Objective To evaluate the current situation of randomized controlled trials/ clinical controlled trials (RCT/CCT) on chronic gastritis and whether it could offer reliable evidence for clinical practice in China. Method RCT/CCT on chronic gastritis from eight Chinese clinical journals were searched manually and assessed according to international standard. Results 823 issues containing 213 therapeutic articles were searched and 81 RCT/CCT were identified and assessed. Conclusions The quantity and quality of RCT/CCT on Chronic gastritis in China could not meet the need of clinical practice. RCT/CCT of western medical therapy are much better than those of traditional Chinese therapy and integrated traditional Chinese and western medical therapy ones.
Objective To evaluate the efficacy and safety of the treatment of chronic prostatitis(CP) in China. Methods We search the related original studies about the treatment for Chinese CP all over the world, and only included randomized controlled trials (RCTs). MEDLINE(1966-2007.5), PubMed (1966-2007.5), EMBASE(1988-2007.05), and four Chinese databases were electronically searched and 6 related journals were handsearched. The studies included in the references of eligible studies were additionally searched. Two reviewers independently screened the studies for eligibility, evaluated the quality and extracted the data from the eligible studies, with confirmation by cross-checking. Divergences of opinion were settled by discussion or consulted by the expert. Meta-analysis was performed by using Rev Man 4.2 software.Results Nine original studies involving 917 participants met inclusion criteria. Compared withplacebo, prostant, Wenglitong, Chuanshentong, alpha-blockers, bioflabonoid and porstat could reduce the NIH-chronic prostatitis symptom index[RR1.99, 95% CI（1.60, 2.48）； RR2.76 95% CI(2.13，3.57)； RR2.49, 95% CI(1.24, 4.97)； WMD -5.90，95%CI（-8.12，-3.68）； WMD -2.50, 95%CI（-4.85，-0.15）；WMD -6.07， 95%CI(-7.92， -4.22)]. Alpha-blockers, Wengl itong, bioflabonoid and porstat can also reduce the symtom index of pain.Conclusion Drug interventions could improve NIH-CPSI and total symptoms of CP in some degree, but can not improve all symptoms, future RCTs must use an appropriate sample size and optimal duration and follow-up of participants. It is important to improve the quality of internal original studies.
ObjectiveTo compare the therapeutic effect of dual-chamber pacing (DDD) and ventricular single-chamber pacing (VVI) on arrhythmia via systematic evaluation. MethodsWith the method of Cochrane system evaluation, we searched Medline, Embase, CNKI, PubMed and Wanfang database (the searching time was up to June 30, 2016) for randomized controlled trials comparing DDD with VVI treatingcardiac arrhythmias. Meta analysis was performed using RevMan5.3 software. ResultsWe collected 12 randomized controlled trials of DDD and VVI pacing treating cardiac arrhythmia including 1 704 patients, but the quality of the studies were not good. The results of Meta analysis showed that:compared with VVI pacing mode, DDD pacing mode reduced the risk of atrial fibrillation[RR=0.36, 95%CI (0.22, 0.59), P < 0.000 1]; besides, it reduced the left atrial diameter[SMD=-0.43, 95%CI (-0.68, -0.17), P=0.001], the left ventricular end diastolic dimension[SMD=-0.33, 95%CI (-0.61, -0.05), P=0.02] and increased the left ventricular ejection fraction[SMD=1.03, 95%CI (0.49, 1.57), P=0.000 2]. ConclusionsComparing DDD with VVI on the treatment of cardiac arrhythmia in patients with cardiac arrhythmia, DDD pacing can reduce the incidence of atrial fibrillation and thrombosis, enhance heart function and improve blood supply. But because of the low quality of the included studies, the curative effect cannot be confirmed, and more randomized controlled trials with high quality needs to be carried out in the future.
针刺平行随机对照试验通常没有准确报告试验组和对照组的干预方法.为促进标准化,国际上有经验的针刺医师和研究者组成的小组制定了一些原则,即针刺临床对照试验中干预措施报告的标准(缩写为STRICTA).在征求意见过程中,一些期刊编辑协助对此标准进行了修改,使之与随机对照试验报告的标准(CON-SORT)格式一致,作为该指南对针剌研究报告的延伸.参与此事的杂志编辑已确定要发表该标准,建议其作者群按照此标准准备论文,并将邀请更多杂志采用该标准.目的是使针剌对照试验的干预措施充分报告,从而有利于对这些研究的严格评价、分析及这些措施的推广.
ObjectiveTo evaluate the efficacy and safety of midazolam in the prevention of etomidate-induced myoclonus. MethodsDatabases including PubMed, EMbase, The Cochrane Library (Issue 8, 2015), CBM, WanFang Data, VIP, and CNKI were electronically searched to collect randomized controlled trials (RCTs) about midazolam in the prevention of etomidate-induced myoclonus from inception to August, 2015. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed by RevMan 5.2 and Stata 12.0 softwares. ResultsA total of 14 RCTs involving 1 274 patients were included. The results of metaanalysis showed that, compared with placebo, pretreatment with midazolam injection could reduce the incidence of myoclonus (RR=0.28, 95%CI 0.19 to 0.42, P<0.000 01). The sub-group analysis based on different doses of midazolam showed that all three different doses of midazolam (0.015 mg/kg, 0.03 mg/kg and 0.05-0.1 mg/kg) could reduce the incidence of myoclonus effectively (all P values <0.05). ConclusionPretreatment with midazolam injection can reduce the incidence of etomidate-induced myoclonus without increasing the risk of recovery latency and over sedation. Due to the limited quality of included studies, the above conclusion needs to be further verified by more high quality studies.
Objective To assess the efficacy and safety of Chinese medicinal herbs for treating endometriosis. Methods We searched Cochrane Library, MEDLINE, EMBASE, CBM (from establishment to 2003). Randomized controlled trials (RCTs) and quasi-randomized controlled trials of patients with endometriosis were included. The quality of included studies such as randomization, blinding, allocation concealment and loss of follow up were evaluated and meta-analysis was performed by RevMan 4.3 software. Results Ten RCTs or quasi-RCTs involving 1 120 patients were included. Because of different therapies in the treatment and control groups, the results of outcome were described separately. Most of included studies suggested that the effects of traditional Chinese medicine (TCM) on general effect, pregnancy rate improvement and alleviating dysmenorrhoea were similar to Danazol or Tamoxifen, only a few studies showed better effects. There was no evidence to support that TCM was more effective than western medicine in reducing the size of endometriotic cysts. Only one study mentioned the recurrence rate and showed that TCM enema had lower recurrence rate than oral Tamoxifen with OR 0.17, 95%CI 0.04 to 0.67. Five studies mentioned adverse reactions and showed TCM had fewer adverse effects than western medicine. Conclusions Chinese medicinal herbs are effective in treating endometriosis with fewer adverse effects. The evidence is not b enough because of low quality of the included studies. Therefore, more high quality randomized controlled trials are required.
Objective To evaluate the efficacy and safety of Tongxiening granule （TXNG） in the treatment of diarrhea-predominant irritable bowel syndrome （IBS） （stagnation of the liver-qi attacking the spleen）. Methods In a prospective, randomized, placebo-controlled, double-blind clinical trial, 60 patients with diarrhea-predominant IBS were randomly divided into the TXNG group （TXNG, 5.0g, 3 times daily; n =30） and the placebo group （placebo, 5. 0g, 3 times daily; n =30）. The treatment was administered for 3 weeks, and the follow-up was conducted for 4 weeks.Results （1）Abdominal pain： The cure rates were 57. 7% vs. 16. 0% （ by per-protocol analysis, PP） and 31.0% vs. 7.1% （ by intention-to-treat analysis （ITT） ; and the overall improvement rates were 92.3% vs. 44.0% （PP） and 82.7% vs. 39.3% （ITT） in the TXNG and the placebo groups respectively （ P 〈0. 05）. （2） Diarrhea ： the cure rates were 46. 2% vs. 20. 0% （PP） and 41.4% vs. 17. 9% （ITT） , and the overall improvement rates were 96. 2% vs 48. 0% （PP） and 86. 2% vs 42.9% （ITT） in the two groups respectively （P 〈0.05）. （3）Traditional Chinese medicine symptoms： the cure rates were 30.8% vs. 4.0% （PP） and 27.6% vs. 3.6% （ITT） ; and the overall improevment rates were 92.3% vs. 48.0% （PP） and 82.7% vs 42.9% （ITT） in the two groups respectively （P 〈0. 05）. The pain duration after treatment in the TXNG group was significantly shortened compared with the placebo group （7.6 ±4. 6d vs 14. 4 ±4. 3d, P =0. 0125）. After 4-week follow-up, it suggested that the recrudescent duration in symptoms related to IBS in the TXNG group was longer than that in the placebo group （11.5 ±5.3 d vs 6.2 ±6.9 d, P = 0. 019）. No adverse effects were found in the TXNG group. Conclusion It was demonstrated that TXNG is effective and safe in the treatment of diarrhea-predominant ms （stagnation of the liver-qi attacking the spleen）.
Cardiac surgery presents specific challenges in conducting randomized controlled trials (RCTs). The American Heart Association made a scientific statement of methodological standards, with the purpose to review key concepts and standards in design, implementation, and analysis of cardiac surgery RCTs, and to provide recommendations. Recommendations include an evaluation of the suitability of the research question, clinical equipoise, feasibility of enrolling a representative patient cohort, impact of practice variations on the effect of the study intervention, likelihood and impact of crossover, and duration of follow-up. Trial interventions and study end points should be predefined, and adequate deliverability of the trial interventions should be ensured. Every effort must be made to keep a high completeness of follow-up. Trial design and analytic techniques must be tailored to the specific research question and trial setting. In this paper, the authors made an interpretation of this scientific statement based on their practical experience.
Objective To evaluate the efficacy and safety of Polyunsaturated phosphatidylcholine (PPC) for chronic hepatitis. Methods We searched EMBASE (1980May,2003), MEDLINE(1966May,2003), CBM (1979May,2003), The Cochrane Library Issue 2, 2003 and handsearched 8 related Chinese journals. Randomized controlled trials(RCT) comparing PPC versus placebo/no treatment for chronic hepatitis were included with no restrictions of blinding, language and publication. Two reviewers independently performed data extraction and assessed the quality . Data were entered and analyzed by RevMan 4.2 software supplied by the Cochrane Collaboration .Results Six high quality trials involving 568 patients were included. Four studies involving 451 patients showed the clinical effective rate of PPC for chronic hepatitis was 52.5% while the control group was 37.5% with statistical difference [RR1.81,95%CI(1.41,2.33),Z=4.69, Plt;0.00001].A meta-analysis involving three studies with 100 patients showed the PPC can statically improve histopathology of chronic hepatitis comparing with control group [RR 2.58,95%CI (1.61,4.15),Z=3.91,Plt;0.0001].No serious adverse events were reported.Conclusions PPC is a safe medicine used for treating chronic viral hepatitis and may relieve clinical symptoms and signs.At the same time ,it has positive effect on hepatic histopathology for patients .However ,more high quality clinical trials are required.
Objectives To systematically review the efficacy of conservative treatment and open reduction with internal fixation for multiple rib fractures. Methods We searched WanFang Data, CNKI, VIP, PubMed, EMbase, The Cochrane Library and Web of Science from inception to December 2017 to collect studies on conservative treatment and open reduction with internal fixation for multiple rib fractures. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. RevMan 5.3 software was used for meta-analysis. Results A total of 16 studies were included, involving 1 374 patients, 723 patients in the surgical group and 651 patients in the conservative group. The meta-analysis showed that the length of stay in the ICU (MD=–3.41, 95%CI –4.92 to –2.43, P<0.000 01), total length of stay (MD=–7.60, 95 %CI–10.67 to–4.53,P<0.000 01), incidence of pulmonary arylene (RR=0.40, 95%CI 0.29 to 0.54,P<0.000 01), incidence of lung infections (RR=0.43, 95%CI 0.30 to 0.61,P<0.000 01), and incidence of chest wall malformation (RR=0.05, 95%CI 0.03 to 0.11,P<0. 0.000 01) in the surgical group were superior to the conservative group. Conclusions Compared with conservative treatment, open reduction with internal fixation can significantly improve the recovery time of patients with multiple rib fractures, reduce hospitalization time, the incidence of perioperative complications, and significantly enhance the prognosis of patients, which is more conducive to the rehabilitation of patients.