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.
Objective To assess the effects and safety of vasodilators for sudden sensorineurial hearing loss (SSHL). Search strategy Electronic databases: MEDLINE from 1966, EMBASE from 1974, the Cochrane Controlled Trials Register, Chinese Bio-medicine Database from 1989. Hand search: Five kinds of Chinese otolaryngology journals were searched. Literature references were checked intensively. Selection criteria Randomized controlled trials comparing vasodilators with placebo or other drugs in patients with SSHL. Data collection and analysis At least two reviewers independently assessed trials quality and extracted data. Main results Thirteen trials with 1 155 patients were eligible and included in the systematic review. Ten of the trials were from developed countries and them were from P. R. China. None of the four trials showed that the effects of vasodilators were better than placebo for SSHL. None of the seven trials showed that the effects of one kind of vasodilators were better than that of the other vasodilators. Two trials showed that other drugs, such as batroxobin and hypaque,were probably better than some vasodilators (dextran, papaverine, 654-2, danshen). Eight trials reported the side effects of vasodilators, such as pruritus, allergy, etc. Reviewers’ conclusions Base on the systematic review of current eligible randomized controlled trials, there is no evidence to prove that vasodilator therapy is better than placebo or other therapies for SSHL, or the effects of one kind of vasodilator are better than that of the other vasodilators. We can’t draw a reliable conclusion about the effects of vasodilators for SSHL at the moment. And we must pay attention to their potential adverse reactions.
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.
In order to improve the understanding of pragmatic randomized controlled trial (pRCT), to promote high-quality implementation of such trials, and to provide technical guidance for researchers to conduct such trials scientifically, the working group of China REal world data and studies ALliance (ChinaREAL) hereby develop a technical guidance. The guidance provides technical specifications of pRCT in terms of the concept and scope of application, planning and study design, conduct, data management and quality control, statistical analysis, and ethical issues. It emphasizes that the trial sites and settings, patient population, interventions, controls, outcomes, follow-ups and other factors should be considered when planning and designing. Meanwhile, the guidance recommends that estimation of sample sizes for different types of trial designs should be based on individual pRCTs, and it also provides suggestions for data management, quality control, principles of statistical analysis, analysis requirements for each type of trial designs, and ethical considerations.
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.
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.
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 evaluate the effectiveness and safety of Puerarin on diabetic peripheral neuropathy. Methods A systematic review and evaluation of all available relevant randomized or quasi-randomized controlled trials of Puerarin for diabetic peripheral neuropathy from Cochrane Controlled Trials Register (150 issue of 2003), Medline (1966-2003. 2), EMbase (1984-2001. 12. 4), and the Chinese Biological Medicine Database (1978-2003. 2) were performed. 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 symptoms, sensory nerve and motor nerve conduction velocities, and severe adverse events of Puerarin. Results Ten randomized controlled clinical trials including 726 patients met the inclusion criteria. At the end of the treatment, compared to general treatment or vitamin B, Puerarin showed significant positive effects on the total effect rate of therapy and increased peripheral nerve conduction velocity. No severe adverse events were observed during the treatment period. However, most included trials show some degree of study design or analysis defect. Conclusions Our analysis suggests that Puerarin appears to be an effective and safe treatment for diabetic peripheral neuropathy. However, due to the low quality trials included in this review, more rigorously designed, randomized, double-blind, placebo-controlled trials of Puerarin for diabetic peripheral neuropathy are needed to further assess its usefulness in diabetes peripheral neuropathy patients.
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.
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.