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: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 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
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
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
Background:Previously published meta-epidemiological studies focused on Western medicine have identified some trial characteristics that impact the treatment effect of randomized controlled trials(RCTs).Nevertheless,i...Background:Previously published meta-epidemiological studies focused on Western medicine have identified some trial characteristics that impact the treatment effect of randomized controlled trials(RCTs).Nevertheless,it remains unclear if similar associations exist in RCTs on Chinese herbal medicine(CHM).Further,Chinese medicine-related characteristics have not been explored yet.Objective:To investigate trial characteristics related to treatment effect estimates on CHM RCTs.Search strategy:This meta-epidemiological study searched 5 databases for systematic reviews on CHM treatment published between January 2011 and July 2021.Inclusion criteria:An eligible systematic review should only include RCTs of CHM and conduct at least one meta-analysis.Data extraction and analysis:Two reviewers independently conducted data extraction on general characteristics of systematic reviews,meta-analyses and included RCTs.They also assessed the risk of bias of RCTs using the Cochrane risk of bias tool.A two-step approach was used for data analyses.The ratio of odds ratios(ROR) and difference in standardized mean differences (dSMD) with 95%confidence interval (CI) were applied to present the difference in effect estimates for binary and continuous outcomes,respectively.Results:Ninety-one systematic reviews,comprising 1338 RCTs were identified.For binary outcomes,RCTs incorporated with syndrome differentiation (ROR:1.23;95%CI:[1.07,1.39]),adopting Chinese medicine formula (ROR:1.19;95%CI:[1.03,1.34]),with low risk of bias on incomplete outcome data (ROR:1.29;95%CI:[1.06,1.52]) and selective outcome reporting (ROR:1.12;95%CI:[1.01,1.24]),as well as a trial size≥100 (ROR:1.23;95%CI:[1.04,1.42]) preferred to show larger effect estimates.As for continuous outcomes,RCTs with Chinese medicine diagnostic criteria (dSMD:0.23;95%CI:[0.06,0.41]),judged as high/unclear risk of bias on allocation concealment (dSMD:-0.70;95%CI:[-0.99,-0.42]),with low risk of bias on incomplete outcome data (dSMD:0.30;95%CI:[0.18,0.43]),conducted at a single center (dSMD:-0.33;95%CI:[-0.61,-0.05]),not using intention-to-treat analysis (dSMD:-0.75;95%CI:[-1.43,-0.07]),and without funding support (dSMD:-0.22;95%CI:[-0.41,-0.02]) tended to show larger effect estimates.Conclusion:This study provides empirical evidence for the development of a specific critical appraisal tool for risk of bias assessments on CHM RCTs.展开更多
Randomized controlled trials(RCTs)have long been recognized as the gold standard for establishing causal relationships in clinical research.Despite that,various limitations of RCTs prevent its widespread implementatio...Randomized controlled trials(RCTs)have long been recognized as the gold standard for establishing causal relationships in clinical research.Despite that,various limitations of RCTs prevent its widespread implementation,ranging from the ethicality of withholding potentially-lifesaving treatment from a group to relatively poor external validity due to stringent inclusion criteria,amongst others.However,with the introduction of propensity score matching(PSM)as a retrospective statistical tool,new frontiers in establishing causation in clinical research were opened up.PSM predicts treatment effects using observational data from existing sources such as registries or electronic health records,to create a matched sample of participants who received or did not receive the intervention based on their propensity scores,which takes into account characteristics such as age,gender and comorbidities.Given its retrospective nature and its use of observational data from existing sources,PSM circumvents the aforementioned ethical issues faced by RCTs.Majority of RCTs exclude elderly,pregnant women and young children;thus,evidence of therapy efficacy is rarely proven by robust clinical research for this population.On the other hand,by matching study patient characteristics to that of the population of interest,including the elderly,pregnant women and young children,PSM allows for generalization of results to the wider population and hence greatly increases the external validity.Instead of replacing RCTs with PSM,the synergistic integration of PSM into RCTs stands to provide better research outcomes with both methods complementing each other.For example,in an RCT investigating the impact of mannitol on outcomes among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial,the baseline characteristics of comorbidities and current medications between treatment and control arms were significantly different despite the randomization protocol.Therefore,PSM was incorporated in its analysis to create samples from the treatment and control arms that were matched in terms of these baseline characteristics,thus providing a fairer comparison for the impact of mannitol.This literature review reports the applications,advantages,and considerations of using PSM with RCTs,illustrating its utility in refining randomization,improving external validity,and accounting for non-compliance to protocol.Future research should consider integrating the use of PSM in RCTs to better generalize outcomes to target populations for clinical practice and thereby benefit a wider range of patients,while maintaining the robustness of randomization offered by RCTs.展开更多
Background:Evidence regarding the effectiveness of prenatal nutritional supplements has mainly considered anthropometric pregnancy outcomes.The effect on markers of health and disease,such as offspring telomere length...Background:Evidence regarding the effectiveness of prenatal nutritional supplements has mainly considered anthropometric pregnancy outcomes.The effect on markers of health and disease,such as offspring telomere length(TL)and mitochondrial DNA content(mtDNAc)is unknown.Objectives:We assessed the efficacy of maternal multiple micronutrient(MMN)-fortified balanced-energy protein(BEP)and iron-folic acid(IFA)supplementation on newborn TL as a secondary outcome and mtDNAc as a non-declared outcome.Design:We conducted a randomized controlled trial in rural Burkina Faso,among pregnant females(15-40 years old)enrolled at<21 weeks of gestation.Mothers received either MMN-fortified BEP and IFA(intervention)or IFA only(control)throughout pregnancy.Whole arterial blood samples were collected from the umbilical cord of 104 control and 90 intervention group infants,respectively.Average relative TL and mtDNAc were measured using quantitative polymerase chain reaction.Linear regression models were fitted to assess TL and mtDNAc differences across trial arms.Results:We found that a combined daily MMN-fortified BEP supplement and IFA tablet did not affect newborn TL[β=-0.010(95%CI:-0.057,0.036);P=0.662]or mtDNAc[β=0.065(95%CI:-0.203,0.073);P=0.354],as compared to an IFA tablet alone.These findings were confirmed(P>0.05)by adjusting the regression models for potential prognostic factors of study outcomes at enrollment.Exploratory analyses indicated higher,but non-significantly different mtDNAc among children born either small-for-gestational age,low birthweight,or preterm.Conclusion:Newborns from mothers who received daily nutritional supplements across gestation did not have different relative TL or mtDNAc.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 effect of Yiqi Liangxue Shengji prescription(益气凉血生肌方,YQLXSJ)on cardiac function and outcomes in acute myocardial infarction(AMI)patients with myocardial ischemiareperfusion injury(MIRI...OBJECTIVE:To evaluate the effect of Yiqi Liangxue Shengji prescription(益气凉血生肌方,YQLXSJ)on cardiac function and outcomes in acute myocardial infarction(AMI)patients with myocardial ischemiareperfusion injury(MIRI)and to determine its clinical efficacy.METHODS:This prospective,randomized,double-blind,placebo-controlled trial enrolled hospitalized patients with AMI who underwent percutaneous coronary intervention and experienced MIRI either intraoperatively or postoperatively.Participants were randomly allocated to the treatment group,which received YQLXSJ,or the control group,which received a placebo,concurrent with standard Western Medicine therapy.The intervention period lasted 8 weeks.The primary outcome measure was left ventricular ejection fraction(LVEF),determined by echocardiography.Secondary outcomes included Nterminal pro brain natriuretic peptide(NT-pro BNP)and cardiac troponin I(cTnI)levels,left ventricular internal diameter,major adverse cardiovascular events(MACE),angina pectoris scores,and Chinese medicine evidence scores.RESULTS:Following 8 weeks of intervention,the treatment group demonstrated a significant increase in LVEF and a marked reduction in NT-pro BNP when compared to the control group.There was also a significant decrease in peak cTnI levels,Chinese medicine evidence scores,and angina pectoris scores.The control group's left ventricular end-systolic diameter(LVESD)significantly increased compared to baseline after 8 weeks(P<0.05),whereas the treatment group's LVESD showed no significant change from baseline(P>0.05).Although the treatment group showed a downward trend in MACE incidence compared to the control group,this difference was not statistically significant(P>0.05).CONCLUSIONS:This study demonstrated that the addition of YQLXSJ to standard therapy can improve cardiac function and alleviate clinical symptoms in AMI patients with MIRI,and also showed a potential to mitigate the incidence of MACE.Furthermore,YQLXSJ displayed a favorable safety profile in clinical application.展开更多
Objective:To evaluate the efficacy and safety of transcutaneous electrical acupoint stimulation(TEAS)for muscle atrophy in patients with immobilization after surgical fixation of foot and ankle fractures.Methods:This ...Objective:To evaluate the efficacy and safety of transcutaneous electrical acupoint stimulation(TEAS)for muscle atrophy in patients with immobilization after surgical fixation of foot and ankle fractures.Methods:This was a two-arm randomized controlled trial wherein 80 patients were recruited and divided into control(n=40)and intervention(n=40)groups.The control group received conventional orthopedic treatment,whereas the intervention group received TEAS and conventional treatment.The intervention group received TEAS 3 times a week for 30 min each time for 8 weeks.The primary out-comes were muscle thickness(MT)and cross-sectional area(CSA)of the rectus femoris and gastroc-nemius muscles,whereas the secondary outcome measure was echo intensity(EI).Data were collected before the fixation operations(baseline assessment)and 4 and 8 weeks after intervention.Results:Compared with baseline,the MT and CSA were reduced in both groups by the end of treatment,whereas EI increased in both groups.At week 4,the reduction in the rectus femoris CSA in the inter-vention group was significantly lower than that in the control group(P=0.02);however,the between-group differences in the MT and EI(all P>0.05)were not significant.No serious adverse events were observed in either group.Conclusion:Our study showed that TEAS can improve muscle atrophy by attenuating the decline in the muscle CSA.Because this was only a pilot trial,subsequent studies will need longer follow-ups and larger sample sizes.展开更多
OBJECTIVE:To explore the efficacy and safety of acupuncture combined with atlantoaxial joint bone-setting therapy for the treatment of Tourette syndrome.METHODS:We randomly divided 600 patients at a ratio of 1∶1∶1 i...OBJECTIVE:To explore the efficacy and safety of acupuncture combined with atlantoaxial joint bone-setting therapy for the treatment of Tourette syndrome.METHODS:We randomly divided 600 patients at a ratio of 1∶1∶1 into three groups:group A(acupuncture combined with atlantoaxial joint bone setting therapy group),group B(acupuncture group),and group C(tiapride group).After two months of treatment,the Yale global tic severity scale(YGTSS)score reduction,improvement in social function impairment,clinical efficacy,and long-term efficacy in the three groups were compared.RESULTS:After treatment,in the analysis of YGTSS score reduction,social function impairment improvement,the clinical control rate,and long-term efficacy,the results were all Group A>Group B>Group C,with a statistically significant difference(P<0.05).However,the total clinical efficacy of treatment in group A(94.9%)was not significantly different from that in group B(91.8%).Adverse reactions did not occur in groups A and B,and several adverse reactions occurred in 29%(n=58)of the group C patients.CONCLUSION:Compared with traditional drug therapy,acupuncture combined with atlantoaxial joint bone setting therapy has better clinical and long-term efficacy.This treatment strategy can improve the social function of children and prevent adverse reactions to drugs.展开更多
BACKGROUND Osteoarthritis(OA)of the knee is a prevalent degenerative joint disease that significantly impairs quality of life and functional mobility.Emerging regenerative therapies,such as stromal vascular fraction(S...BACKGROUND Osteoarthritis(OA)of the knee is a prevalent degenerative joint disease that significantly impairs quality of life and functional mobility.Emerging regenerative therapies,such as stromal vascular fraction(SVF)and nanofat,have demonstrated potential in cartilage repair and symptom alleviation.However,comparative clinical evidence evaluating their efficacy and safety remains limited.AIM To compare the clinical outcomes of SVF vs nanofat therapy in patients with primary knee OA.METHODS Conducted at Mother Cell Regenerative Centre,Trichy,over 18 months(June 2025 to December 2026),the study will enroll 30 patients,randomly assigned to two groups of 15 each.Both interventions will be administered as a single intra-articular injection under sterile conditions,with cell viability(>85%)confirmed by a standardized assay.Group A will receive autologous SVF injections,while Group B will receive autologous nanofat injections.The primary outcome measure is the change in pain scores at 12 months using the visual analog scale(VAS).Secondary outcomes include functional improvement assessed by Osteoarthritis Outcome Score(KOOS),Western Ontario and McMaster Universities(WOMAC),and International Knee Documentation Committee(IKDC)scores,cartilage regeneration evaluated via magnetic resonance imaging with colour coded mapping of the cartilage volume(MR cartigram),and monitoring of adverse events.RESULTS This study aims to evaluate pain reduction at 12 months post-injection,using the VAS as the primary outcome.Secondary outcomes include functional improvement(KOOS,WOMAC,IKDC),cartilage regeneration(T2 cartigram),adverse event incidence,patient satisfaction(standardized questionnaires,Likert scale),and quality of life(EQ-5D).Ethical considerations follow the Declaration of Helsinki and Good Clinical Practice,with IRB approval and participant informed consent ensured.Confidentiality and data security comply with regulations,and a Data Safety Monitoring Board oversees trial safety.Results will be shared via peer-reviewed journals,presentations at international orthopedic conferences,and detailed summaries for stakeholders and participants.The trial is registered under CTRI/2024/03/064076.Findings emphasize patient-centered advancements in knee osteoarthritis management.CONCLUSION This trial evaluates the efficacy and safety of SVF and nanofat therapies in knee OA,addressing a significant evidence gap.It employs robust methods to enhance cartilage repair and patient quality of life.Future research should standardize dosages,protocols,and injection techniques,explore autologous/allogenic preparations,and advance radiological tools,broadening accessibility and clinical applications.展开更多
BACKGROUND Hyponatremia is a prevalent and serious electrolyte imbalance in pediatric pneumonia and is linked to increased disease severity and adverse outcomes.Oral rehydration solution(ORS)is an available,inexpensiv...BACKGROUND Hyponatremia is a prevalent and serious electrolyte imbalance in pediatric pneumonia and is linked to increased disease severity and adverse outcomes.Oral rehydration solution(ORS)is an available,inexpensive,safe,and ready-touse oral solution that can supplement sodium in such cases.AIM To assess the impact of prophylactic sodium supplementation via ORS on clinical and hospital outcomes in infants and children admitted with pneumonia.METHODS A randomized,interventional controlled trial was conducted on 140 infants and children admitted with pneumonia(70 per group).The primary outcome was hospital length of stay,with secondary outcomes including serum sodium and potassium levels,clinical respiratory scores,modified shock index,and nutritional/inflammatory markers.The hospital length of stay and both the laboratory and clinical parameters of the interventional and control groups were compared.RESULTS The hospital stay was longer in the control group than in the intervention group(P value=0.001;effect size=0.59).Clinical respiratory scores on day 4 were significantly lower in the intervention group than in the control group(P value=0.001).Sodium levels were significantly lower in the control group than in the intervention group at discharge(P value=0.002).CONCLUSION Prophylactic oral sodium supplementation through ORS may have a health-promoting effect on infants and children admitted with pneumonia.展开更多
BACKGROUND Knee osteoarthritis(OA)imposes a substantial burden through pain,functional limitation,and progressive cartilage loss.Bone marrow aspirate concentrate(BMAC)has emerged as a promising regenerative therapy fo...BACKGROUND Knee osteoarthritis(OA)imposes a substantial burden through pain,functional limitation,and progressive cartilage loss.Bone marrow aspirate concentrate(BMAC)has emerged as a promising regenerative therapy for OA due to its rich composition of mesenchymal stromal cells(MSCs)and bioactive factors.While intra-articular BMAC injections provide short-term symptomatic relief,recent literature suggests that targeting the subchondral bone—an area crucial to OA progression—may offer superior and longer-lasting clinical benefits.AIM To compares the outcomes of subchondral vs intra-articular BMAC injections in patients with primary knee OA.METHODS In this unicentric,double-blinded,randomized controlled trial,30 patients with radiologically confirmed primary knee OA(Kellgren-Lawrence grades II and III)will be equally randomized to receive either subchondral(Group A)or intra-articular(Group B)BMAC injections.BMAC will be harvested from the posterior iliac crest,processed using a standardized centrifugation protocol to yield a product with>85%cell viability,and administered under image guidance.The primary outcome is the change in pain intensity at 12 months as measured by the Visual Analog Scale(VAS).Secondary outcomes include functional improvement assessed by Knee Injury and Osteoarthritis Outcome Score(KOOS),International Knee Documentation Committee(IKDC),and Western Ontario and McMaster Universities Arthritis Index(WOMAC)scores,structural changes evaluated through advanced magnetic resonance imaging using(MRI)the whole-organ MRI Score,and safety as determined by the incidence of adverse events.RESULTS This study aims to evaluate pain reduction at 12 months post-injection,using the VAS as the primary outcome.Secondary outcomes include functional improvement(KOOS,WOMAC,IKDC),cartilage regeneration(T2 cartigram),adverse event incidence,patient satisfaction(standardized questionnaires,Likert scale),and quality of life(EQ-5D).Ethical considerations follow the Declaration of Helsinki and Good Clinical Practice,with institutional review board approval and participant informed consent ensured.Confidentiality and data security comply with regulations,and a data safety monitoring board oversees trial safety.Results will be shared via peer-reviewed journals,presentations at international orthopedic conferences,and detailed summaries for stakeholders and participants.The trial is registered under clinical trial registry of India/2024/04/065284.Findings emphasize patient-centered advancements in knee osteoarthritis management.CONCLUSION This trial aims to refine regenerative strategies for knee OA by comparing subchondral vs intra-articular BMAC injections,addressing long-term efficacy,safety,and treatment standardization to guide targeted interventions.This trial will provide critical insights into the comparative efficacy and safety of subchondral vs intra-articular BMAC injections in treating primary knee OA.展开更多
Background:Electroacupuncture(EA)may affect the severity of hot flashes(HFs)associated with natural menopause and provide additional benefits for postmenopausal women.However,the evidence for its effectiveness in the ...Background:Electroacupuncture(EA)may affect the severity of hot flashes(HFs)associated with natural menopause and provide additional benefits for postmenopausal women.However,the evidence for its effectiveness in the management of early postmenopausal HFs remains inadequately understood.Objective:We designed this trial to assess the efficacy and safety of EA for relieving early postmenopausal HFs.Design,setting,participants and interventions:This randomized sham-controlled trial involved 72 women with HFs.The participants were divided equally into the intervention and control groups.The intervention group was treated with EA,while the control group was treated with sham acupuncture.The main acupoints used were Hegu(LI4),Guanyuan(RN4),Sanyinjiao(SP6),Taixi(KI3),Fuliu(KI7)and Shenshu(BL23).All participants received 18 treatment sessions,distributed across a 6-week period.The treatment was administered on three occasions per week,adhering to a fixed weekday schedule(Monday,Wednesday,Friday or Tuesday,Thursday,Saturday)with a minimum interval of one day between sessions.Each patient received a 12-week follow-up.Main outcome measures:The HF score was the primary outcome.Participants documented the frequency and severity of HFs in a 7-day symptom diary,which provided data for calculating the HF score.Secondary outcomes were the Menopause Rating Scale(MRS),Menopause-Specific Quality of Life Questionnaire(MENQOL),Pittsburgh Sleep Quality Index(PSQI)and Traditional Chinese Medicine Syndrome Score Scale(TCMSSS),as well as estradiol(E2),luteinizing hormone(LH)and folliclestimulating hormone(FSH)levels.Results:Both groups demonstrated significant reductions in HF scores after the treatment and during the follow-up(P<0.001).Immediately after completion of the 6-week treatment cycle and at 12 weeks postintervention,the HF scores were similar in both groups.At week 6,the intervention group showed significantly greater improvements in MRS,MENQOL(vasomotor,psychosocial,and physical),PSQI and TCMSSS scores(P<0.05).The improvements in the MENQOL(vasomotor,and psychosocial)and PSQI total scores persisted through the follow-up(P<0.05).However,the results showed no significant inter-or intragroup differences in sexual scores on the MENQOL(P>0.05).EA did not significantly decrease E2,LH or FSH levels compared to placebo.The incidence of adverse events was similar in both groups.Conclusion:EA does not significantly improve HFs in early postmenopausal patients.However,it enhances the quality of sleep and decreases menopausal symptoms across vasomotor,psychosocial and physical domains.Trial registration:Chinese Clinical Trial Registry(http://www.chictr.org.cn);Trial ID:Chi CTR2300072002.Please cite this article as:Wang HX,Yu XT,Hu J,Chen JJ,Mei YT,Chen YF.Electroacupuncture for hot flashes in early menopause:A randomized sham-controlled trial.J Integr Med.2025;23(5):519-527.?2025 Shanghai Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine.Published by Elsevier B.V.All rights are reserved,including those for text and data mining,AI training,and similar technologies.展开更多
Ulcerative colitis(UC)is a chronic inflammatory bowel diseasethat significantly affects the quality of life of patients.Traditional treatments often have limitations,and alternative therapies are being explored.Miao M...Ulcerative colitis(UC)is a chronic inflammatory bowel diseasethat significantly affects the quality of life of patients.Traditional treatments often have limitations,and alternative therapies are being explored.Miao Medicine,particularly Jinlong Zhi Xie Fang Enema,is a traditional herbal remedy used to treat UC symptoms,especially in patients with Large Intestine Damp-Heat Syndrome.However,clinical evidence supporting its efficacy is limited.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: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 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.
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 the National Natural Science Foundation of China (No.81973709)Chinese Medicine Development Fund (21B2/018A)State Key Laboratory of Dampness Syndrome of Chinese Medicine Special Fund (SZ2021ZZ05,SZ2021ZZ0502)。
文摘Background:Previously published meta-epidemiological studies focused on Western medicine have identified some trial characteristics that impact the treatment effect of randomized controlled trials(RCTs).Nevertheless,it remains unclear if similar associations exist in RCTs on Chinese herbal medicine(CHM).Further,Chinese medicine-related characteristics have not been explored yet.Objective:To investigate trial characteristics related to treatment effect estimates on CHM RCTs.Search strategy:This meta-epidemiological study searched 5 databases for systematic reviews on CHM treatment published between January 2011 and July 2021.Inclusion criteria:An eligible systematic review should only include RCTs of CHM and conduct at least one meta-analysis.Data extraction and analysis:Two reviewers independently conducted data extraction on general characteristics of systematic reviews,meta-analyses and included RCTs.They also assessed the risk of bias of RCTs using the Cochrane risk of bias tool.A two-step approach was used for data analyses.The ratio of odds ratios(ROR) and difference in standardized mean differences (dSMD) with 95%confidence interval (CI) were applied to present the difference in effect estimates for binary and continuous outcomes,respectively.Results:Ninety-one systematic reviews,comprising 1338 RCTs were identified.For binary outcomes,RCTs incorporated with syndrome differentiation (ROR:1.23;95%CI:[1.07,1.39]),adopting Chinese medicine formula (ROR:1.19;95%CI:[1.03,1.34]),with low risk of bias on incomplete outcome data (ROR:1.29;95%CI:[1.06,1.52]) and selective outcome reporting (ROR:1.12;95%CI:[1.01,1.24]),as well as a trial size≥100 (ROR:1.23;95%CI:[1.04,1.42]) preferred to show larger effect estimates.As for continuous outcomes,RCTs with Chinese medicine diagnostic criteria (dSMD:0.23;95%CI:[0.06,0.41]),judged as high/unclear risk of bias on allocation concealment (dSMD:-0.70;95%CI:[-0.99,-0.42]),with low risk of bias on incomplete outcome data (dSMD:0.30;95%CI:[0.18,0.43]),conducted at a single center (dSMD:-0.33;95%CI:[-0.61,-0.05]),not using intention-to-treat analysis (dSMD:-0.75;95%CI:[-1.43,-0.07]),and without funding support (dSMD:-0.22;95%CI:[-0.41,-0.02]) tended to show larger effect estimates.Conclusion:This study provides empirical evidence for the development of a specific critical appraisal tool for risk of bias assessments on CHM RCTs.
文摘Randomized controlled trials(RCTs)have long been recognized as the gold standard for establishing causal relationships in clinical research.Despite that,various limitations of RCTs prevent its widespread implementation,ranging from the ethicality of withholding potentially-lifesaving treatment from a group to relatively poor external validity due to stringent inclusion criteria,amongst others.However,with the introduction of propensity score matching(PSM)as a retrospective statistical tool,new frontiers in establishing causation in clinical research were opened up.PSM predicts treatment effects using observational data from existing sources such as registries or electronic health records,to create a matched sample of participants who received or did not receive the intervention based on their propensity scores,which takes into account characteristics such as age,gender and comorbidities.Given its retrospective nature and its use of observational data from existing sources,PSM circumvents the aforementioned ethical issues faced by RCTs.Majority of RCTs exclude elderly,pregnant women and young children;thus,evidence of therapy efficacy is rarely proven by robust clinical research for this population.On the other hand,by matching study patient characteristics to that of the population of interest,including the elderly,pregnant women and young children,PSM allows for generalization of results to the wider population and hence greatly increases the external validity.Instead of replacing RCTs with PSM,the synergistic integration of PSM into RCTs stands to provide better research outcomes with both methods complementing each other.For example,in an RCT investigating the impact of mannitol on outcomes among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial,the baseline characteristics of comorbidities and current medications between treatment and control arms were significantly different despite the randomization protocol.Therefore,PSM was incorporated in its analysis to create samples from the treatment and control arms that were matched in terms of these baseline characteristics,thus providing a fairer comparison for the impact of mannitol.This literature review reports the applications,advantages,and considerations of using PSM with RCTs,illustrating its utility in refining randomization,improving external validity,and accounting for non-compliance to protocol.Future research should consider integrating the use of PSM in RCTs to better generalize outcomes to target populations for clinical practice and thereby benefit a wider range of patients,while maintaining the robustness of randomization offered by RCTs.
基金supported by the Bill&Melinda Gates Foundation(OPP1175213)supported by the Research Foundation Flanders(12X9620N and 12X9623N)the European Research Council(ERC)under the European Union’s Horizon 2020 research and innovation program(946192,HUMYCO)。
文摘Background:Evidence regarding the effectiveness of prenatal nutritional supplements has mainly considered anthropometric pregnancy outcomes.The effect on markers of health and disease,such as offspring telomere length(TL)and mitochondrial DNA content(mtDNAc)is unknown.Objectives:We assessed the efficacy of maternal multiple micronutrient(MMN)-fortified balanced-energy protein(BEP)and iron-folic acid(IFA)supplementation on newborn TL as a secondary outcome and mtDNAc as a non-declared outcome.Design:We conducted a randomized controlled trial in rural Burkina Faso,among pregnant females(15-40 years old)enrolled at<21 weeks of gestation.Mothers received either MMN-fortified BEP and IFA(intervention)or IFA only(control)throughout pregnancy.Whole arterial blood samples were collected from the umbilical cord of 104 control and 90 intervention group infants,respectively.Average relative TL and mtDNAc were measured using quantitative polymerase chain reaction.Linear regression models were fitted to assess TL and mtDNAc differences across trial arms.Results:We found that a combined daily MMN-fortified BEP supplement and IFA tablet did not affect newborn TL[β=-0.010(95%CI:-0.057,0.036);P=0.662]or mtDNAc[β=0.065(95%CI:-0.203,0.073);P=0.354],as compared to an IFA tablet alone.These findings were confirmed(P>0.05)by adjusting the regression models for potential prognostic factors of study outcomes at enrollment.Exploratory analyses indicated higher,but non-significantly different mtDNAc among children born either small-for-gestational age,low birthweight,or preterm.Conclusion:Newborns from mothers who received daily nutritional supplements across gestation did not have different relative TL or mtDNAc.
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 Capital’s Funds for Health Improvement and Research:Clinical Study on Yiqi Liangxue Shengji Prescription for Improving Cardiac Function after Myocardial Ischemia Reperfusion Injury in Patients with Acute Myocardial Infarction(CFH 2020-4-4204)Beijing University of Traditional Chinese Medicine Qihuang Yingcai·Excellent Young Science and Technology Talent Cultivation Program(K2023A03)Beijing University of Traditional Chinese Medicine Dongfang Hospital High-level Capacity Building Project"Zhuoyuan"Project National Talent Precision Cultivation Program(DFRCZY-2024GJRC012)。
文摘OBJECTIVE:To evaluate the effect of Yiqi Liangxue Shengji prescription(益气凉血生肌方,YQLXSJ)on cardiac function and outcomes in acute myocardial infarction(AMI)patients with myocardial ischemiareperfusion injury(MIRI)and to determine its clinical efficacy.METHODS:This prospective,randomized,double-blind,placebo-controlled trial enrolled hospitalized patients with AMI who underwent percutaneous coronary intervention and experienced MIRI either intraoperatively or postoperatively.Participants were randomly allocated to the treatment group,which received YQLXSJ,or the control group,which received a placebo,concurrent with standard Western Medicine therapy.The intervention period lasted 8 weeks.The primary outcome measure was left ventricular ejection fraction(LVEF),determined by echocardiography.Secondary outcomes included Nterminal pro brain natriuretic peptide(NT-pro BNP)and cardiac troponin I(cTnI)levels,left ventricular internal diameter,major adverse cardiovascular events(MACE),angina pectoris scores,and Chinese medicine evidence scores.RESULTS:Following 8 weeks of intervention,the treatment group demonstrated a significant increase in LVEF and a marked reduction in NT-pro BNP when compared to the control group.There was also a significant decrease in peak cTnI levels,Chinese medicine evidence scores,and angina pectoris scores.The control group's left ventricular end-systolic diameter(LVESD)significantly increased compared to baseline after 8 weeks(P<0.05),whereas the treatment group's LVESD showed no significant change from baseline(P>0.05).Although the treatment group showed a downward trend in MACE incidence compared to the control group,this difference was not statistically significant(P>0.05).CONCLUSIONS:This study demonstrated that the addition of YQLXSJ to standard therapy can improve cardiac function and alleviate clinical symptoms in AMI patients with MIRI,and also showed a potential to mitigate the incidence of MACE.Furthermore,YQLXSJ displayed a favorable safety profile in clinical application.
基金supported by the funded project(HYZHX M05005)in the field of space medical experiments of manned spaceflight engineering.
文摘Objective:To evaluate the efficacy and safety of transcutaneous electrical acupoint stimulation(TEAS)for muscle atrophy in patients with immobilization after surgical fixation of foot and ankle fractures.Methods:This was a two-arm randomized controlled trial wherein 80 patients were recruited and divided into control(n=40)and intervention(n=40)groups.The control group received conventional orthopedic treatment,whereas the intervention group received TEAS and conventional treatment.The intervention group received TEAS 3 times a week for 30 min each time for 8 weeks.The primary out-comes were muscle thickness(MT)and cross-sectional area(CSA)of the rectus femoris and gastroc-nemius muscles,whereas the secondary outcome measure was echo intensity(EI).Data were collected before the fixation operations(baseline assessment)and 4 and 8 weeks after intervention.Results:Compared with baseline,the MT and CSA were reduced in both groups by the end of treatment,whereas EI increased in both groups.At week 4,the reduction in the rectus femoris CSA in the inter-vention group was significantly lower than that in the control group(P=0.02);however,the between-group differences in the MT and EI(all P>0.05)were not significant.No serious adverse events were observed in either group.Conclusion:Our study showed that TEAS can improve muscle atrophy by attenuating the decline in the muscle CSA.Because this was only a pilot trial,subsequent studies will need longer follow-ups and larger sample sizes.
基金Supported by Traditional Chinese medicine foundation of Zhejiang province:Clinical Study on the Correlation Between Tourette Syndrome and Anatomical Changes in the Atlantoaxial Joint(2010ZB162)Medical Health Science and Technology Project of Zhejiang Provincial Health Commission:Study on Protein Fingerprinting of Tourette Syndrome(2011KYB142)+1 种基金Renowned Traditional Chinese Medicine Expert Inheritance Studio Construction Project of Zhejiang province(No.GZS2020049)Key Disciplines of Traditional Chinese Medicine Foundation of Zhejiang Province(2012-XK-D20)。
文摘OBJECTIVE:To explore the efficacy and safety of acupuncture combined with atlantoaxial joint bone-setting therapy for the treatment of Tourette syndrome.METHODS:We randomly divided 600 patients at a ratio of 1∶1∶1 into three groups:group A(acupuncture combined with atlantoaxial joint bone setting therapy group),group B(acupuncture group),and group C(tiapride group).After two months of treatment,the Yale global tic severity scale(YGTSS)score reduction,improvement in social function impairment,clinical efficacy,and long-term efficacy in the three groups were compared.RESULTS:After treatment,in the analysis of YGTSS score reduction,social function impairment improvement,the clinical control rate,and long-term efficacy,the results were all Group A>Group B>Group C,with a statistically significant difference(P<0.05).However,the total clinical efficacy of treatment in group A(94.9%)was not significantly different from that in group B(91.8%).Adverse reactions did not occur in groups A and B,and several adverse reactions occurred in 29%(n=58)of the group C patients.CONCLUSION:Compared with traditional drug therapy,acupuncture combined with atlantoaxial joint bone setting therapy has better clinical and long-term efficacy.This treatment strategy can improve the social function of children and prevent adverse reactions to drugs.
文摘BACKGROUND Osteoarthritis(OA)of the knee is a prevalent degenerative joint disease that significantly impairs quality of life and functional mobility.Emerging regenerative therapies,such as stromal vascular fraction(SVF)and nanofat,have demonstrated potential in cartilage repair and symptom alleviation.However,comparative clinical evidence evaluating their efficacy and safety remains limited.AIM To compare the clinical outcomes of SVF vs nanofat therapy in patients with primary knee OA.METHODS Conducted at Mother Cell Regenerative Centre,Trichy,over 18 months(June 2025 to December 2026),the study will enroll 30 patients,randomly assigned to two groups of 15 each.Both interventions will be administered as a single intra-articular injection under sterile conditions,with cell viability(>85%)confirmed by a standardized assay.Group A will receive autologous SVF injections,while Group B will receive autologous nanofat injections.The primary outcome measure is the change in pain scores at 12 months using the visual analog scale(VAS).Secondary outcomes include functional improvement assessed by Osteoarthritis Outcome Score(KOOS),Western Ontario and McMaster Universities(WOMAC),and International Knee Documentation Committee(IKDC)scores,cartilage regeneration evaluated via magnetic resonance imaging with colour coded mapping of the cartilage volume(MR cartigram),and monitoring of adverse events.RESULTS This study aims to evaluate pain reduction at 12 months post-injection,using the VAS as the primary outcome.Secondary outcomes include functional improvement(KOOS,WOMAC,IKDC),cartilage regeneration(T2 cartigram),adverse event incidence,patient satisfaction(standardized questionnaires,Likert scale),and quality of life(EQ-5D).Ethical considerations follow the Declaration of Helsinki and Good Clinical Practice,with IRB approval and participant informed consent ensured.Confidentiality and data security comply with regulations,and a Data Safety Monitoring Board oversees trial safety.Results will be shared via peer-reviewed journals,presentations at international orthopedic conferences,and detailed summaries for stakeholders and participants.The trial is registered under CTRI/2024/03/064076.Findings emphasize patient-centered advancements in knee osteoarthritis management.CONCLUSION This trial evaluates the efficacy and safety of SVF and nanofat therapies in knee OA,addressing a significant evidence gap.It employs robust methods to enhance cartilage repair and patient quality of life.Future research should standardize dosages,protocols,and injection techniques,explore autologous/allogenic preparations,and advance radiological tools,broadening accessibility and clinical applications.
文摘BACKGROUND Hyponatremia is a prevalent and serious electrolyte imbalance in pediatric pneumonia and is linked to increased disease severity and adverse outcomes.Oral rehydration solution(ORS)is an available,inexpensive,safe,and ready-touse oral solution that can supplement sodium in such cases.AIM To assess the impact of prophylactic sodium supplementation via ORS on clinical and hospital outcomes in infants and children admitted with pneumonia.METHODS A randomized,interventional controlled trial was conducted on 140 infants and children admitted with pneumonia(70 per group).The primary outcome was hospital length of stay,with secondary outcomes including serum sodium and potassium levels,clinical respiratory scores,modified shock index,and nutritional/inflammatory markers.The hospital length of stay and both the laboratory and clinical parameters of the interventional and control groups were compared.RESULTS The hospital stay was longer in the control group than in the intervention group(P value=0.001;effect size=0.59).Clinical respiratory scores on day 4 were significantly lower in the intervention group than in the control group(P value=0.001).Sodium levels were significantly lower in the control group than in the intervention group at discharge(P value=0.002).CONCLUSION Prophylactic oral sodium supplementation through ORS may have a health-promoting effect on infants and children admitted with pneumonia.
文摘BACKGROUND Knee osteoarthritis(OA)imposes a substantial burden through pain,functional limitation,and progressive cartilage loss.Bone marrow aspirate concentrate(BMAC)has emerged as a promising regenerative therapy for OA due to its rich composition of mesenchymal stromal cells(MSCs)and bioactive factors.While intra-articular BMAC injections provide short-term symptomatic relief,recent literature suggests that targeting the subchondral bone—an area crucial to OA progression—may offer superior and longer-lasting clinical benefits.AIM To compares the outcomes of subchondral vs intra-articular BMAC injections in patients with primary knee OA.METHODS In this unicentric,double-blinded,randomized controlled trial,30 patients with radiologically confirmed primary knee OA(Kellgren-Lawrence grades II and III)will be equally randomized to receive either subchondral(Group A)or intra-articular(Group B)BMAC injections.BMAC will be harvested from the posterior iliac crest,processed using a standardized centrifugation protocol to yield a product with>85%cell viability,and administered under image guidance.The primary outcome is the change in pain intensity at 12 months as measured by the Visual Analog Scale(VAS).Secondary outcomes include functional improvement assessed by Knee Injury and Osteoarthritis Outcome Score(KOOS),International Knee Documentation Committee(IKDC),and Western Ontario and McMaster Universities Arthritis Index(WOMAC)scores,structural changes evaluated through advanced magnetic resonance imaging using(MRI)the whole-organ MRI Score,and safety as determined by the incidence of adverse events.RESULTS This study aims to evaluate pain reduction at 12 months post-injection,using the VAS as the primary outcome.Secondary outcomes include functional improvement(KOOS,WOMAC,IKDC),cartilage regeneration(T2 cartigram),adverse event incidence,patient satisfaction(standardized questionnaires,Likert scale),and quality of life(EQ-5D).Ethical considerations follow the Declaration of Helsinki and Good Clinical Practice,with institutional review board approval and participant informed consent ensured.Confidentiality and data security comply with regulations,and a data safety monitoring board oversees trial safety.Results will be shared via peer-reviewed journals,presentations at international orthopedic conferences,and detailed summaries for stakeholders and participants.The trial is registered under clinical trial registry of India/2024/04/065284.Findings emphasize patient-centered advancements in knee osteoarthritis management.CONCLUSION This trial aims to refine regenerative strategies for knee OA by comparing subchondral vs intra-articular BMAC injections,addressing long-term efficacy,safety,and treatment standardization to guide targeted interventions.This trial will provide critical insights into the comparative efficacy and safety of subchondral vs intra-articular BMAC injections in treating primary knee OA.
基金supported by Shanghai Clinical Research Center for Acupuncture and Moxibustion(No.20MC1920500)National Administration of Traditional Chinese Medicine High-Level Disciplines Construction Project(No.ZYYZDXK-2023068)Three Year Action Plan for Shanghai to Further Accelerate the Inheritance,Innovation and Development of Traditional Chinese Medicine(2025-2027)(No.1-1-2)。
文摘Background:Electroacupuncture(EA)may affect the severity of hot flashes(HFs)associated with natural menopause and provide additional benefits for postmenopausal women.However,the evidence for its effectiveness in the management of early postmenopausal HFs remains inadequately understood.Objective:We designed this trial to assess the efficacy and safety of EA for relieving early postmenopausal HFs.Design,setting,participants and interventions:This randomized sham-controlled trial involved 72 women with HFs.The participants were divided equally into the intervention and control groups.The intervention group was treated with EA,while the control group was treated with sham acupuncture.The main acupoints used were Hegu(LI4),Guanyuan(RN4),Sanyinjiao(SP6),Taixi(KI3),Fuliu(KI7)and Shenshu(BL23).All participants received 18 treatment sessions,distributed across a 6-week period.The treatment was administered on three occasions per week,adhering to a fixed weekday schedule(Monday,Wednesday,Friday or Tuesday,Thursday,Saturday)with a minimum interval of one day between sessions.Each patient received a 12-week follow-up.Main outcome measures:The HF score was the primary outcome.Participants documented the frequency and severity of HFs in a 7-day symptom diary,which provided data for calculating the HF score.Secondary outcomes were the Menopause Rating Scale(MRS),Menopause-Specific Quality of Life Questionnaire(MENQOL),Pittsburgh Sleep Quality Index(PSQI)and Traditional Chinese Medicine Syndrome Score Scale(TCMSSS),as well as estradiol(E2),luteinizing hormone(LH)and folliclestimulating hormone(FSH)levels.Results:Both groups demonstrated significant reductions in HF scores after the treatment and during the follow-up(P<0.001).Immediately after completion of the 6-week treatment cycle and at 12 weeks postintervention,the HF scores were similar in both groups.At week 6,the intervention group showed significantly greater improvements in MRS,MENQOL(vasomotor,psychosocial,and physical),PSQI and TCMSSS scores(P<0.05).The improvements in the MENQOL(vasomotor,and psychosocial)and PSQI total scores persisted through the follow-up(P<0.05).However,the results showed no significant inter-or intragroup differences in sexual scores on the MENQOL(P>0.05).EA did not significantly decrease E2,LH or FSH levels compared to placebo.The incidence of adverse events was similar in both groups.Conclusion:EA does not significantly improve HFs in early postmenopausal patients.However,it enhances the quality of sleep and decreases menopausal symptoms across vasomotor,psychosocial and physical domains.Trial registration:Chinese Clinical Trial Registry(http://www.chictr.org.cn);Trial ID:Chi CTR2300072002.Please cite this article as:Wang HX,Yu XT,Hu J,Chen JJ,Mei YT,Chen YF.Electroacupuncture for hot flashes in early menopause:A randomized sham-controlled trial.J Integr Med.2025;23(5):519-527.?2025 Shanghai Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine.Published by Elsevier B.V.All rights are reserved,including those for text and data mining,AI training,and similar technologies.
基金Research Topic on traditional Chinese medicine and ethnic medicine science and technology of Guizhou Provincial Administration of Traditional Chinese Medicine(Project No.:QZYY-2024-100)。
文摘Ulcerative colitis(UC)is a chronic inflammatory bowel diseasethat significantly affects the quality of life of patients.Traditional treatments often have limitations,and alternative therapies are being explored.Miao Medicine,particularly Jinlong Zhi Xie Fang Enema,is a traditional herbal remedy used to treat UC symptoms,especially in patients with Large Intestine Damp-Heat Syndrome.However,clinical evidence supporting its efficacy is limited.
