1.Introduction Phase Ⅱ trials are typically designed to identify promising treatment therapies that warrant further investigation in subsequent phase Ⅲ con-firmatory trials,playing a vital role in evidence generatio...1.Introduction Phase Ⅱ trials are typically designed to identify promising treatment therapies that warrant further investigation in subsequent phase Ⅲ con-firmatory trials,playing a vital role in evidence generation of drug de-velopment.The basic design features of phase II trials include interim go/no-go decisions to prevent exposing too many patients to poten-tially ineffective treatments.Appropriate go/no-go decisions and effi-cient trial designs can shorten the research duration and increase trial success rates.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:This study aimed to assess the feasibility and safety of the SHURUI single-port robotic surgical system for a range of major urological surgeries.Methods:In this prospective,multicenter clinical trial,we exa...Objective:This study aimed to assess the feasibility and safety of the SHURUI single-port robotic surgical system for a range of major urological surgeries.Methods:In this prospective,multicenter clinical trial,we examined the effectiveness of the SHURUI single-port robotic surgical system in urological interventions.The first 50 patients from four centers in China underwent single-port surgeries including partial nephrectomy,radical prostatectomy,partial adrenalectomy,and pyeloureteroplasty,exclusively by the SHURUI single-port robotic surgical system.The study's primary endpoints focused on the success of surgeries,defined as no deviations from planned procedures,no need for more than one port,and no re-operations within 24 h after surgery.Secondary endpoints encompassed a range of surgical metrics,functional outcomes,and patient demographic data.Clinical assessments were conducted before surgery,before discharge,and 1 month after discharge.Results:The surgical procedures were executed successfully without requiring intraoperative conversions or transfusions.Both estimated blood loss and operation durations were maintained within satisfactory limits.For each type of surgery,the mean console times and estimated blood loss were 179.8(standard deviation[SD]39.4)min and 125.6(SD 126.0)mL for radical prostatectomy,126.7(SD 47.8)min and 39.2(SD 54.4)mL for partial nephrectomy,112.6(SD 37.4)min and 20.0(SD 13.2)mL for partial adrenalectomy,and 148.0(SD 18.2)min and 18.0(SD 17.9)mL for pyeloureteroplasty,respectively.Across the cohort,17 patients experienced a total of 25 adverse events,while 10 postoperative complications,all rated as Clavien-Dindo grade I,were encountered by eight patients.All patients had shown recovery or improvement from these events before the end of this trial.Conclusion:The SHURUI single-port robotic surgical system demonstrated feasibility and safety in the performance of major urological surgeries.These initial findings highlight the system's potential,though further research and longer follow-up are required to assess long-term outcomes.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: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:Electroacupuncture(EA)may affect the severity of hot flashes(HFs)associated with natural menopause and provide additional benefits for postmenopausal women.However,the evidence for its effectiveness in the ...Background:Electroacupuncture(EA)may affect the severity of hot flashes(HFs)associated with natural menopause and provide additional benefits for postmenopausal women.However,the evidence for its effectiveness in the management of early postmenopausal HFs remains inadequately understood.Objective:We designed this trial to assess the efficacy and safety of EA for relieving early postmenopausal HFs.Design,setting,participants and interventions:This randomized sham-controlled trial involved 72 women with HFs.The participants were divided equally into the intervention and control groups.The intervention group was treated with EA,while the control group was treated with sham acupuncture.The main acupoints used were Hegu(LI4),Guanyuan(RN4),Sanyinjiao(SP6),Taixi(KI3),Fuliu(KI7)and Shenshu(BL23).All participants received 18 treatment sessions,distributed across a 6-week period.The treatment was administered on three occasions per week,adhering to a fixed weekday schedule(Monday,Wednesday,Friday or Tuesday,Thursday,Saturday)with a minimum interval of one day between sessions.Each patient received a 12-week follow-up.Main outcome measures:The HF score was the primary outcome.Participants documented the frequency and severity of HFs in a 7-day symptom diary,which provided data for calculating the HF score.Secondary outcomes were the Menopause Rating Scale(MRS),Menopause-Specific Quality of Life Questionnaire(MENQOL),Pittsburgh Sleep Quality Index(PSQI)and Traditional Chinese Medicine Syndrome Score Scale(TCMSSS),as well as estradiol(E2),luteinizing hormone(LH)and folliclestimulating hormone(FSH)levels.Results:Both groups demonstrated significant reductions in HF scores after the treatment and during the follow-up(P<0.001).Immediately after completion of the 6-week treatment cycle and at 12 weeks postintervention,the HF scores were similar in both groups.At week 6,the intervention group showed significantly greater improvements in MRS,MENQOL(vasomotor,psychosocial,and physical),PSQI and TCMSSS scores(P<0.05).The improvements in the MENQOL(vasomotor,and psychosocial)and PSQI total scores persisted through the follow-up(P<0.05).However,the results showed no significant inter-or intragroup differences in sexual scores on the MENQOL(P>0.05).EA did not significantly decrease E2,LH or FSH levels compared to placebo.The incidence of adverse events was similar in both groups.Conclusion:EA does not significantly improve HFs in early postmenopausal patients.However,it enhances the quality of sleep and decreases menopausal symptoms across vasomotor,psychosocial and physical domains.Trial registration:Chinese Clinical Trial Registry(http://www.chictr.org.cn);Trial ID:Chi CTR2300072002.Please cite this article as:Wang HX,Yu XT,Hu J,Chen JJ,Mei YT,Chen YF.Electroacupuncture for hot flashes in early menopause:A randomized sham-controlled trial.J Integr Med.2025;23(5):519-527.?2025 Shanghai Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine.Published by Elsevier B.V.All rights are reserved,including those for text and data mining,AI training,and similar technologies.展开更多
Objective This study aimed to analyze the adverse effects(AEs)of sacituzumab govitecan(SG)through multiple sources of data to provide a reference for clinical safety management.Methods Clinical trials of SG with avail...Objective This study aimed to analyze the adverse effects(AEs)of sacituzumab govitecan(SG)through multiple sources of data to provide a reference for clinical safety management.Methods Clinical trials of SG with available safety data were retrieved and included in the pooled analysis.The adverse drug reaction(ADR)signals of SG were collected from the FDA Adverse Event Reporting System(FAERS)database.Drug interactions with SG in the DDInter database were summarized.Results A total of 6 clinical trials involving 1737 patients were included in the pooled analysis,and the most common AEs of≥grade 3 were neutropenia(46%),leukopenia(13%),and anemia(8%).In the pharmacovigilance study,1024 AE reports were extracted,and the most common toxicities of SG were hematologic and gastrointestinal.AEs not included in the drug instructions also presented high signals,such as meningitis,colitis and lymphedema.A total of 40 drugs identified could induce drug–drug interactions when they were concomitantly administered with SG.Conclusions This study provides the most comprehensive profile of SG toxicity on the basis of data from clinical trials and the FRAES and DDInter databases.Attention should be given not only to common ADRs but also to ADRs not reported in drug instructions,and potential drugs that can induce drug–drug interactions.展开更多
Background Unsedated colonoscopy is an important method used for diagnosing colorectal cancer,but it can cause discomfort such as pain and bloating,as well as anxiety.At present,the relief is mainly achieved through m...Background Unsedated colonoscopy is an important method used for diagnosing colorectal cancer,but it can cause discomfort such as pain and bloating,as well as anxiety.At present,the relief is mainly achieved through methods such as changing positions and manual pressing,but the efficacy is limited.Hence alternative therapies for sedation and analgesia in unsedated colonoscopy warrant further study.Electroacupuncture(EA)can simplify the procedure of anesthesia and analgesia,while the efficacy of EA on unsedated colonoscopy remains unclear.Therefore,a well-designed randomized controlled trial is needed to demonstrate the potential efficacy of acupuncture in unsedated colonoscopy,particularly for pain relief.Methods In this prospective randomized sham-controlled trial,105 eligible participants will be recruited and randomly assigned to either EA group(n=35),sham EA group(n=35),or control group(n=35)in a 1:1:1 ratio.The EA group will receive acupuncture intervention on bilateral Hegu(LI4),Neiguan(PC6),Zusanli(ST36),and Shenmen(HT7),with LI4 and PC6 on both sides connected to the EA device.The sham EA group will received non transdermal needling on points of no meridian,and deliberately connect the needle to the incorrect output socket of EA device to block the stimulation.The needling will conducted from 30 min before the unsedated colonoscopy to the end of the colonoscopy,the whole retention time would be approximately 40 min.The participants in the control group will not receive any acupuncture intervention.All participants of the three groups will not receive any other treatment.Primary outcomes:Numerical Rating Scale(NRS)reported by participants and Face Pain Scale Revised(FPS-R)evaluated by observers of four areas of the participants during the unsedated colonoscopy.Secondary outcomes:tolerance reported by endoscopists,tolerance reported by participants,satisfaction reported by endoscopists,satisfaction reported by participants,adverse events during the unsedated colonoscopy,postoperative discomfort,unsedated colonoscopy smoothness(cecal insertion time,unwinding time,success rate of one-time intubation).Both intention-to-treat(ITT)and per-protocol(PP)analyses will be performed to assess the efficacy of EA.Discussion The trial will explore the efficacy of relieving pain,improving tolerability,and reducing undesirable adverse events of EA for unsedated colonoscopy.The results of this trial will provide sound evidence for promoting the clinical application of EA for unsedated colonoscopy.Trial registration ClinicalTrials.gov Identifier:ChiCTR2300069903,retrospectively registered on March 16,2023.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
BACKGROUND Systematic reviews(SRs)synthesize and evaluate data,mainly from randomized trials,which then guides the development of clinical recommendations in evidence-based medicine.However,the data and methodological...BACKGROUND Systematic reviews(SRs)synthesize and evaluate data,mainly from randomized trials,which then guides the development of clinical recommendations in evidence-based medicine.However,the data and methodological information in the included papers can often be lacking or unclear,and reviewers usually need to contact the authors of included studies for clarifications.Contacting authors is recommended,but it is unclear how often SR teams do it,or what the level of response is.AIM To investigate how often reviewers undertake contact with the authors of included randomized controlled trials(RCTs)for clarification on data and risk of bias concerns,to explore the factors that influence whether SR authors contact or do not contact the authors,and the content and level of responses.METHODS We conducted a systematic electronic database search in MEDLINE using the search string“(systematic review)”AND“(RCT OR randomized OR trial)”for articles published between 1 January 2024 and 19 February 2024,without language restrictions.Screening and data extraction was done independently by two reviewers,and conflicts resolved by a senior author.Contact authors of included SRs were contacted for clarifications.RESULTS Of the 329 included SRs,38%(n=125)explicitly mentioned contact with the authors of included studies.The remaining 62%(n=204)did not.We attempted contact with all SR teams for clarifications and received 90 responses(19.4%).Of the 50 respondents who did not explicitly mention contact in their SRs,25(50%)replied that they did make contact.We received a total of 64 responses on the level and content of information sought.The mean±SD contacts SR teams made were 10(10),replies received 5(6.7),and response waiting time 10.1(28.3)weeks.Resources,time,poor previous experience,perceived likelihood of poor response and bias concerns were reported as barriers to attempting contact.CONCLUSION The majority of SRs published in 2024 did not confirm seeking clarifying or missing information from primary study authors.However,SR teams reported that 50%of contacted primary authors respond.Additional research can clarify this rate of response and establish methods to increase the integration of this core methodological element in SRs.展开更多
OBJECTIVE:To examine the effect of electroacupuncture(EA)application on postoperative pain levels and the amount of analgesic use in patients who underwent periodontal flap surgery.METHODS:In this prospective,randomiz...OBJECTIVE:To examine the effect of electroacupuncture(EA)application on postoperative pain levels and the amount of analgesic use in patients who underwent periodontal flap surgery.METHODS:In this prospective,randomized and controlled study,patients planned for periodontal surgery were divided into two groups[EA group(n=22):patients who received electroacupuncture and control group(n=22):patients who did not receive electroacupuncture].Electroacupuncture was applied bilaterally to the Hegu(LI4),Daying(ST5),and Jiache(ST5)points of the patients in the EA group immediately before and after the flap surgery for 30 min at a frequency of 50 Hz to each point at a current that the patient could tolerate.The patients in the control group underwent flap surgery without applying electroacupuncture.Patients were asked to record their pain levels on the visual analog scale and the number of analgesic tablets they took during the 7 postoperative days on the given form.RESULTS:The total mean score of pain felt in the EA group(16.60±2.78)was found to be significantly lower than that in the control group(31.37±2.78)(P=0.001).No significant difference was found between the groups regarding the amount of analgesics taken(4.77±4.72,5.82±3.11)(P=0.111).CONCLUSIONS:Our study shows that electroacupuncture application is beneficial in reducing pain after periodontal flap surgery.Overall,more research is needed to fully understand the effects of electroacupuncture on postoperative pain.展开更多
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 Pharmacological treatments are commonly used in individuals experiencing perinatal depression(PPD);however,a debate regarding the reproductive safety of antidepressants is ongoing.Many pregnant women opt to...BACKGROUND Pharmacological treatments are commonly used in individuals experiencing perinatal depression(PPD);however,a debate regarding the reproductive safety of antidepressants is ongoing.Many pregnant women opt to discontinue antidepressant out of concern about potential negative effects on the developing fetus,while slow and ineffective antidepressant medications hinder improved outcomes in women with PPD.In recent years,bright light therapy(BLT)has gained traction as a treatment option for PPD;however,clinical trials findings examining the efficacy of BLT in this population have been inconclusive.AIM To validate the feasibility and safety of BLT for the treatment of PPD.METHODS We performed a meta-analysis of randomized controlled trials of patients with PPD treated with BLT vs placebo following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis.We searched PubMed,Embase,the Cochrane Library,and Web of Science for randomized controlled studies published up to December 2023.The results were evaluated using the standardized mean difference of improvement for depression scores and odds ratios(ORs)for remission rate,response rate,incidence of adverse events,and dropout rate.RESULTS The BLT group had higher PPD response rate[50.68%vs 33.08%;OR=2.05;95% confidence interval(CI):1.25-3.35;P=0.004;I^(2)=35%]and remission rate(54.10%vs 18.52%;OR=5.00;95%CI:2.09-11.99;P=0.0003;I^(2)=0%)than the placebo group.Improvements in depression scores were higher in the BLT group than the placebo group for the overall efficacy(standardized mean difference=-0.47;95%CI:-0.80 to-0.13;P=0.007).No significant differences between the two groups in drop-outs(21.84%vs 29.63%;OR=0.63;95%CI:0.31-1.29;P=0.21;I^(2)=0%)or adverse events(17.89%vs 9.68%;OR=2.01;95%CI:0.95-4.25;P=0.07;I^(2)=0%)were observed.CONCLUSION BLT can potentially treat PPD,showing better results than the control group in this study.BLT is effective and safe and could increase the available therapeutic options for PPD.展开更多
BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in ...BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in RCTs of hepatocellular carci-noma(HCC),the response rates and survival status,and adverse events(AEs)were summarized and evaluated.AIM To systematically evaluate the response rates,survival status and AEs in the placebo arms of RCTs for HCC.METHODS A systematic search was performed on PubMed,Ovid MEDLINE,Embase and Cochrane Library to identify relevant trials evaluating the efficacy of drugs for the treatment of HCC,published until December 31,2023.Statistical analysis was performed using R statistical software(version 4.3.2).RESULTS A total of 18 RCTs,involving 2390 patients,met the criteria for inclusion in the meta-analysis.The pooled overall disease control rate and objective response rate in the placebo group were 38%[95%confidence interval(CI):33%-42%]and 1%(95%CI:1%-2%),respectively.Overall survival and progression-free survival in the placebo group were 7.9 months(95%CI:7.6-8.31 months)and 1.9 months(95%CI:1.6-2.1 months),respectively.The incidence of grade 3 or 4 AEs was 37%(95%CI:30%-43%).Additionally,the incidence of interruptions or dose reductions due to AEs was 20%(95%CI:13%-27%),while the incidence of treatment discontinuation due to AEs was 9%(95%CI:6%-12%).CONCLUSION Over one-third of advanced HCC patients exhibit therapy-free disease control,with placebo-arm AEs observed.These findings guide single-arm trials design and enhance patient acceptance of anticancer therapies.展开更多
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 evaluate the efficacy and safety of 14-day Qingwei Zhitong pellets(清胃止痛微丸,QZ)-containing quadruple therapy(QZQT)compared to bismuth-containing quadruple therapy(BQT)in treatment-naive patients with ...OBJECTIVE:To evaluate the efficacy and safety of 14-day Qingwei Zhitong pellets(清胃止痛微丸,QZ)-containing quadruple therapy(QZQT)compared to bismuth-containing quadruple therapy(BQT)in treatment-naive patients with Helicobacter pylori(H.pylori)infection.METHODS:This single-center,randomized controlled clinical trial enrolled 333 patients,who were divided into either the QZQT group(QZ pellets,3.2 g,three times daily;rabeprazole,10 mg,twice daily;amoxicillin 1000 mg,twice daily;clarithromycin,500 mg,twice daily)or the BQT group(bismuth potassium citrate,1000 mg,three times daily;rabeprazole,10 mg,twice daily;amoxicillin,1000 mg,twice daily;clarithromycin,500 mg,twice daily)for 14 d.The 13C-urea breath test assessed eradication success at least four weeks after treatment.The primary outcome focused on the eradication rate,with secondary outcomes including safety and patient compliance.RESULTS:From August 2022 to June 2023,342 subjects were screened,and 333 were randomized.The QZQT and BQT groups showed eradication rates of 68.9%and 67.8%(P=0.838)by intention-to-treat(ITT)analysis,respectively,and 71.1%and 68.3%(P=0.612)by perprotocol(PP)analysis,respectively.QZQT was non-inferior to BQT in both ITT and PP analyses.QZQT was associated with fewer side effects(57.8%of patients)than BQT(90.4%)(P<0.001).CONCLUSION:The 14 d QZQT treatment demonstrates equal efficacy in eradicating H.pylori infection and improved patient compliance and safety compared to BQT.These results provide evidence supporting 14-day QZQT as an acceptable treatment for H.pylori infection.展开更多
In recent years,the obstetrics department has advocated vaginal delivery to reduce the rate of cesarean sections.However,in clinical practice,pregnant women are prone to anxiety before childbirth,making it difficult t...In recent years,the obstetrics department has advocated vaginal delivery to reduce the rate of cesarean sections.However,in clinical practice,pregnant women are prone to anxiety before childbirth,making it difficult to perform a vaginal trial delivery smoothly.The combined approach of ADIET communication and delivery rehearsal for vaginal trial delivery can provide a reference for reducing prenatal anxiety,shortening labor duration,facilitating a smooth delivery,and ensuring the safety of both mothers and babies.AIM To analyze the effect of AIDET communication combined with labor rehearsal on vaginal trial delivery.METHODS A study conducted between January 2023 and December 2023 included 200 vaginal trials.Women were randomly assigned to an observation group(100 women),which received ADIET communication plus delivery intervention,and a control group(100 women),which received routine communication plus delivery intervention.This study aimed to compare antenatal anxiety status as measured using the Maternal Anxiety Scale,labor duration,delivery efficacy as assessed using the simplified Chinese version of the Childbirth Self-Efficacy Inventory,and delivery outcomes.RESULTS After the intervention,the observation group had a lower Maternal Anxiety Scale score and higher Childbirth Self-Efficacy Inventory score(P<0.05)than the control group(P<0.05),whereas the observation group had higher natural delivery,cesarean delivery,vaginal delivery,and neonatal asphyxia rates(P<0.05).CONCLUSION For women undergoing vaginal trial delivery,a combination of AIDET communication and delivery rehearsal can relieve prenatal anxiety,enhance delivery efficiency,shorten labor duration,and somewhat improve delivery outcomes.展开更多
Sham acupuncture,as a control intervention in acupuncture studies,has been widely conducted to eval-uate the specific effect of acupuncture.However,there was no relevant particular reporting guideline,so the reporting...Sham acupuncture,as a control intervention in acupuncture studies,has been widely conducted to eval-uate the specific effect of acupuncture.However,there was no relevant particular reporting guideline,so the reporting quality of sham acupuncture was low,which could hinder the precise understanding and interpretation of details and implementation background of sham acupuncture by researchers.In order to standardize the reporting of sham acupuncture and improve its quality,SHam Acupuncture REporting guidelines and a checklist in clinical trials(SHARE)was developed by a research team from Beijing Univer-sity of Chinese Medicine.The SAHRE standardizes the reporting of sham acupuncture from 10 categories,including brief name,rationales,details of sham acupuncture,treatment regimen of sham acupuncture,the information informed or explained to patients,practitioner information,modifications of protocol,communication between practitioner and patient,practitioner adherence and blinding.This article elab-orates the development process and key content of SHARE in order to facilitate its application by re-searchers.展开更多
基金funded by Beijing Nova Program(grant number:20230484277)National Natural Science Foundation of China(grant number:82303955).
文摘1.Introduction Phase Ⅱ trials are typically designed to identify promising treatment therapies that warrant further investigation in subsequent phase Ⅲ con-firmatory trials,playing a vital role in evidence generation of drug de-velopment.The basic design features of phase II trials include interim go/no-go decisions to prevent exposing too many patients to poten-tially ineffective treatments.Appropriate go/no-go decisions and effi-cient trial designs can shorten the research duration and increase trial success rates.
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funded by the National Key Research and Development Program of China(Grant No.2022YFB4700904 to Wang L)the Shanghai Shenkang Hospital Development Center's project for the Promotion of Clinical Skills and Clinical Innovation Three-Year Action Plan(Project No.SHDC2022CRT006 to Wang L and SHDC2022CRS010B to Tang S).
文摘Objective:This study aimed to assess the feasibility and safety of the SHURUI single-port robotic surgical system for a range of major urological surgeries.Methods:In this prospective,multicenter clinical trial,we examined the effectiveness of the SHURUI single-port robotic surgical system in urological interventions.The first 50 patients from four centers in China underwent single-port surgeries including partial nephrectomy,radical prostatectomy,partial adrenalectomy,and pyeloureteroplasty,exclusively by the SHURUI single-port robotic surgical system.The study's primary endpoints focused on the success of surgeries,defined as no deviations from planned procedures,no need for more than one port,and no re-operations within 24 h after surgery.Secondary endpoints encompassed a range of surgical metrics,functional outcomes,and patient demographic data.Clinical assessments were conducted before surgery,before discharge,and 1 month after discharge.Results:The surgical procedures were executed successfully without requiring intraoperative conversions or transfusions.Both estimated blood loss and operation durations were maintained within satisfactory limits.For each type of surgery,the mean console times and estimated blood loss were 179.8(standard deviation[SD]39.4)min and 125.6(SD 126.0)mL for radical prostatectomy,126.7(SD 47.8)min and 39.2(SD 54.4)mL for partial nephrectomy,112.6(SD 37.4)min and 20.0(SD 13.2)mL for partial adrenalectomy,and 148.0(SD 18.2)min and 18.0(SD 17.9)mL for pyeloureteroplasty,respectively.Across the cohort,17 patients experienced a total of 25 adverse events,while 10 postoperative complications,all rated as Clavien-Dindo grade I,were encountered by eight patients.All patients had shown recovery or improvement from these events before the end of this trial.Conclusion:The SHURUI single-port robotic surgical system demonstrated feasibility and safety in the performance of major urological surgeries.These initial findings highlight the system's potential,though further research and longer follow-up are required to assess long-term outcomes.
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.
文摘OBJECTIVE:In recent years,the number of clinical research reports on acupuncture and manipulation for the treatment of greater occipital neuralgia has gradually increased,but the quality is uneven.There is currently no literature evaluating the quality of published reports,which is not conducive to the promotion of clinical use of these therapies.Therefore,this article assessed the reporting quality of randomized controlled trials on acupuncture and manipulation for greater occipital neuralgia.METHODS:Cochrane Library,PubMed,Web of Science,Embase,China National Knowledge Infrastructure(CNKI),VIP,WanFang Data,and Chinese BioMedical Literature Database(CBM)from inception to May 20,2024 were searched.The reporting quality of included randomized controlled trials was independently evaluated by two investigators using the CONSORT statement,STRICTA checklist,and Cochrane bias of risk assessment tool.A third investigator resolved any disagreement.RESULTS:A total of 62 articles were included.Based on the CONSORT statement,59.46%(22/37)of all entries had a reporting rate of less than 50%,mainly including“Identification as a randomized trial in the title(1/62,1.61%),”“How sample size was determined(7/62,11.29%),”“Implementation(1/62,1.61%),”“Blinding(1/62,1.61%),”and“Reports of Funding(4/62,6.45%).”According to the STRICTA checklist,29.41%(5/17)of all entries had a reporting rate of less than 50%,mainly including“Details of other interventions(7/58,12.07%),”“Setting and context of treatment(0/58,0%),”and“Description of participating acupuncturists(0/58,0%).”CONCLUSION:The reporting quality of randomized controlled trials on acupuncture and manipulation therapy for greater occipital neuralgia remains low.Future researchers need to make greater efforts to strictly adhere to the CONSORT statement and STRICTA checklist during trial design,implementation,and reporting.This will facilitate the standardization of research in this field and enhance the reliability and reproducibility of the research results.
基金supported by Shanghai Clinical Research Center for Acupuncture and Moxibustion(No.20MC1920500)National Administration of Traditional Chinese Medicine High-Level Disciplines Construction Project(No.ZYYZDXK-2023068)Three Year Action Plan for Shanghai to Further Accelerate the Inheritance,Innovation and Development of Traditional Chinese Medicine(2025-2027)(No.1-1-2)。
文摘Background:Electroacupuncture(EA)may affect the severity of hot flashes(HFs)associated with natural menopause and provide additional benefits for postmenopausal women.However,the evidence for its effectiveness in the management of early postmenopausal HFs remains inadequately understood.Objective:We designed this trial to assess the efficacy and safety of EA for relieving early postmenopausal HFs.Design,setting,participants and interventions:This randomized sham-controlled trial involved 72 women with HFs.The participants were divided equally into the intervention and control groups.The intervention group was treated with EA,while the control group was treated with sham acupuncture.The main acupoints used were Hegu(LI4),Guanyuan(RN4),Sanyinjiao(SP6),Taixi(KI3),Fuliu(KI7)and Shenshu(BL23).All participants received 18 treatment sessions,distributed across a 6-week period.The treatment was administered on three occasions per week,adhering to a fixed weekday schedule(Monday,Wednesday,Friday or Tuesday,Thursday,Saturday)with a minimum interval of one day between sessions.Each patient received a 12-week follow-up.Main outcome measures:The HF score was the primary outcome.Participants documented the frequency and severity of HFs in a 7-day symptom diary,which provided data for calculating the HF score.Secondary outcomes were the Menopause Rating Scale(MRS),Menopause-Specific Quality of Life Questionnaire(MENQOL),Pittsburgh Sleep Quality Index(PSQI)and Traditional Chinese Medicine Syndrome Score Scale(TCMSSS),as well as estradiol(E2),luteinizing hormone(LH)and folliclestimulating hormone(FSH)levels.Results:Both groups demonstrated significant reductions in HF scores after the treatment and during the follow-up(P<0.001).Immediately after completion of the 6-week treatment cycle and at 12 weeks postintervention,the HF scores were similar in both groups.At week 6,the intervention group showed significantly greater improvements in MRS,MENQOL(vasomotor,psychosocial,and physical),PSQI and TCMSSS scores(P<0.05).The improvements in the MENQOL(vasomotor,and psychosocial)and PSQI total scores persisted through the follow-up(P<0.05).However,the results showed no significant inter-or intragroup differences in sexual scores on the MENQOL(P>0.05).EA did not significantly decrease E2,LH or FSH levels compared to placebo.The incidence of adverse events was similar in both groups.Conclusion:EA does not significantly improve HFs in early postmenopausal patients.However,it enhances the quality of sleep and decreases menopausal symptoms across vasomotor,psychosocial and physical domains.Trial registration:Chinese Clinical Trial Registry(http://www.chictr.org.cn);Trial ID:Chi CTR2300072002.Please cite this article as:Wang HX,Yu XT,Hu J,Chen JJ,Mei YT,Chen YF.Electroacupuncture for hot flashes in early menopause:A randomized sham-controlled trial.J Integr Med.2025;23(5):519-527.?2025 Shanghai Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine.Published by Elsevier B.V.All rights are reserved,including those for text and data mining,AI training,and similar technologies.
基金supported by grants from the National Natural Science Foundation of China(82200212)and(81902934).
文摘Objective This study aimed to analyze the adverse effects(AEs)of sacituzumab govitecan(SG)through multiple sources of data to provide a reference for clinical safety management.Methods Clinical trials of SG with available safety data were retrieved and included in the pooled analysis.The adverse drug reaction(ADR)signals of SG were collected from the FDA Adverse Event Reporting System(FAERS)database.Drug interactions with SG in the DDInter database were summarized.Results A total of 6 clinical trials involving 1737 patients were included in the pooled analysis,and the most common AEs of≥grade 3 were neutropenia(46%),leukopenia(13%),and anemia(8%).In the pharmacovigilance study,1024 AE reports were extracted,and the most common toxicities of SG were hematologic and gastrointestinal.AEs not included in the drug instructions also presented high signals,such as meningitis,colitis and lymphedema.A total of 40 drugs identified could induce drug–drug interactions when they were concomitantly administered with SG.Conclusions This study provides the most comprehensive profile of SG toxicity on the basis of data from clinical trials and the FRAES and DDInter databases.Attention should be given not only to common ADRs but also to ADRs not reported in drug instructions,and potential drugs that can induce drug–drug interactions.
基金Supported by National Basic Evidence-based Capacity Building Project of Traditional Chinese Medicine([2019]130)Natural Science Foundation of Liaoning Province:2024-MS-042+1 种基金Xingliao Talent Program Medical Master Project:YXMJ-QNMZY-10Liaoning University of Traditional Chinese Medicine Key Laboratory of Traditional Chinese Medicine Theory and Application of Ministry of Education open fund project:zyzx2302.
文摘Background Unsedated colonoscopy is an important method used for diagnosing colorectal cancer,but it can cause discomfort such as pain and bloating,as well as anxiety.At present,the relief is mainly achieved through methods such as changing positions and manual pressing,but the efficacy is limited.Hence alternative therapies for sedation and analgesia in unsedated colonoscopy warrant further study.Electroacupuncture(EA)can simplify the procedure of anesthesia and analgesia,while the efficacy of EA on unsedated colonoscopy remains unclear.Therefore,a well-designed randomized controlled trial is needed to demonstrate the potential efficacy of acupuncture in unsedated colonoscopy,particularly for pain relief.Methods In this prospective randomized sham-controlled trial,105 eligible participants will be recruited and randomly assigned to either EA group(n=35),sham EA group(n=35),or control group(n=35)in a 1:1:1 ratio.The EA group will receive acupuncture intervention on bilateral Hegu(LI4),Neiguan(PC6),Zusanli(ST36),and Shenmen(HT7),with LI4 and PC6 on both sides connected to the EA device.The sham EA group will received non transdermal needling on points of no meridian,and deliberately connect the needle to the incorrect output socket of EA device to block the stimulation.The needling will conducted from 30 min before the unsedated colonoscopy to the end of the colonoscopy,the whole retention time would be approximately 40 min.The participants in the control group will not receive any acupuncture intervention.All participants of the three groups will not receive any other treatment.Primary outcomes:Numerical Rating Scale(NRS)reported by participants and Face Pain Scale Revised(FPS-R)evaluated by observers of four areas of the participants during the unsedated colonoscopy.Secondary outcomes:tolerance reported by endoscopists,tolerance reported by participants,satisfaction reported by endoscopists,satisfaction reported by participants,adverse events during the unsedated colonoscopy,postoperative discomfort,unsedated colonoscopy smoothness(cecal insertion time,unwinding time,success rate of one-time intubation).Both intention-to-treat(ITT)and per-protocol(PP)analyses will be performed to assess the efficacy of EA.Discussion The trial will explore the efficacy of relieving pain,improving tolerability,and reducing undesirable adverse events of EA for unsedated colonoscopy.The results of this trial will provide sound evidence for promoting the clinical application of EA for unsedated colonoscopy.Trial registration ClinicalTrials.gov Identifier:ChiCTR2300069903,retrospectively registered on March 16,2023.
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.
文摘BACKGROUND Systematic reviews(SRs)synthesize and evaluate data,mainly from randomized trials,which then guides the development of clinical recommendations in evidence-based medicine.However,the data and methodological information in the included papers can often be lacking or unclear,and reviewers usually need to contact the authors of included studies for clarifications.Contacting authors is recommended,but it is unclear how often SR teams do it,or what the level of response is.AIM To investigate how often reviewers undertake contact with the authors of included randomized controlled trials(RCTs)for clarification on data and risk of bias concerns,to explore the factors that influence whether SR authors contact or do not contact the authors,and the content and level of responses.METHODS We conducted a systematic electronic database search in MEDLINE using the search string“(systematic review)”AND“(RCT OR randomized OR trial)”for articles published between 1 January 2024 and 19 February 2024,without language restrictions.Screening and data extraction was done independently by two reviewers,and conflicts resolved by a senior author.Contact authors of included SRs were contacted for clarifications.RESULTS Of the 329 included SRs,38%(n=125)explicitly mentioned contact with the authors of included studies.The remaining 62%(n=204)did not.We attempted contact with all SR teams for clarifications and received 90 responses(19.4%).Of the 50 respondents who did not explicitly mention contact in their SRs,25(50%)replied that they did make contact.We received a total of 64 responses on the level and content of information sought.The mean±SD contacts SR teams made were 10(10),replies received 5(6.7),and response waiting time 10.1(28.3)weeks.Resources,time,poor previous experience,perceived likelihood of poor response and bias concerns were reported as barriers to attempting contact.CONCLUSION The majority of SRs published in 2024 did not confirm seeking clarifying or missing information from primary study authors.However,SR teams reported that 50%of contacted primary authors respond.Additional research can clarify this rate of response and establish methods to increase the integration of this core methodological element in SRs.
文摘OBJECTIVE:To examine the effect of electroacupuncture(EA)application on postoperative pain levels and the amount of analgesic use in patients who underwent periodontal flap surgery.METHODS:In this prospective,randomized and controlled study,patients planned for periodontal surgery were divided into two groups[EA group(n=22):patients who received electroacupuncture and control group(n=22):patients who did not receive electroacupuncture].Electroacupuncture was applied bilaterally to the Hegu(LI4),Daying(ST5),and Jiache(ST5)points of the patients in the EA group immediately before and after the flap surgery for 30 min at a frequency of 50 Hz to each point at a current that the patient could tolerate.The patients in the control group underwent flap surgery without applying electroacupuncture.Patients were asked to record their pain levels on the visual analog scale and the number of analgesic tablets they took during the 7 postoperative days on the given form.RESULTS:The total mean score of pain felt in the EA group(16.60±2.78)was found to be significantly lower than that in the control group(31.37±2.78)(P=0.001).No significant difference was found between the groups regarding the amount of analgesics taken(4.77±4.72,5.82±3.11)(P=0.111).CONCLUSIONS:Our study shows that electroacupuncture application is beneficial in reducing pain after periodontal flap surgery.Overall,more research is needed to fully understand the effects of electroacupuncture on postoperative pain.
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 the Hebei Province Natural Science Foundation,No.H2018206034 and No.H2022206544Hebei Province clinical medicine outstanding personnel training project,No.ZF2024135.
文摘BACKGROUND Pharmacological treatments are commonly used in individuals experiencing perinatal depression(PPD);however,a debate regarding the reproductive safety of antidepressants is ongoing.Many pregnant women opt to discontinue antidepressant out of concern about potential negative effects on the developing fetus,while slow and ineffective antidepressant medications hinder improved outcomes in women with PPD.In recent years,bright light therapy(BLT)has gained traction as a treatment option for PPD;however,clinical trials findings examining the efficacy of BLT in this population have been inconclusive.AIM To validate the feasibility and safety of BLT for the treatment of PPD.METHODS We performed a meta-analysis of randomized controlled trials of patients with PPD treated with BLT vs placebo following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis.We searched PubMed,Embase,the Cochrane Library,and Web of Science for randomized controlled studies published up to December 2023.The results were evaluated using the standardized mean difference of improvement for depression scores and odds ratios(ORs)for remission rate,response rate,incidence of adverse events,and dropout rate.RESULTS The BLT group had higher PPD response rate[50.68%vs 33.08%;OR=2.05;95% confidence interval(CI):1.25-3.35;P=0.004;I^(2)=35%]and remission rate(54.10%vs 18.52%;OR=5.00;95%CI:2.09-11.99;P=0.0003;I^(2)=0%)than the placebo group.Improvements in depression scores were higher in the BLT group than the placebo group for the overall efficacy(standardized mean difference=-0.47;95%CI:-0.80 to-0.13;P=0.007).No significant differences between the two groups in drop-outs(21.84%vs 29.63%;OR=0.63;95%CI:0.31-1.29;P=0.21;I^(2)=0%)or adverse events(17.89%vs 9.68%;OR=2.01;95%CI:0.95-4.25;P=0.07;I^(2)=0%)were observed.CONCLUSION BLT can potentially treat PPD,showing better results than the control group in this study.BLT is effective and safe and could increase the available therapeutic options for PPD.
文摘BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in RCTs of hepatocellular carci-noma(HCC),the response rates and survival status,and adverse events(AEs)were summarized and evaluated.AIM To systematically evaluate the response rates,survival status and AEs in the placebo arms of RCTs for HCC.METHODS A systematic search was performed on PubMed,Ovid MEDLINE,Embase and Cochrane Library to identify relevant trials evaluating the efficacy of drugs for the treatment of HCC,published until December 31,2023.Statistical analysis was performed using R statistical software(version 4.3.2).RESULTS A total of 18 RCTs,involving 2390 patients,met the criteria for inclusion in the meta-analysis.The pooled overall disease control rate and objective response rate in the placebo group were 38%[95%confidence interval(CI):33%-42%]and 1%(95%CI:1%-2%),respectively.Overall survival and progression-free survival in the placebo group were 7.9 months(95%CI:7.6-8.31 months)and 1.9 months(95%CI:1.6-2.1 months),respectively.The incidence of grade 3 or 4 AEs was 37%(95%CI:30%-43%).Additionally,the incidence of interruptions or dose reductions due to AEs was 20%(95%CI:13%-27%),while the incidence of treatment discontinuation due to AEs was 9%(95%CI:6%-12%).CONCLUSION Over one-third of advanced HCC patients exhibit therapy-free disease control,with placebo-arm AEs observed.These findings guide single-arm trials design and enhance patient acceptance of anticancer therapies.
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 China Zhongguancun Precision Medicine Science and Technology Foundation:Study on the Evaluation of Eradication Rate and Safety of Helicobacter Pylori in a Quadruple Therapy using Qingwei Zhitong Pellets as a Substitute for Bismuth Agent(320.6799.2022.09.24)。
文摘OBJECTIVE:To evaluate the efficacy and safety of 14-day Qingwei Zhitong pellets(清胃止痛微丸,QZ)-containing quadruple therapy(QZQT)compared to bismuth-containing quadruple therapy(BQT)in treatment-naive patients with Helicobacter pylori(H.pylori)infection.METHODS:This single-center,randomized controlled clinical trial enrolled 333 patients,who were divided into either the QZQT group(QZ pellets,3.2 g,three times daily;rabeprazole,10 mg,twice daily;amoxicillin 1000 mg,twice daily;clarithromycin,500 mg,twice daily)or the BQT group(bismuth potassium citrate,1000 mg,three times daily;rabeprazole,10 mg,twice daily;amoxicillin,1000 mg,twice daily;clarithromycin,500 mg,twice daily)for 14 d.The 13C-urea breath test assessed eradication success at least four weeks after treatment.The primary outcome focused on the eradication rate,with secondary outcomes including safety and patient compliance.RESULTS:From August 2022 to June 2023,342 subjects were screened,and 333 were randomized.The QZQT and BQT groups showed eradication rates of 68.9%and 67.8%(P=0.838)by intention-to-treat(ITT)analysis,respectively,and 71.1%and 68.3%(P=0.612)by perprotocol(PP)analysis,respectively.QZQT was non-inferior to BQT in both ITT and PP analyses.QZQT was associated with fewer side effects(57.8%of patients)than BQT(90.4%)(P<0.001).CONCLUSION:The 14 d QZQT treatment demonstrates equal efficacy in eradicating H.pylori infection and improved patient compliance and safety compared to BQT.These results provide evidence supporting 14-day QZQT as an acceptable treatment for H.pylori infection.
文摘In recent years,the obstetrics department has advocated vaginal delivery to reduce the rate of cesarean sections.However,in clinical practice,pregnant women are prone to anxiety before childbirth,making it difficult to perform a vaginal trial delivery smoothly.The combined approach of ADIET communication and delivery rehearsal for vaginal trial delivery can provide a reference for reducing prenatal anxiety,shortening labor duration,facilitating a smooth delivery,and ensuring the safety of both mothers and babies.AIM To analyze the effect of AIDET communication combined with labor rehearsal on vaginal trial delivery.METHODS A study conducted between January 2023 and December 2023 included 200 vaginal trials.Women were randomly assigned to an observation group(100 women),which received ADIET communication plus delivery intervention,and a control group(100 women),which received routine communication plus delivery intervention.This study aimed to compare antenatal anxiety status as measured using the Maternal Anxiety Scale,labor duration,delivery efficacy as assessed using the simplified Chinese version of the Childbirth Self-Efficacy Inventory,and delivery outcomes.RESULTS After the intervention,the observation group had a lower Maternal Anxiety Scale score and higher Childbirth Self-Efficacy Inventory score(P<0.05)than the control group(P<0.05),whereas the observation group had higher natural delivery,cesarean delivery,vaginal delivery,and neonatal asphyxia rates(P<0.05).CONCLUSION For women undergoing vaginal trial delivery,a combination of AIDET communication and delivery rehearsal can relieve prenatal anxiety,enhance delivery efficiency,shorten labor duration,and somewhat improve delivery outcomes.
文摘Sham acupuncture,as a control intervention in acupuncture studies,has been widely conducted to eval-uate the specific effect of acupuncture.However,there was no relevant particular reporting guideline,so the reporting quality of sham acupuncture was low,which could hinder the precise understanding and interpretation of details and implementation background of sham acupuncture by researchers.In order to standardize the reporting of sham acupuncture and improve its quality,SHam Acupuncture REporting guidelines and a checklist in clinical trials(SHARE)was developed by a research team from Beijing Univer-sity of Chinese Medicine.The SAHRE standardizes the reporting of sham acupuncture from 10 categories,including brief name,rationales,details of sham acupuncture,treatment regimen of sham acupuncture,the information informed or explained to patients,practitioner information,modifications of protocol,communication between practitioner and patient,practitioner adherence and blinding.This article elab-orates the development process and key content of SHARE in order to facilitate its application by re-searchers.
