Adjuvant Rectal Diclofenac for Post Operative Analgesia after Caesarean Section—A Randomized Controlled Study

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.

Efficacy and safety of intravenous tranexamic acid in total shoulder arthroplasty:A meta-analysis

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.

Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis:study protocol of a multicenter randomized controlled trial

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.

A systematic review of effi cacy and tolerability of mebeverine in irritable bowel syndrome

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.

Arginine vasopressin as a target in the treatment of acute heart failure

Congestive heart failure(CHF) is one of the most common reasons for hospitalization in the United States. Despite multiple different beneficial medications for the treatment of chronic CHF, there are no therapies with a demonstrated mortality benefit in the treatment of acute decompensated heart failure. In fact, studies of inotropes used in this setting have demonstrated more harm than good. Arginine vasopressin has been shown to be up regulated in CHF. When bound to the V1 a and/or V2 receptors, vasopressin causes vasoconstriction, left ventricular remodeling and free water reabsorption. Recently, two drugs have been approved for use that antagonize these receptors. Studies thus far have indicated that these medications, while effective at aquaresis(free water removal), are safe and not associated with increased morbidity such as renal failure and arrhythmias. Both conivaptan and tolvaptan have been approved for the treatment of euvolemic and hypervolemic hyponatremia. We review the results of these studies in patients with heart failure.

Effect of probiotics on length of hospitalization in mild acute pancreatitis:A randomized,double-blind,placebo-controlled trial

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.

Incretin-based therapies in prediabetes: Current evidence and future perspectives

The prevalence of type 2 diabetes(T2D) is evolving globally at an alarming rate. Prediabetes is an intermediate state of glucose metabolism that exists between normal glucose tolerance(NGT) and the clinical entity of T2 D. Relentless β-cell decline and failure is responsible for the progression from NGT to prediabetes and eventually T2 D. The huge burden resulting from the complications of T2 D created the need of therapeutic strategies in an effort to prevent or delay its development. The beneficial effects of incretin-based therapies, dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1(GLP-1) receptor agonists, on β-cell function in patients with T2 D, together with their strictly glucose-depended mechanism of action, suggested their possible use in individuals with prediabetes when greater β-cell mass and function are preserved and the possibility of β-cell salvage is higher. The present paper summarizes the main molecular intracellular mechanisms through which GLP-1 exerts its activity on β-cells. It also explores the current evidence of incretin based therapies when administered in a prediabetic state, both in animal models and in humans. Finally it discusses the safety of incretin-based therapies as well as their possible role in order to delay or prevent T2 D.

Systematic review: The placebo effect of psychological interventions in the treatment of irritable bowel syndrome

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.

Early mortality of alcoholic hepatitis: A review of data from placebo-controlled clinical trials

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.

Efficacy of Chinese herbal medicine in functional dyspepsia: A meta-analysis of randomized, double-blind, placebo-controlled trials

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.

Curcuminoids Target Decreasing Serum Adipocyte-fatty Acid Binding Protein Levels in Their Glucose-lowering Effect in Patients with Type 2 Diabetes

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.

CLINICAL AND EXPERIMENTAL STUDIES OF CORONARY HEART DISEASE TREATED WITH YI-QI HUO-XUE INJECTION

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 TXB2 level in CHD was reduced from260.28±164.4 to 139.29±57.01 pg/ml;8.the plasma6-keto-PGF1α 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.

PAID study design on the role of PKC activation in immune/inflammation-related depression:a randomised placebo-controlled trial protocol

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.

Efficacy and Safety of Vortioxetine and Duloxetine 60 mg Compared Placebo for the Treatment of Major Depressive Disorder: A Systematic Review and Meta-Analysis

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-&Aring;sberg 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.

AN EXPERIMENTAL STUDY BY SINGLE BLIND METHOD ON THE ANTIOBESITY EFFECT OF XIAOPANGMEI

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.

THE THERAPEUTIC EFFECT OF MULBERRY IN THE TREATMENT OF CONSTIPATION AND INSOMNIA IN THE ELDERLY

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.

Flavonoid-rich beverage effects on lipid profile and blood pressure in diabetic patients

AIM: To compare freeze-dried strawberry(FDS) beverage and strawberry-flavored drink effects on lipid profile and blood pressure in type 2 diabetic(T2D) patients.METHODS: In a randomized, double-blind, controlled trial, 36 subjects with T2D(23 females; mean ± SE age: 51.57 ± 10 years) were randomly divided into two groups. Participants consumed two cups of either pure FDS beverage(each cup containing 25 g freeze-dried strawberry powder equivalent to one serving of fresh strawberries; intervention group) or an iso-caloric drinkwith strawberry flavoring(similar to the FDS drink in fiber content and color; placebo group) daily for 6 wk. Anthropometric measurements, 3 d, 24 h dietary recall, and fasting blood samples were collected at baseline and at weeks 6 intervention. After lying down and relaxing for approximately 10 min, each participant's blood pressure was recorded in triplicate with 5 min intervals; recordings were made at baseline and the trial end-point. Each participant's lipid profile was assessed before and after intervention.RESULTS: Assessment at the weeks 6 intervention showed a significant reduction from baseline in total cholesterol levels and total cholesterol to high-density lipoprotein cholesterol(HDL-C) ratio in the intervention group(179.01 ± 31.86 to 165.9 ± 32.4 mg/L; P = 0.00 and 3.9 ± 0.88 to 3.6 ± 0.082 mg/L; P = 0.00 respectively), but the change was not significantly different between the two groups(P = 0.07, P = 0.29 respectively). Systolic blood pressure levels were significantly reduced from baseline in both the FDS and placebo drink groups(129.95 ± 14.9 to 114.3 ± 27.5 mm Hg; P = 0.02 and 127.6 ± 15.6 to 122.9 ± 14.47 mm Hg; P = 0.00 respectively), but the reduction was not significantly different between the two groups. Diastolic blood pressure was significantly reduced post-intervention in the FDS drink group compared to placebo group(78.7 ± 7.2 vs 84.4 ± 5.8; P = 0.01), the reduction was also significant within the FDS drink group(84.2 ± 8.03 to 78.7 ± 7.2; P = 0.00). Triglycerides, HDL-C concentrations and anthropometric indices showed no significant differences between or within groups. CONCLUSION: Short-term FDS supplementation improved selected cardiovascular risk factors in subjects with T2 D. Long-term effects on other metabolic biomarkers need to be investigated in future trials.

Place of sodium-glucose co-transporter type 2 inhibitors for treatment of type 2 diabetes

Inhibitors of sodium-glucose co-transporter type 2(SGLT2), such as canagliflozin and dapagliflozin, are recently approved for treatment of type 2 diabetes. These agents lower blood glucose mainly by increasing urinary glucose excretion. Compared with placebo, SGLT2 inhibitors reduce hemoglobin A1c(Hb A1c) levels by an average of 0.5%-0.8% when used as monotherapy or add-on therapy. Advantages of this drug class include modest weight loss of approximately 2 kg, low risk of hypoglycemia, and decrease blood pressure of approximately 4 mm Hg systolic and 2 mm Hg diastolic. These characteristics make these agents potential add-on therapy in patients with Hb A1 c levels close to 7%-8.0%, particularly if these patients are obese, hypertensive, and/or prone for hypoglycemia. Meanwhile, these drugs are limited by high frequency of genital mycotic infections. Less common adverse effects include urinary tract infections, hypotension, dizziness, and worsening renal function. SGLT2 inhibitors should be used with caution in the elderly because of increased adverse effects, and should not be used in chronic kidney disease due to decreased or lack of efficacy and nephrotoxicity. Overall, SGLT2 inhibitors are useful addition for treatment of select groups of patients with type 2 diabetes,but their efficacy and safety need to be established in long-term clinical trials.

叶酸和甲钴胺治疗卒中患者髋关节骨折的随机对照试验

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.

The effects of traditional medicine in health care:placebo or body-mind therapy?

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.