Objective To introduce how to use Stata software to implement the randomization of clinical trials. Methods Some examples were taken to describe how to implement the randomization of each kind of clinical trials. Results Stata implemented its required functions, such as simple randomization, stratified randomization, block randomization and the randomization of group treatment. Conclusion Stata can easily implement the randomization of clinical trials.
Objective To evaluate the efficacy and safety of genus Phyllanthus for chronic HBV infection. Design a systematic review of randomized clinical trials. Methods Randomized trials comparing genus Phyllanthus versus placebo, no intervention, general non-specific treatment, other herbal medicine, or interferon treatment for chronic HBV infection were identified by electronic and manual searches. Trials of Phyllanthus herb plus interferon versus interferon alone were also included. No blinding and language limitations were applied. The methodological quality of trials was assesses, by the Jadadscale plus allocation concealment. Results Twenty-two randomized trials (n=1 947) were identified. The methodological quality was high in five double blind trials and rest was low. The combined results showed that Phyllanthus species had positive effect on clearance of serum HBsAg (relative risk 5.64, 95%C1 1.85 to 17.21) compared with placebo or no intervention. There was no significant difference on clearance of serum HBsAg, HBeAg and HBV DNA between Phyllanthus and interferon. Phyllanthus species were better than non-specific treatment or other herbal medicines on clearance of serum HBeAg, HBeAg, HBV DNA, and liver enzyme normalization. Analyses showed a better effect of the Phyllanthus plus interferon combination on clearance of serum (1.56, 1.06 to 2.32) and HBV DNA (1.52, 1.05 to 2.21) than interferon alone. No serious adverse events were reported. Conclusions Based on the review Phyllanthus species may have positive effect on antiviral activity and liver biochemistry in chronic HBV infection. However, the evidence is not b due to the general low methodological quality and the variations of the herb. Further large trials are needed.
Objective To assess efficacy of mepivacaine on local anesthesia in dentistry and oral surgery and its safety. Methods Parallel group, stratified randomization, double blinded, muti-center clinical trial was designed. Two percent lidocaine with adrenaline in same cartridge was as control. Healthy patients with deep decay, pulpitis needed operative dentistry, or indication for extraction of the teeth, which located in the maxilla or front part of the mandible were included. Results Except 17 cases, 127 patients fulfilled inclusion criteria: 66 in treatment group and 61 in control group, dental filling for 60 and extraction for 67 cases, male 55 and female 72, average at 38.84 + 12.06 years. Submucous infiltration of 1.5 ml mepivacaine at labial or buccal side of the alveolar process produced onset of anesthesia in the median of 60 seconds which was same as that of lidocaine, anesthesia duration for 146.7 minutes with the median of 125 minutes, permitting painless filling or extractions. In the treatment group 81.82% freed of pain, while 15.15% had slight pain but received no extra local anesthetic for implementation of the treatment procedures, making the successful rate of 96.97%. In the mepivacaine group, 13.64% of the cases had transient elevation of the systolic pressure to the level of 145-162 mmHg, 8.33% diastolic pressure to the level of 91-93 mmHg. Only one case had transient palpitation in half minute after one minute injection of the drug with no medical care needed. All the cardiovascular reactions might result from adrenaline containing in the injections. Conclusion Mepivacaine is an effective, safe and reliable anesthetic agent for dentistry and oral surgery.
Objective To demonstrate the efficacy, tolerability, and safety of domestic Acarbose tablet compared with Glucobay (Acarbose tablet produced by Bayer company) in patients with type 2 diabetic patients. Method A multicenter randomized controlled parallel-group comparison study was conducted. 177 Chinese type 2 diabetic patients were recruited from 4 clinical centers. The patients were divided randomly into domestic Acarbose tablet (A group) or Glucoby (B group) treatment group. The trial consisted of a 2-4 weeks equilibrated period followed by an 8 week course of treatment. Results 165 patients have finished the trial (81 in A group and 84 in B group). After 4 weeks of treatment, the mean of fasting blood glucose (FBG) in A and B group were reduced 1.61 and 2.08 mmol/L respectively, and mean of postprandial blood glucose (PBG) lowered 5.06 and 5.09mmol/L respectively. After 8 weeks of treatment, the mean of FBG were reduced 1.95 and 2.62mmol/L respectively, and mean of PBG lowered 4.88 and 5.98 mmol/L, respectively, and mean of HbA1c were lowered 1.13% and 1.20% respectively in A and B group. The differences in reduction of FBG, PBG, and HbA1c between A and B group were no statistic significance. The serum triglyceride levels and BMI were decreased significantly in both A, B groups. 3 patients who drinking wine during trial on A group had asymptomatic elevations in serum transaminases that normalized in 2 weeks after stopped drinking and Acarbose withdrawal. Flatulence was the most common side effect. Conclusions In this multicenter study, domestic Acarbose tablet 50 mg t.i.d. was an effective, safe, and generally well-tolerated therapy as similar as Glucobay in type 2 diabetic patients.
Objective To evaluate the efficacy and safety of Salviae miltiorrhizae Injection (include Danshen Injection and Fufang Danshen Injection) for chronic cor pulmonale. Design A systematic review of randomized clinical trials. Method Randomized trials comparing Salviae miltiorrhizae Injection plus routine treatment versus muting treatment alone were identified by electronic and manual searches. No blinding and language limitations were applied. The Jadad scale assessed the methodological quality of trials. Results Thirty randomized trials (n=2 161) were identified. The methodological quality of all trials included was low. The combined results (RR and 95%CI) of symptom scores was 1.20 (1.15 to 1.26). Because of the significant heterogeneity, many other markers of the blood rheology can not be combined. The reason for heterogeneity should include the differences among cases and studies. Because of lacking enough studies, the conclusions about mortality and oxidants/antioxidants markers were not b. Only a few studies had reported adverse events. Conclusions Based in the review, Salviae miltiorrhizae Injection may have positive effect on symptom scores in patients with chronic cor pulmonale. But for mortality, the markers of blood rheology and oxidants/antioxidants, there is no reliable conclusion. However, the evidence is not b due to the general low methodological quality, the variations among studies and experimental markers themselves, and lacking of more relevant and important markers. Further large trials are needed.
The re-evaluation of the effectiveness of new drugs is of great importance when they are in post-market for there exist some limitations in clinical trials before these drugs are put on the market. The large sample multi-centre randomized controlled trial is the best method of re-evaluation of the effectiveness of new drugs. It could appropriately evaluate not only the large-term efficacy and safety of drugs, but the treatment effect on the survival state and its complications as well. This method will also lead to a great social amp; economic benefit.
Medical ethics must be considered for protecting the fights and interests of patients in clinical trials. Now the fights of the subjects are more and more emphasised, but there are some problems. It is evidence-based medicine (EBM) and emphasis of evidence that need the high-quality clinical trials, yet it violates the principle of ethics in some degree. It will be helpful for the administrators to supervise the clinical trials on drugs well from the point of ethical views.
The randomized controlled trial is the best evidence in the evidence-based medicine. The cardiovascular disease internal department is the typical example of the evidence-based medicine. A serial large-scale randomized controlled trials provided the evidence and improved clinical treatment level. For normal development of a large-scale randomized controlled trials need to enhance the standard management.
目的 为避免选择和发表偏倚,系统评价者应采用多种查询技术,并尽力获得未发表的研究.本文试图探讨,英特网检索对鉴定未发表和正在进行的临床试验是否有用.研究设计 利用七个Cochrane系统评价的查询策略回顾性地在英特网上检索未纳入的随机对照试验.方法 检索策略 以普通检索式"研究方法学 NEAR干预措施NERA 条件"、用AltaVista在英特网上搜索.测量指标包括搜索时间、英特网搜索已发表研究的回溯率、精确度(已发表和未发表的随机临床试验链接的网页比例)、英特网检索到的未纳入的未发表和正在进行的研究数.结果 用21小时查询了429个网页,找到14个链接到未发表的、正在进行的或最近完成的试验,至少有9个与4篇系统评价相关.英特网检索已发表研究文献的回溯率在0～43.6%,其链接已发表和未发表研究的精确度在0～20.2%.结论 未发表尤其是正在进行的试验的信息可在英特网上找到.潜在的问题是如何评价未经同行评审的电子出版物的质量.急需更强的搜索工具.建议用"Open Trial Initiative"定义英特网发表试验的语法,以加强试验登记的共同操作性.因此,专门的搜索引擎可找到更多有关正在进行和已完成的临床试验信息.
Objective To investigate the quality of the randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) integrated with western medicine for severe acute respiratory syndrome (SARS). Method All the randomized controlled trials of traditional Chinese medicine integrated with western medicine for SARS worldwide were gained by electronic searching and hand searching. The quality of the RCTs was analyzed by the quality grade evaluation used in Cochrane handbook.The sample size, the baseline data, the results indexes were also analyzed. Results Seven RCTs included 501 SARS cases were identified. The quality grade of one RCT is B, the other six RCTs were graded C. None pre-specified sample size. One RCT tested the differences of the baseline data by statistic method. One RCT reported quality of life as result index. None reported the adverse events.Conclusions Current RCTs of TCM integrated with western medicine can’t provide b evidence for clinical practice because of the poor quality.