Laryngeal preservation with induction chemotherapy for hypopharyngeal squamous cell carcinoma : 10-year results of EORTC trial 24891 . BACKGROUND We report the 10-year results of the EORTC trial 24891 comparing a larynx-preservation approach to immediate surgery in hypopharynx and lateral epilarynx squamous cell carcinoma . MATERIAL AND METHODS Two hundred and two patients were randomized to either the surgical approach ( total laryngectomy with partial pharyngectomy and neck dissection , followed by irradiation ) or to the chemotherapy arm up to three cycles of induction chemotherapy ( cisplatin 100 mg/m ( 2 ) day 1 + 5-FU 1000 mg/m ( 2 ) day 1-5 ) followed for complete responders by irradiation and otherwise by conventional treatment . The end points were overall survival [ OS , noninferiority : hazard ratio ( preservation/surgery ) ≤ 1.428 , one-sided α = 0.05 ] , progression-free survival ( PFS ) and survival with a functional larynx ( SFL ) . RESULTS At a median follow-up of 10.5 years on 194 eligible patients , disease evolution was seen in 54 and 49 patients in the surgery and chemotherapy arm , respectively , and 81 and 83 patients had died . The 10-year OS rate was 13.8 % in the surgery arm and 13.1 % in the chemotherapy arm . The 10-year PFS rates were 8.5 % and 10.8 % , respectively . In the chemotherapy arm , the 10-year SFL rate was 8.7 % . CONCLUSION This strategy did not compromise disease control or survival ( that remained poor ) and allowed more than half of the survivors to retain their larynx .

induction chemotherapy

larynx-preservation approach

immediate surgery

chemotherapy

irradiation

overall survival

Two hundred and two patients


Competitive memory training ( COMET ) for treating low self-esteem in patients with depressive disorders : a randomized clinical trial . BACKGROUND Self-esteem is a major concern in mood disorders . Low self-esteem is a symptom of depressive disorders and is considered by some to be a predictor for relapse , whereas high self-esteem seems to buffer against depression . Recently , Competitive Memory Training ( COMET ) has shown to be effective for the enhancement of self-esteem in several psychopathological conditions . The current study assesses whether COMET is also an effective intervention for patients with depressive disorders . METHODS Sixty-one patients with depressive disorders who were already in therapy in an outpatient mental health institution were randomly assigned to either eight group sessions of COMET in addition to their regular therapy ( COMET + therapy as usual [ TAU ] : the experimental group ) or to 8 weeks of ongoing regular therapy ( TAU only : the control group ) . These latter ( control ) patients received COMET after their TAU only period . All patients in both groups that completed COMET were contacted 3 and 6 months later to assess whether the effects of COMET had remained stable . RESULTS Compared to the patients who received TAU only , patients in the COMET + TAU condition showed significant improvement with large effect sizes on indices of self-esteem , depression , and depressive rumination . The therapeutic effects of COMET + TAU remained stable after 3 and 6 months on all outcome measures or improved even further . CONCLUSION COMET for low self-esteem seems to be an efficacious trans-diagnostic intervention that can relatively easily be added to the regular treatment of patients with depressive disorders .

Competitive memory training ( COMET )

Competitive Memory Training ( COMET )

COMET

of

ongoing regular therapy ( TAU only

COMET

TAU

COMET

COMET

TAU

COMET

TAU

COMET

TAU

COMET

low self-esteem

Low self-esteem

Competitive Memory Training ( COMET )

effects of COMET

significant improvement

therapeutic effects

stable

low self-esteem

depressive disorders

Sixty-one

depressive disorders


Effect of sulfasalazine on inflammation and endothelial function in patients with established coronary artery disease . Inflammation is critical for atherosclerosis development and may be a target for risk-reduction therapy . In experimental studies , activation of the inflammatory regulator , nuclear factor kappa B ( NFlB ) , contributes to endothelial activation and reduced nitric oxide production . We treated patients with coronary artery disease with sulfasalazine , an inhibitor of NFκB , and placebo in a randomized , double-blind , crossover study design . Brachial artery flow-mediated dilation ( FMD ) and digital vascular function were measured at baseline and after each 6-week treatment period . Of the 53 patients enrolled in the crossover study , 32 ( age 60 ± 10 , 22 % female ) completed all the visits , with a high rate of study withdrawal due to gastrointestinal side effects . In a subset of 10 participants , we compared the effects of 4 days of sulfasalazine treatment ( n = 5 ) to no treatment ( n = 5 ) on NFκB-regulated gene expression in peripheral blood mononuclear cells . Tumor necrosis factor α-stimulated expression of CD69 and NFlB subunit p50 was significantly blunted after 4 days of sulfasalazine treatment but not after no treatment . However , FMD and digital vasodilator response did not significantly change from baseline with long-term sulfasalazine treatment . Short-term sulfasalazine inhibited NFlB activity ; however , long-term treatment was poorly tolerated and did not improve endothelial function . Our findings suggest that sulfasalazine therapy is not the optimal anti-inflammatory treatment for reversing endothelial dysfunction in cardiovascular disease . Further studies are warranted to investigate the potential for NFlB inhibition to reduce cardiovascular risk .

sulfasalazine

inflammation and endothelial function


Visit-to-visit blood pressure variability in the European Lacidipine Study on Atherosclerosis : methodological aspects and effects of antihypertensive treatment . BACKGROUND Recent studies have reported that in patients under antihypertensive treatment visit-to-visit ( or long-term ) variability of clinic BP within a given patient has an independent prognostic significance . Partly based on between-patient dispersion of BP values during treatment ( interindividual variability ) it has also been reported that long-term clinic BP variability is greater for β-blocker than for calcium antagonist and other types of treatment . GOALS To measure visit-to-visit intraindividual variations of both clinic and 24-h mean BP in the hypertensive patients of the European Lacidipine Study on Atherosclerosis ( ELSA ) trial treated for 4 years with either atenolol or lacidipine , and to check whether interindividual clinic and 24-h BP variabilities during treatment can really be considered a surrogate of intraindividual variabilities in exploring differences between β-blocker and calcium antagonist treatments . METHODS Long-term intraindividual BP variability was defined as the coefficient of variation of the average systolic or diastolic values of clinic and 24-h BP measured at each visit throughout the treatment period . Patients in whom at least seven clinic ( 6-month intervals ) or at least three ( yearly intervals ) 24-h values were available from the end of the drug titration phase to the end of the study were considered . RESULTS Visit-to-visit 24-h SBP/DBP variabilities were 20-25 % smaller than , and loosely correlated with clinic BP variability ( r ( 2 ) < 0.022 ) . There was also a very limited relationship ( r ( 2 ) < 0.026 ) between visit-to-visit and within 24-h ambulatory BP variabilities , the latter being two to three times greater than the former . Visit-to-visit intraindividual clinic SBP variability was only slightly lower on calcium antagonist than on β-blocker treatment but little or no between-treatment difference was found for visit-to-visit clinic DBP and ambulatory SBP/DBP particularly in patients under monotherapy throughout the study . Interindividual BP variability was markedly greater than the intra-individiual one of which it did not precisely reflect the treatment-induced changes . CONCLUSION In mild-to-moderate hypertensive patients , visit-to-visit BP variability does not differ substantially between β-blocker and calcium antagonist treatment . Major discrepancies exist between visit-to-visit BP variability as quantified by 24-h vs. clinic BP , making investigation of which of these indices is clinically more relevant important . Interindividual BP variability during treatment shows marked quantitative differences with intraindividual BP variability questioning whether its use can accurately reflect individual BP variations from one visit to another .

antihypertensive treatment

blood pressure variability

variability of clinic BP

long-term clinic BP variability


Kata techniques training consistently decreases stereotypy in children with autism spectrum disorder . The effects of 14 weeks of Kata techniques training on stereotypic behaviors of children with autism spectrum disorders ( ASD ) were investigated . The study included 30 eligible ( diagnosed ASD , school age ) children with ages ranging from 5 to 16 years whom they assigned to an exercise ( n=15 ) or a no-exercise control group ( n=15 ) . Participants of the exercise group received Kata techniques instruction four times per week for 14 weeks ( 56 sessions ) . Stereotypy was assessed at baseline ( pre-intervention ) , week 14 ( post-intervention ) , and at one month follow up in both groups . Results showed that Kata techniques training significantly reduced stereotypy in the exercise group . Following participation in Kata techniques training , stereotypy decreased from baseline levels by a M of 42.54 % across participants . Interestingly , after 30 days of no practice , stereotypy in the exercise group remained significantly decreased compared to pre-intervention time . The participants of the control group did not show significant changes in the stereotypy . Teaching martial arts techniques to children with ASD for a long period of time consistently decreased their stereotypic behaviors .

Kata techniques training

Kata techniques training

no-exercise control group

Kata techniques instruction

Stereotypy

stereotypy .


Osteopontin is a prognostic factor for survival of acute myeloid leukemia patients . Osteopontin ( OPN ) is a glycoprotein that is secreted by osteoblasts and hematopoietic cells . OPN suppresses the proliferation of hematopoietic stem cells in vitro and may regulate the hematopoietic stem cell pool . Increased serum OPN concentrations occur in chronic myeloid leukemia , multiple myeloma , and acute myeloid leukemia ( AML ) . In the present study , we analyzed the prognostic impact of OPN in AML by investigating the expression and relevance of OPN in newly diagnosed AML patients from 2 large study groups ( the German AML Cooperative Group and the Dutch-Belgian Hematology Oncology Cooperative group ) . IHC ( n = 84 ) , ELISAs of blood/BM sera ( n = 41 ) , and microarray data for mRNA levels ( n = 261 ) were performed . Expression of OPN protein was increased in AML patients both in BM blasts ( IHC ) and in BM serum ( ELISA ) compared with healthy controls . Patients expressing high levels of OPN within the BM ( IHC ) experienced shortened overall survival ( OS ; P = .025 ) . Multivariate analysis identified karyotype , blast clearance ( day 16 ) , and the level of OPN expression as independent prognostic factors for OS . This prompted us to analyze microarray data from 261 patients from a third cohort . The analysis confirmed OPN as a prognostic marker . In summary , high OPN mRNA expression indicated decreased event-free survival ( P = .0002 ) and OS ( P = .001 ) . The prognostic role of OPN was most prominent in intermediate-risk AML . These data provide evidence that OPN expression is an independent prognostic factor in AML .

Osteopontin

Osteopontin

OPN

OPN

ELISAs

microarray data for mRNA levels

OPN

IHC

ELISA

OPN

OPN

OPN

OPN

survival

Osteopontin ( OPN )

expression and relevance of OPN

IHC

Expression of OPN protein

levels of OPN within the BM

overall survival

level of OPN expression

OS

OPN mRNA expression

event-free survival

OPN expression

acute myeloid leukemia patients .

261 patients from a third cohort


Right ventricular function during high-frequency oscillatory ventilation in adults with acute respiratory distress syndrome . OBJECTIVE To evaluate the effect of mean airway pressure under high-frequency oscillatory ventilation on right ventricular function . DESIGN Prospective randomized study . SETTING Intensive care unit of a tertiary care hospital . PATIENTS Sixteen consecutive patients within the first 48 hrs of mainly pulmonary acute respiratory distress syndrome . INTERVENTIONS After a 6-hr-period of protective conventional mechanical ventilation , patients were submitted to three 1-hr periods of high-frequency oscillatory ventilation ( +5 , +10 , +15 ) in a randomized order , with a mean airway pressure level determined by adding 5 , 10 , or 15 cm H2O to the mean airway pressure recorded during conventional mechanical ventilation . MEASUREMENTS AND MAIN RESULTS Mean airway pressure was 18±3 cm H2O during conventional mechanical ventilation and was increased until 33±3 cm H2O at high-frequency oscillatory ventilation+15 . Right ventricular function was assessed using transesophageal echocardiography . During conventional mechanical ventilation , nine patients presented a right ventricular dysfunction ( right ventricular end-diastolic area/left ventricular end-diastolic area ratio > 0.6 ) of whom four patients had a right ventricular failure ( right ventricular end-diastolic area/left ventricular end-diastolic area ratio > 0.9 ) . High-frequency oscillatory ventilation+10 and +15 further worsened right ventricular function , resulting in about a 40 % increase in right ventricular end-diastolic area/left ventricular end-diastolic area ratio and a 30 % increase in end-diastolic eccentricity index when compared with conventional mechanical ventilation or high-frequency oscillatory ventilation+5 periods . At high-frequency oscillatory ventilation+15 , 15 patients had right ventricular dysfunction and nine had right ventricular failure . High-frequency oscillatory ventilation did not improve oxygenation whatever the mean airway pressure level . A significant redistribution of tidal variation to the posterior parts of the lung was observed on electrical impedance tomography measurements when increasing mean airway pressure . However , this redistribution was not observed in patients who presented a worsening of right ventricular function ( right ventricular end-diastolic area/left ventricular end-diastolic area increase > 40 % ) at high-frequency oscillatory ventilation+15 . CONCLUSIONS In patients with mainly pulmonary acute respiratory distress syndrome , using high mean airway pressure under high-frequency oscillatory ventilation can worsen right ventricular function when compared with protective conventional mechanical ventilation , notably in patients in whom high-frequency oscillatory ventilation produced less alveolar recruitment of the posterior parts of the lungs . This study highlights the interest of monitoring right ventricular function during high-frequency oscillatory ventilation .

high-frequency oscillatory ventilation

high-frequency oscillatory ventilation

Mean airway pressure


The Social Communication Intervention Project : a randomized controlled trial of the effectiveness of speech and language therapy for school-age children who have pragmatic and social communication problems with or without autism spectrum disorder . BACKGROUND Children who show disproportionate difficulty with the pragmatic as compared with the structural aspects of language are described as having pragmatic language impairment ( PLI ) or social communication disorder ( SCD ) . Some children who have PLI also show mild social impairments associated with high-functioning autism or autism spectrum disorder ( ASD ) . There is little robust evidence of effectiveness of speech-language interventions which target the language , pragmatic or social communication needs of these children . AIMS To evaluate the effectiveness of an intensive manualized social communication intervention ( SCIP ) for children who have PLI with or without features of ASD . METHODS & PROCEDURES In a single-blind RCT design , 88 children with pragmatic and social communication needs aged 5 ; 11-10 ; 8 , recruited from UK speech and language therapy services , were randomly assigned in a 2:1 ratio to SCIP or to treatment-as-usual . Children in the SCIP condition received up to 20 sessions of direct intervention from a specialist research speech and language therapist working with supervised assistants . All therapy content and methodology was derived from an intervention manual . A primary outcome measure of structural language and secondary outcome measures of narrative , parent-reported pragmatic functioning and social communication , blind-rated perceptions of conversational competence and teacher-reported ratings of classroom learning skills were taken pre-intervention , immediately post-intervention and at 6-month follow-up . Analysis was by intention to treat . OUTCOMES & RESULTS No significant treatment effect was found for the primary outcome measure of structural language ability or for a measure of narrative ability . Significant treatment effects were found for blind-rated perceptions of conversational competence , for parent-reported measures of pragmatic functioning and social communication , and for teacher-reported ratings of classroom learning skills . CONCLUSIONS & IMPLICATIONS There is some evidence of an intervention effect on blind and parent/teacher-reported communication outcomes , but not standardized language assessment outcomes , for 6-11-year-old children who have pragmatic and social communication needs . These findings are discussed in the context of the increasingly central role of service user outcomes in providing evidence for an intervention . The substantial overlap between the presence of PLI and ASD ( 75 % ) across the whole cohort suggests that the intervention may also be applicable to some verbally able children with ASD who have pragmatic communication needs .

SCIP

treatment-as-usual

SCIP

structural language

narrative

structural language ability

a measure of narrative ability

autism spectrum disorder

pragmatic language impairment ( PLI )

PLI with or without features of ASD

aged 5 ; 11-10 ; 8

Children in the SCIP condition

6-11-year-old children


Efficacy and safety of 10 % HES 130/0.4 versus 10 % HES 200/0.5 for plasma volume expansion in cardiac surgery patients . AIM Hydroxyethyl starch ( HES ) solutions are frequently used for perioperative volume replacement . Whereas older HES specimen tended to accumulate in the plasma and to cause negative effects on hemostasis , more recent products , e.g. , HES 130/0.4 , are characterised by improved pharmacological properties . The present study was designed to compare the efficacy and safety of 10 % HES 130/0.4 and 10 % HES 200/0.5 . METHODS In this post-hoc analysis of a prospective , randomised , double-blind , multi-center therapeutic equivalence trial , 76 patients undergoing elective on-pump cardiac surgery received perioperative volume replacement using either 10 % HES 130/0.4 ( N.=37 ) or 10 % HES 200/0.5 ( N.=39 ) up to a maximum dose of 20 mL kg-1 . RESULTS Equivalent volumes of investigational medication were infused until 24 hours after the first administration ( 1577 vs. 1540 mL ; treatment difference 37 [ -150 ; 223 ] mL ; P < 0.0001 for equivalence ) . Whereas standard laboratory tests of coagulation were comparable between groups , von Willebrand factor activity on the first postoperative morning tended to be higher following treatment with 10 % HES 130/0.4 as compared to 10 % HES 200/0.5 ( P=0.025 ) with this difference being statistically significant only in the per-protocol analysis ( P=0.02 ) . Treatment groups were comparable concerning other safety parameters and the incidence of adverse drug reactions . In particular , renal function was well preserved in both groups . CONCLUSION Ten percent HES 130/0.4 was equally effective and safe as compared to 10 % HES 200/0.5 for volume therapy in patients undergoing cardiovascular surgery . Postoperative coagulation and renal function , as measured by standard laboratory tests , were similar among groups .

HES

HES

Hydroxyethyl starch

Efficacy and safety

efficacy

safety

von Willebrand factor activity

safety parameters

incidence of adverse drug reactions

renal function


Longitudinal follow-up of children with autism receiving targeted interventions on joint attention and play . OBJECTIVE This study examines the cognitive and language outcomes of children with an autism spectrum disorder ( ASD ) over a 5-year period after receiving targeted early interventions that focused on joint attention and play skills . METHOD Forty children from the original study ( n = 58 ) had complete data at the 5-year follow-up . RESULTS In all , 80 % of children had achieved functional use of spoken language with baseline play level predicting spoken language at the 5-year follow-up . Of children who were using spoken language at age 8 years , several baseline behaviors predicted their later ability , including earlier age of entry into the study , initiating joint attention skill , play level , and assignment to either the joint attention or symbolic play intervention group . Only baseline play diversity predicted cognitive scores at age 8 years . CONCLUSIONS This study is one of the only long-term follow-up studies of children who participated in preschool early interventions aimed at targeting core developmental difficulties . The study findings suggest that focusing on joint attention and play skills in comprehensive treatment models is important for long-term spoken language outcomes .

joint attention

play

joint attention or symbolic play

cognitive and language outcomes

functional use of spoken language

joint attention skill , play level

long-term spoken language outcomes

children

autism

children

autism spectrum disorder ( ASD )

Forty

children

children

core developmental difficulties


Efficacy and safety of intraseptal and periodontal ligament anesthesia achieved by computer-controlled articaine + epinephrine delivery : a dose-finding study . OBJECTIVES The main purpose of this study was to evaluate the dose-dependent anesthetic efficacy of the intraseptal anesthesia ( ISA ) and periodontal ligament anesthesia ( PLA ) obtained with different volumes of 4 % articaine and 1:100,000 epinephrine ( Ar + Ep ) in human mandibular premolars , using a computer-controlled local anesthetic delivery system ( CCLADS ) . The safety profile of Ar + Ep was also studied by investigating the stability of cardiovascular parameters . MATERIAL AND METHODS One hundred and eighty randomly selected healthy volunteers ( ASA I ) entered the single-blinded study to receive 16 mg + 4 μg , 24 mg + 6 μg , and 32 mg + 8 μg of Ar + Ep , obtained with different volumes ( 0.4 , 0.6 , and 0.8 ml , respectively ) , for the ISA and PLA . Success rate , onset , and duration of profound pulpal anesthesia were evaluated by the electrical pulp tester , while the width of the anesthetic field and duration of soft tissue anesthesia were recorded using the pinprick testing . A monitor was used for the measurement of cardiovascular parameters . RESULTS A dose-dependent duration of pulpal and soft tissue anesthesia was obtained only by the ISA . Success rate , duration of both pulpal and soft tissue anesthesia , and its width were significantly better in the ISA compared with the PLA . No significant cardiovascular changes were seen in both groups . CONCLUSIONS It can be suggested that 0.6 and 0.8 ml of 4 % Ar + 1:100,000 Ep , delivered by CCLADS , offer high success rate and effective clinical parameters of ISA as a primary anesthesia . CLINICAL RELEVANCE It seems that dental procedures requiring profound pulpal , bone , and soft tissue anesthesia could be effectively and safely obtained by mentioned anesthetic protocol .

intraseptal anesthesia ( ISA )

periodontal ligament anesthesia ( PLA )

articaine

epinephrine ( Ar + Ep )

Efficacy

safety

anesthetic efficacy

safety profile

width

One hundred and eighty

healthy


Successful treatment of blepharitis with bibrocathol ( Posiformin® 2 % ) . BACKGROUND Bibrocathol is a well-established antiseptic drug for the treatment of acute eyelid diseases like blepharitis . Despite its frequent use in clinical practice , no controlled clinical trial on the efficacy of bibrocathol 2 % eye ointment has been performed until now . The aim of the study was to investigate efficacy , safety and tolerability of bibrocathol ( Posiformin® 2 % ) eye ointment in patients diagnosed with blepharitis . METHODS In this multi-center , randomized , double-masked , placebo-controlled parallel-group comparison , the change of signs and symptoms ( sum score ) of blepharitis in 197 patients ( ITT ( intention-to-treat-group ) ; mean age 56 ± 18 years , 56 % female , active drug : vehicle = 97:100 ) over 2 weeks treatment with bibrocathol 2 % eye ointment was evaluated . RESULTS Patients receiving bibrocathol 2 % showed greater improvement in the sum score than the placebo patients ( p < 0.0001 , Cohen 's effect size d = 0.73 ) . Also , the results from further efficacy assessments improvement of single symptoms and ocular discomfort measured by a VAS ( visual analogue scale ) supported treatment with bibrocathol . Patients and investigators provided favorable tolerability ratings preferring bibrocathol over placebo . No safety issues were observed with regard to intraocular pressure , visual acuity , or occurrence of adverse events . CONCLUSIONS Blepharitis therapy with the antiseptic bibrocathol 2 % in this trial was highly efficacious and safe .

bibrocathol ( Posiformin® 2 % )

Bibrocathol

bibrocathol 2 %

bibrocathol ( Posiformin®

antiseptic

single symptoms

discomfort

intraocular pressure , visual acuity ,

blepharitis


Breaking it down is better : haptic decomposition of complex movements aids in robot-assisted motor learning . Training with haptic guidance has been proposed as a technique for learning complex movements in rehabilitation and sports , but it is unclear how to best deliver guidance-based training . Here , we hypothesized that breaking down a complex movement , similar to a tennis backhand , into simpler parts and then using haptic feedback from a robotic exoskeleton would help the motor system learn the movement . We also examined how the particular form of the decomposition affected learning . Three groups of unimpaired participants trained with the target arm movement broken down in three ways : 1 ) elbow flexion/extension and the unified shoulder motion independently ( " anatomical " decomposition ) , 2 ) three component shoulder motions in Euler coordinates and elbow flexion/extension ( " Euler " decomposition ) , or 3 ) the motion of the tip of the elbow and motion of the hand with respect to the elbow , independently ( " visual " decomposition ) . A control group practiced the same number of movements , but experienced the target motion only , achieving eight times more direct practice with this motion . Despite less experience with the target motion , part training was better , but only when the arm trajectory was decomposed into anatomical components . Varying robotic movement training to include practice of simpler , anatomically-isolated motions may enhance its efficacy .

robot-assisted motor learning .

Training with haptic guidance

motor learning .

learning .

number of movements

target motion only

direct practice

part training

efficacy .

unimpaired


Placebo-controlled pilot trial of mecamylamine for treatment of autism spectrum disorders . OBJECTIVE To explore possible benefits of a nicotinic acetylcholine receptor ( nAChR ) agent for autistic symptoms based on postmortem observation of nAChR abnormalities ( deficient α4β2 nAChRs , excess α7 nAChRs ) in brains of patients with autism . METHOD Mecamylamine , because of its safety record in children with other disorders , was chosen for this first exploration . Twenty children with autism spectrum disorder age 4-12 years were randomly assigned for 14 weeks to placebo ( n=8 ) or mecamylamine ( n=12 ) in ascending fixed doses : 0.5 mg/day for 6 weeks , 2.5 mg for 2 weeks , then 5 mg/day for 6 weeks . Improvement was rated by a blinded independent evaluator . Because of small sample , data analysis was descriptive . RESULTS Eighteen participants ( 10 mecamylamine , 8 placebo ) completed the study . All doses were well tolerated ; the only side effect of note was constipation ( 50 % compared with 25 % of placebo group ) . Three children had clinically nonsignificant electrocardiographic QT prolongation . Both groups showed modest to moderate improvement , but differences between groups were negligible . On the primary outcome measure , the Ohio Autism Clinical Impressions Scale , 90 % of the active treatment group showed improvement at some point ( but only 40 % sustained it ) , compared with 62 % on placebo . Of the four in active treatment that sustained improvement , three had a maximum dose of 0.13-0.15 mg/kg/day , while those who regressed had doses ≥0.18 mg/kg/day . Graphed means suggested better outcome with lower mg/kg and longer medication duration . Four parents spontaneously reported reduced hyperactivity and irritability and better verbalization and continued mecamylamine at their own expense . CONCLUSION Mecamylamine appeared to be safe , but not very effective in autism . The suggestion of better results at lower doses and longer exposure warrants consideration for future trials . The next step would be exploration of a more specific α4β2 nAChR agonist , such as varenicline .

mecamylamine

autism spectrum disorders

autistic symptoms

constipation

autism spectrum disorders .


Effectiveness of Dader Method for pharmaceutical care on control of blood pressure and total cholesterol in outpatients with cardiovascular disease or cardiovascular risk : EMDADER-CV randomized controlled trial . BACKGROUND Although some studies have demonstrated that pharmacist intervention can improve drug therapy among patients with cardiovascular disease ( CVD ) , more evidence derived from randomized controlled trials ( RCTs ) is needed , including assessment of the effect of community pharmacist interventions in patients with CVD . OBJECTIVE To assess the effectiveness of the Dader Method for pharmaceutical care on achieving therapeutic goals for blood pressure ( BP ) , total cholesterol ( TC ) , and both BP and TC ( BP/TC ) in patients with CVD and/or high or intermediate cardiovascular ( CV ) risk attending community pharmacies in Spain . METHODS Patients aged 25 to 74 years attending community pharmacies with a prescription for at least 1 drug indicated for CVD or CV risk factors were randomized to 2 groups : an intervention group that received pharmaceutical care , which was provided by specially trained pharmacists working in collaboration with physicians , and a control group that received usual care ( routine dispensing counseling ) and verbal and written counseling regarding CVD prevention . Patients were recruited from December 2005 to September 2006 , and both groups were followed for 8 months . Study outcomes were assessed at baseline and at 16 and 32 weeks after randomization . The primary outcome measures were the proportions of patients achieving BP , TC , and BP/TC therapeutic goals ( BP lower than 140/90 mm Hg for patients with uncomplicated hypertension and lower than 130/80 mm Hg for patients with diabetes , chronic kidney disease , or history of myocardial infarction or stroke ; TC lower than 200 mg per dL for patients without CVD and lower than 175 mg per dL for patients with CVD ) . Secondary outcomes were mean BP and TC values . BP was assessed manually by the pharmacist after a 10-minute rest in the supine position . This measurement was performed twice for every participant , and the average of the 2 measurements was calculated . TC was measured by the pharmacist during the study visit using the enzymatic dry method . Statistical analyses were performed using 2-tailed McNemar tests , Pearson chi-square tests , and Student 's t-tests ; P < 0.05 was considered statistically significant . RESULTS 714 patients were included in the study ( 356 intervention , 358 control ) , and the mean [ SD ] age was 62.8 [ 8.1 ] years . The 2 groups were similar at baseline in clinical and demographic characteristics , including the proportion of patients at therapeutic goals for BP , TC , and BP/TC . After 8 months of follow-up , there were statistically significant differences in favor of pharmaceutical care in the proportions of patients who achieved therapeutic goals for BP ( 52.5 % vs. 43.0 % , P=0.017 ) , TC ( 56.5 % vs. 44.1 % , P=0.001 ) , and BP/TC ( 37.1 % vs. 21.8 % , P < 0.001 ) . CONCLUSION Compared with usual care plus written education , pharmaceutical care focused on patient evaluation and follow-up in collaboration with physicians improved the achievement of BP , TC , and BP/TC treatment goals in patients with CVD and/or high or intermediate CV risk attending community pharmacies in Spain .

Dader Method

pharmacist intervention

community pharmacist interventions

Dader Method for pharmaceutical care

routine dispensing counseling

control of blood pressure

total cholesterol

blood pressure ( BP )

total cholesterol ( TC )

both BP

TC ( BP/TC )

proportions of patients achieving BP

TC

BP/TC therapeutic goals

mean BP

TC values

BP

TC

BP

TC

BP/TC

BP

TC

BP/TC

BP

TC

BP/TC

cardiovascular disease

cardiovascular risk

cardiovascular disease ( CVD )

CVD

CVD

25 to 74 years

CVD

CV risk

62.8 [ 8.1 ] years

CVD

high or intermediate CV risk


B-type natriuretic peptide in the evaluation and management of dyspnoea in primary care . OBJECTIVES The rapid and accurate diagnosis of heart failure in primary care is a major unmet clinical need . We evaluated the additional use of B-type natriuretic peptide ( BNP ) levels . DESIGN A randomized controlled trial . SETTING Twenty-nine primary care physicians in Switzerland and Germany coordinated by the University Hospital Basel , Switzerland . SUBJECTS A total of 323 consecutive patients presenting with dyspnoea . INTERVENTIONS Assignment in a 1 : 1 ratio to a diagnostic strategy including point-of-care measurement of BNP ( n = 163 ) or standard assessment without BNP ( n = 160 ) . The total medical cost at 3 months was the primary end-point . Secondary end-points were diagnostic certainty , time to appropriate therapy , functional capacity , hospitalization and mortality . The final diagnosis was adjudicated by a physician blinded to the BNP levels . RESULTS Heart failure was the final diagnosis in 34 % of patients . The number of hospitalizations , functional status and total medical cost at 3 months [ median $ 1655 , interquartile range ( IQR ) , 850-3331 vs. $ 1541 , IQR 859-2827 ; P = 0.68 ] were similar in both groups . BNP increased diagnostic certainty as defined by the need for further diagnostic work-up ( 33 % vs. 45 % ; P = 0.02 ) and accelerated the initiation of the appropriate treatment ( 13 days vs. 25 days ; P = 0.01 ) . The area under the receiver-operating characteristics curve for BNP to identify heart failure was 0.87 ( 95 % confidence interval , 0.81-0.93 ) . CONCLUSIONS The use of BNP levels in primary care did not reduce total medical cost , but improved some of the secondary end-points including diagnostic certainty and time to initiation of appropriate treatment .

B-type natriuretic peptide

B-type natriuretic peptide ( BNP )

standard assessment without BNP

BNP levels

total medical cost at 3 months

hospitalization

mortality

Heart failure

number of hospitalizations

functional status

total medical cost at 3 months

BNP

diagnostic certainty

dyspnoea

Twenty-nine

dyspnoea


Once-daily MMX ( ® ) mesalamine for endoscopic maintenance of remission of ulcerative colitis . OBJECTIVES Treatment with mesalamine to maintain endoscopic remission ( mucosal healing ) of ulcerative colitis ( UC ) has been shown to reduce the risk of relapse and is the recommended first-line maintenance therapy . To improve treatment adherence , a mesalamine formulation that can be administered once-daily , MMX ( ® ) mesalamine ( Lialda ; Shire Pharmaceuticals LLC , Wayne , PA ) , was developed . This study was conducted to determine the efficacy and safety of once-daily MMX mesalamine compared with twice-daily delayed-release mesalamine ( Asacol ; Warner Chilcott , Dublin , Ireland ) for maintaining endoscopic remission in patients with UC . METHODS A multicenter , randomized , double-blind , 6-month , active-control trial was conducted to assess the non-inferiority of once-daily MMX mesalamine 2.4 g/day compared with twice-daily delayed-release mesalamine at a total daily dose of 1.6 g/day in patients with UC in endoscopic remission . The primary end point was maintenance of endoscopic remission at month 6 in the per-protocol ( PP ) population . RESULTS Overall , 826 patients were randomized and dosed . The primary objective ( non-inferiority ) was met . At month 6 , 83.7 and 77.8 % of patients receiving MMX mesalamine in the PP and intent-to-treat ( ITT ) populations , respectively , had maintained endoscopic remission compared with 81.5 % ( PP ) and 76.9 % ( ITT ) of patients receiving delayed-release mesalamine ( 95 % confidence interval for difference : -3.9 % , 8.1 % ( PP ) ; -5.0 % , 6.9 % ( ITT ) ) . Time to relapse was not significantly different between the two treatment groups ( log-rank test , P=0.5116 ( PP ) ; P=0.5455 ( ITT ) ) . The proportion of patients with adverse events was 37.1 and 36.0 % in patients receiving MMX mesalamine and delayed-release mesalamine , respectively . CONCLUSIONS Once-daily dosing of MMX mesalamine 2.4 g/day was shown to be well tolerated and non-inferior to twice-daily dosing with delayed-release mesalamine 1.6 g/day for maintenance of endoscopic remission in patients with UC .

mesalamine

Asacol

ulcerative colitis


Internet-based program for coping with cancer : a randomized controlled trial with hematologic cancer patients . OBJECTIVE Psychosocial patient care in oncology is no longer limited to the inpatient setting . Outpatient services are in demand . Internet-based interventions could aid in optimizing service delivery across disciplines . The effectiveness of an Internet-based program for hematologic cancer patients was tested in a randomized controlled trial under field experimental conditions . METHODS A 4-week cognitive-behavioral program for coping with cancer was offered to hematologic cancer patients online . One hundred eighty-six registrants were randomly assigned to an intervention group ( n = 105 ) or a waiting list ( n = 81 ) . The outcome measures , 'mental adjustment ' ( MAC ) and 'psychological distress ' ( BSI ) , were assessed at registration and after 4 weeks . Patient satisfaction was assessed ( ZUF-8 ) , and complete-cases and intention-to-treat analyses were performed . RESULTS At registration , the majority of participants displayed clinically significant distress ( BSI ) and lacked alternative access concerning psychosocial care . One hundred eleven patients filled out the post questionnaire at 4 weeks . In contrast to the waiting list , the intervention group displayed a significant increase in fighting spirit ( d = 0.42 ; CI 95 % , 0.04 to 0.80 ) . The effect was confirmed by intention-to-treat analysis ( d = 0.33 ; CI 95 % , 0.04 to 0.62 ) . Otherwise , no effects were observed . Patient satisfaction with the program was high . CONCLUSION The results demonstrate the potential efficacy of Internet-based programs while highlighting their limitations . Future research is needed to clarify and optimize efficacy , taking different program components and patient characteristics into particular consideration .

Internet-based program

Internet-based interventions

intervention group

waiting list

Patient satisfaction

( BSI )

fighting spirit

Patient satisfaction

hematologic cancer

hematologic cancer

hematologic cancer

One hundred eighty-six registrants

One hundred eleven patients


Roles of adapalene in the treatment of pityriasis versicolor . BACKGROUND Ketoconazole is a typical treatment available for pityriasis versicolor ; tretinoin cream is effective , too . Adapalene gel is a tretinoin derivative and has a lower incidence of irritation compared with other topical retinoid products . However , there are no reports on adapalene gel for the treatment of pityriasis versicolor . OBJECTIVE To study the effect of adapalene gel comparing the treatment with adapalene gel and 2 % ketoconazole cream in pityriasis versicolor . METHODS Eighty patients suffering from pityriasis versicolor were randomly divided into two groups ; one group were treated with 2 % ketoconazole cream topically twice daily for 2 weeks , adapalene gel was used for the other group in a similar fashion . RESULTS There were no significant differences in efficacy between the two groups . No major side effects were noted in any of the groups either . CONCLUSION Adapalene was the favorable option in the treatment of pityriasis versicolor . The probable therapeutic mechanism of adapalene is also discussed .

adapalene

Ketoconazole

tretinoin cream

Adapalene gel

adapalene gel

adapalene gel

adapalene gel

2 % ketoconazole cream

2 % ketoconazole cream

adapalene gel

Adapalene

adapalene

Roles of adapalene

irritation

efficacy

side effects

pityriasis versicolor

pityriasis versicolor

pityriasis versicolor

pityriasis versicolor

Eighty

pityriasis versicolor

pityriasis versicolor


[ Effects of shuxuening injection on the levels of serum matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in acute exacerbated chronic obstructive pulmonary disease patients ] . OBJECTIVE To observe the effects of Shuxuening Injection ( SI ) on the levels of serum matrix metalloproteinase-9 ( MMP-9 ) and tissue inhibitor of metalloproteinase ( TIMP-1 ) in acute exacerbated chronic obstructive pulmonary disease ( COPD ) patients . METHODS Seventy-nine patients with acute exacerbated COPD were randomly assigned to the treatment group ( 39 cases ) and the control group ( 40 cases ) . Routine therapies for COPD were given to patients in the control group , while 15 mL SI was given to those in the treatment group by intravenous dripping , twice daily for total 14 days . The forced expiratory volume in one second ( FEV1 ) and forced vital capacity ( FVC ) were detected by Spirometer . The FEV1/FVC ( % ) and the FEV1 % were calculated . The levels of serum MMP-9 and TIMP-1 were detected using ELISA before and after treatment , and compared with 20 healthy subjects as the control . RESULTS The FEV1 , FVC , FEV1/FVC ( % ) , and FEV1 % were significantly improved after treatment in the treatment group when compared with before treatment and with the control group ( P < 0.05 , P < 0.01 ) . When compared with before treatment and with the control group , the levels of serum MMP-9 , TIMP-1 , and the ratio of MMP-9/TIMP-1 decreased more significantly in the treatment group after treatment ( P < 0.01 ) . Correlation analyses showed that obvious negative correlation existed between the levels of serum MMP-9 and TIMP-1 and FEV1/FVC ( % ) ( r = -0.677 , -0.629 , P < 0.01 ) . Obvious negative correlation existed between the levels of serum MMP-9 and TIMP-1 and FEV1 % ( r = -0.562 , -0.661 , P < 0.01 ) . Furthermore , obvious negative correlation also existed between the ratio of MMP-9/ TIMP-1 and FEV1 % , as well as FEV1/FVC ( % ) ( r = -0.732 , -0.891 , P < 0.01 ) . CONCLUSIONS SI could improve the pulmonary ventilation function of acute exacerbated COPD patients . One of its mechanisms might be correlated with lowering the serum levels of MMP-9 and TIMP-1 , and correcting the imbalance of MMP-9/TIMP-1 .

shuxuening injection

Shuxuening Injection ( SI )

Routine therapies for COPD

15 mL SI

SI

serum matrix metalloproteinase-9

tissue inhibitor of metalloproteinase-1

forced vital capacity ( FVC )

serum MMP-9

serum MMP-9 and TIMP-1 and FEV1 %

acute exacerbated COPD patients .


Carbon dioxide insufflation in open-chamber cardiac surgery : a double-blind , randomized clinical trial of neurocognitive effects . OBJECTIVE The aims of this study were first to analyze neurocognitive outcomes of patients after open-chamber cardiac surgery to determine whether carbon dioxide pericardial insufflation reduces incidence of neurocognitive decline ( primary end point ) as measured 6 weeks postoperatively and second to assess the utility of carbon dioxide insufflation in cardiac chamber deairing as assessed by transesophageal echocardiography . METHODS A multicenter , prospective , double-blind , randomized , controlled trial compared neurocognitive outcomes in patients undergoing open-chamber ( left-sided ) cardiac surgery who were assigned carbon dioxide insufflation or placebo ( control group ) in addition to standardized mechanical deairing maneuvers . RESULTS One hundred twenty-five patients underwent surgery and were randomly allocated . Neurocognitive testing showed no clinically significant differences in z scores between preoperative and postoperative testing . Linear regression was used to identify factors associated with neurocognitive decline . Factors most strongly associated with neurocognitive decline were hypercholesterolemia , aortic atheroma grade , and coronary artery disease . There was significantly more intracardiac gas noted on intraoperative transesophageal echocardiography in all cardiac chambers ( left atrium , left ventricle , and aorta ) at all measured times ( after crossclamp removal , during weaning from cardiopulmonary bypass , and at declaration of adequate deairing by the anesthetist ) in the control group than in the carbon dioxide group ( P < .04 ) . Deairing time was also significantly longer in the control group ( 12 minutes [ interquartile range , 9-18 ] versus 9 minutes [ interquartile range , 7-14 minutes ] ; P = .002 ) . CONCLUSIONS Carbon dioxide pericardial insufflation in open-chamber cardiac surgery does not affect postoperative neurocognitive decline . The most important factor is atheromatous vascular disease .

Carbon dioxide insufflation

carbon dioxide pericardial insufflation

carbon dioxide insufflation

carbon dioxide insufflation

placebo

Carbon dioxide

neurocognitive outcomes

neurocognitive decline

intracardiac gas

Deairing time

neurocognitive decline .

open-chamber cardiac surgery

One hundred twenty-five

atheromatous vascular disease


Teacher-implemented joint attention intervention : pilot randomized controlled study for preschoolers with autism . OBJECTIVE The vast majority of children with an autism spectrum disorder ( ASD ) attend public preschools at some point in their childhood . Community preschool practices often are not evidence based , and almost none target the prelinguistic core deficits of ASD . This study investigated the effectiveness of public preschool teachers implementing a validated intervention ( the Joint Attention and Symbolic Play/Engagement and Regulation intervention ; JASP/ER ) on a core deficit of autism , initiating joint attention . METHOD Sixteen dyads ( preschoolers with ASD and the public school teachers who worked in the child 's classroom ) were randomly assigned to the 6-week JASP/ER intervention or a control group . RESULTS At the end of the intervention , JASP/ER teachers used more JASP/ER strategies than the control teachers , and JASP/ER preschoolers used more joint attention in their classroom than control children . Additionally , JASP/ER children spent more time in supported engagement and less time in object engagement than control preschoolers on a taped play interaction . CONCLUSIONS Findings suggest that teachers were able to improve a core deficit of children with ASD in a public preschool context .

JASP/ER intervention

control group .

JASP/ER

JASP/ER

JASP/ER

JASP/ER

taped play interaction

joint attention

core deficit

of children with ASD

preschoolers

autism

children

public preschool teachers

Sixteen

preschoolers

ASD

teachers

children

ASD

public preschool


Mapping from disease-specific measures to health-state utility values in individuals with migraine . OBJECTIVE The objective of this study was to develop empirical algorithms that estimate health-state utility values from disease-specific quality-of-life scores in individuals with migraine . METHODS Data from a cross-sectional , multicountry study were used . Individuals with episodic and chronic migraine were randomly assigned to training or validation samples . Spearman 's correlation coefficients between paired EuroQol five-dimensional ( EQ-5D ) questionnaire utility values and both Headache Impact Test ( HIT-6 ) scores and Migraine-Specific Quality-of-Life Questionnaire version 2.1 ( MSQ ) domain scores ( role restrictive , role preventive , and emotional function ) were examined . Regression models were constructed to estimate EQ-5D questionnaire utility values from the HIT-6 score or the MSQ domain scores . Preferred algorithms were confirmed in the validation samples . RESULTS In episodic migraine , the preferred HIT-6 and MSQ algorithms explained 22 % and 25 % of the variance ( R ( 2 ) ) in the training samples , respectively , and had similar prediction errors ( root mean square errors of 0.30 ) . In chronic migraine , the preferred HIT-6 and MSQ algorithms explained 36 % and 45 % of the variance in the training samples , respectively , and had similar prediction errors ( root mean square errors 0.31 and 0.29 ) . In episodic and chronic migraine , no statistically significant differences were observed between the mean observed and the mean estimated EQ-5D questionnaire utility values for the preferred HIT-6 and MSQ algorithms in the validation samples . CONCLUSIONS The relationship between the EQ-5D questionnaire and the HIT-6 or the MSQ is adequate to use regression equations to estimate EQ-5D questionnaire utility values . The preferred HIT-6 and MSQ algorithms will be useful in estimating health-state utilities in migraine trials in which no preference-based measure is present .

MSQ algorithms

MSQ algorithms

MSQ

MSQ

Spearman 's correlation coefficients

Headache Impact Test ( HIT-6 )

individuals with migraine .

individuals with migraine .


Long-term decrease in bladder cancer recurrence with hexaminolevulinate enabled fluorescence cystoscopy . PURPOSE We assessed the impact of hexaminolevulinate fluorescence cystoscopic detection of papillary , nonmuscle invasive bladder cancer on the long-term recurrence rate . MATERIALS AND METHODS Long-term followup was assessed in 551 participants enrolled in a prospective , randomized study of fluorescence cystoscopy for Ta or T1 urothelial bladder cancer . In the original study 280 patients in the white light cystoscopy group and 271 in the fluorescence cystoscopy group were followed with cystoscopy for 3 , 6 and 9 months after initial resection or until recurrence . A study extension protocol was done for long-term followup of these patients . RESULTS Followup information was obtained for 261 of the 280 patients ( 93 % ) in the white light group and 255 of the 271 ( 94 % ) in the fluorescence group . Median followup in the white light and fluorescence groups was 53.0 and 55.1 months , and 83 ( 31.8 % ) and 97 patients ( 38 % ) remained tumor free , respectively . Median time to recurrence was 9.4 months in the white light group and 16.4 months in the fluorescence group ( p = 0.04 ) . The intravesical therapy rate was similar in the 2 groups ( 46 % and 45 % , respectively ) . Cystectomy was done in 22 of 280 cases ( 7.9 % ) in the white light group and in 13 of the 271 ( 4.8 % ) in the fluorescence group ( p = 0.16 ) . CONCLUSIONS Hexaminolevulinate fluorescence cystoscopy significantly improves long-term bladder cancer time to recurrence with a trend toward improved bladder preservation .

white light cystoscopy

fluorescence cystoscopy

cystoscopy

white light

fluorescence

white light

fluorescence

white light

fluorescence

Cystectomy

white light

fluorescence

bladder cancer recurrence

long-term recurrence rate

Median time to recurrence

intravesical therapy rate


Effectiveness and safety of the Levitan FPS Scope™ for tracheal intubation under general anesthesia with a simulated difficult airway . PURPOSE Studies show that the Levitan FPS ( first pass success ) Scope™ ( LFS ) is analogous to a bougie in simulated difficult airways with comparable tracheal intubation success rates . In this study , the efficacy and safety of tracheal intubation with the LFS was compared with that of the Macintosh laryngoscope utilizing manual in-line stabilization ( MILS ) to simulate difficult airways . METHODS Ninety-four subjects successfully completed the trial . Manual in-line stabilization of the cervical spine was applied and the initial laryngoscopy was performed using either the Macintosh or the LFS in conjunction with the Macintosh . Following the initial grading , a second laryngoscopy was repeated using the second randomized technique . Cormack-Lehane grades , percentage of glottic opening ( POGO ) scores , time to intubate , number of intubation attempts , and the use of alternate techniques were recorded . The anesthesiologist rated the subjective difficulty in using each technique with a numeric rating scale and a visual rating scale . RESULTS There was no significant difference in the primary outcome " good laryngoscopic views " ( Cormack-Lehane grade 1 and 2 ) compared with " poor laryngoscopic views " ( Cormack-Lehane grade 3 and 4 ) between the LFS and the Macintosh . There were higher POGO scores with the LFS compared with the Macintosh ( 80 % vs 20 % , respectively ; P < 0.0001 ) , but this did not translate to easier intubations , as documented by the need for an alternate intubation technique or time to intubate ( < 30 and < 60 sec , respectively ) . The incidence of mucosal trauma , sore throat , and hemodynamic responses did not differ significantly between the two techniques . CONCLUSION The LFS in conjunction with the Macintosh laryngoscope does not improve the efficacy or safety of tracheal intubation in a simulated difficult airway .

Levitan FPS Scope™

Cormack-Lehane grades

time to intubate

number of intubation attempts

use of alternate techniques

was no significant difference

with " poor laryngoscopic views " (

were higher POGO scores

tracheal intubation

general anesthesia

Ninety-four


Immunologic response after laparoscopic colon cancer operation within an enhanced recovery program . OBJECTIVE It has been demonstrated that colon operation combined with fast-track ( FT ) surgery and laparoscopic technique can shorten the length of hospital stay , accelerate recovery of intestinal function , and reduce the occurrence of post-operative complications . However , there are no reports regarding the combined effects of FT colon operation and laparoscopic technique on humoral inflammatory cellular immunity . METHODS This was a prospective , controlled study . One hundred sixty-three colon cancer patients underwent the traditional protocol and open operation ( traditional open group , n=42 ) , the traditional protocol and laparoscopic operation ( traditional laparoscopic group , n=40 ) , the FT protocol and open operation ( FT open group , n=41 ) , or the FT protocol and laparoscopic operation ( FT laparoscopic group , n=40 ) . Blood samples were taken prior to operation as well as on days 1 , 3 , and 5 after operation . The number of lymphocyte subpopulations was determined by flow cytometry , and serum interleukin-6 and C-reactive protein levels were measured . Post-operative hospital stay , post-operative morbidity , readmission rate , and in-hospital mortality were recorded . RESULTS Compared with open operation , laparoscopic colon operation effectively inhibited the release of post-operative inflammatory factors and yielded good protection via post-operative cell immunity . FT surgery had a better protective role with respect to the post-operative immune system compared with traditional peri-operative care . Inflammatory reactions , based on interleukin-6 and C-reactive protein levels , were less intense following FT laparoscopic operation compared to FT open operation ; however , there were no differences in specific immunity ( CD3+ and CD4+ counts , and the CD4+/CD8+ ratio ) during these two types of surgical procedures . Post-operative hospital stay in patients randomized to the FT laparoscopic group was significantly shorter than in the other three treatment groups ( P < 0.01 ) . Post-operative complications in patients who underwent FT laparoscopic treatment were less than in the other three treatment groups ( P < 0.05 ) . There were no significant differences between the four treatment groups regarding readmission rate and in-hospital mortality . CONCLUSIONS The laparoscopic technique and FT surgery rehabilitation program effectively inhibited release of post-operative inflammatory factors with a reduction in peri-operative trauma and stress , which together played a protective role on the post-operative immune system . Combining two treatment measures during colon operation produced better protective effects via the immune system . The beneficial clinical effects support that the better-preserved post-operative immune system may also contribute to the improvement of post-operative results in FT laparoscopic patients .

traditional protocol

open operation

traditional protocol

laparoscopic operation

FT protocol

open operation

FT protocol

laparoscopic operation

Immunologic response

length of hospital stay

number of lymphocyte subpopulations

Post-operative hospital stay

post-operative morbidity

readmission rate ,

in-hospital mortality

post-operative inflammatory factors

Post-operative hospital stay

Post-operative complications

readmission rate

in-hospital mortality

improvement of post-operative results

laparoscopic colon cancer operation

One hundred sixty-three

colon cancer

laparoscopic operation


The effect of the PostureJac on deep cervical flexor endurance : implications in the management of cervicogenic headache and mechanical neck pain . The convergence of cervical and trigeminal afferents on second-order neurons in the trigeminocervical nucleus may refer pain from the upper cervical spine into the head and face . Furthermore , " bi-directional interactions " between trigeminal and upper cervical afferents may also explain neck symptoms of trigeminal origin ( e.g. , migraine ) . It is known that cervicogenic headache sufferers present with several musculoskeletal changes including poor endurance of the deep cervical flexor muscles . These intrinsic muscles of the neck contribute to stabilization and protection of the cervical spine and are critical for the control of both intervertebral motion and the cervical lordosis . The purpose of this study was to determine whether the use of the PostureJac ( SomatoCentric Systems , Inc. , Toronto , Ontario , Canada ) , a posture support and exercise jacket , was effective in enhancing deep cervical muscle endurance . Forty-five ( 45 ) female subjects , between the ages of 18 and 40 years , were randomly assigned to three groups consisting of the no-treatment control , the treatment-control ( table stabilization ) , and the experimental ( PostureJac ) group . The outcome measure of deep cervical flexor muscle endurance was based on the Flexor Endurance Test and was recorded in seconds . The results indicated that the PostureJac group was superior to the no-treatment control ( p=.001 ) and the treatment-control ( p=.004 ) groups in terms of increasing endurance of the deep cervical flexors . Consequently , the PostureJac may be a useful therapeutic tool in the management of cervicogenic headache and mechanical neck pain .

PostureJac

PostureJac

no-treatment control

experimental ( PostureJac )

deep cervical flexor endurance

cervicogenic headache

mechanical neck pain

deep cervical muscle endurance

deep cervical flexor muscle endurance

Flexor Endurance Test

endurance of the deep cervical flexors

cervicogenic headache

mechanical neck pain

Forty-five

female

18 and 40 years


Effect of a mobile safety alarm on going outside , feeling safe , fear of falling , and quality of life in community-living older persons : a randomized controlled trial .

mobile safety alarm

quality of life

older persons


The Coping Cat program for children with anxiety and autism spectrum disorder : a pilot randomized controlled trial . The purpose of this pilot study was to evaluate whether a modified version of the Coping Cat program could be effective in reducing anxiety in children with autism spectrum disorder ( ASD ) . Twenty-two children ( ages 8-14 ; IQ ≥ 70 ) with ASD and clinically significant anxiety were randomly assigned to 16 sessions of the Coping Cat program ( cognitive-behavioral therapy ; CBT ) or a 16-week waitlist . Children in the CBT condition evidenced significantly larger reductions in anxiety than those in the waitlist . Treatment gains were largely maintained at two-month follow-up . Results provide preliminary evidence that a modified version of the Coping Cat program may be a feasible and effective program for reducing clinically significant levels of anxiety in children with high-functioning ASD .

anxiety

children

anxiety and autism spectrum disorder

children

autism spectrum disorder ( ASD

Twenty-two

children ( ages 8-14 ;

ASD and clinically significant anxiety

anxiety


Ambient temperature and biomarkers of heart failure : a repeated measures analysis . BACKGROUND Extreme temperatures have been associated with hospitalization and death among individuals with heart failure , but few studies have explored the underlying mechanisms . OBJECTIVES We hypothesized that outdoor temperature in the Boston , Massachusetts , area ( 1- to 4-day moving averages ) would be associated with higher levels of biomarkers of inflammation and myocyte injury in a repeated-measures study of individuals with stable heart failure . METHODS We analyzed data from a completed clinical trial that randomized 100 patients to 12 weeks of tai chi classes or to time-matched education control . B-type natriuretic peptide ( BNP ) , C-reactive protein ( CRP ) , and tumor necrosis factor ( TNF ) were measured at baseline , 6 weeks , and 12 weeks . Endothelin-1 was measured at baseline and 12 weeks . We used fixed effects models to evaluate associations with measures of temperature that were adjusted for time-varying covariates . RESULTS Higher apparent temperature was associated with higher levels of BNP beginning with 2-day moving averages and reached statistical significance for 3- and 4-day moving averages . CRP results followed a similar pattern but were delayed by 1 day . A 5°C change in 3- and 4-day moving averages of apparent temperature was associated with 11.3 % [ 95 % confidence interval ( CI ) : 1.1 , 22.5 ; p = 0.03 ) and 11.4 % ( 95 % CI : 1.2 , 22.5 ; p = 0.03 ) higher BNP . A 5°C change in the 4-day moving average of apparent temperature was associated with 21.6 % ( 95 % CI : 2.5 , 44.2 ; p = 0.03 ) higher CRP . No clear associations with TNF or endothelin-1 were observed . CONCLUSIONS Among patients undergoing treatment for heart failure , we observed positive associations between temperature and both BNP and CRP-predictors of heart failure prognosis and severity .

12 weeks of tai chi classes or to

time-matched education control

myocyte injury

B-type natriuretic peptide ( BNP )

C-reactive protein ( CRP )

tumor necrosis factor ( TNF )

BNP

CRP

CRP

TNF

heart failure

stable heart failure


Effects of skin-to-skin contact on autonomic pain responses in preterm infants . UNLABELLED The purpose of this randomized crossover trial was to determine the effects on autonomic responses in preterm infants of longer Kangaroo Care ( 30 minutes , KC30 ) and shorter KC ( 15 minutes , KC15 ) before and throughout heel stick compared with incubator care ( IC ) . Beat-to-beat heart rate ( HR ) and spectral power analysis of heart rate variability , low frequency power ( LF ) , high frequency power ( HF ) , and LF/HF ratio were measured in 26 infants . HR changes from Baseline to Heel Stick were significantly less in KC30 and KC15 than in IC , and more infants had HR decrease in IC than in 2 KC conditions . In IC , LF and HF significantly increased from Baseline to Heel Stick and dropped from Heel Stick to Recovery ; in 2 KC conditions , no changes across study phases were found . During Heel Stick , LF and HF were significantly higher in IC than in KC30 . In all 3 conditions , LF/HF ratio decreased from Baseline to Heel Stick and increased to Recovery ; no differences were found between IC and two KC conditions . Both longer and shorter KC before and throughout heel stick can stabilize HR response in preterm infants , and longer KC significantly affected infants ' sympathetic and parasympathetic responses during heel stick compared with incubator care . PERSPECTIVE This study showed that KC has a significant effect on reducing autonomic pain responses in preterm infants . The findings support that KC is a safe and effective pain intervention in the neonatal intensive care unit .

skin-to-skin contact

Kangaroo Care

KC

incubator care ( IC

IC

KC

KC

KC

incubator care

KC

KC

autonomic pain responses

HR

HR

LF

HF

LF

HF

LF/HF ratio

HR response

preterm infants

infants

preterm infants .


Healthcare costs around the time of smoking cessation . BACKGROUND The Affordable Care Act mandates that new insurance plans cover smoking-cessation therapy without cost-sharing . Previous cost difference estimates , which show a spike around the time of cessation , suggest premiums might rise as a result of covering these services . PURPOSE The goal of the study was to test ( 1 ) whether individuals in an RCT of pharmacotherapy and counseling for smoking cessation differed in their healthcare costs around the cessation period , and ( 2 ) whether the healthcare costs of those in the trial who successfully quit were different from a matched sample of smokers in the community . METHODS Generalized linear regression models were used to analyze healthcare cost data on individuals enrolled in a comparative effectiveness trial of cessation therapies between October 2005 and May 2007 ( 1346 total participants ; 1338 with requisite data for further analysis ) . Cost differences for the period preceding and subsequent to the cessation attempt were assessed by trial participants ' 12-month sustained quit status . Healthcare cost differences between sustained quitters and a sample of community-dwelling smokers , matched to these quitters on the basis of health services use around the time trial participant enrolled and by demographics , were also examined . Data were analyzed in 2011 . RESULTS All three groups had a spike in cost associated with the index clinic visit . Regression results revealed little difference in healthcare costs by quit status for trial participants until the sixth quarter post-quit . By that quarter , continuous sustained quitters cost $ 541 ( p < 0.001 ) less than continuing smokers . Continuous sustained quitters cost less than their matched community- dwelling smokers in almost every quarter observed . The cost difference ranged from $ 270 ( p=0.01 ) during the quarter of quit , to $ 490 ( p < 0.01 ) in the 6th quarter after quitting . CONCLUSIONS The inclusion of smoking-cessation therapy does not appear to raise short-term healthcare costs . By the sixth quarter post-quit , sustained quitters were less costly than trial participants who continued smoking .

smoking-cessation therapy

pharmacotherapy

counseling

smoking-cessation therapy

healthcare cost data

Cost differences

Healthcare cost differences

healthcare costs

cost

cost

short-term healthcare costs


Study of the therapeutic effects of a hippotherapy simulator in children with cerebral palsy : a stratified single-blind randomized controlled trial . OBJECTIVE To investigate whether hippotherapy ( when applied by a simulator ) improves postural control and balance in children with cerebral palsy . DESIGN Stratified single-blind randomized controlled trial with an independent assessor . Stratification was made by gross motor function classification system levels , and allocation was concealed . SUBJECTS Children between 4 and 18 years old with cerebral palsy . INTERVENTIONS Participants were randomized to an intervention ( simulator ON ) or control ( simulator OFF ) group after getting informed consent . Treatment was provided once a week ( 15 minutes ) for 10 weeks . MAIN MEASURES Gross Motor Function Measure ( dimension B for balance and the Total Score ) and Sitting Assessment Scale were carried out at baseline ( prior to randomization ) , end of intervention and 12 weeks after completing the intervention . RESULTS Thirty-eight children participated . The groups were balanced at baseline . Sitting balance ( measured by dimension B of the Gross Motor Function Measure ) improved significantly in the treatment group ( effect size = 0.36 ; 95 % CI 0.01-0.71 ) and the effect size was greater in the severely disabled group ( effect size = 0.80 ; 95 % CI 0.13-1.47 ) . The improvements in sitting balance were not maintained over the follow-up period . Changes in the total score of the Gross Motor Function Measure and the Sitting Assessment Scale were not significant . CONCLUSION Hippotherapy with a simulator can improve sitting balance in cerebral palsy children who have higher levels of disability . However , this did not lead to a change in the overall function of these children ( Gross Motor Function Classification System level V ) .

hippotherapy simulator

intervention ( simulator ON )

control ( simulator OFF )

Hippotherapy

Sitting balance

effect size

improvements in sitting balance

Sitting Assessment Scale

sitting balance

children

cerebral palsy

children

cerebral palsy

Children

4 and 18 years old

Thirty-eight

children

cerebral palsy

children


Controlled-release melatonin , singly and combined with cognitive behavioural therapy , for persistent insomnia in children with autism spectrum disorders : a randomized placebo-controlled trial . Although melatonin and cognitive-behavioural therapy have shown efficacy in treating sleep disorders in children with autism spectrum disorders , little is known about their relative or combined efficacy . One hundred and sixty children with autism spectrum disorders , aged 4-10 years , suffering from sleep onset insomnia and impaired sleep maintenance , were assigned randomly to either ( 1 ) combination of controlled-release melatonin and cognitive-behavioural therapy ; ( 2 ) controlled-release melatonin ; ( 3 ) four sessions of cognitive-behavioural therapy ; or ( 4 ) placebo drug treatment condition for 12 weeks in a 1 : 1 : 1 : 1 ratio . Children were studied at baseline and after 12 weeks of treatment . Treatment response was assessed with 1-week actigraphic monitoring , sleep diary and sleep questionnaire . Main outcome measures , derived actigraphically , were sleep latency , total sleep time , wake after sleep onset and number of awakenings . The active treatment groups all resulted in improvements across all outcome measures , with moderate-to-large effect sizes from baseline to a 12-week assessment . Melatonin treatment was mainly effective in reducing insomnia symptoms , while cognitive-behavioural therapy had a light positive impact mainly on sleep latency , suggesting that some behavioural aspects might play a role in determining initial insomnia . The combination treatment group showed a trend to outperform other active treatment groups , with fewer dropouts and a greater proportion of treatment responders achieving clinically significant changes ( 63.38 % normative sleep efficiency criterion of > 85 % and 84.62 % , sleep onset latency < 30 min ) . This study demonstrates that adding behavioural intervention to melatonin treatment seems to result in a better treatment response , at least in the short term .

melatonin

melatonin

cognitive-behavioural therapy

controlled-release melatonin

cognitive-behavioural therapy

controlled-release melatonin

placebo drug treatment condition

Melatonin

cognitive-behavioural therapy

behavioural intervention

melatonin

insomnia symptoms

sleep latency

initial insomnia

insomnia

children

autism spectrum disorders

autism spectrum disorders

One hundred and sixty

autism spectrum disorders

aged 4-10 years


Phase II multi-institutional prospective randomised trial comparing S-1+paclitaxel with S-1+cisplatin in patients with unresectable and/or recurrent advanced gastric cancer . BACKGROUND A combination of S-1 and cisplatin has been shown to be effective with acceptable safety for the first-line treatment of far-advanced gastric cancer in Japan . This is the first randomised phase II trial to compare S-1+paclitaxel with S-1+cisplatin in this setting . METHODS Patients with unresectable and/or recurrent advanced gastric cancer were randomly assigned to receive one of the two regimens : S-1 ( 40 mg m ( -2 ) twice daily ) on days 1-14 plus paclitaxel ( 60 mg m ( -2 ) ) on days 1 , 8 , and 15 of a 4-week cycle ( S-1+paclitaxel ) or S-1 ( 40 mg m ( -2 ) twice daily ) on days 1-21 plus cisplatin ( 60 mg m ( -2 ) ) on day 8 of a 5-week cycle ( S-1+cisplatin ) . The primary end point was the response rate ( RR ) . Secondary end points included progression-free survival ( PFS ) , overall survival ( OS ) , and safety . RESULTS A total of 83 patients were eligible for safety and efficacy analyses . In the S-1+paclitaxel and S-1+cisplatin groups , RRs ( 52.3 % vs 48.7 % ; P=0.74 ) and median PFS ( 9 vs 6 months ; P=0.50 ) were similar . The median OS was similar in the S-1+paclitaxel and S-1+cisplatin groups ( 16 vs 17 months ; P=0.84 ) . The incidence of grade 3 or higher haematological toxicity was 19.0 % with S-1+paclitaxel and 19.5 % with S-1+cisplatin . The incidence of grade 3 or higher non-haematological toxicity was 14.2 % with S-1+paclitaxel and 17.1 % with S-1+cisplatin . CONCLUSION S-1+paclitaxel was suggested to be a feasible and effective non-platinum-based regimen for chemotherapy in patients with advanced gastric cancer . Our results should be confirmed in multicenter , phase III-controlled clinical trials .

cisplatin

response rate ( RR )

progression-free survival ( PFS )

overall survival ( OS )

safety

RRs

median OS

gastric cancer

advanced gastric cancer


A comparison of a short nurse-based and a long multidisciplinary version of structured patient education in irritable bowel syndrome . OBJECTIVE Structured multidisciplinary patient group education has positive effects on symptoms , health-related quality of life , and disease-related knowledge in patients with irritable bowel syndrome ( IBS ) , but few studies comparing different forms of educational interventions are available . Our aim was to compare the effects of long multidisciplinary group education with a short nurse-based group education with regard to symptoms , knowledge , quality of life , and satisfaction with the intervention in IBS patients . METHODS Patients with IBS according to the Rome II criteria were randomized to either short nurse-based or a long multidisciplinary-based education . The effects were evaluated by self-administered questionnaires at 3 , 6 , and 12 months after baseline , and compared between the groups . RESULTS No differences in effects were detected in the between-group comparisons at any of the follow-up assessments . However , positive effects on symptoms , knowledge , quality of life , and satisfaction with the intervention were found in both the short and the long version . CONCLUSION A short , nurse-based educational intervention seems to be as efficacious as a longer multidisciplinary version . In both groups , positive effects on patients ' well-being were found to a similar extent . This is an important finding that , from a cost-effective perspective , could contribute toward an optimized management of patients with IBS .

long multidisciplinary group education

short nurse-based group education

self-administered questionnaires

longer multidisciplinary

symptoms

knowledge

quality of life

satisfaction

irritable bowel syndrome .

IBS patients .


Enhancing HIV medication adherence in India . BACKGROUND This pilot study evaluated an intervention designed to enhance adherence among those new to antiretroviral therapy . METHODS Participants ( n = 80 ) were recruited from a hospital clinic in Chandigarh , India , and randomized to a 3-month group intervention or individual enhanced standard of care followed by crossover of condition and assessed over 6 months . Adherence was measured by prescription refill , pill count , and self-report . RESULTS At baseline , 56 % of group condition ( immediate intervention ) and 54 % of individual condition ( delayed intervention ) participants were nonadherent by pill count and 23 % of group and 26 % of individual condition participants self-reported skipping medication at least once over the last 3 months . From the postintervention to long-term follow-up , adherence in the group condition ( immediate intervention ) improved in comparison with adherence in the individual condition ( delayed intervention ; χ ( 2 ) = 5.67 , P = .02 ) . CONCLUSIONS Results support the use of interventions early in treatment to provide information and social support to establish long-term healthy adherence behaviors .

adherence

pill count

self-reported skipping medication

n = 80


Evaluation of the pharmacodynamics of acetylsalicylic acid 81 mg with or without esomeprazole 20 mg in healthy volunteers . BACKGROUND The absence of a pharmacokinetic interaction between the proton pump inhibitor esomeprazole ( 40 mg ) and acetylsalicylic acid ( aspirin , ASA ; 325 mg ) has previously been established . OBJECTIVE This study set out to investigate the potential for pharmacodynamic interaction between low-dose ASA and esomeprazole in healthy volunteers , by measuring ASA antiplatelet activity . STUDY DESIGN This was a single-center , open-label , two-period , randomized crossover study . PARTICIPANTS Healthy male and female volunteers aged 18-75 years were included . All volunteers received ASA 81 mg once daily for 5 days prior to the study ( pre-screen ) . Subjects were eligible for inclusion if they had aspirin reactivity units ( ARU , as measured by the VerifyNow ASA assay ) of < 550 on Day 6 . INTERVENTION After pre-screening and a washout period of at least 14 days , eligible volunteers received ASA 81 mg with or without esomeprazole 20 mg once daily for 5 days in randomized order , with a 14-day washout between treatments . MAIN OUTCOME MEASURE The main outcome measure was the antiplatelet activity of ASA , as assessed by ARU ratio relative to baseline in the VerifyNow ASA assay ; suppression of serum thromboxane B ( 2 ) ( TXB ( 2 ) ) was a secondary endpoint . Statistical comparisons were made using linear mixed models . RESULTS A total of 29 volunteers ( 19 aged ≥50 years ; 8 women ; 21 men ) were evaluable for pharmacodynamic analysis ( per protocol ) . All volunteers on both treatments achieved ARU < 550 at Day 6 . The geometric mean ratio of Day 6 to Day 1 ( baseline ) platelet aggregation was 0.70 ( 95 % confidence interval [ CI ] 0.68 , 0.72 ) with ASA alone and 0.71 ( 95 % CI 0.69 , 0.74 ) with ASA + esomeprazole . The ratio of platelet aggregation ( ASA + esomeprazole/ASA ) was 1.02 ( 95 % CI 0.99 , 1.05 ) . ASA administered alone or with esomeprazole reduced serum TXB ( 2 ) by more than 99.5 % . The ratio of suppression of serum TXB ( 2 ) levels ( ASA + esomeprazole/ASA ) was 1.06 ( 95 % CI 0.88 , 1.29 ) . The combination of ASA and esomeprazole was well tolerated . CONCLUSION No pharmacodynamic interaction between low-dose ASA and esomeprazole was found with regard to platelet function . TRIAL REGISTRATION Registered at ClinicalTrials . gov as NCT01199328 .

ASA 81 mg

aspirin

ASA 81 mg

esomeprazole 20 mg

Evaluation

pharmacokinetic interaction

pharmacodynamic interaction

antiplatelet activity

aspirin reactivity units

healthy volunteers .


A randomized trial of immunotherapy for persistent genital warts . AIM To determine whether immunotherapy with HPV6 L1 virus like particles ( VLPs ) without adjuvant ( VLP immunotherapy ) reduces recurrence of genital warts following destructive therapy . TRIAL DESIGN A randomized placebo controlled blinded study of treatment of recurrent genital warts amenable to destructive therapy , conducted independently in Australia and China . METHODS Patients received conventional destructive therapy of all evident warts together with intramuscular administration of 1 µg , 5 µg or 25 µg of VLP immunotherapy , or of placebo immunotherapy ( 0.9 % NaCl ) , as immunotherapy at week 0 and week 4 . Primary outcome , assessed at week 8 , was recurrence of visible warts . RESULTS Of 33 protocol compliant Brisbane recipients of placebo immunotherapy , 11 were disease free at two months , and a further 9 demonstrated reduction of > 50 % in total wart area . Wart area reduction following destructive treatment correlated with prior duration of disease . Among 102 protocol compliant Brisbane recipients of VLP immunotherapy , disease reduction was significantly greater than among the placebo immunotherapy ( 50 % ± s.e.m . 7 % ) recipients for subjects receiving 5 µg or 25 µg of VLP immunotherapy/dose ( 71 % ± s.e.m . 7 % ) but not for those receiving 1 µg VLP immunotherapy/dose ( 42 % ± 7 % ) . Of 52 protocol compliant placebo immunotherapy recipients in Wenzhou , 37 were disease free at two months , and a further 8 had > 50 % disease reduction . Prior disease duration was much shorter in Wenzhou subject ( 8.1 ± 1.1 mo ) than in Brisbane subjects ( 53.7 ± 5.5 mo ) . No significant reduction in mean wart area was observed for the 168 Wenzhou protocol compliant subjects who also received VLP immunotherapy . CONCLUSIONS This study confirms the findings in a previous open label trial that administration of VLP immunotherapy may assist in clearance of recurrent genital warts in patients for whom destructive therapy is unsuccessful and that unsuccessful destructive therapy is more common with increasing prior disease duration .

immunotherapy

placebo

conventional destructive therapy

genital warts

persistent genital warts

recurrent genital warts


Propofol sedation with bispectral index monitoring is useful for endoscopic submucosal dissection : a randomized prospective phase II clinical trial . BACKGROUND AND STUDY AIMS Endoscopic submucosal dissection ( ESD ) has become a standard treatment . However , the treatment time tends to be relatively long and insufflation and manipulation of the endoscope can increase pain and discomfort . We aimed to find an optimal method for sedation during ESD . PATIENTS AND METHODS Patients scheduled to undergo ESD for early gastric cancer or adenoma were randomly assigned to sedation with midazolam or propofol , and consciousness level was evaluated by bispectral index ( BIS ) monitoring . Primary end points of effectiveness ( three parameters ) and secondary end points of safety during ESD and after return to the ward were compared between the groups . Study registration was in the UMIN Clinical Trial Registry ( UMIN 000001497 ) , and the institutional trial number was KDOG 0801 . RESULTS From June 2008 through June 2009 , we enrolled 178 patients ( 90 midazolam , 88 propofol ) . Regarding safety after ESD , recovery was significantly better in the propofol group immediately after and at 1 hour and 2 hours after return to the ward ( P < 0.001 ) . The number of patients who required a continuous supply of oxygen 2 hours after returning to the ward was significantly lower in the propofol group ( midazolam 18 ; propofol 6 ; P = 0.010 ) . Though propofol seemed to be better for effectiveness and safety , there were no statistically significant differences for all three primary end points and the safety parameters ( hypotension , hypoxia , bradycardia ) . CONCLUSIONS Propofol with BIS monitoring improved recovery of patients after ESD , though this study was underpowered to prove the effectiveness and safety of propofol .

Propofol

midazolam

propofol

Propofol

safety

recovery

effectiveness

safety

safety parameters

hypotension

hypoxia

bradycardia

recovery

early gastric cancer or adenoma


Impact on learning of an e-learning module on leukaemia : a randomised controlled trial . BACKGROUND e-learning resources may be beneficial for complex or conceptually difficult topics . Leukaemia is one such topic , yet there are no reports on the efficacy of e-learning for leukaemia . This study compared the learning impact on senior medical students of a purpose-built e-learning module on leukaemia , compared with existing online resources . METHODS A randomised controlled trial was performed utilising volunteer senior medical students . Participants were randomly allocated to Study and Control groups . Following a pre-test on leukaemia administered to both groups , the Study group was provided with access to the new e-learning module , while the Control group was directed to existing online resources . A post-test and an evaluation questionnaire were administered to both groups at the end of the trial period . RESULTS Study and Control groups were equivalent in gender distribution , mean academic ability , pre-test performance and time studying leukaemia during the trial . The Study group performed significantly better than the Control group in the post-test , in which the group to which the students had been allocated was the only significant predictor of performance . The Study group 's evaluation of the module was overwhelmingly positive . CONCLUSIONS A targeted e-learning module on leukaemia had a significant effect on learning in this cohort , compared with existing online resources . We believe that the interactivity , dialogic feedback and integration with the curriculum offered by the e-learning module contributed to its impact . This has implications for e-learning design in medicine and other disciplines .

e-learning

e-learning module

existing online resources .

directed to existing online resources

learning

post-test

and an

evaluation questionnaire

post-test

learning

students

senior medical students


Oral magnesium supplementation in children with cystic fibrosis improves clinical and functional variables : a double-blind , randomized , placebo-controlled crossover trial . BACKGROUND Magnesium is one of the most important minerals in the body . Although some studies reported that patients with cystic fibrosis ( CF ) lack magnesium , no international study has assessed the importance of oral magnesium supplementation in CF patients . OBJECTIVE We prospectively investigated the long-term effect of oral magnesium supplementation on respiratory muscle strength by using manuvacuometry and the Shwachman-Kulczycki ( SK ) score among children and adolescents with CF . DESIGN This double-blind , randomized , placebo-controlled crossover study included 44 CF patients ( aged 7-19 y ; 20 males ) who were randomly assigned to receive magnesium ( n = 22 ; 300 mg/d ) or placebo ( n = 22 ) for 8 wk with a 4-wk washout period between trials . All patients were undergoing conventional treatment of CF . The experimental protocol included clinical evaluation , assessment of urinary concentration of magnesium , and manuvacuometric measurements [ maximal inspiratory pressure ( MIP ) and maximal expiratory pressure ( MEP ) ] . MIP was the primary outcome . RESULTS Urinary magnesium increased after the administration of magnesium ( change : 36.38 mg/d after magnesium compared with 0.72 mg/d after placebo ; P < 0.001 ) . Moreover , MIP and MEP significantly improved only after magnesium administration ( change in MIP : 11 % predicted after magnesium compared with 0.5 % predicted after placebo ; change in MEP : 11.9 % predicted after magnesium compared with 0.8 % predicted after placebo ; P < 0.001 for both ) . Magnesium administration had a beneficial effect on clinical variables assessed by the SK score ( change : 4.48 points after magnesium compared with -1.30 points after placebo ; P < 0.001 ) . CONCLUSION Oral magnesium supplementation helped improve both the SK score and respiratory muscle strength in pediatric patients with CF .

magnesium supplementation

magnesium

magnesium

placebo

magnesium

magnesium

respiratory muscle strength

Shwachman-Kulczycki ( SK ) score

maximal inspiratory pressure ( MIP )

maximal expiratory pressure ( MEP )

MIP

Urinary magnesium

MIP

MEP

SK score

children

cystic fibrosis

children and adolescents

CF

aged 7-19 y

20 males


[ Effect of probucol on serum malondialdehyde and superoxide dismutase in patients with primary hypertension ] . OBJECTIVE To observe the therapeutic effect of probucol on serum malondialdehyde ( MDA ) and superoxide dismutase ( SOD ) in patients with primary hypertension . METHODS A randomized study was performed on 40 patients with hypertension . The patients were randomly assigned to the control ( levamlodipine besylate 2.5 mg/d plus benazepril 10 mg/d , n=20 ) or probucol group ( levamlodipine besylate 2.5 mg/d plus benazepril 10 mg/d plus probucol 500 mg/d , n=20 ) . An additional twenty healthy people were enrolled in the study ( normal group ) . All subjects were followed up for a period of four weeks . Lipids and hepatic/renal function were measured at baseline and after 4 weeks . The levels of serum MDA and SOD activity were assayed by chemical colorimetry , and other indices , including blood pressure , lipids and hepatic/renal function , were measured at baseline and after 4 weeks . RESULTS Compared to the normal group , the levels of MDA in all of the hypertension patient groups were higher , SOD was lower . The antihypertensive treatment decreased serum MDA levels but increased SOD content , and probucol treatment exaggerated these effects , with greater reduction of serum MDA levels and greater increase of SOD content . CONCLUSION The treatment with probucol can improve oxidative stress in hypertension patients , resulting in reduced serum MDA levels and improved SOD activity , thus contributing agreater antihypertensive effect .

probucol

probucol

control ( levamlodipine besylate

plus benazepril 10

plus benazepril

plus probucol

serum MDA and SOD

levels of MDA

greater reduction of serum MDA levels

greater increase of SOD content .

reduced serum MDA levels

improved SOD activity

patients with primary hypertension .

hypertension patients


A randomised comparison of the self-pressurised air-QTM intubating laryngeal airway with the LMA Unique™ in children . We conducted a randomised trial comparing the self-pressurised air-Q™ intubating laryngeal airway ( air-Q SP ) with the LMA-Unique in 60 children undergoing surgery . Outcomes measured were airway leak pressure , ease and time for insertion , fibreoptic examination , incidence of gastric insufflation and complications . Median ( IQR [ range ] ) time to successful device placement was faster with the air-Q SP ( 12 ( 10-15 [ 5-18 ] ) ) s than with the LMA-Unique ( 14 ( 12-17 [ 6-22 ] ) s ; p=0.05 ) . There were no statistically significant differences between the air-Q SP and LMA-Unique in initial airway leak pressures ( 16 ( 14-18 [ 10-29 ] ) compared with 18 ( 15-20 [ 10-30 ] ) cmH2 O , p=0.12 ) , an airway leak pressures at 10 min ( 19 ( 16-22 [ 12-30 ] ) compared with 20 ( 16-22 [ 10-30 ] ) cmH2 O , p=0.81 ) ; fibreoptic position , incidence of gastric insufflation , or complications . Both devices provided effective ventilation without the need for airway manipulation . The air-Q SP is an alternative to the LMA-Unique should the clinician prefer a device not requiring cuff monitoring during anaesthesia .

laryngeal

complications

children

undergoing surgery


Impact of an Asha intervention on depressive symptoms among rural women living with AIDS in India : comparison of the Asha-Life and Usual Care program . The purpose of this randomized pilot study is to conduct an intervention with 68 rural women living with AIDS to compare the effectiveness of two different programs on depressive symptoms . The trial was designed to assess the impact of the Asha-Life intervention engaging with an HIV-trained village woman , Asha ( Accredited Social Health Activist ) , to participate in the care of women living with AIDS ( WLA ) , along with other health care providers compared to a Usual Care group . Two high prevalence HIV/AIDS villages in rural Andhra Pradesh , which were demographically alike and served by distinct Public Health Centers , were selected randomly from a total of 16 villages . The findings of this study demonstrated that the Asha-Life participants significantly reduced their depressive symptom scores compared to the Usual Care participants . Moreover , women living with AIDS who demonstrated higher depressive symptom scores at baseline had greater reduction in their depressive symptoms than women with lower scores .

Asha intervention

Asha-Life and Usual Care program

Asha-Life intervention

Usual Care group

Asha-Life

depressive symptoms

significantly reduced

depressive symptom scores

depressive symptom scores

depressive symptoms

women

living with AIDS in India

women

living with AIDS

women

living with AIDS


The memory support system for mild cognitive impairment : randomized trial of a cognitive rehabilitation intervention . OBJECTIVE Individuals with amnestic mild cognitive impairment ( MCI ) have few empirically based treatment options for combating their memory loss . This study sought to examine the efficacy of a calendar/notebook rehabilitation intervention , the memory support system ( MSS ) , for individuals with amnestic MCI . METHODS Forty individuals with single domain amnestic MCI and their program partners were randomized to receive the MSS , either with training or without ( controls ) . Measures of adherence , activities of daily living , and emotional impact were completed at the first and last intervention sessions and again at 8 weeks and 6 months post intervention . RESULTS Training in use of a notebook/calendar system significantly improved adherence over those who received the calendars but no training . Functional ability and memory self-efficacy significantly improved for those who received MSS training . Change in functional ability remained significantly better in the intervention group than in the control group out to 8-week follow-up . Care partners in the intervention group demonstrated improved mood by 8-week and 6-month follow-ups , whereas control care partners reported worse caregiver burden by 6-month follow-up . CONCLUSIONS Memory support system training resulted in improvement in activities of daily living and sense of memory self-efficacy for individuals with MCI . Although activities of daily living benefits were maintained out to 8 weeks post intervention , future inclusion of booster sessions may help extend the therapeutic effect out even further . Improved mood of care partners of trained individuals and worsening sense of caregiver burden over time for partners of untrained individuals further support the efficacy of the MSS for MCI .

cognitive rehabilitation intervention

memory support system ( MSS )

amnestic MCI

Memory support system training

memory loss .

memory support system ( MSS )

Functional ability

memory self-efficacy

mood

caregiver burden

mild cognitive impairment :

amnestic MCI .

Forty

single domain amnestic MCI


Plerixafor plus granulocyte colony-stimulating factor versus placebo plus granulocyte colony-stimulating factor for mobilization of CD34 ( + ) hematopoietic stem cells in patients with multiple myeloma and low peripheral blood CD34 ( + ) cell count : results of a subset analysis of a randomized trial . Preapheresis peripheral blood ( PB ) CD34 ( + ) cell count is a strong predictor of hematopoietic stem cell ( HSC ) mobilization and is routinely used to optimize the timing , cost , and success of HSC collection in patients with multiple myeloma . However , a uniform PB CD34 ( + ) cell count that predicts mobilization failure has not been defined , resulting in the development of institute-specific algorithms for mobilization , particularly regarding the decision of when to use the novel stem cell mobilization agent plerixafor . In this post hoc analysis , we evaluated the mobilization efficacy of plerixafor plus granulocyte colony-stimulating factor ( G-CSF ) versus placebo plus G-CSF in patients with multiple myeloma , stratified by preapheresis PB CD34 ( + ) cell count : < 10 , < 15 , < 20 , and ≥20 cells/μL . Regardless of the PB CD34 ( + ) cell count , the total yield of CD34 ( + ) cells from apheresis was significantly higher in the plerixafor group than in the placebo group , and significantly more patients in the plerixafor group collected the minimum ( ≥2 × 10 ( 6 ) cells/kg ) and optimum ( ≥6 × 10 ( 6 ) cells/kg ) stem cell yields on each day of apheresis . As a corollary , the greater stem cell collection in plerixafor-treated patients resulted in the need for significantly fewer days of apheresis to reach minimum and optimum cell doses across all cell count groups . For all CD34 ( + ) cell count groups , the proportion of patients proceeding to transplantation and the median time to platelet and neutrophil engraftment were similar in the plerixafor and placebo groups . Our findings demonstrate that in patients with multiple myeloma who might be predicted to fail mobilization based on low PB CD34 ( + ) cell count , the addition of plerixafor to G-CSF allows for collection of the minimal and optimal cell doses in a greater proportion of patients compared with G-CSF alone . In addition , plerixafor plus G-CSF significantly improves the likelihood of optimal HSC collection in patients with higher preapheresis PB CD34 ( + ) cell counts ( ≥20 cells/μL ) compared with placebo plus G-CSF . Collectively , this analysis of predicted poor mobilizers validates the superiority of plerixafor plus G-CSF compared with G-CSF alone , which had been demonstrated previously in the overall patient population .

placebo plus G-CSF

multiple myeloma

multiple myeloma

multiple myeloma