BACKGROUND: Pain management following caesarean section still remains a challenge in our environment. Most potent analgesics are either not readily available or expensive. Diclofenac suppository is an NSAID that can b...BACKGROUND: Pain management following caesarean section still remains a challenge in our environment. Most potent analgesics are either not readily available or expensive. Diclofenac suppository is an NSAID that can be used for postoperative analgesia. It is available and affordable. OBJECTIVE: To compare the efficacy and safety of combined rectal diclofenac and intramuscular pentazocine with intramuscular pentazocine alone for post operative pain control following lower segment caesarean section. METHODOLOGY: A total of 120 women who met the selection criteria scheduled for caesarean section under spinal anaesthesia with bupivacaine were randomized into two equal groups to receive either 75 mg diclofenac suppository 12 hourly for 24 hours or one anusol suppository (the placebo) 12 hourly for 24 hours. Both groups received pentazocine as primary analgesia. RESULT: The primary outcome measure is the proportion of patients with severe pain at 24 hours using the visual analogue rating scale. Secondary outcome measures are the time from surgery to ambulation, Passage of flatus, maternal satisfaction and presence of complications. Statistical analysis was done using spss version 22 and graph pad statistical package. Student T-test was used for continuous variables whereas chi square was used for categorical variables P CONCLUSION: Adjuvant rectal diclofenac is superior to pentazocine alone in the management of pain after caesarean section. Less number of patients had moderate to severe pain at 24 hours post operation. Maternal satisfaction in relation to pain management is better with diclofenac suppository. The levels of complications were comparable in both groups.展开更多
BACKGROUND Total shoulder arthroplasty(TSA)results in a large amount of perioperative blood loss due to severe trauma.AIM To investigate the safety and efficacy of intravenous tranexamic acid(TXA)in TSA.METHODS We sea...BACKGROUND Total shoulder arthroplasty(TSA)results in a large amount of perioperative blood loss due to severe trauma.AIM To investigate the safety and efficacy of intravenous tranexamic acid(TXA)in TSA.METHODS We searched the PubMed,Cochrane Library,Embase and Web of Science databases for randomized controlled trials(RCTs)on the use of TXA in TSA.And all the results were checked and assessed by Reference Citation Analysis(https://www.referencecitationanalysis.com/).A meta-analysis was performed with Review Manager 5.3 to calculate the odds ratio(OR)or weighted mean difference(WMD)of related outcome indicators.RESULTS A total of 5 RCTs with level 1 evidence were included.There were 369 cases,with 186 in the TXA group and 183 in the placebo group.The meta-analysis showed that TXA can significantly reduce total blood loss during the perioperative period[WMD=-249.56,95%confidence interval(CI):-347.6 to-151.52,P<0.0001],and the incidence of adverse reactions was low(OR=0.36,95%CI:0.16-0.83,P=0.02).Compared with the placebo group,the TXA group had significantly less total haemoglobin loss(WMD=-34.39,95%CI:-50.56 to-18.22),less haemoglobin fluctuation before and after the operation(WMD=-0.6,95%CI:-0.93 to-0.27)and less 24-h drain output(WMD=-136.87,95%CI:-165.87 to-106.49).There were no significant differences in the operation time(P=0.11)or hospital length of stay(P=0.30)between the two groups.CONCLUSION The application of intravenous TXA in the perioperative period of TSA can significantly reduce the total volume of perioperative blood loss and reduce the incidence of adverse reactions,so TXA is worthy of widespread clinical use.展开更多
BACKGROUND: Rheumatoid arthritis (RA), as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does...BACKGROUND: Rheumatoid arthritis (RA), as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN: This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1:1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo (imitation leflunomide). The control group will receive leflunomide and an herbal placebo (imitation Xinfeng Capsule). The American College of Rheumatology (ACR) Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate (ACR20), which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION: The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION: This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.展开更多
We evaluated the eff icacy and tolerability of mebeverine, a musculotropic antispasmodic agent, in irritable bowel syndrome (IBS) and compared its usual dosages by meta-analysis. Medical databases and all relevant lit...We evaluated the eff icacy and tolerability of mebeverine, a musculotropic antispasmodic agent, in irritable bowel syndrome (IBS) and compared its usual dosages by meta-analysis. Medical databases and all relevant literature were searched from 1965 to June 2009 for any placebo-controlled clinical trials of mebeverine, using search terms such as mebeverine, clinical trials, and IBS. Eight randomized trials met our criteria, including six trials that compared mebeverine with placebo and two that compared mebeverine tablets with capsules. These eight trials included 555 patients randomized to receive either mebeverine or placebo with 352 (63%)women and 203 (37%) men in all subtypes of IBS. The pooled relative risk (RR) for clinical improvement of mebeverine was 1.13 (95% CI: 0.59-2.16, P = 0.7056) and 1.33 (95% CI: 0.92-1.93, P = 0.129) for relief of abdominal pain. The efficacy of mebeverine 200 mg compared to mebeverine 135 mg indicated RRs of 1.12 (95% CI: 0.96-1.3, P = 0.168) for clinical or global improvement and 1.08 (95% CI: 0.87-1.34, P = 0.463) for relief of abdominal pain. Thus, mebeverine is mostly well tolerated with no signif icant adverse effects; however, its eff icacy in global improvement of IBS is not statistically signif icant.展开更多
The purpose of this work was to assess the evidence for effectiveness of acupuncture (AC) treatment in gastrointestinal diseases. A systematic review of the Medline-cited literature for clinical trials was performed...The purpose of this work was to assess the evidence for effectiveness of acupuncture (AC) treatment in gastrointestinal diseases. A systematic review of the Medline-cited literature for clinical trials was performed up to May 2006. Controlled trials assessing acupuncture point stimulation for patients with gastrointestinal diseases were considered for inclusion. The search identified 18 relevant trials meeting the inclusion criteria. Two irritable bowel syndrome (IBS) trials, 1 Crohn's disease and 1 colitis ulcerosa trial had a robust random controlled trial (RCT) design. In regard to other gastrointestinal disorders, study quality was poor. In all trials, quality of life (QoL) improved significantly independently from the kind of acupuncture, real or sham. Real AC was significantly superior to sham acupuncture with regard to disease activity scores in the Crohn and Colitis trials. Efficacy of acupuncture related to QoL in IBS may be explained by unspecific effects. This is the same for QoL in inflammatory bowel diseases (IBD), whereas specific acupuncture effects may be found in clinical scores. Further trials for IBDs and in particular for all other gastrointestinal disorders would be necessary to evaluate the efficacy of acupuncture treatment. However, it must be discussed on what terms patients benefit when this harmless and obviously powerful therapy with regard to QoL is demystified by further placebo controlled trials.展开更多
BACKGROUND Acute pancreatitis is the leading cause of hospitalization for acute gastrointestinal disease worldwide.The effects of probiotics in mild acute pancreatitis have not been studied.We hypothesized that the ad...BACKGROUND Acute pancreatitis is the leading cause of hospitalization for acute gastrointestinal disease worldwide.The effects of probiotics in mild acute pancreatitis have not been studied.We hypothesized that the administration of probiotics may accelerate the recovery of intestinal function and shorten the length of hospital stay(LOS)in patients with mild pancreatitis.AIM To investigate the value of probiotics in reducing the LOS in patients with mild acute pancreatitis.METHODS We conducted a double-blind randomized clinical trial to evaluate the effects of probiotics administered to patients with mild acute pancreatitis at a tertiary medical center.The patients were given probiotics capsules(a mixed preparation of Bacillus subtilis and Enterococcus faecium)or placebo.The primary study endpoint was the LOS.The secondary endpoints included time to abdominal pain relief,recurrent abdominal pain,and time to successful oral feeding.RESULTS A total of 128 patients were included,with 64 patients in each arm.The severity of illness and the etiological distribution of disease were similar in the two groups.There was a significant reduction in the LOS in the probiotics treatment group vs the placebo group(5.36±0.15 vs 6.02±0.17 d,P<0.05).The probiotics group was associated with a shorter time to abdominal pain relief and time to successful oral feeding(P<0.01 for both)than the placebo group.No statistical difference was found in recurrent abdominal pain between the two groups.CONCLUSION The study results showed that the administration of probiotics capsules is associated with a shorter duration of hospitalization in patients with mild acute pancreatitis.展开更多
Over the last several years there has been a growing interest in placebo, not only as an inert control in clinical trials, but also in the placebo effect as a group effect as well as a reaction in individual subjects....Over the last several years there has been a growing interest in placebo, not only as an inert control in clinical trials, but also in the placebo effect as a group effect as well as a reaction in individual subjects. Methodological factors such as regression to the mean and natural history of the disease play a role in the evaluation of a possible placebo effect. In this report, we discuss several factors including PavIovian conditioning, beliefs outcome, expectations, and other factors as potential mediators of the placebo response. Placebo effects are common in gastrointestinal diseases and there seems to be no clear difference between placebo effects in functional gastrointestinal diseases (functional dyspepsia and irritable bowel syndrome) and organic gastrointestinal disease (duodenal ulcer and inflammatory bowel disease).展开更多
AIM To determine the placebo response rate associated with different types of placebo interventions used in psychological intervention studies for irritable bowel syndrome. METHODS Randomized controlled trials compari...AIM To determine the placebo response rate associated with different types of placebo interventions used in psychological intervention studies for irritable bowel syndrome. METHODS Randomized controlled trials comparing psychological interventions(stress management/relaxation therapy(cognitive) behavioral therapy, short-term psychodynamic therapy, and hypnotherapy) for the treatment of adult patients with irritable bowel syndrome(IBS) diagnosed with the Manning or Rome criteria with an adequate placebo control treatment and reporting data on IBS symptom severity were identified by searching Pub Med, Embase, the Cochrane Library, CINAHL and Psyc INFO databases. Full-text articles that were written in English and published between 1966 and February 2016 in peer-reviewed journals were selected for the present review. Placebo interventions were considered to be adequate if the number of sessions and the amount of time spent with the therapist were the same as in the active treatment. The placebo response rate(PRR) was computed for IBS symptom severity(primary outcome measure) as well as for anxiety, depression and quality of life(secondary outcome measures). RESULTS Six studies, with a total of 555 patients met the inclusion criteria. Four studies used an educational intervention, whereas two studies used a form of supportive therapy as the placebo intervention. The PRR for IBS symptom severity ranged from 25% to 59%, with a pooled mean of 41.4%. The relative PRR for the secondary outcome measures ranged from 0% to 267% for anxiety, 6% to 52% for depression 20% to 125% for quality of life. The PRR associated with pharmacological treatments, treatment with dietary bran and complementary medicine ranged from 37.5% to 47%. Contrary to our expectations, the PRR in studies on psychological interventions was comparable to that in studies on pharmacological, dietary and alternative medical interventions.CONCLUSION The PRR is probably determined to a larger extent by patient-related factors, such as expectations and desire for the treatment to be effective, than the content of the placebo intervention.展开更多
AIM: To investigate the early mortality of placebo-treated alcoholic hepatitis patients. METHODS: Mortality data about alcoholic hepatitis patients who participated in randomized placebo-controlled trials were searche...AIM: To investigate the early mortality of placebo-treated alcoholic hepatitis patients. METHODS: Mortality data about alcoholic hepatitis patients who participated in randomized placebo-controlled trials were searched from PubMed, EMBASE, and Cochrane Library, extracted and analyzed. RESULTS: A total of 661 placebo-treated patients in 19 trials were included. The overall mortality rate was 34.19% with a median observation time of 160 d (range 21-720 d). Hepatic failure, gastrointestinal bleeding and infection were the three main causes of death, accounting for 55.47%, 21.17% and 7.30% of all deaths, respectively. One-month mortality data about 324 placebo-treated alcoholic hepatitis patients in 10 trials were reported with a pooled mortality rate of 20.37%. The one-month mortality rate of patients with moderate to severe alcoholic hepatitis tended to be higherthan that of general patients (22.69% vs 10.93%, P < 0.05), whereas no signifi cant difference was observed between the patients from North America or Europe (22.43% vs 18.45%, P > 0.05), neither any difference was found between the studies published before and after 1990 (18.18% vs 21.88%, P > 0.05). CONCLUSION: Alcoholic hepatitis is a severe liver disease with a high mortality rate, and hepatic failure, gastrointestinal bleeding and infection are the three main causes of death.展开更多
Objective:To evaluate the efficacy and safety of Chinese herbal medicine(CHM)for the treatment of functional dyspepsia(FD).Methods:Web of Science,PubMed,EMBASE,Cochrane Library,and four other Chinese electronic databa...Objective:To evaluate the efficacy and safety of Chinese herbal medicine(CHM)for the treatment of functional dyspepsia(FD).Methods:Web of Science,PubMed,EMBASE,Cochrane Library,and four other Chinese electronic databases,including China National Knowledge Infrastructure(CNKI),Chinese Biological Medical Database(CBM),Chinese Scientific Journals Database(VIP),and WanFang Database were used to search(up to Feb,2016)for randomized,double-blind,placebocontrolled trials recruiting adults with FD treated with CHM.Study selection,data extraction,quality assessment,and data analyses were conducted based on Cochrane standards using Review Manager software.Results:Fourteen publications(1424 patients)were included.Evidence revealed that CHM was more efficacious than the placebo in improving global dyspepsia symptoms(RR,1.45;95%CI,1.31e1.60),Chinese medicine syndrome(CMS)(RR,1.36;95%CI,1.23e1.50),and quality of life(SMD,0.30;95%CI,0.15e0.45)in FD patients.Furthermore,the difference in the incidence of adverse events between CHM and placebo groups had no statistical significance(RR,1.06;95%CI,0.66e1.70).Conclusion:This meta-analysis demonstrates that CHM has a therapeutic potential in treating FD with a certain safety.However,due to the restricted number of trials included,wellplanned,long-term studies are necessary to provide credible evidence.展开更多
BACKGROUND: Sleep deprivation resulting from night shifts, is a major cause of burnout among physicians. Exogenous melatonin may improve sleep quality in night-shift workers. The study aims to compare the effectivenes...BACKGROUND: Sleep deprivation resulting from night shifts, is a major cause of burnout among physicians. Exogenous melatonin may improve sleep quality in night-shift workers. The study aims to compare the effectiveness of melatonin versus placebo on sleep effi ciency in emergency medicine(EM) residents. METHODS: A randomized, double-blind, replicated crossover trial was performed on EM residents. This study consisted of 4 phases within a month with intervention periods of 2 nights and washouts of 6 days. In our study, EM residents had nine-hour shifts on 6 consecutive days, 2 mornings, 2 evenings and 2 nights and then 2 days off. At the end of shifts' cycle, 24 EM residents were given 3 mg melatonin or placebo(12 in each arm of the study) for 2 consecutive nights after the second night shift with crossover to the other arm after a six-day off drug. This crossover intervention was repeated for two more another time. Finally, we created 48 cases and comparisons in each arm. Different items related to sleep quality were assessed and compared both within the same group and between the two groups. RESULTS: In the melatonin group, daytime sleepiness(calculated by Karolinska Sleep Scale) had a signifi cant reduction after taking the second dose of drug(P=0.003) but the same result was not observed when comparing the 2 groups. Mood status(calculated by Profile of Mood States) showed no remarkable difference between the 2 groups. CONCLUSION: Melatonin might have a limited benefi t on sleep quality in EM residents working night shifts.展开更多
Whether supplementation of curcuminoids decreases serum adipocyte-fatty acid binding protein(A-FABP) level and whether this decrease benefits glucose control is unclear.One-hundred participants(n=50 administered cu...Whether supplementation of curcuminoids decreases serum adipocyte-fatty acid binding protein(A-FABP) level and whether this decrease benefits glucose control is unclear.One-hundred participants(n=50 administered curcuminoids,n=50 administered placebo) from our previous report on the effect of curcuminoids on type 2 diabetes in a 3-month intervention were assessed for levels of serum A-FABP,oxidative stress,and inflammatory biomarkers.Curcuminoids supplementation led to significant decreases in serum A-FABP,C-reactive protein(CRP),tumor necrosis factor-α,and interleukin-6 levels.Curcuminoids supplementation also significantly increased serum superoxide dismutase(SOD) activity.The change in serum A-FABP levels showed positive correlations with changes in levels of glucose,free fatty acids(FFAs),and CRP in subjects supplemented with curcuminoids.Further stepwise regression analysis showed that A-FABP was an independent predictor for levels of FFAs,SOD,and CRP.These results suggest that curcuminoids may exert anti-diabetic effects,at least in part,by reductions in serum A-FABP level.A-FABP reduction is associated with improved metabolic parameters in human type 2 diabetes.展开更多
The purpose of the present work was to evaluatethe clinical efficacy and the mechanism of Yi-qiHuo-xue Injection(YHI 益气活血注射液)in treat-ment of coronary heart disease.YHI consists ofGinseng,Astragalus and Angel...The purpose of the present work was to evaluatethe clinical efficacy and the mechanism of Yi-qiHuo-xue Injection(YHI 益气活血注射液)in treat-ment of coronary heart disease.YHI consists ofGinseng,Astragalus and Angelicae Sinensis.(人参黄芪,当归).The 10% dextrose serves as a pla-cebo.The results were as follows:1.the frequencyand severity of angina episodes were reduced by90.63%;2.the isehemic ST-T in ECG was improvedin 56.25% of eases;3.the tolerance to treadmillexercise was increased from 348,50 to 505.50 M.;4.the left ventricular function was strengthened,PEP/LVET ratio reduced from 0.45 to 0.36,the activityof(Na+-K+)ATPase in myocardial cell membraneof rats inhibited by 19.2%;5.the blood viscosity anderythrocyte electrophoretic time lowered;6.theadhesion and aggregation of platelet in patients withCHD were inhibited by 27% and 59.4% respectively;7.the plasma TXB<sub>2</sub> level in CHD was reduced from260.28±164.4 to 139.29±57.01 pg/ml;8.the plasma6-keto-PGF<sub>1α</sub> level in CHD was increased from33.45±22.5 to 57.48±13.1 pg/ml,and in rats from185.77 to 366.33 pg/ml.The differences were allstatistically significant(P【0.05-0.01)in comparisonwith the placebo group.展开更多
Objective To evaluate the efficacy and safety of traditional Chinese medicine(TCM)compounds for the treatment of functional dyspepsia(FD).Methods The Pub Med,Embase,Cochrane Library,Web of Science,Chinese Biomedical D...Objective To evaluate the efficacy and safety of traditional Chinese medicine(TCM)compounds for the treatment of functional dyspepsia(FD).Methods The Pub Med,Embase,Cochrane Library,Web of Science,Chinese Biomedical Database(CBM),Wanfang Data,China National Knowledge Infrastructure(CNKI),and China Science and Technology Journal Database(VIP)were searched to collect randomized,double-blind,and placebo-controlled trials of FD treated with TCM compounds.The search duration was from the establishment of the database to March 2,2021.After two researchers independently screened the literature,extracted the data,and evaluated the bias risk included in the study,they used Rev Man 5.4 software for meta-analysis.Results A total of 23 clinical trials were included,including 2898 patients.Meta-analysis showed that the overall remission rate of FD treated with TCM compounds was significantly higher than that of placebo(73.8%vs.46.2%)[RR=1.50,95%CI(1.29,1.76),P<0.00001].Among the single symptoms,TCM compounds were superior to the placebo in improving epigastric pain[MD=﹣0.99,95%CI(﹣1.37,﹣0.61),P<0.00001],epigastric burning sensation[MD=﹣0.32,95%CI(﹣0.59,﹣0.05),P=0.02],postprandial fullness discomfort[MD=﹣1.59,95%CI(﹣1.96,﹣1.21),P<0.00001],and early satiety symptoms[MD=﹣0.93,95%CI(﹣1.32,﹣0.54),P<0.00001].Compared with the placebo,TCM compounds treatment can obviously improve TCM syndrome in patients with FD[MD=﹣5.58,95%CI(﹣7.55,﹣3.61),P<0.00001],gastric emptying rate[MD=12.22,95%CI(8.90,15.55),P<0.00001],and helped to improve patients’quality of life[MD=11.27,95%CI(0.10,22.43),P=0.05].No severe adverse events were reported between the two groups[RR=1.34,95%CI(0.91,1.96),P=0.14].Conclusion Our results showed that TCM compounds treatment could significantly alleviate FD symptoms,improve gastric emptying in FD patients,and help to improve their quality of life.No severe adverse reactions have been reported in clinical applications.Due to the limitation of the quantity and quality of the included studies,the above conclusions need to be verified by more high-quality studies.展开更多
Background Inflammation that is mediated by microglia activation plays an important role in the pathogenesis of depression.Microglia activation can lead to an increase in the levels of proinflammatory cytokines,includ...Background Inflammation that is mediated by microglia activation plays an important role in the pathogenesis of depression.Microglia activation can lead to an increase in the levels of proinflammatory cytokines,including TNF-α,which leads to neuronal apoptosis in the specific neural circuits of some brain regions,abnormal cognition and treatment-resistant depression(TRD).Protein kinase C(PKC)is a key regulator of the microglia activation process.We assume that the abnormality in PKC might result in abnormal microglia activation,neuronal apoptosis,significant changes in emotional and cognitive neural circuits,and TRD.In the current study,we plan to target at the PKC signal pathway to improve the TRD treatment outcome.Methods and analysis This is a 12-week,ongoing,randomised,placebo-controlled trial.Patients with TRD(N=180)were recruited from Shanghai Mental Health Center,Shanghai Jiao Tong University.Healthy control volunteers(N=60)were recruited by advertisement.Patients with TRD were randomly assigned to‘escitalopram+golimumab(TNF-αinhibitor)’,‘escitalopram+calcium tablet+vitamin D(PKC activator)’or‘escitalopram+placebo’groups.We define the primary outcome as changes in the 17-item Hamilton Depression Rating Scale(HAMD-17).The secondary outcome is defined as changes in anti-inflammatory effects,cognitive function and quality of life.Discussion This study might be the first randomised,placebo-controlled trial to target at the PKC signal pathway in patients with TRD.Our study might help to propose individualised treatment strategies for depression.Trial registration number The trial protocol is registered with ClinicalTrials.gov under protocol ID 81930033 and ClinicalTrials.gov ID NCT04156425.展开更多
Background: Major depressive disorder is a serious public health problem affecting the lives of millions in the worldwide and leading causes of disability and disease. This study aimed to evaluate the efficacy and saf...Background: Major depressive disorder is a serious public health problem affecting the lives of millions in the worldwide and leading causes of disability and disease. This study aimed to evaluate the efficacy and safety of Vortioxetine and Duloxetine 60 mg compared to placebo for the treatment of major depressive disorder. Method: We searched the Cochrane library, Pub Med, CRD, Scopus, and Central Register of Controlled Trials to January 2015. We also searched ClinicalTrials.gov, International depressive disorder Conference and the Anxiety Disorders and Depression Conference. We identified that five randomized clinical trials were ultimately included in a Meta analysis. Data analysis was conducted by Standardized Mean Differences (SMD) for Montgomery-Åsberg Depression Rating Scale (MADRS), and Odds Ratio (OR) for adverse events. The SMD and OR reported by 95% CI. Results: Results showed statistical significance in the MADRS for Vortioxetine (SMD = ﹣3.29;95% CI ﹣4.47 to ﹣2.10;I2 = 99.3%) and for Duloxetine 60 mg (SMD = ﹣6.35;95% CI ﹣8.84, ﹣3.87;I2 = 99.3%). Results showed that the Vortioxetine 2.5, 5, 10, 15, 20 mg and overall compared to placebo showed a significance for Nausea and no significance for diarrhea, dry mouth, dizziness, fatigue and headache. Also results of Duloxetine 60 mg showed a significant effect for dry mouth, dizziness, fatigue and nausea. Conclusion: It is necessary to do more studies so as to better assess and much more powerful than the evidence for the use of this drug in the treatment of depression.展开更多
Constipation and insomnia are commonamong aged person and refractory to treatment.The authors used mulberry extract for this pur-pose and found it effective in most cases.Syrupof Fructus Crataegi was used as placebo f...Constipation and insomnia are commonamong aged person and refractory to treatment.The authors used mulberry extract for this pur-pose and found it effective in most cases.Syrupof Fructus Crataegi was used as placebo fordouble blind control.展开更多
To evaluate the anti-obesity effect of Xiaopang-mei,an experimental study by single method in threegroups of rats was done.The first group were fedwith Xiaopangmei-01,the second group with aplacebo,and the third group...To evaluate the anti-obesity effect of Xiaopang-mei,an experimental study by single method in threegroups of rats was done.The first group were fedwith Xiaopangmei-01,the second group with aplacebo,and the third group were controls.Ascompared with the control and the placebo groups,the rata that had been fed Xiaopangmei for six weeksshowed body weight,food intake,weight of epididy-mis fat pad and the intestinal absorption of glucoseall significantly decreased.The swimming tolerancetest showed they swam longer than the other twogroups.No significant difference was found betweenthe three groups in the growth and developmentindices such as body length,length of femur and tibia,weight of heart,lungs,spleen,kidneys,stomach,smallintestines,gastrocnemius muscle,and adrenal glands.No side effects were found on the liver and kidney.The secretion of insulin was inhibited after the swim-ming tolerance test and the gestrocnemius muscletest was similar for all three groups of rats.Weconcluded that Xiaopangmei is an effective anti-obesity drug.展开更多
Context: Stroke increases the risk of subsequent hip fracture by 2 to 4 times. Hyperhomocysteinemia is a risk factor for both ischemic stroke and osteoporotic fractures in elderly men and women. Treatment with folate ...Context: Stroke increases the risk of subsequent hip fracture by 2 to 4 times. Hyperhomocysteinemia is a risk factor for both ischemic stroke and osteoporotic fractures in elderly men and women. Treatment with folate and mecobalamin (vita min B12) may improve hyperhomocysteinemia.Objective: To investigate whether trea tment with folate and vitamin B12 reduces the incidence of hip fractures in pati ents with hemiplegia following stroke.Design, Setting, and Patients: A double-b lind, randomized controlled study of 628 consecutive patients aged 65 years or o lder with residual hemiplegia at least 1 year following first ischemic stroke, w ho were recruited from a single Japanese hospital from April 1, 2000, to May 31, 2001. Patients were assigned to daily oral treatment with 5 mg of folate and 15 00 μg of mecobalamin,or double placebo; 559 completed the 2-year follow-up.Ma in Outcome Measure: Incidence of hip fractures in the 2 patient groups during th e 2-year follow-up. Results:At baseline, patients in both groups had high leve ls of plasma homocysteine and low levels of serum cobalamin and serum folate. Af ter 2 years, plasma homocysteine levels decreased by 38%in the treatment group and increased by 31%in the placebo group (P < .001). The number of hip fracture s per 1000 patient-years was 10 and 43 for the treatment and placebo groups, re spectively(P < .001). The adjusted relative risk, absolute risk reduction,and th e number needed to treat for hip fractures in the treatment vs placebo groups we re 0.20 (95%confidence interval [CI], 0.08-0.50), 7.1%(95%CI, 3.6%-10.8%) , and 14 (95%CI, 9-28), respectively. No significant adverse effects were repo rted. Conclusion: In this Japanese population with a high baseline fracture risk , combined treatment with folate and vitamin B12 is safe and effective in reduci ng the risk of a hip fracture in elderly patients following stroke.展开更多
Chronic diseases such as Alzheimer's disease (AD), diabetes and scapulohumeral periarthritis present a special challenge to clinicians because of high incidence, lethality and disability which directly result in t...Chronic diseases such as Alzheimer's disease (AD), diabetes and scapulohumeral periarthritis present a special challenge to clinicians because of high incidence, lethality and disability which directly result in the economical and family burden. The current special issue of'health care and rehabilitation'mainly focuses on the area of traditional medicine therapy to chronic diseases. The following six papers cover three different methods of traditional medicine therapy including drug therapy, non-drug therapy and manipulation therapy.展开更多
文摘BACKGROUND: Pain management following caesarean section still remains a challenge in our environment. Most potent analgesics are either not readily available or expensive. Diclofenac suppository is an NSAID that can be used for postoperative analgesia. It is available and affordable. OBJECTIVE: To compare the efficacy and safety of combined rectal diclofenac and intramuscular pentazocine with intramuscular pentazocine alone for post operative pain control following lower segment caesarean section. METHODOLOGY: A total of 120 women who met the selection criteria scheduled for caesarean section under spinal anaesthesia with bupivacaine were randomized into two equal groups to receive either 75 mg diclofenac suppository 12 hourly for 24 hours or one anusol suppository (the placebo) 12 hourly for 24 hours. Both groups received pentazocine as primary analgesia. RESULT: The primary outcome measure is the proportion of patients with severe pain at 24 hours using the visual analogue rating scale. Secondary outcome measures are the time from surgery to ambulation, Passage of flatus, maternal satisfaction and presence of complications. Statistical analysis was done using spss version 22 and graph pad statistical package. Student T-test was used for continuous variables whereas chi square was used for categorical variables P CONCLUSION: Adjuvant rectal diclofenac is superior to pentazocine alone in the management of pain after caesarean section. Less number of patients had moderate to severe pain at 24 hours post operation. Maternal satisfaction in relation to pain management is better with diclofenac suppository. The levels of complications were comparable in both groups.
文摘BACKGROUND Total shoulder arthroplasty(TSA)results in a large amount of perioperative blood loss due to severe trauma.AIM To investigate the safety and efficacy of intravenous tranexamic acid(TXA)in TSA.METHODS We searched the PubMed,Cochrane Library,Embase and Web of Science databases for randomized controlled trials(RCTs)on the use of TXA in TSA.And all the results were checked and assessed by Reference Citation Analysis(https://www.referencecitationanalysis.com/).A meta-analysis was performed with Review Manager 5.3 to calculate the odds ratio(OR)or weighted mean difference(WMD)of related outcome indicators.RESULTS A total of 5 RCTs with level 1 evidence were included.There were 369 cases,with 186 in the TXA group and 183 in the placebo group.The meta-analysis showed that TXA can significantly reduce total blood loss during the perioperative period[WMD=-249.56,95%confidence interval(CI):-347.6 to-151.52,P<0.0001],and the incidence of adverse reactions was low(OR=0.36,95%CI:0.16-0.83,P=0.02).Compared with the placebo group,the TXA group had significantly less total haemoglobin loss(WMD=-34.39,95%CI:-50.56 to-18.22),less haemoglobin fluctuation before and after the operation(WMD=-0.6,95%CI:-0.93 to-0.27)and less 24-h drain output(WMD=-136.87,95%CI:-165.87 to-106.49).There were no significant differences in the operation time(P=0.11)or hospital length of stay(P=0.30)between the two groups.CONCLUSION The application of intravenous TXA in the perioperative period of TSA can significantly reduce the total volume of perioperative blood loss and reduce the incidence of adverse reactions,so TXA is worthy of widespread clinical use.
基金supported by the Twelfth Five-Year Support Project of the Ministry of Science and Technology for clinical studies investigating Xin'an medicine in the treatment of complicated ascites diseases(No.2012BAI26B02)
文摘BACKGROUND: Rheumatoid arthritis (RA), as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN: This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1:1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo (imitation leflunomide). The control group will receive leflunomide and an herbal placebo (imitation Xinfeng Capsule). The American College of Rheumatology (ACR) Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate (ACR20), which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION: The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION: This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.
文摘We evaluated the eff icacy and tolerability of mebeverine, a musculotropic antispasmodic agent, in irritable bowel syndrome (IBS) and compared its usual dosages by meta-analysis. Medical databases and all relevant literature were searched from 1965 to June 2009 for any placebo-controlled clinical trials of mebeverine, using search terms such as mebeverine, clinical trials, and IBS. Eight randomized trials met our criteria, including six trials that compared mebeverine with placebo and two that compared mebeverine tablets with capsules. These eight trials included 555 patients randomized to receive either mebeverine or placebo with 352 (63%)women and 203 (37%) men in all subtypes of IBS. The pooled relative risk (RR) for clinical improvement of mebeverine was 1.13 (95% CI: 0.59-2.16, P = 0.7056) and 1.33 (95% CI: 0.92-1.93, P = 0.129) for relief of abdominal pain. The efficacy of mebeverine 200 mg compared to mebeverine 135 mg indicated RRs of 1.12 (95% CI: 0.96-1.3, P = 0.168) for clinical or global improvement and 1.08 (95% CI: 0.87-1.34, P = 0.463) for relief of abdominal pain. Thus, mebeverine is mostly well tolerated with no signif icant adverse effects; however, its eff icacy in global improvement of IBS is not statistically signif icant.
文摘The purpose of this work was to assess the evidence for effectiveness of acupuncture (AC) treatment in gastrointestinal diseases. A systematic review of the Medline-cited literature for clinical trials was performed up to May 2006. Controlled trials assessing acupuncture point stimulation for patients with gastrointestinal diseases were considered for inclusion. The search identified 18 relevant trials meeting the inclusion criteria. Two irritable bowel syndrome (IBS) trials, 1 Crohn's disease and 1 colitis ulcerosa trial had a robust random controlled trial (RCT) design. In regard to other gastrointestinal disorders, study quality was poor. In all trials, quality of life (QoL) improved significantly independently from the kind of acupuncture, real or sham. Real AC was significantly superior to sham acupuncture with regard to disease activity scores in the Crohn and Colitis trials. Efficacy of acupuncture related to QoL in IBS may be explained by unspecific effects. This is the same for QoL in inflammatory bowel diseases (IBD), whereas specific acupuncture effects may be found in clinical scores. Further trials for IBDs and in particular for all other gastrointestinal disorders would be necessary to evaluate the efficacy of acupuncture treatment. However, it must be discussed on what terms patients benefit when this harmless and obviously powerful therapy with regard to QoL is demystified by further placebo controlled trials.
基金National Natural Science Foundation of China,No.81370364.
文摘BACKGROUND Acute pancreatitis is the leading cause of hospitalization for acute gastrointestinal disease worldwide.The effects of probiotics in mild acute pancreatitis have not been studied.We hypothesized that the administration of probiotics may accelerate the recovery of intestinal function and shorten the length of hospital stay(LOS)in patients with mild pancreatitis.AIM To investigate the value of probiotics in reducing the LOS in patients with mild acute pancreatitis.METHODS We conducted a double-blind randomized clinical trial to evaluate the effects of probiotics administered to patients with mild acute pancreatitis at a tertiary medical center.The patients were given probiotics capsules(a mixed preparation of Bacillus subtilis and Enterococcus faecium)or placebo.The primary study endpoint was the LOS.The secondary endpoints included time to abdominal pain relief,recurrent abdominal pain,and time to successful oral feeding.RESULTS A total of 128 patients were included,with 64 patients in each arm.The severity of illness and the etiological distribution of disease were similar in the two groups.There was a significant reduction in the LOS in the probiotics treatment group vs the placebo group(5.36±0.15 vs 6.02±0.17 d,P<0.05).The probiotics group was associated with a shorter time to abdominal pain relief and time to successful oral feeding(P<0.01 for both)than the placebo group.No statistical difference was found in recurrent abdominal pain between the two groups.CONCLUSION The study results showed that the administration of probiotics capsules is associated with a shorter duration of hospitalization in patients with mild acute pancreatitis.
文摘Over the last several years there has been a growing interest in placebo, not only as an inert control in clinical trials, but also in the placebo effect as a group effect as well as a reaction in individual subjects. Methodological factors such as regression to the mean and natural history of the disease play a role in the evaluation of a possible placebo effect. In this report, we discuss several factors including PavIovian conditioning, beliefs outcome, expectations, and other factors as potential mediators of the placebo response. Placebo effects are common in gastrointestinal diseases and there seems to be no clear difference between placebo effects in functional gastrointestinal diseases (functional dyspepsia and irritable bowel syndrome) and organic gastrointestinal disease (duodenal ulcer and inflammatory bowel disease).
文摘AIM To determine the placebo response rate associated with different types of placebo interventions used in psychological intervention studies for irritable bowel syndrome. METHODS Randomized controlled trials comparing psychological interventions(stress management/relaxation therapy(cognitive) behavioral therapy, short-term psychodynamic therapy, and hypnotherapy) for the treatment of adult patients with irritable bowel syndrome(IBS) diagnosed with the Manning or Rome criteria with an adequate placebo control treatment and reporting data on IBS symptom severity were identified by searching Pub Med, Embase, the Cochrane Library, CINAHL and Psyc INFO databases. Full-text articles that were written in English and published between 1966 and February 2016 in peer-reviewed journals were selected for the present review. Placebo interventions were considered to be adequate if the number of sessions and the amount of time spent with the therapist were the same as in the active treatment. The placebo response rate(PRR) was computed for IBS symptom severity(primary outcome measure) as well as for anxiety, depression and quality of life(secondary outcome measures). RESULTS Six studies, with a total of 555 patients met the inclusion criteria. Four studies used an educational intervention, whereas two studies used a form of supportive therapy as the placebo intervention. The PRR for IBS symptom severity ranged from 25% to 59%, with a pooled mean of 41.4%. The relative PRR for the secondary outcome measures ranged from 0% to 267% for anxiety, 6% to 52% for depression 20% to 125% for quality of life. The PRR associated with pharmacological treatments, treatment with dietary bran and complementary medicine ranged from 37.5% to 47%. Contrary to our expectations, the PRR in studies on psychological interventions was comparable to that in studies on pharmacological, dietary and alternative medical interventions.CONCLUSION The PRR is probably determined to a larger extent by patient-related factors, such as expectations and desire for the treatment to be effective, than the content of the placebo intervention.
基金Supported by Chinese State Key Project for High Technology, No. 2006AA02A308National Key Technology R&D Program, No. 2008BAI52B03Science and Technology Foundation of Zhejiang Province, No. 2008C13027-1
文摘AIM: To investigate the early mortality of placebo-treated alcoholic hepatitis patients. METHODS: Mortality data about alcoholic hepatitis patients who participated in randomized placebo-controlled trials were searched from PubMed, EMBASE, and Cochrane Library, extracted and analyzed. RESULTS: A total of 661 placebo-treated patients in 19 trials were included. The overall mortality rate was 34.19% with a median observation time of 160 d (range 21-720 d). Hepatic failure, gastrointestinal bleeding and infection were the three main causes of death, accounting for 55.47%, 21.17% and 7.30% of all deaths, respectively. One-month mortality data about 324 placebo-treated alcoholic hepatitis patients in 10 trials were reported with a pooled mortality rate of 20.37%. The one-month mortality rate of patients with moderate to severe alcoholic hepatitis tended to be higherthan that of general patients (22.69% vs 10.93%, P < 0.05), whereas no signifi cant difference was observed between the patients from North America or Europe (22.43% vs 18.45%, P > 0.05), neither any difference was found between the studies published before and after 1990 (18.18% vs 21.88%, P > 0.05). CONCLUSION: Alcoholic hepatitis is a severe liver disease with a high mortality rate, and hepatic failure, gastrointestinal bleeding and infection are the three main causes of death.
基金the National Natural Science Foundation of China(Grant No.81273746,and 81573806)Foundation on Beijing Key Laboratory of Functional Gastrointestinal Disorders Diagnosis and Treatment of Traditional Chinese Medicine(Grant No.BZ0374).
文摘Objective:To evaluate the efficacy and safety of Chinese herbal medicine(CHM)for the treatment of functional dyspepsia(FD).Methods:Web of Science,PubMed,EMBASE,Cochrane Library,and four other Chinese electronic databases,including China National Knowledge Infrastructure(CNKI),Chinese Biological Medical Database(CBM),Chinese Scientific Journals Database(VIP),and WanFang Database were used to search(up to Feb,2016)for randomized,double-blind,placebocontrolled trials recruiting adults with FD treated with CHM.Study selection,data extraction,quality assessment,and data analyses were conducted based on Cochrane standards using Review Manager software.Results:Fourteen publications(1424 patients)were included.Evidence revealed that CHM was more efficacious than the placebo in improving global dyspepsia symptoms(RR,1.45;95%CI,1.31e1.60),Chinese medicine syndrome(CMS)(RR,1.36;95%CI,1.23e1.50),and quality of life(SMD,0.30;95%CI,0.15e0.45)in FD patients.Furthermore,the difference in the incidence of adverse events between CHM and placebo groups had no statistical significance(RR,1.06;95%CI,0.66e1.70).Conclusion:This meta-analysis demonstrates that CHM has a therapeutic potential in treating FD with a certain safety.However,due to the restricted number of trials included,wellplanned,long-term studies are necessary to provide credible evidence.
文摘BACKGROUND: Sleep deprivation resulting from night shifts, is a major cause of burnout among physicians. Exogenous melatonin may improve sleep quality in night-shift workers. The study aims to compare the effectiveness of melatonin versus placebo on sleep effi ciency in emergency medicine(EM) residents. METHODS: A randomized, double-blind, replicated crossover trial was performed on EM residents. This study consisted of 4 phases within a month with intervention periods of 2 nights and washouts of 6 days. In our study, EM residents had nine-hour shifts on 6 consecutive days, 2 mornings, 2 evenings and 2 nights and then 2 days off. At the end of shifts' cycle, 24 EM residents were given 3 mg melatonin or placebo(12 in each arm of the study) for 2 consecutive nights after the second night shift with crossover to the other arm after a six-day off drug. This crossover intervention was repeated for two more another time. Finally, we created 48 cases and comparisons in each arm. Different items related to sleep quality were assessed and compared both within the same group and between the two groups. RESULTS: In the melatonin group, daytime sleepiness(calculated by Karolinska Sleep Scale) had a signifi cant reduction after taking the second dose of drug(P=0.003) but the same result was not observed when comparing the 2 groups. Mood status(calculated by Profile of Mood States) showed no remarkable difference between the 2 groups. CONCLUSION: Melatonin might have a limited benefi t on sleep quality in EM residents working night shifts.
基金supported by the China Postdoctoral Science Foundation(No.2012M520774,No.2013T60393)Heilongjiang Postdoctoral Science Foundation(LBH-Z12156)
文摘Whether supplementation of curcuminoids decreases serum adipocyte-fatty acid binding protein(A-FABP) level and whether this decrease benefits glucose control is unclear.One-hundred participants(n=50 administered curcuminoids,n=50 administered placebo) from our previous report on the effect of curcuminoids on type 2 diabetes in a 3-month intervention were assessed for levels of serum A-FABP,oxidative stress,and inflammatory biomarkers.Curcuminoids supplementation led to significant decreases in serum A-FABP,C-reactive protein(CRP),tumor necrosis factor-α,and interleukin-6 levels.Curcuminoids supplementation also significantly increased serum superoxide dismutase(SOD) activity.The change in serum A-FABP levels showed positive correlations with changes in levels of glucose,free fatty acids(FFAs),and CRP in subjects supplemented with curcuminoids.Further stepwise regression analysis showed that A-FABP was an independent predictor for levels of FFAs,SOD,and CRP.These results suggest that curcuminoids may exert anti-diabetic effects,at least in part,by reductions in serum A-FABP level.A-FABP reduction is associated with improved metabolic parameters in human type 2 diabetes.
文摘The purpose of the present work was to evaluatethe clinical efficacy and the mechanism of Yi-qiHuo-xue Injection(YHI 益气活血注射液)in treat-ment of coronary heart disease.YHI consists ofGinseng,Astragalus and Angelicae Sinensis.(人参黄芪,当归).The 10% dextrose serves as a pla-cebo.The results were as follows:1.the frequencyand severity of angina episodes were reduced by90.63%;2.the isehemic ST-T in ECG was improvedin 56.25% of eases;3.the tolerance to treadmillexercise was increased from 348,50 to 505.50 M.;4.the left ventricular function was strengthened,PEP/LVET ratio reduced from 0.45 to 0.36,the activityof(Na+-K+)ATPase in myocardial cell membraneof rats inhibited by 19.2%;5.the blood viscosity anderythrocyte electrophoretic time lowered;6.theadhesion and aggregation of platelet in patients withCHD were inhibited by 27% and 59.4% respectively;7.the plasma TXB<sub>2</sub> level in CHD was reduced from260.28±164.4 to 139.29±57.01 pg/ml;8.the plasma6-keto-PGF<sub>1α</sub> level in CHD was increased from33.45±22.5 to 57.48±13.1 pg/ml,and in rats from185.77 to 366.33 pg/ml.The differences were allstatistically significant(P【0.05-0.01)in comparisonwith the placebo group.
基金funding support from the National Natural Science Foundation of China Project(No.81820108033)the Project of Wangjing Hospital,China Academy of Chinese Medical Sciences(No.WJYY2020-18)。
文摘Objective To evaluate the efficacy and safety of traditional Chinese medicine(TCM)compounds for the treatment of functional dyspepsia(FD).Methods The Pub Med,Embase,Cochrane Library,Web of Science,Chinese Biomedical Database(CBM),Wanfang Data,China National Knowledge Infrastructure(CNKI),and China Science and Technology Journal Database(VIP)were searched to collect randomized,double-blind,and placebo-controlled trials of FD treated with TCM compounds.The search duration was from the establishment of the database to March 2,2021.After two researchers independently screened the literature,extracted the data,and evaluated the bias risk included in the study,they used Rev Man 5.4 software for meta-analysis.Results A total of 23 clinical trials were included,including 2898 patients.Meta-analysis showed that the overall remission rate of FD treated with TCM compounds was significantly higher than that of placebo(73.8%vs.46.2%)[RR=1.50,95%CI(1.29,1.76),P<0.00001].Among the single symptoms,TCM compounds were superior to the placebo in improving epigastric pain[MD=﹣0.99,95%CI(﹣1.37,﹣0.61),P<0.00001],epigastric burning sensation[MD=﹣0.32,95%CI(﹣0.59,﹣0.05),P=0.02],postprandial fullness discomfort[MD=﹣1.59,95%CI(﹣1.96,﹣1.21),P<0.00001],and early satiety symptoms[MD=﹣0.93,95%CI(﹣1.32,﹣0.54),P<0.00001].Compared with the placebo,TCM compounds treatment can obviously improve TCM syndrome in patients with FD[MD=﹣5.58,95%CI(﹣7.55,﹣3.61),P<0.00001],gastric emptying rate[MD=12.22,95%CI(8.90,15.55),P<0.00001],and helped to improve patients’quality of life[MD=11.27,95%CI(0.10,22.43),P=0.05].No severe adverse events were reported between the two groups[RR=1.34,95%CI(0.91,1.96),P=0.14].Conclusion Our results showed that TCM compounds treatment could significantly alleviate FD symptoms,improve gastric emptying in FD patients,and help to improve their quality of life.No severe adverse reactions have been reported in clinical applications.Due to the limitation of the quantity and quality of the included studies,the above conclusions need to be verified by more high-quality studies.
基金This work was supported by the National Key R&D Program of China(2016YFC1307100)the National Natural Science Foundation of China(81930033,81771465,81201057)+2 种基金the Shanghai Key Project of Science&Technology(2018SHZDZX05)the National Key Technologies R&D Program of China(2012BAI01B04)the Innovative Research Team of High-level Local Universities in Shanghai.
文摘Background Inflammation that is mediated by microglia activation plays an important role in the pathogenesis of depression.Microglia activation can lead to an increase in the levels of proinflammatory cytokines,including TNF-α,which leads to neuronal apoptosis in the specific neural circuits of some brain regions,abnormal cognition and treatment-resistant depression(TRD).Protein kinase C(PKC)is a key regulator of the microglia activation process.We assume that the abnormality in PKC might result in abnormal microglia activation,neuronal apoptosis,significant changes in emotional and cognitive neural circuits,and TRD.In the current study,we plan to target at the PKC signal pathway to improve the TRD treatment outcome.Methods and analysis This is a 12-week,ongoing,randomised,placebo-controlled trial.Patients with TRD(N=180)were recruited from Shanghai Mental Health Center,Shanghai Jiao Tong University.Healthy control volunteers(N=60)were recruited by advertisement.Patients with TRD were randomly assigned to‘escitalopram+golimumab(TNF-αinhibitor)’,‘escitalopram+calcium tablet+vitamin D(PKC activator)’or‘escitalopram+placebo’groups.We define the primary outcome as changes in the 17-item Hamilton Depression Rating Scale(HAMD-17).The secondary outcome is defined as changes in anti-inflammatory effects,cognitive function and quality of life.Discussion This study might be the first randomised,placebo-controlled trial to target at the PKC signal pathway in patients with TRD.Our study might help to propose individualised treatment strategies for depression.Trial registration number The trial protocol is registered with ClinicalTrials.gov under protocol ID 81930033 and ClinicalTrials.gov ID NCT04156425.
文摘Background: Major depressive disorder is a serious public health problem affecting the lives of millions in the worldwide and leading causes of disability and disease. This study aimed to evaluate the efficacy and safety of Vortioxetine and Duloxetine 60 mg compared to placebo for the treatment of major depressive disorder. Method: We searched the Cochrane library, Pub Med, CRD, Scopus, and Central Register of Controlled Trials to January 2015. We also searched ClinicalTrials.gov, International depressive disorder Conference and the Anxiety Disorders and Depression Conference. We identified that five randomized clinical trials were ultimately included in a Meta analysis. Data analysis was conducted by Standardized Mean Differences (SMD) for Montgomery-Åsberg Depression Rating Scale (MADRS), and Odds Ratio (OR) for adverse events. The SMD and OR reported by 95% CI. Results: Results showed statistical significance in the MADRS for Vortioxetine (SMD = ﹣3.29;95% CI ﹣4.47 to ﹣2.10;I2 = 99.3%) and for Duloxetine 60 mg (SMD = ﹣6.35;95% CI ﹣8.84, ﹣3.87;I2 = 99.3%). Results showed that the Vortioxetine 2.5, 5, 10, 15, 20 mg and overall compared to placebo showed a significance for Nausea and no significance for diarrhea, dry mouth, dizziness, fatigue and headache. Also results of Duloxetine 60 mg showed a significant effect for dry mouth, dizziness, fatigue and nausea. Conclusion: It is necessary to do more studies so as to better assess and much more powerful than the evidence for the use of this drug in the treatment of depression.
文摘Constipation and insomnia are commonamong aged person and refractory to treatment.The authors used mulberry extract for this pur-pose and found it effective in most cases.Syrupof Fructus Crataegi was used as placebo fordouble blind control.
文摘To evaluate the anti-obesity effect of Xiaopang-mei,an experimental study by single method in threegroups of rats was done.The first group were fedwith Xiaopangmei-01,the second group with aplacebo,and the third group were controls.Ascompared with the control and the placebo groups,the rata that had been fed Xiaopangmei for six weeksshowed body weight,food intake,weight of epididy-mis fat pad and the intestinal absorption of glucoseall significantly decreased.The swimming tolerancetest showed they swam longer than the other twogroups.No significant difference was found betweenthe three groups in the growth and developmentindices such as body length,length of femur and tibia,weight of heart,lungs,spleen,kidneys,stomach,smallintestines,gastrocnemius muscle,and adrenal glands.No side effects were found on the liver and kidney.The secretion of insulin was inhibited after the swim-ming tolerance test and the gestrocnemius muscletest was similar for all three groups of rats.Weconcluded that Xiaopangmei is an effective anti-obesity drug.
文摘Context: Stroke increases the risk of subsequent hip fracture by 2 to 4 times. Hyperhomocysteinemia is a risk factor for both ischemic stroke and osteoporotic fractures in elderly men and women. Treatment with folate and mecobalamin (vita min B12) may improve hyperhomocysteinemia.Objective: To investigate whether trea tment with folate and vitamin B12 reduces the incidence of hip fractures in pati ents with hemiplegia following stroke.Design, Setting, and Patients: A double-b lind, randomized controlled study of 628 consecutive patients aged 65 years or o lder with residual hemiplegia at least 1 year following first ischemic stroke, w ho were recruited from a single Japanese hospital from April 1, 2000, to May 31, 2001. Patients were assigned to daily oral treatment with 5 mg of folate and 15 00 μg of mecobalamin,or double placebo; 559 completed the 2-year follow-up.Ma in Outcome Measure: Incidence of hip fractures in the 2 patient groups during th e 2-year follow-up. Results:At baseline, patients in both groups had high leve ls of plasma homocysteine and low levels of serum cobalamin and serum folate. Af ter 2 years, plasma homocysteine levels decreased by 38%in the treatment group and increased by 31%in the placebo group (P < .001). The number of hip fracture s per 1000 patient-years was 10 and 43 for the treatment and placebo groups, re spectively(P < .001). The adjusted relative risk, absolute risk reduction,and th e number needed to treat for hip fractures in the treatment vs placebo groups we re 0.20 (95%confidence interval [CI], 0.08-0.50), 7.1%(95%CI, 3.6%-10.8%) , and 14 (95%CI, 9-28), respectively. No significant adverse effects were repo rted. Conclusion: In this Japanese population with a high baseline fracture risk , combined treatment with folate and vitamin B12 is safe and effective in reduci ng the risk of a hip fracture in elderly patients following stroke.
文摘Chronic diseases such as Alzheimer's disease (AD), diabetes and scapulohumeral periarthritis present a special challenge to clinicians because of high incidence, lethality and disability which directly result in the economical and family burden. The current special issue of'health care and rehabilitation'mainly focuses on the area of traditional medicine therapy to chronic diseases. The following six papers cover three different methods of traditional medicine therapy including drug therapy, non-drug therapy and manipulation therapy.