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.
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 seek the statistical solution in the comparison of different effects from multi-center randomized controlled trials （RCTs）. Methods The data collected from a multi-center RCT were used as the examples and processed by CMH test and meta-analysis. Results The result of CMH test indicated that the significant difference of the effect values existed among centers （P 〈0. 05 ）. While meta-analysis showed no significant difference （P 〉0.05 ） by heterogeneity test. However, when using fixed effect model, inter-group significant difference of merged effect values was observed （P 〈0.05 ）. Conclusions In the clinical research based on the method of multi-center RCT, met.a-analysis can be applied if the difference of inclination of the inter-group therapeutic effect is found among different centers. The proper mathematical model should be selected based on the result of heterogeneity test to merge and compare the effect values. The conclusions should be drawn from the results of both meta-analysis and CMH test.
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.
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 review the eradication rate for Helicobacter Pylori (H. pylori) eradication therapy with Ranitidine bismuth citrate (RBC). Methods A systematic review of all the relevant randomized controlled trials (RCTs) was performed according to International Cochrane Collaboration. Data Source RCTs were identified from specialized trials register of Cochrane U GDP Group, the Cochrane library, additional electronic search (including MEDLINE and CBM), handsearching, and personal contact with pharmaceutical companies. Data Selection Randomized clinical trials comparing RBC or RBC in combination with other antibiotics such as proton pump inhibitor, H2-receptor antagonist, other bismuth or placebo were included. No language and blinding limitations were applied. Inclusion criteria Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad-scale plus allocation concealment. Statistics analysis was managed by using RevMan 4. 1. Results Fifteen randomized clinical trials including 3 638 patients were included, with eight trials of high methodological quality. Meta-analysis indicated that odds ratio was 3.06 (95%CI 2.62 to 3. 58, P lt; 0. 000 01) comparing RBC to controls. But the heterogeneity was significant (P lt; 0. 000 01), so we choose random effects model. Then the odds ratio was 2.05 (95%CI 1. 29 to 3. 25, P=0.002). No serious adverse effects were found. Sensitivity analysis showed that the specimens and the quality of RCT haven’t affected researching result. Conclusion RBC is more effective in Helicobacter Pylori eradication therapy than others.
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.
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 investigate the current situation of randomized controlled trials or clinical controlled trial (RCT/CCT) on chronic hepatitis B and whether to offer reliable evidence for clinical practice in China. Methods RCT/CCT identified from six Chinese clinical journals were searched manually and assessed according to international standard of evidence-based medicine. Results 308 issues containing 212 therapeutic articles and 88 RCT/CCT on chronic hepatitis B were identified and analyzed. Conclusion the quantity and quality of RCT/CCT of chronic hepatitis B did not meet the need of clinical practice.
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.