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 assess the efficacy and safety of sevoflurane versus ketamine in the anesthesia of child short period surgery. Methods Such databases as EMbase, PubMed, The Cochrane Library, CNKI, VIP, CBMdisc, Ongoing Controlled Trial and Conference Articles were searched from their establishment to April 2011 to collect randomized controlled trials (RCTs) and the quasi-RCTs. The quality of those studies meeting the inclusive criteria was assessed, the data were extracted and the meta-analysis was conducted by using RevMan 5.1.1 software. Results Ten studies involving 600 participants were included. Seven studies showed that the intraoperative heart rate of the sevoflurane group was lower than that of the ketamine group (MD= –11.85, 95%CI –16.47 to –7.23, Plt;0.000 01). Nine studies showed that the revival time of the sevoflurane group was shorter than that of the ketamine group (MD= –29.05, 95%CI –37.98 to –20.12, Plt;0.000 01). Three studies showed that the anesthesia induction time of the sevoflurane group was shorter than that of the ketamine group (MD= –208.45, 95%CI –359.22 to –57.68, P=0.007). Six studies showed that the influence on mean arterial pressure (MAP) had no significante difference (MD= –4.86, 95%CI –10.02 to 0.29, P=0.06). Meanwhile, seven studies showed that the adverse events of the sevoflurane group were fewer than those of the ketamine group (Peto OR=0.29, 95%CI 0.20 to 0.40, Plt;0.000 01). Conclusion The results of this system review show that sevoflurane is more effective than ketamine with fewer adverse reactions, and it provides a new choice for clinical anesthesia for child short period surgery. However, ketamine is still the main drug in clinical anesthesia for the child short period surgery at present, so high quality studies are needed for further clinical researches.
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
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 systematically review the effect of self-management intervention on the prevention and management of lymphedema in breast cancer patients. MethodsThe Cochrane Library, Embase, PubMed, Web of Science, CINAHL, PsycINFO, SinoMed, CNKI, WanFang Data and VIP databases were electronically searched to collect studies on self-management intervention on the prevention and management of lymphedema in breast cancer patients, from inception to June 16. Two reviewers independently screened the literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was performed using RevMan 5.4 software. ResultsA total of 37 references were included, comprising 25 randomized controlled trials (RCTs), 12 controlled clinical trials (CCTs), and a total of 3 697 patients. There were 26 studies in the meta-analysis, and the results of the meta-analysis showed that, compared with the control group, patients in the intervention group exhibited better performance in lymphedema management-related behaviors (SMD=2.65, 95%CI 1.53 to 3.78, P<0.01), symptoms related to lymphedema (SMD=?2.01, 95%CI ?3.66 to ?0.37, P<0.05), occurrence of lymphedema (RR=0.37, 95%CI 0.32 to 0.45, P<0.01), upper limb function (SMD=?1.88, 95%CI ?2.83 to ?0.92, P<0.01), quality of life (SMD=2.79, 95%CI 2.05 to 3.54, P<0.01), and the difference was statistically significant. The intervention mainly included information support, material support, emotional support and decision support. ConclusionThere are currently a variety of self-management interventions, but they mainly focus on information support. Self-management interventions can improve the self-management behavior of breast cancer patients with lymphedema and reduce the impact of lymphedema on patients.
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.
High-quality randomized controlled trials can balance between-group confounding factors and are an important source of comprehensive information on benefits and harms. The CONSORT (consolidated standards of reporting trials) working group released the CONSORT Harms 2022 statement to further improve the harm reporting quality in randomized controlled trials. Traditional Chinese medicine formulas have unique characteristics such as compatibility taboos and using toxic herbs. The harms of traditional Chinese medicine formulas need to be reported in a standard. This study suggests that researchers should pay attention to enhancing the professional competence of research teams, developing suitable standards for reporting the harm of traditional Chinese medicine formulas in randomized controlled trials, and incorporating relevant guidelines into journal publication requirements. These efforts are essential for laying the necessary groundwork for the global dissemination and promotion of traditional Chinese medicine.
Objective To evaluate the efficacy and safety of traditional Chinese medicine (TCM) in treatingchronic obstructive pulmonary disease (COPD) in a stable stage. Methods We searched MEDLINE (1950 to July 2008), PubMed (1996 to July 2008), VIP (1989 to July 2008), WanFang (1998 to July 2008), CNKI (1979 to July 2008), and CBM (1978 to July 2008)for randomized control trials about TCM to treat stable COPD. Trial screening, quality assessment of included trials, and data extract were conducted. Statistical analysis was conducted by using RevMan 4.2.7 software. Results A total of 30 randomized controlled trials (RCTs) in the Chinese language were identified. No pooled analysis was performed because of the significant heterogeneity among the included trials. (1) For TCM alone versus blank therapy or placebo: 3 RCTs reported the clinical effective rate and only 1 indicated TCM was more effective; 5 RCTs reported forced expiratory volume in one second (FEV1)% after treatment and 2 indicated TCM alone as more effective in improving lung function; 4 RCTs reported quality of life after therapy and 2 indicated TCM alone was more effective in improving quality of life after therapy. (2) For integrated tradtional and western medicine versus western medicine alone: 11 RCTs included the clinical effective rate, 3 RCTs showed that integrated traditional and western medicine was more effective. Of 8 RCTs reporting FEV1%, 2 RCTs suggested that integrated traditional and western medicine was more effective. There were 3 RCTs studying 6 minute walking distance and 4 RCTs about quality of life, which also showed that integrated traditional and western medicine was more effective. No obvious adverse reaction to TCM was reported.Conclusions The current evidence shows TCM tends to relieve the symptoms and improve quality of life for patients with stable COPD without obvious adverse reaction. Due to the low methodological quality of trials included, more RCTsof high quality and large scale are required.
ObjectivesTo systematically review the efficacy and safety of bevacizumab combined with STUPP regimen for newly diagnosed glioblastoma.MethodsPubMed, EMbase, the Cochrane Library, CBM, CNKI, VIP and WanFang Data databases were searched to obtain randomized controlled trials (RCTs) of bevacizumab combined with STUPP regimen for newly diagnosed glioblastoma patients from inception to September 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software.ResultsA total of 6 RCTs involving 2 835 patients were included. The results of meta-analysis showed that: the bevacizumab combined with STUPP regimen group was superior to the control group on PFS (HR=0.69, 95%CI 0.62 to 0.77, P<0.000 01). But the adverse events rate at the three and above three levels was significantly higher than the control group (P<0.05).ConclusionsCurrent evidence shows that bevacizumab combined with STUPP regimen for newly diagnosed glioblastoma can significantly prolong the PFS. The treatment group performs not as well as the control group on adverse event rate. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
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.