Objective To appraise the current situation of randomized controlled trials (RCTs) on information of common-used digestive-related medicines afforded by medicine-salesmen. Methods RCTs on digestive-related medicines were assessed according to clinical epidemiologic standard. Results 60 medicines containing 252 therapeutic articles were searched and 75 RCTs were identified and assessed. Conclusion The qualities and quantities of RCTs of information on digestive-related medicines were of large difference, the RCTs afforded by the joint pharmaceutical enterprises are much better than those of foreign ones and domestic ones.
Background Acute pancreatitis is one of the most severe acute abdominal conditions. Recently with the understanding of pathophysiology and pathogenesis of acute pancreatitis, cytokines, especially platelet-activating factor (PAF), have been shown to play an important role. Lexipafant is a potent inhibitor of PAF. It has shown exiting results in the animal experiments, so randomized controlled studies are needed to assess the impact of lexipafant for acute pancreatitis. Objectives To determine whether lexipafant can alter the course, prevent or treat organ failure and reduce mortality in acute pancreatitis. Search strategy Electronic databases were searched and reference lists from included studies were also handsearched. Published abstracts from conference proceedings and ten kinds of Chinese medical journals were handsearched for additional citations. Personal contaction with colleagues and experts in the field of pancreatitis was performed to identify potentially relevant trials. Selection criteria Randomized, controlled trials, In which participants went in hospital within 72 hours of belliache episode, comparing lexipafant to placebo or other interventions on organ failure rate or mortality of acute pancreatitis. Data collection and analysis Data related to the clinical outcomes were extracted by two reviewers independently, if there was any divarication, they would have a discussion. Main Results Three studies meet the inclusion criteria up to 2001. Compared with control group, lexipafant had the tendency of reducing the early deaths (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.23 to1.38, P=0.2), accelerating the recovery of organ failure (OR 0.40, 95%CI 0.12 to 1.32, P=0.13) and reducing the occurrence of new organ failure OR 0.34, but these results had no statistical significance. A large-scale multicentre randomized controlled trial including 1 500 patients has been completed in America, but the result has not been published. Reviewers’ Conclusions Current evidence couldn’t draw the final conclusion. So the large-scale of randomized controlled trials is required.
The randomized controlled trial is the best evidence in the evidence-based medicine. The cardiovascular disease internal department is the typical example of the evidence-based medicine. A serial large-scale randomized controlled trials provided the evidence and improved clinical treatment level. For normal development of a large-scale randomized controlled trials need to enhance the standard management.
Cardiac surgery presents specific challenges in conducting randomized controlled trials (RCTs). The American Heart Association made a scientific statement of methodological standards, with the purpose to review key concepts and standards in design, implementation, and analysis of cardiac surgery RCTs, and to provide recommendations. Recommendations include an evaluation of the suitability of the research question, clinical equipoise, feasibility of enrolling a representative patient cohort, impact of practice variations on the effect of the study intervention, likelihood and impact of crossover, and duration of follow-up. Trial interventions and study end points should be predefined, and adequate deliverability of the trial interventions should be ensured. Every effort must be made to keep a high completeness of follow-up. Trial design and analytic techniques must be tailored to the specific research question and trial setting. In this paper, the authors made an interpretation of this scientific statement based on their practical experience.
Objective To evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with transurethral resection of bladder tumor (TURBT) for muscle-invasive bladder cancer (MIBC). Methods China National Knowledge Infrastructure, Chongqing VIP, Wanfang, SinoMed, PubMed, Web of Science, and Cochrane Library were searched from the establishment of databases until December 2023. All randomized controlled trials of TACE combined with TURBT for MIBC were collected and subjected to meta-analysis using RevMan 5.4 software. Results A total of 7 studies were included, involving 490 patients, with 246 in the TACE+TURBT group and 244 in the TURBT group. The meta-analysis results showed that compared with TURBT, TACE+TURBT had certain advantages in reducing recurrence rate [relative risk (RR)=0.49, 95% confidence interval (CI) (0.35, 0.68)], improving survival rate [RR=1.16, 95%CI (1.07, 1.27)], shortening surgical time [standardized mean difference (SMD)=−4.97, 95%CI (−7.54, −2.40)], reducing intraoperative bleeding [SMD=−4.19, 95%CI (−5.78, −2.60)], and improving quality of life [SMD=4.51, 95%CI (2.15, 6.86)]. The adverse reactions of the two groups were similar. Conclusions Existing evidence suggests that TACE may reduce intraoperative bleeding and shorten surgical time to help achieve maximum TURBT. TACE combined with TURBT may be superior to simple TURBT in terms of tumor recurrence rate and survival rate. TACE combined with TURBT can benefit MIBC patients in bladder-preserving treatment plans.
ObjectivesTo systematically review the efficacy and safety of mechanical thrombectomy for patients with acute ischemic stroke in different ages.MethodsPubMed, EMbase, The Cochrane Library, Web of Science, CNKI, and WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) on the efficacy and safety of mechanical thrombectomy for patients with acute ischemic stroke in different ages from inception to August, 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, meta-analysis was performed by using Stata 12.0 software.ResultsA total of 13 studies involving 2 995 patients were included. The results of meta-analysis showed that compared with the control group, patients aged 80 and above had no statistically significant difference in reperfusion success rates (OR=0.90, 95%CI 0.71 to 1.14, P=0.378), and incidence of symptomatic intracranial hemorrhage (OR=1.30, 95%CI 0.86 to 1.94, P=0.212), however, with higher incidence of arbitrary intracranial bleeding events (OR=1.61, 95%CI 1.28 to 2.04, P<0.001), 3-month mortality (OR=2.14, 95%CI 1.73 to 2.64, P<0.001) and lower good functional prognosis rate at 3 months (OR=0.46, 95%CI 0.30 to 0.71, P<0.001).ConclusionsCurrent evidence suggests that people aged 80 and above can obtain effective perfusion through mechanical thrombectomy, however, the incidence of postoperative adverse outcome events is higher and the prognosis is relatively poor. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
Objective To conduct a meta-analysis of the evidence on the efficacy and safety of hyperbaric oxygen therapy for vascular cognitive impairment. Methods China National Knowledge Infrastructure, Chongqing VIP, Wanfang, SinoMed, PubMed, Embase, CINHAL, Cochrance Library were searched for all literatures on randomized controlled trials of hyperbaric oxygen therapy for vascular cognitive impairment from the establishment of databases to May 2022. Literature screening was performed by Endnote X9 software, and meta-analysis was performed by RevMan 5.4.1 software. Results A total of 36 papers were included, with 3093 patients, including 1549 cases in the observation group (hyperbaric oxygen combined with drug treatment) and 1544 cases in the control group (drug treatment alone). Compared with the control group, the effective rate of the observation group [relative risk=1.23, 95% confidence interval (CI) (1.15, 1.30), P<0.00001], the scores of Mini Mental Status Examination [mean difference (MD)=3.19, 95%CI (2.66, 3.73), P<0.00001], and the scores of Montreal Cognitive Assessment [MD=2.98, 95%CI (2.07, 3.89), P<0.00001] were better than those of the control group. There was no significant difference in adverse reactions between the observation group and the control group (P>0.05). For the scores of Activities of Daily Living, subgroup analysis showed high heterogeneity among studies, so pooled analysis was not performed. Conclusion Compared with drug therapy alone, hyperbaric oxygen combined with drug therapy can improve the cognitive function of patients with vascular cognitive impairment to a certain extent without increasing adverse reactions.
In the study of real-world data, the pragmatic randomized controlled trial can provide the optimal evidence for clinical decisions. Although randomization protects against confounding, post-randomization confounding may still arise due to non-compliance. Traditional intention-to-treat analysis will drift apart from true estimation and lead to deviation of clinical decisions. Meanwhile, the alternative traditional methods would subject to bias and confounding. Thus, new methods are required for revolution, i.e., instrument variable method and modern per-protocol analysis. Our study reviews the defects of traditional methods in pragmatic randomized controlled trials, and then refers to two new methods with a detailed discussion of strengths and weaknesses. We aim to provide researches with insights on choosing the statistical methods for pragmatic trial.
ObjectivesTo collect the methodology and original articles on the published cohort multiple randomized controlled trial (cmRCT), and evaluate the development and application of cmRCT.MethodsPubMed, EMbase, CNKI, WanFang Data and CBM databases were electronically searched to collect studies on cmRCT from inception to September 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then qualitative analysis was conducted.ResultsA total of 21 studies were enrolled, including 5 original studies and 16 methodology studies. The design of cmRCT was proposed in year 2010 and continuous progress was observed, including aspect of informed consent and statistical analysis, etc. This design has been mainly utilized for chronic diseases (oncology etc.) in Europe; most of these ongoing studies were unpublished. However, to our knowledge, there were none published Chinese original studies or protocols using cmRCT design.ConclusionscmRCT design has been continuously developed and applied since its introduction. This design can be considered in Chinese studies based on Chinese large cohorts to provide more evidence for disease prevention and treatment.
To address the persistent challenges in surgical clinical research, we provide a comprehensive analysis of the series of articles on randomized controlled trials (RCTs) methodology guidance published in JAMA Surgery from 2022 to 2023. This section contents focus on critical aspects of RCTs, including trial design, selection criteria, ethical considerations, quality control, budgeting, and funding support. The objective is to enhance the understanding of RCTs among researchers, particularly surgeons, thereby guiding them in conducting high-quality and scientifically robust RCTs.