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 We handsearched the related published and unpublished data and their references.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.
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.
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.