Effect of Xingnao-Jianshen granules in treating AIS patients:study protocol for a non-randomized controlled intervention trial

Objective:Acute ischemic stroke(AIS)is characterized by high morbidity and high mortality.In recent years,complementary and alternative medicine has gradually been widely accepted and applied.At present,traditional Chinese medicine therapy and standard treatments are used for the treatment of AIS.Xingnao-Jianshen prescriptions(XNJS)is an effective prescription for the clinical treatment of AIS,but there is a lack of large-scale clinical evidence to confirm its clinical efficacy.Therefore,our team designed this protocol to evaluate the initial therapeutic effect of XNJS.Methods:The protocol for a non-randomized controlled trial is designed in which 72 eligible patients will be allocated to one of two groups.The control group(n=36)will receive standard treatment for AIS,the test group(n=36)will receive XNJS and standard treatment.Patients will be recruited after stroke onset and will receive the intervention continuously over 10±1 days,with a follow-up period of 90 days.The primary outcome will be the change in the NIHSS,BI,mRS scores.All outcome measures will be assessed at inception,after the intervention(10±1 days),and at the follow-up(90 days).The results will be disseminated to the public through peerreviewed journals and academic conferences.Discussion:The study will provide evidence of the preliminary effects.

Lessons learned from the TIMI trials in rescue interventions for elderly patients after failed fibrinolytic therapy:look beyond the TIMI flow

In ST-segment elevation myocardial infarction (STEMI), acute reperfusion of the infarct-related artery (IRA)is the main goal in the early minutes after the patient seeks medical attention. Fibrinolytic therapy (FT) and/or primary coronary intervention (PCI) were proven to be effective in opening the IRA.

Determination of serum biomarkers in osteoarthritis patients：a previous interventional imaging study revisited

To evaluate in an interventional trial on knee osteoarthritis（OA） the level and change of two serum biomarkers and their correlation with imaging parameters.The previously reported interventional OA study（ClinicalTrials.gov：NCT00536302） identified a positive effect of collagen hydrolysate（CH） on cartilage morphology in patients with knee OA using delayed gadolinium enhanced magnetic resonance imaging（dGEMRIC）.It was the objective in this research project to evaluate in an interventional clinical trial on knee OA the level and change of two serum biomarkers and their correlation with imaging parameters.In blood samples of study participants,we determined the concentration of procollagen type II N-terminal propeptide（PIIANP） and aggrecan chondroitin sulfate 846 epitope（CS846） at baseline（BL） and at the follow-up（FU） visits at 24 and 48 weeks.We measured the level and change of biomarker concentrations in both study groups,and the correlation of those changes with changes in dGEMRIC.For the biomarker PIIANP,we observed a significantly greater increase in the CH group（29.9%vs.1.2%at week 24,P =0.001）.For CS846,the mean concentration was lower among the CH treated participants at 24 weeks（78%vs.96%,P= 0.045）.Consistent correlations of changes in biomarkers PIIANP and CS846 with changes of the dGEMRIC score could not be observed.In this study,different changes per treatment group,CH and placebo were seen for dGEMRIC and PIIANP BL to 24 weeks FU,but only weak correlations between changes in dGEMRIC and biochemical markers.

Helicobacter pylori eradication for primary prevention of gastric cancer:progresses and challenges

Gastric cancer remains a significant global health challenge,causing a substantial number of cancer-related deaths,particularly in China.While the exact causes of gastric cancer are still being investigated,Helicobac-ter pylori(H.pylori)infection has been identified as the primary risk factor,which triggers chronic inflammation and a multistage progression of gastric lesions that may lead to carcinogenesis over a long latency time.Since the 1990s,numerous efforts have focused on assessing the effectiveness of H.pylori eradication in preventing new cases of gastric cancer among both the general population and patients who have undergone early-stage cancer treatment.This body of work,including several community-based interventions and meta-analyses,has shown a reduction in both the incidence of and mortality from gastric cancer following H.pylori treatment,alongside a decreased risk of metachronous gastric cancer.In this review,we seek to consolidate current knowledge on the effects of H.pylori treatment on gastric cancer prevention,its systemic consequences,cost-effectiveness,and the influence of antibiotic resistance and host characteristics on treatment outcomes.We further discuss the potential for precision primary prevention of H.pylori treatment and comment on the efficient implementation of test-and-treat policies and allocation of health resources towards minimizing the burden of gastric cancer globally.

The Impact of an eLearning Course on Nurses’Attitudes towards Mental Illness

Patients with mental illness are stigmatized. Health care professionals may even perpetuate stigma towards mental illness. Thus it is important to ensure that health care professionals have positive attitudes towards patients with mental illness. The aim of this study was to estimate the impact of an eLearning course on psychiatric nurses’ attitudes towards mental illness. A cluster-randomized trial (ISRCTN32869544) design was used. Twelve wards were randomly assigned to the eLearning course (ePsychNurse.Net) group or the education as a usual group. The participants (N = 228) were allocated to the intervention (n = 115) or control group (n = 113) according their baseline ward affiliation. Attitudes were rated according to the Community Attitude towards the Mentally Ill scale. Both groups were found to have positive, not stigmatized attitudes towards mental illness. No statistically significant changes were found at three-month or nine-month follow-up. It may be that by developing the ePsychNurse.Net course to include more material related to nurses’ attitudes and as nurses become more familiar with eLearning, the course may be effective in shaping nurses’ attitudes towards mental illness. On the other hand, our study’s nine- month time span may have been too short to change nurses’ attitudes.

Diet,H pylori infection and gastric cancer:Evidence and controversies

Despite decreasing incidence and mortality rates, gastric cancer (GC) still remains the fourth most common cancer and the second most common cause of cancer-related deaths worldwide. Due to the limited treatment options, at present, prevention is likely to be the only effective means of controlling this disease. The success of a prevention strategy depends upon the understanding of etiological and pathogenic mechanisms underlying gastric carcinogenesis. The etiology of GC is multi-factorial, however, in the recent years, mounting evidence suggests that environmental factors play a key role. The most important environmental factors implicated in the pathogenesis of GC are diet and H pylori infection. Thus, modifications in lifestyle and dietary habit associated with eradication of H pylori infection could hypothetically represent the most promising potential targets for GC prevention. In this review we will address the evidence and the controversies on the role of these agents in noncardia GC by focusing on retrospective and prospective observational studies and interventional trials.

Neuroflament light and heterogeneity of disease progression in amyotrophic lateral sclerosis:development and validation of a prediction model to improve interventional trials

Background:Interventional trials in amyotrophic lateral sclerosis(ALS)sufer from the heterogeneity of the disease as it considerably reduces statistical power.We asked if blood neuroflament light chains(NfL)could be used to antici‑pate disease progression and increase trial power.Methods:In 125 patients with ALS from three independent prospective studies-one observational study and two interventional trials-we developed and externally validated a multivariate linear model for predicting disease pro‑gression,measured by the monthly decrease of the ALS Functional Rating Scale Revised(ALSFRS-R)score.We trained the prediction model in the observational study and tested the predictive value of the following parameters assessed at diagnosis:NfL levels,sex,age,site of onset,body mass index,disease duration,ALSFRS-R score,and monthly ALSFRS-R score decrease since disease onset.We then applied the resulting model in the other two study cohorts to assess the actual utility for interventional trials.We analyzed the impact on trial power in mixed-efects models and compared the performance of the NfL model with two currently used predictive approaches,which anticipate disease progression using the ALSFRS-R decrease during a three-month observational period(lead-in)or since disease onset(ΔFRS).Results:Among the parameters provided,the NfL levels(P<0.001)and the interaction with site of onset(P<0.01)contributed signifcantly to the prediction,forming a robust NfL prediction model(R=0.67).Model application in the trial cohorts confrmed its applicability and revealed superiority over lead-in andΔFRS-based approaches.The NfL model improved statistical power by 61%and 22%(95%confdence intervals:54%-66%,7%-29%).Conclusion:The use of the NfL-based prediction model to compensate for clinical heterogeneity in ALS could signif‑cantly increase the trial power.NCT00868166,registered March23,2009;NCT02306590,registered December 2,2014.

Impact Evaluation of CONSORT and STRICTA Guidelines on Reporting Quality for Randomized Controlled Trials of Acupuncture Conducted in China

Objective： To evaluate and compare the reports＇ qualities of acupuncture randomized controlled trials （RCTs） conducted in China before and after the implementation of two guidelines, i.e., the Consolidated Standards of Reporting Trials （CONSORT） statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture （STRICTA）. Methods： Proportions of studies that reported CONSORT and STRICTA items were compared for the years before and after implementation of these two guidelines. In addition, the total score of each item＇s reporting were calculated and reported differences during different date ranges were compared. Results： For CONSORT items （maximum score 8）, there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined （2.5 ± 0.6） and 2004-2006 and 2009-2010 combined （3.0 ± 0.9; difference 0.4, 95% confidence interval, 0.3 to 0.6, P〈0.01）. For STRICTA items （maximum score 17）, there was evidence that a slight improvement in reporting between 1994-1995 and 1999-2000 combined （8.6±2.1） and 2004-2005 and 2009-2010 combined （10.1 ±1.8; difference 1.5, 95% confidence interval, 1.1 to 1.9, P〈0.01）. Conclusion： Quality of reporting for RCTs of acupuncture treatment conducted in China have generally improved since the introduction of the STRICTA and CONSORT guidelines.