The Content of Statistical Requirements for Authors in Biomedical Research Journals / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Robust statistical designing, sound statistical analysis, and standardized presentation are important to enhance the quality and transparency of biomedical research. This systematic review was conducted to summarize the statistical reporting requirements introduced by biomedical research journals with an impact factor of 10 or above so that researchers are able to give statistical issues' serious considerations not only at the stage of data analysis but also at the stage of methodological design.</p><p><b>METHODS</b>Detailed statistical instructions for authors were downloaded from the homepage of each of the included journals or obtained from the editors directly via email. Then, we described the types and numbers of statistical guidelines introduced by different press groups. Items of statistical reporting guideline as well as particular requirements were summarized in frequency, which were grouped into design, method of analysis, and presentation, respectively. Finally, updated statistical guidelines and particular requirements for improvement were summed up.</p><p><b>RESULTS</b>Totally, 21 of 23 press groups introduced at least one statistical guideline. More than half of press groups can update their statistical instruction for authors gradually relative to issues of new statistical reporting guidelines. In addition, 16 press groups, covering 44 journals, address particular statistical requirements. The most of the particular requirements focused on the performance of statistical analysis and transparency in statistical reporting, including "address issues relevant to research design, including participant flow diagram, eligibility criteria, and sample size estimation," and "statistical methods and the reasons."</p><p><b>CONCLUSIONS</b>Statistical requirements for authors are becoming increasingly perfected. Statistical requirements for authors remind researchers that they should make sufficient consideration not only in regards to statistical methods during the research design, but also standardized statistical reporting, which would be beneficial in providing stronger evidence and making a greater critical appraisal of evidence more accessible.</p>

Ketoconazole associated hepatotoxicity: a systematic review and meta- analysis / 生物医学与环境科学（英文）

<p><b>OBJECTIVE</b>To evaluate the incidence of Ketoconazole associated hepatotoxicity and related factor.</p><p><b>METHODS</b>Literature retrieval was conducted by using multi-databases for meta-analysis on Ketoconazole associated hepatotoxicity. The data were collected with a standardized form. Overall estimation of incidence of hepatotoxicity for specific study type was calculated by using a DerSimonian-Laird random-effects model owing to the substantial differences among the studies.</p><p><b>RESULTS</b>Totally 204 eligible studies were included in the analysis. The incidence of Ketoconazole associated hepatotoxicity was 3.6%-4.2%. The dosage and duration specific subgroup analyses did not show any significant difference among groups, while the age specific subgroup analysis showed the incidence in children and people aged >60 years was 1.4% (95% CI: 0.5%-4.2%) and 3.2% (95% CI: 1.1%-8.7%) respectively. Additionally, the incidence of the hepatotoxicity was higher in people who had oral administration of ketoconazole beyond the provisions of the usage instructions, and the incidence was 5.7% (95% CI: 4.5%-7.2%).</p><p><b>CONCLUSION</b>Ketoconazole associated hepatotoxicity was common. Off-label use might increase the risk of liver damage. Well-designed large sample studies are needed to identify the risk factors in future.</p>

Meta-analysis of Shenmai injection treatment for acute myocardial infarction / 中国中药杂志

<p><b>OBJECTIVE</b>To assess the efficacy and safety of Shenmai injection for acute myocardial infarction (AMI).</p><p><b>METHOD</b>All clinical studies of Shenmai for AMI were searched from Cochrane library, Medline, EMbase, CBM, CNKI, Wanfang and VIP. For efficacy analysis of Shenmai, randomized controlled trials (RCTs) and quasi-RCTs were included and the Cochrane Collaboration's RevMan 5.1 was used for data analysis.</p><p><b>RESULT</b>1) Fifty studies were included for efficacy analysis, in which, only 1 study was true RCT, all of studies did not mention allocation concealment, blind and information of loss to follow-up. The fatality rate during hospitalization (OR 0.43, 95% CI [0.31-0.60]), incidence of heart failure (OR 0.49, 95% CI [0.34-0.70]), incidence of shock (OR 0.53, 95% CI[0.30-0.93]) and incidence of re-infarction (OR 0.16, 95% CI [0.03-0.77]) in Shenmai injection plus conventional treatment group was lower than that in the conventional treatment group, while the rate of recanalization (OR 1.24, 95% CI [0.90-1.71]) was similar between the two groups. 2) For safety analysis, we did not found serious adverse drug reaction/adverse events (ADR/AE) of Shenmai injection for AMI.</p><p><b>CONCLUSION</b>The currently available evidence showed that Shenmai injection plus conventional treatment group may decrease the fatality rate during hospitalization, the incidence of cardiac failure, shock and re-infarction. However, these findings should be carefully interpreted due to the low methodological quality and small sample size of trials. Although serious ADR/AE was did not report of Shenmai injection, the post-marketing safety evaluation is need to be performed.</p>

Meta-analysis of Dengzhanxixin injection treatment for unstable angina pectoris / 中国中药杂志

<p><b>OBJECTIVE</b>To assess the efficacy and safety of Dengzhanxixin injection for unstable angina pectoris.</p><p><b>METHOD</b>All clinical studies of Dengzhanxixin injection for unstable angina pectoris (UAP) were searched from Cochrane library, Medline, EM-base, CBM, CNKI, Wanfang and VIP. Quality assessment and information extraction were done by two independent screening . The quality of the included documents was evaluated by the Cochrane Collaboration's tool for assessing risk of bias and allocation concealment. Revman 5.1.4 software was used for data analysis.</p><p><b>RESULT</b>A total of 17 randomized controlled trials were included (1 644 patients), in which, only 2 studies were true RCT, 1 study used single blind method, while other studies did not mention allocation concealment, blind and loss-up information. Meta-analysis showed that the Dengzhanxixin injection group was better than the conventional treatment group in efficiency (OR = 3.54, 95% CI [2.60-4.82]) and ECG (OR = 2.36, 95% CI[1.88-2.96]). Researches with ADR/AE information of Dengzhanxixin injection showed that the symptoms of ADR/AE were slight. This study may exist publication bias.</p><p><b>CONCLUSION</b>Dengzhanxixin injection on the basis of conventional treatment can improve the efficacy of the treatment of unstable angina pectoris. However, due to the sample size of included studies were small and of lower quality, conclusions above still need high-qualitied randomized, double-blind, controlled trials be confirmed.</p>

Systematic review of Shuxuetong injection for progressive ischaemic stroke / 中国中药杂志

<p><b>OBJECTIVE</b>To assess the clinical efficacy and safety of Shuxuetong injection against progressive ischaemic stroke.</p><p><b>METHOD</b>Randomized controlled trials (RCTs) and quasi randomized controlled trials (quasi-RCTs), which focused on treating patients with progressive ischaemic stroke using Shuxuetong injection were identified from Cochrane library, Medline, EMbase, CBM database, CNKI database, VIP database and Wanfang database. Data was extracted and evaluated with designed form. RevMan 5.1 software was used for data analysis.</p><p><b>RESULT</b>Eleven RCTs with 972 patients were included in this review. Only one research reported the mortality rate. None of the trials mentioned dependency of the patients during the follow-up period. The results of Meta analysis were listed as follows. Compared with normal treatment measures, total effective rate of 11 RCTs suggested that Shuxuetong were more effective with OR 4.46, 95% CI [3.02-6.59]. A greater difference in patients using Shuxuetong injection was found in 7 RCTs about the NDS with MD 5.86, 95% CI [4.80-6.93], compared with normal treatment measures. Researches with ADR/AE information of Shuxuetong injection showed that the symptoms of ADR/AE were moderate.</p><p><b>CONCLUSION</b>Conclusions from this review may have a high risk of bias because of the low quality of the researches, hence it was not adequate to draw any reliable conclusions about the efficacy of Shuxuetong injection in progressive ischaemic stroke. More trials with high quality are required in the following researches.</p>