Randomized controlled trials(RCTs)have long been recognized as the gold standard for establishing causal relationships in clinical research.Despite that,various limitations of RCTs prevent its widespread implementatio...Randomized controlled trials(RCTs)have long been recognized as the gold standard for establishing causal relationships in clinical research.Despite that,various limitations of RCTs prevent its widespread implementation,ranging from the ethicality of withholding potentially-lifesaving treatment from a group to relatively poor external validity due to stringent inclusion criteria,amongst others.However,with the introduction of propensity score matching(PSM)as a retrospective statistical tool,new frontiers in establishing causation in clinical research were opened up.PSM predicts treatment effects using observational data from existing sources such as registries or electronic health records,to create a matched sample of participants who received or did not receive the intervention based on their propensity scores,which takes into account characteristics such as age,gender and comorbidities.Given its retrospective nature and its use of observational data from existing sources,PSM circumvents the aforementioned ethical issues faced by RCTs.Majority of RCTs exclude elderly,pregnant women and young children;thus,evidence of therapy efficacy is rarely proven by robust clinical research for this population.On the other hand,by matching study patient characteristics to that of the population of interest,including the elderly,pregnant women and young children,PSM allows for generalization of results to the wider population and hence greatly increases the external validity.Instead of replacing RCTs with PSM,the synergistic integration of PSM into RCTs stands to provide better research outcomes with both methods complementing each other.For example,in an RCT investigating the impact of mannitol on outcomes among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial,the baseline characteristics of comorbidities and current medications between treatment and control arms were significantly different despite the randomization protocol.Therefore,PSM was incorporated in its analysis to create samples from the treatment and control arms that were matched in terms of these baseline characteristics,thus providing a fairer comparison for the impact of mannitol.This literature review reports the applications,advantages,and considerations of using PSM with RCTs,illustrating its utility in refining randomization,improving external validity,and accounting for non-compliance to protocol.Future research should consider integrating the use of PSM in RCTs to better generalize outcomes to target populations for clinical practice and thereby benefit a wider range of patients,while maintaining the robustness of randomization offered by RCTs.展开更多
Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight onli...Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight online databases were searched from their inception to December 31,2022,to assess outcomes reported in randomized controlled trials(RCTs)of HMG treated with TCM.The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool.All outcomes were extracted,classified,and described.Results:A total of 8249 articles were initially retrieved.Of these,70 articles were eligible and involved 10618 participants with HMG.A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains.Conclusions:The core outcomes of RCTs of HMG treated with TCM are large and divergent.There are problems in evaluation standards,primary and secondary outcomes,TCM characteristic indicators,long-term prognosis,and standardization of reporting.It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG.展开更多
Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preven...Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preventing AMS, compared with a placebo, no treatment or acetazolamide. The literature was searched in 6major databases. RevMan 5.4 software was used for the meta-analysis. The relative risk for discrete variables and the mean difference for continuous variables with 95% confidence intervals(CIs) were applied to express the effect size. The risk of bias in the included studies was evaluated using the Cochrane risk assessment tool 2.0(RoB 2.0), and the evidence certainty was assessed using the Grading of Recommendations Assessment and the Development and Evaluation(GRADE) approach.Results: Twenty RCTs involving 3015 participants and 16 TCM patent drugs were included. The overall risk of bias in the majority of studies(15/20) was of some concerns. In terms of the AMS incidence,Rhodiola rosea(R. rosea, Hong Jing Tian) and Ginkgo biloba(G. biloba, Yin Xing Ye) were equivalent to the placebo/no treatment [RR(95% CI): 0.66(0.43-1.01), 0.82(0.63-1.06), respectively]. The AMS incidence in the G. biloba group was higher than that in the acetazolamide group [RR(95% CI): 2.92(1.69-5.06)]. In terms of improving the AMS symptom score on days 1 and 3 in the plateau, R. rosea and G. biloba were superior to the placebo or no treatment [MD(95% CI):-0.98(-1.71,-0.25),-2.05(-3.14,-0.95), respectively]. The other 14 Chinese patent medicines were evaluated in a single trial, and the majority of the results were negative. The subgroup analysis showed that the effect of R. rosea was related to the intervention time, way of ascending, and altitude.Conclusion: R. rosea and G. biloba were effective in improving AMS symptoms but had no effect in reducing the AMS incidence. There was insufficient evidence to support the use of other TCM patent drugs to prevent AMS. More randomized double-blind placebo-controlled trials are warranted to evaluate and screen effective Chinese patent medicines for AMS prevention.展开更多
Objective:To explore the characteristics of Xiao Chai Hu(XCH)decoction in randomized controlled trials(RCTs)using a bibliometric method.Methods:Seven databases including PubMed,Web of Science,Embase,Cochrane library,C...Objective:To explore the characteristics of Xiao Chai Hu(XCH)decoction in randomized controlled trials(RCTs)using a bibliometric method.Methods:Seven databases including PubMed,Web of Science,Embase,Cochrane library,China National Knowledge Infrastructure(CNKI),Chinese Scientific Journal Database(VIP)and Wanfang database were retrieved from inception to May 27,2022.In the study,XCH decoction(or modified)used alone or combined with conventional Western medicine as an intervention measure was included.The basic characteristics,funding support,relevant diseases,intervention methods,and adverse events(AEs)were analyzed.Data analysis was performed using SPSS 26.0 software.Results:A total of 813 RCTs were included,published from 1989 to 2022.There was only one Englishlanguage literature with the recent impact factor of 5.374.There were 147 studies were from Chineselanguage core journals,with the highest impact factor of 2.414.Only 6.15%of the literatures mentioned funding support.96.31%of the included literature reported the statistical significance of using XCH decoction.The diseases treated mainly included chronic hepatitis B(9.35%),cough variant asthma(5.66%),dizziness(5.54%),bile reflux gastritis(4.43%),and fever(4.18%).However,the overall research design of the included literature was poor,and large sample size,multicenter RCTs are needed.The incidence of AEs of XCH decoction alone was 8.86%,which was significantly lower than that of conventional Western medicine treatment.The combination of XCH decoction and conventional Western medicine treatment could reduce the incidence of AEs,and no serious adverse event was reported.Conclusion:Although the included studies show that XCH decoction is widely used,and has good efficacy and few AEs.Due to the low quality of the included RCTs,there may be some bias,and its rational use based on the specific conditions is recommended in clinical practice.展开更多
Objective:To systematically evaluate the incidence of adverse reactions to coronavirus disease 2019(COVID-19)vaccination.Methods:We systematically searched PubMed,Embase,The Cochrane Library,Web of Science,CNKI,WanFan...Objective:To systematically evaluate the incidence of adverse reactions to coronavirus disease 2019(COVID-19)vaccination.Methods:We systematically searched PubMed,Embase,The Cochrane Library,Web of Science,CNKI,WanFang Data,and VIP Database from the inception of each database to August 31,2021.Randomized controlled clinical trials(RCTs)on the safety of different types of COVID-19 vaccines were retrieved and analyzed.A random or fixed-effects model was used with an odds ratio as the effect size.The quality of each reference was evaluated.The incidence of the adverse reactions of the placebo group and the vaccination group was compared.Heterogeneity and publication bias were taken care of by meta-regression and sub-group analyses.Results:A total of 13 articles were included,with 81287 subjects.Compared with the placebo group,the vaccination group showed a higher combined risk ratio(RR)of total adverse reactions(RR=1.67,95%CI:1.46-1.91,P<0.01),local adverse reactions(RR=2.86,95%CI:2.11-3.87,P<0.01),systemic adverse reactions(RR=1.25,95%CI:0.92-1.72,P=0.16),pain(RR=2.55,95%CI:1.75-3.70,P<0.01),swelling(RR=4.16,95%CI:1.71-10.17,P=0.002),fever(RR=2.34,95%CI:1.84-2.97,P<0.01),fatigue(RR=1.36,95%CI:1.32-1.41,P<0.01)and headache(RR=1.22,95%CI:1.18-1.26,P<0.01).The subgroup analysis showed the incidence of adverse reactions of the vaccination group after injection of the three COVID-19 vaccines(inactivated viral vaccines,mRNA vaccines and adenovirus vector vaccines)was higher than that of the placebo group,and the difference between the placebo group and the vaccination group in the mRNA vaccine subgroup and the adenovirus vector vaccine subgroup was statistically significant(P<0.01).The incidence of adverse reactions after injection of COVID-19 vaccine in subgroups of different ages was significantly higher than that in the placebo group(P<0.01).Conclusions:COVID-19 vaccines have a good safety,among which adenovirus vector vaccine has the highest incidence of adverse reactions.Both adolescents and adults vaccinated with novel coronavirus vaccine have a certain proportion of adverse reactions,but the symptoms are mild and can be relieved by themselves.Our meta-analysis can help boost global awareness of vaccine safety,promote mass vaccination,help build regional and global immune barriers and effectively curb the recurrency of COVID-19.展开更多
Objective:This study assessed whether Chinese herbal medicine(CHM)combined with probiotics/synbiotics for irritable bowel syndrome-diarrhea(IBS-D)was more effective and safer than probiotics/synbiotics alone.Methods:T...Objective:This study assessed whether Chinese herbal medicine(CHM)combined with probiotics/synbiotics for irritable bowel syndrome-diarrhea(IBS-D)was more effective and safer than probiotics/synbiotics alone.Methods:Ten databases were searched for randomized control trials(RCTs)of IBS-D as diagnosed by Manning or Rome criteria.Trials comparing probiotics and probiotics with CHM were included.The Cochrane risk of bias(ROB)was evaluated for each trial.RevMan 5.3 was used to conduct a meta-analysis.Results:Twenty-six RCTs were included(25 Chinese,1 English),involving 2045 participants.Metaanalysis was conducted on two outcomes:overall symptom improvement and relapse.CHM combined with live Bifidobacterium and Lactobacillus preparations reduced relapse rate(RR 0.28,95%CI 0.15e0.52,3 trials,n?205)compared with probiotics alone.The subgroup analysis showed the benefit of CHM prescriptions based on soothing liver and invigorating spleen(1.28,1.14e1.44,3,244),invigorating spleen and resolving dampness(1.20,1.03e1.41,2,128),or warming and invigorating spleen and kidney formulae(1.27,1.09e1.46,2,210)combined with triple Bifidobacterium preparations than the same probiotics alone which improved overall symptoms for IBS-D.There was unclear bias in almost domains of ROB.Most studies had a high risk of bias due to lack of blinding of investigator and participants,and selective reporting.Conclusions:This study showed that CHM combined with probiotics may reduce relapse rate by 72%,and improve overall symptoms of IBS-D(as diagnosed by Rome II and III)compared to probiotics alone.From the limited subgroup analysis,only soothing liver and invigorating spleen formulae,represented by Tongxie Yaofang,added to triple Bifidobacterium preparations may be superior to the single preparations in terms of overall symptoms.However,due to the poor methodological quality and small sample size of the trials,these findings must be interpreted with caution.展开更多
Background:A growing number of randomized controlled trials(RCTs)have explored the significance of adjusting constitution for preventive treatment of disease in traditional Chinese medicine(TCM).In this study,we sough...Background:A growing number of randomized controlled trials(RCTs)have explored the significance of adjusting constitution for preventive treatment of disease in traditional Chinese medicine(TCM).In this study,we sought to comprehensively analyze the characteristics of these RCTs.Methods:All RCTs related to constitutional adjustment and preventive treatment of disease were included in the study.Literature was screened searching seven databases,including Pubmed,Web of Science,Embase,SinoMed,CNKI,Chongqing VIP,and Wangfang Database,from inception to December 2018.Data pertaining to bibliometrics,participants,and interventions were extracted and analyzed.Results:Two hundred and forty papers were published between 2007 and 2018,involving 240 RCTs with 55977 total participants.Sample size in these RCTs ranged from 30 to 7800.Among them,59 RCTs addressed disease prevention prior to onset involving 11 healthy states of participants,mainly for general health or sub-health population(40.68%)using health care and non-drug therapy.In control the development of existing disease(n Z 174),59 diseases were involved.Based on the number of RCTs and sample sizes,diseases including type 2 diabetes mellitus,primary hypertension,nonalcoholic fatty liver disease,and hyperlipoproteinemia accounted for 51.15%of the total patients studied.Drug therapy as an intervention was frequently used.In preventing recurrence after recovery(n Z 7),over 4 kinds of health status in participants were involved.Drug therapy combined with health care was mostly used.Most RCTs reported positive outcomes,with only one reporting negative findings(1/240).Conclusion:The number of RCTs of constitutional adjustment on preventive treatment of disease has gradually increased since 2012.Participants and intervention measures from the above-mentioned types of RCTs exhibit their own characteristics.Future systematic reviews or meta-analyses on constitutional adjustment for preventive treatment of disease are warranted.展开更多
BACKGROUND Spine surgery is evolving and in the due course of its evolution,it is useful to have a comprehensive summary of the process to have a greater understanding to refine our future directives.With the multiple...BACKGROUND Spine surgery is evolving and in the due course of its evolution,it is useful to have a comprehensive summary of the process to have a greater understanding to refine our future directives.With the multiple domains of research in the spine,it has become difficult for a surgeon to find the potential hotspots in research or identify the emerging research frontiers.AIM To analyze RCTs(1990–2019)for potential research domains along with their research networks and identify the hot topics for future research.METHODS A comprehensive and systematic analysis of all the RCTs published on spinal surgery from 1990 to 2019 retrieved from the Web of Science Core Collection database.Scientometric and visual analysis of their characteristics,cooperation networks,keywords,and citations were made using CiteSpace software.Journal and article impact index were retrieved from Reference Citation Analysis(RCA)Database.RESULTS A total of 696 RCTs were published on spinal surgery from 1990 to 2019;of which,the United States(n=263)and China(n=71)made a significant contribution.Thomas Jefferson University(n=16)was the leading contributor to RCTs on spinal surgery.Weinstein JN was the most cited author in the field followed by Deyo RA.Spine(n=559)remained the top-cited journal for RCTs on spinal surgery.On literature co-citation analysis,spinal stenosis,anterior cervical discectomy and fusion,degenerative disc disease,and minimally invasive decompression were identified as the hotspots and potential research frontiers.CONCLUSION The identified hotspots that extending the frontiers in the management of degenerative disorders of the spine through further research holds the potential for advancement in spinal care.展开更多
Background:The increasing number of Alzheimer’s Disease has become a global health issue.Whether randomized controlled trials are fully reported has an immediate effect on the translation as well as implementation of...Background:The increasing number of Alzheimer’s Disease has become a global health issue.Whether randomized controlled trials are fully reported has an immediate effect on the translation as well as implementation of research conclusions.However,the overall reporting quality of randomized controlled trials for cognitive interventions among Alzheimer’s Disease is unclear.Methods:Randomized controlled trials of cognitive inter-ventions among Alzheimer’s Dementia were searched from Cnki,Embase,Pubmed,Web of Science,WanFang Data,Cochrane Library,and VIP from their inception to December9th 2019.Firstly,the average CONSORT(Consolidated Standards of Reporting Trials)compliance of randomized controlled trials for cognitive interventions among Alzheimer’s Disease was estab-lished.Secondly,the compliance of per CONSORT item was calculated.Furthermore,the possible factors that determine the reporting quality were explored using univariate analysis and binary logistic regression.Results:A total of 55 studies were included.Mean CONSORT compliance of randomized controlled trials was 57.16%and standard deviation was 0.11.Univariate analysis showed that journal impact factor(p<0.001),sample size(p=0.002)as well as number of authors(p<0.001)were statistically significant,but post-2010 publication(p=0.206)as well as reporting of funding(p=0.221)had no significance.However,none of the above factors had statistical significance in binary logistic regression.Conclusions:The overall reporting quality was low,which would not be conducive to the evidence transformation and implementation.Furthermore,the reporting quality was not probably affected by aforementioned factors.展开更多
Objective: To systematically evaluate the effectiveness of fall prevention and balance function in the elderly.Methods: Databases, including Pub Med, Web of Science, Cochrane Library, Chinese Biomedical Literature Dat...Objective: To systematically evaluate the effectiveness of fall prevention and balance function in the elderly.Methods: Databases, including Pub Med, Web of Science, Cochrane Library, Chinese Biomedical Literature Database(CBM), and CNKI were electronically searched, and the relevant references of the included papers were also manually searched. Two reviewers independently screened the articles according to the inclusion and exclusion criteria, extracted the data, and assessed the methodological quality. A metaanalysis was performed using the Cochrane Collaboration's Rev Man 5.1 software.Results: Six randomized controlled trials(RCTs) involving 2796 participants were included. The results of the meta-analysis showed that compared with a physiotherapy intervention, Tai Chi could significantly reduce the incidence rates of falls [relative risk(RR) ? 0.82, 95% confidence interval(CI)(0.73, 0.92)],while there were significant differences in the Timed Up and Go test, Functional Reach Test and Berger Balance Scale.Conclusions: Tai Chi is effective in reducing the risk of falls and improving balance in the elderly.展开更多
AIM: To evaluate the relative efficacy and safety of aflibercept for treatment of diabetic macular oedema(DMO).METHODS: A comprehensive search in MEDLINE, CENTRAL and EMBASE was undertaken for randomized controlled tr...AIM: To evaluate the relative efficacy and safety of aflibercept for treatment of diabetic macular oedema(DMO).METHODS: A comprehensive search in MEDLINE, CENTRAL and EMBASE was undertaken for randomized controlled trials(RCTs) comparing intravitreal antivascular endothelial growth factor(anti-VEGF) versus another treatment. Primary outcome measures were proportion of patients with at least 15 letters of gain or loss on a log MAR visual acuity chart, and change in best corrected visual acuity(BCVA) and central macular thickness(CMT) from baseline. Safety outcomes were rates of death, thromboembolic events and any systemic or ocular serious adverse events. The final search was performed on November 2017.RESULTS: Four RCTs were included. Only one trial compared efficacy and safety of aflibercept with bevacizumab and ranibizumab over 1 or 2 y. Three trials were included for Meta-analysis comprising 661 patients(331 in the aflibercept, and 330 in the photocoagulation group). Aflibercept was more efficacious compared to photocoagulation in the proportion of patients with at least 15 letters of improvement and worsening, and in improvement of BCVA and reduction in CMT at 1 or 2 y. The safety estimates at 1 or 2 y did not differ statistically.CONCLUSION: Aflibercept offers superior benefits over photocoagulation in improving and preserving vision, with no differences in safety. Further comparative effectiveness trials between aflibercept and other anti-VEGF agents will aid ophthalmologists in treatment decisions.展开更多
Background: Nursing practice has to contribute to evidence pointing out why there is a need for more nurse-designed randomized control trials (RCTs) focusing on evidence-based practice (EBP). How far this EBP has prog...Background: Nursing practice has to contribute to evidence pointing out why there is a need for more nurse-designed randomized control trials (RCTs) focusing on evidence-based practice (EBP). How far this EBP has progressed in different health aspects is usually established by systematic reviews of RCTs. Nurse-led RCTs exist but no study has addressed the essentials of nursing care. Aim: The aim was therefore to determine the essentials of nurses’ interventions by means of nurse-led RCTs in somatic care focusing on the stated context, goals, content, strategies as well as the nurse’s role related to effectiveness. Methods: A systematic review was realized according to Cochrane review assumptions to identify, appraise and synthesize all empirical evidence meeting pre-specified eligibility criteria. The PRISMA statement guided the data extraction process (n = 55) from PubMed and CINAHL. Results: Of the RCTs in somatic care, 71% showed a positive effectiveness of nurse-led interventions, of which the nurse had a significant role with regard to being the main responsible in 67% of the studies. Also, 47% of the RCTs presented a theoretical standpoint related to the nurse-led interventions and most prominent were international evidence-based guidelines. Goals were found to have either a patient-centered or a professional-centered ambition. Strategies were based on patient-directed initiatives, nurse-patient-directed initiatives or nurse-directed initiatives, while contents were built upon either a patient-nurse interaction or a nursing management plan. Conclusions: This review underlines the necessity of a holistic view of a person, as nurse-led RCTs comprising a patient-centered ambition, patient-directed initiative and patient-nurse interaction plan showed beneficial nursing care effectiveness, particularly if theory-based. In a nurse-led RCT, a basic theoretical perspective is advantageous as well as to elucidate the role of the nurse in relation to the estimated effects.展开更多
Objective:This study was to evaluate the quality of the randomized controlled trials on Roy adaptation model nursing in individuals suffering from acute myocardial infarction in China.Methods:We systematically searche...Objective:This study was to evaluate the quality of the randomized controlled trials on Roy adaptation model nursing in individuals suffering from acute myocardial infarction in China.Methods:We systematically searched the Cnki,Wanfang and Vipdatabases,to get randomized controlled trials on Roy adaptation model nursing in individuals suffering from acute myocardial infarction.The search period was from inception to October 2020.According to the Cochrane risk bias assessment tool,the quality of the studies included was appraised.Results:A total of 55 studies were retrieved,and 11 were eventually included in the study.Among the studies included,the first study was published in 2008.The overall quality of the 11 studies included was relatively low.Conclusions:The overall quality of the randomized controlled trials on Roy adaptation model nursing in individuals suffering from acute myocardial infarction was not high,which would hinder the evidence transformation as well as clinical practice.展开更多
Objective: To assess the effectiveness and safety of manipulation intervention for degenerative lumbar spondylolisthesis(DLS).Methods: This is a systematic review and meta-analysis. A full-scale retrieval method was p...Objective: To assess the effectiveness and safety of manipulation intervention for degenerative lumbar spondylolisthesis(DLS).Methods: This is a systematic review and meta-analysis. A full-scale retrieval method was performed until February 1, 2021, including nine databases. The homogeneity of different studies was summarized using the Review Manager. The quality of studies was determined with the Cochrane risk-of-bias tool.The evidence quality was graded with the Grading of Recommendations, Assessment, Development, and Evaluations approach.Results: A total of 6 studies involving 524 participants were included. The review demonstrated that manipulation has statistically significant improvements for treating DLS according to Japanese Orthopedic Association scores(mean difference, 3.76;95% confidence interval, 2.63 to 4.90;P <.001) and visual analog scale scores(mean difference,-1.50;95% confidence interval,-1.66 to-1.33;P <.001)compared to the control group. One study reported that the difference in the Oswestry Disability Index between the traction group and the combination of manipulation and traction group was statistically significant(P <.05), while another reported that manipulation treatment can significantly improve the lumbar spine rotation angle on X-ray images compared with the baseline data(P <.05). Moreover, the manipulation group(experimental group) had fewer adverse events than the lumbar traction group(control group).Conclusion: Manipulation intervention is more effective and safer for DLS. Nevertheless, large-scale randomized controlled trials are required to confirm the current conclusions.展开更多
BACKGROUND Colorectal cancer is one of the most common cancers globally.In China,its prevalence ranks fourth and fifth among females and males,respectively.Presently,treatment of rectal cancer follows a multidisciplin...BACKGROUND Colorectal cancer is one of the most common cancers globally.In China,its prevalence ranks fourth and fifth among females and males,respectively.Presently,treatment of rectal cancer follows a multidisciplinary comprehensive treatment approach involving surgery,radiotherapy,chemotherapy,and targeted therapy.With deepening theoretical and molecular research on colorectal cancer,randomized controlled trials(RCTs)on colorectal cancer have made significant progress.However,many RCTs have shortfalls.AIM To investigate the RCTs of global colorectal cancer spanning from 2008 to 2018.To provide suggestions for conducting Chinese RCTs of colorectal cancer.METHODS PubMed and Web of Science databases were searched to obtain RCTs of colorectal cancer carried out between January 1,2008,and January 1,2018.The bibliometric method was used for statistical analysis of the publication years,countries/regions,authors,institutions,source journals,quoted times,key words,and authors.RESULTS Colorectal cancer RCTs showed an upward trend between 2008 to 2018;the top 10 research institutions in the included literature were from the United States,the United Kingdom,and other countries with a high incidence of colorectal cancer.Most of the related research journals are sponsored by European and American countries.The 15 most cited studies involved international multicenter clinical research,having few participants from Chinese research institutions.Network visualization using key words showed that RCTs on colorectal cancer focus on screening,disease-free survival,drug treatment,surgical methods,clinical trials,quality of life,and prognosis.The result of the coauthorship network analysis showed that Chinese researchers are less involved in international exchanges compared to those from leading publication countries.CONCLUSION High-quality RCTs are increasingly favored by leading international journals.However,there is still a large gap in clinical research between China and leading countries.Researchers should implement standardized and accurate clinical trials,strengthen international multicenter cooperation,and emphasize quality control.展开更多
Objective:To assess the effectiveness and safety of acupoint injection for the treatment of asthma.Methods:Six electronic databases were searched for randomized controlled trials(RCTs)of acupoint injection for asthma....Objective:To assess the effectiveness and safety of acupoint injection for the treatment of asthma.Methods:Six electronic databases were searched for randomized controlled trials(RCTs)of acupoint injection for asthma.Two authors extracted data and assessed methodological quality independently using the Cochrane Collaboration Risk of Bias tool.Data were evaluated using RevMan v5.2.Results:Eighteen RCTs involving 1913 participants with asthma were identified.Overall methodological quality of the RCTs was classified as unclear risk of bias.Western medicine(12 RCTs)was injected most frequently into acupoints,followed by Chinese herbal medicine(four RCTs),vitamins(one RCT),and Chinese herbal medicine combined with Western medicine(one RCT).Four RCTs used only one acupoint[ST36(two RCTs),BL13,CV22],whereas the other RCTs selected multiple acupoints(among which BL13 was used most frequently).One RCT reported mortality,no RCT reported quality of life,15 RCTs reported the symptom improvement rate,one RCT reported asthma control test(ACT)data,one RCT reported the duration of asthma,three RCTs reported the mean time that asthma was controlled(MTAC),and 13 RCTs reported lung-function tests(LFTs).Some RCTs showed acupoint injection may improve the attack time of asthma,MTAC,and LFTs.Five RCTs reported the outcome of adverse events and showed no significant differences between the acupoint injection group and control group.Conclusions:The findings suggest that acupoint injection may be effective for improving ACT data,duration of asthma,MTAC and LFTs.However,the evidence is insufficient owing to the poor methodological quality of the RCTs.展开更多
Objective:Though Chinese medicine(CM)has showed its clinical efficacy for the treatment of obstructive sleep apnea(OSA)in China,no systematic reviews or meta-analyses provide evidences for its therapeutic effects on O...Objective:Though Chinese medicine(CM)has showed its clinical efficacy for the treatment of obstructive sleep apnea(OSA)in China,no systematic reviews or meta-analyses provide evidences for its therapeutic effects on OSA and the long-term safety.The aim of the present study is to evaluate the effectiveness and safety of CM on OSA using meta-analysis.Methods:We used search items of"Chinese Medicine"AND"obstructive sleep apnea"to retrieve the randomized control trials(RCTs)of CM treatments for OSA in PubMed,Embase,Cochrane Library,China National Knowledge Infrastructure(CNKI),VIP database,and Wanfang database from their respective inception dates to December 2019.Only RCTs of CM therapy versus no treatment which could be quantitatively synthesized were included.Finally,20 studies representing 1,297 participants were included after extraction.Two investigators independently extracted and analyzed the data using RevMan5.3 software.Results:The treatment group using CM decoctions or CM granules presented significantly ameliorative effects on apnoea-hypopnoea index(AHI)compared with the control group(MD:-2.58,95%CI:-3.59 to-1.56,P<0.00001 and MD:-5.47,95%CI:-6.75 to-4.19,P<0.00001,respectively)in the sensitivity analysis.However,there were non significant differences in the duration of treatment between subgroups,indicating that the duration of treatment has no impacts on the therapeutic effects on AHI.CM granules also showed significantly ameliorative effects on the lowest nocturnal oxygen saturation(LSaO2)(MD:2.76,95%CI:1.85 to 3.68,P<0.00001).CM decoctions exhibited significantly improved Epworth Sleepiness Scale(ESS)scores compared with the control group in a sensitivity analysis(MD:-1.50,95%CI:-2.13 to-0.88,P<0.00001).CM granules showed a better improvement of ESS than the control group(MD:-1.35,95%CI:-1.92 to-0.78,P<0.00001).Mild adverse reactions occurred only in five patients and disappeared without special treatment.Conclusion:This study showed favorable therapeutic efficacy of CM on OSA.However,in consideration of the low methodological quality of the included RCTs,more rigorous designed,large sample size RCTs are recommended for providing more high-quality evidences.展开更多
Background: Teamcare should, like all patient care, also contribute to evidence-based practice (EBP). Randomized controlled trials (RCTs) focusing on teamcare have been performed but no study has addressed its essenti...Background: Teamcare should, like all patient care, also contribute to evidence-based practice (EBP). Randomized controlled trials (RCTs) focusing on teamcare have been performed but no study has addressed its essentials. How far this EBP has progressed in different health aspects is generally established in systematic reviews of RCTs. Aim: The aim is to determine the essentials of teamcare including the nurse profession in RCTs of multi- or interdisciplinary interventions in somatic care focusing on the stated context, goals, strategies, content as well as effectiveness of quality of care. Methods: A systematic review was performed according to Cochrane review assumptions to identify, appraise and synthesize all empirical evidence meeting pre-specified eligibility criteria. The PRISMA statement guided the data selection process of 27 articles from PubMed and CINAHL. Results: Eighty-five percent of RCTs in somatic care showed a positive effectiveness of teamcare interventions, of which interdisciplinary ones showed a greater effectiveness compared with the multidisciplinary approach (100% vs 76%). Also theory-based RCTs presented higher positive effectiveness (85%) compared with non-theory-based RCTs (79%). The RCTs with positive effectiveness showed greater levels for professional-centered ambition in terms of goals and for team-directed initiatives in terms of strategy, and a significantly higher level for patient-team interaction plans in terms of content was shown. Conclusions: Teamcare RCTs are still grounded in the multidisciplinary approach having a professional-centered ambition while interdisciplinary approaches especially those that are theory-based appear to be essential with regard to positive effectiveness and preferable when person-centered careis applied.展开更多
Background:The effects of acupuncture have varied in different randomized controlled trials(RCTs),and there are many factors that influence treatment effect of acupuncture in different outcomes,with conflicting result...Background:The effects of acupuncture have varied in different randomized controlled trials(RCTs),and there are many factors that influence treatment effect of acupuncture in different outcomes,with conflicting results.Objective:To identify factors and their impact on the treatment effect of acupuncture in different outcomes.Methods:Acupuncture RCTs were searched from 7 databases including Medline(Pub Med),Embase,Cochrane Central Register of Controlled Trials,China National Knowledge Infrastructure,Wanfang Database,VIP Database,and China Biology Medicine disc between January 1st,2015 and December 31st,2019.Eligible studies must compare acupuncture to no acupuncture,sham acupuncture,or waiting lists,and report at least 1patient-important outcome.A multi-level meta-regression was conducted using a 3-level robust mixed model and univariate analyses were performed for all independent variables,even those excluded from the multivariable model due to collinearities.We used thresholds of 0.2 and 0.4 for the difference of standardized mean differences(SMDs),categorising them as small(<0.2),moderate(0.2–0.4),or large(>0.4) effects.Results:The pain construct analysis involved 211 effect estimates from 153 studies and 14 independent variables.High-frequency acupuncture treatment sessions produced larger effects compared to low-frequency sessions [large magnitude,the difference of adjusted SMDs 0.46,95% confidence interval(CI) 0.07 to 0.84;P=0.02].The non-pain symptoms construct analysis comprised 323 effect estimates from 231 studies and 15 independent variables.Penetrating acupuncture showed moderately larger effects when compared to non-penetrating acupuncture(0.30,95% CI 0.06 to 0.53;P=0.01).The function construct analysis included 495 effect estimates from 274 studies and 14 independent variables.Penetrating acupuncture and the flexible acupuncture regimen showed moderately larger effects,compared to non-penetrating acupuncture and fixed regimen,respectively(0.40,95% CI 0 to 0.80;P=0.05;0.29,95% CI 0.06 to 0.53;P=0.01).Conclusions:High-frequency acupuncture sessions appear to be a more effective approach to managing painful symptoms.Penetrating acupuncture demonstrated greater effect in relieving nonpainful symptoms.Both penetrating acupuncture type and flexible acupuncture regimen were linked to significant treatment effects in function outcomes.Future studies should consider the factors that are significantly associated with the effects of acupuncture in patient-important outcomes.展开更多
Background:Randomized controlled trials(RCTs)are often considered the gold standard and the cornerstone for clinical practice.However,bibliometric studies on worldwide RCTs of ophthalmology published in the 21st centu...Background:Randomized controlled trials(RCTs)are often considered the gold standard and the cornerstone for clinical practice.However,bibliometric studies on worldwide RCTs of ophthalmology published in the 21st century have not been reported in detail yet.This study aims to perform a bibliometric study and visualization analysis of worldwide ophthalmologic RCTs in the 21st century.Methods:Global ophthalmologic RCTs from 2000 to 2022 were searched in the Web of Science Core Collection.The number of publications,country/region,institution,author,journal,and research hotspots of RCTs were analyzed using HistCite,VOSviewer,CiteSpace,and Excel software.Results:2366 institutions and 90 journals from 83 countries/regions participated in the publication of 1769 global ophthalmologic RCTs,with the United States leading in the number of volumes and research field,and the Moorfields Eye Hospital contributing to the most publications.Ophthalmology received the greatest number of publications and co-citations.Jeffrey S.Heier owned the most publications and Jost B.Jonas owned the most cocitations.The knowledge foundations of global ophthalmologic RCTs were mainly retinopathy,glaucoma,dry eye disease(DED),and cataracts,and anti-vascular endothelial growth factor(VEGF)therapy(ranibizumab),topical ocular hypotensive medication,laser trabeculoplasty.Anti-VEGF therapy for age-related macular degeneration(AMD),DME(diabetic macular edema),and DED,the use of new diagnostic tools,and myopia were the hottest research highlights.Anti-VEGF therapy,prompt laser,triamcinolone,and verteporfin photodynamic therapy for AMD,DME,and CNV(choroidal neovascularization),DED,myopia,and open-angle glaucoma were the research hotspots with the longest duration.The future research hotspots might be DED and the prevention and control of myopia.Conclusions:Overall,the number of global ophthalmologic RCTs in the 21st century was keeping growing,there was an imbalance between the regions and institutions,and more efforts are required to raise the quantity,quality,and global impact of high-quality clinical evidence in developing countries/regions.展开更多
文摘Randomized controlled trials(RCTs)have long been recognized as the gold standard for establishing causal relationships in clinical research.Despite that,various limitations of RCTs prevent its widespread implementation,ranging from the ethicality of withholding potentially-lifesaving treatment from a group to relatively poor external validity due to stringent inclusion criteria,amongst others.However,with the introduction of propensity score matching(PSM)as a retrospective statistical tool,new frontiers in establishing causation in clinical research were opened up.PSM predicts treatment effects using observational data from existing sources such as registries or electronic health records,to create a matched sample of participants who received or did not receive the intervention based on their propensity scores,which takes into account characteristics such as age,gender and comorbidities.Given its retrospective nature and its use of observational data from existing sources,PSM circumvents the aforementioned ethical issues faced by RCTs.Majority of RCTs exclude elderly,pregnant women and young children;thus,evidence of therapy efficacy is rarely proven by robust clinical research for this population.On the other hand,by matching study patient characteristics to that of the population of interest,including the elderly,pregnant women and young children,PSM allows for generalization of results to the wider population and hence greatly increases the external validity.Instead of replacing RCTs with PSM,the synergistic integration of PSM into RCTs stands to provide better research outcomes with both methods complementing each other.For example,in an RCT investigating the impact of mannitol on outcomes among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial,the baseline characteristics of comorbidities and current medications between treatment and control arms were significantly different despite the randomization protocol.Therefore,PSM was incorporated in its analysis to create samples from the treatment and control arms that were matched in terms of these baseline characteristics,thus providing a fairer comparison for the impact of mannitol.This literature review reports the applications,advantages,and considerations of using PSM with RCTs,illustrating its utility in refining randomization,improving external validity,and accounting for non-compliance to protocol.Future research should consider integrating the use of PSM in RCTs to better generalize outcomes to target populations for clinical practice and thereby benefit a wider range of patients,while maintaining the robustness of randomization offered by RCTs.
基金This study was supported by the National Administration of Traditional Chinese Medicine(SATCM-2015-BZ402).
文摘Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight online databases were searched from their inception to December 31,2022,to assess outcomes reported in randomized controlled trials(RCTs)of HMG treated with TCM.The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool.All outcomes were extracted,classified,and described.Results:A total of 8249 articles were initially retrieved.Of these,70 articles were eligible and involved 10618 participants with HMG.A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains.Conclusions:The core outcomes of RCTs of HMG treated with TCM are large and divergent.There are problems in evaluation standards,primary and secondary outcomes,TCM characteristic indicators,long-term prognosis,and standardization of reporting.It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG.
基金supported by the Institute Projects of China Tibetology Research Center in 2022(CTRC20226JS05).
文摘Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preventing AMS, compared with a placebo, no treatment or acetazolamide. The literature was searched in 6major databases. RevMan 5.4 software was used for the meta-analysis. The relative risk for discrete variables and the mean difference for continuous variables with 95% confidence intervals(CIs) were applied to express the effect size. The risk of bias in the included studies was evaluated using the Cochrane risk assessment tool 2.0(RoB 2.0), and the evidence certainty was assessed using the Grading of Recommendations Assessment and the Development and Evaluation(GRADE) approach.Results: Twenty RCTs involving 3015 participants and 16 TCM patent drugs were included. The overall risk of bias in the majority of studies(15/20) was of some concerns. In terms of the AMS incidence,Rhodiola rosea(R. rosea, Hong Jing Tian) and Ginkgo biloba(G. biloba, Yin Xing Ye) were equivalent to the placebo/no treatment [RR(95% CI): 0.66(0.43-1.01), 0.82(0.63-1.06), respectively]. The AMS incidence in the G. biloba group was higher than that in the acetazolamide group [RR(95% CI): 2.92(1.69-5.06)]. In terms of improving the AMS symptom score on days 1 and 3 in the plateau, R. rosea and G. biloba were superior to the placebo or no treatment [MD(95% CI):-0.98(-1.71,-0.25),-2.05(-3.14,-0.95), respectively]. The other 14 Chinese patent medicines were evaluated in a single trial, and the majority of the results were negative. The subgroup analysis showed that the effect of R. rosea was related to the intervention time, way of ascending, and altitude.Conclusion: R. rosea and G. biloba were effective in improving AMS symptoms but had no effect in reducing the AMS incidence. There was insufficient evidence to support the use of other TCM patent drugs to prevent AMS. More randomized double-blind placebo-controlled trials are warranted to evaluate and screen effective Chinese patent medicines for AMS prevention.
基金supported by a Project of National Administration of Traditional Chinese Medicine(TB2021011)“Excellence Program”of the Beijing University of Chinese Medicine.
文摘Objective:To explore the characteristics of Xiao Chai Hu(XCH)decoction in randomized controlled trials(RCTs)using a bibliometric method.Methods:Seven databases including PubMed,Web of Science,Embase,Cochrane library,China National Knowledge Infrastructure(CNKI),Chinese Scientific Journal Database(VIP)and Wanfang database were retrieved from inception to May 27,2022.In the study,XCH decoction(or modified)used alone or combined with conventional Western medicine as an intervention measure was included.The basic characteristics,funding support,relevant diseases,intervention methods,and adverse events(AEs)were analyzed.Data analysis was performed using SPSS 26.0 software.Results:A total of 813 RCTs were included,published from 1989 to 2022.There was only one Englishlanguage literature with the recent impact factor of 5.374.There were 147 studies were from Chineselanguage core journals,with the highest impact factor of 2.414.Only 6.15%of the literatures mentioned funding support.96.31%of the included literature reported the statistical significance of using XCH decoction.The diseases treated mainly included chronic hepatitis B(9.35%),cough variant asthma(5.66%),dizziness(5.54%),bile reflux gastritis(4.43%),and fever(4.18%).However,the overall research design of the included literature was poor,and large sample size,multicenter RCTs are needed.The incidence of AEs of XCH decoction alone was 8.86%,which was significantly lower than that of conventional Western medicine treatment.The combination of XCH decoction and conventional Western medicine treatment could reduce the incidence of AEs,and no serious adverse event was reported.Conclusion:Although the included studies show that XCH decoction is widely used,and has good efficacy and few AEs.Due to the low quality of the included RCTs,there may be some bias,and its rational use based on the specific conditions is recommended in clinical practice.
基金funded the Province Natural Science key Foundation of Hainan(No:ZDYFXGFY2020004 and No:ZDYF 2019125)the National Natural Science Foundation of China(No:81960351)Hainan Province Clinical Medical Center.
文摘Objective:To systematically evaluate the incidence of adverse reactions to coronavirus disease 2019(COVID-19)vaccination.Methods:We systematically searched PubMed,Embase,The Cochrane Library,Web of Science,CNKI,WanFang Data,and VIP Database from the inception of each database to August 31,2021.Randomized controlled clinical trials(RCTs)on the safety of different types of COVID-19 vaccines were retrieved and analyzed.A random or fixed-effects model was used with an odds ratio as the effect size.The quality of each reference was evaluated.The incidence of the adverse reactions of the placebo group and the vaccination group was compared.Heterogeneity and publication bias were taken care of by meta-regression and sub-group analyses.Results:A total of 13 articles were included,with 81287 subjects.Compared with the placebo group,the vaccination group showed a higher combined risk ratio(RR)of total adverse reactions(RR=1.67,95%CI:1.46-1.91,P<0.01),local adverse reactions(RR=2.86,95%CI:2.11-3.87,P<0.01),systemic adverse reactions(RR=1.25,95%CI:0.92-1.72,P=0.16),pain(RR=2.55,95%CI:1.75-3.70,P<0.01),swelling(RR=4.16,95%CI:1.71-10.17,P=0.002),fever(RR=2.34,95%CI:1.84-2.97,P<0.01),fatigue(RR=1.36,95%CI:1.32-1.41,P<0.01)and headache(RR=1.22,95%CI:1.18-1.26,P<0.01).The subgroup analysis showed the incidence of adverse reactions of the vaccination group after injection of the three COVID-19 vaccines(inactivated viral vaccines,mRNA vaccines and adenovirus vector vaccines)was higher than that of the placebo group,and the difference between the placebo group and the vaccination group in the mRNA vaccine subgroup and the adenovirus vector vaccine subgroup was statistically significant(P<0.01).The incidence of adverse reactions after injection of COVID-19 vaccine in subgroups of different ages was significantly higher than that in the placebo group(P<0.01).Conclusions:COVID-19 vaccines have a good safety,among which adenovirus vector vaccine has the highest incidence of adverse reactions.Both adolescents and adults vaccinated with novel coronavirus vaccine have a certain proportion of adverse reactions,but the symptoms are mild and can be relieved by themselves.Our meta-analysis can help boost global awareness of vaccine safety,promote mass vaccination,help build regional and global immune barriers and effectively curb the recurrency of COVID-19.
基金This study was supported by the key program of the National Natural Science Foundation of China(No.81830115)Prof.Nicola Robinson(Visiting Professor of Beijing University of Chinese Medicine)is funded by Overseas Expertise Project,Ministry of Education of China(MS200800090).
文摘Objective:This study assessed whether Chinese herbal medicine(CHM)combined with probiotics/synbiotics for irritable bowel syndrome-diarrhea(IBS-D)was more effective and safer than probiotics/synbiotics alone.Methods:Ten databases were searched for randomized control trials(RCTs)of IBS-D as diagnosed by Manning or Rome criteria.Trials comparing probiotics and probiotics with CHM were included.The Cochrane risk of bias(ROB)was evaluated for each trial.RevMan 5.3 was used to conduct a meta-analysis.Results:Twenty-six RCTs were included(25 Chinese,1 English),involving 2045 participants.Metaanalysis was conducted on two outcomes:overall symptom improvement and relapse.CHM combined with live Bifidobacterium and Lactobacillus preparations reduced relapse rate(RR 0.28,95%CI 0.15e0.52,3 trials,n?205)compared with probiotics alone.The subgroup analysis showed the benefit of CHM prescriptions based on soothing liver and invigorating spleen(1.28,1.14e1.44,3,244),invigorating spleen and resolving dampness(1.20,1.03e1.41,2,128),or warming and invigorating spleen and kidney formulae(1.27,1.09e1.46,2,210)combined with triple Bifidobacterium preparations than the same probiotics alone which improved overall symptoms for IBS-D.There was unclear bias in almost domains of ROB.Most studies had a high risk of bias due to lack of blinding of investigator and participants,and selective reporting.Conclusions:This study showed that CHM combined with probiotics may reduce relapse rate by 72%,and improve overall symptoms of IBS-D(as diagnosed by Rome II and III)compared to probiotics alone.From the limited subgroup analysis,only soothing liver and invigorating spleen formulae,represented by Tongxie Yaofang,added to triple Bifidobacterium preparations may be superior to the single preparations in terms of overall symptoms.However,due to the poor methodological quality and small sample size of the trials,these findings must be interpreted with caution.
基金the National Program on Key Basic Research Project of China(973 Program,2011CB505405)the National Natural Science Foundation of China(81730112).
文摘Background:A growing number of randomized controlled trials(RCTs)have explored the significance of adjusting constitution for preventive treatment of disease in traditional Chinese medicine(TCM).In this study,we sought to comprehensively analyze the characteristics of these RCTs.Methods:All RCTs related to constitutional adjustment and preventive treatment of disease were included in the study.Literature was screened searching seven databases,including Pubmed,Web of Science,Embase,SinoMed,CNKI,Chongqing VIP,and Wangfang Database,from inception to December 2018.Data pertaining to bibliometrics,participants,and interventions were extracted and analyzed.Results:Two hundred and forty papers were published between 2007 and 2018,involving 240 RCTs with 55977 total participants.Sample size in these RCTs ranged from 30 to 7800.Among them,59 RCTs addressed disease prevention prior to onset involving 11 healthy states of participants,mainly for general health or sub-health population(40.68%)using health care and non-drug therapy.In control the development of existing disease(n Z 174),59 diseases were involved.Based on the number of RCTs and sample sizes,diseases including type 2 diabetes mellitus,primary hypertension,nonalcoholic fatty liver disease,and hyperlipoproteinemia accounted for 51.15%of the total patients studied.Drug therapy as an intervention was frequently used.In preventing recurrence after recovery(n Z 7),over 4 kinds of health status in participants were involved.Drug therapy combined with health care was mostly used.Most RCTs reported positive outcomes,with only one reporting negative findings(1/240).Conclusion:The number of RCTs of constitutional adjustment on preventive treatment of disease has gradually increased since 2012.Participants and intervention measures from the above-mentioned types of RCTs exhibit their own characteristics.Future systematic reviews or meta-analyses on constitutional adjustment for preventive treatment of disease are warranted.
文摘BACKGROUND Spine surgery is evolving and in the due course of its evolution,it is useful to have a comprehensive summary of the process to have a greater understanding to refine our future directives.With the multiple domains of research in the spine,it has become difficult for a surgeon to find the potential hotspots in research or identify the emerging research frontiers.AIM To analyze RCTs(1990–2019)for potential research domains along with their research networks and identify the hot topics for future research.METHODS A comprehensive and systematic analysis of all the RCTs published on spinal surgery from 1990 to 2019 retrieved from the Web of Science Core Collection database.Scientometric and visual analysis of their characteristics,cooperation networks,keywords,and citations were made using CiteSpace software.Journal and article impact index were retrieved from Reference Citation Analysis(RCA)Database.RESULTS A total of 696 RCTs were published on spinal surgery from 1990 to 2019;of which,the United States(n=263)and China(n=71)made a significant contribution.Thomas Jefferson University(n=16)was the leading contributor to RCTs on spinal surgery.Weinstein JN was the most cited author in the field followed by Deyo RA.Spine(n=559)remained the top-cited journal for RCTs on spinal surgery.On literature co-citation analysis,spinal stenosis,anterior cervical discectomy and fusion,degenerative disc disease,and minimally invasive decompression were identified as the hotspots and potential research frontiers.CONCLUSION The identified hotspots that extending the frontiers in the management of degenerative disorders of the spine through further research holds the potential for advancement in spinal care.
基金National Natural Science Foundation of China(No.81603565)Tianjin University of Traditional Chinese Medicine Postgraduate Research Innovation Project(YJSKC-20201032).
文摘Background:The increasing number of Alzheimer’s Disease has become a global health issue.Whether randomized controlled trials are fully reported has an immediate effect on the translation as well as implementation of research conclusions.However,the overall reporting quality of randomized controlled trials for cognitive interventions among Alzheimer’s Disease is unclear.Methods:Randomized controlled trials of cognitive inter-ventions among Alzheimer’s Dementia were searched from Cnki,Embase,Pubmed,Web of Science,WanFang Data,Cochrane Library,and VIP from their inception to December9th 2019.Firstly,the average CONSORT(Consolidated Standards of Reporting Trials)compliance of randomized controlled trials for cognitive interventions among Alzheimer’s Disease was estab-lished.Secondly,the compliance of per CONSORT item was calculated.Furthermore,the possible factors that determine the reporting quality were explored using univariate analysis and binary logistic regression.Results:A total of 55 studies were included.Mean CONSORT compliance of randomized controlled trials was 57.16%and standard deviation was 0.11.Univariate analysis showed that journal impact factor(p<0.001),sample size(p=0.002)as well as number of authors(p<0.001)were statistically significant,but post-2010 publication(p=0.206)as well as reporting of funding(p=0.221)had no significance.However,none of the above factors had statistical significance in binary logistic regression.Conclusions:The overall reporting quality was low,which would not be conducive to the evidence transformation and implementation.Furthermore,the reporting quality was not probably affected by aforementioned factors.
文摘Objective: To systematically evaluate the effectiveness of fall prevention and balance function in the elderly.Methods: Databases, including Pub Med, Web of Science, Cochrane Library, Chinese Biomedical Literature Database(CBM), and CNKI were electronically searched, and the relevant references of the included papers were also manually searched. Two reviewers independently screened the articles according to the inclusion and exclusion criteria, extracted the data, and assessed the methodological quality. A metaanalysis was performed using the Cochrane Collaboration's Rev Man 5.1 software.Results: Six randomized controlled trials(RCTs) involving 2796 participants were included. The results of the meta-analysis showed that compared with a physiotherapy intervention, Tai Chi could significantly reduce the incidence rates of falls [relative risk(RR) ? 0.82, 95% confidence interval(CI)(0.73, 0.92)],while there were significant differences in the Timed Up and Go test, Functional Reach Test and Berger Balance Scale.Conclusions: Tai Chi is effective in reducing the risk of falls and improving balance in the elderly.
基金Supported by the University of Sydney,Sydney,Australia
文摘AIM: To evaluate the relative efficacy and safety of aflibercept for treatment of diabetic macular oedema(DMO).METHODS: A comprehensive search in MEDLINE, CENTRAL and EMBASE was undertaken for randomized controlled trials(RCTs) comparing intravitreal antivascular endothelial growth factor(anti-VEGF) versus another treatment. Primary outcome measures were proportion of patients with at least 15 letters of gain or loss on a log MAR visual acuity chart, and change in best corrected visual acuity(BCVA) and central macular thickness(CMT) from baseline. Safety outcomes were rates of death, thromboembolic events and any systemic or ocular serious adverse events. The final search was performed on November 2017.RESULTS: Four RCTs were included. Only one trial compared efficacy and safety of aflibercept with bevacizumab and ranibizumab over 1 or 2 y. Three trials were included for Meta-analysis comprising 661 patients(331 in the aflibercept, and 330 in the photocoagulation group). Aflibercept was more efficacious compared to photocoagulation in the proportion of patients with at least 15 letters of improvement and worsening, and in improvement of BCVA and reduction in CMT at 1 or 2 y. The safety estimates at 1 or 2 y did not differ statistically.CONCLUSION: Aflibercept offers superior benefits over photocoagulation in improving and preserving vision, with no differences in safety. Further comparative effectiveness trials between aflibercept and other anti-VEGF agents will aid ophthalmologists in treatment decisions.
文摘Background: Nursing practice has to contribute to evidence pointing out why there is a need for more nurse-designed randomized control trials (RCTs) focusing on evidence-based practice (EBP). How far this EBP has progressed in different health aspects is usually established by systematic reviews of RCTs. Nurse-led RCTs exist but no study has addressed the essentials of nursing care. Aim: The aim was therefore to determine the essentials of nurses’ interventions by means of nurse-led RCTs in somatic care focusing on the stated context, goals, content, strategies as well as the nurse’s role related to effectiveness. Methods: A systematic review was realized according to Cochrane review assumptions to identify, appraise and synthesize all empirical evidence meeting pre-specified eligibility criteria. The PRISMA statement guided the data extraction process (n = 55) from PubMed and CINAHL. Results: Of the RCTs in somatic care, 71% showed a positive effectiveness of nurse-led interventions, of which the nurse had a significant role with regard to being the main responsible in 67% of the studies. Also, 47% of the RCTs presented a theoretical standpoint related to the nurse-led interventions and most prominent were international evidence-based guidelines. Goals were found to have either a patient-centered or a professional-centered ambition. Strategies were based on patient-directed initiatives, nurse-patient-directed initiatives or nurse-directed initiatives, while contents were built upon either a patient-nurse interaction or a nursing management plan. Conclusions: This review underlines the necessity of a holistic view of a person, as nurse-led RCTs comprising a patient-centered ambition, patient-directed initiative and patient-nurse interaction plan showed beneficial nursing care effectiveness, particularly if theory-based. In a nurse-led RCT, a basic theoretical perspective is advantageous as well as to elucidate the role of the nurse in relation to the estimated effects.
基金This research was supported by National Natural Science Foundation of China(No.81603565)Tianjin University of Traditional Chinese Medicine Postgraduate Research Innovation Project(YJSKC-20201032).
文摘Objective:This study was to evaluate the quality of the randomized controlled trials on Roy adaptation model nursing in individuals suffering from acute myocardial infarction in China.Methods:We systematically searched the Cnki,Wanfang and Vipdatabases,to get randomized controlled trials on Roy adaptation model nursing in individuals suffering from acute myocardial infarction.The search period was from inception to October 2020.According to the Cochrane risk bias assessment tool,the quality of the studies included was appraised.Results:A total of 55 studies were retrieved,and 11 were eventually included in the study.Among the studies included,the first study was published in 2008.The overall quality of the 11 studies included was relatively low.Conclusions:The overall quality of the randomized controlled trials on Roy adaptation model nursing in individuals suffering from acute myocardial infarction was not high,which would hinder the evidence transformation as well as clinical practice.
基金supported by grants from the Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine (ZYYCXTD-C-202003)the China Academy of Chinese Medical Sciences Evidence-based Capacity Improvement Project (ZZ13-024-7)
文摘Objective: To assess the effectiveness and safety of manipulation intervention for degenerative lumbar spondylolisthesis(DLS).Methods: This is a systematic review and meta-analysis. A full-scale retrieval method was performed until February 1, 2021, including nine databases. The homogeneity of different studies was summarized using the Review Manager. The quality of studies was determined with the Cochrane risk-of-bias tool.The evidence quality was graded with the Grading of Recommendations, Assessment, Development, and Evaluations approach.Results: A total of 6 studies involving 524 participants were included. The review demonstrated that manipulation has statistically significant improvements for treating DLS according to Japanese Orthopedic Association scores(mean difference, 3.76;95% confidence interval, 2.63 to 4.90;P <.001) and visual analog scale scores(mean difference,-1.50;95% confidence interval,-1.66 to-1.33;P <.001)compared to the control group. One study reported that the difference in the Oswestry Disability Index between the traction group and the combination of manipulation and traction group was statistically significant(P <.05), while another reported that manipulation treatment can significantly improve the lumbar spine rotation angle on X-ray images compared with the baseline data(P <.05). Moreover, the manipulation group(experimental group) had fewer adverse events than the lumbar traction group(control group).Conclusion: Manipulation intervention is more effective and safer for DLS. Nevertheless, large-scale randomized controlled trials are required to confirm the current conclusions.
基金Key Research and Promotion Projects of Henan Province,No.202102310094Wu Jieping Medical Foundation of Clinical Research Special Fund,No.320.2710.1836+1 种基金Henan University Graduate“Excellence Program”,No.SYL18060141Henan Province Medical Science and Technology Project Joint Development Project,No.2018020331.
文摘BACKGROUND Colorectal cancer is one of the most common cancers globally.In China,its prevalence ranks fourth and fifth among females and males,respectively.Presently,treatment of rectal cancer follows a multidisciplinary comprehensive treatment approach involving surgery,radiotherapy,chemotherapy,and targeted therapy.With deepening theoretical and molecular research on colorectal cancer,randomized controlled trials(RCTs)on colorectal cancer have made significant progress.However,many RCTs have shortfalls.AIM To investigate the RCTs of global colorectal cancer spanning from 2008 to 2018.To provide suggestions for conducting Chinese RCTs of colorectal cancer.METHODS PubMed and Web of Science databases were searched to obtain RCTs of colorectal cancer carried out between January 1,2008,and January 1,2018.The bibliometric method was used for statistical analysis of the publication years,countries/regions,authors,institutions,source journals,quoted times,key words,and authors.RESULTS Colorectal cancer RCTs showed an upward trend between 2008 to 2018;the top 10 research institutions in the included literature were from the United States,the United Kingdom,and other countries with a high incidence of colorectal cancer.Most of the related research journals are sponsored by European and American countries.The 15 most cited studies involved international multicenter clinical research,having few participants from Chinese research institutions.Network visualization using key words showed that RCTs on colorectal cancer focus on screening,disease-free survival,drug treatment,surgical methods,clinical trials,quality of life,and prognosis.The result of the coauthorship network analysis showed that Chinese researchers are less involved in international exchanges compared to those from leading publication countries.CONCLUSION High-quality RCTs are increasingly favored by leading international journals.However,there is still a large gap in clinical research between China and leading countries.Researchers should implement standardized and accurate clinical trials,strengthen international multicenter cooperation,and emphasize quality control.
基金This work is supported in part by the Project for Capacity Building of TCM Clinical Researchers(grant number,201207007)the Program of Innovative Research Team of Beijing University of Chinese Medicine(2011-CXTD-09)LQ Wang was supported by the Independent Research Project from the Beijing University of Chinese Medicine(2014-JYBZZ-XS-066).
文摘Objective:To assess the effectiveness and safety of acupoint injection for the treatment of asthma.Methods:Six electronic databases were searched for randomized controlled trials(RCTs)of acupoint injection for asthma.Two authors extracted data and assessed methodological quality independently using the Cochrane Collaboration Risk of Bias tool.Data were evaluated using RevMan v5.2.Results:Eighteen RCTs involving 1913 participants with asthma were identified.Overall methodological quality of the RCTs was classified as unclear risk of bias.Western medicine(12 RCTs)was injected most frequently into acupoints,followed by Chinese herbal medicine(four RCTs),vitamins(one RCT),and Chinese herbal medicine combined with Western medicine(one RCT).Four RCTs used only one acupoint[ST36(two RCTs),BL13,CV22],whereas the other RCTs selected multiple acupoints(among which BL13 was used most frequently).One RCT reported mortality,no RCT reported quality of life,15 RCTs reported the symptom improvement rate,one RCT reported asthma control test(ACT)data,one RCT reported the duration of asthma,three RCTs reported the mean time that asthma was controlled(MTAC),and 13 RCTs reported lung-function tests(LFTs).Some RCTs showed acupoint injection may improve the attack time of asthma,MTAC,and LFTs.Five RCTs reported the outcome of adverse events and showed no significant differences between the acupoint injection group and control group.Conclusions:The findings suggest that acupoint injection may be effective for improving ACT data,duration of asthma,MTAC and LFTs.However,the evidence is insufficient owing to the poor methodological quality of the RCTs.
基金National natural science foundation of China(No.81873284)Heilongjiang province postdoctoral funding project(No.LBH-Z18253)+1 种基金Heilongjiang university of Chinese medicine scientific research(No.2019TD01,2019BS02)Shenzhen Guangming new district traditional Chinese medicine research project(No.GM2019020017)
文摘Objective:Though Chinese medicine(CM)has showed its clinical efficacy for the treatment of obstructive sleep apnea(OSA)in China,no systematic reviews or meta-analyses provide evidences for its therapeutic effects on OSA and the long-term safety.The aim of the present study is to evaluate the effectiveness and safety of CM on OSA using meta-analysis.Methods:We used search items of"Chinese Medicine"AND"obstructive sleep apnea"to retrieve the randomized control trials(RCTs)of CM treatments for OSA in PubMed,Embase,Cochrane Library,China National Knowledge Infrastructure(CNKI),VIP database,and Wanfang database from their respective inception dates to December 2019.Only RCTs of CM therapy versus no treatment which could be quantitatively synthesized were included.Finally,20 studies representing 1,297 participants were included after extraction.Two investigators independently extracted and analyzed the data using RevMan5.3 software.Results:The treatment group using CM decoctions or CM granules presented significantly ameliorative effects on apnoea-hypopnoea index(AHI)compared with the control group(MD:-2.58,95%CI:-3.59 to-1.56,P<0.00001 and MD:-5.47,95%CI:-6.75 to-4.19,P<0.00001,respectively)in the sensitivity analysis.However,there were non significant differences in the duration of treatment between subgroups,indicating that the duration of treatment has no impacts on the therapeutic effects on AHI.CM granules also showed significantly ameliorative effects on the lowest nocturnal oxygen saturation(LSaO2)(MD:2.76,95%CI:1.85 to 3.68,P<0.00001).CM decoctions exhibited significantly improved Epworth Sleepiness Scale(ESS)scores compared with the control group in a sensitivity analysis(MD:-1.50,95%CI:-2.13 to-0.88,P<0.00001).CM granules showed a better improvement of ESS than the control group(MD:-1.35,95%CI:-1.92 to-0.78,P<0.00001).Mild adverse reactions occurred only in five patients and disappeared without special treatment.Conclusion:This study showed favorable therapeutic efficacy of CM on OSA.However,in consideration of the low methodological quality of the included RCTs,more rigorous designed,large sample size RCTs are recommended for providing more high-quality evidences.
文摘Background: Teamcare should, like all patient care, also contribute to evidence-based practice (EBP). Randomized controlled trials (RCTs) focusing on teamcare have been performed but no study has addressed its essentials. How far this EBP has progressed in different health aspects is generally established in systematic reviews of RCTs. Aim: The aim is to determine the essentials of teamcare including the nurse profession in RCTs of multi- or interdisciplinary interventions in somatic care focusing on the stated context, goals, strategies, content as well as effectiveness of quality of care. Methods: A systematic review was performed according to Cochrane review assumptions to identify, appraise and synthesize all empirical evidence meeting pre-specified eligibility criteria. The PRISMA statement guided the data selection process of 27 articles from PubMed and CINAHL. Results: Eighty-five percent of RCTs in somatic care showed a positive effectiveness of teamcare interventions, of which interdisciplinary ones showed a greater effectiveness compared with the multidisciplinary approach (100% vs 76%). Also theory-based RCTs presented higher positive effectiveness (85%) compared with non-theory-based RCTs (79%). The RCTs with positive effectiveness showed greater levels for professional-centered ambition in terms of goals and for team-directed initiatives in terms of strategy, and a significantly higher level for patient-team interaction plans in terms of content was shown. Conclusions: Teamcare RCTs are still grounded in the multidisciplinary approach having a professional-centered ambition while interdisciplinary approaches especially those that are theory-based appear to be essential with regard to positive effectiveness and preferable when person-centered careis applied.
基金Supported by the National Natural Science Foundation of China (No.81973968)the China Academy of Chinese Medical Sciences (No.CI2021A03503, GH201901, and 2020YJSZX-1)。
文摘Background:The effects of acupuncture have varied in different randomized controlled trials(RCTs),and there are many factors that influence treatment effect of acupuncture in different outcomes,with conflicting results.Objective:To identify factors and their impact on the treatment effect of acupuncture in different outcomes.Methods:Acupuncture RCTs were searched from 7 databases including Medline(Pub Med),Embase,Cochrane Central Register of Controlled Trials,China National Knowledge Infrastructure,Wanfang Database,VIP Database,and China Biology Medicine disc between January 1st,2015 and December 31st,2019.Eligible studies must compare acupuncture to no acupuncture,sham acupuncture,or waiting lists,and report at least 1patient-important outcome.A multi-level meta-regression was conducted using a 3-level robust mixed model and univariate analyses were performed for all independent variables,even those excluded from the multivariable model due to collinearities.We used thresholds of 0.2 and 0.4 for the difference of standardized mean differences(SMDs),categorising them as small(<0.2),moderate(0.2–0.4),or large(>0.4) effects.Results:The pain construct analysis involved 211 effect estimates from 153 studies and 14 independent variables.High-frequency acupuncture treatment sessions produced larger effects compared to low-frequency sessions [large magnitude,the difference of adjusted SMDs 0.46,95% confidence interval(CI) 0.07 to 0.84;P=0.02].The non-pain symptoms construct analysis comprised 323 effect estimates from 231 studies and 15 independent variables.Penetrating acupuncture showed moderately larger effects when compared to non-penetrating acupuncture(0.30,95% CI 0.06 to 0.53;P=0.01).The function construct analysis included 495 effect estimates from 274 studies and 14 independent variables.Penetrating acupuncture and the flexible acupuncture regimen showed moderately larger effects,compared to non-penetrating acupuncture and fixed regimen,respectively(0.40,95% CI 0 to 0.80;P=0.05;0.29,95% CI 0.06 to 0.53;P=0.01).Conclusions:High-frequency acupuncture sessions appear to be a more effective approach to managing painful symptoms.Penetrating acupuncture demonstrated greater effect in relieving nonpainful symptoms.Both penetrating acupuncture type and flexible acupuncture regimen were linked to significant treatment effects in function outcomes.Future studies should consider the factors that are significantly associated with the effects of acupuncture in patient-important outcomes.
基金The present study was supported by Medical Innovation and Development Project of Lanzhou University and Cuiying Scientific Training Program for Undergraduates of Lanzhou University Second Hospital(Item No.CYXZ2023-09 and CYXZ2021-07).
文摘Background:Randomized controlled trials(RCTs)are often considered the gold standard and the cornerstone for clinical practice.However,bibliometric studies on worldwide RCTs of ophthalmology published in the 21st century have not been reported in detail yet.This study aims to perform a bibliometric study and visualization analysis of worldwide ophthalmologic RCTs in the 21st century.Methods:Global ophthalmologic RCTs from 2000 to 2022 were searched in the Web of Science Core Collection.The number of publications,country/region,institution,author,journal,and research hotspots of RCTs were analyzed using HistCite,VOSviewer,CiteSpace,and Excel software.Results:2366 institutions and 90 journals from 83 countries/regions participated in the publication of 1769 global ophthalmologic RCTs,with the United States leading in the number of volumes and research field,and the Moorfields Eye Hospital contributing to the most publications.Ophthalmology received the greatest number of publications and co-citations.Jeffrey S.Heier owned the most publications and Jost B.Jonas owned the most cocitations.The knowledge foundations of global ophthalmologic RCTs were mainly retinopathy,glaucoma,dry eye disease(DED),and cataracts,and anti-vascular endothelial growth factor(VEGF)therapy(ranibizumab),topical ocular hypotensive medication,laser trabeculoplasty.Anti-VEGF therapy for age-related macular degeneration(AMD),DME(diabetic macular edema),and DED,the use of new diagnostic tools,and myopia were the hottest research highlights.Anti-VEGF therapy,prompt laser,triamcinolone,and verteporfin photodynamic therapy for AMD,DME,and CNV(choroidal neovascularization),DED,myopia,and open-angle glaucoma were the research hotspots with the longest duration.The future research hotspots might be DED and the prevention and control of myopia.Conclusions:Overall,the number of global ophthalmologic RCTs in the 21st century was keeping growing,there was an imbalance between the regions and institutions,and more efforts are required to raise the quantity,quality,and global impact of high-quality clinical evidence in developing countries/regions.
