Objective To systematically review the effects of fenofibrate on kidney function in various populations, so as to provide references for selecting the methods of treating hyperuricemia. Methods Such databases as PubMed (1966-2013), EMbase (1984-2013), The Cochrane Library (Issue 1, 2012), CBM (1978-2013), and CNKI (1989-2013) were electronically searched for relevant randomized controlled trials or non-randomized controlled trials on fenofibrate for treating hyperuricemia. According to the Cochrane methods, two reviewers independently screened literature, extracted data, and assessed the methodological quality of included studies. Then, meta-analysis was performed using RevMan 5.0 software. Results A total of 16 studies involving 346 patients were included in total. The results of meta-analysis showed that: a) compared with the control group, the fenofibrate group had the lower serum uric acid level (WMD=48.68, 95%CI 10.02 to 87.34, Plt;0.000 01), lower Ccr (endogenous creatinine clearance) level (WMD=8.88, 95%CI 1.29 to 16.47, P=0.002), and similar serum creatinine level (WMD=1.78, 95%CI –2.86 to 6.42, P=0.45); and b) adverse reaction included gastrointestinal discomforts, skin rashes and transient increase of GPT and transaminase, most of which were mild. Conclusion Fenofibrate has good effects. Due to the low quality of the included studies, the exact effectiveness and adverse reaction need to be rigorously verified based on more multi-center, double-blind, randomized controlled trials with large sample size.
Objective To systematically review the effectiveness and safety of cordyceps sinensis for chronic obstructive pulmonary diseases (COPD). Methods We electronically searched databases including CBM, CNKI, WanFang Data, VIP, PubMed, Cochrane Central Register of Controlled Trials (Issue 7, 2013) and EMbase for randomized controlled trial (RCT) and quasi-RCTs on the effectiveness and safety of cordyceps sinensis for COPD. According to Cochrane methods, two reviewers independently screened literature, extracted data, assessed methodological quality. Then, meta-analysis was performed using RevMan 5.2 software. Results Fourteen quasi-RCTs involving 1 162 patients were included. The results of meta-analysis showed that: a) compared with routine treatment alone, cultured cordyceps sinensis in combination of routine treatment improved total effective rates (stationary stage: RR=1.33, 95%CI 1.14 to 1.54, P=0.000 3; advanced period: RR=1.36, 95%CI 1.14 to 1.62, P=0.000 8). Also cultured cordyceps sinensis in combination of routine treatment improved lung function (FEV1/FVC: MD=5.48, 95%CI 3.22 to 7.74, Plt;0.000 01; FEV1%: MD=3.75, 95%CI 0.91 to 6.59, P=0.010), and prolonged exercise duration (MD=43.51, 95%CI 27.66 to 59.36, Plt;0.000 01) for COPD patients in stationary stage. However, no evidence was found in blood gas analysis, immune function, and quality of life; and b) the results of one study showed that, cultured cordyceps sinensis in combination of routine treatment was comparable with immune regulator (BCG-PSY) in combination of routine treatment with regards to total effective rates, but it could better improve lung function of patients. Conclusion Current evidence suggests that cultured cordyceps sinensis is effective in treating COPD, especially in treating lung function and exercise duration of COPD patients in stationary stage and increasing total effective rates. However, the strength of evidence is affected by poor methodological quality of the included studies. High-quality trials with large sample size are needed to verify its clinical effects.
Objective To evaluate the effectiveness of topical fluoride on prevention of enamel demineralization during the orthodontic treatment in China. Methods The Cochrane Library（Issue 9, 2012), MEDLINE (1996 to 2012.10), EMbase (1974 to 2012.10), CNKI (1994 to 2012.10), VIP (1994 to 2012.10), WanFang data (1998 to 2012.10) and CBM (1978 to 2012.10) are searched for the randomized controlled trials (RCTs) and quasi-Randomized controlled trials (qRCTs) about topical fluoride preventing enamel demineralization during the orthodontic treatment. The bibliographies of the included studies were searched, too. Two reviewers evaluated the quality of the included studies and extracted data critically and independently, and then the extracted data were analyzed using RevMan 5.2 software. Results A total of 20 studies within 19 articles were included, which involved 26 323 teeth. The results of meta-analysis results show that, the rate of enamel demineralization of the fluoride varnish group (8.4%) was lower than that of the control group (16.0%) (OR=0.44, 95%CI 0.33 to 0.59, Plt;0.000 01); the rate of enamel demineralization of the fluoride coating group (8.3%) was lower than that of the control group (17.7%) (OR=0.46, 95%CI 0.35 to 0.60, Plt;0.000 01); the rate of enamel demineralization of the fluoride toothpaste group (9.0%) was lower than that of the control group (14.5%) (OR=0.59, 95%CI 0.49 to 0.71, Plt;0.000 01); the rate of enamel demineralization of the fluoride foam group (11.6%) was lower than that of the control group (18.2%) (OR=0.48, 95%CI 0.24 to 0.96, P=0.04); the rate of enamel demineralization of other groups (12.0%) was lower than that of the control group (21.8%) (OR=0.43, 95%CI 0.30 to 0.60, Plt;0.000 01). Two outcomes were low quality in the GRADE system and the other three are very low quality. Conclusion Current domestic evidence shows that topical fluoride is effective to prevent enamel demineralization during the orthodontic treatment. However, given the low methodological quality of most included studies, this conclusion still needs to be further proved by conducting more strictly-designed, high-quality and large-scale studies.
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 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 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 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 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 demonstrate the efficacy, tolerability, and safety of domestic Acarbose tablet compared with Glucobay (Acarbose tablet produced by Bayer company) in patients with type 2 diabetic patients. Method A multicenter randomized controlled parallel-group comparison study was conducted. 177 Chinese type 2 diabetic patients were recruited from 4 clinical centers. The patients were divided randomly into domestic Acarbose tablet (A group) or Glucoby (B group) treatment group. The trial consisted of a 2-4 weeks equilibrated period followed by an 8 week course of treatment. Results 165 patients have finished the trial (81 in A group and 84 in B group). After 4 weeks of treatment, the mean of fasting blood glucose (FBG) in A and B group were reduced 1.61 and 2.08 mmol/L respectively, and mean of postprandial blood glucose (PBG) lowered 5.06 and 5.09mmol/L respectively. After 8 weeks of treatment, the mean of FBG were reduced 1.95 and 2.62mmol/L respectively, and mean of PBG lowered 4.88 and 5.98 mmol/L, respectively, and mean of HbA1c were lowered 1.13% and 1.20% respectively in A and B group. The differences in reduction of FBG, PBG, and HbA1c between A and B group were no statistic significance. The serum triglyceride levels and BMI were decreased significantly in both A, B groups. 3 patients who drinking wine during trial on A group had asymptomatic elevations in serum transaminases that normalized in 2 weeks after stopped drinking and Acarbose withdrawal. Flatulence was the most common side effect. Conclusions In this multicenter study, domestic Acarbose tablet 50 mg t.i.d. was an effective, safe, and generally well-tolerated therapy as similar as Glucobay in type 2 diabetic patients.