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.
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.
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.
Objective To review systematically whether there is enough existing evidence that methylcobalamin is effective and safe in the treatment of the patients with diabetic peripheral neuropathy.Methods A Cochrane systematic review of all relevant randomized or quasi-randomized controlled trials of methycobalamin for diabetic peripheral neuropathy was performed. Clinical trials were searched from Cochrane Controlled Trials Register (Issue 4, 2003), MEDLINE (January 1966 to January 2004), EMBASE (January 1980 to January 2004), the Chinese Biological Medicine Database (1978 to January 2004), the Chinese Science and Technology Journal Full-text Database (1989 to January 2004) and references of all included trials. The selection of studies, data extraction and assessment of methodological quality were performed independently by two reviewers. The following outcomes were assessed: effectiveness of clinical signs and symptoms, sensory nerve and motor nerve conduction velocities and serious adverse events of methylcobalamin. Results Thirty randomized clinical trials including 1 949 patients met the inclusion criteria. The quality of the most included trials was of low level. The "funnel plot" of the comparison of thirteen studies of methylcobalamin with other B Vitamins studies showed symmetry, which indicated less possible publication bias and the result was partly reliable, but it could not indicate the whole publication biases. The results of meta-analysis indicated that methylcobalamin showed significantly positive effects on the improvement of the signs and symptoms of peripheral neuropathy, and the effects were better than the other vitamin B agents. The increase of some nerves conduction velocities by methylcobalamin was better than by the other vitamin B. No serious adverse events were observed during the treatment period.Conclusions Methylcobalamin appears to be a safe and effective treatment on diabetic peripheral neuropathy. However, the evidence is not b because of the low quality of most trials. Rigorously designed, randomized, double-blinded, placebo-controlled trials of methylcobalamin for diabetic peripheral neuropathy are needed to further assess the effect.
Objective To systematically review the efficacy of different exercises on inflammatory cytokines in individuals with overweight or obesity. Methods The CNKI, WanFang Data, VIP, PubMed, EBSCO, Cochrane Library, Web of Science and Embase databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy of exercise on inflammatory cytokines in individuals with overweight or obesity from January, 2000 to April, 2021. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. The network meta-analysis was then performed using Stata 16.0 software. Results A total of 63 RCTs were included, 49 of which reported the changes in IL-6, 47 of which reported the changes in TNF-α, and 16 of which reported the changes in IL-10. The results of the network meta-analysis found that compared with those in the control group, aerobic exercise (AE) (SMD=−0.9, 95%CI −1.4 to −0.5, P<0.01) and high-intensity interval training (HIIT) (SMD=−1.3, 95%CI −2.3 to −0.3, P=0.011) significantly reduced IL-6. AE (SMD=−1.3, 95%CI −1.7 to −0.9, P<0.01), combined exercise (COM) (SMD=−0.7, 95%CI −1.3 to −0.1, P=0.02), and HIIT (SMD=−1.8, 95%CI −2.6 to −0.9, P<0.01) significantly reduced TNF-α; AE (SMD=0.8, 95%CI 0.1 to 1.5, P=0.03) significantly increased IL-10. The cumulative probability ranking results showed that HIIT was the most effective in reducing IL-6 and TNF-α and increasing IL-10, followed by AE and COM, and resistance training (RT) was the least effective. Conclusion Different exercise types have different effects on improving inflammation in individuals with overweight or obesity. HIIT can be suggested as the best exercise program to improve chronic inflammation in individuals with overweight or obesity. Due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the above conclusion.
Objectives To assess the effectiveness and safety of additional bedtime H2-receptor antagonists (H2RAs) in suppressing nocturnal gastric acid breakthrough (NAB). Methods We identified eligible trials by searching The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMbase and CINAHL. We handsearched the data from the proceedings of correlated conferences, eight kinds of important Chinese journals and references of all included trials. All randomized controlled trials evaluating H2RAs for the control of NAB were eligible for inclusion. The systematic review was conducted using methods recommended by The Cochrane Collaboration. Results Only two randomized crossover studies including 32 participants met the inclusion criteria. Because the design, dosage and duration of the treatment were different between the studies, it was impossible to conduct Meta-analysis. There was no consistent conclusion between the two included studies in evaluating H2RAs for the control of NAB. Conclusion We can not conclude any implications for practice at this stage. Appropriately designed large-scale randomized controlled trials with long-term follow-up are needed to decide the effects of additional bedtime H2RAs in suppressing NAB.
Objective To systematically evaluate the effectiveness and safety of itopride vs. mosapride in patients with functional dyspepsia, so as to provide references for clinical practice. Methods According to strict inclusive and exclusive criteria, relevant randomized controlled trials (RCTs) on itopride vs. mosapride for functional dyspepsia were searched in CENTRAL, Medline, Embase, ISI, OVID, CBM, VIP, WanFang Data and CNKI from the date of their establishment to November 2011. Two reviewers independently screened literature, extracted data and evaluated methodological quality. Meta-analyses were conducted using Revman 5.1 software. Results A total of 4 trials involving 363 patients were included and data were coped with meta-analysis. a) About the improvement of overall symptoms: itopride was not superior to mosapride, with no significant difference (OR=1.62, 95%CI 0.53 to 4.93, P=0.4); b) About the improvement of single symptom: itopride was not superior to mosapride in improving single symptom as follows: postprandial fullness, upper abdominal distention, poor appetite, and upper abdominal pain, with no significant difference; and c) About the incidence of adverse events: itopride was similar to mosapride (OR=0.63, 95%CI 0.31 to 1.29, P=0.21). Conclusion Current evidence shows that itopride is similar to mosapride in effectively improving overall symptoms and single symptom, and it has fewer side effects than mosapride does. Due to the low quality of most included studies, more strictly-designed and large-scale RCTs are needed to provide reasonable proofs for clinic.
Objective To identify and investigate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in 11 non-key Chinese medical journals so as to learn about the current status and problems. Methods Eleven non-key medical journals of TCM from 1995 to 2000 were hand searched to identify the RCT and controlled clinical trials (CCTs). Each identified RCT or CCT was page by page verified by handsearchers based on the criteria developed by the Cochrane Handbook; the RCTs’ design, randomization method description, blind, baseline comparison, inclusion and exclusion criteria, diagnostic criteria,criteria for theraputic effectiveness, sample size, statistical method，described outcome, side effects, and follow up etc. were analyzed. Results In the related journals from 1995 to 2000, a total of 66 volumes and 390 issues were checked. As a result, 22 739 clinical studies were identified, of which 1 416 RCTs, only 24 (1.69%) were done with double blinding. There were 141 CCTs from 1995 to 2000, the total number of RCT increased from 95 to 1 416 and most of studies were on digestives diseases. Most of these studies had no detailed randomization method description, only 38 (2.68%) studies provided a methodology description. In addition, 1 220 (86.16% ) described outcome index, 1 203 (84.96%) used statistical method，934 (65.96%) had baseline comparison，828 (58.47%) described diagnostic criteria, 197 (13.91%) had inclusion and exclusion criteria，finally only 89 (6.29%) reported side effects. Conclusions Although the number of RCT has increased in the 11 non-key medical journals of TCM in the past six years, the quality of these RCTs needs to be improved.
Objective To review the eradication rate for Helicobacter Pylori (H. pylori) eradication therapy with Ranitidine bismuth citrate (RBC). Methods A systematic review of all the relevant randomized controlled trials (RCTs) was performed according to International Cochrane Collaboration. Data Source RCTs were identified from specialized trials register of Cochrane U GDP Group, the Cochrane library, additional electronic search (including MEDLINE and CBM), handsearching, and personal contact with pharmaceutical companies. Data Selection Randomized clinical trials comparing RBC or RBC in combination with other antibiotics such as proton pump inhibitor, H2-receptor antagonist, other bismuth or placebo were included. No language and blinding limitations were applied. Inclusion criteria Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad-scale plus allocation concealment. Statistics analysis was managed by using RevMan 4. 1. Results Fifteen randomized clinical trials including 3 638 patients were included, with eight trials of high methodological quality. Meta-analysis indicated that odds ratio was 3.06 (95%CI 2.62 to 3. 58, P lt; 0. 000 01) comparing RBC to controls. But the heterogeneity was significant (P lt; 0. 000 01), so we choose random effects model. Then the odds ratio was 2.05 (95%CI 1. 29 to 3. 25, P=0.002). No serious adverse effects were found. Sensitivity analysis showed that the specimens and the quality of RCT haven’t affected researching result. Conclusion RBC is more effective in Helicobacter Pylori eradication therapy than others.
Objective To evaluate the reporting quality and influencing factors of patient-reported outcome (PRO) data in randomized controlled trials (RCTs) of lung cancer. Methods RCTs of lung cancer with PRO as either primary or secondary endpoints were searched from PubMed, EMbase, Medline, CNKI, Wanfang Data, and VIP databases between January 1, 2010 and April 20, 2024. Reporting quality of included RCTs were assessed based on the CONSORT-PRO extension. Descriptive statistics and bivariate regression analysis were used to describe the reporting quality and analyze the factors influencing the reporting quality. Results A total of 740 articles were retrieved. After screening, 53 eligible RCTs of lung cancer with 22 780 patients were included. The patients were mainly with non-small cell lung cancer (84.91%), with the median sample size of the included studies was 364.0 (160.5, 599.5) patients. The primary PRO tool used was the EORTC QLQ-C30 (60.38%). There were 52 (98.11%) studies whose PRO measured the domain of "symptom management of cough, dyspnea, fatigue, pain, etc.", and 45 (84.91%) studies measured "health-related quality of life". Multicenter studies accounted for 84.91%, and randomized non-blind trials accounted for 62.26%. PRO was used as the primary endpoint in 33.96% of the studies and as secondary endpoints in 66.04%. The reliability and validity of the PRO tools were explicitly mentioned in 11.32% and 7.55% of the studies, respectively. The average completeness of reporting according to the CONSORT-PRO guidelines was 60.00%, ranging from 25.00% to 93.00%. The main factors affecting the completeness of CONSORT-PRO reporting included sample size and publication year. For every increment in sample size, the completeness of reporting increased by 27.5% (SE=0.00, t=2.040, P=0.046). Additionally, studies published after 2018 had a 67.2% higher completeness of reporting compared to those published in or before 2018 (SE=17.8, t=–3.273, P=0.006). Conclusion The study reveals that the overall reporting quality of PRO in lung cancer RCTs is poor. Particularly, the reporting of PRO measures reliability and validity, PRO assumptions, applicability, and handling of missing data need further improvement. Future research should emphasize comprehensive adherence to the CONSORT-PRO guidelines.