ObjectiveTo compare the therapeutic effect of dual-chamber pacing (DDD) and ventricular single-chamber pacing (VVI) on arrhythmia via systematic evaluation. MethodsWith the method of Cochrane system evaluation, we searched Medline, Embase, CNKI, PubMed and Wanfang database (the searching time was up to June 30, 2016) for randomized controlled trials comparing DDD with VVI treatingcardiac arrhythmias. Meta analysis was performed using RevMan5.3 software. ResultsWe collected 12 randomized controlled trials of DDD and VVI pacing treating cardiac arrhythmia including 1 704 patients, but the quality of the studies were not good. The results of Meta analysis showed that:compared with VVI pacing mode, DDD pacing mode reduced the risk of atrial fibrillation[RR=0.36, 95%CI (0.22, 0.59), P < 0.000 1]; besides, it reduced the left atrial diameter[SMD=-0.43, 95%CI (-0.68, -0.17), P=0.001], the left ventricular end diastolic dimension[SMD=-0.33, 95%CI (-0.61, -0.05), P=0.02] and increased the left ventricular ejection fraction[SMD=1.03, 95%CI (0.49, 1.57), P=0.000 2]. ConclusionsComparing DDD with VVI on the treatment of cardiac arrhythmia in patients with cardiac arrhythmia, DDD pacing can reduce the incidence of atrial fibrillation and thrombosis, enhance heart function and improve blood supply. But because of the low quality of the included studies, the curative effect cannot be confirmed, and more randomized controlled trials with high quality needs to be carried out in the future.
Objective To evaluate the effectiveness and safety of early enteral nutrition (EN) versus total parenteral nutrition (TPN) after pancreaticoduodenectomy (PD). Methods Such databases as MEDLINE, EMbase, The Cochrane Library, CBM, VIP, CNKI were electronically searched to collect the randomized controlled trials (RCTs) about EN versus TPN after PD published from 2000 to March 2010. The quality of the included trials was assessed according to the inclusive and exclusive criteria, and the data were extracted and analyzed by using RevMan 5.0 software. Results A total of 4 RCTs involving 322 PD patients were included. The meta-analysis showed that the EN (the treatment group) was superior to the TPN (the control group) in the average postoperative hospital stay (MD= –2.34, 95%CI –3.91 to –0.77, Plt;0.05), the total incidence rate of complication (RR=0.75, 95%CI 0.57 to 0.99, P=0.04), the recovery time of enterocinesia (MD= –29.87, 95%CI –33.01 to –26.73, Plt;0.05) and the nutrition costs (MD= –30.51, 95%CI –35.78 to –25.24, Plt;0.05); there were no differences in mortality (RR=0.23, 95%CI 0.03 to 2.03, P=0.19), pancreatic leakage (RR=0.78, 95%CI 0.45 to 1.35, P=0.38), infectious complications (RR=0.71, 95%CI 0.43 to 1.18, P=0.19), non-infectious complications (RR=0.78, 95%CI 0.5 1 to 1.20, P=0.26) and postoperative serum albumin level (MD= –0.79, 95%CI –2.84 to 1.27, P=0.45). Conclusion Compared with total parenteral nutrition, the enteral nutrition used earlier after pancreatoduodenectomy shows significant advantages. But more reasonably-designed and double blind RCTs with large scale are expected to provide high quality proof.
ObjectivesTo systematically review the efficacy and safety of bevacizumab combined with STUPP regimen for newly diagnosed glioblastoma.MethodsPubMed, EMbase, the Cochrane Library, CBM, CNKI, VIP and WanFang Data databases were searched to obtain randomized controlled trials (RCTs) of bevacizumab combined with STUPP regimen for newly diagnosed glioblastoma patients from inception to September 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software.ResultsA total of 6 RCTs involving 2 835 patients were included. The results of meta-analysis showed that: the bevacizumab combined with STUPP regimen group was superior to the control group on PFS (HR=0.69, 95%CI 0.62 to 0.77, P<0.000 01). But the adverse events rate at the three and above three levels was significantly higher than the control group (P<0.05).ConclusionsCurrent evidence shows that bevacizumab combined with STUPP regimen for newly diagnosed glioblastoma can significantly prolong the PFS. The treatment group performs not as well as the control group on adverse event rate. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
Objective To assess the efficacy of medical expulsive therapy for ureteral calculi with tamsulosin. Methods We searched PubMed, MEDLINE, EMBASE, BIOSIS, International Pharmaceutical Abstracts (IPA) Database, The Cochrane Library and Chinese Journal Full-text Database from 1995 to September 2006, as well as the proceedings of urological scientific conferences from 2000 to 2006. Randomized controlled trials(RCTs) comparing tamsulosin and other therapies for ureteral calculi among adults were included. Data were extracted by two reviewers independently and synthesized by STATA 9.0 software. Results A total of 16 studies involving 1521 patients with distal or juxtavesical ureteral calculi were included. Compared with conservative therapy, tamsulosin showed higher expulsion rate [RR 1.50, 95%CI (1.20 to 1.87), Plt;0.0001], shorter expulsion time [SMD –1.29, 95%CI (–2.27, –0.31)] and fewer patients requiring ESWL or ureteroscopy [RR 0.40, 95%CI (0.27, 0.59), Plt;0.05]. Compared with conservative therapy, the combination of tamsulosin plus deflazacort also showed higher expulsion rate [RR 1.59, 95%CI (1.31, 1.93)], shorter expulsion time [SMD –0.8, 95%CI (–1.18, –0.42)] and fewer patients requiring ESWL or ureteroscopy [RR 0.13, 95%CI (0.06, 0.31), Plt;0.05]. Compared with deflazacort alone, the combination of tamsulosin plus deflazacort demonstrated similar expulsion rate [RR 1.31, 95%CI (0.78, 2.23), P=0.31], but significantly reduced the dosage of analgesics [SMD 15.20, 95%CI (14.98, 15.52)] and decreased the proportion of patients requiring ESWL or ureteroscopy [RR 0.09,, 95%CI (0.02, 0.47), Plt;0.05]. Compared with deflazacort plus nifedipine, the combination of tamsulosin plus deflazacort showed higher expulsion rate [RR 1.20, 95%CI (1.07, 1.35), P=0.002], but similar expulsion time [SMD –1.34, 95%CI (–3.47, 0.79)] and proportion of patients requiring ESWL or ureteroscopy [RR 0.34, 95%CI (0.05, 2.22), Pgt;0.05]. As for side effects, tamsulosin-based treatment and conservative therapy were comparable (Pgt;0.05). Conclusions Tamsulosin has a beneficial effect on the expulsion of ureteral calculi, especially for distal and juxtavesical ureteral calculi. Tamsulosin-based medical expulsive therapy at the dosage of 0.4mg daily is effective and safe for patients with distal ureteral calculi. More large-scale studies are required to define the efficacy of combination therapy of tamsulosin plus deflazacort.
Traditional randomized controlled trial and real-world study have different advantages in internal validity and external extensibility, respectively. With the development of evidence-based health decisions, randomized controlled trial was no longer the only golden standard of interventional study, the research evidence of the real world was gradually involved in health decisions. This study mainly analyzed the requirements of evidence and actual application of evidence in the evaluation of the effectiveness of NICE in the UK. It was found that NICE still used the results of randomized controlled trials as a primary basis. Although real-world research has developed rapidly in recent years, it was limited used in health decision because of its bias by design and other factors. However, in recent years, real-world evidence has played a significant role in the field of innovative drugs or diseases that lack therapeutic drugs. With the improvement of real-world research in experimental design and data analysis, it is expected that it will play a more important role in health decision-making.
Objective To assess the effectiveness and safety of Chinese medicinal herbs for female immune-caused subfertility. Methods Databases included: MEDLINE (1966-2002.2), EMBASE (1984-2002.2), CBM (1978-2002.2) and Cochrane Controlled Trial Register, CCTR (Issue 1, 2002). Reference lists of trials were handsearched. Published randomized controlled trials (RCTs) whether blind or unblind, any languages and length of follow up were included. Treatments included Chinese medicinal herbs (single or compound). Controls were placebo and western medicine, or no intervention. Data were extracted independently by two reviewers and analyzed with Revman 4.2. Results Six RCTs were included, all of which were poor in methodological quality. Because of different therapies in the treatment and control groups, we did not perform meta-analysis. The No.1 anti-immune tablet was more effective than corticosteroid plus condom during intercourse both in the pregnancy rate (RR 3.75, 95%CI 1.61 to 8.75, P=0.002) and AsAb negative rate (RR 1.66, 95%CI 1.23 to 2.22, P=0.000 8). Bushen Xiezhuo Soup was more effective than antibiotic in the pregnancy rate (RR 2.97, 95%CI 1.60 to 5.50, P=0.000 6) and antisperm antibody (AsAb) negative rate (RR 2.33, 95%CI 1.54 to 3.54, Plt;0.000 1)。Zhenqi Zhuanyin Soup was as effective as IUI in pregnancy rate (RR 1.80, 95%CI 0.58 to 5.60, P＝0.31) but more effective than IUI in AsAb negative conversion rate (RR 9.61, 95%CI 3.22 to 28.67, Plt;0.000 1), Zhenqi Zhuanyin Soup combined with IUI was more effective than IUI in pregnancy rate (RR 3.60, 95%CI 1.32 to 9.85,P=0.01) and AsAb negative rate (RR 8.92, 95%CI 2.98 to 26.75, Plt;0.000 1). Conclusions Some Chinese medicinal herbs may work well in subfertility treatment. However, the evidence is too weak to draw a conclusion for there are deficiencies in strict randomization, blinding and follow-up.More strictly designed, randomized, double-blind, placebo-controlled trials are required.
Objective To explore whether the placebo-controlled trials in traditional Chinese medicine (TCM) were scientific and ethical. Method An electronic search concerned with placebo-controlled trials of TCM was performed at Chinese Journal Full-text Database, Chinese Scientific and Technological Periodical Database (VIP), Wanfang Database and Chinese Bio-medicine Database (CBM) from January 1979 to April 2008. In addition, we handsearched the trials in specialized journals of TCM. The trials were assessed regard with their scientificalness, ethic and traits of TCM of placebo-controlled trials. Results A total of 231 trials were included, occupying about 2.09% of all the randomized controlled trials (RCTs) of TCM; among which there were 79 (34.20%) with sequence generation, 10 (4.33%) with allocation concealment, 129 (55.84%) with blind methods; 106 (45.89%)with basic intervention, 13 (5.63%) with criteria of intervention quality control, 139 (60.17%) with preparation of placebo, 10 (10.33%) with aggravating scheme, 70 (30.30%) with syndrome type of TCM, 48 (20.78%) with the outcome measurement of TCM. There were 48 RCTs (20.78%) were not scientific. There were 221 RCTs without institutional review board and 187 RCTs without informed consent. Conclusion Placebo-controlled trials of TCM are not applied extensively, and some of them are not scientific. Most of than do not meet the ethical requirements.
High-quality randomized controlled trials (RCTs) are regarded as the gold standard for assessing the efficiency and safety of drugs. However, conducting RCTs is expensive and time consumed, and providing timely evidence by RCTs for regulatory agencies and medical decision-makers can be challenging, particularly for new or emerging serious diseases. Additionally, the strict design of RCTs often results in a weakly external validity, making it difficult to provide the evidence of the clinical efficacy and safety of drugs in a broader population. In contrast, large simple clinical trials (LSTs) can expedite the research process and provide better extrapolation and reliable evidence at a lower cost. This article presents the development, features, and distinctions between LSTs and RCTs, as well as special considerations when conducting LSTs, in accordance with literature and guidance principles from regulatory agencies both from China and other countries. Furthermore, this paper assesses the potential of real-world data to bolster the development of LSTs, offering relevant researchers’ insight and guidance on how to conduct LSTs.
Objective To identify and investigate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in 11 non-key Chinese medical journals so as to learn about the current status and problems. Methods Eleven non-key medical journals of TCM from 1995 to 2000 were hand searched to identify the RCT and controlled clinical trials (CCTs). Each identified RCT or CCT was page by page verified by handsearchers based on the criteria developed by the Cochrane Handbook; the RCTs’ design, randomization method description, blind, baseline comparison, inclusion and exclusion criteria, diagnostic criteria,criteria for theraputic effectiveness, sample size, statistical method，described outcome, side effects, and follow up etc. were analyzed. Results In the related journals from 1995 to 2000, a total of 66 volumes and 390 issues were checked. As a result, 22 739 clinical studies were identified, of which 1 416 RCTs, only 24 (1.69%) were done with double blinding. There were 141 CCTs from 1995 to 2000, the total number of RCT increased from 95 to 1 416 and most of studies were on digestives diseases. Most of these studies had no detailed randomization method description, only 38 (2.68%) studies provided a methodology description. In addition, 1 220 (86.16% ) described outcome index, 1 203 (84.96%) used statistical method，934 (65.96%) had baseline comparison，828 (58.47%) described diagnostic criteria, 197 (13.91%) had inclusion and exclusion criteria，finally only 89 (6.29%) reported side effects. Conclusions Although the number of RCT has increased in the 11 non-key medical journals of TCM in the past six years, the quality of these RCTs needs to be improved.
Objective To assess the effects and possible adverse reactions of traditional Chinese medicine (TCM) in treating arteriosclerosis obliterans. Methods Materials were collected with both electronic retrieval including EMbase (1978 to October 2009), OVID-MEDLINE (1950 to October 2009), Cochrane Controlled Trials Register (Issue 3, 2009), Current Controlled Trials, The National Research Register, CBM (1983 to September 2009), CNKI (1995 to September 2009), Wanfang Data (1994 to 2009), and VIP Data (1989 to 2009), and manual retrieval of related journals. All the retrievals were published before November 10, 2009 without limitation of languages. The quality of included studies was evaluated, and meta-analysis was conducted with RevMan 5.0.2 software. Results A total of 10 included studies were all randomized controlled trials, including 837 patients, and the sample size of each study was from 36 to 260 cases. Because both Chinese medicines and control drugs used in studies were different from each other, the effect size of each study can only be singley described and newly calculated. Most included studies showed that, the effects of TCM on cure rate, total effective rate and decrease of TC and TG were similar to that of aspirin, acipimox, prostaglandin E1; a few studies showed the effect of TCM was much better; one study on side effect showed that, TCM was less than western medicine. Conclusion The evidences of TCM effects in treating arteriosclerosis obliterans is quite limited, which has to be strengthened by more studies of high quality.