Objective To assess the clinical efficacy and safety of Shuxuetong in the treatment of cerebral infarction. Methods Randomized controlled trials (RCTs) were identified from MEDLINE (1996 to Feb. 2006), EMBASE (1984 to Dec. 2005), Cochrane Controlled Trials Register (Issue 4, 2005), Chinese Cochrane Centre Database, CBMdisc (1978 to Dec. 2005). We handsearched the related published and unpublished data and their references. All trials about Shuxuetong injection for cerebral infarction were included. Data were extracted and evaluated by two reviewers independently with designed extraction form. RevMan 4.2.8 software was used for data analysis. Results Eleven RCTs involving 1 122 patients were included. The results of meta-analysis were listed as follows: ① Total effective rate: Compared with Danshen, three studies showed that Shuxuetong were more effective with OR 4.01, 95%CI 2.00 to 8.04; ② Adverse effect: The number of adverse drug reaction was small and the symptoms were moderate; ③ Neurologic impairment score: Compared with safflower, one study showed that Shuxuetong had better improvement with WMD -2.60, 95%CI -3.23 to -1.97. Conclusions Shuxuetong may increase the total effective rate of cerebral infarction. More high quality trials are required.
Blinding is an effective measure to control and reduce the bias caused by the subjective factors of participants in a study. However, the failure of blinding results in more bias. Therefore, it is necessary to assess blinding quality in clinical trials involving blinding. The relevant international articles and methods of blinding assessment were summarized in this study. According to the present situation of blinding assessment, researchers don't pay enough attention to the assessment of blinding quality, relevant studies lack, comprehensive methods and tools for blinding quality, and researchers have discrepancy with time points in blinding quality. Therefore, it is necessary to conduct further studies in all aspects, and it is suggested that comprehensive blinding quality scales should be developed according to the key influencing factors of the implementation of blinding. Through the assessment of the implementation of key factors, the risk and degree of blinding should be confirmed in order to better interpret and assess researcher results.
Through summarizing the definition, concept, and development of patient registry, and also retrieving ClinicalTrials.gov, we introduce its application areas, application range, disease, research number. Based on the application situation, we present the challenges faced now and future development of direction.
This article introduces a dynamical stratified blocked randomized algorithm when the static stratified blocked randomized algorithm is not suitable to resolve the problem caused by uncertain stratified factors and levels during calculation of the sample size at the stage of clinical trial design. Prior to the start of the clinical trial, a list of random numbers is created by blocked randomized algorithm. During field implementation, a block of random numbers is dynamically allocated to a stratify level. Thereafter, a subject is randomized into different groups in that block. The study of Chinese medicine for gastric cancer anemia and blood hypercoagulability is used as an example to illustrate how to design and implement dynamic stratified block randomized algorithm. The results show that the dynamic stratified block randomized algorithm is more flexible and adaptable than the static stratified blocked randomized algorithm. However, its application is more complex and requires higher standards in clinical trials.
ObjectiveTo compare the risk factors of angina pectoris and atherosclerotic thrombotic cerebral infarction, and to study the possible risk factors of angina pectoris complicated with atherosclerotic thrombotic cerebral infarction (XNHB abbr. in Chinese) and provide the basis for the prevention of XNHB. MethodsClinical epidemiological cross-sectional survey methods were used. Information of angina pectoris patients, atherosclerotic thrombotic cerebral infarction patients and XNHB patients were collected. The statistical software SPSS 17.0 was used to analyze the single risk factors, and then logistic regression analysis was used to filter the independent risk factors of XNHB. Results1 002 cases of angina pectoris, 963 cases of atherosclerotic thormbotic cerebral infaction and 982 cases of XNHB were included. There were significant differences among the three diseases in the following index:age (P=0.000 0), gender (P < 0.000 1), resting lifestyle (P=0.000 0), body mass index (BMI) (P=0.000 0), diabetes (P=0.001 9), hypertension (P < 0.000 1), diabetes complicated with hypertension (P < 0.000 1), smoking (P < 0.000 1), alcohol consumption (P < 0.000 1), and the combination of more than 3 risk factors (P=0.000 0). Age (OR=1.690, 95%CI 1.420 to 2.012), hypertension (OR=1.558, 95%CI 1.312 to 1.850), abnormal BMI (OR=1.356, 95%CI 1.158 to 1.587) and resting lifestyle (OR=1.319, 95%CI 1.107 to 1.572) were shown as the independent risk factors of XNHB filtering by logistic multiple regression analysis. ConclusionThe elderly with hypertension, abnormal BMI or live a resting way of life are more likely to have XNHB, so positive control of risk factors should be needed.
ObjectiveSham acupuncture control is a commonly employed method to assess the specific effects of acupuncture in clinical trials. However, due to the absence of specific reporting standards, the reporting quality of sham acupuncture in these trials is low. In order to standardize the reporting of sham acupuncture and improve the reporting quality of sham acupuncture, our project team has developed SHam Acupuncture REporting guidelines and a checklist in clinical trials (SHARE). MethodsThe development process included four parts: we conducted literature research to form initial items of sham acupuncture reporting; two rounds of Delphi surveys were carried out to evaluate the reporting necessity of these initial items; two expert consensus meetings were held to further discuss and agree upon the Delphi results and approve the SHARE checklist; a pilot testing was conducted to assess the feasibility and practicality of the list and make necessary revisions to generate the final SHARE checklist. ResultsThe SHARE checklist consisted of 10 categories with 19 items. The requirements for reporting sham acupuncture primarily focused on sham acupuncture detailed information as well as relevant background factors. ConclusionThe SHARE serves as specialized reporting guidelines for sham acupuncture that offers clear guidance on comprehensive and concise reporting of sham acupuncture.