Large-scale Randomized Controlled Trials Research Articles

Liver resection had better disease-free survival rates compared with radiofrequency ablation in hepatocellular carcinoma: A meta-analysis based on randomized clinical trials.

Liver resection (LR) and radiofrequency ablation (RFA) are the most commonly used treatment modalities for early-stage hepatocellular carcinoma (ES-HCC). The comparative efficacy of LR and RFA in ES-HCC remains debated. We conducted a meta-analysis based on randomized trials to compare the outcomes of LR and RFA. We searched PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov for randomized controlled trials (RCTs) comparing RFA and LR interventions for the treatment of ES-HCC. The primary outcomes were overall survival (OS) and disease-free survival (DFS). We used meta-regression to determine the source of heterogeneity and conducted a trial sequential analysis to examine whether the outcome was statistically reliable. Our meta-analysis included nine RCTs with a total of 1,516 HCC patients. Compared with patients receiving RFA, those receiving LR did not have significantly different 2-year OS (HR=1.28, 95% CI: 0.73-2.23) and 5-year OS (HR=1.49, 95% CI: 0.99-2.24). However, patients receiving LR showed a favorable trend in 2-year DFS (HR=1.40, 95% CI: 1.16-1.69) and 5-year DFS (HR=1.37; 95% CI: 1.05-1.77), although these results are not conclusive due to underpowered significance. The heterogeneity was low, and the outcomes were statistically reliable. Meta-analysis suggests that while LR shows a favorable trend in DFS compared to RFA for ES-HCC, the present evidence does not thoroughly support recommending LR over RFA. The inconclusive nature of these findings highlights the need for further large-scale RCTs to establish definitive comparative efficacy.

Efficacy and safety of direct oral anticoagulants versus warfarin in the treatment of cerebral venous sinus thrombosis.

Given the evolving application and promising outcomes of direct oral anticoagulants (DOACs) in various thromboembolic conditions, we aimed to compare the efficacy and safety of DOACs with warfarin in the post-acute treatment of cerebral venous sinus thrombosis (CVST) using clinical and radiological parameters. A total of 140 CVST patients were enrolled, with 95 receiving warfarin and 45 receiving DOACs as post-acute treatment. Clinical and imaging parameters of the patients in follow-up visits were investigated, including the last modified Rankin Scale (mRS), venousthromboembolic events, CVST recurrence, mortality rate, recanalization status, and hemorrhagic events, to compare the efficacy and safety of treatment between the two groups. At baseline, patients' assessments using two prognostic scores, ISCVT-RS and IN-REvASC, revealed that there was no statistically significant difference in the distribution of prognostic risk categories between the warfarin and DOACs groups. Following acute therapy, patients in the warfarin and DOACs groups were followedup forthemedian of359 and325days, respectively. Analysis to compare the efficacy of warfarin and DOACs revealed no significant difference in last mRS scores, CVST recurrencerate, venousthromboembolic events, and recanalizationstatus between the two groups. Additionally, there was no statistically significant difference in the risk of hemorrhagic events between warfarin and DOACsgroups. Our findings show that DOACs have comparable safety and efficacy in the post-acute treatment of CVST patients; however, large-scalerandomized controlled trials are required to validate our findings.

Long COVID Brain Fog Treatment: Findings from a Pilot Randomized Controlled Trial of Constraint-Induced Cognitive Therapy.

Long COVID brain fog is often disabling. Yet, no empirically-supported treatments exist. This study's objectives were to evaluate feasibility and efficacy, provisionally, of a new rehabilitation approach, Constraint-Induced Cognitive Therapy (CICT), for post-COVID-19 cognitive sequelae. Sixteen community-residents ≥ 3-months post-COVID-19 infection with mild cognitive impairment and dysfunction in instrumental activities of daily living (IADL) were enrolled. Participants were randomized to Immediate-CICT or treatment-as-usual (TAU) with crossover to CICT. CICT combined behavior change techniques modified from Constraint-Induced Movement Therapy with Speed of Processing Training, a computerized cognitive-training program. CICT was deemed feasible if (a) ≥80% of participants completed treatment, (b) the same found treatment highly satisfying and at most moderately difficult, and (c) <2 study-related, serious adverse-events occurred. The primary outcome was IADL performance in daily life (Canadian Occupational Performance Measure). Employment status and brain fog (Mental Clutter Scale) were also assessed. Fourteen completed Immediate-CICT ( n =7) or TAU ( n =7); two withdrew from TAU before their second testing session. Completers were [ M (S D )]: 10 (7) months post-COVID; 51 (13) years old; 10 females, 4 males; 1 African American, 13 European American. All the feasibility benchmarks were met. Immediate-CICT, relative to TAU, produced very large improvements in IADL performance ( M =3.7 points, p<.001, d =2.6) and brain fog ( M =-4 points, p<.001, d =-2.9). Four of five non-retired Immediate-CICT participants returned-to-work post-treatment; no TAU participants did, p =.048. CICT has promise for reducing brain fog, improving IADL, and promoting returning-to-work in adults with Long COVID. Findings warrant a large-scale RCT with an active-comparison group. Brain fog in adults with Long COVID is often associated with dysfunction in everyday activities and unemployment. Yet, there are no empirically supported treatments targeting cognition in this population. Findings from this small-scale, pilot randomized controlled trial (RCT) suggest that a novel intervention, i.e., Constraint-Induced Cognitive Therapy, is a feasible cognitive rehabilitation method in adults with Long COVID cognitive sequelae with promise of (a) improving performance of cognition-based tasks in daily life and (b) promoting return-to-work. Further studies with larger sample sizes are warranted.Speed of Processing Training (SOPT) has been shown to increase processing speed in older adults without neurological disorders but has not been applied to adults with brain fog due to Long COVID, in whom slowing of cognitive processing speed is common. The results of this pilot RCT suggest that SOPT, in conjunction with behavior change techniques, may increase cognitive processing speed in this brain-injured population.

Medical Assistant Health Coaching for Type 2 Diabetes in Primary Care: Results From a Pragmatic Cluster Randomized Controlled Trial.

This cluster (clinic-level) randomized controlled trial (RCT) compared medical assistant (MA) health coaching (MAC) with usual care (UC) among at-risk adults with type 2 diabetes in two diverse real-world primary care environments: a federally qualified health center (FQHC; Neighborhood Healthcare) and a large nonprofit private insurance-based health system (Scripps Health). A total of 600 adults with type 2 diabetes who met one or more of the following criteria in the last 90 days were enrolled: HbA1c ≥8% and/or LDL cholesterol ≥100 mg/dL and/or systolic blood pressure (SBP) ≥140 mmHg. Participants at MAC clinics received in-person and telephone self-management support from a specially trained MA health coach for 12 months. Electronic medical records were used to examine clinical outcomes in the overall sample. Behavioral and psychosocial outcomes were evaluated in a subsample (n = 300). All clinical outcomes improved significantly over 1 year in the overall sample (P < 0.001). The reduction in HbA1c was significantly greater in the MAC versus UC group (unstandardized Binteraction = -0.06; P = 0.002). A significant time by group by site interaction also showed that MAC resulted in greater improvements in LDL cholesterol than UC at Neighborhood Healthcare relative to Scripps Health (Binteraction = -1.78 vs. 1.49; P < 0.05). No other statistically significant effects were observed. This was the first large-scale pragmatic RCT supporting the real-world effectiveness of MAC for type 2 diabetes in U.S. primary care settings. Findings suggest that this team-based approach may be particularly effective in improving diabetes outcomes in FQHC settings.

Lipid-lowering therapies and long-term stroke prevention in East Asians: A systematic review and meta-analysis of randomized controlled trials.

Stroke prevention is a pressing global health priority, with reducing elevated lipids recognized as a key strategy. East Asians, constituting more than 1.6 billion individuals and the largest racial group worldwide, are a key demographic in this effort. Yet, the effectiveness of lipid-lowering therapies for stroke prevention in this population remains uncertain. We conducted a systematic review and meta-analysis of large-scale randomized controlled trials (RCTs) with at least 3 years of follow-up to evaluate the long-term impact of lipid-lowering therapies on stroke incidence in East Asians. We systematically searched four electronic databases up to 11 January 2024. The association was quantified using relative risk (RR) with a 95% confidence interval (CI), and between-study heterogeneity was evaluated using the I2 statistic. In addition, we utilized the Cochrane Risk of Bias Tool to assess the risk of bias in each included RCT and applied the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to evaluate the certainty of the evidence. This study incorporated data from nine large-scale RCTs involving 54,354 participants. Our findings of overall analyses revealed that lipid-lowering therapies did not significantly affect the long-term incidence of all strokes (9 RCTs; 54,354 participants; RR = 0.98 (95% CI = 0.87-1.10); P = 0.75), ischemic stroke (7 RCTs; 52,059 participants; RR = 0.91 (95% CI, = 0.79-1.04); P = 0.16), or hemorrhage stroke (7 RCTs; 52,059 participants; RR = 1.24 (95% CI = 0.97-1.59); P = 0.09) in East Asians. Notably, there was no evidence of heterogeneity or publication bias, and the quality of evidence assessed using GRADE methodologies was rated as high. Sensitivity analyses confirmed the robustness of our results, with no single study significantly affecting the overall findings. Furthermore, subgroup analyses consistently supported the conclusions, further bolstering the reliability of our study. Lipid-lowering therapies did not demonstrate any beneficial effects on long-term stroke prevention among East Asians.

Effect of exercise on postoperative recovery of patients with non-small cell lung cancer: a systematic review and meta-analysis

Patients with non-small cell lung cancer (NSCLC) in the postoperative recovery period often experience reduced exercise capacity and impaired lung function, which affects their overall quality of life. This paper investigated the effect of exercise interventions on exercise capacity, lung function, quality of life, and symptoms in these patients. Methods: We performed a literature search across Cochrane, Embase, PubMed, Web of Science, and EBSCO databases were comprehensively searched for randomized controlled trials (RCTs) from inception to September 2023, all English RCTs were eligible if they assessed the effects of exercise interventions on postoperative NSCLC patients. Results: Twelve articles met our inclusion criteria, evidencing that exercise interventions could significantly improve the functional capacity of NSCLC patients in postoperative recovery. Notably, Forced Expiratory Volume in 1 s (FEV1) was improved, indicating enhanced lung function. Furthermore, exercise improved the physical and mental health scores of SF-36, along with increased quadriceps strength and relieved dyspnea. However, fatigue levels were not significantly changed. Conclusions: Exercise interventions of NSCLC patients in the postoperative recovery are associated with improved functional capacity, lung function, quality of life, and quadriceps strength, as well as alleviated symptoms of dyspnea. These findings underscore the potential benefits of incorporating exercise into postoperative care for NSCLC patients. Nonetheless, further large-scale RCTs are required to solidify the evidence base on the clinical outcomes of exercise following pneumonectomy.

The efficacy and safety of Xiao-Ban-Xia-Tang in the treatment of chemotherapy-induced nausea and vomiting: A systematic review and meta-analysis.

Chemotherapy-induced nausea and vomiting (CINV) is one of the most frequent and critical side effects due to chemotherapeutics. In China, Xiao-Ban-Xia-Tang (XBXT) has already been applied extensively to prevent and treat CINV. However, there is limited testimony on the effectiveness and safety of this purpose, and there was no correlative systematic review. The aim of this review was to systematically evaluate the effectiveness and safety of XBXT in preventing and treating CINV. The systematic search was conducted in eight databases to acquire randomized controlled trials (RCTs) that appraised the effect of XBXT in treating CINV. The vomiting and nausea relief efficiency, eating efficiency, quality of life, and adverse reactions were explored for efficacy assessment. Bias risk was rated by manipulating the Cochrane risk of bias tool 2.0 (RoB 2). The retrieved investigations were analyzed by utilizing ReviewManager 5.4 and Stata 17.0. The quality of evidence was evaluated adopting the GRADE tool. A total of 16 clinical RCTs of XBXT in the treatment of CINV were incorporated into the investigation, with a total of 1246 participants. The meta-analysis showed that compared with conventional antiemetic drugs, XBXT and antiemetics improved the vomiting relief efficiency (RR 1.35, 95% confidence interval: 1.25-1.46, p < 0.00001), nausea relief efficiency (N = 367, RR 1.23, 95% CI: 1.09-1.38, p < 0.00001), and quality of life (RR = 1.37, 95% CI: 1.14-1.65, p = 0.0009) and reduced the adverse events (N = 370, RR 0.53, 95% CI: 0.29-0.96, p = 0.04). XBXT and DARAs raised eating efficiency compared with DARAs (N = 208, RR 1.30, 95% CI: 1.07-1.57, p = 0.007). The data existed as statistically significant, and the publication bias was identified as relatively low from the funnel plot and trim and fill analysis. In addition, sensitivity analysis demonstrated robust outcomes. The quality of evidence for each outcome ranged from moderate to high. There is some encouraging evidence that XBXT and antiemetics had better therapeutic effects and safety in treating CINV than antiemetic drugs alone. The quality assessment and low publication bias indicated that the overall criterion was scientific. Better research is required to verify the evidence designed with large-scale RCTs and rigorous methods.

Benchmarking the transcriptomic predictive biomarkers for immunotherapy plus chemotherapy: Results from phase III RATIONALE-309 and ORIENT-11 randomized trials.

e14624 Background: The combination of PD-(L)1 inhibitors and chemotherapy (IO+Chemo) has become the standard first-line treatment for multiple types of cancer. In contrast to PD-(L)1 monotherapy, there is a lack of established biomarkers to distinguish the outcomes of IO+Chemo. The paucity of high-quality omics data in this setting has not allowed for deep biomarker exploration. We utilized RNA-seq data from two in-house randomized controlled trials (RCTs), RATIONALE-309 and ORIENT-11, with the goal to find transcriptomic biomarkers to identify patients who may not derive benefit from IO+Chemo. Methods: RATIONALE-309 (NCT03924986) was a phase 3 study conducted at 42 sites in Asia. Treatment-naive recurrent/metastatic nasopharyngeal cancer patients were randomly allocated to either PD-1 inhibitor tislelizumab or placebo plus gemcitabine and cisplatin. ORIENT-11 (NCT03607539) was a phase 3 study that enrolled patients from 47 centers in China who had previously untreated locally advanced/metastatic nonsquamous non-small cell lung cancer. Patients were randomized to PD-1 inhibitor sintilimab or placebo plus pemetrexed and platinum. We compared several immune-related biomarkers, including IFN-γ signature, PD-L1, cytolytic score (CYT), T-cell inflamed gene expression profile, B cell infiltration, and ESTIMATE immune score, and explored the optimal predictive threshold. Results: In the RATIONALE-309 and ORIENT-11 trials, 247 and 171 patients with RNA-seq data were analyzed, respectively. Although the addition of Chemo to IO could theoretically benefit tumors with low immune activation, we hypothesized that patients might not benefit from IO+Chemo if their activation level is extremely low. We first tested the predictiveness of several thresholds (20-50th quantiles) for each selected biomarker in the two RCTs. We found that low CYT and B cell are the two best indicators for identifying a lack of survival benefits from IO+Chemo versus Chemo, especially when using 20-30th quantile as threshold. To incorporate their distinct biological information and predictive value, we combined their genes into a single gene signature to represent immune activation. We found that patients in the lower quantile (&lt;20th) showed no benefit of IO+Chemo over Chemo in terms of overall survival (OS) (RATIONALE-309: HR=1.01, P=0.99; ORIENT-11: HR=1.54, P=0.31) and progression-free survival (PFS) (RATIONALE-309: HR=0.76, P=0.42; ORIENT-11: HR=1.30, P=0.52). Moreover, this lack of advantage was maintained in key subgroups such as PD-L1-positive patients and former/current smokers across the two RCTs. Conclusions: Based on the two large-scale RCTs, our findings have implications for the selection of biomarkers when identifying suitable candidates for IO+Chemo treatment. B cells and CYT are crucial components required for the efficacy of IO+Chemo.

Adaptive clinical trials in surgery: A scoping review of methodological and reporting quality.

Adaptive surgical trials are scarce, but adopting these methods may help elevate the quality of surgical research when large-scale RCTs are impractical. Randomized-controlled trials (RCTs) are the gold standard for evidence-based healthcare. Despite an increase in the number of RCTs, the number of surgical trials remains unchanged. Adaptive clinical trials can streamline trial design and time to trial reporting. The advantages identified for ACTs may help to improve the quality of future surgical trials. We present a scoping review of the methodological and reporting quality of adaptive surgical trials. We performed a search of Ovid, Web of Science, and Cochrane Collaboration for all adaptive surgical RCTs performed from database inception to October 12, 2023. We included any published trials that had at least one surgical arm. All review and abstraction were performed in duplicate. Risk of bias (RoB) was assessed using the RoB 2.0 instrument and reporting quality was evaluated using CONSORT ACE 2020. All results were analyzed using descriptive methods. Of the 1338 studies identified, six trials met inclusion criteria. Trials were performed in cardiothoracic, oral, orthopedic, and urological surgery. The most common type of adaptive trial was group sequential design with pre-specified interim analyses planned for efficacy, futility, and/or sample size re-estimation. Two trials did use statistical simulations. Our risk of bias evaluation identified a high risk of bias in 50% of included trials. Reporting quality was heterogeneous regarding trial design and outcome assessment and details in relation to randomization and blinding concealment. Surgical trialists should consider implementing adaptive components to help improve patient recruitment and reduce trial duration. Reporting of future adaptive trials must adhere to existing CONSORT ACE 2020 guidelines. Future research is needed to optimize standardization of adaptive methods across medicine and surgery.

The safety profile of mesenchymal stem cell therapy administered through intrathecal injections for treating neurological disorders: a systematic review and meta-analysis of randomised controlled trials.

Based on previous in vivo studies and human trials, intrathecal cell delivery is a safe and relevant therapeutic tool for improving patient's quality of life with neurological conditions. We aimed to characterise the safety profile of intrathecally delivered Mesenchymal stem cells (MSCs). Ovid MEDLINE, Embase, Scopus, Cochrane Library, KCI-Korean Journal Database, and Web of Science. Databases were searched from their inception until April 13, 2023. Randomised Controlled Trials (RCTs) that compared intrathecal delivery of MSCs to controls in adult populations were included. Adverse events (AEs) were pooled and meta-analysed using DerSimonian-Laird random effects models with a correction factor 0.5 added to studies with zero count cells. Pooled AEs were described using Risk ratio (RR) and 95% confidence intervals (95% CI). Then, a random-effects meta-regress model on study-level summary data was performed to explore the relationship between the occurrence of AEs and covariates thought to modify the overall effect estimate. Finally, publication bias was assessed. 303 records were reviewed, and nine RCTs met the inclusion criteria and were included in the quantitative synthesis (n = 540 patients). MSCs delivered intrathecally, as compared to controls, were associated with an increased probability of AEs of musculoskeletal and connective tissue disorders (categorised by Common Terminology Criteria for Adverse Events-CTCAE version 5.0) (RR: 1.61, 95% CI 1.19-2.19, I2 = 0%). The random-effects meta-regress model suggested that fresh MSCs increased the probability of occurrence of AEs compared to cryopreserved MSCs (RR: 1.554; p-value = 0.048; 95% CI 1.004-2.404), and the multiple-dose, decreased the probability of AEs by 36% compared to single doses (RR: 0.644; p-value = 0.048; 95% CI 0.416-0.996); however, univariate random effects meta-regression models revealed a not significant association between the occurrence of AEs from MSCs intrathecal delivery and each covariate. Intrathecal delivery of MSCs was associated with a slight increase in AEs associated with musculoskeletal and connective tissue disorders, albeit without serious AEs. We conclude that intrathecal MSCs delivery is safe for patients with neurological conditions. However, further high-quality, large-scale RCTs are needed to confirm these findings.

THE PROTECT TRIAL - PREOPERATIVE EXERCISE THERAPY FOR PATIENTS WITH CANCER: A PILOT RANDOMISED-CONTROLLED TRIAL

INTRODUCTION &amp; AIMS Prehabilitation exercise is a promising strategy in oncology to optimise pre-operative cardiorespiratory fitness (CRF), which could reduce post-operative complications, mortality and enhance quality of life. This trial aimed to investigate the safety, feasibility, and effects of an aerobic prehabilitation exercise program in breast, colorectal, and prostate cancer patients. Primary outcomes were serious adverse events (SAE), adverse events (AE), participant adherence and compliance. Secondary outcomes were CRF variables and patient well-being. METHODS A CONSORT-compliant pilot randomised controlled trial (RCT) was conducted at a regional hospital in Ballarat, Australia. Prostate, breast, and colorectal cancer patients scheduled for surgery were randomised 1:1 into prehabilitation (PREHAB) or usual care (UCARE). PREHAB involved aerobic exercises informed by baseline cardio-pulmonary testing findings, with supervised sessions every two/three days for a minimum of 2-weeks. UCARE involved standard oncology treatment. Data on physical activity (actigraphy), resting vitals, and post-operative outcomes (Clavien-Dindo) were also collected. RESULTS Among 47 approached patients, 23 were randomised. Overall, 11 patients were analysed in the PREHAB and 9 in the UCARE groups. No SAEs were reported, and an exercise-related AE occurred every 756 minutes (total 3780). Participants attended 91.3% of PREHAB sessions. PREHAB participants attended 5.25 (SD = 2.16) sessions and had an average of 15 days from baseline testing to surgery. No significant time x group interactions were observed in V̇O2peak, ventilatory threshold (VT), or overall patient well-being (p = 0.90, 0.58, 0.82); PREHAB achieved small within-group increases in absolute V̇O2peak and VT (+4.9% and +1.8%, respectively). CONCLUSIONS The PROTECT trial demonstrated the safety and feasibility of delivering prehabilitation, revealing small clinically relevant increases in CRF fitness measures. Potentially due to the sample size, no significant improvements were observed in well-being or post-operative complications; future research should prioritise larger-scale RCTs further to explore the benefits of prehabilitation in this population.

The Role of Dietary Patterns and Nutritional Supplements in the Management of Mental Disorders in Children and Adolescents: An Umbrella Review of Meta-Analyses: Le rôle des habitudes alimentaires et des suppléments nutritionnels dans la prise en charge des troubles mentaux chez les enfants et les adolescents : une méta-revue de méta-analyses.

In recent years, the relationship between nutrition and mental health has gained considerable interest. We identified, synthesized, and appraised all meta--analyses of randomized controlled trials (RCTs) and observational studies reporting on the efficacy of dietary patterns and nutrient supplements in the prevention and treatment of mental disorders in children and adolescents. Systematic research in MEDLINE, PsycINFO, Scopus, and Cochrane Database of Systematic Reviews was completed on 8 January 2024. Our research found 24 meta-analyses: 14 on RCTs, 8 on observational studies, and 2 combining both. Emerging evidence suggests that omega-3, in particular eicosapentaenoic acid, and Vitamin D may have adjunctive benefits in the treatment of attention deficit hyperactivity disorder (ADHD), while no evidence was found for autism spectrum disorder (ASD). Observational data also indicated that prenatal folic acid supplementation (>400 μg daily) was associated with a reduced risk of ASD in offspring. In terms of dietary habits, several meta-analyses of observational data revealed that healthy dietary patterns (rich in fruits, vegetables, and fibre, low in saturated fats) during the prenatal period, childhood, and adolescence were linked to a significantly reduced risk of internalizing disorders and externalizing disorders. Conversely, unhealthy dietary habits (high in sugars, saturated animal fats, and industrial foods, low in fruits, vegetables, and fibre) are associated with an elevated risk of these mental health issues. However, the number of available studies on dietary interventions for the treatment of depression, ASD, and ADHD was limited, and the results obtained were either nonsignificant or contradictory. Our findings emphasize the need to establish clear causal relationships between dietary habits and the risk of mental illness in children and adolescents. Moreover, further investigation of the benefits observed with some nutrient supplements (such as omega-3 and vitamin D for ADHD) through larger-scale RCTs is imperative to establish more robust conclusions.

Personalizing or reminding? How to better incentivize savings among underbanked individuals

We use a large-scale randomized control trial to evaluate information interventions to motivate savings in a mostly unbanked population. We find positive impacts of personalized SMSs on savings during the messaging period and larger than existing studies. However, they fade away after messaging stops, like in other experiments. Compared to the existing literature, we can better identify the sources of that effect. Personalized SMSs are not more likely to be received or more memorable. Highlighting a specific monetary goal appears to be more effective than tangibility. Also, salience or personalization separately do little to increase the intensive margin of savings. Heterogeneous effects are consistent with limited attention co-existing with other behavioral biases; for groups where reactance and frustration play a role, those are overcome only when personalized SMSs are employed.

Efficacy of fire needle combined with 308 nm excimer laser therapy for vitiligo: A systematic review and meta-analysis of randomized controlled trials.

Vitiligo is a common depigmenting skin disorder. This work is performed to systematically evaluate the efficacy and safety of fire needles combined with 308 nm excimer laser therapy in treating vitiligo. We searched the PubMed, EMBASE, Cochrane Library, Web of Science, CNKI, Wanfang, and VIP databases. Randomized controlled trials (RCTs) on fire needles combined with 308 nm excimer laser therapy with 308 nm excimer laser therapy alone for vitiligo were included. The Cochrane Collaborative Network Tool was used to assess the risk of bias. Statistical analysis was completed using RevMan5.3 software and Stata 15.0 software. The GRADE system was used to evaluate the quality of evidence for outcomes. In this study, 10 RCTs and 1333 patients were included. The results showed that compared with 308 nm excimer laser therapy alone, fire needle combined with 308 nm excimer laser therapy is more effective in improving clinical effective rate (RR = 1.36, 95% CI [1.24, 1.50], p < 0.00001), serum CD4+ level (MD = 3.12, 95% CI [2.50, 3.74], p < 0.00001), CD4+/CD8+ ratio (MD = 0.24, 95% CI [0.09, 0.39], p = 0.001), and quality of life measured by the Dermatology Life Quality Index (DLQI) (MD = 3.76, 95% CI [3.33, 4.19], p < 0.00001), and reducing the Vitiligo Area Score Index (VASI) (MD = -5.47, 95% CI [-6.56, -4.37], p < 0.00001). The reported adverse events, including redness, swelling, pain, blisters, and itching, were controllable, and all these events were well tolerated. The current evidence indicates that fire needle combined with 308 nm excimer laser therapy is effective and safe for vitiligo. However, owing to the suboptimal quality of the included studies, more high-quality and large-scale RCTs are needed for comprehensive analysis and further validation.

Electronic health intervention to manage symptoms of immunotherapy in patients with cancer (SOFIA): Results from a randomized controlled pilot trial.

For patients receiving immune checkpoint inhibitors, early detection of immune-related adverse events (irAEs) is critical for one's safety. To this end, a smartphone app (SOFIA) was developed that featured the assessment of electronic patient-reported outcomes (ePROs) focusing on irAEs as well as a set of comprehensive supportive information. Its feasibility and preliminary efficacywere evaluated in a randomized controlled trial (RCT). Patients who received immune checkpoint inhibition therapy were randomly assigned to an intervention group (IG) or a control group (CG; care as usual). During the 12-week intervention period, IG patients used SOFIA to report twice weekly ePROs and receive cancer- and immunotherapy-relevant contents. Before a patient's next clinical visit, the physician in charge was given the ePRO reports. The primary objective was to test the feasibility of SOFIA. Furthermore, the preliminary efficacy of SOFIA for health-related quality of life (HRQOL), psychosocial outcomes, and medical data was examined. Clinical outcomes were assessed at baseline (T0), post-intervention (T1), and a 3-month follow-up (T2). Seventy-one patients were randomized to the IG (n=34) or the CG (n=37). SOFIA showed high feasibility and acceptance. At T1, patients in the IG reported significantly better HRQOL and role functioning and less depression, distress, and appetite loss. No significant differences were revealed regarding medical data, the utilization of supportive care services, or survival. SOFIA showed high feasibility and acceptance and improved HRQOL and psychosocial outcomes. These results suggest further evaluation of efficacy in a large-scale confirmatory multicenter RCT.

Effects of Hyperbaric Oxygen Therapy on Long COVID: A Systematic Review.

The coronavirus disease (COVID-19) pandemic has resulted in an increasing population that is experiencing a wide range of long-lasting symptoms after recovery from the acute infection. Long COVID refers to this specific condition and is associated with diverse symptoms, such as fatigue, myalgias, dyspnea, headache, cognitive impairment, neurodegenerative symptoms, anxiety, depression, and a sense of despair. The potential of hyperbaric oxygen therapy (HBOT) to improve chronic fatigue, cognitive impairments, and neurological disorders has been established; therefore, the use of HBOT to treat long COVID has also been studied. We conducted a literature search between 1 January 2019 and 30 October 2023, focusing on the clinical efficacy and utility of HBOT for treating long COVID and found ten clinical studies that fit the review topic, including one case report, five one-group pretest-posttest design studies, one safety report from a randomized controlled trial (RCT), and three complete reports of RCTs. Most studies found that HBOT can improve quality of life, fatigue, cognition, neuropsychiatric symptoms, and cardiopulmonary function. Although HBOT has shown some benefits for long COVID symptoms, further rigorous large-scale RCTs are required to establish precise indications, protocols, and post-treatment evaluations.

Role of Antioxidant Therapy in the Treatment and Prognosis of COVID-19: A Systematic Review and Meta-analysis of Randomized Controlled Trials

BackgroundA significant aspect of the SARS-CoV-2 pathology involves oxidative stress, characterized by an imbalance between the production of harmful free radicals and the body’s antioxidant defenses. With the ongoing evolution of SARS-CoV-2, the investigation into non–virus-specific therapeutic options, such as antioxidant therapy, has gained importance. ObjectivesThis systematic review and meta-analysis aimed to summarize data from randomized control trials (RCTs) to evaluate the effectiveness and safety of antioxidant therapy in patients with SARS-CoV-2 infection. MethodsWe searched the peer-reviewed indexed literature on MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, EMBASE, International Pharmaceutical Abstracts, and Scopus, from inception to July 2023. ResultsThe search identified 3306 articles from which 25 were included for quantitative synthesis, with 5 studies eligible for meta-analysis. Antioxidant therapies included zinc, vitamin A, vitamin C, and combination treatments. Zinc interventions showed mixed results regarding intensive care unit admissions and hospital stays. Vitamin A studies indicated improvements in inflammatory markers. Vitamin C studies displayed inconsistent effects on clinical improvement and hospitalization. Combination treatments suggested benefits in symptom clearance and cytokine storm reduction. Meta-analysis of vitamin C studies found no significant difference in C-reactive protein concentrations (−0.50; 95% CI: −3.63, 2.63; I2 = 0%), intensive care unit stay duration (pooled mean difference: 1.44; 95% CI: 0.07, 2.81; I2 = 0%), or mortality (pooled odds ratio: 0.55; 95% CI: 0.28, 1.09; I2 = 0%), with a slight trend favoring reduced hospitalization duration (pooled mean difference: −2.37; 95% CI: −2.99, −1.76; I2 = 49%). Of the 25 studies, 8 were high quality with low bias, 6 had some concerns, and 11 were low quality with high bias. ConclusionsThe review presents mixed efficacy of antioxidant therapies for SARS-CoV-2, with some studies indicating potential benefits. Further well-designed large-scale RCTs are warranted to determine the definitive role of antioxidants in SARS-CoV-2 treatment.This systematic review was registered at PROSPERO as CRD42023430805.

Health coaching intervention with or without the support of an exercise buddy to increase physical activity of people with chronic low back pain compared to usual care: a feasibility and pilot randomised controlled trial

BackgroundExercise buddies (people to exercise together with) might support people with low back pain (LBP) to become active. However, involving buddies in randomised controlled trials (RCT) might challenge recruitment, data collection and follow-up. ObjectivesTo explore the feasibility of the intervention, recruitment and data collection approaches and potential effects of a health coaching intervention (focused on physical activity) with or without exercise buddies’ support on physical activity of people with chronic LBP versus usual discharge care. DesignFeasibility and pilot RCT. MethodsAdults (n = 30) discharged from LBP treatment were randomised to the Buddy-Assisted (health coaching intervention with exercise buddy's support), Individual-Only (health coaching only), or usual care groups. Data were collected at baseline, three and six months. The feasibility of trial's procedures was assessed through recruitment rate (acceptable if >70%), data completion rate (acceptable if ≤ 20% missing data), and follow-up rate (successful if ≥ 85%). The intervention's acceptability was assessed via feedback questionnaires. Preliminary effects on physical activity and other outcomes were also explored. ResultsRecruitment and baseline data completion were acceptable. However, data collection and follow-up rates post-randomisation were not. 85% of the Buddy-Assisted Group believed the buddies helped them to increase physical activity and would recommend the intervention. 70% of the Individual-Only and Control groups believed exercise buddies would help them to become further active. ConclusionThe data collection and follow-up approaches were not successful and need amending before a large-scale RCT. Nonetheless, the buddy-assisted intervention was well-accepted. A future RCT will focus on differences in clinical outcomes. Trial registrationThe study was registered at the Australian New Zealand Clinical Trial Registry (ACTRN12620001118998).

Efficacy of Angiotensin Receptor-Neprilysin Inhibitor and Its Renal Outcome in Heart Failure Patients: A Systematic Review of Randomized Clinical Trials.

Heart failure (HF) is a major cause of morbidity and mortality and imposes a significant financial burden on healthcare systems globally. Angiotensin receptor-neprilysin inhibitor (ARNI), a novel neuroendocrine inhibitor, is frequently used in treating HF. However, there is still limited understanding regarding how it compares to other neuroendocrine inhibitors, such as angiotensin-converting enzyme inhibitors (ACEis) and angiotensin receptor blockers (ARBs). The purpose of this research is to present the most recent data regarding the efficacy and renal impact of ARNIs in the treatment of HF in comparison to ACE inhibitors and ARBs. Several large-scale randomized controlled trials (RCTs) have recently been conducted to evaluate the benefits of this drug in patients with different types of HF, regardless of their renal status. We searched multiple databases, including PubMed, PubMed Central (PMC), and Google Scholar, to find relevant RCTs. The efficacy outcome was a composite of the rate of death from cardiovascular causes, the frequency of HF hospitalizations (HFH), and alterations in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. The renal outcome was impairment of renal function. This systematic review analyzed large-scale RCTs involving 17,327 participants, with an average follow-up time of approximately 2.9 years. sacubitril/valsartan showed notable improvements compared to ACEis and ARBs in the following areas: reduction in NT-proBNP levels, prevention of further deterioration in renal function, and decreased hospitalizations for HF. Interestingly, there is no increased risk of mortality from cardiovascular causes with sacubitril or valsartan.

The efficacy of gastric aspiration in reducing postoperative vomiting after oral and maxillofacial surgery: A meta-analysis.

Gastric aspiration is applied in oral and maxillofacial procedures to reduce postoperative vomiting (POV), yet its clinical benefit remains largely uncertain. Our study aimed to determine the role of gastric aspiration in the amelioration of POV by a meta-analysis. With adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, global recognized databases, including PubMed, Embase, and Cochrane Central, were searched to obtain randomized controlled trials (RCTs) investigating the effects of gastric aspiration in oral and maxillofacial surgery. The incidence and the number of episodes of POV and the frequency of rescue antiemetic use were extracted as parametric data for pooled estimation. Funnel plots and Egger's test were utilized to assess bias. The recommendation of evidence was rated by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. After detailed evaluation, 5 RCTs containing 274 participants were eventually included. The results of pooled estimation indicated that gastric aspiration could not reduce the incidence of POV (risk ratio [95% CI] = 0.94 [0.73, 1.21], P = .621), the number of episodes of POV (standard mean difference [95% CI] = -0.13 [-0.45, 0.19], P = .431) or the frequency of rescue antiemetic use (RR [95% CI] = 0.86 [0.49, 1.52], P = .609). No publication bias was detected by the funnel plot and Egger test. The overall recommendation of evidence was rated low regarding each outcome. Based on current evidence, gastric aspiration is not recommended for oral and maxillofacial surgery. Meanwhile, more large-scale high-quality RCTs are needed.