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.
针刺平行随机对照试验通常没有准确报告试验组和对照组的干预方法.为促进标准化,国际上有经验的针刺医师和研究者组成的小组制定了一些原则,即针刺临床对照试验中干预措施报告的标准(缩写为STRICTA).在征求意见过程中,一些期刊编辑协助对此标准进行了修改,使之与随机对照试验报告的标准(CON-SORT)格式一致,作为该指南对针剌研究报告的延伸.参与此事的杂志编辑已确定要发表该标准,建议其作者群按照此标准准备论文,并将邀请更多杂志采用该标准.目的是使针剌对照试验的干预措施充分报告,从而有利于对这些研究的严格评价、分析及这些措施的推广.
Objective To review systematically whether there is enough existing evidence that methylcobalamin is effective and safe in the treatment of the patients with diabetic peripheral neuropathy.Methods A Cochrane systematic review of all relevant randomized or quasi-randomized controlled trials of methycobalamin for diabetic peripheral neuropathy was performed. Clinical trials were searched from Cochrane Controlled Trials Register (Issue 4, 2003), MEDLINE (January 1966 to January 2004), EMBASE (January 1980 to January 2004), the Chinese Biological Medicine Database (1978 to January 2004), the Chinese Science and Technology Journal Full-text Database (1989 to January 2004) and references of all included trials. The selection of studies, data extraction and assessment of methodological quality were performed independently by two reviewers. The following outcomes were assessed: effectiveness of clinical signs and symptoms, sensory nerve and motor nerve conduction velocities and serious adverse events of methylcobalamin. Results Thirty randomized clinical trials including 1 949 patients met the inclusion criteria. The quality of the most included trials was of low level. The "funnel plot" of the comparison of thirteen studies of methylcobalamin with other B Vitamins studies showed symmetry, which indicated less possible publication bias and the result was partly reliable, but it could not indicate the whole publication biases. The results of meta-analysis indicated that methylcobalamin showed significantly positive effects on the improvement of the signs and symptoms of peripheral neuropathy, and the effects were better than the other vitamin B agents. The increase of some nerves conduction velocities by methylcobalamin was better than by the other vitamin B. No serious adverse events were observed during the treatment period.Conclusions Methylcobalamin appears to be a safe and effective treatment on diabetic peripheral neuropathy. However, the evidence is not b because of the low quality of most trials. Rigorously designed, randomized, double-blinded, placebo-controlled trials of methylcobalamin for diabetic peripheral neuropathy are needed to further assess the effect.
Objectives To assess the effectiveness and safety of additional bedtime H2-receptor antagonists (H2RAs) in suppressing nocturnal gastric acid breakthrough (NAB). Methods We identified eligible trials by searching The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMbase and CINAHL. We handsearched the data from the proceedings of correlated conferences, eight kinds of important Chinese journals and references of all included trials. All randomized controlled trials evaluating H2RAs for the control of NAB were eligible for inclusion. The systematic review was conducted using methods recommended by The Cochrane Collaboration. Results Only two randomized crossover studies including 32 participants met the inclusion criteria. Because the design, dosage and duration of the treatment were different between the studies, it was impossible to conduct Meta-analysis. There was no consistent conclusion between the two included studies in evaluating H2RAs for the control of NAB. Conclusion We can not conclude any implications for practice at this stage. Appropriately designed large-scale randomized controlled trials with long-term follow-up are needed to decide the effects of additional bedtime H2RAs in suppressing NAB.
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 evaluate the reporting quality and influencing factors of patient-reported outcome (PRO) data in randomized controlled trials (RCTs) of lung cancer. Methods RCTs of lung cancer with PRO as either primary or secondary endpoints were searched from PubMed, EMbase, Medline, CNKI, Wanfang Data, and VIP databases between January 1, 2010 and April 20, 2024. Reporting quality of included RCTs were assessed based on the CONSORT-PRO extension. Descriptive statistics and bivariate regression analysis were used to describe the reporting quality and analyze the factors influencing the reporting quality. Results A total of 740 articles were retrieved. After screening, 53 eligible RCTs of lung cancer with 22 780 patients were included. The patients were mainly with non-small cell lung cancer (84.91%), with the median sample size of the included studies was 364.0 (160.5, 599.5) patients. The primary PRO tool used was the EORTC QLQ-C30 (60.38%). There were 52 (98.11%) studies whose PRO measured the domain of "symptom management of cough, dyspnea, fatigue, pain, etc.", and 45 (84.91%) studies measured "health-related quality of life". Multicenter studies accounted for 84.91%, and randomized non-blind trials accounted for 62.26%. PRO was used as the primary endpoint in 33.96% of the studies and as secondary endpoints in 66.04%. The reliability and validity of the PRO tools were explicitly mentioned in 11.32% and 7.55% of the studies, respectively. The average completeness of reporting according to the CONSORT-PRO guidelines was 60.00%, ranging from 25.00% to 93.00%. The main factors affecting the completeness of CONSORT-PRO reporting included sample size and publication year. For every increment in sample size, the completeness of reporting increased by 27.5% (SE=0.00, t=2.040, P=0.046). Additionally, studies published after 2018 had a 67.2% higher completeness of reporting compared to those published in or before 2018 (SE=17.8, t=–3.273, P=0.006). Conclusion The study reveals that the overall reporting quality of PRO in lung cancer RCTs is poor. Particularly, the reporting of PRO measures reliability and validity, PRO assumptions, applicability, and handling of missing data need further improvement. Future research should emphasize comprehensive adherence to the CONSORT-PRO guidelines.
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.
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.
ObjectiveTo systematically review efficacy application of fibrin glue (FG) after thyroidectomy.MethodsPubMed, EMbase, The Cochrane Library, ClinicalTrials.gov, CBM, CNKI, WanFang Data and VIP databases were searched to collect randomized controlled trials (RCTs) regarding the use of FG after thyroidectomy from inception to October 29th, 2019. 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 15 RCTs involving 2 406 patients were included. The results of meta-analysis showed that compared with non-FG group, the use of FG could reduce postoperative drainage amount at the initial 24 hours (MD=−17.98, 95%CI −28.35 to −7.60, P=0.000 7), total amount of wound drainage (MD=−40.92, 95%CI −46.25 to −35.59, P<0.000 01), and postoperative discomfort (RR=0.48, 95%CI 0.35 to 0.66, P<0.000 01), as well as shorten drainage time (MD=−9.99, 95%CI −15.74 to −4.23, P=0.000 7) and stitches removal time (MD=−1.49, 95%CI −2.1 to −0.87, P<0.000 01). However, there was no statistically significant difference concerning postoperative short-term complications such as swelling (RR=0.78, 95%CI 0.48 to 1.28, P=0.32), recurrent laryngeal nerve injury (RR=0.83, 95%CI 0.21 to 3.29, P=0.79) and wound infection (RR=0.28, 95%CI 0.07 to 1.21, P=0.09) between two groups.ConclusionsThe current evidence shows that FG can reduce postoperative drainage amount and shorten postoperative recovery time in thyroidectomy. Due to the limited quality and quantity of included studies, more high quality studies are required to verify above conclusions.
Objective To assess the efficacy and safety of sevoflurane versus ketamine in the anesthesia of child short period surgery. Methods Such databases as EMbase, PubMed, The Cochrane Library, CNKI, VIP, CBMdisc, Ongoing Controlled Trial and Conference Articles were searched from their establishment to April 2011 to collect randomized controlled trials (RCTs) and the quasi-RCTs. The quality of those studies meeting the inclusive criteria was assessed, the data were extracted and the meta-analysis was conducted by using RevMan 5.1.1 software. Results Ten studies involving 600 participants were included. Seven studies showed that the intraoperative heart rate of the sevoflurane group was lower than that of the ketamine group (MD= –11.85, 95%CI –16.47 to –7.23, Plt;0.000 01). Nine studies showed that the revival time of the sevoflurane group was shorter than that of the ketamine group (MD= –29.05, 95%CI –37.98 to –20.12, Plt;0.000 01). Three studies showed that the anesthesia induction time of the sevoflurane group was shorter than that of the ketamine group (MD= –208.45, 95%CI –359.22 to –57.68, P=0.007). Six studies showed that the influence on mean arterial pressure (MAP) had no significante difference (MD= –4.86, 95%CI –10.02 to 0.29, P=0.06). Meanwhile, seven studies showed that the adverse events of the sevoflurane group were fewer than those of the ketamine group (Peto OR=0.29, 95%CI 0.20 to 0.40, Plt;0.000 01). Conclusion The results of this system review show that sevoflurane is more effective than ketamine with fewer adverse reactions, and it provides a new choice for clinical anesthesia for child short period surgery. However, ketamine is still the main drug in clinical anesthesia for the child short period surgery at present, so high quality studies are needed for further clinical researches.