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Image recognition-based detection system for preventing accidental dislodgement of head-and-neck medical supplies in ICU patients:A feasibility randomized controlled trial
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作者 Zhongjie Shi Taotao Shi +5 位作者 Xin Gao Jian Li Hong Xu Xiaojun Li Zhanxiang Wang Sifang Chen 《International Journal of Nursing Sciences》 2026年第1期3-10,I0001,共9页
Objectives This study aimed to design and evaluate a detection system for the accidental dislodgement of head-and-neck medical supplies through hand position recognition and tracking in Intensive Care Unit(ICU)patient... Objectives This study aimed to design and evaluate a detection system for the accidental dislodgement of head-and-neck medical supplies through hand position recognition and tracking in Intensive Care Unit(ICU)patients.Methods We conducted a single-center,prospective,parallel-group feasibility randomized controlled trial.We recruited 80 participants using convenience sampling from the ICU of a hospital in Ningbo City,Zhejiang Province,between March 2025 and June 2025,and they were randomly assigned to either the control group(routine care)or the intervention group(routine care plus image recognition-based detection system).The system continuously tracked patients’hand positions via bedside cameras and generated real-time alarms when hands entered predefined risk zones,notifying on-duty nurses to enable early intervention.System stability was assessed by continuous system uptime;system performance and clinical feasibility were evaluated by the frequencies of risk actions and accidental dislodgement of medical supplies(ADMS).Results All 80 participants completed the intervention,with 40 patients in each group.The baseline characteristics and median observation time of the two groups were balanced(intervention group:48 h/patient vs.control group:49 h/patient).Compared with the control group,the intervention group showed fewer ADMS(2/40 vs.9/40)and detected more risk actions per 100 h(36 vs.25);all system-detected events had corroborating images with complete concordance on manual review,and all nurse-recorded hand-contact events were accurately captured.Conclusions The study demonstrated that the image recognition-based detection system can function stably in clinical settings,providing accurate and continuous surveillance while supporting the early detection of risk actions.By reducing the observation burden and offering real-time cognitive support,the system complements routine nursing care and serves as an additional safety measure in ICU practice.With further optimization and larger multicenter validation,this approach could have the potential to make a significant contribution to the development of smart ICUs and the broader digital transformation of nursing care. 展开更多
关键词 Accidental dislodgement of medical supplies Feasibility randomized trial Image recognition Intensive Care Unit Risk monitoring
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Comparative outcome analyses of stromal vascular fraction vs nanofat in primary osteoarthritis knee:A double-blinded randomized controlled trial protocol
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作者 Naveen Jeyaraman Sandeep Shrivastava +4 位作者 Ravi Velamoor Rangarajan Arulkumar Nallakumarasamy Swaminathan Ramasubramanian Sathish Muthu Madhan Jeyaraman 《World Journal of Experimental Medicine》 2025年第3期221-231,共11页
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
关键词 OSTEOARTHRITIS Stromal vascular fraction Nanofat Regenerative therapy Cartilage regeneration randomized controlled trial
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Clinical efficacy of Angong Jiangya pill (安宫降压丸) for grade 2 hypertension with liver-fire hyperactivity syndrome:a randomized,double-blind,placebo-controlled,multicenter trial
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作者 LAI Xiaolei SHANG Juju +4 位作者 LIU Hongxu HU Jing LI Xiang ZHANG Zhenmin XING Wenlong 《Journal of Traditional Chinese Medicine》 2025年第2期422-429,共8页
OBJECTIVE:To investigate the efficacy and safety of Angong Jiangya pill(AGJY,安宫降压丸)in the treatment of grade 2 hypertension with liver-fire hyperactivity syndrome.METHODS:This multicenter,randomized,double-blind,... OBJECTIVE:To investigate the efficacy and safety of Angong Jiangya pill(AGJY,安宫降压丸)in the treatment of grade 2 hypertension with liver-fire hyperactivity syndrome.METHODS:This multicenter,randomized,double-blind,placebo-controlled trial was conducted in eight medical institutions.Eligible patients with grade 2 hypertension were randomly allocated to receive AGJY or a placebo for 12 weeks.The primary outcome was the change in blood pressure(BP).The secondary outcomes were BP compliance rate,Traditional Chinese Medicine(TCM)symptoms,and Duchenne Hypertension Quality of Life Scale score.RESULTS:Data were analyzed for 117 participants in the AGJY group and 118 participants in the placebo group.After 12 weeks of treatment,AGJY compared with placebo resulted in a higher and significant reduction in systolic/diastolic BP(-15.58±10.16/-9.72±7.41 vs-8.13±8.28/-4.86±5.68 mm Hg,P<0.0001,<0.0001,respectively).BP compliance rate(31.86%vs 19.13%,P=0.027)was significantly higher in the AGJY group than in the placebo group.The AGJY group showed a significant reduction in TCM symptom score compared with the placebo group(10.82±2.03 vs 7.83±1.24,P<0.0001).Single TCM syndrome clinical control rates of the primary symptoms(dizziness,headache,and irritability)were superior in the AGJY group(71.95%,94.62%,72.53%,respectively)compared with the placebo group(48.39%,68.00%,30.52%,respectively).Scores on the Duchenne Hypertension Quality of Life Scale showed a significant increase in the AGJY group compared with the placebo group(30.65±21.06 vs 9.96±10.72,P=0.000).No serious adverse events occurred.CONCLUSION:AGJY demonstrated efficacy in lowering BP,increasing the rate of BP compliance,and improving TCM symptoms and quality of life in patients with grade 2 hypertension liver-fire hyperactivity syndrome.However,further in-depth studies are required to determine the mechanism of TCM in treating hypertension. 展开更多
关键词 HYPERTENSION multicenter study randomized controlled trial liver-fire hyperactivity syndrome Angong Jiangya
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Comparative outcome analyses of subchondral vs intra-articular bone marrow aspirate concentrate in primary osteoarthritis knee:A double-blinded randomized controlled trial protocol
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作者 Arulkumar Nallakumarasamy Sandeep Shrivastava +4 位作者 Ravi Velamoor Rangarajan Naveen Jeyaraman Swaminathan Ramasubramanian Sathish Muthu Madhan Jeyaraman 《World Journal of Experimental Medicine》 2025年第3期232-239,共8页
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
关键词 OSTEOARTHRITIS Bone marrow aspirate concentrate Subchondral injection Intra-articular injection Regenerative therapy randomized controlled trial
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Clinical study of Yiqi Liangxue Shengji prescription(益气凉血生肌方)for improving cardiac function after myocardial ischemiareperfusion injury in patients with acute myocardial infarction:arandomized,double-blind,placebo-controlled trial
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作者 LI Yuxuan LI Yan +7 位作者 WANG Wujiao CUI Xiaoyun WAN Jie ZHOU Kun LU Jinjin LIU Jing LIN Qian LI Dong 《Journal of Traditional Chinese Medicine》 2025年第4期836-844,共9页
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
关键词 myocardial reperfusion injury stroke volume natriuretic peptide brain troponin I randomized controlled trial BLIND Yiqi Liangxue Shengji prescription
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Efficacy and safety of Tuomin Zhiti decoction(脱敏止嚏汤)onpatients with seasonal allergic rhinitis:a randomized,double-blind,placebo-controlled trial
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作者 ZHAO Weibo WANG Yaqi +6 位作者 KONG Lingyao WANG Tianyi ZHAO Haihong ZHANG Ying LUO Bin WANG Ji WANG Qi 《Journal of Traditional Chinese Medicine》 2025年第4期829-835,共7页
OBJECTIVE:To evaluate the clinical efficacy and safety of Tuomin Zhiti decoction(脱敏止嚏汤,TZD)in the shortterm treatment of seasonal allergic rhinitis(SAR).METHODS:This study is a randomized,double-blind placebo-con... OBJECTIVE:To evaluate the clinical efficacy and safety of Tuomin Zhiti decoction(脱敏止嚏汤,TZD)in the shortterm treatment of seasonal allergic rhinitis(SAR).METHODS:This study is a randomized,double-blind placebo-controlled,and single-center clinical trial.In April 2021,during the spring pollen season in Beijing,94 SAR patients aged 19-60 years were randomized(1∶1 ratio)to receive two weeks of TZD or placebo.The primary outcomes were the change of Total Nasal Symptom Score(TNSS)and Total Ocular Symptom Score(TOSS)from baseline to the end of treatment.Secondary outcomes were the changed score of the mini Rhinoconjunctivitis Quality of Life Questionnaire(RQLQ),Rescue Medication Score(RMS),and Patient Global Impression of Change(PGIC).All adverse events were recorded and evaluated by two senior physicians.RESULTS:TZD significantly reduced both the total nasal symptom scores and total ocular symptom scores compared to scores at baseline,while the placebo group showed an increasing trajectory in both symptom scores.Compared to the placebo group,the TZD group also showed a greater improvement in the quality of life,scores of RMS,nasal and eye symptoms scores after TZD treatment(P<0.001).Most notably,at the end of treatment,the proportion of remission measured by PGIC was significantly higher in the TZD group(82.97%)compared with the placebo group(47.72%,P<0.001).CONCLUSION:This study suggested that two weeks of TZD is an effective and safe treatment for SAR patients and spring pollen allergy,TZD could significantly improve the nasal and eye symptoms and improve the quality of life of patients. 展开更多
关键词 rhinitis allergic seasonal quality of life Tuomin Zhiti decoction randomized controlled trial
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Psychological effects of virtual reality intervention on breast cancer patients with different personalities: A randomized controlled trial 被引量:5
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作者 Shanshan Wu Guodu Liu +9 位作者 Jie Yang Xinxin Xie Mei-E Wu Lili Wang Yanhui Zhang Jinmei Chen Xiaowei Wang Wanjiao Li Yihong Qiu Jie Chen 《International Journal of Nursing Sciences》 2025年第2期107-114,共8页
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
关键词 Breast neoplasms Rehabilitation research randomized controlled trial Type D personality Virtual reality
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Electroacupuncture versus conventional acupuncture of scalp motor area for post-stroke wrist dyskinesia and its effect on muscle function: a randomized, controlled clinical trial 被引量:2
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作者 ZHENG Ruwen DONG Xu +7 位作者 WANG Tianyi FENG Liyuan ZHANG Hongyan HUO Hong ZHANG Ying ZHANG Qianshi ZHU Xingyan WANG Dongyan 《Journal of Traditional Chinese Medicine》 2025年第4期852-859,共8页
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
关键词 stroke wrist joint movement disorders ELECTROACUPUNCTURE ELECTROMYOGRAPHY randomized controlled trial
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Advancements and challenges of acupuncture randomized controlled trials 被引量:1
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作者 Wei Song Seetoh Rachel Qin Rui Lim +3 位作者 Run-bing Xu Ming-xun Sun Peng Zhang Mi-na Wang 《Journal of Integrative Medicine》 2025年第4期333-343,共11页
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
关键词 ACUPUNCTURE randomized controlled trials METHODOLOGY Chinese medicine
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Effects of acupuncture combined with bone-setting therapy to treat tourette syndrome:a three-arm randomized controlled trial 被引量:1
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作者 LANG Jiawang JIN Lingqing +1 位作者 LUO Jianchang LANG Boxu 《Journal of Traditional Chinese Medicine》 2025年第1期176-183,共8页
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
关键词 Tourette syndrome ACUPUNCTURE atlanto-axial joint tiapride hydrochloride bone setting randomized controlled trial
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Impact of Helicobacter pylori Eradication on Clinical and Laboratory Parameters in Non-alcoholic Fatty Liver Disease Patients:A Systematic Review and Meta-analysis of Randomized Controlled Trials 被引量:1
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作者 Fouad Jaber Saqr Alsakarneh +12 位作者 Azizullah Beran Tala Alsharaeh Ahmed-Jordan Salahat Abdelrahman Abdelshafi Islam Mohamed Willie Johnson Khaled Elfert Mohammad Jaber Mohammad Almeqdadi Mohamed Ahmed Hassan Ghoz Wendell K.Clarkston John H.Helzberg 《Current Medical Science》 2025年第1期1-10,共10页
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
关键词 Non-alcoholic fatty liver disease Helicobacter pylori randomized controlled trials Hepatic steatosis Anthropometric measurements Insulin resistance
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Effect of Compound Danshen Dripping Pills on cardiac function after acute anterior ST-segment elevation myocardial infarction:A randomized trial 被引量:1
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作者 Bo Deng Sibo Wang +14 位作者 Yujie Wu Qiming Wang Rui Qiao Xiwen Zhang Yuan Lu Li Wang Shunzhong Gu Yuqing Zhang Kaiqiao Li Zongliang Yu Lixing Wu Shengbiao Zhao Shuanglin Zhou Yang Yang Liansheng Wang 《Journal of Biomedical Research》 2025年第4期407-416,I0018,共11页
The current study aimed to evaluate the efficacy and safety of Compound Danshen Dripping Pills(CDDP)in improving cardiac function in patients with acute anterior ST-segment elevation myocardial infarction(AAMI).Betwee... The current study aimed to evaluate the efficacy and safety of Compound Danshen Dripping Pills(CDDP)in improving cardiac function in patients with acute anterior ST-segment elevation myocardial infarction(AAMI).Between February 2021 and February 2023,247 eligible patients with AAMI after primary percutaneous coronary intervention were enrolled and randomly assigned(1∶1)to receive CDDP(n=126)or placebo(n=121),with a follow-up of 48 weeks.Compared with the placebo group,the CDDP group demonstrated a significant increase in left ventricular ejection fraction values after 24 weeks of treatment(least squares mean:3.31;95%confidence interval[CI]:1.72–4.90;P<0.001)and at the 48-week follow-up(least squares mean:4.35;95%CI:2.76–5.94;P<0.001).Significant reductions in N-terminal pro-B-type natriuretic peptide levels were observed in both groups at the 24-and 48-week visits with no significant difference between the two groups(P>0.1 for all).The incidence of major adverse cardiovascular and cerebrovascular events was 6.35%in the CDDP group and 5.79%in the placebo group(P=0.822).Notably,no serious adverse events were attributed to CDDP.These findings suggest that CDDP may be well tolerated and could improve left ventricular ejection fraction in patients with AAMI at 24 and 48 weeks. 展开更多
关键词 Compound Danshen Dripping Pills cardiac function acute anterior myocardial infarction randomized controlled trial
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Effectiveness of combining Qingyanyin formulated granules(轻燕饮配方颗粒) with press needles in treating abdominal obesity:a multicenter randomized controlled trial 被引量:1
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作者 YE Wujie YANG Yawei +6 位作者 ZHANG Da TANG Ling CUI Minying FU Bin ZHANG Meng HU Xingang ZHAO Yan 《Journal of Traditional Chinese Medicine》 2025年第1期107-114,共8页
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
关键词 obesity abdominal body mass index press needle randomized controlled trial Qingyanyin formulated granules
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Hewei Jiangni recipe(和胃降逆方)improved the quality of life in patients with cold-heat mixed nonerosive reflux disease:a randomized,double-blinded study 被引量:1
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作者 ZHANG Xiaosi ZHANG Shuangyuan +4 位作者 CHEN Hanqing LIN Zhengdao XIE Chune LI Junxiang LI Xiaohong 《Journal of Traditional Chinese Medicine》 2025年第5期1106-1118,共13页
OBJECTIVE:To evaluate the safety and efficacy of Hewei Jiangni recipe(和胃降逆方,HWJNR)for treating nonerosive gastroesophageal reflux(NERD)with cold-heat complex syndrome and to clarify its mechanism based on correla... OBJECTIVE:To evaluate the safety and efficacy of Hewei Jiangni recipe(和胃降逆方,HWJNR)for treating nonerosive gastroesophageal reflux(NERD)with cold-heat complex syndrome and to clarify its mechanism based on correlation analyses of intestinal flora and metabolites.METHODS:Seventy-two patients with NERD and the Traditional Chinese Medicine(TCM)syndrome of intermingled heat and cold were randomly assigned to either the TCM group or the Western Medicine group,each receiving 8 weeks of treatment.The primary outcome was the score of the gastroesophageal reflux disease questionnaire(GERD-Q).Additionally,10 healthy individuals were recruited.Mechanistic outcomes included correlation analyses of intestinal flora and metabolites in healthy individuals and NERD participants before and after treatment.RESULTS:After 8 weeks,the effectiveness rate was 90%in the TCM group and 86.67%in the Western Medicine group(P>0.05).Compared with omeprazole,the TCM group significantly improved quality of life and alleviated symptoms such as loss of appetite,fatigue,bowel sounds,and coldness in the hands and feet(P<0.05).Dysregulation of intestinal flora and metabolic pathways in NERD patients was restored to balance after TCM treatment,which appeared related to the TCM regulation of"cold and heat disorders."CONCLUSION:HWJNR was clinically as effective as omeprazole and demonstrated advantages in improving quality of life. 展开更多
关键词 non-erosive gastroesophageal reflux disease randomized controlled trial Hewei Jiangni recipe Chinese herbal medicine gut microbiota
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Tissue-Bone Homeostasis Manipulation Restores Quadriceps-Patellar Ligament Biomechanical Homeostasis and Functional Performance in Knee Osteoarthritis: A Randomized Controlled Trial
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作者 CHENG Lulu HU Sheng +2 位作者 CHEN Zhaohui LI Dongjing CHEN Zeng 《南京中医药大学学报》 北大核心 2025年第10期1365-1372,共8页
OBJECTIVE To investigate the intervention effects of tissue-bone homeostasis manipulation(TBHM)on peripatellar biomechanical parameters and knee joint function in knee osteoarthritis(KOA)patients.METHODS Sixty patient... OBJECTIVE To investigate the intervention effects of tissue-bone homeostasis manipulation(TBHM)on peripatellar biomechanical parameters and knee joint function in knee osteoarthritis(KOA)patients.METHODS Sixty patients with KOA(Kellgren-Lawrence gradeⅡ-Ⅲ)were recruited from the Acupuncture-Moxibustion Rehabilitation Department,Anhui University of Chinese Medicine between October 2024 and May 2025.Participants were randomized into a TBHM group(n=30)or a transcutaneous electrical neuromuscular stimulation(TENS)group(n=30).Using two-way repeated measures ANOVA,biomechanical indicators,including rectus femoris tension,vastus medialis tension,vastus lateralis tension,patellar ligament tension,lateral patellar displacement(LPD),medial patellar displacement(MPD),normalized patellar mobility(LPD/patellar width[PW],MPD/PW),knee flexion range of motion,and functional indicators,including KOOS subscales,time up and go test(TUGT),were compared between groups at baseline and after 6 weeks of intervention.RESULTS After intervention,all biomechanical and knee joint function indicators in the TBHM group were significantly improved(P<0.05,P<0.01),while only the vastus medialis tension,TUGT and KOOS Pain,ADL and QoL scores in the control group were significantly improved(P<0.01).The improvement amplitudes of biomechanical indicators in the TBHM group,including rectus femoris tension,vastus lateralis tension,patellar ligament tension,MPD/PW,LPD/PW and knee flexion range of motion were better than those in the control group(P<0.05,P<0.01).In the functional evaluation,the interaction effects of the TBHM group in all dimensions of the KOOS score and TUGT were statistically significant(P<0.05,P<0.01).Post-hoc simple effect analysis confirmed that there were significant differences in the above indicators between the two groups after intervention(P<0.05),and all indicators showed a significant main effect of time(P<0.01),suggesting that the intervention measures had continuous and cumulative curative effects.CONCLUSION TBHM effectively improves joint function and quality of life in KOA patients by restoring dynamic equilibrium in soft tissue tension and patellar mobility,ultimately achieving the therapeutic goal of concurrent tissue-bone management. 展开更多
关键词 knee osteoarthritis MANIPULATION muscle tension BIOMECHANICAL patellar mobility HOMEOSTASIS function randomized controlled trial
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Reporting quality of randomized controlled trials on acupuncture and manipulation for greater occipital neuralgia evaluated using the CONSORT statement and STRICTA checklist
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作者 Liu Liguo Qiu Mingwang +3 位作者 Huang Yanling Fan Zhiyong Wu Shan Guo Rusong 《中国组织工程研究》 北大核心 2025年第30期6566-6573,共8页
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
关键词 reporting quality ACUPUNCTURE MANIPULATION CONSORT statement STRICTA checklist ROB clinical randomized controlled trials greater occipital neuralgia
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Evaluation of the effect of acupuncture on hand pain,functional deficits and health-related quality of life in patients with rheumatoid arthritis--A study protocol for a multicenter,double-blind,randomized clinical trial 被引量:14
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作者 Susana Seca Sebastian Kirch +1 位作者 António S.Cabrita Henry J.Greten 《Journal of Integrative Medicine》 SCIE CAS CSCD 2016年第3期219-227,共9页
BACKGROUND: Rheumatoid arthritis(RA) is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, until now Western acupuncture studies on RA have not sho... BACKGROUND: Rheumatoid arthritis(RA) is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, until now Western acupuncture studies on RA have not shown conclusive positive results. Acupuncture is regarded as a reflex therapy that has effects on the human autonomic nervous system. By establishing a traditional Chinese medicine(TCM) diagnosis first, the practitioner is able to choose acupoints according to the state of each individual patient.METHODS/DESIGN: We are interested if acupuncture, using a classical diagnostic procedure to allocate acupoints to the patient according to the Shang Han Lun theory, can be effective in relieving pain, improving hand function and increasing health-related quality of life in RA.The authors intend to harmonize TCM diagnosis according to clinical and genetic profiles. Patients with the TCM diagnosis of a so-called Turning Point syndrome will be followed up in a randomized, prospective, double-blind, placebo-controlled, multicenter and three-armed parallel-group study with a standardized treatment in order to optimize potential therapeutic effects of acupuncture on pain, strength and muscle function of patients with RA as well as the influence on inflammation and quality of life.DISCUSSION: The findings of this study will provide important clinical information about the feasibility and efficacy of acupuncture treatment for RA patients. In addition, it will explore the feasibility of further acupuncture research.TRIAL REGISTRATION NUMBER: Clinical Trials.gov Identifier NCT02553005. 展开更多
关键词 ACUPUNCTURE rheumatoid arthritis quality of life PAIN hand strength study protocol randomized clinical trial double-blind method
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Efficacy and safety of Yiqi Huoxue Jiedu decoction for the treatment of advanced epithelial ovarian cancer patients: a double-blind randomized controlled clinical trial 被引量:13
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作者 Li Yifan Li Juan +5 位作者 Fan Bifa Wang Yitong Jiang Juling Zhang Zhenhua Wang Xinxing Lu Wenping 《Journal of Traditional Chinese Medicine》 SCIE CAS CSCD 2020年第1期103-111,共9页
OBJECTIVE:To further evaluate the complementary effect of Yiqi Huoxue Jiedu decoction(YHJD)on patients with advanced epithelial ovarian cancer(EOC).METHODS:All 330 enrolled participants diagnosed with stageⅢc EOC wer... OBJECTIVE:To further evaluate the complementary effect of Yiqi Huoxue Jiedu decoction(YHJD)on patients with advanced epithelial ovarian cancer(EOC).METHODS:All 330 enrolled participants diagnosed with stageⅢc EOC were randomly divided into two groups that received YHJD or a placebo.The primary end point was health-related quality of life(HRQL)measured by the functional assessment of cancer therapy-ovary cancer(FACT-O)questionnaire.The secondary end point was progression-free survival(PFS).RESULTS:A total of 299 participants completed the trial with 153 and 146 in YHJD and control groups,respectively.After 6 months of treatment,YHJD increased physical wellbeing(PWB),functional wellbeing(FWB),additional concerns(AC),and the trial outcome index(TOI)(P<0.05)by various degrees compared with the baseline.YHJD also had notable advantages over the placebo at 3 and 6 months in terms of PWB,FWB,AC(P<0.05),and TOI(P<0.01).In addition,YHJD had a significant advantage in terms of PFS compared with the placebo(21 vs18 months,P<0.05).No adverse events were reported.CONCLUSION:YHJD is an effective and safe choice as a complementary therapy to improve HRQL and prolong PFS of stageⅢc EOC patients. 展开更多
关键词 OVARIAN NEOPLASMS Quality of life Disease-free survival Yiqi Huoxue Jiedu DECOCTION randomized controlled trial
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Current state of nutritional psychiatry:A scoping review of randomized controlled trials
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作者 Takahiko Nagamine 《World Journal of Methodology》 2025年第4期364-373,共10页
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
关键词 Nutritional psychiatry randomized controlled trial Mendelian randomization Fundamental research PROBIOTICS Gut microbiota
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Global acupuncture randomized controlled trials:Evaluating status,guideline impact,and future research trends
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作者 Gao-feng LIU Xiao-li HUANG +7 位作者 Wei-xing ZHONG Yin XIE Si-yuan XIE Yuan-xun LIN Yun-ao-long ZHANG Hong-wen LIU Qing-guang QIN Yi-kai LI 《World Journal of Acupuncture-Moxibustion》 2025年第4期331-340,共10页
Objectives:This study aims to evaluate the current state of acupuncture randomized controlled trials(RCTs),their impact on guidelines,and future development trends,providing a reference for future re-search directions... Objectives:This study aims to evaluate the current state of acupuncture randomized controlled trials(RCTs),their impact on guidelines,and future development trends,providing a reference for future re-search directions.Methods:Search for acupuncture-related RCT articles in the Web of Science Core Collection and con-firm their guideline inclusion on Google Scholar.Analyze study characteristics to predict future research directions.Results:The analysis covered 1422 articles,reflecting a substantial rise in publications from 77 articles between 1993 and 2002 to 960 articles between 2013 and 2022.The Western Pacific region led in pub-lication numbers with 622 articles(43.7%),followed by Europe(466 articles;32.8%),Americas(250 articles;17.6%),Eastern Mediterranean(62 articles;4.4%),and Southeast Asia(22 articles;1.5%),with Africa showing a research void.Regrettably,only 29.6%(421 articles)were incorporated into guidelines.The low rate of inclusion of research results in guidelines and the uneven distribution of research fields are particularly prominent.From 1993 to 2002,there were 77 articles,among which 51(66.2%)were included in the guidelines;from 2003 to 2012,there were 385 articles,with 202(52.5%)included;from 2013 to 2022,there were 960 articles,and only 168(17.5%)were included,showing a decreasing trend in the inclusion rate year by year.Regarding geographical distribution,1167 articles were from the East-ern Hemisphere,with 326(27.9%)included;255 were from the Western Hemisphere,and 95(37.3%)were included.Regionally,179 articles(42.5%)from Europe were included,140(33.3%)from the West-ern Pacific,95(22.6%)from the Americas,6(1.4%)from the Eastern Mediterranean,and 1(0.2%)from Southeast Asia.China,the United States,and Germany were the top publishing countries,with consis-tent growth in countries like China,South Korea,Spain,Brazil,Turkey,and Iran.Noteworthy researchers such as Cesar Fernandez-de-las-Penas,Zhi-shun LIU,Jing-wen YANG,Cun-zhi LIU,Li-xing LAO,Stefan N Willich,and Benno Brinkhaus have collaborated on research in areas such as pain management,cognitive impairments,insomnia,digestive system diseases,and urinary system diseases.There has been a partic-ular increase in research focus on neck pain and myofascial trigger points. 展开更多
关键词 ACUPUNCTURE randomized controlled trial HOTSPOT GUIDELINE TRENDS
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