Nonintubated video-assisted thoracic surgery （VATS） that is also defined awake VATS entails thoracoscopic procedures performed by regional anesthesia in spontaneously ventilating,mildly sedated or fully awake patients.
The amount of scientific knowledge from randomized parallel group trials have been improved by the CONSORT Guideline, but important intelligence with important clinical implications remains to be extracted. This may t...The amount of scientific knowledge from randomized parallel group trials have been improved by the CONSORT Guideline, but important intelligence with important clinical implications remains to be extracted. This may though be obtained if the conventional statistical significance testing is supplied by 1) Addition of an unbiased and reproducible quantification of the magnitude or size of the clinical significance/importance of a difference in treatment outcome;2) Addition of a quantification of the credulity of statements on any possible effect size and finally;3) Addition of a quantification of the risk of committing an error when the null hypothesis is either accepted or rejected. These matters are crucial to proper conversion of trial results into good usage in every-day clinical practice and may produce immediate therapeutic consequence in quite opposite direction to the usual ones. In our drug eluting stent trial “SORT OUT II”, the implementation of our suggestions would have led to immediate cessation of use of the paclitaxel-eluting stent, which the usual Consort like reporting did not lead to. Consequently harm to subsequent patients treated by this stent might have been avoided. Our suggestions are also useful in cancer treatment trials and in fact generally so in most randomized trial. Therefore increased scientific knowledge with immediate and potentially altered clinical consequence may be the result if hypothesis testing is made complete and the corresponding adjustments are added to the CONSORT Guideline—first of all— for the potential benefit of future patients.展开更多
In the present study, we aimed to evaluate the effects of cilnidipine and L-type calcium channel blockers（L-type CCBs） on renal function in hypertensive patients. The randomized controlled trials（RCTs） of cilnidip...In the present study, we aimed to evaluate the effects of cilnidipine and L-type calcium channel blockers（L-type CCBs） on renal function in hypertensive patients. The randomized controlled trials（RCTs） of cilnidipine and L-type CCBs on hypertension treatment were selected from Pubmed, Embase, Google Scholar, CNKI, Science Direct, Ebsco, Springer, Ovid, Cochrane Library, Medline, VIP and Wanfang databases（from the date of databases＇ establishment to September 2014）. Data were independently evaluated following the Jadad standard. The percentage changes of serum creatinine（SCr） value, urinary protein excretion（UPE）, urinary protein/creatinine ratio（UPCR） and estimated glomerular filtration rate（e GFR） pre- and post-treatment were extracted for the subsequent meta-analysis. The mean difference（MD） and the 95% confidence interval（95% CI） were determined using RevM an 5.3 software. A total of 10 RCTs of high quality were included and analyzed by fixedor random-effect models. The results indicated that UPE（MD = –36.59, 95% CI： –70.85, –2.33） or UPCR（MD = –46.56, 95% CI： –88.50, –4.62） was significantly reduced by cilnidipine compared with L-type CCBs. However, such significant difference was not detected in reduction of SCr（MD = 0.01, 95% CI： –2.97, 2.98） or eG FR（MD = 1.56, 95% CI： –0.19, 3.31）. Compared with L-type CCBs, cilnidipine was more effective in reducing proteinuria or preventing the proteinuria progression. In addition, we did not find significant differences in SCr and eG FR between the two groups.展开更多
Objective:To evaluate the effectiveness and safety of Chinese herbal medicines(CHMs)for incomplete immune reconstruction in patients with HIV/AIDS.Methods:Eight electronic databases were searched for randomized contro...Objective:To evaluate the effectiveness and safety of Chinese herbal medicines(CHMs)for incomplete immune reconstruction in patients with HIV/AIDS.Methods:Eight electronic databases were searched for randomized controlled trials(RCTs)on the use of CHM for patients with HIV/AIDS with incomplete immune reconstruction.Outcomes included CD4þcell count,quality of life,and adverse events/effects.The Cochrane Risk of Bias was employed to evaluate the methodological quality of the included RCTs.Results:We identified 13 eligible RCTs,with an overall high risk of bias,on 10 different CHMs.There was a significant increase in CD4þcell count after the use of Jianpi Yiqi medicinal paste for 3 months;tripterygium glycosides tablets(TGTs)for 3 months(mean difference[MD]52.63 cells/mL,95%confidence interval[CI,46.98,58.28]),6,9,and 12 months;Wenshen Jianpi granules for 6 months;Shenling Fuzheng capsules for 6 months(MD 49.53 cells/mL,95%CI[8.45,90.61])and 12 months;Aikeqing granules for 9 months(MD 61.51 cells/mL,95%CI[16.25,106.77])and 12 months;Guipi decoction for 12 months;Mianyi No.2 granules(JT)for 12 and 18 months;and Chinese medicine granules for 18 months.The increase in the mean difference of CD4þcell count from 6 to 18 months was larger in Chinese medicine granules and Mianyi No.2 granules(JT).Guipi decoction and Jianpi Qushi decoction improved the Karnofsky score.Four RCTs reported the outcome of adverse events/effects,while four cases of minor adverse effects were reported in the TGTs group.Conclusion:Jianpi Yiqi medicinal paste,Wenshen Jianpi granules,Shenling Fuzheng capsules,Aikeqing granules,Guipi decoction,and TGTs may be effective in increasing CD4þwithin 12 months,and Mianyi No.2 granules(JT)and Chinese medicine granules may show long-term effects.High-quality large RCTs on the effectiveness and safety of CHMs are still warranted.展开更多
The introduction of prostate-specific antigen （PSA） for prostate cancer screening in the late 1980s led to an epidemic of prostate cancer, particularly in developed countries. However, the first valid reports from r...The introduction of prostate-specific antigen （PSA） for prostate cancer screening in the late 1980s led to an epidemic of prostate cancer, particularly in developed countries. However, the first valid reports from randomized controlled trials on the efficacy of screening were not published until 2009. Men in the screening group in the European Randomized Study of Screening for Prostate Cancer were 20% less likely than those in the control group to die from prostate cancer. The absolute difference was only 0.7/1000, implying that over 1400 men needed to be screened to prevent one prostate cancer death. Screening was also associated with a 70% increased risk for being diagnosed with prostate cancer. The American Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial found no survival benefit for screening. Results were not conclusive because a substantial proportion of study subjects had previously undergone PSA testing, over half of the control group had PSA testing, follow-up was relatively short, and fewer than 100 subjects died from prostate cancer. Balancing the potential survival benefit from screening is the risk of overdiagnosis--finding cancers that would not otherwise cause clinical problems^and the risk of treatment complications, including urinary, sexual and bowel dysfunction. Prostate cancer screening efforts would benefit from improved biomarkers, which more readily identify clinically important cancers. Cancer control efforts might also need to include chemoprevention, though currently available agents are controversial. In the meantime, oatients need to be supoorted in achievine informed decisions on whether to be screened for orostate cancer.展开更多
Objective Helicobacter pylori(HP)infection is associated with non-alcoholic fatty liver disease(NAFLD)and insulin resistance;however,the correlation between HP eradication and NAFLD remains controversial.This systemat...Objective Helicobacter pylori(HP)infection is associated with non-alcoholic fatty liver disease(NAFLD)and insulin resistance;however,the correlation between HP eradication and NAFLD remains controversial.This systematic review and meta-analysis examined the effect of HP treatment on clinical and laboratory parameters in NAFLD patients.Methods We conducted a literature search of the PubMed,Embase,Scopus,and Web of Science databases through Septem-ber 2023 for randomized controlled trials(RCTs)examining the effect of HP treatment on NAFLD patients versus lifestyle changes alone.The primary outcome was the change in steatosis parameters.The secondary endpoints were changes in anthropometric parameters,inflammatory markers(TNF-α),and metabolic parameters(fasting blood glucose,homeostasis model assessment of insulin resistance,AST/ALT,and lipid profile).The random effects model was used to calculate the standardized mean difference(SMD)with associated 95%confidence intervals(CIs)for our desired outcome.Results Four RCTs met our inclusion criteria.A total of 453 patients were included(mean age 42.8 years,58.5%males),228(50.3%)of whom were in the HP eradication group and 225(49.7%)of whom were in the lifestyle modification group.Compared with lifestyle modification alone,HP eradication had a significant effect on reducing liver steatosis and TNF-αlevels(SMD:-0.9;95%CI-14.67,-3.82,I^(2)=0%and SMD:-6.3;95%CI-9.04,-3.56,I^(2)=0%,respectively).No sig-nificant effect on other metabolic parameters was found.Conclusions HP eradication significantly reduced liver steatosis and TNF-αlevels in NAFLD patients.However,HP eradi-cation did not significantly affect other metabolic indices compared to lifestyle changes alone.展开更多
Acupuncture is an ancient treatment method used in traditional Chinese medicine and has been popularized worldwide.Over the past decade,there has been an increase in the amount of acupuncture research,mostly comprised...Acupuncture is an ancient treatment method used in traditional Chinese medicine and has been popularized worldwide.Over the past decade,there has been an increase in the amount of acupuncture research,mostly comprised of randomized controlled trials(RCTs)that aimed to answer the question on the efficacy of acupuncture.However,poor methodology and low replicability in these acupuncture RCTs have resulted in uncertainty about the efficacy of acupuncture.In this review,current advancements and challenges in acupuncture RCTs,regarding the methodological aspects of randomization,blinding,sham acupuncture and quality of reporting,were discussed.While there have been advancements in various aspects,current acupuncture RCTs still face pressing issues such as inadequate randomization and blinding,unviable sham acupuncture controls,and poor reporting quality.Given these limitations,this review seeks to identify the methodological problems that are responsible for these problems and to suggest solutions that could help to overcome them so as to improve the quality of future studies evaluating the efficacy of acupuncture.展开更多
OBJECTIVE:In recent years,the number of clinical research reports on acupuncture and manipulation for the treatment of greater occipital neuralgia has gradually increased,but the quality is uneven.There is currently n...OBJECTIVE:In recent years,the number of clinical research reports on acupuncture and manipulation for the treatment of greater occipital neuralgia has gradually increased,but the quality is uneven.There is currently no literature evaluating the quality of published reports,which is not conducive to the promotion of clinical use of these therapies.Therefore,this article assessed the reporting quality of randomized controlled trials on acupuncture and manipulation for greater occipital neuralgia.METHODS:Cochrane Library,PubMed,Web of Science,Embase,China National Knowledge Infrastructure(CNKI),VIP,WanFang Data,and Chinese BioMedical Literature Database(CBM)from inception to May 20,2024 were searched.The reporting quality of included randomized controlled trials was independently evaluated by two investigators using the CONSORT statement,STRICTA checklist,and Cochrane bias of risk assessment tool.A third investigator resolved any disagreement.RESULTS:A total of 62 articles were included.Based on the CONSORT statement,59.46%(22/37)of all entries had a reporting rate of less than 50%,mainly including“Identification as a randomized trial in the title(1/62,1.61%),”“How sample size was determined(7/62,11.29%),”“Implementation(1/62,1.61%),”“Blinding(1/62,1.61%),”and“Reports of Funding(4/62,6.45%).”According to the STRICTA checklist,29.41%(5/17)of all entries had a reporting rate of less than 50%,mainly including“Details of other interventions(7/58,12.07%),”“Setting and context of treatment(0/58,0%),”and“Description of participating acupuncturists(0/58,0%).”CONCLUSION:The reporting quality of randomized controlled trials on acupuncture and manipulation therapy for greater occipital neuralgia remains low.Future researchers need to make greater efforts to strictly adhere to the CONSORT statement and STRICTA checklist during trial design,implementation,and reporting.This will facilitate the standardization of research in this field and enhance the reliability and reproducibility of the research results.展开更多
Objectives:This study aims to evaluate the current state of acupuncture randomized controlled trials(RCTs),their impact on guidelines,and future development trends,providing a reference for future re-search directions...Objectives:This study aims to evaluate the current state of acupuncture randomized controlled trials(RCTs),their impact on guidelines,and future development trends,providing a reference for future re-search directions.Methods:Search for acupuncture-related RCT articles in the Web of Science Core Collection and con-firm their guideline inclusion on Google Scholar.Analyze study characteristics to predict future research directions.Results:The analysis covered 1422 articles,reflecting a substantial rise in publications from 77 articles between 1993 and 2002 to 960 articles between 2013 and 2022.The Western Pacific region led in pub-lication numbers with 622 articles(43.7%),followed by Europe(466 articles;32.8%),Americas(250 articles;17.6%),Eastern Mediterranean(62 articles;4.4%),and Southeast Asia(22 articles;1.5%),with Africa showing a research void.Regrettably,only 29.6%(421 articles)were incorporated into guidelines.The low rate of inclusion of research results in guidelines and the uneven distribution of research fields are particularly prominent.From 1993 to 2002,there were 77 articles,among which 51(66.2%)were included in the guidelines;from 2003 to 2012,there were 385 articles,with 202(52.5%)included;from 2013 to 2022,there were 960 articles,and only 168(17.5%)were included,showing a decreasing trend in the inclusion rate year by year.Regarding geographical distribution,1167 articles were from the East-ern Hemisphere,with 326(27.9%)included;255 were from the Western Hemisphere,and 95(37.3%)were included.Regionally,179 articles(42.5%)from Europe were included,140(33.3%)from the West-ern Pacific,95(22.6%)from the Americas,6(1.4%)from the Eastern Mediterranean,and 1(0.2%)from Southeast Asia.China,the United States,and Germany were the top publishing countries,with consis-tent growth in countries like China,South Korea,Spain,Brazil,Turkey,and Iran.Noteworthy researchers such as Cesar Fernandez-de-las-Penas,Zhi-shun LIU,Jing-wen YANG,Cun-zhi LIU,Li-xing LAO,Stefan N Willich,and Benno Brinkhaus have collaborated on research in areas such as pain management,cognitive impairments,insomnia,digestive system diseases,and urinary system diseases.There has been a partic-ular increase in research focus on neck pain and myofascial trigger points.展开更多
BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in ...BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in RCTs of hepatocellular carci-noma(HCC),the response rates and survival status,and adverse events(AEs)were summarized and evaluated.AIM To systematically evaluate the response rates,survival status and AEs in the placebo arms of RCTs for HCC.METHODS A systematic search was performed on PubMed,Ovid MEDLINE,Embase and Cochrane Library to identify relevant trials evaluating the efficacy of drugs for the treatment of HCC,published until December 31,2023.Statistical analysis was performed using R statistical software(version 4.3.2).RESULTS A total of 18 RCTs,involving 2390 patients,met the criteria for inclusion in the meta-analysis.The pooled overall disease control rate and objective response rate in the placebo group were 38%[95%confidence interval(CI):33%-42%]and 1%(95%CI:1%-2%),respectively.Overall survival and progression-free survival in the placebo group were 7.9 months(95%CI:7.6-8.31 months)and 1.9 months(95%CI:1.6-2.1 months),respectively.The incidence of grade 3 or 4 AEs was 37%(95%CI:30%-43%).Additionally,the incidence of interruptions or dose reductions due to AEs was 20%(95%CI:13%-27%),while the incidence of treatment discontinuation due to AEs was 9%(95%CI:6%-12%).CONCLUSION Over one-third of advanced HCC patients exhibit therapy-free disease control,with placebo-arm AEs observed.These findings guide single-arm trials design and enhance patient acceptance of anticancer therapies.展开更多
BACKGROUND Nutritional psychiatry is a rapidly expanding field of research,with mounting evidence suggesting that nutritional factors may play a role in the development of psychiatric disorders.AIM To examine the leve...BACKGROUND Nutritional psychiatry is a rapidly expanding field of research,with mounting evidence suggesting that nutritional factors may play a role in the development of psychiatric disorders.AIM To examine the level of evidence for nutritional psychiatry.METHODS A scoping review was conducted to assess the current state of nutritional psychiatry,including a search for randomized controlled trials(RCTs).RESULTS The review identified a total of seven papers,with many concentrating on the relationship between depression and the gut microbiome.A salient issue that emerged from this review was the paucity of sample size in many studies.The inherent complexity of nutritional studies,characterized by a multitude of potential factors and exposures that often act as confounders,poses significant challenges to the development of effective RCT designs.The analysis revealed that probiotics,though demonstrating efficacy,exhibited a modest effect size.CONCLUSION Conducting RCTs with effective markers is imperative from these studies.The implementation of Mendelian randomization and the investigation of mechanisms in basic research are essential complementary approaches.展开更多
BACKGROUND Systematic reviews(SRs)synthesize and evaluate data,mainly from randomized trials,which then guides the development of clinical recommendations in evidence-based medicine.However,the data and methodological...BACKGROUND Systematic reviews(SRs)synthesize and evaluate data,mainly from randomized trials,which then guides the development of clinical recommendations in evidence-based medicine.However,the data and methodological information in the included papers can often be lacking or unclear,and reviewers usually need to contact the authors of included studies for clarifications.Contacting authors is recommended,but it is unclear how often SR teams do it,or what the level of response is.AIM To investigate how often reviewers undertake contact with the authors of included randomized controlled trials(RCTs)for clarification on data and risk of bias concerns,to explore the factors that influence whether SR authors contact or do not contact the authors,and the content and level of responses.METHODS We conducted a systematic electronic database search in MEDLINE using the search string“(systematic review)”AND“(RCT OR randomized OR trial)”for articles published between 1 January 2024 and 19 February 2024,without language restrictions.Screening and data extraction was done independently by two reviewers,and conflicts resolved by a senior author.Contact authors of included SRs were contacted for clarifications.RESULTS Of the 329 included SRs,38%(n=125)explicitly mentioned contact with the authors of included studies.The remaining 62%(n=204)did not.We attempted contact with all SR teams for clarifications and received 90 responses(19.4%).Of the 50 respondents who did not explicitly mention contact in their SRs,25(50%)replied that they did make contact.We received a total of 64 responses on the level and content of information sought.The mean±SD contacts SR teams made were 10(10),replies received 5(6.7),and response waiting time 10.1(28.3)weeks.Resources,time,poor previous experience,perceived likelihood of poor response and bias concerns were reported as barriers to attempting contact.CONCLUSION The majority of SRs published in 2024 did not confirm seeking clarifying or missing information from primary study authors.However,SR teams reported that 50%of contacted primary authors respond.Additional research can clarify this rate of response and establish methods to increase the integration of this core methodological element in SRs.展开更多
BACKGROUND Prolonged immobility during intensive care unit(ICU)admission has been a cause of muscle atrophy and worsening functional outcomes with longer recovery times.Prior research has demonstrated that mobilizatio...BACKGROUND Prolonged immobility during intensive care unit(ICU)admission has been a cause of muscle atrophy and worsening functional outcomes with longer recovery times.Prior research has demonstrated that mobilization within a week of ICU admission potentially benefits physical function in critically ill patients.AIM To evaluate the effects of initiating mobilization within 72 hours of ICU admission in critically ill patients through an updated systematic review and meta-analysis.METHODS A systematic search was performed through MEDLINE,Scopus,and Cochrane Library from inception until September 2024 for randomized controlled trials(RCTs)comparing early mobilization(EM)with usual or conventional care in critically ill adult patients.Primary outcomes included length of ICU(days)and ventilation duration(days).Secondary outcomes included muscle strength,functional status,adverse events,all-cause mortality,and quality of life(QOL).A random effects meta-analysis was performed for pooled effect estimates and to derive risk ratios(RR)and corresponding 95%confidence intervals(CI).RESULTS Out of 3487 results,16 RCTs were included with a population of 2385 patients(1195 receiving EM and 1190 with usual care.)A significant reduction in the length of ICU stays[mean difference(MD)=-1.02,95%CI:-1.96 to-0.09;P=0.03;I2=60%]and ventilation duration(MD=-1.07,95%CI:-1.91 to-0.23,P=0.01;I2=57%)was observed in the EM group compared to usual care.EM significantly improved muscle strength[standard MD(SMD)=0.47,95%CI:0.18-0.75,P=0.001;I2=79%]and functional status(SMD=0.70,95%CI:0.40-1.00,P<0.00001;I2=81%)in ICU patients.No statistically significant difference was observed in adverse events(RR=1.72,95%CI:1.01-2.94,P=0.05;I2=31%),all-cause mortality(RR=1.10,95%CI:0.79-1.53,P=0.57;I2=30%),and QOL(SMD=0.04,95%CI:-0.07-0.15,P=0.50;I2=9%)between the two groups.CONCLUSION Initiating mobilization within 72 hours of ICU admission is associated with improved functional outcomes and reduced ICU length of stay and ventilation duration.These findings indicate that EM may be a safe option for ICU patients,contributing to lower recovery times and healthcare costs.Further extensive research is required to validate the long-term effects on survival and QOL.展开更多
BACKGROUND External gastrointestinal fistulas(EGIFs)are serious postoperative complications associated with prolonged hospital stays,sepsis,malnutrition,and high mortality rates.Reducing gastrointestinal secretions wi...BACKGROUND External gastrointestinal fistulas(EGIFs)are serious postoperative complications associated with prolonged hospital stays,sepsis,malnutrition,and high mortality rates.Reducing gastrointestinal secretions with somatostatin or its analogues may facilitate fistula closure.The clinical effectiveness of these therapies,however,remains uncertain.AIM To investigate the effectiveness of somatostatin-based therapy for EGIFs.METHODS A systematic review and meta-analysis(Prospero CRD420251054344)of nine randomized controlled trials(442 patients)compared somatostatin-based therapies with standard care in tertiary care settings.Protocols included somatostatin,octreotide,or lanreotide,administered at various dosages(250 micrograms/hour intravenous infusion or 100 micrograms subcutaneous injection three times daily)for 7 to 56 days.Primary outcomes were fistula closure rates and time to closure.Secondary outcomes were hospital length of stay,complications,need for surgical intervention,and mortality.Mean differences and risk ratios(RRs)with 95%confidence intervals(CIs)were calculated using random-effects models.Risk of bias was assessed with the Cochrane RoB 2 tool.RESULTS There was no statistically significant difference in closure rate(RR:1.11,95%CI:0.95-1.28,P=0.19,I^(2)=0%)between 134/193 patients receiving somatostatin-based therapy and 99/170 control patients.Time to closure was reduced by 6.16 days(mean difference-6.16,95%CI:-7.44 to-4.88,P<0.001,I^(2)=0%)in 126 patients in intervention group vs 114 in control group.Hospital stay was shortened by 4.00 days(mean difference-4.00,95%CI:-7.99 to-0.01,P=0.05,I^(2)=0%)in 56 vs 62 patients.There were no differences in complications(RRs:0.76,95%CI:0.55-1.05),need for surgical intervention(RRs:0.67,95%CI:0.38-1.19),or mortality(RRs:0.77,95%CI:0.44-1.35).Limitations include small sample sizes,heterogeneity in treatment regimens,and inconsistent outcome definitions,which may affect generalizability.Limited data for some outcomes,such as hospital stay,and exclusion of some datasets for methodological reasons reduced statistical power.CONCLUSION Somatostatin-based therapies did not significantly improve fistula closure rates but were associated with shorter time to closure and hospital stay.Mortality,complications,and surgical intervention requirements remained unchanged,suggesting that these therapies may serve only as an adjunctive option in selected patients.展开更多
In the present study,a comprehensive systematic review and meta-analysis were conducted to assess the short-term efficacy and safety of blonanserin compared with control interventions,including placebo,risperidone,and...In the present study,a comprehensive systematic review and meta-analysis were conducted to assess the short-term efficacy and safety of blonanserin compared with control interventions,including placebo,risperidone,and haloperidol,in the treatment of schizophrenia.The goal was to provide a robust pharmacological foundation to inform clinical decision-making regarding the therapeutic use of blonanserin.We systematically searched five major databases-PubMed,Web of Science,Scopus,CNKI,and the WanFang Database-for randomized controlled trials(RCTs)evaluating blonanserin against standard comparators in patients with schizophrenia.Key data extracted included study authorship,publication year,geographic location,diagnostic criteria,sample size,treatment duration,dosing regimen,and clinical outcomes.Meta-analytic synthesis was performed using RevMan 5.3 software.Out of an initial pool of 718 articles,11 trials met the inclusion criteria and were incorporated into the final analysis.In terms of clinical efficacy,short-term administration of blonanserin demonstrated non-inferiority to risperidone,with no indication of inferior performance across Positive and Negative Syndrome Scale(PANSS)subscales.Moreover,blonanserin significantly outperformed the placebo in terms of PANSS response rates,underscoring its therapeutic potential in managing acute symptoms.Regarding safety,the incidence of overall and serious adverse events did not differ significantly between blonanserin and the comparator agents.However,noteworthy distinctions were observed in the adverse event profiles(≥5%incidence in either group),underscoring differences in tolerability among the antipsychotics examined.These findings collectively supported the short-term use of blonanserin as a viable and well-tolerated alternative in the pharmacological management of schizophrenia.展开更多
Background:The use of inserted sham acupuncture as a placebo in randomized controlled trials(RCTs)is controversial,because it may produce specific effects that cause an underestimation of the effect of acupuncture tre...Background:The use of inserted sham acupuncture as a placebo in randomized controlled trials(RCTs)is controversial,because it may produce specific effects that cause an underestimation of the effect of acupuncture treatment.Objective:This systematic survey investigates the magnitude of insert-specific effects of sham acupuncture and whether they affect the estimation of acupuncture treatment effects.Search strategy:PubMed,Embase and Cochrane Central Register of Controlled Trials were searched to identify acupuncture RCTs from their inception until December 2022.Inclusion criteria:RCTs that evaluated the effects of acupuncture compared to sham acupuncture and no treatment.Data extraction and analysis:The total effect measured for an acupuncture treatment group in RCTs were divided into three components,including the natural history and/or regression to the mean effect(controlled for no-treatment group),the placebo effect,and the specific effect of acupuncture.The first two constituted the contextual effect of acupuncture,which is mimicked by a sham acupuncture treatment group.The proportion of acupuncture total effect size was considered to be 1.The proportion of natural history and/or regression to the mean effect(PNE)and proportional contextual effect(PCE)of included RCTs were pooled using meta-analyses with a random-effect model.The proportion of acupuncture placebo effect was the difference between PCE and PNE in RCTs with non-inserted sham acupuncture.The proportion of insert-specific effect of sham acupuncture(PIES)was obtained by subtracting the proportion of acupuncture placebo effect and PNE from PCE in RCTs with inserted sham acupuncture.The impact of PIES on the estimation of acupuncture's treatment effect was evaluated by quantifying the percentage of RCTs that the effect of outcome changed from no statistical difference to statistical difference after removing PIES in the included studies,and the impact of PIES was externally validated in other acupuncture RCTs with an inserted sham acupuncture group that were not used to calculate PIES.Results:This analysis included 32 studies with 5492 patients.The overall PNE was 0.335(95%confidence interval[CI],0.255-0.415)and the PCE of acupuncture was 0.639(95%CI,0.567-0.710)of acupuncture's total effect.The proportional contribution of the placebo effect to acupuncture's total effect was 0.191,and the PIES was 0.189.When we modeled the exclusion of the insert-specific effect of sham acupuncture,the acupuncture treatment effect changed from no difference to a significant difference in 45.45%of the included RCTs,and in 40.91%of the external validated RCTs.Conclusion:The insert-specific effect of sham acupuncture in RCTs represents 18.90%of acupuncture's total effect and significantly affects the evaluation of the acupuncture treatment effect.More than 40%of RCTs that used inserted sham acupuncture would draw different conclusions if the PIES had been controlled for.Considering the impact of the insert-specific effect of sham acupuncture,caution should be taken when using inserted sham acupuncture placebos in RCTs.展开更多
As a new oral hypoglycemic agent, saxagliptin belongs to the class of dipeptidyl peptidase-4 （DPP-4） inhibitors. However, it remains inconclusive whether saxagliptin is associated with increased risk of adverse even...As a new oral hypoglycemic agent, saxagliptin belongs to the class of dipeptidyl peptidase-4 （DPP-4） inhibitors. However, it remains inconclusive whether saxagliptin is associated with increased risk of adverse events （AE） and efficacy as add-on treatment. Therefore, we performed an up-to-date meta-analysis to compare the efficacy and safety of saxagliptin with placebo and other oral hypoglycemic agents in adult patients with type 2 diabetes mellitus （T2DM）. Randomized clinical trials （RCTs） comparing saxagliptin with comparators were retrieved by selecting articles from Pubmed, Embase, Cochrane Library and Clinical Trials Registry Platform up to Oct. 2013. Weighted mean difference （WMD） was used to analyze the effect of hypoglycemic agents on HbAlc, weight and fasting plasma glucose （FPG）. While the patients who achieved HbAlc〈7.0% and had AE were analyzed as relative risks （RR）. A total of 18 articles from 16 RCTs and one clinic trial from the WHO International Clinical Trials Registry Platform met the included criterion. Clinically significant decrease from baseline HbAlc compared with placebo was certified for 2.5 mg/day saxagliptin （WMD = -0.45%, 95% CI, -0.48% to -0.42%） and 5 mg/d saxagliptin （WMD = -0.52%, 95% CI, -0.60% to -0.44%）. Saxagliptin as add-on therapy was superior to thiazolidinediones, up-titrated glyburide, up-titrated metformin or metformin monotherapy in achieving HbA1c〈7.0%. Treatment with saxagliptin had negligible effect on weight, and it was considered weight neutral. Saxagliptin treatment did not increase the risk of hypoglycemia （RR = 1.28, 95% CI 0.72 to 2.27, P = 0.40） and serious adverse experiences （RR = 1.25, 95% CI 0.94 to 1.66, P = 0.13）. No statistically significant differences were observed between saxagliptin and comparators in terms of the risk of infections. The present study showed that saxagliptin was effective in improving glycaemic control in T2DM with a low risk of hypoglycaemia and incidence of infections in either monotherapy or add-on treatment. This founding should be further certified by large-sample size and good-designed RCT.展开更多
Objective:Single-incision laparoscopic sugery has emerged as a safe and less invasive approach to conventional multi-port laparoscopy.The present meta-analysis aimed to assess the collective outcomes of single-incisio...Objective:Single-incision laparoscopic sugery has emerged as a safe and less invasive approach to conventional multi-port laparoscopy.The present meta-analysis aimed to assess the collective outcomes of single-incision laparoscopic gastrectomy(SILG)compared to multi-port laparoscopic gastrectomy(MLG)for gastric cancer.Methods:A PRISMA-compliant systematic review of randomized controlled trials(RCTs)that compared SILG and MLG for gastric cancer in PubMed and Scopus through January 2023 was conducted.The main outcomes of the review were complications,postoperative pain,conversion to open surgery,hospital stay,and recovery.Results:Three RCTs including 301 patients(61.8%male)were incuded.A total of 151 patients underwent SILG,and 150 underwent MLG.SILG was associated with a shorter operative time(WMD=-16.39,95%CI:=27.38 to=5.40,p=0.003;2=0%)and lower pain scores at postoperative day 3(WMD=-1.18,95%CI:=2.27 to=0.091,p=0.033;I^(2)=99%)than MLG.There were no statistically significant differences between the two groups in es timated blood loss(WMD=-16.95,95%CI:-35.84 to 1.95,p=0.078;I^(2)=82%),complications(OR=0.71,95%Cl:0.36 to 1.42,p=0.337;I^(2)=0%),conversion to open surgery(OR=0.33,95%C:0.01 to 8.38,p=0.504),hospital stay(WMD=0.72,95%CI:-0.92 to 2.36,p=0.056;P=84%),time to first flatus(WMD=0.06,95%CI:=0.14 to 0.26,p=0.566;I^(2)=0%),time to first defecation(WMD=-0.14,95%CI:=0.46 to 0.18,p=0.392;I^(2)=0%),or time to first oral intake(WMD=0.37,95%a:=0.75 to 1.49,p=0.520;I^(2)=94%).Conclusions:SILG is associated with shorter operative times and less early postoperative pain than MLG.The odds of complications,blood loss,hospital stay,and gastrointestinal recovery were similar between the two procedures.展开更多
The objective of this study was to assess the quality of randomized controlled trials（RCTs） on pharmaceutical care for asthma tic patients conducted by pharmacists in China's Mainland, to identify the problems i...The objective of this study was to assess the quality of randomized controlled trials（RCTs） on pharmaceutical care for asthma tic patients conducted by pharmacists in China's Mainland, to identify the problems in current studies, and to provide some references for further studies. The China National Knowledge Infrastructure（CNKI）, Wanfang Database, and VIP Database were searched for randomized controlled trials on pharmaceutical care for asthma tic patients, and only those studies undertaken by pharmacists were included. Information about the study design and reporting of selected studies was extracted and collected to systematically analyze these studies. Meanwhile, the Cochrane Collaboration＇s tool for assessing risk of bias was used to assess potential biases related to these studies. Ultimately, 14 articles were included in this study. No study determined the sample size in a scientific way. No article reported a scientific and detailed method of random sequence generation or allocation concealment. Two（14.3%） studies claimed to have implemented a double-blinding and a single-blinding respectively, but neither of them reported any details about how they performed the blinding. No study employed a blinding of outcome assessment. Five（35.7%） studies either stated statistical methods incompletely or used them incorrectly. One（7.1%） study reported an attrition without employing an intention-to-treat analysis. All studies reported eligibility criteria for participants to some extent, and all these criteria involved diagnosis of asthma, but only four（28.6%） of them reported patients＇ ages and three（21.4%） described the severity and the stage of asthma. Nine（64.3%） reported baseline data in the text rather than in a table, and 13（92.9%） involved comparisons between groups with significance tests either explicitly or implicitly. No report made a distinction between primary and secondary outcomes. Two（14.3%） mentioned informed consent of subjects, while no article reported ethical approval. ＂Unclear risk＂ made up the highest percentage of the studies analyzed according to the risk of bias assessment by the Cochrane Collaboration＇s tool. Our study demonstrates that the quality of RCTs on pharmaceutical care for asthma tic patients conducted by Chinese pharmacists is suboptimal, especially with regards to study design and reporti ng.展开更多
OBJECTIVE：This meta-analysis was performed to systematically assess the efficacy and safety of the Chinese herbal medicine Huangqi Guizhi Wuwu Decoction（HGWWD） for treating diabetic peripheral neuropathy.DATA SOUR...OBJECTIVE：This meta-analysis was performed to systematically assess the efficacy and safety of the Chinese herbal medicine Huangqi Guizhi Wuwu Decoction（HGWWD） for treating diabetic peripheral neuropathy.DATA SOURCES：Six electronic databases,including the Cochrane Library,MEDLINE database,Chinese Biomedical Database,Chinese National Knowledge Infrastructure Database,Chinese Science and Technique Journals Database,and the Wanfang Database,were search ed on the internet for randomized controlled trials published up until 1 December 2015.The search terms included ＂Chinese herbal medicine＂,＂diabetic peripheral neuropathy＂ and ＂randomized controlled trials＂ in Chinese and in English.DATA SELECTION：We included randomized controlled trials using HGWWD/modified HGWWD for the treatment group,without restriction for the control group.We assessed literature quality in accordance with the Cochrane Review Handbook.A random or a fixed effects model was used to analyze outcomes using Rev Man 5.2 software.OUTCOME MEASURES：The primary outcomes were changes in symptoms and nerve conduction velocities.The secondary outcomeswere fasting blood glucose and hemorheological indexes.RESULTS：Sixteen randomized controlled trials,with a total of 1,173 patients,were included.Meta-analysis revealed that the efficacy of HGWWD for diabetic peripheral neuropathy was significantly superior compared with the control treatment（i.e.,control group）（risk ratio = 0.36,95% confidence interval（CI）：0.29–0.46,Z =8.33,P 〈 0.00001） Compared with the control group,there was an increase in median motor nerve conduction velocity（mean difference（MD） = 3.46,95%CI：1.88–5.04,Z = 4.30,P 〈 0.01） and median sensory nerve conduction velocity（MD = 3.30,95%CI：2.04–4.56,Z = 5.14,P 〈 0.01）.There was also an increase in peroneal motor nerve conduction velocity（MD = 3.22,95%CI：2.45–3.98,Z = 8.21,P 〈 0.01） and peroneal sensory nerve conduction velocity（MD = 3.05,95%CI：2.01–4.09,Z = 5.75,P 〈 0.01） in the treatment groups.No significant difference in fasting blood glucose was found between the treatment groups and the control groups（MD =-0.12,95%CI：-0.42–0.19,Z = 0.76,P = 0.45）.Plasma viscosity was significantly decreased after treatment（MD =-0.11,95%CI：-0.21 to-0.02,Z = 2.30,P = 0.02）.No significant difference in fibrinogen was detectable（MD =-0.53,95%CI：-1.28–0.22,Z = 1.38,P = 0.17）.Four trials reported that treatment groups experienced no adverse reactions.Adverse events were not mentioned in the other 12 trials.No trial reported the incidence of complications,quality of life outcomes,or health economics.CONCLUSION：HGWWD treatment improves diabetic neurologic symptoms and ameliorates nerve conduction velocities.Our study suggests that HGWWD may have significant therapeutic efficacy for the treatment of diabetic peripheral neuropathy.However,the methodological quality of the randomized controlled trials was generally low.Larger and better-designed randomized controlled trials are required to more reliably assess the clinical effectiveness of HGWWD.展开更多
文摘Nonintubated video-assisted thoracic surgery （VATS） that is also defined awake VATS entails thoracoscopic procedures performed by regional anesthesia in spontaneously ventilating,mildly sedated or fully awake patients.
文摘The amount of scientific knowledge from randomized parallel group trials have been improved by the CONSORT Guideline, but important intelligence with important clinical implications remains to be extracted. This may though be obtained if the conventional statistical significance testing is supplied by 1) Addition of an unbiased and reproducible quantification of the magnitude or size of the clinical significance/importance of a difference in treatment outcome;2) Addition of a quantification of the credulity of statements on any possible effect size and finally;3) Addition of a quantification of the risk of committing an error when the null hypothesis is either accepted or rejected. These matters are crucial to proper conversion of trial results into good usage in every-day clinical practice and may produce immediate therapeutic consequence in quite opposite direction to the usual ones. In our drug eluting stent trial “SORT OUT II”, the implementation of our suggestions would have led to immediate cessation of use of the paclitaxel-eluting stent, which the usual Consort like reporting did not lead to. Consequently harm to subsequent patients treated by this stent might have been avoided. Our suggestions are also useful in cancer treatment trials and in fact generally so in most randomized trial. Therefore increased scientific knowledge with immediate and potentially altered clinical consequence may be the result if hypothesis testing is made complete and the corresponding adjustments are added to the CONSORT Guideline—first of all— for the potential benefit of future patients.
基金Chongqing Municipal Commission of Health and Family Planning(Grant No.2015ZBXM005)
文摘In the present study, we aimed to evaluate the effects of cilnidipine and L-type calcium channel blockers（L-type CCBs） on renal function in hypertensive patients. The randomized controlled trials（RCTs） of cilnidipine and L-type CCBs on hypertension treatment were selected from Pubmed, Embase, Google Scholar, CNKI, Science Direct, Ebsco, Springer, Ovid, Cochrane Library, Medline, VIP and Wanfang databases（from the date of databases＇ establishment to September 2014）. Data were independently evaluated following the Jadad standard. The percentage changes of serum creatinine（SCr） value, urinary protein excretion（UPE）, urinary protein/creatinine ratio（UPCR） and estimated glomerular filtration rate（e GFR） pre- and post-treatment were extracted for the subsequent meta-analysis. The mean difference（MD） and the 95% confidence interval（95% CI） were determined using RevM an 5.3 software. A total of 10 RCTs of high quality were included and analyzed by fixedor random-effect models. The results indicated that UPE（MD = –36.59, 95% CI： –70.85, –2.33） or UPCR（MD = –46.56, 95% CI： –88.50, –4.62） was significantly reduced by cilnidipine compared with L-type CCBs. However, such significant difference was not detected in reduction of SCr（MD = 0.01, 95% CI： –2.97, 2.98） or eG FR（MD = 1.56, 95% CI： –0.19, 3.31）. Compared with L-type CCBs, cilnidipine was more effective in reducing proteinuria or preventing the proteinuria progression. In addition, we did not find significant differences in SCr and eG FR between the two groups.
基金supported by the National Natural Science Foundation of China(81673828).
文摘Objective:To evaluate the effectiveness and safety of Chinese herbal medicines(CHMs)for incomplete immune reconstruction in patients with HIV/AIDS.Methods:Eight electronic databases were searched for randomized controlled trials(RCTs)on the use of CHM for patients with HIV/AIDS with incomplete immune reconstruction.Outcomes included CD4þcell count,quality of life,and adverse events/effects.The Cochrane Risk of Bias was employed to evaluate the methodological quality of the included RCTs.Results:We identified 13 eligible RCTs,with an overall high risk of bias,on 10 different CHMs.There was a significant increase in CD4þcell count after the use of Jianpi Yiqi medicinal paste for 3 months;tripterygium glycosides tablets(TGTs)for 3 months(mean difference[MD]52.63 cells/mL,95%confidence interval[CI,46.98,58.28]),6,9,and 12 months;Wenshen Jianpi granules for 6 months;Shenling Fuzheng capsules for 6 months(MD 49.53 cells/mL,95%CI[8.45,90.61])and 12 months;Aikeqing granules for 9 months(MD 61.51 cells/mL,95%CI[16.25,106.77])and 12 months;Guipi decoction for 12 months;Mianyi No.2 granules(JT)for 12 and 18 months;and Chinese medicine granules for 18 months.The increase in the mean difference of CD4þcell count from 6 to 18 months was larger in Chinese medicine granules and Mianyi No.2 granules(JT).Guipi decoction and Jianpi Qushi decoction improved the Karnofsky score.Four RCTs reported the outcome of adverse events/effects,while four cases of minor adverse effects were reported in the TGTs group.Conclusion:Jianpi Yiqi medicinal paste,Wenshen Jianpi granules,Shenling Fuzheng capsules,Aikeqing granules,Guipi decoction,and TGTs may be effective in increasing CD4þwithin 12 months,and Mianyi No.2 granules(JT)and Chinese medicine granules may show long-term effects.High-quality large RCTs on the effectiveness and safety of CHMs are still warranted.
文摘The introduction of prostate-specific antigen （PSA） for prostate cancer screening in the late 1980s led to an epidemic of prostate cancer, particularly in developed countries. However, the first valid reports from randomized controlled trials on the efficacy of screening were not published until 2009. Men in the screening group in the European Randomized Study of Screening for Prostate Cancer were 20% less likely than those in the control group to die from prostate cancer. The absolute difference was only 0.7/1000, implying that over 1400 men needed to be screened to prevent one prostate cancer death. Screening was also associated with a 70% increased risk for being diagnosed with prostate cancer. The American Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial found no survival benefit for screening. Results were not conclusive because a substantial proportion of study subjects had previously undergone PSA testing, over half of the control group had PSA testing, follow-up was relatively short, and fewer than 100 subjects died from prostate cancer. Balancing the potential survival benefit from screening is the risk of overdiagnosis--finding cancers that would not otherwise cause clinical problems^and the risk of treatment complications, including urinary, sexual and bowel dysfunction. Prostate cancer screening efforts would benefit from improved biomarkers, which more readily identify clinically important cancers. Cancer control efforts might also need to include chemoprevention, though currently available agents are controversial. In the meantime, oatients need to be supoorted in achievine informed decisions on whether to be screened for orostate cancer.
文摘Objective Helicobacter pylori(HP)infection is associated with non-alcoholic fatty liver disease(NAFLD)and insulin resistance;however,the correlation between HP eradication and NAFLD remains controversial.This systematic review and meta-analysis examined the effect of HP treatment on clinical and laboratory parameters in NAFLD patients.Methods We conducted a literature search of the PubMed,Embase,Scopus,and Web of Science databases through Septem-ber 2023 for randomized controlled trials(RCTs)examining the effect of HP treatment on NAFLD patients versus lifestyle changes alone.The primary outcome was the change in steatosis parameters.The secondary endpoints were changes in anthropometric parameters,inflammatory markers(TNF-α),and metabolic parameters(fasting blood glucose,homeostasis model assessment of insulin resistance,AST/ALT,and lipid profile).The random effects model was used to calculate the standardized mean difference(SMD)with associated 95%confidence intervals(CIs)for our desired outcome.Results Four RCTs met our inclusion criteria.A total of 453 patients were included(mean age 42.8 years,58.5%males),228(50.3%)of whom were in the HP eradication group and 225(49.7%)of whom were in the lifestyle modification group.Compared with lifestyle modification alone,HP eradication had a significant effect on reducing liver steatosis and TNF-αlevels(SMD:-0.9;95%CI-14.67,-3.82,I^(2)=0%and SMD:-6.3;95%CI-9.04,-3.56,I^(2)=0%,respectively).No sig-nificant effect on other metabolic parameters was found.Conclusions HP eradication significantly reduced liver steatosis and TNF-αlevels in NAFLD patients.However,HP eradi-cation did not significantly affect other metabolic indices compared to lifestyle changes alone.
基金supported by the National High-Level Chinese Medicine Hospital Clinical Research Funding(No.DFGZRB-2024GJRC015)。
文摘Acupuncture is an ancient treatment method used in traditional Chinese medicine and has been popularized worldwide.Over the past decade,there has been an increase in the amount of acupuncture research,mostly comprised of randomized controlled trials(RCTs)that aimed to answer the question on the efficacy of acupuncture.However,poor methodology and low replicability in these acupuncture RCTs have resulted in uncertainty about the efficacy of acupuncture.In this review,current advancements and challenges in acupuncture RCTs,regarding the methodological aspects of randomization,blinding,sham acupuncture and quality of reporting,were discussed.While there have been advancements in various aspects,current acupuncture RCTs still face pressing issues such as inadequate randomization and blinding,unviable sham acupuncture controls,and poor reporting quality.Given these limitations,this review seeks to identify the methodological problems that are responsible for these problems and to suggest solutions that could help to overcome them so as to improve the quality of future studies evaluating the efficacy of acupuncture.
文摘OBJECTIVE:In recent years,the number of clinical research reports on acupuncture and manipulation for the treatment of greater occipital neuralgia has gradually increased,but the quality is uneven.There is currently no literature evaluating the quality of published reports,which is not conducive to the promotion of clinical use of these therapies.Therefore,this article assessed the reporting quality of randomized controlled trials on acupuncture and manipulation for greater occipital neuralgia.METHODS:Cochrane Library,PubMed,Web of Science,Embase,China National Knowledge Infrastructure(CNKI),VIP,WanFang Data,and Chinese BioMedical Literature Database(CBM)from inception to May 20,2024 were searched.The reporting quality of included randomized controlled trials was independently evaluated by two investigators using the CONSORT statement,STRICTA checklist,and Cochrane bias of risk assessment tool.A third investigator resolved any disagreement.RESULTS:A total of 62 articles were included.Based on the CONSORT statement,59.46%(22/37)of all entries had a reporting rate of less than 50%,mainly including“Identification as a randomized trial in the title(1/62,1.61%),”“How sample size was determined(7/62,11.29%),”“Implementation(1/62,1.61%),”“Blinding(1/62,1.61%),”and“Reports of Funding(4/62,6.45%).”According to the STRICTA checklist,29.41%(5/17)of all entries had a reporting rate of less than 50%,mainly including“Details of other interventions(7/58,12.07%),”“Setting and context of treatment(0/58,0%),”and“Description of participating acupuncturists(0/58,0%).”CONCLUSION:The reporting quality of randomized controlled trials on acupuncture and manipulation therapy for greater occipital neuralgia remains low.Future researchers need to make greater efforts to strictly adhere to the CONSORT statement and STRICTA checklist during trial design,implementation,and reporting.This will facilitate the standardization of research in this field and enhance the reliability and reproducibility of the research results.
基金Supported by the National Natural Science Foundation of China:82074529Guangdong Province Famous Traditional Chinese Medicine Inheritance Studio Construction Project:Guangdong Traditional Chinese Medicine Office Letter 2023_108+1 种基金Sanming Project of Medicine in Shenzhen:SZZYSM202108013Hainan General Hospital Science and Technology Start-up Fund for Braught-in Talents:YJRC2022001。
文摘Objectives:This study aims to evaluate the current state of acupuncture randomized controlled trials(RCTs),their impact on guidelines,and future development trends,providing a reference for future re-search directions.Methods:Search for acupuncture-related RCT articles in the Web of Science Core Collection and con-firm their guideline inclusion on Google Scholar.Analyze study characteristics to predict future research directions.Results:The analysis covered 1422 articles,reflecting a substantial rise in publications from 77 articles between 1993 and 2002 to 960 articles between 2013 and 2022.The Western Pacific region led in pub-lication numbers with 622 articles(43.7%),followed by Europe(466 articles;32.8%),Americas(250 articles;17.6%),Eastern Mediterranean(62 articles;4.4%),and Southeast Asia(22 articles;1.5%),with Africa showing a research void.Regrettably,only 29.6%(421 articles)were incorporated into guidelines.The low rate of inclusion of research results in guidelines and the uneven distribution of research fields are particularly prominent.From 1993 to 2002,there were 77 articles,among which 51(66.2%)were included in the guidelines;from 2003 to 2012,there were 385 articles,with 202(52.5%)included;from 2013 to 2022,there were 960 articles,and only 168(17.5%)were included,showing a decreasing trend in the inclusion rate year by year.Regarding geographical distribution,1167 articles were from the East-ern Hemisphere,with 326(27.9%)included;255 were from the Western Hemisphere,and 95(37.3%)were included.Regionally,179 articles(42.5%)from Europe were included,140(33.3%)from the West-ern Pacific,95(22.6%)from the Americas,6(1.4%)from the Eastern Mediterranean,and 1(0.2%)from Southeast Asia.China,the United States,and Germany were the top publishing countries,with consis-tent growth in countries like China,South Korea,Spain,Brazil,Turkey,and Iran.Noteworthy researchers such as Cesar Fernandez-de-las-Penas,Zhi-shun LIU,Jing-wen YANG,Cun-zhi LIU,Li-xing LAO,Stefan N Willich,and Benno Brinkhaus have collaborated on research in areas such as pain management,cognitive impairments,insomnia,digestive system diseases,and urinary system diseases.There has been a partic-ular increase in research focus on neck pain and myofascial trigger points.
文摘BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in RCTs of hepatocellular carci-noma(HCC),the response rates and survival status,and adverse events(AEs)were summarized and evaluated.AIM To systematically evaluate the response rates,survival status and AEs in the placebo arms of RCTs for HCC.METHODS A systematic search was performed on PubMed,Ovid MEDLINE,Embase and Cochrane Library to identify relevant trials evaluating the efficacy of drugs for the treatment of HCC,published until December 31,2023.Statistical analysis was performed using R statistical software(version 4.3.2).RESULTS A total of 18 RCTs,involving 2390 patients,met the criteria for inclusion in the meta-analysis.The pooled overall disease control rate and objective response rate in the placebo group were 38%[95%confidence interval(CI):33%-42%]and 1%(95%CI:1%-2%),respectively.Overall survival and progression-free survival in the placebo group were 7.9 months(95%CI:7.6-8.31 months)and 1.9 months(95%CI:1.6-2.1 months),respectively.The incidence of grade 3 or 4 AEs was 37%(95%CI:30%-43%).Additionally,the incidence of interruptions or dose reductions due to AEs was 20%(95%CI:13%-27%),while the incidence of treatment discontinuation due to AEs was 9%(95%CI:6%-12%).CONCLUSION Over one-third of advanced HCC patients exhibit therapy-free disease control,with placebo-arm AEs observed.These findings guide single-arm trials design and enhance patient acceptance of anticancer therapies.
文摘BACKGROUND Nutritional psychiatry is a rapidly expanding field of research,with mounting evidence suggesting that nutritional factors may play a role in the development of psychiatric disorders.AIM To examine the level of evidence for nutritional psychiatry.METHODS A scoping review was conducted to assess the current state of nutritional psychiatry,including a search for randomized controlled trials(RCTs).RESULTS The review identified a total of seven papers,with many concentrating on the relationship between depression and the gut microbiome.A salient issue that emerged from this review was the paucity of sample size in many studies.The inherent complexity of nutritional studies,characterized by a multitude of potential factors and exposures that often act as confounders,poses significant challenges to the development of effective RCT designs.The analysis revealed that probiotics,though demonstrating efficacy,exhibited a modest effect size.CONCLUSION Conducting RCTs with effective markers is imperative from these studies.The implementation of Mendelian randomization and the investigation of mechanisms in basic research are essential complementary approaches.
文摘BACKGROUND Systematic reviews(SRs)synthesize and evaluate data,mainly from randomized trials,which then guides the development of clinical recommendations in evidence-based medicine.However,the data and methodological information in the included papers can often be lacking or unclear,and reviewers usually need to contact the authors of included studies for clarifications.Contacting authors is recommended,but it is unclear how often SR teams do it,or what the level of response is.AIM To investigate how often reviewers undertake contact with the authors of included randomized controlled trials(RCTs)for clarification on data and risk of bias concerns,to explore the factors that influence whether SR authors contact or do not contact the authors,and the content and level of responses.METHODS We conducted a systematic electronic database search in MEDLINE using the search string“(systematic review)”AND“(RCT OR randomized OR trial)”for articles published between 1 January 2024 and 19 February 2024,without language restrictions.Screening and data extraction was done independently by two reviewers,and conflicts resolved by a senior author.Contact authors of included SRs were contacted for clarifications.RESULTS Of the 329 included SRs,38%(n=125)explicitly mentioned contact with the authors of included studies.The remaining 62%(n=204)did not.We attempted contact with all SR teams for clarifications and received 90 responses(19.4%).Of the 50 respondents who did not explicitly mention contact in their SRs,25(50%)replied that they did make contact.We received a total of 64 responses on the level and content of information sought.The mean±SD contacts SR teams made were 10(10),replies received 5(6.7),and response waiting time 10.1(28.3)weeks.Resources,time,poor previous experience,perceived likelihood of poor response and bias concerns were reported as barriers to attempting contact.CONCLUSION The majority of SRs published in 2024 did not confirm seeking clarifying or missing information from primary study authors.However,SR teams reported that 50%of contacted primary authors respond.Additional research can clarify this rate of response and establish methods to increase the integration of this core methodological element in SRs.
文摘BACKGROUND Prolonged immobility during intensive care unit(ICU)admission has been a cause of muscle atrophy and worsening functional outcomes with longer recovery times.Prior research has demonstrated that mobilization within a week of ICU admission potentially benefits physical function in critically ill patients.AIM To evaluate the effects of initiating mobilization within 72 hours of ICU admission in critically ill patients through an updated systematic review and meta-analysis.METHODS A systematic search was performed through MEDLINE,Scopus,and Cochrane Library from inception until September 2024 for randomized controlled trials(RCTs)comparing early mobilization(EM)with usual or conventional care in critically ill adult patients.Primary outcomes included length of ICU(days)and ventilation duration(days).Secondary outcomes included muscle strength,functional status,adverse events,all-cause mortality,and quality of life(QOL).A random effects meta-analysis was performed for pooled effect estimates and to derive risk ratios(RR)and corresponding 95%confidence intervals(CI).RESULTS Out of 3487 results,16 RCTs were included with a population of 2385 patients(1195 receiving EM and 1190 with usual care.)A significant reduction in the length of ICU stays[mean difference(MD)=-1.02,95%CI:-1.96 to-0.09;P=0.03;I2=60%]and ventilation duration(MD=-1.07,95%CI:-1.91 to-0.23,P=0.01;I2=57%)was observed in the EM group compared to usual care.EM significantly improved muscle strength[standard MD(SMD)=0.47,95%CI:0.18-0.75,P=0.001;I2=79%]and functional status(SMD=0.70,95%CI:0.40-1.00,P<0.00001;I2=81%)in ICU patients.No statistically significant difference was observed in adverse events(RR=1.72,95%CI:1.01-2.94,P=0.05;I2=31%),all-cause mortality(RR=1.10,95%CI:0.79-1.53,P=0.57;I2=30%),and QOL(SMD=0.04,95%CI:-0.07-0.15,P=0.50;I2=9%)between the two groups.CONCLUSION Initiating mobilization within 72 hours of ICU admission is associated with improved functional outcomes and reduced ICU length of stay and ventilation duration.These findings indicate that EM may be a safe option for ICU patients,contributing to lower recovery times and healthcare costs.Further extensive research is required to validate the long-term effects on survival and QOL.
文摘BACKGROUND External gastrointestinal fistulas(EGIFs)are serious postoperative complications associated with prolonged hospital stays,sepsis,malnutrition,and high mortality rates.Reducing gastrointestinal secretions with somatostatin or its analogues may facilitate fistula closure.The clinical effectiveness of these therapies,however,remains uncertain.AIM To investigate the effectiveness of somatostatin-based therapy for EGIFs.METHODS A systematic review and meta-analysis(Prospero CRD420251054344)of nine randomized controlled trials(442 patients)compared somatostatin-based therapies with standard care in tertiary care settings.Protocols included somatostatin,octreotide,or lanreotide,administered at various dosages(250 micrograms/hour intravenous infusion or 100 micrograms subcutaneous injection three times daily)for 7 to 56 days.Primary outcomes were fistula closure rates and time to closure.Secondary outcomes were hospital length of stay,complications,need for surgical intervention,and mortality.Mean differences and risk ratios(RRs)with 95%confidence intervals(CIs)were calculated using random-effects models.Risk of bias was assessed with the Cochrane RoB 2 tool.RESULTS There was no statistically significant difference in closure rate(RR:1.11,95%CI:0.95-1.28,P=0.19,I^(2)=0%)between 134/193 patients receiving somatostatin-based therapy and 99/170 control patients.Time to closure was reduced by 6.16 days(mean difference-6.16,95%CI:-7.44 to-4.88,P<0.001,I^(2)=0%)in 126 patients in intervention group vs 114 in control group.Hospital stay was shortened by 4.00 days(mean difference-4.00,95%CI:-7.99 to-0.01,P=0.05,I^(2)=0%)in 56 vs 62 patients.There were no differences in complications(RRs:0.76,95%CI:0.55-1.05),need for surgical intervention(RRs:0.67,95%CI:0.38-1.19),or mortality(RRs:0.77,95%CI:0.44-1.35).Limitations include small sample sizes,heterogeneity in treatment regimens,and inconsistent outcome definitions,which may affect generalizability.Limited data for some outcomes,such as hospital stay,and exclusion of some datasets for methodological reasons reduced statistical power.CONCLUSION Somatostatin-based therapies did not significantly improve fistula closure rates but were associated with shorter time to closure and hospital stay.Mortality,complications,and surgical intervention requirements remained unchanged,suggesting that these therapies may serve only as an adjunctive option in selected patients.
基金The Guangdong Provincial Hospital Pharmacy Research Fund(Grant No.2024A34)the Guangdong Provincial Medical Research Fund(Grant Nos.A2024493,A2024771)+2 种基金the International Medical Exchange Foundation of China(Grant No.Z-2014-08-2309-5)the Science and Technology Program of Guangzhou(Grant Nos.20251A011047,20252A011018)the Guangzhou Municipal Key Discipline in Medicine(Suiwei Letter[2024]No.2184)。
文摘In the present study,a comprehensive systematic review and meta-analysis were conducted to assess the short-term efficacy and safety of blonanserin compared with control interventions,including placebo,risperidone,and haloperidol,in the treatment of schizophrenia.The goal was to provide a robust pharmacological foundation to inform clinical decision-making regarding the therapeutic use of blonanserin.We systematically searched five major databases-PubMed,Web of Science,Scopus,CNKI,and the WanFang Database-for randomized controlled trials(RCTs)evaluating blonanserin against standard comparators in patients with schizophrenia.Key data extracted included study authorship,publication year,geographic location,diagnostic criteria,sample size,treatment duration,dosing regimen,and clinical outcomes.Meta-analytic synthesis was performed using RevMan 5.3 software.Out of an initial pool of 718 articles,11 trials met the inclusion criteria and were incorporated into the final analysis.In terms of clinical efficacy,short-term administration of blonanserin demonstrated non-inferiority to risperidone,with no indication of inferior performance across Positive and Negative Syndrome Scale(PANSS)subscales.Moreover,blonanserin significantly outperformed the placebo in terms of PANSS response rates,underscoring its therapeutic potential in managing acute symptoms.Regarding safety,the incidence of overall and serious adverse events did not differ significantly between blonanserin and the comparator agents.However,noteworthy distinctions were observed in the adverse event profiles(≥5%incidence in either group),underscoring differences in tolerability among the antipsychotics examined.These findings collectively supported the short-term use of blonanserin as a viable and well-tolerated alternative in the pharmacological management of schizophrenia.
基金the National Key R&D Program of China(No.2023YFC3503300 and No.2023YFC3503304)National Natural Science Foundation of China for Distinguished Young Scholars(No.82225049)and Youths(No.82305045)Fundamental Research Funds for the Central Public Welfare Research Institutes(No.2020YJSZX-3)。
文摘Background:The use of inserted sham acupuncture as a placebo in randomized controlled trials(RCTs)is controversial,because it may produce specific effects that cause an underestimation of the effect of acupuncture treatment.Objective:This systematic survey investigates the magnitude of insert-specific effects of sham acupuncture and whether they affect the estimation of acupuncture treatment effects.Search strategy:PubMed,Embase and Cochrane Central Register of Controlled Trials were searched to identify acupuncture RCTs from their inception until December 2022.Inclusion criteria:RCTs that evaluated the effects of acupuncture compared to sham acupuncture and no treatment.Data extraction and analysis:The total effect measured for an acupuncture treatment group in RCTs were divided into three components,including the natural history and/or regression to the mean effect(controlled for no-treatment group),the placebo effect,and the specific effect of acupuncture.The first two constituted the contextual effect of acupuncture,which is mimicked by a sham acupuncture treatment group.The proportion of acupuncture total effect size was considered to be 1.The proportion of natural history and/or regression to the mean effect(PNE)and proportional contextual effect(PCE)of included RCTs were pooled using meta-analyses with a random-effect model.The proportion of acupuncture placebo effect was the difference between PCE and PNE in RCTs with non-inserted sham acupuncture.The proportion of insert-specific effect of sham acupuncture(PIES)was obtained by subtracting the proportion of acupuncture placebo effect and PNE from PCE in RCTs with inserted sham acupuncture.The impact of PIES on the estimation of acupuncture's treatment effect was evaluated by quantifying the percentage of RCTs that the effect of outcome changed from no statistical difference to statistical difference after removing PIES in the included studies,and the impact of PIES was externally validated in other acupuncture RCTs with an inserted sham acupuncture group that were not used to calculate PIES.Results:This analysis included 32 studies with 5492 patients.The overall PNE was 0.335(95%confidence interval[CI],0.255-0.415)and the PCE of acupuncture was 0.639(95%CI,0.567-0.710)of acupuncture's total effect.The proportional contribution of the placebo effect to acupuncture's total effect was 0.191,and the PIES was 0.189.When we modeled the exclusion of the insert-specific effect of sham acupuncture,the acupuncture treatment effect changed from no difference to a significant difference in 45.45%of the included RCTs,and in 40.91%of the external validated RCTs.Conclusion:The insert-specific effect of sham acupuncture in RCTs represents 18.90%of acupuncture's total effect and significantly affects the evaluation of the acupuncture treatment effect.More than 40%of RCTs that used inserted sham acupuncture would draw different conclusions if the PIES had been controlled for.Considering the impact of the insert-specific effect of sham acupuncture,caution should be taken when using inserted sham acupuncture placebos in RCTs.
基金Xinjiang Medical University Scientific Research and Innovation Foundation(Grant No.XYDCX2014117)
文摘As a new oral hypoglycemic agent, saxagliptin belongs to the class of dipeptidyl peptidase-4 （DPP-4） inhibitors. However, it remains inconclusive whether saxagliptin is associated with increased risk of adverse events （AE） and efficacy as add-on treatment. Therefore, we performed an up-to-date meta-analysis to compare the efficacy and safety of saxagliptin with placebo and other oral hypoglycemic agents in adult patients with type 2 diabetes mellitus （T2DM）. Randomized clinical trials （RCTs） comparing saxagliptin with comparators were retrieved by selecting articles from Pubmed, Embase, Cochrane Library and Clinical Trials Registry Platform up to Oct. 2013. Weighted mean difference （WMD） was used to analyze the effect of hypoglycemic agents on HbAlc, weight and fasting plasma glucose （FPG）. While the patients who achieved HbAlc〈7.0% and had AE were analyzed as relative risks （RR）. A total of 18 articles from 16 RCTs and one clinic trial from the WHO International Clinical Trials Registry Platform met the included criterion. Clinically significant decrease from baseline HbAlc compared with placebo was certified for 2.5 mg/day saxagliptin （WMD = -0.45%, 95% CI, -0.48% to -0.42%） and 5 mg/d saxagliptin （WMD = -0.52%, 95% CI, -0.60% to -0.44%）. Saxagliptin as add-on therapy was superior to thiazolidinediones, up-titrated glyburide, up-titrated metformin or metformin monotherapy in achieving HbA1c〈7.0%. Treatment with saxagliptin had negligible effect on weight, and it was considered weight neutral. Saxagliptin treatment did not increase the risk of hypoglycemia （RR = 1.28, 95% CI 0.72 to 2.27, P = 0.40） and serious adverse experiences （RR = 1.25, 95% CI 0.94 to 1.66, P = 0.13）. No statistically significant differences were observed between saxagliptin and comparators in terms of the risk of infections. The present study showed that saxagliptin was effective in improving glycaemic control in T2DM with a low risk of hypoglycaemia and incidence of infections in either monotherapy or add-on treatment. This founding should be further certified by large-sample size and good-designed RCT.
文摘Objective:Single-incision laparoscopic sugery has emerged as a safe and less invasive approach to conventional multi-port laparoscopy.The present meta-analysis aimed to assess the collective outcomes of single-incision laparoscopic gastrectomy(SILG)compared to multi-port laparoscopic gastrectomy(MLG)for gastric cancer.Methods:A PRISMA-compliant systematic review of randomized controlled trials(RCTs)that compared SILG and MLG for gastric cancer in PubMed and Scopus through January 2023 was conducted.The main outcomes of the review were complications,postoperative pain,conversion to open surgery,hospital stay,and recovery.Results:Three RCTs including 301 patients(61.8%male)were incuded.A total of 151 patients underwent SILG,and 150 underwent MLG.SILG was associated with a shorter operative time(WMD=-16.39,95%CI:=27.38 to=5.40,p=0.003;2=0%)and lower pain scores at postoperative day 3(WMD=-1.18,95%CI:=2.27 to=0.091,p=0.033;I^(2)=99%)than MLG.There were no statistically significant differences between the two groups in es timated blood loss(WMD=-16.95,95%CI:-35.84 to 1.95,p=0.078;I^(2)=82%),complications(OR=0.71,95%Cl:0.36 to 1.42,p=0.337;I^(2)=0%),conversion to open surgery(OR=0.33,95%C:0.01 to 8.38,p=0.504),hospital stay(WMD=0.72,95%CI:-0.92 to 2.36,p=0.056;P=84%),time to first flatus(WMD=0.06,95%CI:=0.14 to 0.26,p=0.566;I^(2)=0%),time to first defecation(WMD=-0.14,95%CI:=0.46 to 0.18,p=0.392;I^(2)=0%),or time to first oral intake(WMD=0.37,95%a:=0.75 to 1.49,p=0.520;I^(2)=94%).Conclusions:SILG is associated with shorter operative times and less early postoperative pain than MLG.The odds of complications,blood loss,hospital stay,and gastrointestinal recovery were similar between the two procedures.
文摘The objective of this study was to assess the quality of randomized controlled trials（RCTs） on pharmaceutical care for asthma tic patients conducted by pharmacists in China's Mainland, to identify the problems in current studies, and to provide some references for further studies. The China National Knowledge Infrastructure（CNKI）, Wanfang Database, and VIP Database were searched for randomized controlled trials on pharmaceutical care for asthma tic patients, and only those studies undertaken by pharmacists were included. Information about the study design and reporting of selected studies was extracted and collected to systematically analyze these studies. Meanwhile, the Cochrane Collaboration＇s tool for assessing risk of bias was used to assess potential biases related to these studies. Ultimately, 14 articles were included in this study. No study determined the sample size in a scientific way. No article reported a scientific and detailed method of random sequence generation or allocation concealment. Two（14.3%） studies claimed to have implemented a double-blinding and a single-blinding respectively, but neither of them reported any details about how they performed the blinding. No study employed a blinding of outcome assessment. Five（35.7%） studies either stated statistical methods incompletely or used them incorrectly. One（7.1%） study reported an attrition without employing an intention-to-treat analysis. All studies reported eligibility criteria for participants to some extent, and all these criteria involved diagnosis of asthma, but only four（28.6%） of them reported patients＇ ages and three（21.4%） described the severity and the stage of asthma. Nine（64.3%） reported baseline data in the text rather than in a table, and 13（92.9%） involved comparisons between groups with significance tests either explicitly or implicitly. No report made a distinction between primary and secondary outcomes. Two（14.3%） mentioned informed consent of subjects, while no article reported ethical approval. ＂Unclear risk＂ made up the highest percentage of the studies analyzed according to the risk of bias assessment by the Cochrane Collaboration＇s tool. Our study demonstrates that the quality of RCTs on pharmaceutical care for asthma tic patients conducted by Chinese pharmacists is suboptimal, especially with regards to study design and reporti ng.
基金supported by a grant from the National Basic Research Program of China(973 Program),No.2010CB530600Institutes Project from Guang’anmen Hospital of China Academy of Chinese Medical Sciences,No.2011261
文摘OBJECTIVE：This meta-analysis was performed to systematically assess the efficacy and safety of the Chinese herbal medicine Huangqi Guizhi Wuwu Decoction（HGWWD） for treating diabetic peripheral neuropathy.DATA SOURCES：Six electronic databases,including the Cochrane Library,MEDLINE database,Chinese Biomedical Database,Chinese National Knowledge Infrastructure Database,Chinese Science and Technique Journals Database,and the Wanfang Database,were search ed on the internet for randomized controlled trials published up until 1 December 2015.The search terms included ＂Chinese herbal medicine＂,＂diabetic peripheral neuropathy＂ and ＂randomized controlled trials＂ in Chinese and in English.DATA SELECTION：We included randomized controlled trials using HGWWD/modified HGWWD for the treatment group,without restriction for the control group.We assessed literature quality in accordance with the Cochrane Review Handbook.A random or a fixed effects model was used to analyze outcomes using Rev Man 5.2 software.OUTCOME MEASURES：The primary outcomes were changes in symptoms and nerve conduction velocities.The secondary outcomeswere fasting blood glucose and hemorheological indexes.RESULTS：Sixteen randomized controlled trials,with a total of 1,173 patients,were included.Meta-analysis revealed that the efficacy of HGWWD for diabetic peripheral neuropathy was significantly superior compared with the control treatment（i.e.,control group）（risk ratio = 0.36,95% confidence interval（CI）：0.29–0.46,Z =8.33,P 〈 0.00001） Compared with the control group,there was an increase in median motor nerve conduction velocity（mean difference（MD） = 3.46,95%CI：1.88–5.04,Z = 4.30,P 〈 0.01） and median sensory nerve conduction velocity（MD = 3.30,95%CI：2.04–4.56,Z = 5.14,P 〈 0.01）.There was also an increase in peroneal motor nerve conduction velocity（MD = 3.22,95%CI：2.45–3.98,Z = 8.21,P 〈 0.01） and peroneal sensory nerve conduction velocity（MD = 3.05,95%CI：2.01–4.09,Z = 5.75,P 〈 0.01） in the treatment groups.No significant difference in fasting blood glucose was found between the treatment groups and the control groups（MD =-0.12,95%CI：-0.42–0.19,Z = 0.76,P = 0.45）.Plasma viscosity was significantly decreased after treatment（MD =-0.11,95%CI：-0.21 to-0.02,Z = 2.30,P = 0.02）.No significant difference in fibrinogen was detectable（MD =-0.53,95%CI：-1.28–0.22,Z = 1.38,P = 0.17）.Four trials reported that treatment groups experienced no adverse reactions.Adverse events were not mentioned in the other 12 trials.No trial reported the incidence of complications,quality of life outcomes,or health economics.CONCLUSION：HGWWD treatment improves diabetic neurologic symptoms and ameliorates nerve conduction velocities.Our study suggests that HGWWD may have significant therapeutic efficacy for the treatment of diabetic peripheral neuropathy.However,the methodological quality of the randomized controlled trials was generally low.Larger and better-designed randomized controlled trials are required to more reliably assess the clinical effectiveness of HGWWD.
