Randomized controlled trials(RCTs)have long been recognized as the gold standard for establishing causal relationships in clinical research.Despite that,various limitations of RCTs prevent its widespread implementatio...Randomized controlled trials(RCTs)have long been recognized as the gold standard for establishing causal relationships in clinical research.Despite that,various limitations of RCTs prevent its widespread implementation,ranging from the ethicality of withholding potentially-lifesaving treatment from a group to relatively poor external validity due to stringent inclusion criteria,amongst others.However,with the introduction of propensity score matching(PSM)as a retrospective statistical tool,new frontiers in establishing causation in clinical research were opened up.PSM predicts treatment effects using observational data from existing sources such as registries or electronic health records,to create a matched sample of participants who received or did not receive the intervention based on their propensity scores,which takes into account characteristics such as age,gender and comorbidities.Given its retrospective nature and its use of observational data from existing sources,PSM circumvents the aforementioned ethical issues faced by RCTs.Majority of RCTs exclude elderly,pregnant women and young children;thus,evidence of therapy efficacy is rarely proven by robust clinical research for this population.On the other hand,by matching study patient characteristics to that of the population of interest,including the elderly,pregnant women and young children,PSM allows for generalization of results to the wider population and hence greatly increases the external validity.Instead of replacing RCTs with PSM,the synergistic integration of PSM into RCTs stands to provide better research outcomes with both methods complementing each other.For example,in an RCT investigating the impact of mannitol on outcomes among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial,the baseline characteristics of comorbidities and current medications between treatment and control arms were significantly different despite the randomization protocol.Therefore,PSM was incorporated in its analysis to create samples from the treatment and control arms that were matched in terms of these baseline characteristics,thus providing a fairer comparison for the impact of mannitol.This literature review reports the applications,advantages,and considerations of using PSM with RCTs,illustrating its utility in refining randomization,improving external validity,and accounting for non-compliance to protocol.Future research should consider integrating the use of PSM in RCTs to better generalize outcomes to target populations for clinical practice and thereby benefit a wider range of patients,while maintaining the robustness of randomization offered by RCTs.展开更多
Objective This study aimed to evaluate the effects of a mindfulness-based psychosomatic intervention on depression,anxiety,fear of childbirth(FOC),and life satisfaction of pregnant women in China.Methods Women experie...Objective This study aimed to evaluate the effects of a mindfulness-based psychosomatic intervention on depression,anxiety,fear of childbirth(FOC),and life satisfaction of pregnant women in China.Methods Women experiencing first-time pregnancy(n=104)were randomly allocated to the intervention group or a parallel active control group.We collected data at baseline(T0),postintervention(T1),3 days after delivery(T2),and 42 days after delivery(T3).The participants completed questionnaires for the assessment of the levels of depression,anxiety,FOC,life satisfaction,and mindfulness.Differences between the two groups and changes within the same group were analyzed at four time points using repeated-measures analysis of variance.Results Compared with the active control group,the intervention group reported lower depression levels at T2(P=0.038)and T3(P=0.013);reduced anxiety at T1(P=0.001)and T2(P=0.003);reduced FOC at T1(P<0.001)and T2(P=0.04);increased life satisfaction at T1(P<0.001)and T3(P=0.015);and increased mindfulness at T1(P=0.01)and T2(P=0.006).Conclusion The mindfulness-based psychosomatic intervention effectively increased life satisfaction and reduced perinatal depression,anxiety,and FOC.展开更多
BACKGROUND Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography(ERCP).Currently,there is no suitable treatment for post-ERCP pancreatitis(PEP)prophylaxis.Few studies hav...BACKGROUND Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography(ERCP).Currently,there is no suitable treatment for post-ERCP pancreatitis(PEP)prophylaxis.Few studies have prospectively evaluated interventions to prevent PEP in children.AIM To assess the efficacy and safety of the external use of mirabilite to prevent PEP in children.METHODS This multicenter,randomized controlled clinical trial enrolled patients with chronic pancreatitis scheduled for ERCP according to eligibility criteria.Patients were randomly divided into the external use of mirabilite group(external use of mirabilite in a bag on the projected abdominal area within 30 min before ERCP)and blank group.The primary outcome was the incidence of PEP.The secondary outcomes included the severity of PEP,abdominal pain scores,levels of serum inflammatory markers[tumor necrosis factor-alpha(TNF-α)and serum interleukin-10(IL-10)],and intestinal barrier function markers[diamine oxidase(DAO),D-lactic acid,and endotoxin].Additionally,the side effects of topical mirabilite were investigated.RESULTSA total of 234 patients were enrolled,including 117 in the external use of mirabilite group and theother 117 in the blank group.The pre-procedure and procedure-related factors were notsignificantly different between the two groups.The incidence of PEP in the external use ofmirabilite group was significantly lower than that in the blank group(7.7%vs 26.5%,P<0.001).The severity of PEP decreased in the mirabilite group(P=0.023).At 24 h after the procedure,thevisual analog scale score in the external use of mirabilite group was lower than that in the blankgroup(P=0.001).Compared with those in the blank group,the TNF-αexpressions weresignificantly lower and the IL-10 expressions were significantly higher at 24 h after the procedurein the external use of mirabilite group(P=0.032 and P=0.011,respectively).There were nosignificant differences in serum DAO,D-lactic acid,and endotoxin levels before and after ERCPbetween the two groups.No adverse effects of mirabilite were observed.CONCLUSIONExternal use of mirabilite reduced the PEP occurrence.It significantly alleviated post-proceduralpain and reduced inflammatory response.Our results favor the external use of mirabilite toprevent PEP in children.展开更多
BACKGROUND Severe acute pancreatitis(AP)is one of the most common diseases of the gastrointestinal tract and carries a significant financial burden with high disability and mortality.There are no effective drugs in th...BACKGROUND Severe acute pancreatitis(AP)is one of the most common diseases of the gastrointestinal tract and carries a significant financial burden with high disability and mortality.There are no effective drugs in the clinical management of severe AP,and there is an absence of evidence-based medicine concerning the treatment of severe AP.AIM To explore whether ulinastatin(UTI)can improve the outcome of severe AP.METHODS The present research included patients who were hospitalized in intensive critical care units(ICUs)after being diagnosed with severe AP.Patients received UTI(400000 IU)or placebos utilizing computer-based random sequencing(in a 1:1 ratio).The primary outcome measures were 7-d mortality,clinical efficacy,inflammatory response,coagulation function,infection,liver function,renal function,and drug-related adverse effects were evaluated.RESULTS A total of 181 individuals were classified into two groups,namely,the placebo group(n=90)and the UTI group(n=91).There were no statistically significant differences in baseline clinical data between the two groups.The 7-d mortality and clinical efficacy in the UTI group were remarkably improved compared with those in the placebo group.UTI can protect against hyperinflammation and improve coagulation dysfunction,infection,liver function,and renal function.UTI patients had markedly decreased hospital stays and hospitalization expenditures compared with the placebo group.CONCLUSION The findings from the present research indicated that UTI can improve the clinical outcomes of patients with severe AP and has fewer adverse reactions.展开更多
Objective:To evaluate the effectiveness and safety of ivermectin in patients with mild and moderate COVID-19.Methods:This study was a single-center,randomized,open-label,controlled trial with a 2-arm parallel-group de...Objective:To evaluate the effectiveness and safety of ivermectin in patients with mild and moderate COVID-19.Methods:This study was a single-center,randomized,open-label,controlled trial with a 2-arm parallel-group design on 68 patients with COVID-19.According to the 1:1 ratio between the study groups(ivermectin group and standard treatment group),patients were randomly admitted to each intervention arm.Results:The mean age of the participants in the ivermectin group was(48.37±13.32)years.Eighteen of them were males(54.5%)and the participants in the control group had a mean age of(46.28±14.47)years,with nineteen of them being males(59.4%).As a primary outcome,after 5 days of randomization,there was no significant difference between the ivermectin group and the control group in the length of stay in the hospital(P=0.168).ICU admission(P=0.764),length of stay in ICU(P=0.622),in-hospital mortality(P=0.427),adverse drug reactions,and changes in the mean difference of laboratory data had not any significant difference between the two groups(except for urea change).In addition,the radiologic findings of the two groups of patients were not significantly different.Linear regression analysis showed that for every 10 years increase of age,0.6 day of hospitalization duration was increased.There was no statistically significant association between other variables and clinical outcomes.Conclusions:Among adult hospitalized patients with moderate to severe COVID-19,there was no significant relationship between the administration of ivermectin single dose in a five-day course and clinical improvement,and mortality of the participants.展开更多
Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preven...Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preventing AMS, compared with a placebo, no treatment or acetazolamide. The literature was searched in 6major databases. RevMan 5.4 software was used for the meta-analysis. The relative risk for discrete variables and the mean difference for continuous variables with 95% confidence intervals(CIs) were applied to express the effect size. The risk of bias in the included studies was evaluated using the Cochrane risk assessment tool 2.0(RoB 2.0), and the evidence certainty was assessed using the Grading of Recommendations Assessment and the Development and Evaluation(GRADE) approach.Results: Twenty RCTs involving 3015 participants and 16 TCM patent drugs were included. The overall risk of bias in the majority of studies(15/20) was of some concerns. In terms of the AMS incidence,Rhodiola rosea(R. rosea, Hong Jing Tian) and Ginkgo biloba(G. biloba, Yin Xing Ye) were equivalent to the placebo/no treatment [RR(95% CI): 0.66(0.43-1.01), 0.82(0.63-1.06), respectively]. The AMS incidence in the G. biloba group was higher than that in the acetazolamide group [RR(95% CI): 2.92(1.69-5.06)]. In terms of improving the AMS symptom score on days 1 and 3 in the plateau, R. rosea and G. biloba were superior to the placebo or no treatment [MD(95% CI):-0.98(-1.71,-0.25),-2.05(-3.14,-0.95), respectively]. The other 14 Chinese patent medicines were evaluated in a single trial, and the majority of the results were negative. The subgroup analysis showed that the effect of R. rosea was related to the intervention time, way of ascending, and altitude.Conclusion: R. rosea and G. biloba were effective in improving AMS symptoms but had no effect in reducing the AMS incidence. There was insufficient evidence to support the use of other TCM patent drugs to prevent AMS. More randomized double-blind placebo-controlled trials are warranted to evaluate and screen effective Chinese patent medicines for AMS prevention.展开更多
Objective:To explore the characteristics of Xiao Chai Hu(XCH)decoction in randomized controlled trials(RCTs)using a bibliometric method.Methods:Seven databases including PubMed,Web of Science,Embase,Cochrane library,C...Objective:To explore the characteristics of Xiao Chai Hu(XCH)decoction in randomized controlled trials(RCTs)using a bibliometric method.Methods:Seven databases including PubMed,Web of Science,Embase,Cochrane library,China National Knowledge Infrastructure(CNKI),Chinese Scientific Journal Database(VIP)and Wanfang database were retrieved from inception to May 27,2022.In the study,XCH decoction(or modified)used alone or combined with conventional Western medicine as an intervention measure was included.The basic characteristics,funding support,relevant diseases,intervention methods,and adverse events(AEs)were analyzed.Data analysis was performed using SPSS 26.0 software.Results:A total of 813 RCTs were included,published from 1989 to 2022.There was only one Englishlanguage literature with the recent impact factor of 5.374.There were 147 studies were from Chineselanguage core journals,with the highest impact factor of 2.414.Only 6.15%of the literatures mentioned funding support.96.31%of the included literature reported the statistical significance of using XCH decoction.The diseases treated mainly included chronic hepatitis B(9.35%),cough variant asthma(5.66%),dizziness(5.54%),bile reflux gastritis(4.43%),and fever(4.18%).However,the overall research design of the included literature was poor,and large sample size,multicenter RCTs are needed.The incidence of AEs of XCH decoction alone was 8.86%,which was significantly lower than that of conventional Western medicine treatment.The combination of XCH decoction and conventional Western medicine treatment could reduce the incidence of AEs,and no serious adverse event was reported.Conclusion:Although the included studies show that XCH decoction is widely used,and has good efficacy and few AEs.Due to the low quality of the included RCTs,there may be some bias,and its rational use based on the specific conditions is recommended in clinical practice.展开更多
Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight onli...Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight online databases were searched from their inception to December 31,2022,to assess outcomes reported in randomized controlled trials(RCTs)of HMG treated with TCM.The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool.All outcomes were extracted,classified,and described.Results:A total of 8249 articles were initially retrieved.Of these,70 articles were eligible and involved 10618 participants with HMG.A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains.Conclusions:The core outcomes of RCTs of HMG treated with TCM are large and divergent.There are problems in evaluation standards,primary and secondary outcomes,TCM characteristic indicators,long-term prognosis,and standardization of reporting.It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG.展开更多
Objective:The aim of this study is to compare the effect of Vitamin D and Vitamin E supplementations,alone,and in combination,on reducing the intensity and duration of dysmenorrhea in women who were referred to the Ko...Objective:The aim of this study is to compare the effect of Vitamin D and Vitamin E supplementations,alone,and in combination,on reducing the intensity and duration of dysmenorrhea in women who were referred to the Kowsar gynecological clinics of Shahid Motahari Hospital of Urmia University of Medical Sciences.Materials and Methods:A double-blinded clinical trial was conducted on 112 women with dysmenorrhea who were randomly allocated into the four study groups.Finally,100 women complete the study and received capsules containing a placebo(n=25),1000 IU of Vitamin D(n=25),400 mg of Vitamin E(n=25),and 1000 IU of Vitamin D+400 mg of Vitamin E(n=25)every 24 h for 2 consecutive months at the beginning of the menstrual period.The pain intensity and duration among groups were compared before and after the intervention.Results:The mean menstrual pain duration in all three experimental groups(Vitamin E,Vitamin D,and the combination of them)was lower than the placebo group(all P<0.05),and the mean pain intensity scores in all three experimental groups were significantly lower than the placebo group(all P<0.05).The results(means)for all of the drugs administered at the end of the 2nd month were better than the 1st month(all P<0.01).Conclusions:Vitamin E and Vitamin D,as well as their combination,are recommended as an effective and safe treatment for the management of the complications of dysmenorrhea.展开更多
1Background:Irritable bowel syndrome(IBS)is a disorder of bowel function,and diarrhea-predominant irritable bowel syndrome(IBS-D)is the most common.The current treatment for IBS-D is focused on improving patients’gas...1Background:Irritable bowel syndrome(IBS)is a disorder of bowel function,and diarrhea-predominant irritable bowel syndrome(IBS-D)is the most common.The current treatment for IBS-D is focused on improving patients’gastrointestinal-related symptoms,but there are limitations such as unstable effects and adverse drug reactions.Acupuncture and moxibustion exerts advantages in treating IBS-D.They include several forms,of which moxibustion is one of the most commonly used.And moxibustion is a common way used in treating IBS-D,but there is a lack of relevant evidence-based medical research data.This protocol aims to compare the efficacy of moxibustion(mild-warm moxibustion)in treating IBS-D(spleen deficiency and dampness excess syndrome)with the first-line treatment.Methods:In this prospective,parallel,randomized controlled trial(RCT)protocol,patients will be randomly allocated for 4-week treatment or control therapies and then 4-week follow-up in both groups.We will use Irritable Bowel Syndrome-Symptom Severity Scale(IBS-SSS)score,Irritable Bowel Syndrome-Quality of Life(IBS-QOL)score,serum brain-gut peptide levels,and traditional Chinese medicine(TCM)syndrome scale score to produce more evidence on IBS-D treatment with moxibustion.Finally,we will use SPSS 22.0 software to statistically analyze the data.Discussion:Mild-warm moxibustion is a complementary alternative therapy that fits with the pathogenesis of IBS-D.We hope to see more clinical evidence for mild-warm moxibustion against IBS-D that this RCT supported.展开更多
BACKGROUND Venous thromboembolism(VTE)is a common neurosurgical complication after brain tumor resection,and its prophylaxis has been widely studied.There are no effective drugs in the clinical management of venous th...BACKGROUND Venous thromboembolism(VTE)is a common neurosurgical complication after brain tumor resection,and its prophylaxis has been widely studied.There are no effective drugs in the clinical management of venous thromboembolism,and there is an absence of evidence-based medicine concerning the treatment of severe multiple traumas.AIM To explore whether ulinastatin(UTI)can prevent VTE after brain tumor resection.METHODS The present research included patients who underwent brain tumor resection.Patients received UTIs(400,000 IU)or placebos utilizing computer-based random sequencing(in a 1:1 ratio).The primary outcome measures were the incidence of VTE,coagulation function,pulmonary emboli,liver function,renal function,and drug-related adverse effects.RESULTS A total of 405 patients were evaluated between January 2019 and December 2021,and 361 of these were initially enrolled in the study to form intention-to-treat,which was given UTI(n=180)or placebo(n=181)treatment in a random manner.There were no statistically significant differences in baseline clinical data between the two groups.The incidence of VTE in the UTI group was remarkably improved compared with that in the placebo group.UTI can improve coagulation dysfunction,pulmonary emboli,liver function,and renal function.No significant difference was identified between the two groups in the side effects of UTI-induced diarrhea,vomiting,hospital stays,or hospitalization costs.The incidence of allergies was higher in the UTI group than in the placebo group.CONCLUSION The findings from the present research indicated that UTI can decrease the incidence of VTE and clinical outcomes of patients after brain tumor resection and has fewer adverse reactions.展开更多
BACKGROUND Recent research suggests that although prokinetic agents,acid suppressors,and radical treatment for Helicobacter pylori infection may be effective in patients with functional dyspepsia(FD),a large proportio...BACKGROUND Recent research suggests that although prokinetic agents,acid suppressors,and radical treatment for Helicobacter pylori infection may be effective in patients with functional dyspepsia(FD),a large proportion of patients still fail to respond to these treatments or may suffer from severe adverse reactions.Many traditional Chinese medicinal herbs can regulate the status of the entire body and have special advantages in the treatment of functional diseases.The present study was designed to verify the efficacy of Biling Weitong Granules(BLWTG),a traditional Chinese medicinal herbal compound formula,in alleviating epigastric pain syndrome(EPS)in FD patients,in an attempt to provide an effective prescription for the clinical treatment of this disease.AIM To evaluate the clinical efficacy and safety of BLWTG in treating EPS in patients with FD.METHODS In this multicenter,stratified,randomized,double-blind,placebo-controlled,parallel group clinical trial,eligible patients were randomized into the BLWTG and placebo groups who were treated for 6 wk.Efficacy indicators including the severity and frequency of EPS and the time to pain resolution and safety indicators including adverse events were observed and compared.RESULTS The baseline demographic data and clinical characteristics,such as epigastric pain symptoms,pain intensity,and frequency of attacks,were matched between the two groups before randomization.After 6 wk of treatment and after the center effect was eliminated,the epigastric pain was significantly improved in 28.33%and 85.59%of the patients in the placebo and BLWTG groups,respectively(P<0.05).At 6 wk,the resolution rate of epigastric pain was 15%and 69.49%in the placebo and BLWTG groups,respectively(P<0.05).The differences of total FD clinical score between these two groups were significant(P<0.05)at 2,4,and 6 wk(P<0.05).The scores of each item and the total score in the Functional Digestive Disorders Quality of Life Questionnaire showed significant differences between the two groups at 6 wk after both the center and interaction effects were eliminated(P<0.05).There was no significant difference in the incidence of adverse events between the two groups,and no serious adverse event was noted during the observation.CONCLUSION Compared with placebo,BLWTG markedly improved EPS in FD patients without causing serious adverse reactions.展开更多
AIM:To compare hemorrhoidectomy with a bipolar electrothermal device or hemorrhoidectomy using an ultrasonically activated scalpel.METHODS:Sixty patients with grade Ⅲ or Ⅳ hemorrhoids were prospectively randomized t...AIM:To compare hemorrhoidectomy with a bipolar electrothermal device or hemorrhoidectomy using an ultrasonically activated scalpel.METHODS:Sixty patients with grade Ⅲ or Ⅳ hemorrhoids were prospectively randomized to undergo closed hemorrhoidectomy assisted by bipolar diathermy(group 1) or hemorrhoidectomy with the ultrasonic scalpel(group 2).Operative data were recorded,and patients were followed at 1,3,and 6 wk to evaluate complications.Independent assessors were assigned to obtain postoperative pain scores,oral analgesic requirement and satisfaction scores.RESULTS:Reduced intraoperative blood loss median 0.9 mL(95% CI:0.8-3.7) vs 4.6 mL(95% CI:3.8-7.0),P = 0.001 and a short operating time median 16(95% CI:14.6-18.2) min vs 31(95% CI:28.1-35.3) min,P < 0.0001 was observed in group 1 compared with group 2.There was a trend towards lower postoperative pain scores on day 1 group 1 median 2(95% CI:1.8-3.5) vs group 2 median 3(95% CI:2.6-4.2),P = 0.135.Reduced oral analgesic requirement during postoperative 24 h after operation median 1(95% CI:0.4-0.9) tablet vs 1(95% CI:0.9-1.3) tablet,P = 0.006 was observed in group 1 compared with group 2.There was no difference between the two groups in the degree of patient satisfaction or number of postoperative complications.CONCLUSION:Bipolar diathermy hemorrhoidectomy is quick and bloodless and,although as painful as closed hemorrhoidectomy with the ultrasonic scalpel,is associated with a reduced analgesic requirement immediately after operation.展开更多
Objective: To systematically evaluate the effectiveness of fall prevention and balance function in the elderly.Methods: Databases, including Pub Med, Web of Science, Cochrane Library, Chinese Biomedical Literature Dat...Objective: To systematically evaluate the effectiveness of fall prevention and balance function in the elderly.Methods: Databases, including Pub Med, Web of Science, Cochrane Library, Chinese Biomedical Literature Database(CBM), and CNKI were electronically searched, and the relevant references of the included papers were also manually searched. Two reviewers independently screened the articles according to the inclusion and exclusion criteria, extracted the data, and assessed the methodological quality. A metaanalysis was performed using the Cochrane Collaboration's Rev Man 5.1 software.Results: Six randomized controlled trials(RCTs) involving 2796 participants were included. The results of the meta-analysis showed that compared with a physiotherapy intervention, Tai Chi could significantly reduce the incidence rates of falls [relative risk(RR) ? 0.82, 95% confidence interval(CI)(0.73, 0.92)],while there were significant differences in the Timed Up and Go test, Functional Reach Test and Berger Balance Scale.Conclusions: Tai Chi is effective in reducing the risk of falls and improving balance in the elderly.展开更多
Objective:To prove the effectiveness of puboprostatic ligament-preserving robotic-assisted laparoscopic radical(RARP)on enhancing early continence.Methods:Ninety-two patients with localized adenocarcinoma of the prost...Objective:To prove the effectiveness of puboprostatic ligament-preserving robotic-assisted laparoscopic radical(RARP)on enhancing early continence.Methods:Ninety-two patients with localized adenocarcinoma of the prostate scheduled for RARP from April 2018 to January 2019 were prospectively single-blinded and randomized into two groups,standard RARP(Group A)and puboprostatic ligament-sparing RARP(Group B).The outcomes were continent status at Foley catheter removal and 3 months after surgery using the score from the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form(ICIQ-UI SF),pad usage,pathological margin status,blood loss,operative time,and complications.Results:Ninety-six patients were randomized(46 patients in each group),with a mean±SD age of 67.30±6.07 years.There were no differences in baseline characteristics.At 3 months after surgery,ICIQ-UI SF score(mean±SD)in Group A was significantly higher than Group B(8.74±4.28 vs.6.93±3.96,p=0.038)but no difference at Foley catheter removal.Group A also had a significant higher score for interference with daily life(median[interquartile range,IQR]:4[1,5]vs.2[0,4];p=0.041)and higher pad use(median[IQR]:2[0,3]vs.1[1,2];p=0.041)at 3 months.One case in Group A had complete or severe incontinence(>5 pads/day)at 3 months.Groups A and B did not exhibit significant difference in margin status(p=0.828).There were no differences in operative time,blood loss,drain output or complications.Conclusions:Use of puboprostatic ligament-sparing RARP could be a method to accelerate early continence without affecting the final oncological outcome.展开更多
BACKGROUND Poor sleep quality is a common clinical feature in patients with type 2 diabetes mellitus(T2DM),and often negatively related with glycemic control.Cognitive behavioral therapy(CBT)may improve sleep quality ...BACKGROUND Poor sleep quality is a common clinical feature in patients with type 2 diabetes mellitus(T2DM),and often negatively related with glycemic control.Cognitive behavioral therapy(CBT)may improve sleep quality and reduce blood sugar levels in patients with T2DM.However,it is not entirely clear whether CBT delivered by general practitioners is effective for poor sleep quality in T2DM patients in community settings.AIM To test the effect of CBT delivered by general practitioners in improving sleep quality and reducing glycemic levels in patients with T2DM in community.METHODS A cluster randomized controlled trial was conducted from September 2018 to October 2019 in communities of China.Overall 1033 persons with T2DM and poor sleep quality received CBT plus usual care or usual care.Glycosylated hemoglobin A1c(HbAlc)and sleep quality[Pittsburgh Sleep Quality Index(PSQI)]were assessed.Repeated measures analysis of variance and generalized linear mixed effects models were used to estimate the intervention effects on hemoglobin A1c and sleep quality.RESULTS The CBT group had 0.64,0.50,and 0.9 lower PSQI scores than the control group at 2 mo,6 mo,and 12 mo,respectively.The CBT group showed 0.17 and 0.43 lower HbAlc values than the control group at 6 mo and 12 mo.The intervention on meanΔHbAlc values was significant at 12 mo(t=3.68,P<0.01)and that meanΔPSQI scores were closely related toΔHbAlc values(t=7.02,P<0.01).Intentionto-treat analysis for primary and secondary outcomes showed identical results with completed samples.No adverse events were reported.CONCLUSION CBT delivered by general practitioners,as an effective and practical method,could reduce glycemic levels and improve sleep quality for patients with T2DM in community.展开更多
AIM: To evaluate the relative efficacy and safety of aflibercept for treatment of diabetic macular oedema(DMO).METHODS: A comprehensive search in MEDLINE, CENTRAL and EMBASE was undertaken for randomized controlled tr...AIM: To evaluate the relative efficacy and safety of aflibercept for treatment of diabetic macular oedema(DMO).METHODS: A comprehensive search in MEDLINE, CENTRAL and EMBASE was undertaken for randomized controlled trials(RCTs) comparing intravitreal antivascular endothelial growth factor(anti-VEGF) versus another treatment. Primary outcome measures were proportion of patients with at least 15 letters of gain or loss on a log MAR visual acuity chart, and change in best corrected visual acuity(BCVA) and central macular thickness(CMT) from baseline. Safety outcomes were rates of death, thromboembolic events and any systemic or ocular serious adverse events. The final search was performed on November 2017.RESULTS: Four RCTs were included. Only one trial compared efficacy and safety of aflibercept with bevacizumab and ranibizumab over 1 or 2 y. Three trials were included for Meta-analysis comprising 661 patients(331 in the aflibercept, and 330 in the photocoagulation group). Aflibercept was more efficacious compared to photocoagulation in the proportion of patients with at least 15 letters of improvement and worsening, and in improvement of BCVA and reduction in CMT at 1 or 2 y. The safety estimates at 1 or 2 y did not differ statistically.CONCLUSION: Aflibercept offers superior benefits over photocoagulation in improving and preserving vision, with no differences in safety. Further comparative effectiveness trials between aflibercept and other anti-VEGF agents will aid ophthalmologists in treatment decisions.展开更多
Background: Traumatic brain injury is a major health problem that frequently leads to deficits in executive function. Self-regulation processes, such as goal-setting, may become disordered after traumatic brain injury...Background: Traumatic brain injury is a major health problem that frequently leads to deficits in executive function. Self-regulation processes, such as goal-setting, may become disordered after traumatic brain injury, particularly when the frontal regions of the brain and their connections are involved. Such impairments reduce injured veterans' ability to return to work or school and to regain satisfactory personal lives. Understanding the neurologically disabling effects of brain injury on executive function is necessary for both the accurate diagnosis of impairment and the individual tailoring of rehabilitation processes to help returning service members recover independent function.Methods/design: The COMPASSgoal(Community Participation through Self-Efficacy Skills Development) program develops and tests a novel patient-centered intervention framework for community reintegration psychosocial research in veterans with mild traumatic brain injury. COMPASSgoal integrates the principles and best practices of goal self-management. Goal setting is a core skill in self-management training by which persons with chronic health conditions learn to improve their status and decrease symptom effects. Over a three-year period, COMPASSgoal will recruit 110 participants with residual executive dysfunction three months or more post-injury. Inclusion criteria combine both clinical diagnosis and standardized scores that are >1 SD from the normative score on the Frontal Systems Rating Scale. Participants are randomized into two groups: goal-management(intervention) and supported discharge(control). The intervention is administered in eight consecutive, weekly sessions. Assessments occur at enrollment, post-intervention/supported discharge, and three months post-treatment follow-up.Discussion: Goal management is part of the "natural language" of rehabilitation. However, collaborative goal-setting between clinicians/case managers and clients can be hindered by the cognitive deficits that follow brain injury. Re-training returning veterans with brain injury in goal management, with appropriate help and support, would essentially treat deficits in executive function. A structured approach to goal self-management may foster greater independence and self-efficacy, help veterans gain insight into goals that are realistic for them at a given time, and help clinicians and veterans to work more effectively as true collaborators.展开更多
Objective: The objective of this randomized controlled trial study was to evaluate the education training in relation to lifestyle improvement in patients with type 2 diabetes through its influence in the levels of gl...Objective: The objective of this randomized controlled trial study was to evaluate the education training in relation to lifestyle improvement in patients with type 2 diabetes through its influence in the levels of glycated hemoglobin(HbA1 c), blood pressure, triglyceride, cholesterol levels, and body mass index(BMI).Methods: The study included patients with type 2 diabetes randomly selected from 20 residential areas in Tirana, Albania where family physicians provide services. The sample size in total was 200 patients in both groups(control and intervention). The education training(four sessions) was conducted by trained nursing staff for 6 months. Patients were screened for the biochemical profile before and after the intervention. To compare the groups with respect to the interest outcomes, the t-test was used. The value of P < 0.05 was considered significant.Results: There were 104 male patients and 96 female patients. The mean age was 54.9 ± 8.7. No significant differences were found between the study groups in relation to clinical and biochemical data before the education sessions. After the intervention, in the intervention group, the mean level of HbA1 c was significantly lower than the value in the control group(6.2% vs 6.8%, P = 0.001) as well as for the mean values of BMI. The mean reduction(more than 15%) in HbA1 c after the intervention was 43% in the intervention group and 2% in the control group(OR = 36.9, P < 0.05). Differences in BMI, HbA1 c, triglycerides, and cholesterol were more significantly visible in the intervention group. However, the difference in systolic and diastolic blood pressure values was almost the same(P > 0.05).Conclusions: The results of this study further support that the approach for education of patients with type 2 diabetes on changing lifestyle benefit the patient in controlling diabetes. It is believed that the establishment of diabetes education classes in health centers is an important investment in improving the management of type 2 diabetes.展开更多
Objective:Pain is a prevalent and distressing symptom in patients with cancer which has a significant impact on patients’physical health,psychological well-being,and quality of life(QOL).Deficiency of pain care,inade...Objective:Pain is a prevalent and distressing symptom in patients with cancer which has a significant impact on patients’physical health,psychological well-being,and quality of life(QOL).Deficiency of pain care,inadequate pain communication,and reluctance toward pain medication contribute to the difficulties in improving the situation of patients with cancer pain.Fortunately,the integration of self-management and professional healthcare provides new opportunities for patients with cancer pain.Methods:A two-arm randomized controlled trial will be conducted to assess the effectiveness of self-management application compared with routine care among patients with cancer pain.Based on Orem’s self-care theory and Naylor’s transitional care theory,cancer pain self-management application“Pain-housekeeper”was developed with dual client:patient client and medical client.A total of 120 patients with cancer pain are recruited from two university-affiliated tertiary public hospitals in China.They are randomly assigned to the control group and the intervention group.The patients in the control group get routine care while the patients in the intervention group get routine care and Pain-housekeeper App.The intervention is delivered by registered doctors,nurses,and postgraduate nursing students specialized in pain care.Effect measurements for both groups are carried out with questionnaires at baseline(T0),after 4 weeks(T1)and after 12 weeks(T2).The primary outcomes include pain condition,self-efficacy,and QOL.The secondary outcomes include pain medication adherence,satisfaction,anxiety,and depression.Compliance of data submission,economic evaluation,usage,and clinical data are also considered in the test.Data for the evaluation are gathered continuously during the study period.Discussion:This article provides insight into the effectiveness of a theory-based self-management mobile application intervention delivered to patients with uncontrolled cancer pain.The results are used to help patients to improve cancer pain control,self-efficacy,and QOL.Conclusions:The findings of this article provide evidence to support the implementation of an innovative and easily accessible intervention that enhances health outcomes.展开更多
文摘Randomized controlled trials(RCTs)have long been recognized as the gold standard for establishing causal relationships in clinical research.Despite that,various limitations of RCTs prevent its widespread implementation,ranging from the ethicality of withholding potentially-lifesaving treatment from a group to relatively poor external validity due to stringent inclusion criteria,amongst others.However,with the introduction of propensity score matching(PSM)as a retrospective statistical tool,new frontiers in establishing causation in clinical research were opened up.PSM predicts treatment effects using observational data from existing sources such as registries or electronic health records,to create a matched sample of participants who received or did not receive the intervention based on their propensity scores,which takes into account characteristics such as age,gender and comorbidities.Given its retrospective nature and its use of observational data from existing sources,PSM circumvents the aforementioned ethical issues faced by RCTs.Majority of RCTs exclude elderly,pregnant women and young children;thus,evidence of therapy efficacy is rarely proven by robust clinical research for this population.On the other hand,by matching study patient characteristics to that of the population of interest,including the elderly,pregnant women and young children,PSM allows for generalization of results to the wider population and hence greatly increases the external validity.Instead of replacing RCTs with PSM,the synergistic integration of PSM into RCTs stands to provide better research outcomes with both methods complementing each other.For example,in an RCT investigating the impact of mannitol on outcomes among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial,the baseline characteristics of comorbidities and current medications between treatment and control arms were significantly different despite the randomization protocol.Therefore,PSM was incorporated in its analysis to create samples from the treatment and control arms that were matched in terms of these baseline characteristics,thus providing a fairer comparison for the impact of mannitol.This literature review reports the applications,advantages,and considerations of using PSM with RCTs,illustrating its utility in refining randomization,improving external validity,and accounting for non-compliance to protocol.Future research should consider integrating the use of PSM in RCTs to better generalize outcomes to target populations for clinical practice and thereby benefit a wider range of patients,while maintaining the robustness of randomization offered by RCTs.
基金supported by the National Center for Women and Children’s Health of the Chinese Center for Disease Control and Prevention。
文摘Objective This study aimed to evaluate the effects of a mindfulness-based psychosomatic intervention on depression,anxiety,fear of childbirth(FOC),and life satisfaction of pregnant women in China.Methods Women experiencing first-time pregnancy(n=104)were randomly allocated to the intervention group or a parallel active control group.We collected data at baseline(T0),postintervention(T1),3 days after delivery(T2),and 42 days after delivery(T3).The participants completed questionnaires for the assessment of the levels of depression,anxiety,FOC,life satisfaction,and mindfulness.Differences between the two groups and changes within the same group were analyzed at four time points using repeated-measures analysis of variance.Results Compared with the active control group,the intervention group reported lower depression levels at T2(P=0.038)and T3(P=0.013);reduced anxiety at T1(P=0.001)and T2(P=0.003);reduced FOC at T1(P<0.001)and T2(P=0.04);increased life satisfaction at T1(P<0.001)and T3(P=0.015);and increased mindfulness at T1(P=0.01)and T2(P=0.006).Conclusion The mindfulness-based psychosomatic intervention effectively increased life satisfaction and reduced perinatal depression,anxiety,and FOC.
基金Supported by Shanghai Municipal Health Commission of China,No. 2018LP018
文摘BACKGROUND Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography(ERCP).Currently,there is no suitable treatment for post-ERCP pancreatitis(PEP)prophylaxis.Few studies have prospectively evaluated interventions to prevent PEP in children.AIM To assess the efficacy and safety of the external use of mirabilite to prevent PEP in children.METHODS This multicenter,randomized controlled clinical trial enrolled patients with chronic pancreatitis scheduled for ERCP according to eligibility criteria.Patients were randomly divided into the external use of mirabilite group(external use of mirabilite in a bag on the projected abdominal area within 30 min before ERCP)and blank group.The primary outcome was the incidence of PEP.The secondary outcomes included the severity of PEP,abdominal pain scores,levels of serum inflammatory markers[tumor necrosis factor-alpha(TNF-α)and serum interleukin-10(IL-10)],and intestinal barrier function markers[diamine oxidase(DAO),D-lactic acid,and endotoxin].Additionally,the side effects of topical mirabilite were investigated.RESULTSA total of 234 patients were enrolled,including 117 in the external use of mirabilite group and theother 117 in the blank group.The pre-procedure and procedure-related factors were notsignificantly different between the two groups.The incidence of PEP in the external use ofmirabilite group was significantly lower than that in the blank group(7.7%vs 26.5%,P<0.001).The severity of PEP decreased in the mirabilite group(P=0.023).At 24 h after the procedure,thevisual analog scale score in the external use of mirabilite group was lower than that in the blankgroup(P=0.001).Compared with those in the blank group,the TNF-αexpressions weresignificantly lower and the IL-10 expressions were significantly higher at 24 h after the procedurein the external use of mirabilite group(P=0.032 and P=0.011,respectively).There were nosignificant differences in serum DAO,D-lactic acid,and endotoxin levels before and after ERCPbetween the two groups.No adverse effects of mirabilite were observed.CONCLUSIONExternal use of mirabilite reduced the PEP occurrence.It significantly alleviated post-proceduralpain and reduced inflammatory response.Our results favor the external use of mirabilite toprevent PEP in children.
基金Supported by Wuxi Science and Technology Development Fund,No.WX03-02B0205-072001-10.
文摘BACKGROUND Severe acute pancreatitis(AP)is one of the most common diseases of the gastrointestinal tract and carries a significant financial burden with high disability and mortality.There are no effective drugs in the clinical management of severe AP,and there is an absence of evidence-based medicine concerning the treatment of severe AP.AIM To explore whether ulinastatin(UTI)can improve the outcome of severe AP.METHODS The present research included patients who were hospitalized in intensive critical care units(ICUs)after being diagnosed with severe AP.Patients received UTI(400000 IU)or placebos utilizing computer-based random sequencing(in a 1:1 ratio).The primary outcome measures were 7-d mortality,clinical efficacy,inflammatory response,coagulation function,infection,liver function,renal function,and drug-related adverse effects were evaluated.RESULTS A total of 181 individuals were classified into two groups,namely,the placebo group(n=90)and the UTI group(n=91).There were no statistically significant differences in baseline clinical data between the two groups.The 7-d mortality and clinical efficacy in the UTI group were remarkably improved compared with those in the placebo group.UTI can protect against hyperinflammation and improve coagulation dysfunction,infection,liver function,and renal function.UTI patients had markedly decreased hospital stays and hospitalization expenditures compared with the placebo group.CONCLUSION The findings from the present research indicated that UTI can improve the clinical outcomes of patients with severe AP and has fewer adverse reactions.
基金Hormozgan University of Medical Sciences,Bandar Abbas,Iran(grant No.990238)。
文摘Objective:To evaluate the effectiveness and safety of ivermectin in patients with mild and moderate COVID-19.Methods:This study was a single-center,randomized,open-label,controlled trial with a 2-arm parallel-group design on 68 patients with COVID-19.According to the 1:1 ratio between the study groups(ivermectin group and standard treatment group),patients were randomly admitted to each intervention arm.Results:The mean age of the participants in the ivermectin group was(48.37±13.32)years.Eighteen of them were males(54.5%)and the participants in the control group had a mean age of(46.28±14.47)years,with nineteen of them being males(59.4%).As a primary outcome,after 5 days of randomization,there was no significant difference between the ivermectin group and the control group in the length of stay in the hospital(P=0.168).ICU admission(P=0.764),length of stay in ICU(P=0.622),in-hospital mortality(P=0.427),adverse drug reactions,and changes in the mean difference of laboratory data had not any significant difference between the two groups(except for urea change).In addition,the radiologic findings of the two groups of patients were not significantly different.Linear regression analysis showed that for every 10 years increase of age,0.6 day of hospitalization duration was increased.There was no statistically significant association between other variables and clinical outcomes.Conclusions:Among adult hospitalized patients with moderate to severe COVID-19,there was no significant relationship between the administration of ivermectin single dose in a five-day course and clinical improvement,and mortality of the participants.
基金supported by the Institute Projects of China Tibetology Research Center in 2022(CTRC20226JS05).
文摘Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preventing AMS, compared with a placebo, no treatment or acetazolamide. The literature was searched in 6major databases. RevMan 5.4 software was used for the meta-analysis. The relative risk for discrete variables and the mean difference for continuous variables with 95% confidence intervals(CIs) were applied to express the effect size. The risk of bias in the included studies was evaluated using the Cochrane risk assessment tool 2.0(RoB 2.0), and the evidence certainty was assessed using the Grading of Recommendations Assessment and the Development and Evaluation(GRADE) approach.Results: Twenty RCTs involving 3015 participants and 16 TCM patent drugs were included. The overall risk of bias in the majority of studies(15/20) was of some concerns. In terms of the AMS incidence,Rhodiola rosea(R. rosea, Hong Jing Tian) and Ginkgo biloba(G. biloba, Yin Xing Ye) were equivalent to the placebo/no treatment [RR(95% CI): 0.66(0.43-1.01), 0.82(0.63-1.06), respectively]. The AMS incidence in the G. biloba group was higher than that in the acetazolamide group [RR(95% CI): 2.92(1.69-5.06)]. In terms of improving the AMS symptom score on days 1 and 3 in the plateau, R. rosea and G. biloba were superior to the placebo or no treatment [MD(95% CI):-0.98(-1.71,-0.25),-2.05(-3.14,-0.95), respectively]. The other 14 Chinese patent medicines were evaluated in a single trial, and the majority of the results were negative. The subgroup analysis showed that the effect of R. rosea was related to the intervention time, way of ascending, and altitude.Conclusion: R. rosea and G. biloba were effective in improving AMS symptoms but had no effect in reducing the AMS incidence. There was insufficient evidence to support the use of other TCM patent drugs to prevent AMS. More randomized double-blind placebo-controlled trials are warranted to evaluate and screen effective Chinese patent medicines for AMS prevention.
基金supported by a Project of National Administration of Traditional Chinese Medicine(TB2021011)“Excellence Program”of the Beijing University of Chinese Medicine.
文摘Objective:To explore the characteristics of Xiao Chai Hu(XCH)decoction in randomized controlled trials(RCTs)using a bibliometric method.Methods:Seven databases including PubMed,Web of Science,Embase,Cochrane library,China National Knowledge Infrastructure(CNKI),Chinese Scientific Journal Database(VIP)and Wanfang database were retrieved from inception to May 27,2022.In the study,XCH decoction(or modified)used alone or combined with conventional Western medicine as an intervention measure was included.The basic characteristics,funding support,relevant diseases,intervention methods,and adverse events(AEs)were analyzed.Data analysis was performed using SPSS 26.0 software.Results:A total of 813 RCTs were included,published from 1989 to 2022.There was only one Englishlanguage literature with the recent impact factor of 5.374.There were 147 studies were from Chineselanguage core journals,with the highest impact factor of 2.414.Only 6.15%of the literatures mentioned funding support.96.31%of the included literature reported the statistical significance of using XCH decoction.The diseases treated mainly included chronic hepatitis B(9.35%),cough variant asthma(5.66%),dizziness(5.54%),bile reflux gastritis(4.43%),and fever(4.18%).However,the overall research design of the included literature was poor,and large sample size,multicenter RCTs are needed.The incidence of AEs of XCH decoction alone was 8.86%,which was significantly lower than that of conventional Western medicine treatment.The combination of XCH decoction and conventional Western medicine treatment could reduce the incidence of AEs,and no serious adverse event was reported.Conclusion:Although the included studies show that XCH decoction is widely used,and has good efficacy and few AEs.Due to the low quality of the included RCTs,there may be some bias,and its rational use based on the specific conditions is recommended in clinical practice.
基金This study was supported by the National Administration of Traditional Chinese Medicine(SATCM-2015-BZ402).
文摘Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight online databases were searched from their inception to December 31,2022,to assess outcomes reported in randomized controlled trials(RCTs)of HMG treated with TCM.The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool.All outcomes were extracted,classified,and described.Results:A total of 8249 articles were initially retrieved.Of these,70 articles were eligible and involved 10618 participants with HMG.A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains.Conclusions:The core outcomes of RCTs of HMG treated with TCM are large and divergent.There are problems in evaluation standards,primary and secondary outcomes,TCM characteristic indicators,long-term prognosis,and standardization of reporting.It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG.
文摘Objective:The aim of this study is to compare the effect of Vitamin D and Vitamin E supplementations,alone,and in combination,on reducing the intensity and duration of dysmenorrhea in women who were referred to the Kowsar gynecological clinics of Shahid Motahari Hospital of Urmia University of Medical Sciences.Materials and Methods:A double-blinded clinical trial was conducted on 112 women with dysmenorrhea who were randomly allocated into the four study groups.Finally,100 women complete the study and received capsules containing a placebo(n=25),1000 IU of Vitamin D(n=25),400 mg of Vitamin E(n=25),and 1000 IU of Vitamin D+400 mg of Vitamin E(n=25)every 24 h for 2 consecutive months at the beginning of the menstrual period.The pain intensity and duration among groups were compared before and after the intervention.Results:The mean menstrual pain duration in all three experimental groups(Vitamin E,Vitamin D,and the combination of them)was lower than the placebo group(all P<0.05),and the mean pain intensity scores in all three experimental groups were significantly lower than the placebo group(all P<0.05).The results(means)for all of the drugs administered at the end of the 2nd month were better than the 1st month(all P<0.01).Conclusions:Vitamin E and Vitamin D,as well as their combination,are recommended as an effective and safe treatment for the management of the complications of dysmenorrhea.
基金This work is supported by Jiangsu Traditional Chinese Medicine Science and Technology Development Project(No.MS2021058)Natural Science Foundation of Nanjing University of Chinese Medicine(No.XZR2020062)+2 种基金Suzhou Municipal Science and Technology Bureau Supporting Project(No.SKY2022072)Open Project of Zhenjiang Traditional Chinese Medicine Spleen and Stomach Diseases Clinical Medicine Research Center(No.SSPW2022-KF08)Changshu Municipal Science and Technology Bureau Supporting Project(No.CS202030).
文摘1Background:Irritable bowel syndrome(IBS)is a disorder of bowel function,and diarrhea-predominant irritable bowel syndrome(IBS-D)is the most common.The current treatment for IBS-D is focused on improving patients’gastrointestinal-related symptoms,but there are limitations such as unstable effects and adverse drug reactions.Acupuncture and moxibustion exerts advantages in treating IBS-D.They include several forms,of which moxibustion is one of the most commonly used.And moxibustion is a common way used in treating IBS-D,but there is a lack of relevant evidence-based medical research data.This protocol aims to compare the efficacy of moxibustion(mild-warm moxibustion)in treating IBS-D(spleen deficiency and dampness excess syndrome)with the first-line treatment.Methods:In this prospective,parallel,randomized controlled trial(RCT)protocol,patients will be randomly allocated for 4-week treatment or control therapies and then 4-week follow-up in both groups.We will use Irritable Bowel Syndrome-Symptom Severity Scale(IBS-SSS)score,Irritable Bowel Syndrome-Quality of Life(IBS-QOL)score,serum brain-gut peptide levels,and traditional Chinese medicine(TCM)syndrome scale score to produce more evidence on IBS-D treatment with moxibustion.Finally,we will use SPSS 22.0 software to statistically analyze the data.Discussion:Mild-warm moxibustion is a complementary alternative therapy that fits with the pathogenesis of IBS-D.We hope to see more clinical evidence for mild-warm moxibustion against IBS-D that this RCT supported.
基金The registration number for the study was CWXH-IPR-2018004(date:January 11,2019).
文摘BACKGROUND Venous thromboembolism(VTE)is a common neurosurgical complication after brain tumor resection,and its prophylaxis has been widely studied.There are no effective drugs in the clinical management of venous thromboembolism,and there is an absence of evidence-based medicine concerning the treatment of severe multiple traumas.AIM To explore whether ulinastatin(UTI)can prevent VTE after brain tumor resection.METHODS The present research included patients who underwent brain tumor resection.Patients received UTIs(400,000 IU)or placebos utilizing computer-based random sequencing(in a 1:1 ratio).The primary outcome measures were the incidence of VTE,coagulation function,pulmonary emboli,liver function,renal function,and drug-related adverse effects.RESULTS A total of 405 patients were evaluated between January 2019 and December 2021,and 361 of these were initially enrolled in the study to form intention-to-treat,which was given UTI(n=180)or placebo(n=181)treatment in a random manner.There were no statistically significant differences in baseline clinical data between the two groups.The incidence of VTE in the UTI group was remarkably improved compared with that in the placebo group.UTI can improve coagulation dysfunction,pulmonary emboli,liver function,and renal function.No significant difference was identified between the two groups in the side effects of UTI-induced diarrhea,vomiting,hospital stays,or hospitalization costs.The incidence of allergies was higher in the UTI group than in the placebo group.CONCLUSION The findings from the present research indicated that UTI can decrease the incidence of VTE and clinical outcomes of patients after brain tumor resection and has fewer adverse reactions.
基金National New Drug Innovation Program,No.2017ZX09304003Special Research on Modernization of Traditional Chinese Medicine in the National Key Research and Development Program in the 13th Five-Year Plan Demonstrative Research,No.2017YFC1703703.Institutional review board statement:This study was approved by the IRB of Xiyuan Hospital of China Academy of Chinese Medical Sciences(No.2016XL011).
文摘BACKGROUND Recent research suggests that although prokinetic agents,acid suppressors,and radical treatment for Helicobacter pylori infection may be effective in patients with functional dyspepsia(FD),a large proportion of patients still fail to respond to these treatments or may suffer from severe adverse reactions.Many traditional Chinese medicinal herbs can regulate the status of the entire body and have special advantages in the treatment of functional diseases.The present study was designed to verify the efficacy of Biling Weitong Granules(BLWTG),a traditional Chinese medicinal herbal compound formula,in alleviating epigastric pain syndrome(EPS)in FD patients,in an attempt to provide an effective prescription for the clinical treatment of this disease.AIM To evaluate the clinical efficacy and safety of BLWTG in treating EPS in patients with FD.METHODS In this multicenter,stratified,randomized,double-blind,placebo-controlled,parallel group clinical trial,eligible patients were randomized into the BLWTG and placebo groups who were treated for 6 wk.Efficacy indicators including the severity and frequency of EPS and the time to pain resolution and safety indicators including adverse events were observed and compared.RESULTS The baseline demographic data and clinical characteristics,such as epigastric pain symptoms,pain intensity,and frequency of attacks,were matched between the two groups before randomization.After 6 wk of treatment and after the center effect was eliminated,the epigastric pain was significantly improved in 28.33%and 85.59%of the patients in the placebo and BLWTG groups,respectively(P<0.05).At 6 wk,the resolution rate of epigastric pain was 15%and 69.49%in the placebo and BLWTG groups,respectively(P<0.05).The differences of total FD clinical score between these two groups were significant(P<0.05)at 2,4,and 6 wk(P<0.05).The scores of each item and the total score in the Functional Digestive Disorders Quality of Life Questionnaire showed significant differences between the two groups at 6 wk after both the center and interaction effects were eliminated(P<0.05).There was no significant difference in the incidence of adverse events between the two groups,and no serious adverse event was noted during the observation.CONCLUSION Compared with placebo,BLWTG markedly improved EPS in FD patients without causing serious adverse reactions.
文摘AIM:To compare hemorrhoidectomy with a bipolar electrothermal device or hemorrhoidectomy using an ultrasonically activated scalpel.METHODS:Sixty patients with grade Ⅲ or Ⅳ hemorrhoids were prospectively randomized to undergo closed hemorrhoidectomy assisted by bipolar diathermy(group 1) or hemorrhoidectomy with the ultrasonic scalpel(group 2).Operative data were recorded,and patients were followed at 1,3,and 6 wk to evaluate complications.Independent assessors were assigned to obtain postoperative pain scores,oral analgesic requirement and satisfaction scores.RESULTS:Reduced intraoperative blood loss median 0.9 mL(95% CI:0.8-3.7) vs 4.6 mL(95% CI:3.8-7.0),P = 0.001 and a short operating time median 16(95% CI:14.6-18.2) min vs 31(95% CI:28.1-35.3) min,P < 0.0001 was observed in group 1 compared with group 2.There was a trend towards lower postoperative pain scores on day 1 group 1 median 2(95% CI:1.8-3.5) vs group 2 median 3(95% CI:2.6-4.2),P = 0.135.Reduced oral analgesic requirement during postoperative 24 h after operation median 1(95% CI:0.4-0.9) tablet vs 1(95% CI:0.9-1.3) tablet,P = 0.006 was observed in group 1 compared with group 2.There was no difference between the two groups in the degree of patient satisfaction or number of postoperative complications.CONCLUSION:Bipolar diathermy hemorrhoidectomy is quick and bloodless and,although as painful as closed hemorrhoidectomy with the ultrasonic scalpel,is associated with a reduced analgesic requirement immediately after operation.
文摘Objective: To systematically evaluate the effectiveness of fall prevention and balance function in the elderly.Methods: Databases, including Pub Med, Web of Science, Cochrane Library, Chinese Biomedical Literature Database(CBM), and CNKI were electronically searched, and the relevant references of the included papers were also manually searched. Two reviewers independently screened the articles according to the inclusion and exclusion criteria, extracted the data, and assessed the methodological quality. A metaanalysis was performed using the Cochrane Collaboration's Rev Man 5.1 software.Results: Six randomized controlled trials(RCTs) involving 2796 participants were included. The results of the meta-analysis showed that compared with a physiotherapy intervention, Tai Chi could significantly reduce the incidence rates of falls [relative risk(RR) ? 0.82, 95% confidence interval(CI)(0.73, 0.92)],while there were significant differences in the Timed Up and Go test, Functional Reach Test and Berger Balance Scale.Conclusions: Tai Chi is effective in reducing the risk of falls and improving balance in the elderly.
文摘Objective:To prove the effectiveness of puboprostatic ligament-preserving robotic-assisted laparoscopic radical(RARP)on enhancing early continence.Methods:Ninety-two patients with localized adenocarcinoma of the prostate scheduled for RARP from April 2018 to January 2019 were prospectively single-blinded and randomized into two groups,standard RARP(Group A)and puboprostatic ligament-sparing RARP(Group B).The outcomes were continent status at Foley catheter removal and 3 months after surgery using the score from the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form(ICIQ-UI SF),pad usage,pathological margin status,blood loss,operative time,and complications.Results:Ninety-six patients were randomized(46 patients in each group),with a mean±SD age of 67.30±6.07 years.There were no differences in baseline characteristics.At 3 months after surgery,ICIQ-UI SF score(mean±SD)in Group A was significantly higher than Group B(8.74±4.28 vs.6.93±3.96,p=0.038)but no difference at Foley catheter removal.Group A also had a significant higher score for interference with daily life(median[interquartile range,IQR]:4[1,5]vs.2[0,4];p=0.041)and higher pad use(median[IQR]:2[0,3]vs.1[1,2];p=0.041)at 3 months.One case in Group A had complete or severe incontinence(>5 pads/day)at 3 months.Groups A and B did not exhibit significant difference in margin status(p=0.828).There were no differences in operative time,blood loss,drain output or complications.Conclusions:Use of puboprostatic ligament-sparing RARP could be a method to accelerate early continence without affecting the final oncological outcome.
基金The Preventive Medicine Research Projects of Jiangsu Province Health Department,No.Y2015010 and No.Y2018016The Science and Technology projects of Xuzhou city,No.KC15SM046the Youth Medical Talent Project of“Ke Jiao Qiang Wei Projects”in Jiangsu Province,No.QNRC2016375.
文摘BACKGROUND Poor sleep quality is a common clinical feature in patients with type 2 diabetes mellitus(T2DM),and often negatively related with glycemic control.Cognitive behavioral therapy(CBT)may improve sleep quality and reduce blood sugar levels in patients with T2DM.However,it is not entirely clear whether CBT delivered by general practitioners is effective for poor sleep quality in T2DM patients in community settings.AIM To test the effect of CBT delivered by general practitioners in improving sleep quality and reducing glycemic levels in patients with T2DM in community.METHODS A cluster randomized controlled trial was conducted from September 2018 to October 2019 in communities of China.Overall 1033 persons with T2DM and poor sleep quality received CBT plus usual care or usual care.Glycosylated hemoglobin A1c(HbAlc)and sleep quality[Pittsburgh Sleep Quality Index(PSQI)]were assessed.Repeated measures analysis of variance and generalized linear mixed effects models were used to estimate the intervention effects on hemoglobin A1c and sleep quality.RESULTS The CBT group had 0.64,0.50,and 0.9 lower PSQI scores than the control group at 2 mo,6 mo,and 12 mo,respectively.The CBT group showed 0.17 and 0.43 lower HbAlc values than the control group at 6 mo and 12 mo.The intervention on meanΔHbAlc values was significant at 12 mo(t=3.68,P<0.01)and that meanΔPSQI scores were closely related toΔHbAlc values(t=7.02,P<0.01).Intentionto-treat analysis for primary and secondary outcomes showed identical results with completed samples.No adverse events were reported.CONCLUSION CBT delivered by general practitioners,as an effective and practical method,could reduce glycemic levels and improve sleep quality for patients with T2DM in community.
基金Supported by the University of Sydney,Sydney,Australia
文摘AIM: To evaluate the relative efficacy and safety of aflibercept for treatment of diabetic macular oedema(DMO).METHODS: A comprehensive search in MEDLINE, CENTRAL and EMBASE was undertaken for randomized controlled trials(RCTs) comparing intravitreal antivascular endothelial growth factor(anti-VEGF) versus another treatment. Primary outcome measures were proportion of patients with at least 15 letters of gain or loss on a log MAR visual acuity chart, and change in best corrected visual acuity(BCVA) and central macular thickness(CMT) from baseline. Safety outcomes were rates of death, thromboembolic events and any systemic or ocular serious adverse events. The final search was performed on November 2017.RESULTS: Four RCTs were included. Only one trial compared efficacy and safety of aflibercept with bevacizumab and ranibizumab over 1 or 2 y. Three trials were included for Meta-analysis comprising 661 patients(331 in the aflibercept, and 330 in the photocoagulation group). Aflibercept was more efficacious compared to photocoagulation in the proportion of patients with at least 15 letters of improvement and worsening, and in improvement of BCVA and reduction in CMT at 1 or 2 y. The safety estimates at 1 or 2 y did not differ statistically.CONCLUSION: Aflibercept offers superior benefits over photocoagulation in improving and preserving vision, with no differences in safety. Further comparative effectiveness trials between aflibercept and other anti-VEGF agents will aid ophthalmologists in treatment decisions.
基金supported by Merit Review Award#I 01 RX000637-01A3 from the United States Department of Veterans Af airs Rehabilitation Research and Development Service Programsupport for the preparatory phase of the project was provided through the Med Star Health Research Institute,a component of the Georgetown Howard Universities Center for Clinical and Translational Sciencesupported by Grant U54 RR026076-01 from the National Center for Research Resources,a component of the National Institutes of Health
文摘Background: Traumatic brain injury is a major health problem that frequently leads to deficits in executive function. Self-regulation processes, such as goal-setting, may become disordered after traumatic brain injury, particularly when the frontal regions of the brain and their connections are involved. Such impairments reduce injured veterans' ability to return to work or school and to regain satisfactory personal lives. Understanding the neurologically disabling effects of brain injury on executive function is necessary for both the accurate diagnosis of impairment and the individual tailoring of rehabilitation processes to help returning service members recover independent function.Methods/design: The COMPASSgoal(Community Participation through Self-Efficacy Skills Development) program develops and tests a novel patient-centered intervention framework for community reintegration psychosocial research in veterans with mild traumatic brain injury. COMPASSgoal integrates the principles and best practices of goal self-management. Goal setting is a core skill in self-management training by which persons with chronic health conditions learn to improve their status and decrease symptom effects. Over a three-year period, COMPASSgoal will recruit 110 participants with residual executive dysfunction three months or more post-injury. Inclusion criteria combine both clinical diagnosis and standardized scores that are >1 SD from the normative score on the Frontal Systems Rating Scale. Participants are randomized into two groups: goal-management(intervention) and supported discharge(control). The intervention is administered in eight consecutive, weekly sessions. Assessments occur at enrollment, post-intervention/supported discharge, and three months post-treatment follow-up.Discussion: Goal management is part of the "natural language" of rehabilitation. However, collaborative goal-setting between clinicians/case managers and clients can be hindered by the cognitive deficits that follow brain injury. Re-training returning veterans with brain injury in goal management, with appropriate help and support, would essentially treat deficits in executive function. A structured approach to goal self-management may foster greater independence and self-efficacy, help veterans gain insight into goals that are realistic for them at a given time, and help clinicians and veterans to work more effectively as true collaborators.
文摘Objective: The objective of this randomized controlled trial study was to evaluate the education training in relation to lifestyle improvement in patients with type 2 diabetes through its influence in the levels of glycated hemoglobin(HbA1 c), blood pressure, triglyceride, cholesterol levels, and body mass index(BMI).Methods: The study included patients with type 2 diabetes randomly selected from 20 residential areas in Tirana, Albania where family physicians provide services. The sample size in total was 200 patients in both groups(control and intervention). The education training(four sessions) was conducted by trained nursing staff for 6 months. Patients were screened for the biochemical profile before and after the intervention. To compare the groups with respect to the interest outcomes, the t-test was used. The value of P < 0.05 was considered significant.Results: There were 104 male patients and 96 female patients. The mean age was 54.9 ± 8.7. No significant differences were found between the study groups in relation to clinical and biochemical data before the education sessions. After the intervention, in the intervention group, the mean level of HbA1 c was significantly lower than the value in the control group(6.2% vs 6.8%, P = 0.001) as well as for the mean values of BMI. The mean reduction(more than 15%) in HbA1 c after the intervention was 43% in the intervention group and 2% in the control group(OR = 36.9, P < 0.05). Differences in BMI, HbA1 c, triglycerides, and cholesterol were more significantly visible in the intervention group. However, the difference in systolic and diastolic blood pressure values was almost the same(P > 0.05).Conclusions: The results of this study further support that the approach for education of patients with type 2 diabetes on changing lifestyle benefit the patient in controlling diabetes. It is believed that the establishment of diabetes education classes in health centers is an important investment in improving the management of type 2 diabetes.
基金This project was supported by the Xuzhou Science and Technology Plan Project(No.KC19223)Natural Science Project of Xuzhou Medical University(No.2018KJ07).
文摘Objective:Pain is a prevalent and distressing symptom in patients with cancer which has a significant impact on patients’physical health,psychological well-being,and quality of life(QOL).Deficiency of pain care,inadequate pain communication,and reluctance toward pain medication contribute to the difficulties in improving the situation of patients with cancer pain.Fortunately,the integration of self-management and professional healthcare provides new opportunities for patients with cancer pain.Methods:A two-arm randomized controlled trial will be conducted to assess the effectiveness of self-management application compared with routine care among patients with cancer pain.Based on Orem’s self-care theory and Naylor’s transitional care theory,cancer pain self-management application“Pain-housekeeper”was developed with dual client:patient client and medical client.A total of 120 patients with cancer pain are recruited from two university-affiliated tertiary public hospitals in China.They are randomly assigned to the control group and the intervention group.The patients in the control group get routine care while the patients in the intervention group get routine care and Pain-housekeeper App.The intervention is delivered by registered doctors,nurses,and postgraduate nursing students specialized in pain care.Effect measurements for both groups are carried out with questionnaires at baseline(T0),after 4 weeks(T1)and after 12 weeks(T2).The primary outcomes include pain condition,self-efficacy,and QOL.The secondary outcomes include pain medication adherence,satisfaction,anxiety,and depression.Compliance of data submission,economic evaluation,usage,and clinical data are also considered in the test.Data for the evaluation are gathered continuously during the study period.Discussion:This article provides insight into the effectiveness of a theory-based self-management mobile application intervention delivered to patients with uncontrolled cancer pain.The results are used to help patients to improve cancer pain control,self-efficacy,and QOL.Conclusions:The findings of this article provide evidence to support the implementation of an innovative and easily accessible intervention that enhances health outcomes.
