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
To review the preventive approaches for recurrence after curative resection of hepatic metastases from colorectal carcinoma, we have summarized all available publications reporting randomized control trials (RCTs) cov...To review the preventive approaches for recurrence after curative resection of hepatic metastases from colorectal carcinoma, we have summarized all available publications reporting randomized control trials (RCTs) covered in PubMed. The treatment approaches presented above include adjuvant intrahepatic arterial infusion chemotherapy, systemic chemotherapy, neoadjuvant chemotherapy, and immunotherapy. Although no standard treatment has been established, several approaches present promising results, which are both effective and tolerable in post-hepatectomy patients. Intrahepatic arterial infusion chemotherapy should be regarded as effective and tolerable and it increases overall survival (OS) and disease free survival (DFS) of patients, while 5-fluorouracil-based systemic chemotherapy has not shown any significant survival benefit. Fortunately chemotherapy combined with hepatic arterial infusion and intravenous infusion has shown OS and DFS benefit in many researches. Few neoadjuvant RCT studies have been conducted to evaluate its effect on prolonging survivals although many retrospective studies and case reports are published in which unresectable colorectal liver metastases are downstaged and made resectable with neoadjuvant chemotherapy. Liver resection supplemented with immunotherapy is associated with optimal results; however, it is also questioned by others. In conclusion, several adjuvant approaches have been studied for their efficacy on recurrence after hepatectomy for liver metastases from colorectal cancer (CRC), but multi-centric RCT is still needed for further evaluation on their efficacy and systemic or local toxicities. In addition, new adjuvant treatment should be investigated to provide more effective and tolerable methods for the patients with resectable hepatic metastases from CRC.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
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
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 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
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
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
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
Objectives:To explore the efficacy and safety of virtual reality(VR)in relieving negative emotions in patients with breast cancer with different personalities.Methods:A randomized controlled trial was conducted.Betwee...Objectives:To explore the efficacy and safety of virtual reality(VR)in relieving negative emotions in patients with breast cancer with different personalities.Methods:A randomized controlled trial was conducted.Between April 2023 and October 2023,we enrolled patients with breast cancer treated in the Department of Breast Cancer and Oncology at Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University,Guangdong Province.The patients were randomly divided into an intervention group(n=118)and a control group(n=119)using block randomization.The intervention group received the VR intervention 3-5 times over 5±2 weeks using natural landscapes with music or relaxation guidance,and the duration of each VR intervention was 15±3 min.The control group received routine nursing care,including disease education and psychological counseling.Patients were assessed using the Type D Scale,Positive and Negative Affect Scale,and Distress Thermometer,and adverse events during the intervention were recorded.Results:Overall,85 patients completed the study(44 in the intervention group and 41 in the control group).Patients with Type D personalities showed more negative emotions[25.0(21.5,27.5)vs.19.0(16.0,24.0),P=0.001]and distressed attitudes[4.0(2.0,5.0)vs.3.0(1.0,4.0),P=0.020]with fewer positive emotions(27.2±5.6 vs.31.0±5.9,P=0.014)than those with non-Type D personalities.Total population analysis revealed no significant differences between the groups.However,in the subgroup analysis,patients with Type D personalities in the intervention group showed greater relief from negative emotions than those in the control group[median difference,-5.0(-9.0,-2.5)vs.-2.0(-4.0,2.0),P=0.046].No significant differences were found between groups of patients with non-Type D personality traits.The proportion of adverse events was not significantly different between groups(P=0.110).Conclusions:Breast cancer patients with Type D personalities suffer more severe negative emotions and distress,and more attention should be paid to them.VR intervention significantly and safely reduced negative emotions in patients with Type D personalities.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
OBJECTIVE： To evaluate the efficacy and safety of acupuncture therapy for children with cerebral palsy. DATA SOURCES： We conducted electronic searches of PUBMED（1950/2017）, EMBASE（1974/2017）, Science Direct（198...OBJECTIVE： To evaluate the efficacy and safety of acupuncture therapy for children with cerebral palsy. DATA SOURCES： We conducted electronic searches of PUBMED（1950/2017）, EMBASE（1974/2017）, Science Direct（1986/2017）, Academic Source Premier（1887/2017）, the Cochrane Library（Issue 4, April 2017）, Science Citation Index Expanded（1900/2017）, China National Knowledge Infrastructure（1915/2017）, China Biological Medicine（1990/2017-04）, Wan Fang（1980/2017）, VIP（1989/2017）, and Chinese Science Citation Database（1989/2017）. DATA SELECTION： We included randomized controlled trials that aimed to compare the effect of acupuncture plus rehabilitation training versus rehabilitation training alone. Data about functional motor abilities, daily activity/social participation, effective rate, intellectual development, and adverse effects were included. We used Revman 5.2 software for statistical analysis. OUTCOME MEASURES： The primary outcomes included functional motor abilities, daily activity, and effective rate. The secondary outcomes included intellectual development and adverse effects.RESULTS： Twenty-one studies with a total of 1718 participants met the inclusion criteria. The effect size of gross motor function（SMD = 0.64, 95% CI： 0.52 to 0.76, P 〈 0.00001; I^2 = 0%, P = 0.69; in 13 studies with 1144 patients） and the total effective rate（RR = 1.28, 95% CI： 1.20 to 1.37, P 〈 0.00001; I^2 = 18%, P = 0.27; in 12 studies with 1106 patients） suggested that acupuncture plus rehabilitation produced a significant improvement in gross motor function and a high total effective rate. The pooled fine motor function（SMD = 3.48, 95% CI： 2.62 to 4.34, P 〈 0.00001; I^2 = 64%, P = 0.10; in 2 studies with 193 patients）, modified Ashworth scale scores（SMD = –0.31, 95% CI： –0.52 to –0.11, P = 0.003; I^2 = 74%, P = 0.004; in 5 studies with 363 patients） and activities of daily living（SMD = 1.45, 95% CI： 1.20 to 1.71, P 〈 0.00001; I^2 = 78%, P = 0.004; in 4 studies with 313 patients） also indicated improvements in children with cerebral palsy. Publication bias was not observed. Only mild adverse events related to acupuncture were reported. CONCLUSION： Acupuncture plus rehabilitation training improved gross motor function, reduced muscle spasms, and enhanced daily life activities in children with cerebral palsy. However, this conclusion should be interpreted with caution due to the small number of randomized controlled trials available and the small sample sizes. More high-quality and large-scale studies are needed.展开更多
OBJECTIVE:To assess the efficacy and safety of heat-sensitive moxibustion in the treatment of lumbar disc herniation(LDH).METHODS:Randomized controlled trials(RCTs) involving heat-sensitive moxibustion in the treatmen...OBJECTIVE:To assess the efficacy and safety of heat-sensitive moxibustion in the treatment of lumbar disc herniation(LDH).METHODS:Randomized controlled trials(RCTs) involving heat-sensitive moxibustion in the treatment of LDH were retrieved from the Chinese Biological Medical Literature database(1978-20011),Weipu database(1989-2011),Wanfang digital journal(1998-2011),China National Knowledge Internet(1979-2011),PubMed(1966-2011),EMBASE(1980-2011),and Cochrane Library(Issue 1,2011).Hand-search of the relevant journals from the Library of Jiangxi University of Traditional Chinese Medicine was also adopted for the collection of data.Data were extracted and evaluated by two reviewers independently with a specially designed extraction form.The Cochrane Collaboration's RevMan 5.0.20 software was used for data analyses.RESULTS:A total of 6 trials involving 580 patients were included.Meta-analysis showed that the total effectiveness rate in the heat-sensitive moxibustion group was significantly different when compared with conventional moxibustion [RR=1.19,95% CI [1.06,1.33)] and diclofenac sodium [RR=1.47,95% CI [1.17,1.85)],but similar to that of acupuncture.The cure rate in the heat-sensitive moxibustion group was significantly different when compared with conventional moxibustion [RR=1.58,95% CI(1.04,2.40)] and diclofenac sodium [RR=1.91,95% CI(1.01,3.60)],but similar with that of acupuncture.In terms of the Japanese Orthopaedic Association scores,significant differences were noted in subjective indices,objective indices,and daily life subscales.Two trials reported that there were no adverse events over the duration of treatment.CONCLUSION:Compared with conventional moxibustion,acupuncture,and diclofenac sodium,heat-sensitive moxibustion in the treatment of LDH is superior in efficacy.Further large-scale trials are required to define the role of heat-sensitive moxibustion in the treatment of this disease.展开更多
OBJECTIVE:To evaluate the efficacy of electroacupuncture(EA)at scalp motor area for treating post-stroke wrist dyskinesia and its influence on the function of wrist movement-related agonistic muscles.METHODS:A randomi...OBJECTIVE:To evaluate the efficacy of electroacupuncture(EA)at scalp motor area for treating post-stroke wrist dyskinesia and its influence on the function of wrist movement-related agonistic muscles.METHODS:A randomized,single-blind,controlled clinical trial was conducted.Sixty-six patients undergoing post-stroke wrist dyskinesia were enrolled and randomized 1:1 to EA or control group.Patients in the control group received manual acupuncture in the scalp motor area(MS 6)on the lesion side.The same acupoint was selected to accept EA stimulation in the EA group.All patients were treated six times a week for three weeks.The primary outcome was the Chinese Stroke Scale(CSS)score.The secondary outcomes included upper limb-related Barthel Index(BI)score,active range of motion(AROM)of the wrist joint,and root mean square(RMS)of the four agonistic muscles associated with wrist motion on the hemiplegic side of patients,i.e.,the extensor carpi radialis longus(ECRL),extensor digitorum(ED),flexor carpi radialis(FCR)and flexor carpi ulnaris(FCU).The above indicators were measured before and after three weeks of treatment.RESULTS:After 3-week treatment,the CSS score and AROM of wrist dorsiflexion of the EA group were better than those in the control group(P=0.038,P=0.047).The differences between the two groups of BI scores and AROM of wrist flexion were not significant(P>0.05).All RMS of the EA group were higher than those in the control group(ECRL:P=0.047,ED:P=0.048,FCR:P=0.049,FCU:P=0.047).The total effective rate in the EA group was 87.50%(28/32),which was higher than that in the control group(77.42%,24/31,P=0.048).CONCLUSION:EA stimulation of the scalp motor area can promote the recovery of the strength and function of the agonistic muscles related to wrist movement and effectively improve post-stroke wrist dyskinesia.展开更多
OBJECTIVE： To evaluate the effectiveness and safety of filiform needle acupuncture for poststroke depression, and to compare acupuncture with the therapeutic efficacy of antidepressant drugs. DATA RETRIEVAL： We retr...OBJECTIVE： To evaluate the effectiveness and safety of filiform needle acupuncture for poststroke depression, and to compare acupuncture with the therapeutic efficacy of antidepressant drugs. DATA RETRIEVAL： We retrieved data from the Chinese National Knowledge Infrastructure （1979-2012）, Wanfang （1980-2012）, VIP （1989-2012）, Chinese Biomedical Literature （1975- 2012）, PubMed （1966-2012）, Ovid Lww （-2012）, and Cochrane Library （-2012） Database using the internet. SELECTION CRITERIA： Randomized controlled trials on filiform needle acupuncture versus antidepressant drugs for treatment of poststroke depression were included. Moreover, the in- cluded articles scored at least 4 points on the Jadad scale. Exclusion criteria： other acupuncture therapies as treatment group, not stroke-induced depression patients, score 〈 4 points, non-ran- domized controlled trials, or animal trials. MAIN OUTCOME MEASURES： These were the Hamilton Depression Scale scores, clinical ef- fective rate, Self-Rating Depression Scale scores, Side Effect Rating Scale scores, and incidence of adverse reaction and events. RESULTS： A total of 17 randomized controlled clinical trials were included. Meta-analysis results displayed that after 4 weeks of treatment, clinical effective rate was better in patients treated with fill- form needle acupuncture than those treated with simple antidepressant drugs [relative risk = 1.11, 95% confidence interval （C/）： 1.03-1.21, P = 0.01]. At 6 weeks, clinical effective rate was similar between filiform needle acupuncture and antidepressant drug groups. At 2 weeks after filiform needle acupuncture, Hamilton Depression Scale （17 items） scores were lower than in the antide- pressant drug group （mean difference = -2.34, 95%CI： -3.46 to -1.22, P 〈 0.000,1）. At 4 weeks, Hamilton Depression Scale （24 items） scores were similar between filiform needle acupuncture and antidepressant drug groups. Self-Rating Depression Scale scores were lower in filiform needle acupuncture group than in the antidepressant drug group. Side Effect Rating Scale was used in only two articles, and no meta-analysis was conducted. Safety evaluation of the 17 arti- cles showed that gastrointestinal tract reactions such as nausea and vomiting were very common in the antidepressant drug group. Incidence of adverse reaction and events was very low in the filiform needle acupuncture group. CONCLUSION： Early filiform needle acupuncture for poststroke depression can perfectly con- trol depression. Filiform needle acupuncture is safe and reliable. Therapeutic effects of filiform needle acupuncture were better than those of antidepressant drugs.展开更多
OBJECTIVE:To evaluate the effectiveness and safety of Chinese herbal medicine(CHM) in the treatmentofsubacutethyroiditis.METHODS: Randomized controlled trials found in PubMed, Cochrane Library, and three Chinese datab...OBJECTIVE:To evaluate the effectiveness and safety of Chinese herbal medicine(CHM) in the treatmentofsubacutethyroiditis.METHODS: Randomized controlled trials found in PubMed, Cochrane Library, and three Chinese databases were selected. RevMan 5.2 software was used to analyze the data with relative risk or mean difference, expressed with 95% of confidence interval. The quality of trials was assessed and gradedthe quality of evidence with GRADE profiler software.RESULTS: Twenty one studies were included. CHM was superior to Western Medicine(include prednisone and NSAIDs) in abating fever, relieving thyroid pain, recovering blood sedimentation, improving thyroid function, and preventing hypothyroidism(P<0.05), while no statistical differences were found in eliminating goiter and reducing relapse rate.CHM plusWestern Medicine were superior toWestern Medicine in abating fever, relieving thyroid pain, eliminating goiter, and reducing relapse rate,while no statistical differences(P>0.05) were found in recovering blood sedimentation and improving thyroid function. The incidence of adverse reactions in treatment group was lower than that in control group(relative risk was 0.12 and 95% confidence interval was 0.03-0.51). The methodological quality of trials is generally poor with a high risk of bias.CONCLUSION: CHM(particularly CHM combined withWestern Medicine) used to treat subacute thyroiditis may improve clinical symptoms and signs,reduce relapse rate, and alleviate the side effects of hormones. Due to poor methodological quality of included trials, further more high-quality studies are warranted to confirm the effectiveness and safety of CHM.展开更多
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To review the preventive approaches for recurrence after curative resection of hepatic metastases from colorectal carcinoma, we have summarized all available publications reporting randomized control trials (RCTs) covered in PubMed. The treatment approaches presented above include adjuvant intrahepatic arterial infusion chemotherapy, systemic chemotherapy, neoadjuvant chemotherapy, and immunotherapy. Although no standard treatment has been established, several approaches present promising results, which are both effective and tolerable in post-hepatectomy patients. Intrahepatic arterial infusion chemotherapy should be regarded as effective and tolerable and it increases overall survival (OS) and disease free survival (DFS) of patients, while 5-fluorouracil-based systemic chemotherapy has not shown any significant survival benefit. Fortunately chemotherapy combined with hepatic arterial infusion and intravenous infusion has shown OS and DFS benefit in many researches. Few neoadjuvant RCT studies have been conducted to evaluate its effect on prolonging survivals although many retrospective studies and case reports are published in which unresectable colorectal liver metastases are downstaged and made resectable with neoadjuvant chemotherapy. Liver resection supplemented with immunotherapy is associated with optimal results; however, it is also questioned by others. In conclusion, several adjuvant approaches have been studied for their efficacy on recurrence after hepatectomy for liver metastases from colorectal cancer (CRC), but multi-centric RCT is still needed for further evaluation on their efficacy and systemic or local toxicities. In addition, new adjuvant treatment should be investigated to provide more effective and tolerable methods for the patients with resectable hepatic metastases from CRC.
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.
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 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.
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.
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 project of the National Natural Science Foundation of China:Research on the integration of artificial intelligence and virtual reality technology to promote psychological rehabilitation of breast cancer patients with different personalities(project approval no.82073408).
文摘Objectives:To explore the efficacy and safety of virtual reality(VR)in relieving negative emotions in patients with breast cancer with different personalities.Methods:A randomized controlled trial was conducted.Between April 2023 and October 2023,we enrolled patients with breast cancer treated in the Department of Breast Cancer and Oncology at Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University,Guangdong Province.The patients were randomly divided into an intervention group(n=118)and a control group(n=119)using block randomization.The intervention group received the VR intervention 3-5 times over 5±2 weeks using natural landscapes with music or relaxation guidance,and the duration of each VR intervention was 15±3 min.The control group received routine nursing care,including disease education and psychological counseling.Patients were assessed using the Type D Scale,Positive and Negative Affect Scale,and Distress Thermometer,and adverse events during the intervention were recorded.Results:Overall,85 patients completed the study(44 in the intervention group and 41 in the control group).Patients with Type D personalities showed more negative emotions[25.0(21.5,27.5)vs.19.0(16.0,24.0),P=0.001]and distressed attitudes[4.0(2.0,5.0)vs.3.0(1.0,4.0),P=0.020]with fewer positive emotions(27.2±5.6 vs.31.0±5.9,P=0.014)than those with non-Type D personalities.Total population analysis revealed no significant differences between the groups.However,in the subgroup analysis,patients with Type D personalities in the intervention group showed greater relief from negative emotions than those in the control group[median difference,-5.0(-9.0,-2.5)vs.-2.0(-4.0,2.0),P=0.046].No significant differences were found between groups of patients with non-Type D personality traits.The proportion of adverse events was not significantly different between groups(P=0.110).Conclusions:Breast cancer patients with Type D personalities suffer more severe negative emotions and distress,and more attention should be paid to them.VR intervention significantly and safely reduced negative emotions in patients with Type D personalities.
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.
基金financially supported by the Science and Technology Department of Sichuan Province of China,No.2016SZ0039,2016a grant from the Sichuan Province Medical Association in China,No.S15063,2015
文摘OBJECTIVE： To evaluate the efficacy and safety of acupuncture therapy for children with cerebral palsy. DATA SOURCES： We conducted electronic searches of PUBMED（1950/2017）, EMBASE（1974/2017）, Science Direct（1986/2017）, Academic Source Premier（1887/2017）, the Cochrane Library（Issue 4, April 2017）, Science Citation Index Expanded（1900/2017）, China National Knowledge Infrastructure（1915/2017）, China Biological Medicine（1990/2017-04）, Wan Fang（1980/2017）, VIP（1989/2017）, and Chinese Science Citation Database（1989/2017）. DATA SELECTION： We included randomized controlled trials that aimed to compare the effect of acupuncture plus rehabilitation training versus rehabilitation training alone. Data about functional motor abilities, daily activity/social participation, effective rate, intellectual development, and adverse effects were included. We used Revman 5.2 software for statistical analysis. OUTCOME MEASURES： The primary outcomes included functional motor abilities, daily activity, and effective rate. The secondary outcomes included intellectual development and adverse effects.RESULTS： Twenty-one studies with a total of 1718 participants met the inclusion criteria. The effect size of gross motor function（SMD = 0.64, 95% CI： 0.52 to 0.76, P 〈 0.00001; I^2 = 0%, P = 0.69; in 13 studies with 1144 patients） and the total effective rate（RR = 1.28, 95% CI： 1.20 to 1.37, P 〈 0.00001; I^2 = 18%, P = 0.27; in 12 studies with 1106 patients） suggested that acupuncture plus rehabilitation produced a significant improvement in gross motor function and a high total effective rate. The pooled fine motor function（SMD = 3.48, 95% CI： 2.62 to 4.34, P 〈 0.00001; I^2 = 64%, P = 0.10; in 2 studies with 193 patients）, modified Ashworth scale scores（SMD = –0.31, 95% CI： –0.52 to –0.11, P = 0.003; I^2 = 74%, P = 0.004; in 5 studies with 363 patients） and activities of daily living（SMD = 1.45, 95% CI： 1.20 to 1.71, P 〈 0.00001; I^2 = 78%, P = 0.004; in 4 studies with 313 patients） also indicated improvements in children with cerebral palsy. Publication bias was not observed. Only mild adverse events related to acupuncture were reported. CONCLUSION： Acupuncture plus rehabilitation training improved gross motor function, reduced muscle spasms, and enhanced daily life activities in children with cerebral palsy. However, this conclusion should be interpreted with caution due to the small number of randomized controlled trials available and the small sample sizes. More high-quality and large-scale studies are needed.
基金Supported by the National "11th 5-year Plan" (2006BAI12B04-2)National Plan on Developing Key Basic Researches("973" Plan)(2009CB522902)+1 种基金State Natural Science Fund(30760320)a project of Key Sci-tech Support Plan in Jiangxi Province
文摘OBJECTIVE:To assess the efficacy and safety of heat-sensitive moxibustion in the treatment of lumbar disc herniation(LDH).METHODS:Randomized controlled trials(RCTs) involving heat-sensitive moxibustion in the treatment of LDH were retrieved from the Chinese Biological Medical Literature database(1978-20011),Weipu database(1989-2011),Wanfang digital journal(1998-2011),China National Knowledge Internet(1979-2011),PubMed(1966-2011),EMBASE(1980-2011),and Cochrane Library(Issue 1,2011).Hand-search of the relevant journals from the Library of Jiangxi University of Traditional Chinese Medicine was also adopted for the collection of data.Data were extracted and evaluated by two reviewers independently with a specially designed extraction form.The Cochrane Collaboration's RevMan 5.0.20 software was used for data analyses.RESULTS:A total of 6 trials involving 580 patients were included.Meta-analysis showed that the total effectiveness rate in the heat-sensitive moxibustion group was significantly different when compared with conventional moxibustion [RR=1.19,95% CI [1.06,1.33)] and diclofenac sodium [RR=1.47,95% CI [1.17,1.85)],but similar to that of acupuncture.The cure rate in the heat-sensitive moxibustion group was significantly different when compared with conventional moxibustion [RR=1.58,95% CI(1.04,2.40)] and diclofenac sodium [RR=1.91,95% CI(1.01,3.60)],but similar with that of acupuncture.In terms of the Japanese Orthopaedic Association scores,significant differences were noted in subjective indices,objective indices,and daily life subscales.Two trials reported that there were no adverse events over the duration of treatment.CONCLUSION:Compared with conventional moxibustion,acupuncture,and diclofenac sodium,heat-sensitive moxibustion in the treatment of LDH is superior in efficacy.Further large-scale trials are required to define the role of heat-sensitive moxibustion in the treatment of this disease.
基金Supported by the National Natural Science Foundation of China:Exploration of Key Factors and Mechanisms of Modulating Motor Function Reconstruction After Cerebral Infarction Through Multimodal Brain Functional Connectivity Perspective in Procedural Acupoint Electrical Stimulation Research(No.82374601)the Jointly Guided Program of Natural Science Foundation of Heilongjiang Province:Quantitative Study on the Role of Scalp Acupuncture in the Motor Area in Promoting Motor Function Reconstruction after Stroke(No.LH2019H113)+1 种基金the Innovation Team Construction Project of Heilongjiang University of Chinese Medicine:Construction of a Doctoral Research and Innovation Team in Acupuncture Science(No.2017sit01)the Traditional Chinese Medicine Research Project of Heilongjiang Province:Clinical Study on the Promotion of Upper Limb Motor Function Reconstruction in Post-Stroke Patients Using Optimal Limb Positioning with Electroacupuncture(No.ZHY2022-171)。
文摘OBJECTIVE:To evaluate the efficacy of electroacupuncture(EA)at scalp motor area for treating post-stroke wrist dyskinesia and its influence on the function of wrist movement-related agonistic muscles.METHODS:A randomized,single-blind,controlled clinical trial was conducted.Sixty-six patients undergoing post-stroke wrist dyskinesia were enrolled and randomized 1:1 to EA or control group.Patients in the control group received manual acupuncture in the scalp motor area(MS 6)on the lesion side.The same acupoint was selected to accept EA stimulation in the EA group.All patients were treated six times a week for three weeks.The primary outcome was the Chinese Stroke Scale(CSS)score.The secondary outcomes included upper limb-related Barthel Index(BI)score,active range of motion(AROM)of the wrist joint,and root mean square(RMS)of the four agonistic muscles associated with wrist motion on the hemiplegic side of patients,i.e.,the extensor carpi radialis longus(ECRL),extensor digitorum(ED),flexor carpi radialis(FCR)and flexor carpi ulnaris(FCU).The above indicators were measured before and after three weeks of treatment.RESULTS:After 3-week treatment,the CSS score and AROM of wrist dorsiflexion of the EA group were better than those in the control group(P=0.038,P=0.047).The differences between the two groups of BI scores and AROM of wrist flexion were not significant(P>0.05).All RMS of the EA group were higher than those in the control group(ECRL:P=0.047,ED:P=0.048,FCR:P=0.049,FCU:P=0.047).The total effective rate in the EA group was 87.50%(28/32),which was higher than that in the control group(77.42%,24/31,P=0.048).CONCLUSION:EA stimulation of the scalp motor area can promote the recovery of the strength and function of the agonistic muscles related to wrist movement and effectively improve post-stroke wrist dyskinesia.
基金supported by the Guangdong Provincial"211 Engineering"Stage-III Key Disciplines Construction Project in China,No.Yue 2009431
文摘OBJECTIVE： To evaluate the effectiveness and safety of filiform needle acupuncture for poststroke depression, and to compare acupuncture with the therapeutic efficacy of antidepressant drugs. DATA RETRIEVAL： We retrieved data from the Chinese National Knowledge Infrastructure （1979-2012）, Wanfang （1980-2012）, VIP （1989-2012）, Chinese Biomedical Literature （1975- 2012）, PubMed （1966-2012）, Ovid Lww （-2012）, and Cochrane Library （-2012） Database using the internet. SELECTION CRITERIA： Randomized controlled trials on filiform needle acupuncture versus antidepressant drugs for treatment of poststroke depression were included. Moreover, the in- cluded articles scored at least 4 points on the Jadad scale. Exclusion criteria： other acupuncture therapies as treatment group, not stroke-induced depression patients, score 〈 4 points, non-ran- domized controlled trials, or animal trials. MAIN OUTCOME MEASURES： These were the Hamilton Depression Scale scores, clinical ef- fective rate, Self-Rating Depression Scale scores, Side Effect Rating Scale scores, and incidence of adverse reaction and events. RESULTS： A total of 17 randomized controlled clinical trials were included. Meta-analysis results displayed that after 4 weeks of treatment, clinical effective rate was better in patients treated with fill- form needle acupuncture than those treated with simple antidepressant drugs [relative risk = 1.11, 95% confidence interval （C/）： 1.03-1.21, P = 0.01]. At 6 weeks, clinical effective rate was similar between filiform needle acupuncture and antidepressant drug groups. At 2 weeks after filiform needle acupuncture, Hamilton Depression Scale （17 items） scores were lower than in the antide- pressant drug group （mean difference = -2.34, 95%CI： -3.46 to -1.22, P 〈 0.000,1）. At 4 weeks, Hamilton Depression Scale （24 items） scores were similar between filiform needle acupuncture and antidepressant drug groups. Self-Rating Depression Scale scores were lower in filiform needle acupuncture group than in the antidepressant drug group. Side Effect Rating Scale was used in only two articles, and no meta-analysis was conducted. Safety evaluation of the 17 arti- cles showed that gastrointestinal tract reactions such as nausea and vomiting were very common in the antidepressant drug group. Incidence of adverse reaction and events was very low in the filiform needle acupuncture group. CONCLUSION： Early filiform needle acupuncture for poststroke depression can perfectly con- trol depression. Filiform needle acupuncture is safe and reliable. Therapeutic effects of filiform needle acupuncture were better than those of antidepressant drugs.
基金Supported by Effectiveness of External Therapy of Traditional Chinese Medicine for Subacute Thyroiditis:a Evaluation Research(sci-tech project,No.WZF2012-12)Research on Professor Wu Ruimin's Academic Thought on Treating Subacute Thyroiditis(research project,No.JJ2010-65)from Beijing Municipality of Traditional Chinese Medicine
文摘OBJECTIVE:To evaluate the effectiveness and safety of Chinese herbal medicine(CHM) in the treatmentofsubacutethyroiditis.METHODS: Randomized controlled trials found in PubMed, Cochrane Library, and three Chinese databases were selected. RevMan 5.2 software was used to analyze the data with relative risk or mean difference, expressed with 95% of confidence interval. The quality of trials was assessed and gradedthe quality of evidence with GRADE profiler software.RESULTS: Twenty one studies were included. CHM was superior to Western Medicine(include prednisone and NSAIDs) in abating fever, relieving thyroid pain, recovering blood sedimentation, improving thyroid function, and preventing hypothyroidism(P<0.05), while no statistical differences were found in eliminating goiter and reducing relapse rate.CHM plusWestern Medicine were superior toWestern Medicine in abating fever, relieving thyroid pain, eliminating goiter, and reducing relapse rate,while no statistical differences(P>0.05) were found in recovering blood sedimentation and improving thyroid function. The incidence of adverse reactions in treatment group was lower than that in control group(relative risk was 0.12 and 95% confidence interval was 0.03-0.51). The methodological quality of trials is generally poor with a high risk of bias.CONCLUSION: CHM(particularly CHM combined withWestern Medicine) used to treat subacute thyroiditis may improve clinical symptoms and signs,reduce relapse rate, and alleviate the side effects of hormones. Due to poor methodological quality of included trials, further more high-quality studies are warranted to confirm the effectiveness and safety of CHM.
