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 in Europe; most of these ongoing studies were unpublished.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.
Objective To assess the effectivess and safety of Shenkang capsule in the treatment of chronic glomerulonephritis （Qiyinliangxu Syndrome）. Methods A double blind, double dummy and randomized controlled method was adopted. A total of 96 patients were randomized to the treatment group （Shenkang capsule, 2 capsules, twice a day） and the control group （Shenyankang capsule, 2 capsules, twice a day）. The therapeutic course for both groups was 2 months. Results All the results were analyzed on the basis of retention-to-treat（ITT） and per-protocol-population （PP）. For effect of chronic glomerulonephritis in the treatment group, the clinical control rates were 12.86% （9/70） with ITT analysis and 14. 75% （9/61） with PP analysis; the good improvement rates were 12. 86% （9/70） with ITT analysis and 14. 75% （9/61） with PP analysis; the total effective rates were 48. 58% （34/70） and 55.73% （34/61）. In the control group, the clinical control rates were 4. 17% （1/24） with ITT analysis and 5.00% （1/20） with PP analysis respectively; the good improvement rates were 4. 17% （1/24） with ITT analysis and 5.00% （1/20） with PP analysis respectively; the total effective rates were 45. 83% （11/24） with ITT analysis and 55.00% （11/20） with PP analysis. There was no statistical difference between the two groups （P〉0.05）. For Qiyinliangxu syndrome improvement, in the treatment group, the clinical control rate and good improvement rate were 18. 57% （13/70） with ITT analysis and 21.31% （13/61） with PP analysis respectively; the total effective rates were 81.43% （57/70） with ITT analysis and 93. 44% （57/61） with PP analysis respectively; In the control group, the clinical control rate and good improvement rate were 20. 84% （ 5/24 ） with ITT analysis and 25.00% （5/20 ） with PP analysis respectively; the total effective rates were 75. 00% （18/24） with ITT analysis and 85. 00% （17/20） with PP analysis respectively. The results showed no statistical difference between the two groups （P 〉0. 05）. No adverse effects were found. Conclusions No statistical difference was detected between Shengkang capsule and Shenyan capsule groups. No obvious toxic adverse effects were found.
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 evaluate the efficacy and safety of 1 470 nm laser vaporization vs. transurethral resection of prostate (TURP) for benign prostatic hyperplasia (BPH).MethodsPubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) about the efficacy and safety of 1 470 nm laser vaporization vs. TURP for BPH from inception to October 22nd, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 6 RCTs and 4 non-RCTs were included. The results of meta-analysis showed that: 1 470 nm laser vaporization was superior to TURP in reducing intraoperative bleeding (MD=?103.87, 95%CI ?148.08 to ?59.65, P<0.000 01), hospital stay (MD=?3.82, 95%CI ?4.35 to ?3.28, P<0.000 01), postoperative indwelling catheter time (MD=?2.24, 95%CI ?3.45 to ?1.02, P=0.000 3), postoperative hemoglobin (MD=?1.63, 95%CI ?3.14 to ?0.12, P=0.03) and rate of secondary hemorrhage (OR=0.13, 95%CI 0.03 to 0.48, P=0.002). There were no significant differences in operative time, bladder irrigation time, transient urinary incontinence and urethral stricture, IPSS Score and Qmax at 3 months after operation between the two groups (P>0.05).ConclusionCurrent evidence shows that 1 470 nm laser vaporization is superior to TURP in reducing intraoperative bleeding and secondary hemorrhage. It may be more suitable for prostate surgery in anticoagulant or coagulative dysfunction patients. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
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.
Although the evidence from randomized controlled trials (RCTs) is regarded as a golden standard, it often fails to be applied in clinical practice for lack of generalizability. Evidence from either RCTs or non-RCTs is mutually complementary and referred. Different designs are suitable for different stages and can resolve different issues. During evaluation of an intervention, the proper research design should be selected in accordance with the objective, feasibility, and merits and limitations of different design modes.
Objective To assess the effect of different thrombolytic agents, and different regimens in acute ischaemic stroke. Methods A systematic review of all the relevant randomized controlled trials (RCTs) was performed. RCTs were identified from the Cochrane Stroke Group trials register, Embase (1980 to 1997), handsearching Japanese and Chinese journals, and personal contact with pharmaceutical companies. We included randomised and quasi-randomised trials in patients with confirmed acute ischaemic stroke comparing different doses of a thrombolytic agent, or different thrombolytic agent, or the same agent given by different routes. Results Eight trials involving 1 334 patients were included. Concealment of allocation was generally adequate. All the trials were conducted in Japan. Different doses (of tissue plasminogen activator or urokinase) were compared in six trials. Different agents (tissue plasminogen activator versus urokinase,or tissue-cultured urokinase versus conventional urokinase) were compared in three trials. Few data were available for functional outcomes. A higher dose of thrombolytic therapy was associated with a five-fold increase in fatal intracranial haernorrhages (odds ratio 5.02, 95% confidence interval 1.56 to 16.18). There was a non-significant trend towards more early deaths or clinically significant intracranial haemorrhages in higher dose group. No difference in late deaths or extra-cranial haemorrhages was shown between low and higher doses. However, very few of these events occurred. No difference was shown between the different thrombolytic agents tested. Conclusions There is not enough evidence to conclude whether lower doses of thrombolytic agents might be safer or more effective than higher doses in acute ischaemic stroke. It is not possible to conclude whether one agent might be better than another, or which route of administration might be best.
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 efficacy and safety of palonosetron hydrochloride injection for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately or highly emetogenic chemotherapy. Methods Searched PubMed, Embase, Web of Science, Cochrane Library, Chinese National Knowledge Infrastructure, Chinese Biological Medical Database, Wanfang Database and VIP Chinese Science and Technology Journal Database to find domestic and abroad published literatures of palonosetron used to control CINV associated with moderately or highly emetogenic chemotherapy. Two reviewers independently selected literatures, extracted data and assessed quality of the included studies by the Cochrane handbook 5.1. Meta-analysis was performed using RevMan 5.3 software. Results Twenty trials involving 4 919 patients were included. The results of meta-analysis showed statistically significant differences between palonosetron and first-generation 5-hydroxytryptamine3 receptor antagonists (5-HT3RAS) in prevention of acute〔RR=1.09, 95%CI (1.40, 1.14),P=0.000 4〕, delayed 〔RR=1.26, 95%CI (1.15, 1.37),P＜0.000 01〕, and overall phase of CINV 〔RR=1.19, 95%CI (1.10, 1.30),P＜0.000 1〕. Subgroup analyses indicated that there were no statistical significances between palonosetron and granisetron (P=0.09) or ondansetron (P=0.08) in prevention of acute CINV, as well as between palonosetron and first-generation 5-HT3RAS in prophylaxis of moderately CINV (P=0.18), while there was statistical significance in favor of palonosetron in prophylaxis of delayed and overall phase of CINV. Compared with first-generation 5-HT3RAS, there were different in prophylaxis of highly chemotherapy-induced acute〔RR=1.10, 95%CI (1.02, 1.18),P=0.01〕, delayed〔RR=1.20, 95%CI (1.06, 1.36),P=0.005〕, and overall phase〔RR=1.18, 95%CI (1.04,1.33),P=0.008〕of CINV. In terms of safety, such as headache, constipation, diarrhea and dizziness, there were no statistical differences between two groups. Conclusions Palonosetron hydrochloride injection showed efficacy in prophylaxis of moderately or highly CINV, and didn't increase adverse events. Palonosetron hydrochloride injection is more better than first-generation 5-HT3RAS, especially in prevention of highly CINV, and can significantly improve the control rate of acute, delayed, and overall phase of CINV.
To explore clinical design methods that suit the characteristics of acupuncture science, this article mainly analyzes the design features of pragmatic randomized controlled trials and the advantages and current problems in clinical research on acupuncture. We discuss the differences between pragmatic randomized controlled trials and explanatory randomized controlled trials and the application status of clinical research about acupuncture. We consider that pragmatic randomized controlled trials suit the characteristics of in clinical research on acupuncture with complicated interventions. Exploring the application of pragmatic randomized controlled trials clinical research on acupuncture is beneficial to exploring appropriate clinical research methods that suit the specific characteristics of acupuncture subject, and to objectively and comprehensively assessing clinical efficacy and safety of acupuncture.