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: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: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 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 In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in ...BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in RCTs of hepatocellular carci-noma(HCC),the response rates and survival status,and adverse events(AEs)were summarized and evaluated.AIM To systematically evaluate the response rates,survival status and AEs in the placebo arms of RCTs for HCC.METHODS A systematic search was performed on PubMed,Ovid MEDLINE,Embase and Cochrane Library to identify relevant trials evaluating the efficacy of drugs for the treatment of HCC,published until December 31,2023.Statistical analysis was performed using R statistical software(version 4.3.2).RESULTS A total of 18 RCTs,involving 2390 patients,met the criteria for inclusion in the meta-analysis.The pooled overall disease control rate and objective response rate in the placebo group were 38%[95%confidence interval(CI):33%-42%]and 1%(95%CI:1%-2%),respectively.Overall survival and progression-free survival in the placebo group were 7.9 months(95%CI:7.6-8.31 months)and 1.9 months(95%CI:1.6-2.1 months),respectively.The incidence of grade 3 or 4 AEs was 37%(95%CI:30%-43%).Additionally,the incidence of interruptions or dose reductions due to AEs was 20%(95%CI:13%-27%),while the incidence of treatment discontinuation due to AEs was 9%(95%CI:6%-12%).CONCLUSION Over one-third of advanced HCC patients exhibit therapy-free disease control,with placebo-arm AEs observed.These findings guide single-arm trials design and enhance patient acceptance of anticancer therapies.展开更多
BACKGROUND 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 Nutritional psychiatry is a rapidly expanding field of research,with mounting evidence suggesting that nutritional factors may play a role in the development of psychiatric disorders.AIM To examine the leve...BACKGROUND Nutritional psychiatry is a rapidly expanding field of research,with mounting evidence suggesting that nutritional factors may play a role in the development of psychiatric disorders.AIM To examine the level of evidence for nutritional psychiatry.METHODS A scoping review was conducted to assess the current state of nutritional psychiatry,including a search for randomized controlled trials(RCTs).RESULTS The review identified a total of seven papers,with many concentrating on the relationship between depression and the gut microbiome.A salient issue that emerged from this review was the paucity of sample size in many studies.The inherent complexity of nutritional studies,characterized by a multitude of potential factors and exposures that often act as confounders,poses significant challenges to the development of effective RCT designs.The analysis revealed that probiotics,though demonstrating efficacy,exhibited a modest effect size.CONCLUSION Conducting RCTs with effective markers is imperative from these studies.The implementation of Mendelian randomization and the investigation of mechanisms in basic research are essential complementary approaches.展开更多
BACKGROUND 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 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:To examine the effect of electroacupuncture(EA)application on postoperative pain levels and the amount of analgesic use in patients who underwent periodontal flap surgery.METHODS:In this prospective,randomiz...OBJECTIVE:To examine the effect of electroacupuncture(EA)application on postoperative pain levels and the amount of analgesic use in patients who underwent periodontal flap surgery.METHODS:In this prospective,randomized and controlled study,patients planned for periodontal surgery were divided into two groups[EA group(n=22):patients who received electroacupuncture and control group(n=22):patients who did not receive electroacupuncture].Electroacupuncture was applied bilaterally to the Hegu(LI4),Daying(ST5),and Jiache(ST5)points of the patients in the EA group immediately before and after the flap surgery for 30 min at a frequency of 50 Hz to each point at a current that the patient could tolerate.The patients in the control group underwent flap surgery without applying electroacupuncture.Patients were asked to record their pain levels on the visual analog scale and the number of analgesic tablets they took during the 7 postoperative days on the given form.RESULTS:The total mean score of pain felt in the EA group(16.60±2.78)was found to be significantly lower than that in the control group(31.37±2.78)(P=0.001).No significant difference was found between the groups regarding the amount of analgesics taken(4.77±4.72,5.82±3.11)(P=0.111).CONCLUSIONS:Our study shows that electroacupuncture application is beneficial in reducing pain after periodontal flap surgery.Overall,more research is needed to fully understand the effects of electroacupuncture on postoperative pain.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 Pharmacological treatments are commonly used in individuals experiencing perinatal depression(PPD);however,a debate regarding the reproductive safety of antidepressants is ongoing.Many pregnant women opt to...BACKGROUND Pharmacological treatments are commonly used in individuals experiencing perinatal depression(PPD);however,a debate regarding the reproductive safety of antidepressants is ongoing.Many pregnant women opt to discontinue antidepressant out of concern about potential negative effects on the developing fetus,while slow and ineffective antidepressant medications hinder improved outcomes in women with PPD.In recent years,bright light therapy(BLT)has gained traction as a treatment option for PPD;however,clinical trials findings examining the efficacy of BLT in this population have been inconclusive.AIM To validate the feasibility and safety of BLT for the treatment of PPD.METHODS We performed a meta-analysis of randomized controlled trials of patients with PPD treated with BLT vs placebo following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis.We searched PubMed,Embase,the Cochrane Library,and Web of Science for randomized controlled studies published up to December 2023.The results were evaluated using the standardized mean difference of improvement for depression scores and odds ratios(ORs)for remission rate,response rate,incidence of adverse events,and dropout rate.RESULTS The BLT group had higher PPD response rate[50.68%vs 33.08%;OR=2.05;95% confidence interval(CI):1.25-3.35;P=0.004;I^(2)=35%]and remission rate(54.10%vs 18.52%;OR=5.00;95%CI:2.09-11.99;P=0.0003;I^(2)=0%)than the placebo group.Improvements in depression scores were higher in the BLT group than the placebo group for the overall efficacy(standardized mean difference=-0.47;95%CI:-0.80 to-0.13;P=0.007).No significant differences between the two groups in drop-outs(21.84%vs 29.63%;OR=0.63;95%CI:0.31-1.29;P=0.21;I^(2)=0%)or adverse events(17.89%vs 9.68%;OR=2.01;95%CI:0.95-4.25;P=0.07;I^(2)=0%)were observed.CONCLUSION BLT can potentially treat PPD,showing better results than the control group in this study.BLT is effective and safe and could increase the available therapeutic options for PPD.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
BACKGROUND Patients with early oral intake after intestinal surgery achieve better nutritional status and fewer postoperative complications.However,no guidelines or expert consensus have established the optimal timing...BACKGROUND Patients with early oral intake after intestinal surgery achieve better nutritional status and fewer postoperative complications.However,no guidelines or expert consensus have established the optimal timing for diet resumption following colorectal polypectomy.AIM To determine the timing,feasibility,and clinical benefits of early diet resumption following colorectal polypectomy.METHODS In the Second Affiliated Hospital of Zhejiang University School of Medicine,a total of 1502 patients with polyps under 3 cm were recruited and randomly assigned to an experimental group(n=751)and a control group(n=751).Following polypectomy,the experimental group consumed rice soup at 2 hours,while the control group received rice soup at 6 hours.The study focused on delayed post-polypectomy bleeding(DPPB),with secondary evaluation of postpolypectomy perforation,hypoglycemia,fever,and length of stay(LOS).RESULTS The comparison between the two groups revealed no significant differences in DPPB rates(4.7%vs 5.5%,P=0.480)and major bleeding rates(1.5%vs 2.1%,P=0.332).Both groups displayed median bleeding times of 2 days.No notable differences in perforation(0.0%vs 0.3%,P=0.479)and fever rates(2.1%vs 2.9%,P=0.324)were observed between the two groups.However,the experimental group showed significantly lower incidence of hypoglycemia(0.4%vs 1.5%,P<0.05)and shorter LOS[1(1,2)day vs 2(1,2)days,P<0.001]following polypectomy.Subgroup analyses further confirmed that early diet resumption had no adverse effects on patients,irrespective of polyp count,size,pathology,or polypectomy modalities.CONCLUSION Early diet resumption following colorectal polypectomy for polyps not exceeding 3 cm is advisable as it does not significantly increase the risk of complications.展开更多
Objective:To evaluate the impact of subcutaneous tunneling on peripherally inserted central catheters(PICCs)dislodgement and malposition.Dislodged or malpositioned PICCs can lead to improper treatment.The subcutaneous...Objective:To evaluate the impact of subcutaneous tunneling on peripherally inserted central catheters(PICCs)dislodgement and malposition.Dislodged or malpositioned PICCs can lead to improper treatment.The subcutaneous tunneling strategy may be effective,but there is insufficient evidence,and proximal movement has not been explored.Methods:We randomized 630 patients who needed PICCs placement to either the tunneled PICCs(experimental group)or the non-tunneled PICCs(control group).Dislodgement and malposition of the catheter were the primary outcomes,and catheter-related infection(CRI)and catheter-related thrombosis(CRT)were the secondary outcomes.Results:Subcutaneous tunneling does not significantly reduce distal catheter movement,but it significantly reduces proximal catheter movement(4.3%vs.9.9%,P=0.007),which may explain the lower incidence of CRI(2.0%vs.5.3%,P=0.030)and CRT(3.6%vs.12.5%,P<0.001).Conclusions:Although subcutaneous tunneling does not significantly improve catheter prolapse,it should still be used clinically because proximal catheter movement can be a more serious problem associated with CRI and CRT.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
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
BACKGROUND Schizophrenia is commonly associated with comorbid depression,which exacerbates cognitive impairments and negatively impacts quality of life.Despite the high prevalence and burden of these comorbidities,eff...BACKGROUND Schizophrenia is commonly associated with comorbid depression,which exacerbates cognitive impairments and negatively impacts quality of life.Despite the high prevalence and burden of these comorbidities,effective treatment options,particularly for cognitive dysfunction,remain limited.AIM To evaluate the efficacy of computerized cognitive behavioral therapy(CCBT)with sertraline vs sertraline monotherapy in improving depressive symptoms,cognitive function,and quality of life in schizophrenia and depressive episodes.METHODS In this single-center,randomized controlled trial,68 adults[mean age(SD)=36.5(10.0),57.4%male]with schizophrenia and depressive symptoms were randomly assigned to receive either CCBT with sertraline or sertraline monotherapy during a 4-week hospitalization.The CCBT intervention involved 45-60-minute sessions twice weekly for four weeks.Outcomes included comparisons of depressive symptoms(Calgary depression scale for schizophrenia),cognitive function[MATRICS consensus cognitive battery(MCCB)],and quality of life(36-item short form survey)between the groups.RESULTS The experimental group showed greater improvements in depressive symptoms at 4,8,and 12 weeks compared to the controls,with the most notable difference at 12 weeks[mean difference(MD)=-1.7;P<0.001;Cohen’s d=0.9].Cognitive function improved across all MCCB domains in the experimental group,with higher processing speed scores(MD=4.1;P=0.043;Cohen’s d=0.5)and social cognition scores(MD=4.9;P=0.006;Cohen’s d=0.7)than in the control group.Quality of life,particularly in mental health,was significantly better in the experimental group.CONCLUSION CCBT with sertraline was more effective than sertraline monotherapy for patients with schizophrenia and depressive episodes,supporting its use as an adjunctive therapy.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:To assess the efficacy and safety of the Qingyanyin formulated granules(轻燕饮配方颗粒,QYY),press needles(PN),and their combined application in addressing abdominal obesity(AO).This trial aims to offer a mor...OBJECTIVE:To assess the efficacy and safety of the Qingyanyin formulated granules(轻燕饮配方颗粒,QYY),press needles(PN),and their combined application in addressing abdominal obesity(AO).This trial aims to offer a more scientifically grounded therapeutic regimen for clinical interventions.METHODS:From March 2021 to July 2021,a multicenter,triple-blind,randomized 2×2 factorial design clinical trial was conducted across 7 centers in 4 major cities within China's mainland.The trial participants were patients diagnosed with AO.The trial followed a 1∶1∶1∶1 random allocation ratio,assigning participants to one of four groups:QYY placebo plus simulated press needles(SPN)(placebo+SPN),QYY plus SPN(QYY+SPN),QYY placebo plus PN(placebo+PN),and QYY plus PN(QYY+PN).The trial participants received treatment for 12 weeks.Observe the changes in waist circumference,body weight,body mass index(BMI),Beck Depression Inventory(BDI),Beck Anxiety Inventory(BAI)scores,and Pittsburgh Sleep Quality Index(PSQI)before and after treatment.RESULTS:The QYY+PN group exhibited significant improvements in waist circumference compared to placebo+PN[Difference=-1.59,95%CI(-3.03,-0.16)]and placebo+SPN groups[Difference=-2.01,95%CI(-3.46,-0.57)].QYY+PN demonstrated a significant advantage over placebo+SPN[Difference=-2.01,95%CI(-3.46,-0.57)],and no statistically significant interaction was observed between the two interventions(P>0.05).In terms of weight and BMI improvements,the QYY+PN,QYY+SPN,and the PN+placebo groups all experienced trending greater reductions in weight compared to the placebo group.In terms of the total scores of PSQI,BAI,and BDI,all four groups exhibited improvements compared to the baseline.Specifically,concerning the change in total PSQI scores,the QYY+PN group exhibited a greater reduction;Regarding the change in total BAI scores,the PN+placebo group demonstrated a greater decrease;As for the change in total BDI scores,the QYY+SPN group displayed a greater reduction.CONCLUSION:This study confirmed that QYY+PN can effectively reduce the waist circumference of patients with AO.Furthermore,the combined approach offers greater benefits than either treatment alone,all without any reported serious adverse events.展开更多
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.
文摘OBJECTIVE:In recent years,the number of clinical research reports on acupuncture and manipulation for the treatment of greater occipital neuralgia has gradually increased,but the quality is uneven.There is currently no literature evaluating the quality of published reports,which is not conducive to the promotion of clinical use of these therapies.Therefore,this article assessed the reporting quality of randomized controlled trials on acupuncture and manipulation for greater occipital neuralgia.METHODS:Cochrane Library,PubMed,Web of Science,Embase,China National Knowledge Infrastructure(CNKI),VIP,WanFang Data,and Chinese BioMedical Literature Database(CBM)from inception to May 20,2024 were searched.The reporting quality of included randomized controlled trials was independently evaluated by two investigators using the CONSORT statement,STRICTA checklist,and Cochrane bias of risk assessment tool.A third investigator resolved any disagreement.RESULTS:A total of 62 articles were included.Based on the CONSORT statement,59.46%(22/37)of all entries had a reporting rate of less than 50%,mainly including“Identification as a randomized trial in the title(1/62,1.61%),”“How sample size was determined(7/62,11.29%),”“Implementation(1/62,1.61%),”“Blinding(1/62,1.61%),”and“Reports of Funding(4/62,6.45%).”According to the STRICTA checklist,29.41%(5/17)of all entries had a reporting rate of less than 50%,mainly including“Details of other interventions(7/58,12.07%),”“Setting and context of treatment(0/58,0%),”and“Description of participating acupuncturists(0/58,0%).”CONCLUSION:The reporting quality of randomized controlled trials on acupuncture and manipulation therapy for greater occipital neuralgia remains low.Future researchers need to make greater efforts to strictly adhere to the CONSORT statement and STRICTA checklist during trial design,implementation,and reporting.This will facilitate the standardization of research in this field and enhance the reliability and reproducibility of the research results.
基金supported by the 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 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 In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in RCTs of hepatocellular carci-noma(HCC),the response rates and survival status,and adverse events(AEs)were summarized and evaluated.AIM To systematically evaluate the response rates,survival status and AEs in the placebo arms of RCTs for HCC.METHODS A systematic search was performed on PubMed,Ovid MEDLINE,Embase and Cochrane Library to identify relevant trials evaluating the efficacy of drugs for the treatment of HCC,published until December 31,2023.Statistical analysis was performed using R statistical software(version 4.3.2).RESULTS A total of 18 RCTs,involving 2390 patients,met the criteria for inclusion in the meta-analysis.The pooled overall disease control rate and objective response rate in the placebo group were 38%[95%confidence interval(CI):33%-42%]and 1%(95%CI:1%-2%),respectively.Overall survival and progression-free survival in the placebo group were 7.9 months(95%CI:7.6-8.31 months)and 1.9 months(95%CI:1.6-2.1 months),respectively.The incidence of grade 3 or 4 AEs was 37%(95%CI:30%-43%).Additionally,the incidence of interruptions or dose reductions due to AEs was 20%(95%CI:13%-27%),while the incidence of treatment discontinuation due to AEs was 9%(95%CI:6%-12%).CONCLUSION Over one-third of advanced HCC patients exhibit therapy-free disease control,with placebo-arm AEs observed.These findings guide single-arm trials design and enhance patient acceptance of anticancer therapies.
文摘BACKGROUND 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 Nutritional psychiatry is a rapidly expanding field of research,with mounting evidence suggesting that nutritional factors may play a role in the development of psychiatric disorders.AIM To examine the level of evidence for nutritional psychiatry.METHODS A scoping review was conducted to assess the current state of nutritional psychiatry,including a search for randomized controlled trials(RCTs).RESULTS The review identified a total of seven papers,with many concentrating on the relationship between depression and the gut microbiome.A salient issue that emerged from this review was the paucity of sample size in many studies.The inherent complexity of nutritional studies,characterized by a multitude of potential factors and exposures that often act as confounders,poses significant challenges to the development of effective RCT designs.The analysis revealed that probiotics,though demonstrating efficacy,exhibited a modest effect size.CONCLUSION Conducting RCTs with effective markers is imperative from these studies.The implementation of Mendelian randomization and the investigation of mechanisms in basic research are essential complementary approaches.
文摘BACKGROUND 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 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:To examine the effect of electroacupuncture(EA)application on postoperative pain levels and the amount of analgesic use in patients who underwent periodontal flap surgery.METHODS:In this prospective,randomized and controlled study,patients planned for periodontal surgery were divided into two groups[EA group(n=22):patients who received electroacupuncture and control group(n=22):patients who did not receive electroacupuncture].Electroacupuncture was applied bilaterally to the Hegu(LI4),Daying(ST5),and Jiache(ST5)points of the patients in the EA group immediately before and after the flap surgery for 30 min at a frequency of 50 Hz to each point at a current that the patient could tolerate.The patients in the control group underwent flap surgery without applying electroacupuncture.Patients were asked to record their pain levels on the visual analog scale and the number of analgesic tablets they took during the 7 postoperative days on the given form.RESULTS:The total mean score of pain felt in the EA group(16.60±2.78)was found to be significantly lower than that in the control group(31.37±2.78)(P=0.001).No significant difference was found between the groups regarding the amount of analgesics taken(4.77±4.72,5.82±3.11)(P=0.111).CONCLUSIONS:Our study shows that electroacupuncture application is beneficial in reducing pain after periodontal flap surgery.Overall,more research is needed to fully understand the effects of electroacupuncture on postoperative pain.
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 the Hebei Province Natural Science Foundation,No.H2018206034 and No.H2022206544Hebei Province clinical medicine outstanding personnel training project,No.ZF2024135.
文摘BACKGROUND Pharmacological treatments are commonly used in individuals experiencing perinatal depression(PPD);however,a debate regarding the reproductive safety of antidepressants is ongoing.Many pregnant women opt to discontinue antidepressant out of concern about potential negative effects on the developing fetus,while slow and ineffective antidepressant medications hinder improved outcomes in women with PPD.In recent years,bright light therapy(BLT)has gained traction as a treatment option for PPD;however,clinical trials findings examining the efficacy of BLT in this population have been inconclusive.AIM To validate the feasibility and safety of BLT for the treatment of PPD.METHODS We performed a meta-analysis of randomized controlled trials of patients with PPD treated with BLT vs placebo following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis.We searched PubMed,Embase,the Cochrane Library,and Web of Science for randomized controlled studies published up to December 2023.The results were evaluated using the standardized mean difference of improvement for depression scores and odds ratios(ORs)for remission rate,response rate,incidence of adverse events,and dropout rate.RESULTS The BLT group had higher PPD response rate[50.68%vs 33.08%;OR=2.05;95% confidence interval(CI):1.25-3.35;P=0.004;I^(2)=35%]and remission rate(54.10%vs 18.52%;OR=5.00;95%CI:2.09-11.99;P=0.0003;I^(2)=0%)than the placebo group.Improvements in depression scores were higher in the BLT group than the placebo group for the overall efficacy(standardized mean difference=-0.47;95%CI:-0.80 to-0.13;P=0.007).No significant differences between the two groups in drop-outs(21.84%vs 29.63%;OR=0.63;95%CI:0.31-1.29;P=0.21;I^(2)=0%)or adverse events(17.89%vs 9.68%;OR=2.01;95%CI:0.95-4.25;P=0.07;I^(2)=0%)were observed.CONCLUSION BLT can potentially treat PPD,showing better results than the control group in this study.BLT is effective and safe and could increase the available therapeutic options for PPD.
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 National Natural Science Foundation of China,No.82073160.
文摘BACKGROUND Patients with early oral intake after intestinal surgery achieve better nutritional status and fewer postoperative complications.However,no guidelines or expert consensus have established the optimal timing for diet resumption following colorectal polypectomy.AIM To determine the timing,feasibility,and clinical benefits of early diet resumption following colorectal polypectomy.METHODS In the Second Affiliated Hospital of Zhejiang University School of Medicine,a total of 1502 patients with polyps under 3 cm were recruited and randomly assigned to an experimental group(n=751)and a control group(n=751).Following polypectomy,the experimental group consumed rice soup at 2 hours,while the control group received rice soup at 6 hours.The study focused on delayed post-polypectomy bleeding(DPPB),with secondary evaluation of postpolypectomy perforation,hypoglycemia,fever,and length of stay(LOS).RESULTS The comparison between the two groups revealed no significant differences in DPPB rates(4.7%vs 5.5%,P=0.480)and major bleeding rates(1.5%vs 2.1%,P=0.332).Both groups displayed median bleeding times of 2 days.No notable differences in perforation(0.0%vs 0.3%,P=0.479)and fever rates(2.1%vs 2.9%,P=0.324)were observed between the two groups.However,the experimental group showed significantly lower incidence of hypoglycemia(0.4%vs 1.5%,P<0.05)and shorter LOS[1(1,2)day vs 2(1,2)days,P<0.001]following polypectomy.Subgroup analyses further confirmed that early diet resumption had no adverse effects on patients,irrespective of polyp count,size,pathology,or polypectomy modalities.CONCLUSION Early diet resumption following colorectal polypectomy for polyps not exceeding 3 cm is advisable as it does not significantly increase the risk of complications.
文摘Objective:To evaluate the impact of subcutaneous tunneling on peripherally inserted central catheters(PICCs)dislodgement and malposition.Dislodged or malpositioned PICCs can lead to improper treatment.The subcutaneous tunneling strategy may be effective,but there is insufficient evidence,and proximal movement has not been explored.Methods:We randomized 630 patients who needed PICCs placement to either the tunneled PICCs(experimental group)or the non-tunneled PICCs(control group).Dislodgement and malposition of the catheter were the primary outcomes,and catheter-related infection(CRI)and catheter-related thrombosis(CRT)were the secondary outcomes.Results:Subcutaneous tunneling does not significantly reduce distal catheter movement,but it significantly reduces proximal catheter movement(4.3%vs.9.9%,P=0.007),which may explain the lower incidence of CRI(2.0%vs.5.3%,P=0.030)and CRT(3.6%vs.12.5%,P<0.001).Conclusions:Although subcutaneous tunneling does not significantly improve catheter prolapse,it should still be used clinically because proximal catheter movement can be a more serious problem associated with CRI and CRT.
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.
基金Supported by Fuzhou Science and Technology Plan Project,No.2023-S-028.
文摘BACKGROUND Schizophrenia is commonly associated with comorbid depression,which exacerbates cognitive impairments and negatively impacts quality of life.Despite the high prevalence and burden of these comorbidities,effective treatment options,particularly for cognitive dysfunction,remain limited.AIM To evaluate the efficacy of computerized cognitive behavioral therapy(CCBT)with sertraline vs sertraline monotherapy in improving depressive symptoms,cognitive function,and quality of life in schizophrenia and depressive episodes.METHODS In this single-center,randomized controlled trial,68 adults[mean age(SD)=36.5(10.0),57.4%male]with schizophrenia and depressive symptoms were randomly assigned to receive either CCBT with sertraline or sertraline monotherapy during a 4-week hospitalization.The CCBT intervention involved 45-60-minute sessions twice weekly for four weeks.Outcomes included comparisons of depressive symptoms(Calgary depression scale for schizophrenia),cognitive function[MATRICS consensus cognitive battery(MCCB)],and quality of life(36-item short form survey)between the groups.RESULTS The experimental group showed greater improvements in depressive symptoms at 4,8,and 12 weeks compared to the controls,with the most notable difference at 12 weeks[mean difference(MD)=-1.7;P<0.001;Cohen’s d=0.9].Cognitive function improved across all MCCB domains in the experimental group,with higher processing speed scores(MD=4.1;P=0.043;Cohen’s d=0.5)and social cognition scores(MD=4.9;P=0.006;Cohen’s d=0.7)than in the control group.Quality of life,particularly in mental health,was significantly better in the experimental group.CONCLUSION CCBT with sertraline was more effective than sertraline monotherapy for patients with schizophrenia and depressive episodes,supporting its use as an adjunctive therapy.
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National Key Research and Development Project:Clinical Evaluation of the Interventional Techniques for Abdominal Obesity(No.2019YFC1710102)。
文摘OBJECTIVE:To assess the efficacy and safety of the Qingyanyin formulated granules(轻燕饮配方颗粒,QYY),press needles(PN),and their combined application in addressing abdominal obesity(AO).This trial aims to offer a more scientifically grounded therapeutic regimen for clinical interventions.METHODS:From March 2021 to July 2021,a multicenter,triple-blind,randomized 2×2 factorial design clinical trial was conducted across 7 centers in 4 major cities within China's mainland.The trial participants were patients diagnosed with AO.The trial followed a 1∶1∶1∶1 random allocation ratio,assigning participants to one of four groups:QYY placebo plus simulated press needles(SPN)(placebo+SPN),QYY plus SPN(QYY+SPN),QYY placebo plus PN(placebo+PN),and QYY plus PN(QYY+PN).The trial participants received treatment for 12 weeks.Observe the changes in waist circumference,body weight,body mass index(BMI),Beck Depression Inventory(BDI),Beck Anxiety Inventory(BAI)scores,and Pittsburgh Sleep Quality Index(PSQI)before and after treatment.RESULTS:The QYY+PN group exhibited significant improvements in waist circumference compared to placebo+PN[Difference=-1.59,95%CI(-3.03,-0.16)]and placebo+SPN groups[Difference=-2.01,95%CI(-3.46,-0.57)].QYY+PN demonstrated a significant advantage over placebo+SPN[Difference=-2.01,95%CI(-3.46,-0.57)],and no statistically significant interaction was observed between the two interventions(P>0.05).In terms of weight and BMI improvements,the QYY+PN,QYY+SPN,and the PN+placebo groups all experienced trending greater reductions in weight compared to the placebo group.In terms of the total scores of PSQI,BAI,and BDI,all four groups exhibited improvements compared to the baseline.Specifically,concerning the change in total PSQI scores,the QYY+PN group exhibited a greater reduction;Regarding the change in total BAI scores,the PN+placebo group demonstrated a greater decrease;As for the change in total BDI scores,the QYY+SPN group displayed a greater reduction.CONCLUSION:This study confirmed that QYY+PN can effectively reduce the waist circumference of patients with AO.Furthermore,the combined approach offers greater benefits than either treatment alone,all without any reported serious adverse events.
