Chaihu Injection (CI), which is widely used in treatment of febrile diseases, is an aqueous solution of Chaihu (Radix Bupleuri Chinensis) or Nanchaihu (Radix Bupleuri Scorzonerifolii) prepared by steam distillation.

The authors briefly introduced the management of clinical test for new drug development, clinical trials for drugs prepared in hospital and post-market drugs, and other types of clinical trials. The mechanism of WHO International Clinical Trial Register Platform (WHO ICTRP), Chinese Clinical Trial Register (ChiCTR) and Chinese Clinical Trial Registration and Publishing Collaboration (ChiCTRPC) were also introduced. The authors suggested the trialists to practice the basic philosophy of evidence-based medicine as the rules of their thought and action, and considered that this is the inner guarantee system for the validity of clinical trials.

Objective To assess the diagnostic value of glycosylated hemoglobin A1c (HbA1c) ≥6.5％ for diabetes in Chinese adults with oral glucose tolerance test(OGTT) as the reference standard.Methods Major databases were searched to get all diagnostic tests with HbA1c ≥ 6.5％ for diabetes in Chinese adults.QUADAS items were used to evaluate the quality of the eligible studies.Meta-disc software was used to perform comprehensive quantitative assessment for all included studies and summary ROC (SROC) curve were drawn.Results A total of 11 studies were included.The outcomes of the diagnostic value with HbA1c ≥6.5％ were as the following:pooled sensitivity 0.62 (95％ CI:0.60-0.64),pooled specificity 0.96 (95％ CI:0.95-0.96),diagnostic odds ratio (DOR) 40.25 (95％ CI:20.79-77.95) and AUCSROC 0.7702 (sx =0.0636).Conclusions The diagnostic specificity is pretty high for the diagnostic test with HbA1c ≥6.5％,while sensitivity is low.Combination of HbA1c and glucose tests is needed to reduce the missed diagnosis rate.

Objective To systematically review the safety and effectiveness of 6% hydroxyethyl starch (HES) 130/0.4 and crystalloid solution for the patients undergoing elective surgery .Methods We searched the Medline , EMBASE , CENTRAL , CNKI and Wanfang databases for randomized controlled trials involving comparison of the safety and effectiveness of 6% HES 130/0.4 and crystalloid solution for the patients undergoing elective surgery . The major evaluation indexes included intraoperative blood loss , postoperative incidence of dialysis and intraoperative incidence of hypotension . The secondary evaluation indexes included mortality , perioperative incidence of nausea and vomiting , coagulation function , renal function and incidence of adverse events .The two reviewers independently screened ,evaluated and extracted the data .Meta-analysis was performed using the Cochrane Collaboration’s RevMan 5.2 software .Results Ten trials involving 693 patients were included in our meta-analysis .Eight trials were in English and 2 trials were in Chinese .Comparison of the safety and effectiveness of 6% HES 130/0.4 and balanced solution was conducted in 7 trials (498 patients in total) ,and the results showed that 6% HES 130/0.4 reduced the intraoperative incidence of hypotension (OR 0.31 ,95% CI 0.13-0.75 ) and perioperative incidence of nausea and vomiting , (OR 0.08 , 95% CI 0.01 to 0.67 ) in the patients undergoing spinal anesthesia ( P< 0.05 );there was no significant difference in the intraoperative incidence of hypotension ,perioperative incidence of nausea and vomiting ,mortality ,and intraoperative blood loss under general anesthesia or combined spinal-epidural anesthesia between the two solution groups ( P> 0.05 );heterogeneity was found in the urine output under general anesthesia ( P<0.000 01 ,I2 =93% ) .The safety and effectiveness were compared between 6% HES 130/0.4 and normal saline in 3 trials (195 patients in total) and the results showed that there was no significant difference in the intraoperative blood loss ,intraoperative incidence of hypotension ,perioperative incidence of nausea and vomiting ,coagulation function ,renal function ,and incidence of adverse events between the two solution groups ( P> 0.05 ) .Conclusion 6% HES 130/0.4 is safe and effective when applied for the patients undergoing elective surgery .

Objective:To assesss the effectiveness of dapoxetine in the treatment of premature ejaculation.Methods:Both English and Chinese studies involving men with prematrue ejaculation who were treated with dapoxetine from the Cochrane Library,MEDLINE,EMBASE and CNKI,CBM,VIP between 1979 and 2009.were included in the randomized controlled trials(RCTs) and the data processed by RevMan.Results:Five RCTs involving 4433 patients were included in the Meta analysis,of which 3 were of grade A and 2 were of grade B according to the quality evaluation of methodology.Intravaginal ejaculatory latency time(IELT),patient-reported global impression of change(PGI),satisfaction with sexual intercourse(SWSI),perceived control over ejaculation(PCOE),personal distress related to ejaculation(PDRE) were used for assessment.Meta analysis based on included studies of patients having been treated with dapoxetine for 9-24 weeks showed that:(1) the difference of the patients' IELT between treatment group and control group was statistically significan [P

Traditional Chinese medicine (TCM) intervention should be concisely and precisely reported in randomized controlled trials (RCTs). Based on State Food and Drug Administration's categories, we recommend reporting the interventions as follows: (1) Single Chinese herbal medicine-based/formula-based/extraction-based intervention includes 1) Name, dosage format and registration; 2) The composition and quality of intervention; 3) Pharmaceutical processing and quality control; 4) Stability of final product and quality control; 5) Function and safety description; 6) Dosage and treatment course; 7) Control group. (2) Active compound-based TCM drug intervention includes 1) Name of active compound(s); 2) Original source of active compound(s); 3) The brief process obtaining active compound(s); 4) Percentage of active compound(s) in final product; 5) Added materials and its quality and quantity control. Besides, the detailed information of intervention can be published as an online supplement in web site.

Evaluating outcome is the primary means by which different medical modalities can be compared with regard to effectiveness. In traditional Chinese medicine (TCM), this focus has prompted practitioners to search for outcome measures that can objectively verify the effectiveness of TCM interventions, especially in the context of randomized controlled trials (RCTs). Commonly used indexes for outcome assessment in RCTs of TCM can be categorized into two types: TCM-specific outcomes such as tongue and pulse characteristics, and Western medicine (WM)-specific outcomes such as blood test and X-ray examination results. Some studies include both types of indicators. During the trial design, it is necessary to consider the rationales of selecting outcome assessments, the purpose and study approach, balance between objective and subjective indexes, standardization of outcome assessment, and standardized outcome indexes. We recommend to report the outcome assessment in RCTs of TCM in the following format: 1) identifying the primary and secondary outcomes based on the purpose and hypothesis of the trial; 2) defining the primary and secondary outcomes clearly; 3) presenting the rationale of selection; 4) presenting the method with aims to standardize the assessment process; 5) presenting the method to improve the reliability of assessment; and 6) stating the termination criteria in the trial.

OBJECTIVE: To discuss the types of control groups in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the design of control group in future clinical studies in this therapeutic area. METHODS: A search of the Cochrane Library was conducted in July 2005 to identify RCTs of CHM, and 66 RCTs with CHM for type 2 diabetes mellitus were obtained as the basis for further analysis. RESULTS: Of 66 RCTs with CHM for type 2 diabetes mellitus, 61 (92.4%) trials had both a treatment group and a control group. Twenty-seven (40.9%) RCTs compared CHM plus conventional drug vs conventional drug, 24 (36.4%) compared CHM vs conventional drug, 5 (7.6%) compared CHM vs placebo, 3 (4.5%) compared CHM plus conventional drug vs conventional drug plus placebo, 3 (4.5%) compared CHM plus conventional drug vs other CHM, 1 (1.5%) compared CHM vs no treatment, 1 (1.5%) compared CHM plus placebo vs conventional drug plus placebo, 1 (1.5%) compared CHM vs CHM plus conventional drug vs conventional drug vs placebo, and 1 (1.5%) compared CHM vs conventional drug vs CHM plus conventional drug. CONCLUSION: A variety of control groups were used in RCTs of CHM for type 2 diabetes mellitus, including placebo, active, and no treatment control groups. Justification for selecting particular types of control groups were not provided in the trials reviewed in this study. Different control groups may be appropriate according to the study objectives, and several factors should be considered prior to selecting control groups in future RCTs of CHM. RECOMMENDATIONS: (1) Investigators of CHM who design clinical trials should understand the rationale for selecting different types of control groups; (2) Control groups for RCTs should be selected according to study objectives; (3) Active control groups should select interventions for comparisons that have the strongest evidence of efficacy and prescribe them as recommended; (4) Placebo control groups should select a placebo that mimics the physical characteristics of test intervention as closely as possible and is completely inert; (5) No treatment control groups should only be used when withholding treatment is ethical and objectives outcomes will not be subject to bias due to absent blinding; (6) Crossover control groups may be appropriate in chronic and stable conditions.