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Psychological effects of virtual reality intervention on breast cancer patients with different personalities: A randomized controlled trial 被引量:4
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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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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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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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Electroacupuncture for hot flashes in early menopause:A randomized sham-controlled trial
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作者 Hui-xian Wang Xin-tong Yu +3 位作者 Jing Hu Jin-jia Chen Yu-ting Mei Yun-fei Chen 《Journal of Integrative Medicine》 2025年第5期519-527,共9页
Background:Electroacupuncture(EA)may affect the severity of hot flashes(HFs)associated with natural menopause and provide additional benefits for postmenopausal women.However,the evidence for its effectiveness in the ... Background:Electroacupuncture(EA)may affect the severity of hot flashes(HFs)associated with natural menopause and provide additional benefits for postmenopausal women.However,the evidence for its effectiveness in the management of early postmenopausal HFs remains inadequately understood.Objective:We designed this trial to assess the efficacy and safety of EA for relieving early postmenopausal HFs.Design,setting,participants and interventions:This randomized sham-controlled trial involved 72 women with HFs.The participants were divided equally into the intervention and control groups.The intervention group was treated with EA,while the control group was treated with sham acupuncture.The main acupoints used were Hegu(LI4),Guanyuan(RN4),Sanyinjiao(SP6),Taixi(KI3),Fuliu(KI7)and Shenshu(BL23).All participants received 18 treatment sessions,distributed across a 6-week period.The treatment was administered on three occasions per week,adhering to a fixed weekday schedule(Monday,Wednesday,Friday or Tuesday,Thursday,Saturday)with a minimum interval of one day between sessions.Each patient received a 12-week follow-up.Main outcome measures:The HF score was the primary outcome.Participants documented the frequency and severity of HFs in a 7-day symptom diary,which provided data for calculating the HF score.Secondary outcomes were the Menopause Rating Scale(MRS),Menopause-Specific Quality of Life Questionnaire(MENQOL),Pittsburgh Sleep Quality Index(PSQI)and Traditional Chinese Medicine Syndrome Score Scale(TCMSSS),as well as estradiol(E2),luteinizing hormone(LH)and folliclestimulating hormone(FSH)levels.Results:Both groups demonstrated significant reductions in HF scores after the treatment and during the follow-up(P<0.001).Immediately after completion of the 6-week treatment cycle and at 12 weeks postintervention,the HF scores were similar in both groups.At week 6,the intervention group showed significantly greater improvements in MRS,MENQOL(vasomotor,psychosocial,and physical),PSQI and TCMSSS scores(P<0.05).The improvements in the MENQOL(vasomotor,and psychosocial)and PSQI total scores persisted through the follow-up(P<0.05).However,the results showed no significant inter-or intragroup differences in sexual scores on the MENQOL(P>0.05).EA did not significantly decrease E2,LH or FSH levels compared to placebo.The incidence of adverse events was similar in both groups.Conclusion:EA does not significantly improve HFs in early postmenopausal patients.However,it enhances the quality of sleep and decreases menopausal symptoms across vasomotor,psychosocial and physical domains.Trial registration:Chinese Clinical Trial Registry(http://www.chictr.org.cn);Trial ID:Chi CTR2300072002.Please cite this article as:Wang HX,Yu XT,Hu J,Chen JJ,Mei YT,Chen YF.Electroacupuncture for hot flashes in early menopause:A randomized sham-controlled trial.J Integr Med.2025;23(5):519-527.?2025 Shanghai Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine.Published by Elsevier B.V.All rights are reserved,including those for text and data mining,AI training,and similar technologies. 展开更多
关键词 POSTMENOPAUSE CLIMACTERIC Hotflashes ELECTROACUPUNCTURE randomized controlled trial
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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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Electroacupuncture versus conventional acupuncture of scalp motor area for post-stroke wrist dyskinesia and its effect on muscle function: a randomized, controlled clinical trial
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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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Primary author contact for systematic reviews of randomized controlled trials:A systematic review
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作者 Vasiliki Sinopoulou Eshan Shah +1 位作者 Morris Gordon Tonia E Tony-Jimmy 《World Journal of Methodology》 2025年第3期124-130,共7页
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
关键词 Systematic review METHODOLOGY Contacting authors Interventions randomized control trials
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Effect of electroacupuncture on pain after periodontal flap surgery:a randomized controlled trial
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作者 Emre Bulut Didem Özkal Eminoğlu Yasemin Çayır 《Journal of Traditional Chinese Medicine》 2025年第1期184-191,共8页
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
关键词 ELECTROACUPUNCTURE pain postoperative ANALGESICS PERIODONTITIS 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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Response rates,survival status and adverse events of placebo in randomized control trials for hepatocellular carcinoma:A metaanalysis
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作者 Wei-Yu Chen Qing Chen +6 位作者 Chen-Chen Wang Chen-Yue Zhang Si-Kun Chen Zhi-Qiang Meng Ping Han Shu Dong Qi-Wen Chen 《World Journal of Hepatology》 2025年第8期296-305,共10页
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
关键词 Hepatocellular carcinoma PLACEBO randomized controlled trials Response rates Survival status Adverse events
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Effects of acupuncture combined with bone-setting therapy to treat tourette syndrome:a three-arm randomized controlled trial
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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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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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Efficacy and safety of acupoint application for gastrointestinal function in treating post-stroke depression:Protocol for a randomized controlled trial
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作者 Xuan Zhang Shuhui Li +2 位作者 Juntao Wang Chung Tai Lau Jacky C.P.Chan 《Journal of Traditional Chinese Medical Sciences》 2025年第4期552-558,共7页
Objective:To evaluate the efficacy and safety of acupoint application for post-stroke depression(PSD)by regulating gastrointestinal function.A secondary objective is to explore the potential mechanism underlying this ... Objective:To evaluate the efficacy and safety of acupoint application for post-stroke depression(PSD)by regulating gastrointestinal function.A secondary objective is to explore the potential mechanism underlying this approach from the perspective of gut microbiota.Methods:This multicenter,randomized,double-blind(patients and assessors),placebo-controlled trial will enroll 80 patients with PSD,and include a 1-week run-in period,a 4-week treatment phase,and a 12-week follow-up.Eligible participants will randomly be assigned in a 1:1 ratio to either the acupoint application or placebo(non-acupoint)groups.Treatments will be administered thrice weekly for 4 weeks.The primary outcome is change in the Hamilton Rating Scale for Depression(HAMD)score.Secondary outcomes include the Beck Depression Inventory(BDI),36-Item Short-Form Health Survey(SF-36),Barthel Index of Activities of Daily Living,Social Adaptation Self-Evaluation Scale(SASS),and gut microbiota profiling.All outcomes will be assessed at baseline(prior to treatment),during treatment(weeks 2 and 4),and during follow-up(weeks 8,12,and 16).The Treatment Emergent Symptom Scale(TESS)will be used for evaluation throughout the 4-week treatment phase.Discussion:The results of this study will provide important evidence supporting a novel treatment strategy for PSD that targets gastrointestinal regulation,potentially informing future clinical practice. 展开更多
关键词 Acupoint application Gut microbiota Post-stroke depression PROTOCOL randomized controlled trial
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Effects of oral rehydration solution-based prophylactic sodium supplementation on clinical outcomes in pediatric pneumonia:A randomized controlled trial
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作者 Hoda Atef Abdelsattar Ibrahim Mohamed Agha Marwa Taha 《World Journal of Clinical Pediatrics》 2025年第4期440-453,共14页
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
关键词 Oral rehydration solution HYPONATREMIA Pediatric pneumonia randomized controlled trial Length of stay EGYPT
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Efficacy of warm needling in patients with persistent allergic rhinitis:A multicenter randomized controlled trial
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作者 Wen-bin NIE Qi FAN +6 位作者 Yi-xuan FENG Yu-xiu SUN Shi-xi HUANG Yong-ming YE Ming-juan HAN Wen-jing BAI Hong ZHAO 《World Journal of Acupuncture-Moxibustion》 2025年第4期349-356,共8页
Objective:Although there is evidence to support the therapeutic effect of acupuncture on allergic rhinitis(AR),it is not clear whether acupuncture can achieve an efficacy comparable to that of pharmacological therapy.... Objective:Although there is evidence to support the therapeutic effect of acupuncture on allergic rhinitis(AR),it is not clear whether acupuncture can achieve an efficacy comparable to that of pharmacological therapy.This multicenter,non-inferiority,single-blinded randomized controlled trial aimed to compare the differences in efficacy between warm needling(WN)therapy and loratadine(LO)in improving AR symptoms and quality of life.Methods:A total of 98 patients with persistent AR(PAR)were randomly divided into two groups in a 1:1 ratio:treatment group receiving WN therapy at Dazhui(GV14)and normal acupuncture at other acupoints for 12 sessions in 4 weeks and control group receiving LO at a dosage of 10 mg/day for oral administration.The study duration was 28 weeks(4-week treatment period with a 24-week follow-up).The primary outcome was the mean change in the Total Nasal Symptom Score(TNSS)from baseline to week 28,and the secondary outcomes included the Total Non-Nasal Symptom Score(TNNSS)and the Rhinoconjunctivitis Quality of Life Questionnaire(RQLQ)score.Statistical analyses were conducted us-ing SPSS22.0.Both intention-to-treat and treatment compliance analyses were performed to analyze all outcomes.Results:After intervention,TNSS scores improved from baseline to week 28 by 5.18(95%confidence interval[CI]:3.91,6.45;P<0.001)in the WN group and 4.59(95%CI 3.28,5.89;P<0.001)in the LO group,but the changes did not differ between the groups(P=0.515).The margin by 95%CI(−1.20,2.38)was not reached,indicating non-inferiority.WN therapy resulted in clinical improvements in TNNSS,with a significant difference com pared with LO treatment(f=5.466,P=0.021).WN therapy also resulted in clinical improvements in RQLQ scores,with a significant difference compared with LO(f=9.222,P=0.003).Conclusions:WN therapy demonstrated comparable efficacy to oral LO in improving nasal symptoms of PAR.However,it showed superior effects in alleviating concomitant nasal symptoms and enhancing patients’quality of life. 展开更多
关键词 ACUPUNCTURE MOXIBUSTION Persistent allergic rhinitis randomized controlled trial Warm needling
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Efficacy of bright light therapy for perinatal depression:A metaanalysis of a randomized controlled trial
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作者 Xue Yang Yuan-Yuan Gao +8 位作者 Shu-Qi Xu Jin-Cheng Wang Yu-Jie Ma Li-Huan Jiao Lan Wang Xue-Yi Wang Shahid Bashir Cui-Xia An Ran Wang 《World Journal of Meta-Analysis》 2025年第1期29-37,共9页
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
关键词 Bright light therapy randomized controlled trial Perinatal depression PREGNANCY META-ANALYSIS
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Prenatal multiple micronutrient-fortified balanced energy-protein supplementation and newborn telomere length and mitochondrial DNA content:a randomized controlled efficacy trial in rural Burkina Faso
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作者 Giles T.Hanley-Cook Yuri Bastos-Moreira +12 位作者 Dries S.Martens Trenton Dailey-Chwalibóg Laeticia Celine Toe Brenda de Kok Lionel OIivier Ouédraogo Alemayehu Argaw Kokeb Tesfamariam Patrick Kolsteren Lieven Huybregts Tim S.Nawrot Sarah De Saeger Marthe De Boevre Carl Lachat 《Food Science and Human Wellness》 2025年第4期1387-1397,共11页
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
关键词 Balanced-energy protein Burkina Faso Iron-folic acid Mitochondrial DNA Multiple micronutrients randomized controlled trial Telomere length
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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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Effects of early diet resumption on the incidence of complications following polypectomy:A randomized controlled trial
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作者 Hui-Hui Yan Zhu-Yun Ding +5 位作者 Lei-Lei Wang Dan-Dan Zhong Xi-Feng Jin Xiao-Chen Liu Jian-Ting Cai Xin-Liang Lu 《World Journal of Gastrointestinal Surgery》 2025年第8期379-392,共14页
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
关键词 Colorectal polyps POLYPECTOMY Early diet resumption Post-polypectomy complications randomized controlled trial
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