BACKGROUND： Traditional Chinese medicine （TCM） is considered an important complementary therapy with beneficial effects for cancer patients. Elderly patients with non-small-cell lung cancer （NSCLC） are a complex ...BACKGROUND： Traditional Chinese medicine （TCM） is considered an important complementary therapy with beneficial effects for cancer patients. Elderly patients with non-small-cell lung cancer （NSCLC） are a complex patient group with increasing co-morbidity and shrinking physiological reserve, and may derive substantial benefit from the supportive aspects of TCM Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer. This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC. METHODS AND DESIGN： This is a double-blind controlled, multi-center, and prospective study with randomly selected participants from elderly NSCLC patients in China. Seventy-six patients who meet the inclusion criteria will be allocated into two groups, which will receive treatments of 3-week single-agent chemotherapy with TCM or placebo for four cycles Progression-free survival （PFS） is the primary end point, and the secondary end points are overall survival, objective response rate, time-to-progression, and quality of life （EORTC QLQ-LC43, and TCM syndrome score） Meanwhile, other end points such as toxicity, side effects and safety of the treatments will be assessed. DISCUSSION： Results from this study may provide evidence on the effectiveness, and parameters for the usage of single-agent chemotherapy combined with or without TCM on PFS of elderly patients with NSCLC.展开更多
Objective:To evaluate the clinical efficacy and safety of Xueshuantong Injection(Lyophilized)(XST)in reducing residual inflammatory risk(RIR)in patients with unstable angina(UA).Methods:This was a randomized,double-bl...Objective:To evaluate the clinical efficacy and safety of Xueshuantong Injection(Lyophilized)(XST)in reducing residual inflammatory risk(RIR)in patients with unstable angina(UA).Methods:This was a randomized,double-blind,parallel-controlled multicenter trial.Patients with UA were recruited from Xiyuan Hospital and Guang'anmen Hospital of the China Academy of Chinese Medical Sciences between January 2024 and March 2025.Eligible participants were randomly assigned to the treatment group(XST 500 mg,30 cases)or the control group(XST 25 mg,30 cases)in a 1:1 ratio.Both groups received intravenous XST for 10 consecutive days along with standard medical therapy.The primary outcome was change in C-reactive protein(CRP)level from baseline to post-treatment.Secondary outcomes included changes in interleukin-6(IL-6),matrix metalloproteinase-9(MMP-9),high-mobility group box 1(HMGB1),vascular endothelial growth factor(VEGF),and von Willebrand factor(vWF),as well as the Canadian Cardiovascular Society(CCS)classification,and Chinese Medicine(CM)syndrome scores.Safety was evaluated by monitoring adverse event(AE)and performing laboratory tests of liver and kidney function before and after treatment.Results:A total of 59 patients completed the trial(30 in the treatment group and 29 in the control group).After treatment,the treatment group showed significantly greater reductions in CRP levels compared to the control group(P<0.01).In addition,the treatment group exhibited significantly improved IL-6,MMP-9,and HMGB1 levels,as well as CM symptom scores and CCS classification compared to the control group(all P<0.05).No serious adverse events were reported.Compared with the control group,the treatment group receiving XST showed greater improvements in RIR and clinical symptoms in UA patients with good safety and tolerability.Conclusion:XST shows potential to reduce RIR in patients with UA and may inform anti-inflammatory management.(Registration No.ITMCTR2025000552).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
BACKGROUND Osteoarthritis(OA)of the knee is a prevalent degenerative joint disease that significantly impairs quality of life and functional mobility.Emerging regenerative therapies,such as stromal vascular fraction(S...BACKGROUND Osteoarthritis(OA)of the knee is a prevalent degenerative joint disease that significantly impairs quality of life and functional mobility.Emerging regenerative therapies,such as stromal vascular fraction(SVF)and nanofat,have demonstrated potential in cartilage repair and symptom alleviation.However,comparative clinical evidence evaluating their efficacy and safety remains limited.AIM To compare the clinical outcomes of SVF vs nanofat therapy in patients with primary knee OA.METHODS Conducted at Mother Cell Regenerative Centre,Trichy,over 18 months(June 2025 to December 2026),the study will enroll 30 patients,randomly assigned to two groups of 15 each.Both interventions will be administered as a single intra-articular injection under sterile conditions,with cell viability(>85%)confirmed by a standardized assay.Group A will receive autologous SVF injections,while Group B will receive autologous nanofat injections.The primary outcome measure is the change in pain scores at 12 months using the visual analog scale(VAS).Secondary outcomes include functional improvement assessed by Osteoarthritis Outcome Score(KOOS),Western Ontario and McMaster Universities(WOMAC),and International Knee Documentation Committee(IKDC)scores,cartilage regeneration evaluated via magnetic resonance imaging with colour coded mapping of the cartilage volume(MR cartigram),and monitoring of adverse events.RESULTS This study aims to evaluate pain reduction at 12 months post-injection,using the VAS as the primary outcome.Secondary outcomes include functional improvement(KOOS,WOMAC,IKDC),cartilage regeneration(T2 cartigram),adverse event incidence,patient satisfaction(standardized questionnaires,Likert scale),and quality of life(EQ-5D).Ethical considerations follow the Declaration of Helsinki and Good Clinical Practice,with IRB approval and participant informed consent ensured.Confidentiality and data security comply with regulations,and a Data Safety Monitoring Board oversees trial safety.Results will be shared via peer-reviewed journals,presentations at international orthopedic conferences,and detailed summaries for stakeholders and participants.The trial is registered under CTRI/2024/03/064076.Findings emphasize patient-centered advancements in knee osteoarthritis management.CONCLUSION This trial evaluates the efficacy and safety of SVF and nanofat therapies in knee OA,addressing a significant evidence gap.It employs robust methods to enhance cartilage repair and patient quality of life.Future research should standardize dosages,protocols,and injection techniques,explore autologous/allogenic preparations,and advance radiological tools,broadening accessibility and clinical applications.展开更多
BACKGROUND Knee osteoarthritis(OA)imposes a substantial burden through pain,functional limitation,and progressive cartilage loss.Bone marrow aspirate concentrate(BMAC)has emerged as a promising regenerative therapy fo...BACKGROUND Knee osteoarthritis(OA)imposes a substantial burden through pain,functional limitation,and progressive cartilage loss.Bone marrow aspirate concentrate(BMAC)has emerged as a promising regenerative therapy for OA due to its rich composition of mesenchymal stromal cells(MSCs)and bioactive factors.While intra-articular BMAC injections provide short-term symptomatic relief,recent literature suggests that targeting the subchondral bone—an area crucial to OA progression—may offer superior and longer-lasting clinical benefits.AIM To compares the outcomes of subchondral vs intra-articular BMAC injections in patients with primary knee OA.METHODS In this unicentric,double-blinded,randomized controlled trial,30 patients with radiologically confirmed primary knee OA(Kellgren-Lawrence grades II and III)will be equally randomized to receive either subchondral(Group A)or intra-articular(Group B)BMAC injections.BMAC will be harvested from the posterior iliac crest,processed using a standardized centrifugation protocol to yield a product with>85%cell viability,and administered under image guidance.The primary outcome is the change in pain intensity at 12 months as measured by the Visual Analog Scale(VAS).Secondary outcomes include functional improvement assessed by Knee Injury and Osteoarthritis Outcome Score(KOOS),International Knee Documentation Committee(IKDC),and Western Ontario and McMaster Universities Arthritis Index(WOMAC)scores,structural changes evaluated through advanced magnetic resonance imaging using(MRI)the whole-organ MRI Score,and safety as determined by the incidence of adverse events.RESULTS This study aims to evaluate pain reduction at 12 months post-injection,using the VAS as the primary outcome.Secondary outcomes include functional improvement(KOOS,WOMAC,IKDC),cartilage regeneration(T2 cartigram),adverse event incidence,patient satisfaction(standardized questionnaires,Likert scale),and quality of life(EQ-5D).Ethical considerations follow the Declaration of Helsinki and Good Clinical Practice,with institutional review board approval and participant informed consent ensured.Confidentiality and data security comply with regulations,and a data safety monitoring board oversees trial safety.Results will be shared via peer-reviewed journals,presentations at international orthopedic conferences,and detailed summaries for stakeholders and participants.The trial is registered under clinical trial registry of India/2024/04/065284.Findings emphasize patient-centered advancements in knee osteoarthritis management.CONCLUSION This trial aims to refine regenerative strategies for knee OA by comparing subchondral vs intra-articular BMAC injections,addressing long-term efficacy,safety,and treatment standardization to guide targeted interventions.This trial will provide critical insights into the comparative efficacy and safety of subchondral vs intra-articular BMAC injections in treating primary knee OA.展开更多
OBJECTIVE:To evaluate the clinical efficacy and safety of Tuomin Zhiti decoction(脱敏止嚏汤,TZD)in the shortterm treatment of seasonal allergic rhinitis(SAR).METHODS:This study is a randomized,double-blind placebo-con...OBJECTIVE:To evaluate the clinical efficacy and safety of Tuomin Zhiti decoction(脱敏止嚏汤,TZD)in the shortterm treatment of seasonal allergic rhinitis(SAR).METHODS:This study is a randomized,double-blind placebo-controlled,and single-center clinical trial.In April 2021,during the spring pollen season in Beijing,94 SAR patients aged 19-60 years were randomized(1∶1 ratio)to receive two weeks of TZD or placebo.The primary outcomes were the change of Total Nasal Symptom Score(TNSS)and Total Ocular Symptom Score(TOSS)from baseline to the end of treatment.Secondary outcomes were the changed score of the mini Rhinoconjunctivitis Quality of Life Questionnaire(RQLQ),Rescue Medication Score(RMS),and Patient Global Impression of Change(PGIC).All adverse events were recorded and evaluated by two senior physicians.RESULTS:TZD significantly reduced both the total nasal symptom scores and total ocular symptom scores compared to scores at baseline,while the placebo group showed an increasing trajectory in both symptom scores.Compared to the placebo group,the TZD group also showed a greater improvement in the quality of life,scores of RMS,nasal and eye symptoms scores after TZD treatment(P<0.001).Most notably,at the end of treatment,the proportion of remission measured by PGIC was significantly higher in the TZD group(82.97%)compared with the placebo group(47.72%,P<0.001).CONCLUSION:This study suggested that two weeks of TZD is an effective and safe treatment for SAR patients and spring pollen allergy,TZD could significantly improve the nasal and eye symptoms and improve the quality of life of patients.展开更多
OBJECTIVE:To evaluate the effect of Yiqi Liangxue Shengji prescription(益气凉血生肌方,YQLXSJ)on cardiac function and outcomes in acute myocardial infarction(AMI)patients with myocardial ischemiareperfusion injury(MIRI...OBJECTIVE:To evaluate the effect of Yiqi Liangxue Shengji prescription(益气凉血生肌方,YQLXSJ)on cardiac function and outcomes in acute myocardial infarction(AMI)patients with myocardial ischemiareperfusion injury(MIRI)and to determine its clinical efficacy.METHODS:This prospective,randomized,double-blind,placebo-controlled trial enrolled hospitalized patients with AMI who underwent percutaneous coronary intervention and experienced MIRI either intraoperatively or postoperatively.Participants were randomly allocated to the treatment group,which received YQLXSJ,or the control group,which received a placebo,concurrent with standard Western Medicine therapy.The intervention period lasted 8 weeks.The primary outcome measure was left ventricular ejection fraction(LVEF),determined by echocardiography.Secondary outcomes included Nterminal pro brain natriuretic peptide(NT-pro BNP)and cardiac troponin I(cTnI)levels,left ventricular internal diameter,major adverse cardiovascular events(MACE),angina pectoris scores,and Chinese medicine evidence scores.RESULTS:Following 8 weeks of intervention,the treatment group demonstrated a significant increase in LVEF and a marked reduction in NT-pro BNP when compared to the control group.There was also a significant decrease in peak cTnI levels,Chinese medicine evidence scores,and angina pectoris scores.The control group's left ventricular end-systolic diameter(LVESD)significantly increased compared to baseline after 8 weeks(P<0.05),whereas the treatment group's LVESD showed no significant change from baseline(P>0.05).Although the treatment group showed a downward trend in MACE incidence compared to the control group,this difference was not statistically significant(P>0.05).CONCLUSIONS:This study demonstrated that the addition of YQLXSJ to standard therapy can improve cardiac function and alleviate clinical symptoms in AMI patients with MIRI,and also showed a potential to mitigate the incidence of MACE.Furthermore,YQLXSJ displayed a favorable safety profile in clinical application.展开更多
Objective:To evaluate the efficacy and safety of Wuda Granule(WDG)on recovery of gastrointestinal function after laparoscopic bowel resection in the setting of enhanced recovery after surgery(ERAS)-based perioperative...Objective:To evaluate the efficacy and safety of Wuda Granule(WDG)on recovery of gastrointestinal function after laparoscopic bowel resection in the setting of enhanced recovery after surgery(ERAS)-based perioperative care.Methods:A total of 108 patients aged 18 years or older undergoing laparoscopic bowel resection with a surgical duration of 2 to 4.5 h were randomly assigned(1:1)to receive either WDG or placebo(10 g/bag)twice a day from postoperative days 1-3,combining with ERAS-based perioperative care.The primary outcome was time to first defecation.Secondary outcomes were time to first flatus,time to first tolerance of liquid or semi-liquid food,gastrointestinal-related symptoms and length of stay.Subgroup analysis of the primary outcome according to sex,age,tumor site,surgical time,histories of underlying disease or history of abdominal surgery was undertaken.Adverse eventse were observed and recorded.Results:A total of 107patients[53 in the WDG group and 54 in the placebo group;61.7±12.1 years;50 males(46.7%)]were included in the intention-to-treat analysis.The patients in the WDG group had a significantly shorter time to first defecation and flatus[between-group difference-11.01 h(95%CI-20.75 to-1.28 h),P=0.012 for defecation;-5.41 h(-11.10 to 0.27 h),P=0.040 for flatus]than the placebo group.Moreover,the extent of improvement in postoperative gastrointestinal-related symptoms in the WDG group was significantly better than that in the placebo group(P<0.05).Subgroup analyses revealed that the benefits of WDG were significantly superior in patients who were male,or under 60 years old,or surgical time less than 3 h,or having no history of basic disease or no history of abdominal surgery.There were no serious adverse events.Conclusion:The addition of WDG to an ERAS postoperative care may be a viable strategy to enhance gastrointestinal function recovery after laparoscopic bowel resection surgery.(Registry No.ChiCTR2100046242)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
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 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
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 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
OBJECTIVE: To evaluate the therapeutic effectiveness and safety of Jinying capsule on pelvic inflammatory disease(PID) in patients with symptoms identified as the pattern of damp and heat accumulation in terms of Trad...OBJECTIVE: To evaluate the therapeutic effectiveness and safety of Jinying capsule on pelvic inflammatory disease(PID) in patients with symptoms identified as the pattern of damp and heat accumulation in terms of Traditional Chinese Medicine(TCM).METHODS: We conducted a double-blinded, multicenter, randomized, placebo-controlled clinical trial which included 155 patients diagnosed with PID and identified as symptom pattern of damp and heat accumulation. They were randomly divided into experimental group(n = 78) and control group(n = 77) according to a random number table. The treatment lasted for a period of 28 d. The experimental group was given Jinying capsules and oral levofloxacin plus oral metronidazole for first 7 d.They continued with Jinying capsules and levofloxacin placebo and metronidazole placebo for another 7 d. For the remaining 14 d, they continued with Jinying capsules only. Whereas, the control group was treated with oral levofloxacin and metronidazole and Jinying capsule placebo for the first 14 d in the same way as the experimental group and then continued with Jinying capsule placebo only for the remaining 14 d. The clinical efficacy was assessed using McCormack scale, TCM symptom pattern scores, physicochemical indexes including white blood cell and erythrocyte sedimentation rate, C-reaction protein, smear of vaginal discharge,and pelvic ultrasound.RESULTS: Comparing McCormack scale between both groups after treatment, the difference in curative effect between both groups was significant (P = 0.0269). The cure rate of the experimental group and control group is 76.32% and 59.46% respectively at week 4. Comparing TCM symptom pattern scores between both groups before and after treatment, the differences in total effective rate were both significant(P < 0.05). The curative effect rate of experimental group is 2.63% and 13.70% of the control group at week 1(P = 0.0131), and73.33% of the experimental group and 56.94% of the control group at week 4(P = 0.0369). No significant differences were found between the two groups on the Physicochemical indexes(all P >0.05). No adverse events or reactions occurred in the experimental groups.CONCLUSION: Jinying capsule can reduce the dosage of antibiotics needed for PID treatment, and improve the symptoms in PID patients.展开更多
BACKGROUND Nutritional psychiatry is a rapidly expanding field of research,with mounting evidence suggesting that nutritional factors may play a role in the development of psychiatric disorders.AIM To examine the leve...BACKGROUND Nutritional psychiatry is a rapidly expanding field of research,with mounting evidence suggesting that nutritional factors may play a role in the development of psychiatric disorders.AIM To examine the level of evidence for nutritional psychiatry.METHODS A scoping review was conducted to assess the current state of nutritional psychiatry,including a search for randomized controlled trials(RCTs).RESULTS The review identified a total of seven papers,with many concentrating on the relationship between depression and the gut microbiome.A salient issue that emerged from this review was the paucity of sample size in many studies.The inherent complexity of nutritional studies,characterized by a multitude of potential factors and exposures that often act as confounders,poses significant challenges to the development of effective RCT designs.The analysis revealed that probiotics,though demonstrating efficacy,exhibited a modest effect size.CONCLUSION Conducting RCTs with effective markers is imperative from these studies.The implementation of Mendelian randomization and the investigation of mechanisms in basic research are essential complementary approaches.展开更多
OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Tot...OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Totally 304 RA patients were assigned to two groups:one group was administered Xinfeng capsule(XFC) plus the placebo of leflunomide and the other given leflunomide(LEF) plus the placebo of XFC for twelve weeks.The clinical and laboratory parameters were compared at baseline and fourth,eighth,and twelfth weeks.RESULTS:After twelve-week treatment,patients in two groups all showed some trend of effectiveness when compared in terms of American Rheumatism Association(ACR) recommended 20%,50%,70%improvement criteria,but it was insignificant.The validity in ameliorate modified disease activity score(DAS28) and laboratory indexes as erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF) were also found no difference.The score of health assessment questionnaire(HAQ),self-rating anxiety scale(SAS),self-rating depression scale(SDS) and quality of life questionnaire with rheumatoid arthritis(RAQOL)both lower than the first week and the changes showed no difference.However,the score of SDS dropped more in XFC group than in the other.A total of 147 adverse reaction cases were reported,which shows no difference between the two groups.The most common adverse reactions were hepatic impairment,anemia,leukocytopenia,epigastric discomfort and phalacrosis.CONCLUSION:XFC demonstrated better improvement in the scores of SDS and compared with those of LEF group.展开更多
基金supported by the Longhua Medicial Project (D-11)The Science and Technology Commission of Shanghai Municipality (No.12401905700)
文摘BACKGROUND： Traditional Chinese medicine （TCM） is considered an important complementary therapy with beneficial effects for cancer patients. Elderly patients with non-small-cell lung cancer （NSCLC） are a complex patient group with increasing co-morbidity and shrinking physiological reserve, and may derive substantial benefit from the supportive aspects of TCM Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer. This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC. METHODS AND DESIGN： This is a double-blind controlled, multi-center, and prospective study with randomly selected participants from elderly NSCLC patients in China. Seventy-six patients who meet the inclusion criteria will be allocated into two groups, which will receive treatments of 3-week single-agent chemotherapy with TCM or placebo for four cycles Progression-free survival （PFS） is the primary end point, and the secondary end points are overall survival, objective response rate, time-to-progression, and quality of life （EORTC QLQ-LC43, and TCM syndrome score） Meanwhile, other end points such as toxicity, side effects and safety of the treatments will be assessed. DISCUSSION： Results from this study may provide evidence on the effectiveness, and parameters for the usage of single-agent chemotherapy combined with or without TCM on PFS of elderly patients with NSCLC.
基金Supported by the Beijing Traditional Chinese Medicine Science and Technology Development Fund Project(No.BJZYYB-2023-53)the Capital Health Development Research Special Fund(No.2024-2-4173)。
文摘Objective:To evaluate the clinical efficacy and safety of Xueshuantong Injection(Lyophilized)(XST)in reducing residual inflammatory risk(RIR)in patients with unstable angina(UA).Methods:This was a randomized,double-blind,parallel-controlled multicenter trial.Patients with UA were recruited from Xiyuan Hospital and Guang'anmen Hospital of the China Academy of Chinese Medical Sciences between January 2024 and March 2025.Eligible participants were randomly assigned to the treatment group(XST 500 mg,30 cases)or the control group(XST 25 mg,30 cases)in a 1:1 ratio.Both groups received intravenous XST for 10 consecutive days along with standard medical therapy.The primary outcome was change in C-reactive protein(CRP)level from baseline to post-treatment.Secondary outcomes included changes in interleukin-6(IL-6),matrix metalloproteinase-9(MMP-9),high-mobility group box 1(HMGB1),vascular endothelial growth factor(VEGF),and von Willebrand factor(vWF),as well as the Canadian Cardiovascular Society(CCS)classification,and Chinese Medicine(CM)syndrome scores.Safety was evaluated by monitoring adverse event(AE)and performing laboratory tests of liver and kidney function before and after treatment.Results:A total of 59 patients completed the trial(30 in the treatment group and 29 in the control group).After treatment,the treatment group showed significantly greater reductions in CRP levels compared to the control group(P<0.01).In addition,the treatment group exhibited significantly improved IL-6,MMP-9,and HMGB1 levels,as well as CM symptom scores and CCS classification compared to the control group(all P<0.05).No serious adverse events were reported.Compared with the control group,the treatment group receiving XST showed greater improvements in RIR and clinical symptoms in UA patients with good safety and tolerability.Conclusion:XST shows potential to reduce RIR in patients with UA and may inform anti-inflammatory management.(Registration No.ITMCTR2025000552).
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BACKGROUND Osteoarthritis(OA)of the knee is a prevalent degenerative joint disease that significantly impairs quality of life and functional mobility.Emerging regenerative therapies,such as stromal vascular fraction(SVF)and nanofat,have demonstrated potential in cartilage repair and symptom alleviation.However,comparative clinical evidence evaluating their efficacy and safety remains limited.AIM To compare the clinical outcomes of SVF vs nanofat therapy in patients with primary knee OA.METHODS Conducted at Mother Cell Regenerative Centre,Trichy,over 18 months(June 2025 to December 2026),the study will enroll 30 patients,randomly assigned to two groups of 15 each.Both interventions will be administered as a single intra-articular injection under sterile conditions,with cell viability(>85%)confirmed by a standardized assay.Group A will receive autologous SVF injections,while Group B will receive autologous nanofat injections.The primary outcome measure is the change in pain scores at 12 months using the visual analog scale(VAS).Secondary outcomes include functional improvement assessed by Osteoarthritis Outcome Score(KOOS),Western Ontario and McMaster Universities(WOMAC),and International Knee Documentation Committee(IKDC)scores,cartilage regeneration evaluated via magnetic resonance imaging with colour coded mapping of the cartilage volume(MR cartigram),and monitoring of adverse events.RESULTS This study aims to evaluate pain reduction at 12 months post-injection,using the VAS as the primary outcome.Secondary outcomes include functional improvement(KOOS,WOMAC,IKDC),cartilage regeneration(T2 cartigram),adverse event incidence,patient satisfaction(standardized questionnaires,Likert scale),and quality of life(EQ-5D).Ethical considerations follow the Declaration of Helsinki and Good Clinical Practice,with IRB approval and participant informed consent ensured.Confidentiality and data security comply with regulations,and a Data Safety Monitoring Board oversees trial safety.Results will be shared via peer-reviewed journals,presentations at international orthopedic conferences,and detailed summaries for stakeholders and participants.The trial is registered under CTRI/2024/03/064076.Findings emphasize patient-centered advancements in knee osteoarthritis management.CONCLUSION This trial evaluates the efficacy and safety of SVF and nanofat therapies in knee OA,addressing a significant evidence gap.It employs robust methods to enhance cartilage repair and patient quality of life.Future research should standardize dosages,protocols,and injection techniques,explore autologous/allogenic preparations,and advance radiological tools,broadening accessibility and clinical applications.
文摘BACKGROUND Knee osteoarthritis(OA)imposes a substantial burden through pain,functional limitation,and progressive cartilage loss.Bone marrow aspirate concentrate(BMAC)has emerged as a promising regenerative therapy for OA due to its rich composition of mesenchymal stromal cells(MSCs)and bioactive factors.While intra-articular BMAC injections provide short-term symptomatic relief,recent literature suggests that targeting the subchondral bone—an area crucial to OA progression—may offer superior and longer-lasting clinical benefits.AIM To compares the outcomes of subchondral vs intra-articular BMAC injections in patients with primary knee OA.METHODS In this unicentric,double-blinded,randomized controlled trial,30 patients with radiologically confirmed primary knee OA(Kellgren-Lawrence grades II and III)will be equally randomized to receive either subchondral(Group A)or intra-articular(Group B)BMAC injections.BMAC will be harvested from the posterior iliac crest,processed using a standardized centrifugation protocol to yield a product with>85%cell viability,and administered under image guidance.The primary outcome is the change in pain intensity at 12 months as measured by the Visual Analog Scale(VAS).Secondary outcomes include functional improvement assessed by Knee Injury and Osteoarthritis Outcome Score(KOOS),International Knee Documentation Committee(IKDC),and Western Ontario and McMaster Universities Arthritis Index(WOMAC)scores,structural changes evaluated through advanced magnetic resonance imaging using(MRI)the whole-organ MRI Score,and safety as determined by the incidence of adverse events.RESULTS This study aims to evaluate pain reduction at 12 months post-injection,using the VAS as the primary outcome.Secondary outcomes include functional improvement(KOOS,WOMAC,IKDC),cartilage regeneration(T2 cartigram),adverse event incidence,patient satisfaction(standardized questionnaires,Likert scale),and quality of life(EQ-5D).Ethical considerations follow the Declaration of Helsinki and Good Clinical Practice,with institutional review board approval and participant informed consent ensured.Confidentiality and data security comply with regulations,and a data safety monitoring board oversees trial safety.Results will be shared via peer-reviewed journals,presentations at international orthopedic conferences,and detailed summaries for stakeholders and participants.The trial is registered under clinical trial registry of India/2024/04/065284.Findings emphasize patient-centered advancements in knee osteoarthritis management.CONCLUSION This trial aims to refine regenerative strategies for knee OA by comparing subchondral vs intra-articular BMAC injections,addressing long-term efficacy,safety,and treatment standardization to guide targeted interventions.This trial will provide critical insights into the comparative efficacy and safety of subchondral vs intra-articular BMAC injections in treating primary knee OA.
基金Supported by the Fundamental Research Funds for the Central Universities(No.2023-JYB-JBZD-009)High level Key Discipline of National Administration of Traditional Chinese Medicine-Traditional Chinese Constitutional Medicine(No.zyyzdxk-2023251)+1 种基金General program of National Natural Science Foundation of China:Study on the Mechanism of"the Simultaneous Prevention of Different Diseases"of Allergic Constitution Regulating Formula based on DNA Trap Mediated Eosinophil-Derived Dendritic Cells Cell Crosstalk(No.82174243)General Project of Beijing Natural Science Foundation:Study on the Mechanism of Guominkang for Treating Allergic Rhinitis through Regulating Body Constitution based on Vacuolating Cytotoxin A-mediated Eosinophil-derived Dendritic Cell Cell immune microenvironment(No.7242227)。
文摘OBJECTIVE:To evaluate the clinical efficacy and safety of Tuomin Zhiti decoction(脱敏止嚏汤,TZD)in the shortterm treatment of seasonal allergic rhinitis(SAR).METHODS:This study is a randomized,double-blind placebo-controlled,and single-center clinical trial.In April 2021,during the spring pollen season in Beijing,94 SAR patients aged 19-60 years were randomized(1∶1 ratio)to receive two weeks of TZD or placebo.The primary outcomes were the change of Total Nasal Symptom Score(TNSS)and Total Ocular Symptom Score(TOSS)from baseline to the end of treatment.Secondary outcomes were the changed score of the mini Rhinoconjunctivitis Quality of Life Questionnaire(RQLQ),Rescue Medication Score(RMS),and Patient Global Impression of Change(PGIC).All adverse events were recorded and evaluated by two senior physicians.RESULTS:TZD significantly reduced both the total nasal symptom scores and total ocular symptom scores compared to scores at baseline,while the placebo group showed an increasing trajectory in both symptom scores.Compared to the placebo group,the TZD group also showed a greater improvement in the quality of life,scores of RMS,nasal and eye symptoms scores after TZD treatment(P<0.001).Most notably,at the end of treatment,the proportion of remission measured by PGIC was significantly higher in the TZD group(82.97%)compared with the placebo group(47.72%,P<0.001).CONCLUSION:This study suggested that two weeks of TZD is an effective and safe treatment for SAR patients and spring pollen allergy,TZD could significantly improve the nasal and eye symptoms and improve the quality of life of patients.
基金Supported by the Capital’s Funds for Health Improvement and Research:Clinical Study on Yiqi Liangxue Shengji Prescription for Improving Cardiac Function after Myocardial Ischemia Reperfusion Injury in Patients with Acute Myocardial Infarction(CFH 2020-4-4204)Beijing University of Traditional Chinese Medicine Qihuang Yingcai·Excellent Young Science and Technology Talent Cultivation Program(K2023A03)Beijing University of Traditional Chinese Medicine Dongfang Hospital High-level Capacity Building Project"Zhuoyuan"Project National Talent Precision Cultivation Program(DFRCZY-2024GJRC012)。
文摘OBJECTIVE:To evaluate the effect of Yiqi Liangxue Shengji prescription(益气凉血生肌方,YQLXSJ)on cardiac function and outcomes in acute myocardial infarction(AMI)patients with myocardial ischemiareperfusion injury(MIRI)and to determine its clinical efficacy.METHODS:This prospective,randomized,double-blind,placebo-controlled trial enrolled hospitalized patients with AMI who underwent percutaneous coronary intervention and experienced MIRI either intraoperatively or postoperatively.Participants were randomly allocated to the treatment group,which received YQLXSJ,or the control group,which received a placebo,concurrent with standard Western Medicine therapy.The intervention period lasted 8 weeks.The primary outcome measure was left ventricular ejection fraction(LVEF),determined by echocardiography.Secondary outcomes included Nterminal pro brain natriuretic peptide(NT-pro BNP)and cardiac troponin I(cTnI)levels,left ventricular internal diameter,major adverse cardiovascular events(MACE),angina pectoris scores,and Chinese medicine evidence scores.RESULTS:Following 8 weeks of intervention,the treatment group demonstrated a significant increase in LVEF and a marked reduction in NT-pro BNP when compared to the control group.There was also a significant decrease in peak cTnI levels,Chinese medicine evidence scores,and angina pectoris scores.The control group's left ventricular end-systolic diameter(LVESD)significantly increased compared to baseline after 8 weeks(P<0.05),whereas the treatment group's LVESD showed no significant change from baseline(P>0.05).Although the treatment group showed a downward trend in MACE incidence compared to the control group,this difference was not statistically significant(P>0.05).CONCLUSIONS:This study demonstrated that the addition of YQLXSJ to standard therapy can improve cardiac function and alleviate clinical symptoms in AMI patients with MIRI,and also showed a potential to mitigate the incidence of MACE.Furthermore,YQLXSJ displayed a favorable safety profile in clinical application.
基金Supported by the Special Subsidy for Clinical Research of Guangdong Provincial Hospital of Chinese Medicine(No.YN10101902)the Double First-Class and High-Level University Discipline Collaborative Innovation Team Project of Guangzhou University of Chinese Medicine(No.2021xk48)。
文摘Objective:To evaluate the efficacy and safety of Wuda Granule(WDG)on recovery of gastrointestinal function after laparoscopic bowel resection in the setting of enhanced recovery after surgery(ERAS)-based perioperative care.Methods:A total of 108 patients aged 18 years or older undergoing laparoscopic bowel resection with a surgical duration of 2 to 4.5 h were randomly assigned(1:1)to receive either WDG or placebo(10 g/bag)twice a day from postoperative days 1-3,combining with ERAS-based perioperative care.The primary outcome was time to first defecation.Secondary outcomes were time to first flatus,time to first tolerance of liquid or semi-liquid food,gastrointestinal-related symptoms and length of stay.Subgroup analysis of the primary outcome according to sex,age,tumor site,surgical time,histories of underlying disease or history of abdominal surgery was undertaken.Adverse eventse were observed and recorded.Results:A total of 107patients[53 in the WDG group and 54 in the placebo group;61.7±12.1 years;50 males(46.7%)]were included in the intention-to-treat analysis.The patients in the WDG group had a significantly shorter time to first defecation and flatus[between-group difference-11.01 h(95%CI-20.75 to-1.28 h),P=0.012 for defecation;-5.41 h(-11.10 to 0.27 h),P=0.040 for flatus]than the placebo group.Moreover,the extent of improvement in postoperative gastrointestinal-related symptoms in the WDG group was significantly better than that in the placebo group(P<0.05).Subgroup analyses revealed that the benefits of WDG were significantly superior in patients who were male,or under 60 years old,or surgical time less than 3 h,or having no history of basic disease or no history of abdominal surgery.There were no serious adverse events.Conclusion:The addition of WDG to an ERAS postoperative care may be a viable strategy to enhance gastrointestinal function recovery after laparoscopic bowel resection surgery.(Registry No.ChiCTR2100046242)
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.
文摘Objective Helicobacter pylori(HP)infection is associated with non-alcoholic fatty liver disease(NAFLD)and insulin resistance;however,the correlation between HP eradication and NAFLD remains controversial.This systematic review and meta-analysis examined the effect of HP treatment on clinical and laboratory parameters in NAFLD patients.Methods We conducted a literature search of the PubMed,Embase,Scopus,and Web of Science databases through Septem-ber 2023 for randomized controlled trials(RCTs)examining the effect of HP treatment on NAFLD patients versus lifestyle changes alone.The primary outcome was the change in steatosis parameters.The secondary endpoints were changes in anthropometric parameters,inflammatory markers(TNF-α),and metabolic parameters(fasting blood glucose,homeostasis model assessment of insulin resistance,AST/ALT,and lipid profile).The random effects model was used to calculate the standardized mean difference(SMD)with associated 95%confidence intervals(CIs)for our desired outcome.Results Four RCTs met our inclusion criteria.A total of 453 patients were included(mean age 42.8 years,58.5%males),228(50.3%)of whom were in the HP eradication group and 225(49.7%)of whom were in the lifestyle modification group.Compared with lifestyle modification alone,HP eradication had a significant effect on reducing liver steatosis and TNF-αlevels(SMD:-0.9;95%CI-14.67,-3.82,I^(2)=0%and SMD:-6.3;95%CI-9.04,-3.56,I^(2)=0%,respectively).No sig-nificant effect on other metabolic parameters was found.Conclusions HP eradication significantly reduced liver steatosis and TNF-αlevels in NAFLD patients.However,HP eradi-cation did not significantly affect other metabolic indices compared to lifestyle changes alone.
基金Supported by 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OBJECTIVE: To evaluate the therapeutic effectiveness and safety of Jinying capsule on pelvic inflammatory disease(PID) in patients with symptoms identified as the pattern of damp and heat accumulation in terms of Traditional Chinese Medicine(TCM).METHODS: We conducted a double-blinded, multicenter, randomized, placebo-controlled clinical trial which included 155 patients diagnosed with PID and identified as symptom pattern of damp and heat accumulation. They were randomly divided into experimental group(n = 78) and control group(n = 77) according to a random number table. The treatment lasted for a period of 28 d. The experimental group was given Jinying capsules and oral levofloxacin plus oral metronidazole for first 7 d.They continued with Jinying capsules and levofloxacin placebo and metronidazole placebo for another 7 d. For the remaining 14 d, they continued with Jinying capsules only. Whereas, the control group was treated with oral levofloxacin and metronidazole and Jinying capsule placebo for the first 14 d in the same way as the experimental group and then continued with Jinying capsule placebo only for the remaining 14 d. The clinical efficacy was assessed using McCormack scale, TCM symptom pattern scores, physicochemical indexes including white blood cell and erythrocyte sedimentation rate, C-reaction protein, smear of vaginal discharge,and pelvic ultrasound.RESULTS: Comparing McCormack scale between both groups after treatment, the difference in curative effect between both groups was significant (P = 0.0269). The cure rate of the experimental group and control group is 76.32% and 59.46% respectively at week 4. Comparing TCM symptom pattern scores between both groups before and after treatment, the differences in total effective rate were both significant(P < 0.05). The curative effect rate of experimental group is 2.63% and 13.70% of the control group at week 1(P = 0.0131), and73.33% of the experimental group and 56.94% of the control group at week 4(P = 0.0369). No significant differences were found between the two groups on the Physicochemical indexes(all P >0.05). No adverse events or reactions occurred in the experimental groups.CONCLUSION: Jinying capsule can reduce the dosage of antibiotics needed for PID treatment, and improve the symptoms in PID patients.
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.
基金Supported by the Key Projects in the National Science&Technology Pillar Program in the Twelfth Five-Year Plan Period:Clinical Research on Xin'an Medicine Prevention and Treatment of Difficult Diseases of Chinese Medicine(No.2012BA126B02).ClinicalTrials.gov Identifier:NCT01774877
文摘OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Totally 304 RA patients were assigned to two groups:one group was administered Xinfeng capsule(XFC) plus the placebo of leflunomide and the other given leflunomide(LEF) plus the placebo of XFC for twelve weeks.The clinical and laboratory parameters were compared at baseline and fourth,eighth,and twelfth weeks.RESULTS:After twelve-week treatment,patients in two groups all showed some trend of effectiveness when compared in terms of American Rheumatism Association(ACR) recommended 20%,50%,70%improvement criteria,but it was insignificant.The validity in ameliorate modified disease activity score(DAS28) and laboratory indexes as erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF) were also found no difference.The score of health assessment questionnaire(HAQ),self-rating anxiety scale(SAS),self-rating depression scale(SDS) and quality of life questionnaire with rheumatoid arthritis(RAQOL)both lower than the first week and the changes showed no difference.However,the score of SDS dropped more in XFC group than in the other.A total of 147 adverse reaction cases were reported,which shows no difference between the two groups.The most common adverse reactions were hepatic impairment,anemia,leukocytopenia,epigastric discomfort and phalacrosis.CONCLUSION:XFC demonstrated better improvement in the scores of SDS and compared with those of LEF group.
