Additional Randomized Controlled Trials Research Articles

Effectiveness of Bairui granules in the treatment of respiratory tract infections: A systematic review and meta-analysis.

Respiratory tract infections (RTIs) are characterized by a high mortality rate and clinical incidence. Bairui granules (BG), which employ a method of heat elimination and detoxification, have demonstrated benefits in the treatment of infectious respiratory diseases. A computerized search of 6 databases was conducted to identify randomized controlled trials (RCTs) relevant to the treatment of RTIs with BG up to November 30, 2023. Two researchers independently conducted data extraction, risk of bias assessment, and grading analysis. To evaluate the stability of the results, trial sequential analysis was employed. This meta-analysis included 31 RCTs with a total of 4073 patients and demonstrated that the use of BG in the treatment of RTIs was associated with enhanced treatment efficacy (relative risk = 1.19, 95% credible interval: 1.16-1.22, P < .001). It also indicated a faster resolution of symptoms including pulmonary rales, cough, and fever, as well as a reduction in serological index factors, compared to the use of Western medicine treatment (WT) alone. Additionally, the duration of hospitalization for patients was significantly reduced (relative risk = -1.36, 95% credible interval: -1.55 to -1.17, P < .001). Trial sequential analysis confirmed the stability and conclusive evidence of the study results. The efficacy of treating RTIs with BG, either alone or in combination with WT, was found to be superior to WT alone. However, further high-quality RCTs are necessary to validate these outcomes. The effectiveness of treating RTIs using BG alone or in combination with WT was determined to be superior to using WT alone, with no serious adverse effects observed. However, additional RCTs are essential to further confirm the findings of this study.

Effect of nutrition-based prehabilitation on the postoperative outcomes of patients with esophagogastric cancer undergoing surgery: A systematic review and meta-analysis.

Meta-analyses have primarily focused on the effects of exercise-based prehabilitation on postoperative outcomes and ignored the role of nutritional intervention. In this study, we filled this gap by investigating the effect of nutrition-based prehabilitation on the postoperative outcomes of patients who underwent esophagectomy and gastrectomy. Five electronic databases, namely, PubMed, the Web of Science, Embase, Cochrane Library, and CINAHL, were searched. Adults diagnosed with esophagogastric cancer who were scheduled to undergo surgery and had undergone uni- or multimodal prehabilitation, with at least a week of mandatory nutritional intervention, were included. Forest plots were used to extract and visualize the data from the included studies. The occurrence of any postoperative complication was considered the primary endpoint. Eight studies met the eligibility criteria, with five randomized controlled trials (RCTs) and three cohort studies. In total, 661 patients were included. Any prehabilitation, that is, unimodal (only nutrition) and multimodal prehabilitation, collectively decreased the risk of any postoperative complication by 23% (95% confidence interval [CI] = 0.66-0.90). A similar effect was exclusively observed for multimodal prehabilitation (risk ratio [RR] = 0.78, 95% CI = 0.66-0.93); however, it was not significant for unimodal prehabilitation. Any prehabilitation significantly decreased the length of hospital stay (LOS) (weighted mean difference = -0.77, 95% CI = -1.46 to -0.09). Nutrition-based prehabilitation, particularly multimodal prehabilitation, confers protective effects against postoperative complications after esophagectomy and gastrectomy. Our findings suggest that prehabilitation slightly decreases LOS; however, the finding is not clinically significant. Therefore, additional rigorous RCTs are warranted for further substantiation.

Factor Xa inhibitors versus low-molecular-weight heparin for preventing coagulopathy following COVID-19: a systematic review and meta-analysis of randomized controlled trials.

Hospitalized patients with COVID-19 have shown a significant occurrence of thromboembolism and a heightened risk of death. It remains unclear whether factor Xa inhibitors are superior to enoxaparin in this context. Hence, there is a need for a direct comparison to assess the preventive effects and safety of factor Xa inhibitors versus enoxaparin in hospitalized COVID-19 patients. MEDLINE, Embase, and Cochrane Central databases were searched for randomized controlled trials (RCTs) or retrospective studies that compared the effectiveness or safety of factor Xa inhibitors and enoxaparin in preventing thromboembolism in hospitalized patients with COVID-19. Embolic incidence, incidence of bleeding, and all-cause mortality were among the outcomes of interest. Mantel-Haenszel weighted random-effects model was used to calculate relative risks (RRs) with 95 percent CIs. The analysis included six RCTs and two retrospective studies containing 4048 patients. Meta-analysis showed a statistically significant reduction among patients on factor Xa inhibitors compared with low-molecular-weight heparin (LMWH) in the embolic incidence [risk ratio (RR) 0.64 (95%, CI 0.42, 0.98); P=0.04, I2=12%]. Upon subgroup analysis by type of study design, no significant reductions were noted in patients on factor Xa inhibitors in RCTs (RR: 0.62; 95% CI: 0.33-1.17; P=0.14) or observational studies (RR: 0.53; 95% CI: 0.23-1.26; P=0.15) when compared with enoxaparin Factor Xa inhibitors were not significantly associated with incidence of bleeding [RR 0.76 (95% CI 0.36, 1.61); P=0.47, I2=0%] or all-cause mortality (RR: 0.81; 95% CI: 0.48-1.36; P=0.43). Consistent results were obtained upon subgroup analysis by the type of study design. Factor Xa inhibitors are more effective than enoxaparin in preventing thromboembolism among patients with COVID-19 who are not acutely ill and are hospitalized. Additional rigorous RCTs comparing factor Xa inhibitors with enoxaparin are warranted.

New non-drug technologies for lymphedema associated with breast cancer: a review

INTRODUCTION. Breast Cancer-Related Lymphedema (BCRL) is the most common complication after radical treatment of breast cancer (BC). Currently, there are no molecular therapeutic targets whose pharmacologic action could prevent edema, making it necessary to study the efficacy of non-pharmacologic techniques. AIM. To study the effectiveness of non-medication technologies in BCRL to develop recommendations for practical application based on the analysis of systematic reviews and meta-analyses of randomized controlled trials (RCTs). MATERIALS AND METHODS. The search was conducted in the Physiotherapy Evidence-Based Database (PEDro, 2002–2024) using the keywords: “lymphedema”, “upper limbs”, “breast cancer”. A total of 203 sources were selected as of March 2024. RESULTS AND DISCUSSION. Numerous studies have found that the use of early postoperative physical exercise with a gradual expansion of the load in patients at risk of developing BCRL is a safe and effective method of rehabilitation. The effectiveness of early preventive use of manual lymphatic drainage (MLD) in 4 RCTs was studied in a Cochrane review. However, the clinical effectiveness of early prophylactic use of MLD to prevent BCRL remains insufficiently proven. In contrast, prophylactic use of compression sleeves has been shown to reduce and delay the onset of arm lymphedema in women at high risk of developing BCRL during the first year after breast cancer surgery. Studies have also confirmed the effectiveness of an early Prospective Surveillance Model using bioimpedance spectroscopy for early detection and immediate treatment of BCRL. It has been proven that in order to reduce the volume of a limb with BCRL, it is necessary to prescribe an intensive phase of complex decongestive therapy (CDT) for at least 3 weeks. Studies have also proven the effectiveness of using a standard or improved intermittent pneumatic compression device in the rehabilitation phases, including at home. CONCLUSION. To reduce the risk of development and progression of BCRL, modern exercise therapy techniques should be used to increase physical activity in order to control body weight, and educational techniques for self-massage and self-application of compression bandages should be actively used. The “golden” standard for conservative treatment of BCRL remains CDT, which is based on MLD. At the same time, the wider use and development of new methods of hardware lymphatic drainage that imitate MLD, which is a highly resourceful and costly method of treatment for BCRL, is justified. To confirm the clinical effectiveness of improved hardware pneumocompression, additional RCTs assessing long-term treatment results are required.

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

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. 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). 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. 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.

Effects of intermittent overload doses of oral vitamin D3 on serum 25(OH)D concentrations and the incidence rates of fractures, falls, and mortality in elderly individuals: A systematic review and meta-analysis.

Vitamin D is commonly used to prevent and treat osteoporosis, with studies indicating its potential to reduce fractures, falls, and mortality. However, meta-analyses present inconsistent findings regarding its efficacy, particularly reflecting significant variability in data and outcomes related to various dosing regimens. In this meta-analysis, we assessed the impact of high-dose intermittent oral administration of vitamin D3 on serum 25(OH)D levels, fractures, falls, and mortality among elderly individuals. We included 14 randomized controlled trials (RCTs) and employed Review Manager 5.4 for statistical analysis. Our findings indicate that intermittent monthly administration of vitamin D3 (over 800 IU per day) significantly raised serum 25(OH)D levels at all timepoints after six months, maintaining levels above 75 nmol/L throughout the year. This regimen showed no increase in all-cause mortality, with a risk ratio (95% CI) of 0.95 (0.87-1.04). Likewise, it did not significantly reduce the risks of falls and fractures, with risk ratios of 1.02 (0.98-1.05) and 0.95 (0.87-1.04) respectively. Although one-year intermittent administration significantly increased the concentration of 25(OH)D in serum, further research is needed to determine if this method would increase the incidence of falls. Therefore, it is not recommended at this stage due to the lack of demonstrated safety in additional relevant RCTs. This study had been registered at PROSPERO (CRD42022363229).

Efficacy of probiotic supplementation and impact on fecal microbiota in patients with inflammatory bowel disease: a systematic review and meta-analysis of randomized controlled trials.

The aim of this meta-analysis was to evaluate the efficacy of probiotics supplementation in patients with IBD. Randomized controlled trials (RCTs) evaluating the efficacy of probiotics in patients with IBD were searched in PubMed, the Google Scholar database, Web of Science, and CrossRef for the period July 2003 to June 2023. The RCTs were extracted, independently by 2 authors, according to the PICOS criteria. Seven studies, including a total of 795 patients, met the study criteria. Five end points were selected to evaluate the efficacy. Of these, 3 indicators showed a statistically significant difference in efficacy: C-reactive protein (odds ratio [OR]: -2.45, 95% confidence interval [CI]: -3.16, -1.73, P < .01), the number of fecal Bifidobacterium (OR: 3.37, 95% CI: 3.28, 3.47, P < .01), and Lactobacillus(OR: 2.00, 95% CI: 1.91, 2.09, P < .01). The other 2 indicators (disease activity for Crohn's disease and for ulcerative colitis) showed no statistically significant difference, while the OR reflected a positive correlation. Probiotics supplementation may have a positive effect on IBD by reducing clinical symptoms, reducing the serological inflammatory markers, and increasing favorable gut flora in patients with IBD. Additional RCTs are needed to evaluate the therapeutic effect of probiotics in IBD.

Are Tai Chi and Qigong effective in the treatment of traumatic brain injury? A systematic review

BackgroundTraumatic brain injury (TBI) adversely affects both young and old and is a growing public health concern. The common functional, psychological, and cognitive changes associated with TBI and recent trends in its management, such as recommending sub-threshold aerobic activity, and multi-modal treatment strategies including vestibular rehabilitation, suggest that Tai Chi/Qigong could be beneficial for TBI. Tai Chi and Qigong are aerobic mind-body practices with known benefits for maintaining health and mitigating chronic disease. To date, no systematic review has been published assessing the safety and effectiveness of Tai Chi/Qigong for traumatic injury.MethodsThe following databases were searched: MEDLINE, CINAHL Cochrane Library, Embase, China National Knowledge Infrastructure Database, Wanfang Database, Chinese Scientific Journal Database, and Chinese Biomedical Literature Database. All people with mild, moderate, or severe TBI who were inpatients or outpatients were included. All Types of Tai Chi and Qigong, and all comparators, were included. All measured outcomes were included. A priori, we chose “return to usual activities” as the primary outcome measure as it was patient-oriented. Cochrane-based risk of bias assessments were conducted on all included trials. Quality of evidence was assessed using the grading of recommendation, assessment, development, and evaluation (GRADE) system.ResultsFive trials were assessed; three randomized controlled trials (RCTs) and two non-RCTs; only two trials were conducted in the last 5 years. No trial measured “return to normal activities” or vestibular status as an outcome. Four trials - two RCTs and two non-RCTS - all found Tai Chi improved functional, psychological and/or cognitive outcomes. One RCT had a low risk of bias and a high level of certainty; one had some concerns. One non-RCTs had a moderate risk of bias and the other a serious risk of bias. The one Qigong RCT found improved psychological outcomes. It had a low risk of bias and a moderate level of certainty. Only one trial reported on adverse events and found that none were experienced by either the exercise or control group.ConclusionBased on the consistent finding of benefit in the four Tai Chi trials, including one RCT that had a high level of certainty, there is a sufficient signal to merit conducting a large, high quality multi-centre trial on Tai Chi for TBI and test it against current trends in TBI management. Based on the one RCT on TBI and Qigong, an additional confirmatory RCT is indicated. Further research is indicated that reflects current management strategies and includes adverse event documentation in both the intervention and control groups. However, these findings suggest that, in addition to Tai Chi’s known health promotion and chronic disease mitigation benefits, its use for the treatment of injury, such as TBI, is potentially a new frontier.Systematic review registrationPROSPERO [CRD42022364385].

Alterations in chromosome 1q in multiple myeloma randomized clinical trials: a systematic review

Extra copies of chromosome 1q21 (+1q: gain = 3 copies, amp >= 4 copies) are associated with worse outcomes in multiple myeloma (MM). This systematic review assesses the current reporting trends of +1q, the efficacy of existing regimens on +1q, and its prognostic implications in MM randomized controlled trials (RCTs). Pubmed, Embase and Cochrane Registry of RCTs were searched from January 2012 to December 2022. Only MM RCTs were included. A total of 124 RCTs were included, of which 29 (23%) studies reported on +1q. Among them, 10% defined thresholds for +1q, 14% reported survival data separately for gain and amp, and 79% considered +1q a high-risk cytogenetic abnormality. Amongst RCTs that met the primary endpoint showing improvement in progression free survival (PFS), lenalidomide maintenance (Myeloma XI), selinexor (BOSTON), and isatuximab (IKEMA and ICARIA) were shown to improve PFS for patients with evidence of +1q. Some additional RCT’s such as Myeloma XI+ (carfilzomib), ELOQUENT-3 (elotuzumab), and HOVON-65/GMMG-HD4 (bortezomib) met their endpoint showing improvement in PFS and also showed improvement in PFS in the +1q cohort, although the confidence interval crossed 1. All six studies that reported HR for +1q patients vs. without (across both arms) showed worse OS and PFS for +1q. There is considerable heterogeneity in the reporting of +1q. All interventions that have shown to be successful in RCTs and have clearly reported on the +1q subgroup have shown concordant direction of results and benefit of the applied intervention. A more standardized approach to reporting this abnormality is needed.

Efficacy of nafamostat mesylate in the prevention of pancreatitis after endoscopic retrograde cholangiopancreatography: a systematic review and meta-analysis of randomized controlled trials

We conducted a systematic review and meta-analysis to evaluate the effect of nafamostat on the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PubMed, Web of Science, and Ichushi Web were searched for randomized controlled trials (RCTs) using nafamostat to prevent PEP. In subgroup analyses, we studied the preventive effects of nafamostat according to the severity of PEP, risk category, and dose. A random-effects model was adopted; heterogeneity between studies was examined using the chi-squared test and I2 statistics. This analysis uses the PRISMA statement as general guidance. 9 RCTs involving 3321 patients were included. The risk of PEP was lower in the nafamostat group than in the control group [4.4% vs. 8.3%, risk ratio (RR): 0.50, 95% confidence interval (CI): 0.36–0.68]. In subgroup analyses, the protective effects were evident in low-risk patients for PEP before ERCP (RR: 0.34, 95% CI: 0.21–0.55). The association between PEP and nafamostat was significant only in patients who developed mild PEP (RR: 0.49; 95% CI: 0.36–0.69). The benefits were independent of the dose. The prophylactic use of nafamostat resulted in a lower risk of PEP. The subgroup analyses suggested uncertain benefits for severe PEP or high-risk patients for PEP. This warrants further investigation through additional RCTs.

The Safety and Efficacy of Human Umbilical Cord-Derived Mesenchymal Stem Cells in Patients With Heart Failure and Myocardial Infarction: A Meta-Analysis of Clinical Trials.

Evidence from preclinical and clinical studies suggests that human umbilical cord-derived mesenchymal stromal cells (HUC-MSCs) may be useful in treating heart failure and acute myocardial infarction (MI). However, the effects of stem cell therapy on patients with heart failure remain the subject of ongoing controversy, and the safety and effectiveness of HUC-MSCs therapy have not yet been proven. To date, there has been no systematic overview and meta-analysis of clinical studies using HUC-MSCs therapy for heart failure and MI. The purpose of this study is to assess the safety and efficacy of HUC-MSC therapy versus a placebo in patients with heart failure and MI. While preparing this systematic review and meta-analysis, we adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A computer literature search of PubMed was performed. We considered randomized controlled trials (RCTs) that reported data on the safety and efficacy of HUC-MSC transplantation in patients with heart failure and MI. Two investigators independently searched the literature, extracted data, and rated the quality of the included research. Pooled data were analyzed using the fixed-effect model or the random-effect model in Review Manager 5.3. The Cochrane risk of bias tool was used to assess the bias of included studies. The primary outcome was ejection fraction (EF), whereas the secondary outcomes were readmission and mortality rates. Three RCTs (201 patients) were included in this meta-analysis. The overall effect did not favor either of the two groups in terms of risk of readmission (risk ratio = 0.5, 95% confidence interval (CI) = 0.22-1.15, p = 0.10) as well as mortality rate (risk ratio = 0.44, 95% CI = 0.14-1.44, p = 0.18). However, there was an improvement in EF in patients who received HUC-MSCs compared to placebo after 12 months of transplantation (mean difference (MD) = 3.21, 95% CI = 2.91-3.51, p < 0.00001). At the six-month follow-up period, there was no significant improvement in EF (MD = 1.30, 95% CI = -1.94-4.54), p = 0.43), indicating that the duration of follow-up can shape the response to therapy. Our findings indicate that HUC-MSC transplantation can improve EF but has no meaningful effect on readmission or mortality rates. Existing evidence is insufficient to confirm the efficacy of HUC-MSCs for broader therapeutic applications. Therefore, additional double-blind RCTs with larger sample sizes are required.

Efficacy of baricitinib for the treatment of systemic lupus erythematosus patients: A meta-analysis of randomized controlled trials.

Systemic lupus erythematosus (SLE) is an autoimmune disorder characterized by abnormal autoantibody production, inflammation, and organ damage. Most SLE treatment strategies aim to induce remission or reduce disease activity while avoiding flares. Baricitinib has been used effectively to manage various inflammatory diseases, and some randomized controlled trials (RCT) have shown that it is beneficial in treating SLE. The current study aims to assess the efficacy of baricitinib in treating SLE patients. Various databases such as PubMed, Scopus, and Science Direct were searched to obtain eligible studies for the present meta-analysis. Data such as baseline characteristics of patients, doses of the baricitinib, follow-up duration, and treatment outcome in the form of SLE responder index-4 (SRI-4) and lupus low disease activity state (LLDAS) were extracted. Combined odds ratio, 95% confidence interval, and probability values were calculated to study the efficacy of baricitinib in treating SLE patients. A p-value less than .05 was taken as significant. Comprehensive meta-analysis v3 was used for all analyses. Three articles were found eligible for the present meta-analysis comprising 614 patients with placebo, 614 SLE patients receiving 4 mg, and 621 patients with 2 mg of baricitinib. Meta-analysis revealed a beneficial effect of 4 mg baricitinib in SLE patients compared to placebo, as measured by an increase in the SRI-4 (p = .006, OR = 1.370) and LLDAS (p = .083, OR = 1.252) rates. In contrast to the placebo group, however, patients receiving 2 mg of baricitinib exhibited no significant improvement. The trial sequential analysis revealed the need for additional RCTs to determine the role of baricitinib in treating SLE patients. In treating SLE patients, administrating a higher dose of baricitinib (4 mg) may be effective. However, additional RCTs in different populations with larger sample sizes are required to validate our findings.

Abstract 18294: The Effect of Intensive Blood Pressure Lowering on Left Ventricular Hypertrophy in Patients With Hypertension: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Introduction: The effect of intensive blood pressure (BP) lowering on cardiac remodeling remains uncertain, with emerging evidence suggesting that it can prevent the development of left ventricular hypertrophy (LVH) in patients with hypertension (HTN). We aim to investigate the effect of intensive BP lowering on LVH and cardiovascular disease (CVD) incidence in HTN patients. Methods: A systematic review and meta-analysis synthesizing randomized controlled trials (RCTs), which were retrieved by systematically searching: PubMed, Web of Science, SCOPUS, and Cochrane through June 8 th , 2023. We used the random-effect model to pool dichotomous data using risk ratio (RR) and hazard ratio (HR), with a 95% confidence interval (CI). Trial sequential analysis (TSA) was performed to weigh type I and II errors, estimating if the effect is large enough to be unaffected by further studies. Results: We included four RCTs with a total of 20,747 patients. Two RCTs investigated an intensive target of &lt; 120 mmHg, and another two investigated &lt;130 mmHg. Intensive BP lowering was associated with a decreased risk of LVH incidence (RR: 0.66, with 95% CI [0.56 - 0.77]). Our TSA revealed that the cumulative Z-curve consistently crossed the TSA boundary, indicating a statistically significant effect, signifying that the available evidence has reached a predefined threshold for statistical significance, providing robust evidence. Also, intensive BP lowering was associated with a decreased risk of CVD (HR: 0.71, with 95% CI [0.60 - 0.85]). Conclusion: Intensive BP lowering protects against LVH in HTN patients. TSA suggests that additional RCTs may not be necessary to establish the efficacy of intensive BP lowering on LVH. Also, intensive BP lowering was associated with decreased CVD incidence; however, LVH did not explain this effect in the included RCTs. Therefore, further research is warranted to explore possible mechanisms of decreasing CVD with intensive BP lowering in HTN patients.

Effects of Moderate- to High-Impact Exercise Training on Bone Structure Across the Lifespan: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Moderate- to high-impact exercise improves bone mineral density (BMD) across the lifespan, but its effects on bone structure, which predicts fracture independent of areal BMD, are unclear. This systematic review and meta-analysis investigated effects of impact exercise on volumetric BMD (vBMD) and bone structure. Four databases (PubMed, Embase, SPORTDiscus, Web of Science) were searched up to March 2022 for randomized controlled trials (RCTs) investigating the effects of impact exercise, with ground reaction forces equal to or greater than running, compared with sham or habitual activity, on bone vBMD and structure. Bone variables were measured by quantitative computed tomography or magnetic resonance imaging at the tibia, radius, lumbar spine, and femur. Percentage changes in bone variables were compared among groups using mean differences (MD) and 95% confidence intervals (CI) calculated via random effects meta-analyses. Subgroup analyses were performed in children/adolescents (<18 years), adults (18-50 years), postmenopausal women, and older men. Twenty-eight RCTs (n = 2985) were included. Across all studies, impact exercise improved trabecular vBMD at the distal tibia (MD = 0.54% [95% CI 0.17, 0.90%]), total vBMD at the proximal femur (3.11% [1.07, 5.14%]), and cortical thickness at the mid/proximal radius (1.78% [0.21, 3.36%]). There was no effect on vBMD and bone structure at the distal radius, femoral shaft, or lumbar spine across all studies or in any subgroup. In adults, impact exercise decreased mid/proximal tibia cortical vBMD (-0.20% [-0.24, -0.15%]). In postmenopausal women, impact exercise improved distal tibia trabecular vBMD (0.79% [0.32, 1.25%]). There was no effect on bone parameters in children/adolescents in overall analyses, and there were insufficient studies in older men to perform meta-analyses. Impact exercise may have beneficial effects on bone structure and vBMD at various skeletal sites, but additional high-quality RCTs in different age and sex subgroups are needed to identify optimal exercise protocols for improving bone health across the lifespan. © 2023 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

The Effect of Additional Whole-Body Vibration on Musculoskeletal System in Children with Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

Nowadays, whole-body vibration (WBV) has become increasingly popular as an additional therapy in the intervention of patients with cerebral palsy (CP). However, the impact of WBV remains a subject of debate. Consequently, a systematic review and meta-analysis were undertaken to evaluate the effects of WBV on the musculoskeletal system in children with CP. Randomized controlled trials (RCTs) were sought in the most frequent databases. The intervention studied was WBV combined with conventional physiotherapy (PT) compared with conventional PT as the control; the main outcomes were changes in the musculoskeletal system. Weighted mean differences with 95%CIs were calculated. A random-effects model was applied, and the publication bias was checked using funnel plots. On the basis of the inclusion and exclusion criteria, 16 articles, including 414 patients, were considered in the final analysis. The improvement in walking performance (speed and step length) was statistically significant (p < 0.05), and although there were no significant differences in the further outcomes, a clear positive tendency was visible in the case of improved muscle strength, decreased spasticity, enhanced gross motor functions, and overall stability. Based on the findings, a clear assessment of the usefulness of this intervention cannot be made; nonetheless, due to the promising results, it would be worthwhile to conduct additional RCTs to enhance the available evidence in this field. Due to the wide range of vibration configurations, including varying durations and intensities, it is suggested to establish guidelines and a strategy for the incorporation of this additional treatment.

Evaluation of Mobile Health Technology Interventions for the Postdischarge Management of Patients With Head and Neck Cancer: Scoping Review.

Patients with head and neck cancer (HNC) often experience various types and degrees of complications and functional impairment following surgery or radiotherapy. Consequently, these patients require extensive postdischarge rehabilitation, either at home or in the community. Numerous studies have shown the advantages of mobile Health (mHealth) technology in assisting patients with cancer with self-management and rehabilitation during the postdischarge period. However, few reviews have focused on the intervention, management, and evaluation of mHealth technology in postdischarge patients with HNC. This study aimed to conduct a scoping review of mHealth technology apps and interventions currently available to patients discharged from hospitals after receiving treatment for HNC. This study sought to identify and summarize the types and effectiveness of existing mHealth interventions as well as the differences in their outcome assessments. The PubMed, Embase, Web of Science, and CINAHL databases were used to identify studies with no publication time limits. The keywords "mobile health technology" and "head and neck cancer" were combined to address the main concepts of the research questions. Of the 1625 papers identified, 13 (0.8%) met the inclusion and exclusion criteria. Most studies (n=8, 61.5%) were randomized controlled trials (RCTs) and cohort studies. These studies were conducted in 6 countries. The main aims of the mHealth interventions in these studies are as follows: (1) symptom monitoring and assessment, (2) rehabilitation training, (3) access to medical health information, (4) telehealth advisers, (5) peer communication and support, and (6) follow-up/review reminders. The outcome evaluations of the 13 included studies were grouped into 4 categories: (1) technology usability and patient satisfaction, (2) self-management of symptoms and patient-reported outcome-related indicators, (3) adherence, and (4) health-related quality of life. A limited number of studies have investigated the use of mHealth technology in the postdischarge self-management of patients with HNC. The existing literature suggests that mHealth technology can effectively assist patients with HNC in self-management and postdischarge interventions. It plays an important role in addressing patients' health information needs, reducing both their somatic and psychological burdens, and improving their overall quality of life. Future research should prioritize conducting additional high-quality RCTs to evaluate the usability and analyze the cost-effectiveness of mHealth technology.

Limosilactobacillus reuteri DSM 17938 as a probiotic in preterm infants: An updated systematic review with meta-analysis and trial sequential analysis.

Our previous strain-specific systematic review (SR) showed that Lactobacillus reuteri (LR) DSM 17938 reduces necrotizing enterocolitis (NEC), late-onset sepsis (LOS), and time to full feeds (TFF) in preterm infants. Considering progress in the field over the past 6 years, we aimed to update our SR. SR of randomized controlled trials (RCTs) and non-RCTs was conducted. MEDLINE, Embase, Emcare, Cochrane CENTRAL, and gray literature were searched in June 2023. Primary outcomes were TFF, NEC stage ≥II, LOS, and all-cause mortality. Meta-analysis was performed using random-effects model. Certainty of evidence (CoE) was summarized using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) guidelines. Trial sequential analysis (TSA) was applied for outcome of NEC in RCTs. Twelve RCTs (n = 2284) and four non-RCTs (n = 1616) were included. Six RCTs and three non-RCTs were new. Meta-analysis of RCTs showed LR significantly reduced TFF (mean difference, -2.70 [95% CI, -4.90 to -1.31] days; P = 0.0001), NEC stage ≥II (risk ratio [RR], 0.57 [95% CI, 0.37-0.87]; P = 0.009; eight RCTs), and LOS (RR, 0.72 [95% CI, 0.54-0.97]; P = 0.03); but not mortality (RR, 0.76 [95% CI, 0.54-1.06]; P = 0.10). TSA showed diversity-adjusted required information size (DARIS) as 3624 for NEC. Overall CoE was "very low." Meta-analysis of non-RCTs showed LR reduced NEC (odds ratio, 0.34 [95% CI, 0.15-0.77]; P = 0.01) but not LOS. LR had no adverse effects. Very low CoE suggests that LR DSM 17938 may reduce NEC and LOS and shorten TFF in preterm infants. Additional RCTs are required to confirm our findings.

Application of “Partnership Care Model” in chronically ill adults and children: A systematic review and dose-response meta-analysis of randomized controlled trials

Background“Partnership Care Model (PCM)”, which is the first partnership conceptual framework founded on the Iranian culture to control chronic diseases, has been recently used in different fields of nursing research with no levels of valid evidence to support its application. Therefore, this systematic review and meta-analysis sought to clarify the impacts of interventions developed based on PCM on quality of life (QoL), sleep quality, anxiety, and depression among adults and children with chronic diseases. MethodsInternational data sources (e.g., PubMed, Web of Science, Scopus) and national databases (e.g., SID, MagIran, IranDoc, IRCT) were searched from 2001 to September 23, 2023, to find Randomized Controlled Trials (RCTs) on PCM-driven interventions for the experimental groups versus no intervention or standard care groups. The studies' methodological quality and evidence quality were rated utilizing the Cochrane risk of bias instruction and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Data were pooled by a random-effects approach employing STATA (vers. 11.2). ResultEighteen RCTs, reported in 22 publications, were qualified. The PCM compared to the standard care significantly improved the QoL among both adults (10 effect sizes [ESs], mean difference [MD]: 3.17, P < 0.001) and children (4 ESs, MD: 4.45, P < 0.001). Likewise, the intervention enhanced adults' sleep quality (3 ESs, MD: 7.15, P < 0.001). The anxiety of adults and children was also significantly lower in the PCM group (4 ESs, MD: −4.52, P = 0.001; 2 ESs, MD: −4.04, P < 0.001, respectively). However, regarding depression, a significant effect of PCM was found only among children (3 ESs, MD: −7.99, P = 0.011). The methodological quality of the studies and the evidence quality were undesirable. ConclusionThe PCM had a promising influence on the caring of adults and children suffering from chronic diseases. However, additional high-quality RCTs are needed to generate a higher quality of evidence concerning the clinical benefits of the PCM. PROSPERO noCRD42021253790.

How to prevent postoperative ileus in colorectal surgery? a systematic review.

Postoperative ileus (PI) after colorectal surgery is a common surgical problem. This systematic review aimed to investigate the available data in the literature to reduce the PI in the area of colorectal surgery out of the enhanced recovery after surgery principles, referring to published randomized controlled trials (RCTs) and meta-analyses, and to provide recommendations according to the Oxford Centre for Evidence-Based Medicine. The authors conducted bibliographic research on 1 December 2022. The authors retained meta-analyses and RCTs. The authors concluded that when we combined colonic mechanical preparation with oral antibiotic decontamination, the authors found a significant reduction in PI. The open approach was associated with a higher PI rate. The robotic and laparoscopic approaches had similar PI rates. Low ligation of the inferior mesenteric artery presented a PI similar to that of high ligation of the inferior mesenteric artery. There was no difference between the isoperistaltic and antiperistaltic anastomoses or between the intracorporeal and extracorporeal anastomoses. This study summarized the available data in the literature, including meta-analyses and RCTs. For a higher level of evidence, additional multicenter RCTs and meta-analyses of RCTs remain necessary.

The impact of abdominal compression devices on colonoscopy outcomes: a systematic review and meta-analysis of randomized controlled trials

Objective Colonoscopy is the gold standard method for colorectal cancer screening. Looping occurs in 91% of cases undergoing colonoscopy and can cause patient discomfort, prolonged cecal intubation time (CIT), and colon perforation. This meta-analysis investigates the impact of abdominal compression devices (ACD) on colonoscopy outcomes. Methods A systematic review and meta-analysis synthesizing randomized controlled trials (RCTs), retrieved by systematically searching: PubMed, EMBASE, WOS, SCOPUS, and Cochrane through February 2nd, 2023. Continuous and dichotomous outcomes were pooled using mean difference (MD) and risk ratio (RR) along with confidence interval (CI) using Revman. Our review protocol was prospectively published on PROSPERO with ID: CRD42023397344. Results We included eight RCTs with a total of 1,889 patients. ACD was effective to decrease CIT (MD: −2.15 with a 95% CI [−3.49, −0.80], p = .002), postural change (RR: 0.57 with 95% CI [0.49, 0.66], p = .00001), and VAS pain score (MD: −1.49 with 95% CI [−1.81, −1.17], p = .0001). However, there was no difference between ACD and control groups regarding manual compression (RR: 0.65 with 95% CI [0.42, 1.00], p = .05), complete colonoscopy rate (CCR) (RR: 1.01 with 95% CI [0.99, 1.04], p = .31), and cecal intubation length (CIL) (MD: −2.25 with 95% CI [−7.64, 3.14], p = .41). Conclusion ACD during colonoscopy may enhance patient comfort by reducing CIT, pain, and postural changes. Nevertheless, additional RCTs are necessary to validate these results and determine the most suitable approach to utilize ACD for colonoscopy.