The important work of Yu,et al.[1]who presented one of the first randomized controlled trials(RCTs)to directly compare robot-assisted and manual percutaneous coronary intervention(PCI),is commendable;offering importan...The important work of Yu,et al.[1]who presented one of the first randomized controlled trials(RCTs)to directly compare robot-assisted and manual percutaneous coronary intervention(PCI),is commendable;offering important insights into the feasibility and outcomes of this emerging technology.While the analysis is timely,several issues warrant further consideration.展开更多
OBJECTIVE:To assess the efficacy of point application therapy(PAT)in alleviating the exacerbation of chronic respiratory diseases represented by bronchial asthma.METHODS:In this multicenter randomized placebocontrolle...OBJECTIVE:To assess the efficacy of point application therapy(PAT)in alleviating the exacerbation of chronic respiratory diseases represented by bronchial asthma.METHODS:In this multicenter randomized placebocontrolled trial,eligible bronchial asthma patients received placebo PAT on the dog days of the first summer to establish a baseline,and then patients who continued to participate in the trial and repassed the eligibility review were randomized to receive regular or placebo PAT in the next two consecutive summers.The primary outcome was the change from baseline in the number of asthma exacerbations at 24 months.Secondary outcomes included severity of asthma exacerbation,asthma control test(ACT)score,percentage of forced expiratory volume in 1 s(FEV1)to the predicated value(FEV1%pred),peak expiratory flow(PEF),ratio of FEV1 to forced vital capacity(FEV1/FVC),and use of palliative drugs during bronchial asthma exacerbations at 12 and 24 months.The adverse events(AEs)were also assessed.RESULTS:A total of 835 patients with bronchial asthma were randomized in this trial.Compared with the placebo control,the PAT significantly decreased the mean number of asthma exacerbations(1.42;95%confidence interval,0.69 to 2.14;P<0.001),and increased the FEV1%pred at 24 months(P=0.039)and FEV1/FVC at 12 months(P=0.01)and 24 months(P=0.01).There were no significant differences between the groups in PEF or ACT score at 12 and 24 months,or in FEV1%pred at 12 months.Treatment-related AEs were mild and more common in the PAT group than in the placebo PAT group.No serious AEs were reported.CONCLUSION:PAT conducted on dog days could reduce asthma exacerbations in patients with bronchial asthma.展开更多
OBJECTIVE:To investigate Acupuncture-herb therapy modulates gut microbiota in abdominal obesity.METHODS:A randomized controlled trial was designed in accordance with standard protocols.Abdominally obese subjects were ...OBJECTIVE:To investigate Acupuncture-herb therapy modulates gut microbiota in abdominal obesity.METHODS:A randomized controlled trial was designed in accordance with standard protocols.Abdominally obese subjects were randomized into four groups:A2(Control):double placebo,A1(Needle):press needle+placebo herb,A3(herb):herbal medicine(Huatan Lishi Fang化痰利湿方)+placebo needle,A4(Combination):press needle+herbal medicine.After 12 weeks of treatment,groups were relabeled B1-B4.Weight,waist circumference,and body mass index were measured monthly.Gut microbiota was analyzed via 16S rRNA sequencing for diversity and abundance.RESULTS:Combined needle-herb therapy significantly reduced waist circumference(P<0.05).All treatments altered gut microbiota composition.The combination group showed significant changes in diversity(Chao1,Shannon,Simpson;P<0.05).Needle therapy increased Bacteroidia;herbs reduced Lachnospiraceae and Megamonas.All results were significant(P<0.05).CONCLUSION:Combined needle-herb treatment modulated 25 key gut flora across multiple taxonomic levels in abdominal obesity.It reduced Firmicutes and Bacteroidota.Bacteroidota,Actinobacteriota,and Prevotellaceae may suppress obesity,whereas Proteobacteria,Lachnospiraceae,and Megamonas may promote it.The combination specifically altered Bacteroidaceae,Lachnospiraceae,Bacteroidia,and Megamonas.展开更多
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
Domain randomization is a widely adopted technique in deep reinforcement learning(DRL)to improve agent generalization by exposing policies to diverse environmental conditions.This paper investigates the impact of diff...Domain randomization is a widely adopted technique in deep reinforcement learning(DRL)to improve agent generalization by exposing policies to diverse environmental conditions.This paper investigates the impact of different reset strategies,normal,non-randomized,and randomized,on agent performance using the Deep Deterministic Policy Gradient(DDPG)and Twin Delayed DDPG(TD3)algorithms within the CarRacing-v2 environment.Two experimental setups were conducted:an extended training regime with DDPG for 1000 steps per episode across 1000 episodes,and a fast execution setup comparing DDPG and TD3 for 30 episodes with 50 steps per episode under constrained computational resources.A step-based reward scaling mechanism was applied under the randomized reset condition to promote broader state exploration.Experimental results showthat randomized resets significantly enhance learning efficiency and generalization,with DDPG demonstrating superior performance across all reset strategies.In particular,DDPG combined with randomized resets achieves the highest smoothed rewards(reaching approximately 15),best stability,and fastest convergence.These differences are statistically significant,as confirmed by t-tests:DDPG outperforms TD3 under randomized(t=−101.91,p<0.0001),normal(t=−21.59,p<0.0001),and non-randomized(t=−62.46,p<0.0001)reset conditions.The findings underscore the critical role of reset strategy and reward shaping in enhancing the robustness and adaptability of DRL agents in continuous control tasks,particularly in environments where computational efficiency and training stability are crucial.展开更多
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
Objectives:To explore the efficacy and safety of virtual reality(VR)in relieving negative emotions in patients with breast cancer with different personalities.Methods:A randomized controlled trial was conducted.Betwee...Objectives:To explore the efficacy and safety of virtual reality(VR)in relieving negative emotions in patients with breast cancer with different personalities.Methods:A randomized controlled trial was conducted.Between April 2023 and October 2023,we enrolled patients with breast cancer treated in the Department of Breast Cancer and Oncology at Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University,Guangdong Province.The patients were randomly divided into an intervention group(n=118)and a control group(n=119)using block randomization.The intervention group received the VR intervention 3-5 times over 5±2 weeks using natural landscapes with music or relaxation guidance,and the duration of each VR intervention was 15±3 min.The control group received routine nursing care,including disease education and psychological counseling.Patients were assessed using the Type D Scale,Positive and Negative Affect Scale,and Distress Thermometer,and adverse events during the intervention were recorded.Results:Overall,85 patients completed the study(44 in the intervention group and 41 in the control group).Patients with Type D personalities showed more negative emotions[25.0(21.5,27.5)vs.19.0(16.0,24.0),P=0.001]and distressed attitudes[4.0(2.0,5.0)vs.3.0(1.0,4.0),P=0.020]with fewer positive emotions(27.2±5.6 vs.31.0±5.9,P=0.014)than those with non-Type D personalities.Total population analysis revealed no significant differences between the groups.However,in the subgroup analysis,patients with Type D personalities in the intervention group showed greater relief from negative emotions than those in the control group[median difference,-5.0(-9.0,-2.5)vs.-2.0(-4.0,2.0),P=0.046].No significant differences were found between groups of patients with non-Type D personality traits.The proportion of adverse events was not significantly different between groups(P=0.110).Conclusions:Breast cancer patients with Type D personalities suffer more severe negative emotions and distress,and more attention should be paid to them.VR intervention significantly and safely reduced negative emotions in patients with Type D personalities.展开更多
OBJECTIVE: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
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
Background:The use of inserted sham acupuncture as a placebo in randomized controlled trials(RCTs)is controversial,because it may produce specific effects that cause an underestimation of the effect of acupuncture tre...Background:The use of inserted sham acupuncture as a placebo in randomized controlled trials(RCTs)is controversial,because it may produce specific effects that cause an underestimation of the effect of acupuncture treatment.Objective:This systematic survey investigates the magnitude of insert-specific effects of sham acupuncture and whether they affect the estimation of acupuncture treatment effects.Search strategy:PubMed,Embase and Cochrane Central Register of Controlled Trials were searched to identify acupuncture RCTs from their inception until December 2022.Inclusion criteria:RCTs that evaluated the effects of acupuncture compared to sham acupuncture and no treatment.Data extraction and analysis:The total effect measured for an acupuncture treatment group in RCTs were divided into three components,including the natural history and/or regression to the mean effect(controlled for no-treatment group),the placebo effect,and the specific effect of acupuncture.The first two constituted the contextual effect of acupuncture,which is mimicked by a sham acupuncture treatment group.The proportion of acupuncture total effect size was considered to be 1.The proportion of natural history and/or regression to the mean effect(PNE)and proportional contextual effect(PCE)of included RCTs were pooled using meta-analyses with a random-effect model.The proportion of acupuncture placebo effect was the difference between PCE and PNE in RCTs with non-inserted sham acupuncture.The proportion of insert-specific effect of sham acupuncture(PIES)was obtained by subtracting the proportion of acupuncture placebo effect and PNE from PCE in RCTs with inserted sham acupuncture.The impact of PIES on the estimation of acupuncture's treatment effect was evaluated by quantifying the percentage of RCTs that the effect of outcome changed from no statistical difference to statistical difference after removing PIES in the included studies,and the impact of PIES was externally validated in other acupuncture RCTs with an inserted sham acupuncture group that were not used to calculate PIES.Results:This analysis included 32 studies with 5492 patients.The overall PNE was 0.335(95%confidence interval[CI],0.255-0.415)and the PCE of acupuncture was 0.639(95%CI,0.567-0.710)of acupuncture's total effect.The proportional contribution of the placebo effect to acupuncture's total effect was 0.191,and the PIES was 0.189.When we modeled the exclusion of the insert-specific effect of sham acupuncture,the acupuncture treatment effect changed from no difference to a significant difference in 45.45%of the included RCTs,and in 40.91%of the external validated RCTs.Conclusion:The insert-specific effect of sham acupuncture in RCTs represents 18.90%of acupuncture's total effect and significantly affects the evaluation of the acupuncture treatment effect.More than 40%of RCTs that used inserted sham acupuncture would draw different conclusions if the PIES had been controlled for.Considering the impact of the insert-specific effect of sham acupuncture,caution should be taken when using inserted sham acupuncture placebos in RCTs.展开更多
Adaptor signature,a new primitive that alleviates the scalability issue of blockchain to some extent,has been widely adopted in the off-chain payment channel and atomic swap.As an extension of standard digital signatu...Adaptor signature,a new primitive that alleviates the scalability issue of blockchain to some extent,has been widely adopted in the off-chain payment channel and atomic swap.As an extension of standard digital signature,adaptor signature can bind the release of a complete digital signature with the exchange of a secret value.Existing constructions of adaptor signatures are mainly based on Schnorr or ECDSA signature algorithms,which suffer low signing efficiency and long signature length.In this paper,to address these issues,we propose a new construction of adaptor signature using randomized EdDSA,which has Schnorr-like structure with higher signing efficiency and shorter signature length.We prove the required security properties,including unforgeability,witness extractability and pre-signature adaptability,of the new adaptor signature scheme in the random oracle model.We conduct a comparative analysis with an ECDSA-based adaptor signature scheme to demonstrate the effectiveness and feasibility of our new proposal.展开更多
OBJECTIVE:To examine the effect of electroacupuncture(EA)application on postoperative pain levels and the amount of analgesic use in patients who underwent periodontal flap surgery.METHODS:In this prospective,randomiz...OBJECTIVE:To examine the effect of electroacupuncture(EA)application on postoperative pain levels and the amount of analgesic use in patients who underwent periodontal flap surgery.METHODS:In this prospective,randomized and controlled study,patients planned for periodontal surgery were divided into two groups[EA group(n=22):patients who received electroacupuncture and control group(n=22):patients who did not receive electroacupuncture].Electroacupuncture was applied bilaterally to the Hegu(LI4),Daying(ST5),and Jiache(ST5)points of the patients in the EA group immediately before and after the flap surgery for 30 min at a frequency of 50 Hz to each point at a current that the patient could tolerate.The patients in the control group underwent flap surgery without applying electroacupuncture.Patients were asked to record their pain levels on the visual analog scale and the number of analgesic tablets they took during the 7 postoperative days on the given form.RESULTS:The total mean score of pain felt in the EA group(16.60±2.78)was found to be significantly lower than that in the control group(31.37±2.78)(P=0.001).No significant difference was found between the groups regarding the amount of analgesics taken(4.77±4.72,5.82±3.11)(P=0.111).CONCLUSIONS:Our study shows that electroacupuncture application is beneficial in reducing pain after periodontal flap surgery.Overall,more research is needed to fully understand the effects of electroacupuncture on postoperative pain.展开更多
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
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
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
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
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
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
OBJECTIVE:In recent years,the number of clinical research reports on acupuncture and manipulation for the treatment of greater occipital neuralgia has gradually increased,but the quality is uneven.There is currently n...OBJECTIVE:In recent years,the number of clinical research reports on acupuncture and manipulation for the treatment of greater occipital neuralgia has gradually increased,but the quality is uneven.There is currently no literature evaluating the quality of published reports,which is not conducive to the promotion of clinical use of these therapies.Therefore,this article assessed the reporting quality of randomized controlled trials on acupuncture and manipulation for greater occipital neuralgia.METHODS:Cochrane Library,PubMed,Web of Science,Embase,China National Knowledge Infrastructure(CNKI),VIP,WanFang Data,and Chinese BioMedical Literature Database(CBM)from inception to May 20,2024 were searched.The reporting quality of included randomized controlled trials was independently evaluated by two investigators using the CONSORT statement,STRICTA checklist,and Cochrane bias of risk assessment tool.A third investigator resolved any disagreement.RESULTS:A total of 62 articles were included.Based on the CONSORT statement,59.46%(22/37)of all entries had a reporting rate of less than 50%,mainly including“Identification as a randomized trial in the title(1/62,1.61%),”“How sample size was determined(7/62,11.29%),”“Implementation(1/62,1.61%),”“Blinding(1/62,1.61%),”and“Reports of Funding(4/62,6.45%).”According to the STRICTA checklist,29.41%(5/17)of all entries had a reporting rate of less than 50%,mainly including“Details of other interventions(7/58,12.07%),”“Setting and context of treatment(0/58,0%),”and“Description of participating acupuncturists(0/58,0%).”CONCLUSION:The reporting quality of randomized controlled trials on acupuncture and manipulation therapy for greater occipital neuralgia remains low.Future researchers need to make greater efforts to strictly adhere to the CONSORT statement and STRICTA checklist during trial design,implementation,and reporting.This will facilitate the standardization of research in this field and enhance the reliability and reproducibility of the research results.展开更多
BACKGROUND Nutritional psychiatry is a rapidly expanding field of research,with mounting evidence suggesting that nutritional factors may play a role in the development of psychiatric disorders.AIM To examine the leve...BACKGROUND Nutritional psychiatry is a rapidly expanding field of research,with mounting evidence suggesting that nutritional factors may play a role in the development of psychiatric disorders.AIM To examine the level of evidence for nutritional psychiatry.METHODS A scoping review was conducted to assess the current state of nutritional psychiatry,including a search for randomized controlled trials(RCTs).RESULTS The review identified a total of seven papers,with many concentrating on the relationship between depression and the gut microbiome.A salient issue that emerged from this review was the paucity of sample size in many studies.The inherent complexity of nutritional studies,characterized by a multitude of potential factors and exposures that often act as confounders,poses significant challenges to the development of effective RCT designs.The analysis revealed that probiotics,though demonstrating efficacy,exhibited a modest effect size.CONCLUSION Conducting RCTs with effective markers is imperative from these studies.The implementation of Mendelian randomization and the investigation of mechanisms in basic research are essential complementary approaches.展开更多
文摘The important work of Yu,et al.[1]who presented one of the first randomized controlled trials(RCTs)to directly compare robot-assisted and manual percutaneous coronary intervention(PCI),is commendable;offering important insights into the feasibility and outcomes of this emerging technology.While the analysis is timely,several issues warrant further consideration.
基金Supported by“12th Five-year” National Science and Technology Pillar Program by the Ministry of Science and Technology of the People’s Republic of China:Clinical Evaluation and Technical Operation Specification Research on Preventing Bronchial Asthma Attacks by Acupoint Application in Winter Disease Summer Treatment(No. 2015BAI04B11)。
文摘OBJECTIVE:To assess the efficacy of point application therapy(PAT)in alleviating the exacerbation of chronic respiratory diseases represented by bronchial asthma.METHODS:In this multicenter randomized placebocontrolled trial,eligible bronchial asthma patients received placebo PAT on the dog days of the first summer to establish a baseline,and then patients who continued to participate in the trial and repassed the eligibility review were randomized to receive regular or placebo PAT in the next two consecutive summers.The primary outcome was the change from baseline in the number of asthma exacerbations at 24 months.Secondary outcomes included severity of asthma exacerbation,asthma control test(ACT)score,percentage of forced expiratory volume in 1 s(FEV1)to the predicated value(FEV1%pred),peak expiratory flow(PEF),ratio of FEV1 to forced vital capacity(FEV1/FVC),and use of palliative drugs during bronchial asthma exacerbations at 12 and 24 months.The adverse events(AEs)were also assessed.RESULTS:A total of 835 patients with bronchial asthma were randomized in this trial.Compared with the placebo control,the PAT significantly decreased the mean number of asthma exacerbations(1.42;95%confidence interval,0.69 to 2.14;P<0.001),and increased the FEV1%pred at 24 months(P=0.039)and FEV1/FVC at 12 months(P=0.01)and 24 months(P=0.01).There were no significant differences between the groups in PEF or ACT score at 12 and 24 months,or in FEV1%pred at 12 months.Treatment-related AEs were mild and more common in the PAT group than in the placebo PAT group.No serious AEs were reported.CONCLUSION:PAT conducted on dog days could reduce asthma exacerbations in patients with bronchial asthma.
基金Supported by National Key R&D Program of China:Clinical Evaluation Research on Intervention Technologies for Abdominal Obesitythe Role of Gut Microbiota in the Effects of Combined Acupuncture and Medication on Abdominal Obesity:an Exploration with 16S rRNA Technology(Project Code:2019YFC1710102)。
文摘OBJECTIVE:To investigate Acupuncture-herb therapy modulates gut microbiota in abdominal obesity.METHODS:A randomized controlled trial was designed in accordance with standard protocols.Abdominally obese subjects were randomized into four groups:A2(Control):double placebo,A1(Needle):press needle+placebo herb,A3(herb):herbal medicine(Huatan Lishi Fang化痰利湿方)+placebo needle,A4(Combination):press needle+herbal medicine.After 12 weeks of treatment,groups were relabeled B1-B4.Weight,waist circumference,and body mass index were measured monthly.Gut microbiota was analyzed via 16S rRNA sequencing for diversity and abundance.RESULTS:Combined needle-herb therapy significantly reduced waist circumference(P<0.05).All treatments altered gut microbiota composition.The combination group showed significant changes in diversity(Chao1,Shannon,Simpson;P<0.05).Needle therapy increased Bacteroidia;herbs reduced Lachnospiraceae and Megamonas.All results were significant(P<0.05).CONCLUSION:Combined needle-herb treatment modulated 25 key gut flora across multiple taxonomic levels in abdominal obesity.It reduced Firmicutes and Bacteroidota.Bacteroidota,Actinobacteriota,and Prevotellaceae may suppress obesity,whereas Proteobacteria,Lachnospiraceae,and Megamonas may promote it.The combination specifically altered Bacteroidaceae,Lachnospiraceae,Bacteroidia,and Megamonas.
文摘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.
基金supported by the Deputyship for Research&Innovation,Ministry of Education in Saudi Arabia(Project No.MoE-IF-UJ-R2-22-04220773-1).
文摘Domain randomization is a widely adopted technique in deep reinforcement learning(DRL)to improve agent generalization by exposing policies to diverse environmental conditions.This paper investigates the impact of different reset strategies,normal,non-randomized,and randomized,on agent performance using the Deep Deterministic Policy Gradient(DDPG)and Twin Delayed DDPG(TD3)algorithms within the CarRacing-v2 environment.Two experimental setups were conducted:an extended training regime with DDPG for 1000 steps per episode across 1000 episodes,and a fast execution setup comparing DDPG and TD3 for 30 episodes with 50 steps per episode under constrained computational resources.A step-based reward scaling mechanism was applied under the randomized reset condition to promote broader state exploration.Experimental results showthat randomized resets significantly enhance learning efficiency and generalization,with DDPG demonstrating superior performance across all reset strategies.In particular,DDPG combined with randomized resets achieves the highest smoothed rewards(reaching approximately 15),best stability,and fastest convergence.These differences are statistically significant,as confirmed by t-tests:DDPG outperforms TD3 under randomized(t=−101.91,p<0.0001),normal(t=−21.59,p<0.0001),and non-randomized(t=−62.46,p<0.0001)reset conditions.The findings underscore the critical role of reset strategy and reward shaping in enhancing the robustness and adaptability of DRL agents in continuous control tasks,particularly in environments where computational efficiency and training stability are crucial.
文摘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.
基金supported by a project of the National Natural Science Foundation of China:Research on the integration of artificial intelligence and virtual reality technology to promote psychological rehabilitation of breast cancer patients with different personalities(project approval no.82073408).
文摘Objectives:To explore the efficacy and safety of virtual reality(VR)in relieving negative emotions in patients with breast cancer with different personalities.Methods:A randomized controlled trial was conducted.Between April 2023 and October 2023,we enrolled patients with breast cancer treated in the Department of Breast Cancer and Oncology at Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University,Guangdong Province.The patients were randomly divided into an intervention group(n=118)and a control group(n=119)using block randomization.The intervention group received the VR intervention 3-5 times over 5±2 weeks using natural landscapes with music or relaxation guidance,and the duration of each VR intervention was 15±3 min.The control group received routine nursing care,including disease education and psychological counseling.Patients were assessed using the Type D Scale,Positive and Negative Affect Scale,and Distress Thermometer,and adverse events during the intervention were recorded.Results:Overall,85 patients completed the study(44 in the intervention group and 41 in the control group).Patients with Type D personalities showed more negative emotions[25.0(21.5,27.5)vs.19.0(16.0,24.0),P=0.001]and distressed attitudes[4.0(2.0,5.0)vs.3.0(1.0,4.0),P=0.020]with fewer positive emotions(27.2±5.6 vs.31.0±5.9,P=0.014)than those with non-Type D personalities.Total population analysis revealed no significant differences between the groups.However,in the subgroup analysis,patients with Type D personalities in the intervention group showed greater relief from negative emotions than those in the control group[median difference,-5.0(-9.0,-2.5)vs.-2.0(-4.0,2.0),P=0.046].No significant differences were found between groups of patients with non-Type D personality traits.The proportion of adverse events was not significantly different between groups(P=0.110).Conclusions:Breast cancer patients with Type D personalities suffer more severe negative emotions and distress,and more attention should be paid to them.VR intervention significantly and safely reduced negative emotions in patients with Type D personalities.
基金Supported by the National Natural Science Foundation of China:Exploration of Key Factors and Mechanisms of Modulating Motor Function Reconstruction After Cerebral Infarction Through Multimodal Brain Functional Connectivity Perspective in Procedural Acupoint Electrical Stimulation Research(No.82374601)the Jointly Guided Program of Natural Science Foundation of Heilongjiang Province:Quantitative Study on the Role of Scalp Acupuncture in the Motor Area in Promoting Motor Function Reconstruction after Stroke(No.LH2019H113)+1 种基金the Innovation Team Construction Project of Heilongjiang University of Chinese Medicine:Construction of a Doctoral Research and Innovation Team in Acupuncture Science(No.2017sit01)the Traditional Chinese Medicine Research Project of Heilongjiang Province:Clinical Study on the Promotion of Upper Limb Motor Function Reconstruction in Post-Stroke Patients Using Optimal Limb Positioning with Electroacupuncture(No.ZHY2022-171)。
文摘OBJECTIVE:To evaluate the efficacy of electroacupuncture(EA)at scalp motor area for treating post-stroke wrist dyskinesia and its influence on the function of wrist movement-related agonistic muscles.METHODS:A randomized,single-blind,controlled clinical trial was conducted.Sixty-six patients undergoing post-stroke wrist dyskinesia were enrolled and randomized 1:1 to EA or control group.Patients in the control group received manual acupuncture in the scalp motor area(MS 6)on the lesion side.The same acupoint was selected to accept EA stimulation in the EA group.All patients were treated six times a week for three weeks.The primary outcome was the Chinese Stroke Scale(CSS)score.The secondary outcomes included upper limb-related Barthel Index(BI)score,active range of motion(AROM)of the wrist joint,and root mean square(RMS)of the four agonistic muscles associated with wrist motion on the hemiplegic side of patients,i.e.,the extensor carpi radialis longus(ECRL),extensor digitorum(ED),flexor carpi radialis(FCR)and flexor carpi ulnaris(FCU).The above indicators were measured before and after three weeks of treatment.RESULTS:After 3-week treatment,the CSS score and AROM of wrist dorsiflexion of the EA group were better than those in the control group(P=0.038,P=0.047).The differences between the two groups of BI scores and AROM of wrist flexion were not significant(P>0.05).All RMS of the EA group were higher than those in the control group(ECRL:P=0.047,ED:P=0.048,FCR:P=0.049,FCU:P=0.047).The total effective rate in the EA group was 87.50%(28/32),which was higher than that in the control group(77.42%,24/31,P=0.048).CONCLUSION:EA stimulation of the scalp motor area can promote the recovery of the strength and function of the agonistic muscles related to wrist movement and effectively improve post-stroke wrist dyskinesia.
基金supported by the National High-Level Chinese Medicine Hospital Clinical Research Funding(No.DFGZRB-2024GJRC015)。
文摘Acupuncture is an ancient treatment method used in traditional Chinese medicine and has been popularized worldwide.Over the past decade,there has been an increase in the amount of acupuncture research,mostly comprised of randomized controlled trials(RCTs)that aimed to answer the question on the efficacy of acupuncture.However,poor methodology and low replicability in these acupuncture RCTs have resulted in uncertainty about the efficacy of acupuncture.In this review,current advancements and challenges in acupuncture RCTs,regarding the methodological aspects of randomization,blinding,sham acupuncture and quality of reporting,were discussed.While there have been advancements in various aspects,current acupuncture RCTs still face pressing issues such as inadequate randomization and blinding,unviable sham acupuncture controls,and poor reporting quality.Given these limitations,this review seeks to identify the methodological problems that are responsible for these problems and to suggest solutions that could help to overcome them so as to improve the quality of future studies evaluating the efficacy of acupuncture.
基金the National Key R&D Program of China(No.2023YFC3503300 and No.2023YFC3503304)National Natural Science Foundation of China for Distinguished Young Scholars(No.82225049)and Youths(No.82305045)Fundamental Research Funds for the Central Public Welfare Research Institutes(No.2020YJSZX-3)。
文摘Background:The use of inserted sham acupuncture as a placebo in randomized controlled trials(RCTs)is controversial,because it may produce specific effects that cause an underestimation of the effect of acupuncture treatment.Objective:This systematic survey investigates the magnitude of insert-specific effects of sham acupuncture and whether they affect the estimation of acupuncture treatment effects.Search strategy:PubMed,Embase and Cochrane Central Register of Controlled Trials were searched to identify acupuncture RCTs from their inception until December 2022.Inclusion criteria:RCTs that evaluated the effects of acupuncture compared to sham acupuncture and no treatment.Data extraction and analysis:The total effect measured for an acupuncture treatment group in RCTs were divided into three components,including the natural history and/or regression to the mean effect(controlled for no-treatment group),the placebo effect,and the specific effect of acupuncture.The first two constituted the contextual effect of acupuncture,which is mimicked by a sham acupuncture treatment group.The proportion of acupuncture total effect size was considered to be 1.The proportion of natural history and/or regression to the mean effect(PNE)and proportional contextual effect(PCE)of included RCTs were pooled using meta-analyses with a random-effect model.The proportion of acupuncture placebo effect was the difference between PCE and PNE in RCTs with non-inserted sham acupuncture.The proportion of insert-specific effect of sham acupuncture(PIES)was obtained by subtracting the proportion of acupuncture placebo effect and PNE from PCE in RCTs with inserted sham acupuncture.The impact of PIES on the estimation of acupuncture's treatment effect was evaluated by quantifying the percentage of RCTs that the effect of outcome changed from no statistical difference to statistical difference after removing PIES in the included studies,and the impact of PIES was externally validated in other acupuncture RCTs with an inserted sham acupuncture group that were not used to calculate PIES.Results:This analysis included 32 studies with 5492 patients.The overall PNE was 0.335(95%confidence interval[CI],0.255-0.415)and the PCE of acupuncture was 0.639(95%CI,0.567-0.710)of acupuncture's total effect.The proportional contribution of the placebo effect to acupuncture's total effect was 0.191,and the PIES was 0.189.When we modeled the exclusion of the insert-specific effect of sham acupuncture,the acupuncture treatment effect changed from no difference to a significant difference in 45.45%of the included RCTs,and in 40.91%of the external validated RCTs.Conclusion:The insert-specific effect of sham acupuncture in RCTs represents 18.90%of acupuncture's total effect and significantly affects the evaluation of the acupuncture treatment effect.More than 40%of RCTs that used inserted sham acupuncture would draw different conclusions if the PIES had been controlled for.Considering the impact of the insert-specific effect of sham acupuncture,caution should be taken when using inserted sham acupuncture placebos in RCTs.
基金supported by the National Key R&D Program of China(2022YFB2701500)the National Natural Science Foundation of China(62272385,62311540156)+2 种基金Shaanxi Distinguished Youth Project(2022JC-47)the Key Research and Development Program of Shaanxi(2021ZDLGY06-04)Major Program of Shandong Provincial Natural Science Foundation for the Fundamental Research(ZR2022ZD03).
文摘Adaptor signature,a new primitive that alleviates the scalability issue of blockchain to some extent,has been widely adopted in the off-chain payment channel and atomic swap.As an extension of standard digital signature,adaptor signature can bind the release of a complete digital signature with the exchange of a secret value.Existing constructions of adaptor signatures are mainly based on Schnorr or ECDSA signature algorithms,which suffer low signing efficiency and long signature length.In this paper,to address these issues,we propose a new construction of adaptor signature using randomized EdDSA,which has Schnorr-like structure with higher signing efficiency and shorter signature length.We prove the required security properties,including unforgeability,witness extractability and pre-signature adaptability,of the new adaptor signature scheme in the random oracle model.We conduct a comparative analysis with an ECDSA-based adaptor signature scheme to demonstrate the effectiveness and feasibility of our new proposal.
文摘OBJECTIVE:To examine the effect of electroacupuncture(EA)application on postoperative pain levels and the amount of analgesic use in patients who underwent periodontal flap surgery.METHODS:In this prospective,randomized and controlled study,patients planned for periodontal surgery were divided into two groups[EA group(n=22):patients who received electroacupuncture and control group(n=22):patients who did not receive electroacupuncture].Electroacupuncture was applied bilaterally to the Hegu(LI4),Daying(ST5),and Jiache(ST5)points of the patients in the EA group immediately before and after the flap surgery for 30 min at a frequency of 50 Hz to each point at a current that the patient could tolerate.The patients in the control group underwent flap surgery without applying electroacupuncture.Patients were asked to record their pain levels on the visual analog scale and the number of analgesic tablets they took during the 7 postoperative days on the given form.RESULTS:The total mean score of pain felt in the EA group(16.60±2.78)was found to be significantly lower than that in the control group(31.37±2.78)(P=0.001).No significant difference was found between the groups regarding the amount of analgesics taken(4.77±4.72,5.82±3.11)(P=0.111).CONCLUSIONS:Our study shows that electroacupuncture application is beneficial in reducing pain after periodontal flap surgery.Overall,more research is needed to fully understand the effects of electroacupuncture on postoperative pain.
基金Supported by Traditional Chinese medicine foundation of Zhejiang province:Clinical Study on the Correlation Between Tourette Syndrome and Anatomical Changes in the Atlantoaxial Joint(2010ZB162)Medical Health Science and Technology Project of Zhejiang Provincial Health Commission:Study on Protein Fingerprinting of Tourette Syndrome(2011KYB142)+1 种基金Renowned Traditional Chinese Medicine Expert Inheritance Studio Construction Project of Zhejiang province(No.GZS2020049)Key Disciplines of Traditional Chinese Medicine Foundation of Zhejiang Province(2012-XK-D20)。
文摘OBJECTIVE:To explore the efficacy and safety of acupuncture combined with atlantoaxial joint bone-setting therapy for the treatment of Tourette syndrome.METHODS:We randomly divided 600 patients at a ratio of 1∶1∶1 into three groups:group A(acupuncture combined with atlantoaxial joint bone setting therapy group),group B(acupuncture group),and group C(tiapride group).After two months of treatment,the Yale global tic severity scale(YGTSS)score reduction,improvement in social function impairment,clinical efficacy,and long-term efficacy in the three groups were compared.RESULTS:After treatment,in the analysis of YGTSS score reduction,social function impairment improvement,the clinical control rate,and long-term efficacy,the results were all Group A>Group B>Group C,with a statistically significant difference(P<0.05).However,the total clinical efficacy of treatment in group A(94.9%)was not significantly different from that in group B(91.8%).Adverse reactions did not occur in groups A and B,and several adverse reactions occurred in 29%(n=58)of the group C patients.CONCLUSION:Compared with traditional drug therapy,acupuncture combined with atlantoaxial joint bone setting therapy has better clinical and long-term efficacy.This treatment strategy can improve the social function of children and prevent adverse reactions to drugs.
基金the Program of Discipline Backbone of high-level Public Health Talents of Beijing Municipal Health Commission:Epidemiological Survey of Acute Myocardial Infarction Inpatients in Hospital of Traditional Chinese Medicine in Beijing Area(Discipline backbone-02-25)Beijing Municipal Hospital Administration Green Seedling Talent Project:Study on Characteristics of Clinical Syndromes,Status of Traditional Chinese Medicine Treatment and Prognosis of Patients with Chronic Heart Failure in Traditional Chinese Medicine Regional Health Service Center(QML20231006)。
文摘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.
文摘Objective Helicobacter pylori(HP)infection is associated with non-alcoholic fatty liver disease(NAFLD)and insulin resistance;however,the correlation between HP eradication and NAFLD remains controversial.This systematic review and meta-analysis examined the effect of HP treatment on clinical and laboratory parameters in NAFLD patients.Methods We conducted a literature search of the PubMed,Embase,Scopus,and Web of Science databases through Septem-ber 2023 for randomized controlled trials(RCTs)examining the effect of HP treatment on NAFLD patients versus lifestyle changes alone.The primary outcome was the change in steatosis parameters.The secondary endpoints were changes in anthropometric parameters,inflammatory markers(TNF-α),and metabolic parameters(fasting blood glucose,homeostasis model assessment of insulin resistance,AST/ALT,and lipid profile).The random effects model was used to calculate the standardized mean difference(SMD)with associated 95%confidence intervals(CIs)for our desired outcome.Results Four RCTs met our inclusion criteria.A total of 453 patients were included(mean age 42.8 years,58.5%males),228(50.3%)of whom were in the HP eradication group and 225(49.7%)of whom were in the lifestyle modification group.Compared with lifestyle modification alone,HP eradication had a significant effect on reducing liver steatosis and TNF-αlevels(SMD:-0.9;95%CI-14.67,-3.82,I^(2)=0%and SMD:-6.3;95%CI-9.04,-3.56,I^(2)=0%,respectively).No sig-nificant effect on other metabolic parameters was found.Conclusions HP eradication significantly reduced liver steatosis and TNF-αlevels in NAFLD patients.However,HP eradi-cation did not significantly affect other metabolic indices compared to lifestyle changes alone.
基金National Key Research and Development Project:Clinical Evaluation of the Interventional Techniques for Abdominal Obesity(No.2019YFC1710102)。
文摘OBJECTIVE:To assess the efficacy and safety of the Qingyanyin formulated granules(轻燕饮配方颗粒,QYY),press needles(PN),and their combined application in addressing abdominal obesity(AO).This trial aims to offer a more scientifically grounded therapeutic regimen for clinical interventions.METHODS:From March 2021 to July 2021,a multicenter,triple-blind,randomized 2×2 factorial design clinical trial was conducted across 7 centers in 4 major cities within China's mainland.The trial participants were patients diagnosed with AO.The trial followed a 1∶1∶1∶1 random allocation ratio,assigning participants to one of four groups:QYY placebo plus simulated press needles(SPN)(placebo+SPN),QYY plus SPN(QYY+SPN),QYY placebo plus PN(placebo+PN),and QYY plus PN(QYY+PN).The trial participants received treatment for 12 weeks.Observe the changes in waist circumference,body weight,body mass index(BMI),Beck Depression Inventory(BDI),Beck Anxiety Inventory(BAI)scores,and Pittsburgh Sleep Quality Index(PSQI)before and after treatment.RESULTS:The QYY+PN group exhibited significant improvements in waist circumference compared to placebo+PN[Difference=-1.59,95%CI(-3.03,-0.16)]and placebo+SPN groups[Difference=-2.01,95%CI(-3.46,-0.57)].QYY+PN demonstrated a significant advantage over placebo+SPN[Difference=-2.01,95%CI(-3.46,-0.57)],and no statistically significant interaction was observed between the two interventions(P>0.05).In terms of weight and BMI improvements,the QYY+PN,QYY+SPN,and the PN+placebo groups all experienced trending greater reductions in weight compared to the placebo group.In terms of the total scores of PSQI,BAI,and BDI,all four groups exhibited improvements compared to the baseline.Specifically,concerning the change in total PSQI scores,the QYY+PN group exhibited a greater reduction;Regarding the change in total BAI scores,the PN+placebo group demonstrated a greater decrease;As for the change in total BDI scores,the QYY+SPN group displayed a greater reduction.CONCLUSION:This study confirmed that QYY+PN can effectively reduce the waist circumference of patients with AO.Furthermore,the combined approach offers greater benefits than either treatment alone,all without any reported serious adverse events.
基金supported by Tasly Pharmaceutical Group Co.,Ltd.(Grant No.303100031BA20)。
文摘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.
基金Supported by Fundamental Research Funds for the Central Universities:Research on the Mechanism of Hewei Jiangni Recipe on Nonerosive Gastroesophageal Reflux Based on the Correlation Analysis of Gut Microbiota and Metabolites (No. 2020-JYB-ZDGG-128)National Natural Science Foundation of China:Exploring the Molecular Mechanism of "Hewei Jiangni Fang" Intervention in Nonerosive Reflux Disease Esophageal Hypersensitivity from the Perspective of Mas-related Gene X2/Stromal Interaction Molecule 1/Cell Adhesion Molecule 1 Pathway Regulation of Mast Cell/Dorsal Root Ganglion Communication Based on the "Xinkai-Kujiang" Method (No. 82374401)
文摘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.
文摘OBJECTIVE:In recent years,the number of clinical research reports on acupuncture and manipulation for the treatment of greater occipital neuralgia has gradually increased,but the quality is uneven.There is currently no literature evaluating the quality of published reports,which is not conducive to the promotion of clinical use of these therapies.Therefore,this article assessed the reporting quality of randomized controlled trials on acupuncture and manipulation for greater occipital neuralgia.METHODS:Cochrane Library,PubMed,Web of Science,Embase,China National Knowledge Infrastructure(CNKI),VIP,WanFang Data,and Chinese BioMedical Literature Database(CBM)from inception to May 20,2024 were searched.The reporting quality of included randomized controlled trials was independently evaluated by two investigators using the CONSORT statement,STRICTA checklist,and Cochrane bias of risk assessment tool.A third investigator resolved any disagreement.RESULTS:A total of 62 articles were included.Based on the CONSORT statement,59.46%(22/37)of all entries had a reporting rate of less than 50%,mainly including“Identification as a randomized trial in the title(1/62,1.61%),”“How sample size was determined(7/62,11.29%),”“Implementation(1/62,1.61%),”“Blinding(1/62,1.61%),”and“Reports of Funding(4/62,6.45%).”According to the STRICTA checklist,29.41%(5/17)of all entries had a reporting rate of less than 50%,mainly including“Details of other interventions(7/58,12.07%),”“Setting and context of treatment(0/58,0%),”and“Description of participating acupuncturists(0/58,0%).”CONCLUSION:The reporting quality of randomized controlled trials on acupuncture and manipulation therapy for greater occipital neuralgia remains low.Future researchers need to make greater efforts to strictly adhere to the CONSORT statement and STRICTA checklist during trial design,implementation,and reporting.This will facilitate the standardization of research in this field and enhance the reliability and reproducibility of the research results.
文摘BACKGROUND Nutritional psychiatry is a rapidly expanding field of research,with mounting evidence suggesting that nutritional factors may play a role in the development of psychiatric disorders.AIM To examine the level of evidence for nutritional psychiatry.METHODS A scoping review was conducted to assess the current state of nutritional psychiatry,including a search for randomized controlled trials(RCTs).RESULTS The review identified a total of seven papers,with many concentrating on the relationship between depression and the gut microbiome.A salient issue that emerged from this review was the paucity of sample size in many studies.The inherent complexity of nutritional studies,characterized by a multitude of potential factors and exposures that often act as confounders,poses significant challenges to the development of effective RCT designs.The analysis revealed that probiotics,though demonstrating efficacy,exhibited a modest effect size.CONCLUSION Conducting RCTs with effective markers is imperative from these studies.The implementation of Mendelian randomization and the investigation of mechanisms in basic research are essential complementary approaches.
