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As a kind of intervention measures of traditional Chinese medicine, acupuncture-moxibustion is highly adopted on global clinical practice. Even though the global clinical trial registration system was established more than 10 years ago, the proportion of acupuncture-moxibustion clinical trial registration is still very low; and it is very problematic on the methodological quality and report quality in the published acupuncture-moxibustion clinical trials. In order to manage particularly the acupuncture-moxibustion clinical trials, China Academy of Chinese Medical Sciences, collaborated with China Association of Acupuncture and Moxibustion and World Federation of Acupuncture Societies, established the Acupuncture-Moxibustion Clinical Trail Registry (AMCTR). AMCTR is a secondary registry platform affiliated to the Chinese Clinical Trial Registry (ChiCTR) and WHO International Clinical Trials Registry Platform (ICTRP), specifically for the acceptance and management of clinical trials in the field of acupuncture and moxibustion. It is a nonprofit academic organization, located in China Academy of Chinese Medical Sciences.
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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 );heterogeneity was found in the urine output under general anesthesia ( P 0.05 ) .Conclusion 6% HES 130/0.4 is safe and effective when applied for the patients undergoing elective surgery .
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The STandards for Reporting Interventions in Clinical Trials Of Moxibustion (STRICTOM), in the form of a checklist and descriptions of checklist items, were designed to improve reporting of moxibustion trials, and thereby facilitating their interpretation and replication. The STRICTOM checklist included 7 items and 16 sub-items. These set out reporting guidelines for the moxibustion rationale, details of moxibustion, treatment regimen, other components of treatment, treatment provider background, control and comparator interventions, and precaution measures. In addition, there were descriptions of each item and examples of good reporting. It is intended that the STRICTOM can be used in conjunction with the main CONSORT Statement, extensions for nonpharmacologic treatment and pragmatic trials, and thereby raise the quality of reporting of clinical trials of moxibustion. Further comments will be solicited from the experts of the CONSORT Group, the STRICTA Group, acupuncture and moxibustion societies, and clinical trial authors for optimizing the STRICTOM.
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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.
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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.
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Objective To evaluate the effectivity and safety of dual antiplatelet therapy with clopidogrel and aspirin in patients with ST-segment elevation acute yocardial infarction(AMI).Methods We searched for randomized controlled trials(RCTs)and quasi-RCTs in the following electronic databases:PubMed,EMBASE,The Cochrane Library(Issue 3,2007),CBM,CNKI,VIP and Wanfang.Quality assessment and data extraction were conducted by two reviewers independently.Disagreement were resolved through discussion.All data were analyzed by using Review Manager 4.2. Results Ten studies involving a total of 52 433 participants met the inclusion criteria.Metaanalysis results showed that:(1)Compared with aspirin alone,the incidence rates of death caused by any reason(RR=0.91,95% CI:0.85～0.97),recurrent myocardial infarction(RR=0.80,95% CI:0.72～0.89),stroke(RR=0.81,95% CI:0.68～0.96),post-infarction angina(RR=0.35,95% CI:0.19～0.66),incoronary thrombus(RR=0.73,95% CI:0.64～0.83)and the combined endpoint events of death,reinfarction or stroke(RR=0.89,95% CI:0.84～0.95)could be reduced by clopidogrel and aspirin.(2)There were no significant differences in ameliorating the cardiac function and increasing TIMI blood flow of infarct-related artery between the two groups RR=0.97,95% CI:0.92～1.03;RR=1.14,95% CI:1.00～1.30;both P＞0.05.(3)There was no significant difference in bleeding between the tWO groups(RR=1.11,95% CI:0.92～1.34). Conclusions Compared with aspirin alone,clopidogrel plus aspirin has good effects on reducing the incidence rates of death caused by any reason,recurrent myocardial infarction,stroke,post-infarction angina,incoronary thrombus and the combined endpoint events of death,reinfarction or stroke in patients with ST-segment elevation AMI,and it has the same efficacy in ameliorating the cardiac function,increasing TIMI blood flow of infarct-related artery and bleeding.
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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.
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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.
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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.
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OBJECTIVE: To discuss the quality of reporting in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the reporting of future clinical studies in this therapeutic area. METHODS: A search of the Cochrane Library was conducted to identify RCTs of CHM. A revised CONSORT checklist designed for CHM clinical studies was implemented. The revised CONSORT checklist contained 63 items, including the following new items added specifically for CHM: (1) "syndrome of disease" based on Chinese medicine theories; (2) rationale of CHM formula; (3) formula composition; (4) preparation form of CHM; (5) quality control of CHM. RESULTS: The overall reporting quality of the RCTs as assessed with the revised CONSORT checklist varied between 19% and 44%, with a median score of 32% (standard deviation 8%). CONCLUSION: The overall quality of reporting of RCTs of CHM evaluated with a revised CONSORT checklist was poor, reflecting the need for improvements in reporting future clinical trials in this area. RECOMMENDATIONS: To improve the quality of reporting of RCTs of CHM, we recommend adopting a revised CONSORT checklist that includes items specific to CHM. We also recommend that editors of CHM journals require authors to use a structured approach to presenting their trials as a condition of publication.
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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.
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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
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<p><b>OBJECTIVE</b>To develop a non-pharmacotherapy program for patients with hyperlipidemia and assess its effectiveness.</p><p><b>METHODS</b>A cluster control trial was used. The experimental group was given non-pharmacotherapy for hyperlipidemia once a week for 6 weeks; the content of non-pharmacotherapy included the basic knowledge about hyperlipidemia, a guide of changing unhealthy diet and life-style. Patients were followed for once every two weeks in the department of out-patient. The control group received general care conducted by university clinicians, without the non-pharmacotherapy program. A self-completion questionnaire on hyperlipidemia-related knowledge level, questionnaires on diet and exercise, body weight, body height and the serum TG, TC were measured at entry point and at the end of 6 month.</p><p><b>RESULTS</b>One hundred and fifty-four patients in experimental group and 150 patients in control group completed the study. The non-pharmacotherapy group showed a significant increase of knowledge on hyperlipidemia in the experimental group comparing with the control group: the mean (sd) score of hyperlipidemia-related knowledge were 22.5 (4.8), 17.4 (4.2) (95% CI: 4.1, 6.1). The diet score and the proportion of regular physical activity had increased 27.20%, 21.78% respectively in experimental group. The mean (sd) of serum TG, TC and body mass index (BMI) for experimental group [2.0 (0.9) mmol/L, 5.4 (0.9) mmol/L, 23.4 (1.9)] lowered significantly comparing to those for control group [2.4 (0.9) mmol/L, 5.9 (1.0) mmol/L, 24.2 (3.0)].</p><p><b>CONCLUSION</b>Non-pharmacotherapy seemed to be an important intervention for the patients with hyperlipidemia. If same patients with hyperlipidemia failed to respond to non-pharmacotherapy, it is necessary to use pharmacotherapy. However, non-pharmacotherapy should be viewed as basic therapy.</p>
Subject(s)
Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Hyperlipidemias , Blood , Therapeutics , Life Style , Lipids , Blood , Regression AnalysisABSTRACT
<p><b>OBJECTIVE</b>To assess the effect of iodised salt for preventing iodine deficiency disorders.</p><p><b>METHOD</b>Cochrane systematic review.</p><p><b>RESULTS</b>Four randomised controlled trials were included. Subgroup analysis performed lay on different ages, interventions and controls. Prevalence of goitre was reduced close to 5% when using distributed iodised salt and market iodised salt plus iodine oil capsule which showed more effective than using market iodised salt alone (OR = 0.10, 95% CI: 0.02 - 0.17). The latter's prevalence of goitre was 14.7%. When using market iodised salt, the iodine urea excretion level showed different results in children group in different countries. Basically, the market iodised salt for preventing iodine deficiency of pregnancy women were effective, but a part of them did not achieve to the ideal status of iodine nutrition.</p><p><b>CONCLUSIONS</b>The needs to be strictly controlled quality of iodised salt and market iodised salt plus iodised oil capsule thus can effectively reduce the prevalence of iodine deficiency disorders. However there was not enough evidence to support that market iodised salt can effectively eliminate these disorders, particularly in children. More eligibility trials are needed for providing more evidences.</p>
Subject(s)
Adult , Child , Humans , China , Epidemiology , Goiter , Epidemiology , Iodine , Randomized Controlled Trials as Topic , Sodium Chloride, DietaryABSTRACT
AIM:To determine the relationship between microhistology and cardiac contractility in myocarditis animal model. METHODS:Setting up myocarditis animal model by injecting Coxsackivevirus B 3 (CVB 3) into mice, then observed myocardial morphological changes and measured left ventricular function of mice at the time of first three days and two weeks after injecting CVB 3.RESULTS:Subcellular structure (mitochondria) changed at the first three days after injecting CVB 3. The left ventricular pressure (LVP) and the rate of intraventricular pressure development (d p /d t ) which is the index of reflecting cardiac contractility depressed in this stage (14.2?0.8) kPa and (273.1?10.0)kPa/s, respectively. There were (17.1?0.7)kPa and (359.8?9.3)kPa/s in normal mice, respectively ( P