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 assess the efficacy and safety of fibfinogen-depleting agents (snake venom extracts) in the treatment of acute ischemic stroke. Method A systematic review of all the relevant randomized controlled trails (RCTs) was performed. RCTs were identified from the Cochrane Stroke Group’s Specialized Trials Register, additional electronic and handsearching, and personal contract with pharmaceutical companies. We included all completed and unconfounded truly or quasi-randomized trials in patients with ischemic stroke comparing fibrinogen depleting agents for analysis. Results Ten completed and one ongoing RCTs have been identified so far. Up to 1998, only three trials using ancrod (182 patients) met the inclusion criteria. Ancrod was associated with a significant reduction in early deaths (5.6% vs. 16%; odds ratio [OR], 0.33; 95% confidence interval [CI], 0.13 to 0.85; 2P=0.02) suggesting that treatment of 100 patients would avoid about 10 early deaths. The frequency of asymptomatic intracranial hemorrhage shown by computed tomography was similar between ancrod-treated and control groups (7.6% vs. 9.6%; OR 0.78; 95%CI 0.26 to 2.33; 2P=0.65). No major intracranial or extracranial hemorrhages or recurrent ischemic strokes occurred in the ancord-allocated patients. There were nonsignificant trends in favor of ancrod in death from any cause (OR 0.57; 95%CI 0.27 to 1.23; 2P=0.15) and death or disability (OR 0.52; 95%CI 0.26 to 1.03; 2P=0.06) at the end of trial follow-up. Up to 2000, other two trials published results. This review will be updated with new trial results soon, which will provide more data. Conclusions There were too few patients and outcome events to draw reliable conclusions from the present data. Although ancrod-like agents appeared promising, their routine use cannot be recommended at the moment. Future trials should test simpler fixed-dose regimens to allow better generalizability.
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.
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 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 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.
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.
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 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 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.