-analysis was performed using RevMan5.4 software. RESULTS: A total of 14 RCTs with 952 patients were included. The Meta-analysis results showed that compared with comprehensive decongestive therapy (CDT), CDT-associated methods and other interventions of the contro group, acupuncture was able to decrease the circumference of the proximal 10 cm to elbow crease (MD=-1.95, P=0.000 5), reduce the difference in arm circumference (MD=-1.30, P<0.000 01), and increase the effective index (MD=27.47, P<0.000 01；RR=1.23, P=0.000 5)；acupuncture improves the range of motion(ROM) scores of shoulder joint in four areas：anteflexion(SMD=0.47, P=0.04), posterior extension (SMD=0.87, P<0.000 01), abduction (SMD=0.48, P=0.03), and adduction (SMD=0.72, P=0.000 5)；acupuncture also could alleviate pain and improve visual analog scale (VAS) scores (MD=-1.15, P<0.000 01). No serious adverse reactions were reported in the literatures. CONCLUSIONS: Acupuncture can effectively improve the degree of limb edema and subjective symptoms in BCRL patients.

The effect of physical exercise intervention on the ability of daily living in patients with Alzheimer's dementia: a meta-analysis.

Objective: To systematically evaluate the effect of physical exercise intervention on the activities of daily living (ADL) on patients with Alzheimer's dementia (AD) and explore the optimal exercise scheme. Methods: PubMed, EMBASE, the Cochrane Library, Web of Science, and Science Direct databases were searched from 1987 to December 2023 to collect randomized controlled trials (RCTs). Two investigators independently screened the literature and extracted data according to the inclusion and exclusion criteria. The quality of the included studies was evaluated using Cochrane Review Manager 5.3. And STATA 16.0 was used for performing the meta-analysis. Results: Fifteen randomized controlled trials were included. The results of the meta-analysis showed that physical exercise had a positive effect on the improvement of ADL in patients with AD [standardized mean difference (SMD) = 0.312, 95% confidence interval (CI 0.039-0.585), P = 0.02], and the difference was statistically significant. The results of subgroup analysis showed that anaerobic exercises such as strength and balance training with a medium cycle of 12-16 weeks and lasting 30-45 min each time were more ideal for the improvement of basic daily living ability of AD patients. Conclusion: Physical exercise can effectively improve activities of daily living in patients with Alzheimer's dementia and it may be a potential non-drug treatment for AD patients.

The Effect of Randomized Beta-Carotene Supplementation on CKD in Men.

Introduction: Beta-carotene (BC) protects the body against free radicals that may damage the kidney and lead to the development of acute kidney injury and chronic kidney disease (CKD). Previous studies in animal models have demonstrated a potential protective effect of 30 mg/kg BC supplementation on renal ischemia or reperfusion injury and subsequently improved kidney function. The extension of these findings to humans, however, remains unclear. Methods: Our study leverages previously collected data from the Physicians' Health Study I (PHS I), a large-scale, long-term, randomized trial of middle-aged and older US male physicians testing 50 mg BC every other day for primary prevention of cardiovascular disease and cancer. We examined the impact of randomized BC supplementation on self-reported incident CKD identified by self-reports stating "yes" to kidney disease from annual follow-up questionnaires from randomization in 1982 through the end of the randomized BC intervention at the end of 1995, and on CKD defined as an estimated glomerular filtration rate (eGFR) < 60 ml/min per 1.73 m2 at the end of 1995. Analyses compared incident CKD between BC supplementation and placebo using Cox proportional hazards regression models and logistic regression. We also examined whether smoking status (current vs. former or never smoker) or other factors modified the effect of randomized BC supplementation on CKD. Results: A total of 10,966 participants were randomized to BC, and 10,952 participants were randomized to a placebo group. Baseline characteristics between randomized BC groups were similar. There was no significant benefit between BC supplementation and self-reported incident CKD after adjusting for age and randomized aspirin treatment (hazard ratio [HR] = 0.97, 95% confidence interval [CI]: 0.86-1.08, P-value = 0.56). Stratified by smoking status, there was no significant benefit of BC supplementation and self-reported incident CKD either among former or never smokers (HR = 0.95, 95% CI: 0.84-1.07, P-value = 0.41) or current smokers (HR = 1.08, 95% CI: 0.78-1.50, P-value = 0.64). Smoking status did not modify the association between BC supplementation and incident CKD (P-interaction = 0.47). In subgroup analysis among those with available serum creatinine at the study end (5480 with BC and 5496 with placebo), there was no significant benefit between BC supplementation and CKD based on eGFR < 60 ml/min per 1.73 m2 (odds ratio [OR] = 0.96, 95% CI: 0.85-1.08, P-value = 0.49). Conclusion: Long-term randomized BC supplementation did not affect the risk of incident CKD in middle-aged and older male physicians.