ObjectiveTo evaluate the efficacy and safety of midazolam in the prevention of etomidate-induced myoclonus. MethodsDatabases including PubMed, EMbase, The Cochrane Library (Issue 8, 2015), CBM, WanFang Data, VIP, and CNKI were electronically searched to collect randomized controlled trials (RCTs) about midazolam in the prevention of etomidate-induced myoclonus from inception to August, 2015. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed by RevMan 5.2 and Stata 12.0 softwares. ResultsA total of 14 RCTs involving 1 274 patients were included. The results of metaanalysis showed that, compared with placebo, pretreatment with midazolam injection could reduce the incidence of myoclonus (RR=0.28, 95%CI 0.19 to 0.42, P<0.000 01). The sub-group analysis based on different doses of midazolam showed that all three different doses of midazolam (0.015 mg/kg, 0.03 mg/kg and 0.05-0.1 mg/kg) could reduce the incidence of myoclonus effectively (all P values <0.05). ConclusionPretreatment with midazolam injection can reduce the incidence of etomidate-induced myoclonus without increasing the risk of recovery latency and over sedation. Due to the limited quality of included studies, the above conclusion needs to be further verified by more high quality studies.
ObjectiveTo compare the therapeutic effect of dual-chamber pacing (DDD) and ventricular single-chamber pacing (VVI) on arrhythmia via systematic evaluation. MethodsWith the method of Cochrane system evaluation, we searched Medline, Embase, CNKI, PubMed and Wanfang database (the searching time was up to June 30, 2016) for randomized controlled trials comparing DDD with VVI treatingcardiac arrhythmias. Meta analysis was performed using RevMan5.3 software. ResultsWe collected 12 randomized controlled trials of DDD and VVI pacing treating cardiac arrhythmia including 1 704 patients, but the quality of the studies were not good. The results of Meta analysis showed that:compared with VVI pacing mode, DDD pacing mode reduced the risk of atrial fibrillation[RR=0.36, 95%CI (0.22, 0.59), P < 0.000 1]; besides, it reduced the left atrial diameter[SMD=-0.43, 95%CI (-0.68, -0.17), P=0.001], the left ventricular end diastolic dimension[SMD=-0.33, 95%CI (-0.61, -0.05), P=0.02] and increased the left ventricular ejection fraction[SMD=1.03, 95%CI (0.49, 1.57), P=0.000 2]. ConclusionsComparing DDD with VVI on the treatment of cardiac arrhythmia in patients with cardiac arrhythmia, DDD pacing can reduce the incidence of atrial fibrillation and thrombosis, enhance heart function and improve blood supply. But because of the low quality of the included studies, the curative effect cannot be confirmed, and more randomized controlled trials with high quality needs to be carried out in the future.
Objective To compare the effects of operative versus nonoperative treatment for displaced intra-articular calcaneal fractures. Methods All randomized controlled trials (RCTs) of operative versus nonoperative treatment for displaced intra-articular calcaneal fractures were identified. Quality assessment and data extraction were performed by two reviewers independently. Results Four published trials involving 530 patients were included. All studies compared operative with nonoperative treatment. It was clear that operative treatment was superior to nonoperative treatment in terms of helping patients back to work, reducing problems wearing shoes, expanding the range of motion of subtalar joint, and improving the recovery of Bohler’s angle. As for foot pain, there was no difference between the two methods. Because the outcome measures varied across the trials, a meta-analysis could not be performed. Conclusions Both operative and nonoperative treatments produce comparable long-term outcomes in the treatment of displaced intra-articular calcaneal fractures. Because of the poor reporting of outcomes, it is not possible to determine if there is any significant difference in outcome measures apart from those listed above. More trials with high methodological quality are needed.
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 assess the effectiveness and safety of hepatitis B immunoglobulin (HBIG) in interrupting the intrauterine transmission of HBV.Methods The Cochrane Library (Issue 3, 2007), MEDLINE (1996 to April 2007), CBM (1978 to April 2007), and EMBASE (1980 to April 2007) were searched. The quality of included studies was evaluated and meta-analysis was performed. Results Four studies involving 359 participants with HBVDNA (+) were included. All the included studies were judged to be inadequate in regard to the reporting of randomization, concealment of allocation and blinding. Meta-analysis based on the included studies showed that HBIG significantly decreased the intrauterine transmission rate of HBV compared to the control group [OR 0.17, 95%CI (0.09 to 0.31), Plt;0.000 01]. No HBIG-related severe adverse reactions were reported. Conclusions HBIG is effective and safe for the interruption of intrauterine transmission of HBV. However, because of the high risk of selection and detection bias in the included studies, this evidence is not b enough. Large-scale randomised trials on the use of HIBG for the interruption of intrauterine transmission of HBV are needed
Objective To assess the efficacy and safety of Zhiling decoction for vascular dementia. Methods The Specialized Register of the Cochrane Dementia and Cognitive Improvement Group was searched in Feb. 2004 using the term Zhiling. In addition, we handsearched 83 traditional Chinese medicine journals （1993 to 2004 ）. We included all randomized controlled trials（RCTs）of Zhiling decoction treating people with vascular dementia. We also evaluated the internal validity of the RCTs . If all included RCTs were of high quality and homogeneity, then the meta-analysis was conducted. Results Only one RCT was identified. The outcomes were listed as the followings ： ① The Hasegawa＇ s dementia scale scoring （ HDS ） scores of the patients in Zhiling decoction group were improved significantly from baseline after 8 weeks course of treatment and there was no significant difference in the control group. The HDS scores improvement was greater than control group（P 〈0.01 ）o ② The latency of P3 was shorter in both groups after treatment, and there was a significant treatment effect in Zhiling group （t = -52. 09, 95% CI -69.79 to -34.39, P 〈0. 000 01 ）. The amplitude of 173 increased in both groups after treatment, and there was a non-sigmficant treatment effect in Zhiling group for change from baseline （t =1.40, 95% CI -0.02 to 2.82, P =0.05）. ③ Brain electrical activity monitoring （BEAM） showed that benefits in those treated by Zhiling decoction were higher than those treated by Naofukang with OR9.90 （ 95% CI 3.34 to 29.38）. ④In the Zhiling group serum cholesterol （P 〈0.01 ） , serum triglyceride （P 〈0.01 ） and LPO（P 〉0. 01 ） decreased after treatment. There was an increase in the level of high density lipoprotein （HDL） and superoxide dismutase （SOD） in red blood cells compared with baseline for Zhiling groups （P 〈0.01 ）. ⑤ The cerebral blood flow decreased in both groups after treatment, and there was a significant treatment effect in favour of Zhiling （treatment effect t = -1.03, 95% CI -1.26 to -0.80, P 〈0. 00001 ）.⑥ No side effects on heart, liver or renal function were reported in Zhiling decoction group. Conclusions The currendy available evidence is insufficient to assess the potential efficacy for Zhiling decoction in the treatment of vascular dementia. Just one RCT concerning the management of Zhifing decoction versus Naofukang suggests that Zhiling decoction may be effective in treating vascular dementia. Further randomised, double-blind, placebo-controlled trials are urgendy needed .
Objective To evaluate the effectiveness and safety of foscarnet sodium in the treatment of chronic hepatitis B. Methods We searched MEDLINE, EMbase, The Cochrane Library and CNKI from 1978 to June 2006. Randomized controlled trials of foscarnet sodium versus other drugs or no drugs in the treatment of chronic hepatitis B were identified. The quality of the included trials was evaluated by two reviewers independently. Meta-analysis was done using The Cochrane Collaboration’s RevMan 4.2.7. Results Seven studies (337 patients) were included; one compared foscarnet sodium versus interferon, and the other six compared foscarnet sodium versus no drugs. All the included studies were graded in terms of the quality of randomization, allocation concealment and blinding. All 7 studies were graded as level C. The meta-analysis showed that: ① foscarnet sodium was not significantly different from interferon in clinical efficacy, liver function, negative-conversion rate of virological markers and side effects. ② compared with the no drugs group, the negative-conversion rate of virological markers was significantly higher for the foscarnet sodium group, HBeAg (RR 6.20, 95%CI 1.76 to 21.79) and HBV-DNA (RR 4.13, 95%CI 1.32 to 12.86); but there were no significant differences in clinical efficacy, liver function and side effects. Conclusions Available evidence shows that: in the treatment of chronic hepatitis B the effectiveness and safety of foscarnet sodium are not significantly different from interferon, but only one trial is included in this review, so the evidence is weak. Compared with no drugs, foscarnet sodium significantly improves the negative-conversion rate of virological markers, but the evidence is insufficient to show whether foscarnet sodium could improve clinical efficacy and liver function, as well as reduce side effects.
ObjectiveTo systematically evaluate the efficacy and safety of Polypill on cardiovascular risk factors. MethodSuch databases as Embase, Cochrane Library, PubMed, Web of Science, China National Knowledge Infrastracture, WanFang, and China Biology Medicine Disc were searched from their establishment to May 2015 for randomized controlled trials on the efficacy and safety of Polypillon on cardiovascular risk factors. Meta-analyses were performed by using the RevMan 5.2 software. ResultsSix studies were included which all came from overseas including 1 155 patients treated with Polypill and 1 149 treated with placebo or single or combined medicaiton. The meta-analysis showed that:when compared with the controls, Polypills could significantly reduce systolic blood pressure[WMD=-9.39 mm Hg (1 mm Hg=0.133 kPa), 95%CI (-14.44, -4.33) mm Hg, P=0.0003], diastolic blood pressure[WMD=-5.32 mm Hg, 95%CI (-8.10, -2.55) mm Hg, P=0.0002], total cholesterol[WMD=-1.11 mmol/L, 95%CI (-1.48, -0.74) mmol/L, P<0.00001], and low density lipoprotein[WMD=-0.91 mmol/L, 95%CI (-1.25, -0.57) mmol/L, P<0.00001]. However, those who took Polypill were easier to discontinue medication [OR=1.49, 95%CI (1.19, 1.87), P=0.0005]. In the respect of adverse effects, there was no significant difference between the two groups[OR=1.47, 95%CI (0.67, 3.25), P=0.34]. ConclusionsThe efficacy of Polypill on cardiovascular risk factors is obvious. Polypills can significantly reduce blood pressure and lipids. Tolerability is lower in those taking Polypills, but the difference is minor. There is no significant difference in the respect of adverse effects.
Multicenter randomized controlled studies can recruit more subjects in a relatively short period of time, avoiding the bias of single research institution studies, resulting in reliable conclusions and providing strong guidance to clinical practice. They are the most scientific and most reliable methods to evaluate clinical researches. However, there are few multicenter clinical trials in China as Chinese doctors are often trapped in difficulties in clinical research, including imperfect research system, lack of experience, capital investment deficient, the tension in the doctor-patient relationship and so on. Although the above problems are related to medical system architecture of our country in a certain extent, compared with the overseas, we also have our own advantages, such as resource of our patients, doctors, and diseases type. Pay attention to discovering of new type of diseases, looking for genetics discipline, and exploring new medical technology is an important task of clinical research. We have plenty of high level ophthalmology centers at present, which provide favorable conditions for launching multi-center clinical trial studies. We have good reasons to believe that, if we can effectively exploit the resources in our hands, carefully observe and discover clinical problems, there will be more convincing clinical results present in the world after bring up hypothesis boldly while prove it conscientiously and carefully.
Objective To evaluate the efficacy and safety of the treatment of chronic prostatitis(CP) in China. Methods We search the related original studies about the treatment for Chinese CP all over the world, and only included randomized controlled trials (RCTs). MEDLINE(1966-2007.5), PubMed (1966-2007.5), EMBASE(1988-2007.05), and four Chinese databases were electronically searched and 6 related journals were handsearched. The studies included in the references of eligible studies were additionally searched. Two reviewers independently screened the studies for eligibility, evaluated the quality and extracted the data from the eligible studies, with confirmation by cross-checking. Divergences of opinion were settled by discussion or consulted by the expert. Meta-analysis was performed by using Rev Man 4.2 software.Results Nine original studies involving 917 participants met inclusion criteria. Compared withplacebo, prostant, Wenglitong, Chuanshentong, alpha-blockers, bioflabonoid and porstat could reduce the NIH-chronic prostatitis symptom index[RR1.99, 95% CI（1.60, 2.48）； RR2.76 95% CI(2.13，3.57)； RR2.49, 95% CI(1.24, 4.97)； WMD -5.90，95%CI（-8.12，-3.68）； WMD -2.50, 95%CI（-4.85，-0.15）；WMD -6.07， 95%CI(-7.92， -4.22)]. Alpha-blockers, Wengl itong, bioflabonoid and porstat can also reduce the symtom index of pain.Conclusion Drug interventions could improve NIH-CPSI and total symptoms of CP in some degree, but can not improve all symptoms, future RCTs must use an appropriate sample size and optimal duration and follow-up of participants. It is important to improve the quality of internal original studies.