Objective To evaluate the current situation of randomized controlled trials/ clinical controlled trials (RCT/CCT) on chronic gastritis and whether it could offer reliable evidence for clinical practice in China. Method RCT/CCT on chronic gastritis from eight Chinese clinical journals were searched manually and assessed according to international standard. Results 823 issues containing 213 therapeutic articles were searched and 81 RCT/CCT were identified and assessed. Conclusions The quantity and quality of RCT/CCT on Chronic gastritis in China could not meet the need of clinical practice. RCT/CCT of western medical therapy are much better than those of traditional Chinese therapy and integrated traditional Chinese and western medical therapy 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.
ObjectiveTo systematically review efficacy of endoscopic ultrasonography guided biliary drainage (EUS-BD) and percutaneous transhepatic biliary drainage (PTBD) on patients with malignant obstructive jaundice.MethodsThe PubMed, EMbase, The Cochrane Library, CBM, WanFang Data, and CNKI were searched online to collect the randomized controlled trials or cohort studies of EUS-BD versus PTBD on the patients with malignant obstructive jaundice from inception to November 30, 2018. Two reviewers independently screened the literatures, extracted the data and assessed the risk of bias of included the studies, then the meta-analysis was performed by using the RevMan 5.3 software.ResultsThree randomized controlled trials and 6 cohort studies involving 496 patients were included. The results of meta-analysis showed that: compared with the PTBD, the EUS-BD had the lower occurrence of complications [OR=0.30, 95% CI (0.20, 0.47), P<0.000 01], lower rate of reintervention [OR=0.11, 95% CI (0.06, 0.22), P<0.000 01], shorter hospital stay [MD=–3.42, 95% CI (–6.72, –0.13), P=0.04], and less hospital costs [SMD=–0.83, 95% CI (–1.16, –0.49), P<0.000 01]. There were no significant differences in the technical success rate [OR=0.88, 95% CI (0.20, 3.85), P=0.86] and clinical effective rate [OR=1.73, 95% CI (0.97, 3.11), P=0.06] between the two groups.ConclusionsCurrent evidence shows that EUS-BD has some advantages of lower occurrence of complications, lower rate of reintervention, shorter hospital stay, and less hospital costs in treatment of patients with malignant obstructive jaundice as compared with PTBD. There are no significant differences between two groups in technical success rate and clinical effective rate. Due to limited quality and quantity of included studies, more high quality studies required to be verified above conclusions.
ObjectiveTo investigate the efficacy and safety of multiple-dose intravenous tranexamic acid (TXA) for reducing blood loss in complex tibial plateau fractures with open reduction internal fixation by a prospective randomized controlled trial. MethodsA study was conducted on patients with Schatzker type Ⅳ-Ⅵ tibial plateau fractures admitted between August 2020 and December 2022. Among them, 88 patients met the selection criteria and were included in the study. They were randomly allocated into 3 groups, the control group (28 cases), single-dose TXA group (31 cases), and multiple-dose TXA group (29 cases), using a random number table method. There was no significant difference (P>0.05) in terms of age, gender, body mass index, the Schatzker type and side of fracture, laboratory examinations [hemoglobin (Hb), activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fib), international normalized ratio (INR), D-dimer, and interleukin 6 (IL-6)], and preoperative blood volume. The control group received intravenous infusion of 100 mL saline at 15 minutes before operation and 3, 6, and 24 hours after the first administration. The single-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at 15 minutes before operation, followed by an equal amount of saline at each time point after the first administration. The multiple-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at each time point. The relevant indicators were recorded and compared between groups to evaluate the effectiveness and safety of TXA, including hospital stays, operation time, occurrence of infection; the occurrence of lower extremity deep vein thrombosis, intermuscular vein thrombosis, and pulmonary embolism at 1 week after operation; the lowest postoperative Hb value and Hb reduction rate, the difference (change value) between pre- and post-operative APTT, PT, Fib, and INR; D-dimer and IL-6 at 24 and 72 hours after operation; total blood loss, intraoperative blood loss, hidden blood loss, drainage flow during 48 hours after operation, and postoperative blood transfusion. Results ① TXA efficacy evaluation: the lowest Hb value in the control group was significantly lower than that in the other two groups (P<0.05), and there was no significant difference between the single- and multiple-dose TXA groups (P>0.05). The Hb reduction rate, total blood loss, intraoperative blood loss, drainage flow during 48 hours after operation, and hidden blood loss showed a gradual decrease trend in the control group, single-dose TXA group, and multiple-dose TXA group. And differences were significant (P<0.05) in the Hb reduction rate and drainage flow during 48 hours after operation between groups, and the total blood loss and hidden blood loss between control group and other two groups. ② TXA safety evaluation: no lower extremity deep vein thrombosis or pulmonary embolism occurred in the three groups after operation, but 3, 4, and 2 cases of intermuscular vein thrombosis occurred in the control group, single-dose TXA group, and multiple-dose TXA group, respectively, and the differences in the incidences between groups were not significant (P>0.05). There was no significant difference in the operation time between groups (P>0.05). But the length of hospital stay was significantly longer in the control group than in the other groups (P<0.05); there was no significant difference between the single- and multiple-dose TXA groups (P>0.05). ③ Effect of TXA on blood coagulation and inflammatory response: the incisions of the 3 groups healed by first intention, and no infections occurred. The differences in the changes of APTT, PT, Fib, and INR between groups were not significant (P>0.05). The D-dimer and IL-6 in the three groups showed a trend of first increasing and then decreasing over time, and there was a significant difference between different time points in the three groups (P<0.05). At 24 and 72 hours after operation, there was no significant difference in D-dimer between groups (P>0.05), while there was a significant difference in IL-6 between groups (P<0.05). Conclusion Multiple intravenous applications of TXA can reduce perioperative blood loss and shorten hospital stays in patients undergoing open reduction and internal fixation of complex tibial plateau fractures, provide additional fibrinolysis control and ameliorate postoperative inflammatory response.
Randomized controlled trials (RCTs) are the gold standard for the design of clinical trials. Because of some practical difficulties, more and more researchers think that the appropriate use of non-randomized controlled trials may make up for the weakness of RCT and will achieve the same research purpose. Therefore, non-RCTs are also very important. Taking studies on multiple sclerosis for example, this article briefly introduces the significance of non-randomized contolled trials.
Objective To systematically evaluate the effect of psychological intervention on the survival outcome of breast cancer patients. Methods PubMed, Web of Science, China National Knowledge Infrastructure, Wanfang, Chongqing VIP were searched by computer. The search time ranged from the establishment of the databases to December 31, 2024. Randomized controlled trials of psychological intervention related to breast cancer were searched, and the studies that met the criteria were qualitatively described and meta-analyzed. Results A total of 11 randomized controlled trials were included. Meta-analysis included five studies, and the results showed that the survival rate of breast cancer patients receiving psychological intervention had no significant difference compared with breast cancer patients receiving only conventional treatment (P＞0.05). Meta-analysis of 3 studies involving early and middle stage breast cancer patients showed that there was no significant difference in survival rate between breast cancer patients receiving psychological intervention and breast cancer patients receiving only conventional treatment (P＞0.05). The qualitative analysis of the impact of psychological intervention on the survival of breast cancer patients showed that 3 studies found that psychological intervention could improve the survival of breast cancer patients, and the main outcome was to prolong the median survival or average survival. ConclusionsQualitative analysis shows that psychological intervention may improve the survival period of breast cancer patients. Due to the limited number of included studies and small sample size, the meta-analysis results failed to provide sufficient evidence that psychological intervention can improve the survival outcome of breast cancer, and this result needs further verification.
ObjectiveTo compare the postoperative enhanced recovery outcomes of lobectomy performed under non-intubated video-assisted thoracic surgery (NIVATS) versus intubated video-assisted thoracic surgery (IVATS). Methods Computerized searches were performed in the following databases: China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP Information, China Biomedical Literature Database (CBMdisc), Web of Science, Clinicaltrials.gov, The Cochrane Library, EMbase, and PubMed. We collected randomized controlled trials (RCTs) and observational studies comparing NIVATS and IVATS. The search period extended from the inception of each database to April 1, 2023. Two independent researchers screened the literature and assessed study quality. ResultsA total of 14 studies were included, comprising 4 RCTs, 7 retrospective cohort studies, and 3 propensity score matching studies, involving 1 840 patients. Meta-analysis results indicated that, compared to IVATS, NIVATS was associated with significantly shorter operative time [MD=–13.39, 95%CI (–20.16, –6.62), P<0.001], shorter length of hospital stay [MD=–0.81, 95%CI (–1.39, –0.22), P=0.005], shorter chest tube duration [MD=–0.73, 95%CI (–1.36, –0.10), P=0.02], shorter postoperative anesthesia recovery time [MD=–20.34, 95%CI (–26.83, –13.84), P<0.001], and shorter time to oral intake after surgery [MD=–5.68, 95%CI (–7.63, –3.73), P<0.001]. Furthermore, NIVATS showed a lower incidence of postoperative airway complications [OR=0.49, 95%CI (0.34, 0.71), P<0.001] and less total chest tube drainage volume [MD=–251.11, 95%CI (–398.25, –103.98), P<0.001], all contributing to significantly accelerated postoperative enhanced recovery for patients. Conclusion NIVATS is a safe and technically feasible anesthesia method in thoracoscopic lobectomy, which can to some extent replace IVATS.
In the late-breaking trials session of the American Heart Association’s Scientific Sessions 2021, which took place in November 2021, six clinical trials in cardiac surgery published their primary results. This review will look into three of them including the management of patients with moderate or less-than-moderate tricuspid regurgitation at the time of surgery for degenerative mitral regurgitation, timing of ticagrelor cessation before coronary artery bypass grafting, and long-term outcomes of ticagrelor-based antiplatelet therapy for secondary prevention of coronary artery bypass grafting.
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 systematically review the effectiveness and safety of cordyceps sinensis for chronic obstructive pulmonary diseases (COPD). Methods We electronically searched databases including CBM, CNKI, WanFang Data, VIP, PubMed, Cochrane Central Register of Controlled Trials (Issue 7, 2013) and EMbase for randomized controlled trial (RCT) and quasi-RCTs on the effectiveness and safety of cordyceps sinensis for COPD. According to Cochrane methods, two reviewers independently screened literature, extracted data, assessed methodological quality. Then, meta-analysis was performed using RevMan 5.2 software. Results Fourteen quasi-RCTs involving 1 162 patients were included. The results of meta-analysis showed that: a) compared with routine treatment alone, cultured cordyceps sinensis in combination of routine treatment improved total effective rates (stationary stage: RR=1.33, 95%CI 1.14 to 1.54, P=0.000 3; advanced period: RR=1.36, 95%CI 1.14 to 1.62, P=0.000 8). Also cultured cordyceps sinensis in combination of routine treatment improved lung function (FEV1/FVC: MD=5.48, 95%CI 3.22 to 7.74, Plt;0.000 01; FEV1%: MD=3.75, 95%CI 0.91 to 6.59, P=0.010), and prolonged exercise duration (MD=43.51, 95%CI 27.66 to 59.36, Plt;0.000 01) for COPD patients in stationary stage. However, no evidence was found in blood gas analysis, immune function, and quality of life; and b) the results of one study showed that, cultured cordyceps sinensis in combination of routine treatment was comparable with immune regulator (BCG-PSY) in combination of routine treatment with regards to total effective rates, but it could better improve lung function of patients. Conclusion Current evidence suggests that cultured cordyceps sinensis is effective in treating COPD, especially in treating lung function and exercise duration of COPD patients in stationary stage and increasing total effective rates. However, the strength of evidence is affected by poor methodological quality of the included studies. High-quality trials with large sample size are needed to verify its clinical effects.