Field efficacy of an inactivated bivalent influenza vaccine in a multi-site swine production system during an outbreak of systemic porcine circovirus associated disease . Swine influenza ( SI ) is a disease of significance for the swine industry , and vaccination is often recommended as a way to reduce its impact on production . The efficacy of SI vaccines is well established under experimental conditions , but information about field efficacy is scarce . The objective of this study was to evaluate the efficacy of a commercial inactivated bivalent ( H1N1/H3N2 ) vaccine under conditions of natural exposure to a field SI variant . To accomplish our goal we used a randomized , blinded , field trial in 2 cohorts of finisher pigs in a multi-site swine production system located in southern Ontario . During the trial , this herd experienced an outbreak of porcine circovirus associated disease ( PCVAD ) . The efficacy of the SI vaccine was assessed through its effect on average daily weight gain , and serological responses to SI over time . The effect of vaccination on pig growth was different in the 2 cohorts . Weight gain was higher in vaccinated pigs than in control pigs in Cohort 1 , but was numerically higher for control pigs than for vaccinated pigs in Cohort 2 . Vaccination against swine influenza , in a herd experiencing an outbreak of PCVAD , was of questionable value .

inactivated bivalent influenza vaccine

SI vaccines

field SI variant

SI vaccine

vaccination

Vaccination

efficacy of the SI vaccine

effect of vaccination

pig growth

Weight gain

2 cohorts


Non-pharmacological care for patients with generalized osteoarthritis : design of a randomized clinical trial . BACKGROUND Non-pharmacological treatment ( NPT ) is a useful treatment option in the management of hip or knee osteoarthritis . To our knowledge however , no studies have investigated the effect of NPT in patients with generalized osteoarthritis ( GOA ) . The primary aim of this study is to compare the effectiveness of two currently existing health care programs with different intensity and mode of delivery on daily functioning in patients with GOA . The secondary objective is to compare the cost-effectiveness of both interventions . METHODS/DESIGN In this randomized , single blind , clinical trial with active controls , we aim to include 170 patients with GOA . The experimental intervention consist of six self-management group sessions provided by a multi-disciplinary team ( occupational therapist , physiotherapist , dietician and specialized nurse ) . The active control group consists of two group sessions and four sessions by telephone , provided by a specialized nurse and physiotherapist . Both therapies last six weeks . Main study outcome is daily functioning during the first year after the treatment , assessed on the Health Assessment Questionnaire . Secondary outcomes are health related quality of life , specific complaints , fatigue , and costs . Illness cognitions , global perceived effect and self-efficacy , will also be assessed for a responder analysis . Outcome assessments are performed directly after the intervention , after 26 weeks and after 52 weeks . DISCUSSION This article describes the design of a randomized , single blind , clinical trial with a one year follow up to compare the costs and effectiveness of two non-pharmacological interventions with different modes of delivery for patients with GOA . TRIAL REGISTRATION Dutch Trial Register NTR2137 .

Non-pharmacological treatment ( NPT )

NPT

six

non-pharmacological interventions

generalized osteoarthritis :

hip or knee osteoarthritis

fatigue

costs

Illness cognitions

costs

effectiveness


Comparison of gonadotropin-releasing hormone agonists and antagonists in assisted reproduction cycles of polycystic ovarian syndrome patients . AIM Gonadotropin-releasing hormone ( GnRH ) antagonists have reduced the incidence of severe ovarian hyper stimulation syndrome ( OHSS ) and rate of hospitalization due to severe OHSS , especially in polycystic ovarian syndrome ( PCOS ) patients . The present study aimed to compare the outcomes of patients with PCOS undergoing controlled ovarian hyperstimulation ( COH ) with GnRH agonist versus GnRH antagonist protocols for assisted reproduction cycles . METHODS The present clinical trial compared GnRH antagonist ( cetrorelix ) and GnRH agonist ( buserelin ) protocols during COH of 112 infertile PCOS patients entering assisted reproduction cycles . The primary outcome measure was pregnancy occurrence . Basal characteristics of the participants , stimulation cycle responses , pregnancy outcomes , incidence of OHSS and types of OHSS were considered in both groups . RESULTS Regarding chemical and clinical pregnancy rates , the number of retrieved oocytes was significantly higher and OHSS was significantly lower in the antagonist group . Follicle stimulating hormone ( FSH ) , luteinizing hormone ( LH ) levels , number of follicles , number of follicles > 18 mm , relative frequency of mature oocytes , number and days of gonadotropin injections , day of human chorionic gonadotropin ( HCG ) administration , estradiol level and abortion were similar between the two groups . CONCLUSION GnRH antagonists are more effective , safe and a well tolerated alternative to agonists for assisted reproduction cycles in PCOS patients . GnRH antagonists are associated with a reduction in the incidence of OHSS in these patients .

gonadotropin-releasing hormone agonists

antagonists

GnRH agonist

GnRH antagonist

GnRH antagonist ( cetrorelix )

GnRH agonist ( buserelin )

pregnancy occurrence .

stimulation cycle responses

pregnancy outcomes

incidence of OHSS

types of OHSS

chemical and clinical pregnancy rates

number of retrieved oocytes

polycystic ovarian syndrome

( PCOS )


Comorbidity , age and overall survival in cetuximab-treated patients with advanced colorectal cancer ( ACRC ) -- results from NCIC CTG CO.17 : a phase III trial of cetuximab versus best supportive care . BACKGROUND the interplay between comorbidity , age and performance status ( PS ) as predictors of outcome in advanced colorectal cancer ( ACRC ) is poorly understood . We examined these factors as predictors of treatment toxicity and outcome in cetuximab-treated patients with ACRC . PATIENTS AND METHODS comorbidity was independently evaluated using the Charlson Comorbidity Index ( CCI ) , a validated measure of comorbidity based on the presence of medical conditions weighted according to their effect on mortality . CCI score was correlated with clinical and outcome data . RESULTS five hundred and seventy-two patients were included ; 41 % were ≥ 65 years and 25 % had comorbidities at randomization . In multivariate analysis ( MVA ) of all covariates , only older age was associated with greater comorbidity ( P = 0.008 ) . Overall survival ( OS ) was significantly better for patients with greater comorbidity in univariate analysis ( P = 0.047 ) . Conversely , better PS was associated with better OS in MVA ( hazard ratio 1.92 for PS = 2 versus PS = 0 , P < 0.0001 ) . Age was not associated with OS ( P = 0.13 ) . Elderly patients had significantly less grade ≥ 3 vomiting ( P = 0.034 ) but more dyspnea ( P = 0.005 ) . Patients with greater comorbidity had significantly less grade ≥ 3 vomiting ( P = 0.002 ) but more non-neutropenic fever ( P = 0.005 ) . CONCLUSION better PS was associated with improved OS . For patients with good PS , restricting cetuximab use in the setting of significant comorbidity does not appear justified .

cetuximab-treated

cetuximab

best supportive care

cetuximab-treated

Comorbidity , age

overall survival

comorbidity , age

performance status ( PS )

toxicity

Charlson Comorbidity Index ( CCI )

comorbidity

CCI score

advanced colorectal cancer ( ACRC )

cetuximab-treated patients

ACRC

five hundred and seventy-two patients

41 % were ≥ 65 years

Elderly patients


Types of parent verbal responsiveness that predict language in young children with autism spectrum disorder . PURPOSE This study examined short-term predictive associations between 5 different types of parent verbal responsiveness and later spoken vocabulary for 32 young children with a confirmed diagnosis of autism spectrum disorder ( ASD ) . METHOD Parent verbal utterances were coded from videotapes of naturalistic parent-child play sessions using interval and event-based coding . A vocabulary difference score , calculated using the MacArthur Communicative Development Inventories ( L. Fenson et al. , 1993 ) , was used as the outcome measure of spoken vocabulary 6 months later . RESULTS Parent follow-in comments and follow-in directives predicted spoken vocabulary after controlling for child engagement . Parent expansions of child verbal utterances predicted spoken vocabulary after controlling for child talkativeness . When entered together into a regression analysis , metrics that represented ( a ) the number of parent utterances following into the child 's focus of attention and ( b ) the number of parent utterances responding to child verbal communication acts both accounted for unique variance in predicting change in spoken vocabulary from Time 1 to Time 2 . CONCLUSION Parent verbal utterances that follow into the child 's current focus of attention or respond to child verbal communication acts may facilitate the process of early vocabulary acquisition by mitigating the need for children with ASD to use attention-following as a word-learning strategy .

parent verbal responsiveness

parent verbal responsiveness

Parent verbal utterances

parent utterances

parent utterances

Parent verbal utterances

vocabulary difference score

spoken vocabulary

spoken vocabulary

parent


[ Assessment of natriuretic peptide indices and oxidative stress in patients with chronic heart failure ] . The authors have studied indices of natriuretic peptide and oxidative stress in patients with chronic heart failure ( CHF ) . 52 male patients with postinfarction cardiosclerosis ( PICS ) who have developed CHF have been observed . The age of the patients varied from 38 till 60 . It was established that CHF patients with progression of the disease had worsening of their clinical condition together with an increase of oxidative stress which was characterized through decrease of NO metabolites , NADPH -- diaphorase ( eNOS ) , increase of nitrite reductase ( iNOS ) and peroxinitrite ( ONOO ) , correlative increase the level of brain natriuretic peptide in blood plazma . Reliable connection between considerable increase of oxidative stress and the level of NT-pro BNP was noted in CHF patients , which demands necessity of correction of observed disorders .

natriuretic peptide

oxidative

natriuretic peptide

52 male

clinical condition

oxidative stress

NO metabolites

NADPH -- diaphorase ( eNOS )

nitrite reductase ( iNOS )

peroxinitrite ( ONOO )

oxidative stress

level of NT-pro BNP

chronic heart failure

chronic heart failure ( CHF )

male

CHF

38 till 60

CHF


Human papillomavirus genotypes in cervical intraepithelial neoplasia grade 3 . BACKGROUND There are few large case series describing the human papillomavirus ( HPV ) genotypes found in women diagnosed with rigorously reviewed cervical intraepithelial neoplasia grade 3 ( CIN3 ) , cervical precancer . METHODS The Atypical Squamous Cells of Undetermined Significance ( ASCUS ) and Low-Grade Squamous Intraepithelial Lesion ( LSIL ) Triage Study ( ALTS ) was a clinical trial to evaluate the best management strategies for women with equivocal ( ASCUS ) or mildly abnormal ( LSIL ) Pap tests . During enrollment and the 2-year follow-up , 608 women had a histopathologic diagnosis of CIN3 and PCR-based HPV genotyping results on cervical specimens . The genotyping results were ranked hierarchically according to cancer risk : HPV16 > other carcinogenic HPV > noncarcinogenic HPV > PCR negative . RESULTS Among the 608 women diagnosed with CIN3 , 601 ( 98.8 % ) cases were positive for any HPV genotype and 95.4 % for any carcinogenic HPV . HPV16 ( 59.9 % ) , HPV31 ( 18.1 % ) , HPV52 ( 14.8 % ) , HPV51 ( 14.0 % ) , and HPV18 ( 13.2 % ) were the five most common HPV genotypes detected . Younger age , consensus histologic confirmation , smoking , and multiparity increased the likelihood of testing HPV 16 positive . Specifically , HPV16-positive CIN3 occurred at a younger age than CIN3 positive for other carcinogenic HPV genotypes ( median of 23.5 years versus 25 years , respectively ; P = 0.0003 , Kruskal-Wallis ) . CONCLUSIONS HPV16-positive CIN3 was more commonly diagnosed in younger women ( versus older women ) , with consensus diagnosis ( versus some disagreement between reviewers ) , and in smokers ( versus nonsmokers ) , and was less commonly diagnosed in multiparous women compared CIN3 positive for other carcinogenic HPV genotypes . IMPACT In populations vaccinated against HPV16 ( and HPV18 ) , the median age of CIN3 in women with ASCUS and LSIL cytology should shift to older ages , possibly permitting later age at first screening .

PCR-based HPV genotyping results

HPV16 ( and HPV18 )

human papillomavirus ( HPV )

carcinogenic HPV . HPV16

testing HPV 16 positive

HPV16-positive CIN3

HPV16-positive CIN3

CIN3 positive

carcinogenic HPV genotypes

cervical intraepithelial neoplasia

cervical precancer

women

women

women


Physician-pharmacist cooperation program for blood pressure control in patients with hypertension : a randomized-controlled trial . BACKGROUND The aim of the trial was to evaluate the effectiveness of a program of cooperation between physician and pharmacist to reduce cardiovascular risk factors in patients with mild to moderate hypertension by promoting better blood pressure ( BP ) control , appropriate changes in antihypertensive medications , and beneficial changes in lifestyle . METHODS The 132 subjects in this randomized , controlled trial were in the age range of 40-79 years . The inclusion criteria were : systolic BP ( SBP ) ranging from 140-179 mm Hg and/or diastolic BP ( DBP ) ranging from 90-99 mm Hg and treatment-naive ( untreated for hypertension ) ; or on a regimen of medication for hypertension . Of these 132 subjects , 124 ( 94 % ) were already receiving treatment with antihypertensive medications . Equal numbers of subjects were randomly assigned to one of two groups : a physician-pharmacist intervention group ( n = 66 ) and a control group ( n = 66 ) . RESULTS The 6-month follow-up rate was 97 % in both groups . At 6 months , the mean decrease in SBP/DBP , as measured at home in the morning , was 2.9/3.3 mm Hg in the intervention group relative to baseline ( P = 0.02 and P < 0.0001 for SBP and DBP , respectively ) . The mean decrease in home morning SBP in the intervention group was not significantly greater than in the control group . However , the DBP decline was significantly greater in the intervention than control groups , which showed a mean decrease of 2.8 mm Hg ( confidence interval : -5.5 to -0.1 ; P = 0.04 ) . The percentage of patients in whom control of home morning BP was achieved was 53 % in the intervention group and 47 % in the control group ( P = 0.40 ) . A higher percentage of patients in the intervention group , relative to the control group , were able to reduce the use of antihypertensive medications ( 31 vs. 8 % , P < 0.0001 ) , and fewer patients in this group required additional medications or increases in dosage relative to the controls ( 11 vs. 28 % , P = 0.03 ) . Patients of the intervention group were more likely to show reduction in body mass index and sodium intake and to stop smoking , as compared with the control group . CONCLUSIONS A program of cooperation between physician and pharmacist was successful in reducing cardiovascular risk factors in patients with mild to moderate hypertension by promoting better blood pressure ( BP ) control , appropriate changes in antihypertensive medications , and beneficial changes in lifestyle .

physician-pharmacist intervention group

control group

systolic BP ( SBP )

diastolic BP ( DBP )

SBP/DBP

home morning SBP

DBP

home morning BP

use of antihypertensive medications

additional medications

body mass index

sodium intake

stop smoking

hypertension

mild to moderate hypertension

40-79 years

hypertension

antihypertensive medications

mild to moderate hypertension


Translucency of zirconia copings made with different CAD/CAM systems . STATEMENT OF PROBLEM Zirconia cores are reported to be less translucent than glass , lithium disilicate , or alumina cores . This could affect the esthetic appearance and the clinical choices made when using zirconia-based restorations . PURPOSE The purpose of this in vitro study was to evaluate the translucency of zirconia copings for single crowns fabricated using different CAD/CAM systems , using lithium disilicate glass ceramic as a control . MATERIAL AND METHODS Using impressions made from a stainless steel complete-crown master die , 9 stone cast replicas were fabricated , numbered , and distributed into 8 ceramic ZrO ( 2 ) CAD/CAM system groups ( Lava Frame 0.3 and 0.5 , IPS e.max ZirCAD , VITA YZ , Procera AllZircon , Digizon , DC Zircon , and Cercon Base ) and to a lithium disilicate glass-ceramic control group ( IPS e.max Press ) using a simple computer-generated randomization method . From each die , the manufacturer 's authorized milling centers supplied 5 copings per group without applying any dying technique to the ceramic base material . The copings were prepared to allow for a 40-mum cement layer and were of different thicknesses according to system specifications . Translucency was measured by the direct transmission method with a digital photoradiometer mounted in a dark chamber . The light source was a 150-W halogen lamp beam . Measurements were repeated 3 times for each specimen . Data obtained were analyzed using 1-way ANOVA and the Bonferroni multiple comparison test ( alpha=.05 ) . RESULTS Among ZrO ( 2 ) copings , Lava ( 0.3 mm and 0.5 mm thick ) showed the highest ( P < .05 ) values of translucency measured as light flow units ( 3.572 + or - 018 x 10 ( 3 ) lx and 3.181 + or - 0.13 x 10 ( 3 ) lx , respectively ) . These values represent 71.7 % and 63.9 % , respectively , of the glass-ceramic control group ( 4.98 x 10 ( 3 ) lx ) . CONCLUSIONS All ZrO ( 2 ) copings demonstrated different levels of light transmission , with the 2 Lava specimens showing the highest values . Translucency of zirconia copings was significantly lower ( P=.001 ) than that of the lithium disilicate glass-ceramic control .

zirconia copings

lithium disilicate glass ceramic

translucency

Translucency

values of

translucency

Translucency

zirconia copings


Effects of intravenous iron combined with low-dose recombinant human erythropoietin on transfusion requirements in iron-deficient patients undergoing bilateral total knee replacement arthroplasty . BACKGROUND The authors examined the impact of parenteral iron and recombinant human erythropoietin-β ( rHuEPO-β ) administered in the bilateral total knee replacement arthroplasty ( TKRA ) , on postoperative anemia and transfusion requirements in iron-deficient patients . STUDY DESIGN AND METHODS A total of 108 iron-deficient patients were randomly assigned to two groups : Group C ( control ) or Group IE ( 200 mg of iron sucrose intravenously over 1 hr and 3000 IU of rHuEPO-β subcutaneously during the operation and during the postoperative period if the hemoglobin [ Hb ] level was 70-80 g/L ) . One or 2 units of blood were transfused to patients in both groups according to postoperative Hb level ( between 60 and 70 g/L or betweeen 50 and 60 g/L , respectively ) . Perioperative laboratory and clinical outcomes ( Hb , iron variables , postoperative bleeding amount , and number of units of RBCs transfused and incidences ) were documented . RESULTS Although preoperative Hb and the amount of postoperative bleeding were comparable in the two groups , Hb levels at 1 , 2 , and 3 days and at 2 and 6 weeks postoperation were significantly higher in Group IE . Furthermore , the transfusion rate was significantly lower in Group IE ( 20.4 % vs. 53.7 % , p=0.011 ) and the mean number of red blood cell units transfused was markedly lower in Group IE ( 0.2±0.5 vs. 0.8±0.8 , p=0.005 ) . Postoperative iron , ferritin , and transferrin saturation levels were significantly higher in Group IE . CONCLUSIONS Treatment with parenteral iron and low-dose rHuEPO-β in bilateral TKRA effectively attenuated anemia and decreased transfusion requirements in iron-deficient patients .

Effects

transfusion requirements


Effect of explicit instruction on Japanese Verbal Learning Test in schizophrenia patients . After random assignment of 20 schizophrenia patients to either an explicit or normal instruction group , the Japanese Verbal Learning Test was administered to them . Results reveal that explicit instruction group patients demonstrated more improved memory performance using semantic clustering , suggesting that explicit and direct teaching facilitates patients ' learning of information .

explicit or normal instruction

Japanese Verbal Learning Test

improved memory performance

schizophrenia

schizophrenia


Efficacy of patient education and supervised exercise vs patient education alone in patients with hip osteoarthritis : a single blind randomized clinical trial . OBJECTIVE To compare the efficacy of patient education and supervised exercise with that of patient education alone for the management of pain in patients with hip osteoarthritis ( OA ) . DESIGN Single blind randomized clinical trial . SETTING Recruitment of patients from hospitals , primary health care and advertisement , Oslo , Norway . PARTICIPANTS 109 patients with radiographic and symptomatic hip OA with mild to moderate symptoms . INTERVENTIONS Patient education ( PE ) . Patient education and supervised exercise ( PE+SE ) . PRIMARY OUTCOME MEASURE The pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC pain ) . RESULTS No significant between group differences were found for WOMAC pain over the 16-month follow-up . Significant improvements were found for the secondary outcome WOMAC physical function ( P=0.011 ) in the group receiving PE+SE compared to the group receiving PE only . No significant differences were found for WOMAC stiffness , the SF-36 subscales or the activity scale . The effect sizes ( 95 % confidence interval ) for WOMAC pain were -0.26 ( 0.11 , -0.64 ) , -0.35 ( 0.07 , -0.77 ) , and -0.30 ( 0.15 , -0.75 ) , and for WOMAC physical function -0.29 ( 0.09 , -0.67 ) , -0.48 ( -0.06 , -0.91 ) , and -0.47 ( -0.02 , -0.93 ) at 4 , 10 and 16 months , respectively , in favor of the group receiving both PE and SE . All patients attended the three-session PE program , and 75 % performed ≥16 sessions of the 12-week SE program . CONCLUSION The study could not demonstrate a significant difference in pain reduction over time between PE+SE vs PE alone . Adding SE to PE may improve physical function , but the magnitude of possible benefit is unknown as the 95 % confidence intervals around the mean difference were wide . TRIAL REGISTRATION Clinical Trials NCT00319423 .

patient education

supervised exercise

patient education alone

patient education

supervised exercise

patient education alone

Patient education ( PE )

Patient education

supervised exercise

PE+SE

PE

PE

SE

PE program

Efficacy

management of pain

pain subscale of the Western Ontario

WOMAC pain

WOMAC physical function

WOMAC stiffness

WOMAC pain

WOMAC physical function

hip osteoarthritis

hip osteoarthritis ( OA )

from hospitals

radiographic and symptomatic hip OA


Effect of " developmental speech and language training through music " on speech production in children with autism spectrum disorders . The study compared the effect of music training , speech training and no-training on the verbal production of children with Autism Spectrum Disorders ( ASD ) . Participants were 50 children with ASD , age range 3 to 5 years , who had previously been evaluated on standard tests of language and level of functioning . They were randomly assigned to one of three 3-day conditions . Participants in music training ( n = 18 ) watched a music video containing 6 songs and pictures of the 36 target words ; those in speech training ( n = 18 ) watched a speech video containing 6 stories and pictures , and those in the control condition ( n = 14 ) received no treatment . Participants ' verbal production including semantics , phonology , pragmatics , and prosody was measured by an experimenter designed verbal production evaluation scale . Results showed that participants in both music and speech training significantly increased their pre to posttest verbal production . Results also indicated that both high and low functioning participants improved their speech production after receiving either music or speech training ; however , low functioning participants showed a greater improvement after the music training than the speech training . Children with ASD perceive important linguistic information embedded in music stimuli organized by principles of pattern perception , and produce the functional speech .

no-training

music training

speech training

control condition

no treatment .

music

speech training

music training

speech production

pre to posttest verbal production .

speech production

improvement

children

autism spectrum disorders .

children

Autism Spectrum Disorders ( ASD

children

ASD

age range 3 to 5 years

Children

ASD


Evaluation of the effect of topical agents on radiation-induced skin disease by reflectance spectrophotometry . OBJECTIVES Radiotherapy may cause severe skin changes that significantly interfere with the patient 's quality of life and reduce radiotherapy effectiveness . Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions , but evidence to support the value of the topical treatments of the irradiated skin is lacking . In the present study we investigated the effects of topical agents used as supportive care to minimise radiation-induced skin disease using an instrumental method . METHODS Subjects who were undergoing a planned course of radiation therapy after breast-conserving surgery were randomised to treatment ( using one of two topical agents ) or non-treatment ( control ) groups and monitored over 8 weeks . The intensity of skin erythema was evaluated once per week by non-invasive instrumental reflectance spectrophotometry in comparison with a visual scoring system . KEY FINDINGS Examination of the erythema time course by a sensitive spectrophotometric reflectance method showed a significant increase of skin reactions in the non-treated group after the second week of treatment and maximal alterations between the fourth and sixth week . CONCLUSIONS From the results obtained , we observed that application of topical agents used in radio-induced skin disease were able to significantly reduce the erythema extent compared to the non-treated group .

topical agents

control

radiation-induced skin disease

radiation-induced skin disease

intensity of skin erythema

erythema time course

skin reactions

erythema


Double-blind , placebo-controlled trial of risperidone plus topiramate in children with autistic disorder . BACKGROUND Autism is a complex neurodevelopmental disorder that forms part of a spectrum of related disorders referred to as Autism Spectrum Disorders . The present study assessed the effects of topiramate plus risperidone in the treatment of autistic disorder . METHOD Forty children between the ages of 4 and 12 years with a DSM IV clinical diagnosis of autism who were outpatients from a specialty clinic for children were recruited . The children presented with a chief complaint of severely disruptive symptoms related to autistic disorder . Patients were randomly allocated to topiramate+risperidone ( Group A ) or placebo+risperidone ( Group B ) for an 8-week , double-blind , placebo-controlled study . The dose of risperidone was titrated up to 2 mg/day for children between 10 and 40 kg and 3 mg/day for children weighting above 40 kg . The dose of topiramate was titrated up to 200 mg/day depending on weight ( 100 mg/day for < 30 kg and 200 mg/day for > 30 kg ) . Patients were assessed at baseline and after 2 , 4 , 6 and 8 weeks after starting medication . Measure of outcome was the Aberrant Behavior Checklist-Community ( ABC-C ) Rating Scale . RESULTS Difference between the two protocols was significant as the group that received topiramate had a greater reduction in ABC-C subscale scores for irritability , stereotypic behavior and hyperactivity/noncompliance . CONCLUSION The results suggest that the combination of topiramate with risperidone may be superior to risperidone monotherapy for children with autistic disorder . However the results need to be further confirmed by a larger randomized controlled trial .

risperidone plus topiramate

topiramate plus risperidone

topiramate+risperidone

placebo+risperidone

risperidone

topiramate

topiramate

topiramate

stereotypic behavior

hyperactivity/noncompliance

children

autistic disorder

autistic disorder

Forty

ages of 4 and 12 years

DSM IV clinical diagnosis of autism

severely disruptive symptoms

autistic disorder

children

autistic disorder


Prospective randomized trial of short-term neoadjuvant chemotherapy for advanced gastric cancer . BACKGROUND We performed short-term neoadjuvant chemotherapy ( s-NAC ) to examine whether anticancer drugs can change the proliferative ability of cancer cells in gastric cancer patients . METHODS Chemotherapy was performed for 72 h before gastrectomy in 63 gastric cancer patients . Patients were classed into four groups : Group F , 16 cases who received a single administration of 5-fluorouracil ( 5-FU ) ; Group C , 15 cases who received a single administration of cis-diamminedichloroplatinum ( CDDP ; cisplatin ) ; Group FC , 16 cases who received both 5-FU+CDDP ; and a Control group , 16 cases who did not receive chemotherapy . We reviewed neoadjuvant biopsy tissue and gastric cancer tissue delivered by operation in these cases . The TUNEL method and immunohistochemistry with an anti-MIB-1 antibody were used to evaluate cellular apoptosis and proliferative ability , respectively . The apoptotic index ( AI ) and an MIB-1 index ( MI ) were also calculated . RESULTS There were no differences in AI or MI in biopsy tissue between the groups . The AI of gastric cancer tissue in Group FC was significantly higher than in the other groups ( P < 0.01 ) . The MI of Group FC was significantly lower than in the other groups ( P < 0.05 ) . In addition , after s-NAC operation there was a significant inhibition of proliferative potency and an induction of apoptosis in Group FC . CONCLUSION Combination of CDDP and 5-FU reduced proliferative potency and increased cellular apoptosis in gastric cancer cells .

short-term neoadjuvant chemotherapy

5-fluorouracil ( 5-FU )

not receive chemotherapy

s-NAC

Combination of CDDP and 5-FU

apoptotic index ( AI )

MIB-1 index ( MI )

AI or MI

AI

gastric cancer tissue

MI of Group FC

proliferative potency

apoptosis

proliferative potency

cellular apoptosis

advanced gastric cancer .

gastric cancer

gastric cancer


Niacin revisited . A randomized , controlled trial of wax-matrix sustained-release niacin in hypercholesterolemia . Two hundred one male and female subjects , aged 20 to 70 years , with elevated low-density lipoprotein cholesterol values ( in the 75th to 95th percentiles ) , participated in a randomized , controlled , double-blind study using a new form of niacin ( Enduracin ) , which employs a wax-matrix vehicle for sustained release . Four niacin treatment groups ( daily doses of 2000 , 1500 , 1250 , and 1000 mg ) were compared with placebo- and diet-treated controls to determine side-effect profile and optimal range of efficacy . The groups given 2000 and 1500 mg demonstrated significant reductions in values of low-density lipoprotein cholesterol ( -26 % and -19.3 % , respectively ) , total cholesterol ( -18.4 % and -13.3 % ) , and total cholesterol-high-density lipoprotein cholesterol ratio ( -20.4 % and -19.4 % ) when compared with diet- and placebo-treated controls . Smaller improvements were seen in high-density lipoprotein cholesterol and triglyceride levels . Blood chemistry monitoring indicated that reduction in low-density lipoprotein cholesterol level strongly correlated with an increase in baseline levels of some enzymes for niacin-treated subjects . The improved side-effect profile of the wax-matrix form of niacin was particularly notable . The dropout rate due to side effects was only 3.4 % and was coupled with good medication compliance .

Niacin

wax-matrix sustained-release niacin

niacin ( Enduracin )

niacin

placebo- and diet-treated controls

niacin

hypercholesterolemia .

low-density lipoprotein cholesterol

total cholesterol

dropout rate

side effects

hypercholesterolemia

Two hundred one

20 to 70


Predictors of stable return-to-work in non-acute , non-specific spinal pain : low total prior sick-listing , high self prediction and young age . A two-year prospective cohort study . BACKGROUND Non-specific spinal pain ( NSP ) , comprising back and/or neck pain , is one of the leading disorders in long-term sick-listing . During 2000-2004 , 125 Swedish primary-care patients with non-acute NSP , full-time sick-listed 6 weeks-2 years , were included in a randomized controlled trial to compare a cognitive-behavioural programme with traditional primary care . This prospective cohort study is a re-assessment of the data from the randomized trial with the 2 treatment groups considered as a single cohort . The aim was to investigate which baseline variables predict a stable return-to-work during a 2-year period after baseline : objective variables from function tests , socioeconomic , subjective and/or treatment variables . Stable return-to-work was a return-to-work lasting for at least 1 month from the start of follow-up . METHODS Stable return-to-work was the outcome variable , the above-mentioned factors were the predictive variables in multiple-logistic regression models , one per follow-up at 6 , 12 , 18 and 24 months after baseline . The factors from univariate analyzes with a p-value of at most .10 were included . The non-significant variables were excluded stepwise to yield models comprising only significant factors ( p < .05 ) . As the comparatively few cases made it risky to associate certain predictors with certain time-points , we finally considered the predictors which were represented in at least 3 follow-ups . They are presented with odds ratios ( OR ) and 95 % confidence intervals . RESULTS Three variables qualified , all of them represented in 3 follow-ups : Low total prior sick-listing ( including all diagnoses ) was the strongest predictor in 2 follow-ups , 18 and 24 months , OR 4.8 [ 1.9-12.3 ] and 3.8 [ 1.6-8.7 ] respectively , High self prediction ( the patients ' own belief in return-to-work ) was the strongest at 12 months , OR 5.2 [ 1.5-17.5 ] and Young age ( max 44 years ) the second strongest at 18 months , OR 3.5 [ 1.3-9.1 ] . CONCLUSIONS In primary-care patients with non-acute NSP , the strong predictors of stable return-to-work were 2 socioeconomic variables , Low total prior sick-listing and Young age , and 1 subjective variable , High self-prediction . Objective variables from function tests and treatment variables were non-predictors . Except for Young age , the predictors have previously been insufficiently studied , and so our study should widen knowledge within clinical practice .

stable return-to-work

cognitive-behavioural programme

with traditional primary care .

stable return-to-work

strongest predictor

High self prediction

Young age

Non-specific spinal pain ( NSP )

back and/or neck pain

non-acute NSP

non-acute NSP


Rationale and design of a randomized trial to evaluate an evidence-based prescription drug label on actual medication use . BACKGROUND Medication errors are an important public health concern , and poor understanding of medication labels are a root cause . Research shows that labels are variable , of poor quality , and not patient-centered . No real-world trials have evaluated whether improved medication labels can affect appropriate medication use , adherence or health outcomes . TRIAL DESIGN We developed an evidence-based prescription label that addresses both content and format . The enhanced label includes a universal medication schedule ( UMS ) that standardizes the directions for use incorporating 1 ) standard time periods for administration ( morning , noon , evening , and bedtime ) , 2 ) numeric vs. alpha characters , 3 ) 'carriage returns ' to separate daily dose and 4 ) a graphic aid to visually depict dose and frequency . We will evaluate the effect of providing this label to randomly sampled patients who receive their care from free clinics , mobile vans and federally qualified health centers ( FQHCs ) in Northern Virginia . We will recruit patients with diabetes or hypertension ; these patients will be randomly assigned to receive all of their medications with improved labels or to receive prescriptions with standard labels . The primary outcome will be the patient 's ability to correctly demonstrate dosing instructions . Other outcomes include adherence , error rates and health outcomes . CONCLUSION To our knowledge , this trial is the first to evaluate the effect of prescription label improvement on understanding , medication use and outcomes in a clinical setting . If successful , these findings could be implemented broadly to promote safe and appropriate medication use and to support evidence-based standards in the development of labels .

evidence-based prescription drug label

evidence-based prescription label

enhanced label

label

adherence

error rates

health outcomes

understanding

medication use

patients with diabetes or hypertension


Letter by Begg et al regarding article , " The effects of vitamin d supplementation on physical function and quality of life in older heart failure patients : a randomized controlled trial " .

vitamin d supplementation

physical function

quality of life

older

heart failure patients


Effects of two combined hormonal contraceptives with the same composition and different doses on female sexual function and plasma androgen levels . BACKGROUND This study was conducted to compare the effects of two contraceptive pills with different doses of the same components , on plasma androgen levels and female sexual function among women without previous sexual dysfunction . STUDY DESIGN The participants were randomized into two groups , to receive pills containing ethynylestradiol ( EE ) 30 mcg and levonorgestrel ( LNG ) 150 mcg or EE 20 mcg and LNG 100 mcg , for six cycles . Sexual function was assessed using a standardized questionnaire [ Female Sexual Function Index ( FSFI ) ] . Hormone assays were performed at baseline and after the sixth cycle . RESULTS Forty-nine women were included in the EE30/LNG150 group and 48 in the EE20/LNG100 group . EE30/LNG150 group presented 54 % and 67 % decreases of total testosterone and free androgen index , respectively , with statistical significance . EE20/LNG100 presented reductions of 20 % and 42 % , respectively , but without statistical significance . Both groups showed improvements in the FSFI " desire " score , but with statistical significance only for EE20/LNG100 group . CONCLUSIONS EE30/LNG150 decreased plasma androgen levels , but there was no impairment in sexual desire , on the other hand , sexual desire score increased with EE20/LNG100 formulation .

hormonal contraceptives

contraceptive pills

plasma androgen levels

Sexual function

Hormone assays

FSFI " desire " score

female


Tensile bond strength of a lithium-disilicate pressed glass ceramic to dentin of different surface treatments . The effects of desensitizer , disinfectant , saliva , blood , and hydrogen peroxide on the tensile bond strength between adhesive and ceramic as well as between adhesive and dentin were examined . Sixty 7x3 mm pressed ceramic discs of IPS e.max were fabricated and randomly assigned to six groups of different dentin surface treatments ( control , desensitizer , disinfectant , saliva , blood , and hydrogen peroxide ) . Representative samples of fractured specimens were observed by SEM ( scanning electron microscopy ) . There were significant differences between the control group and saliva , blood , and hydrogen peroxide groups ( p < 0.05 ) . However , there were no significant differences between any other dentin surface treatment groups ( p > 0.05 ) . Results of this study suggested that only saliva , blood , and hydrogen peroxide influenced the tensile bond strength between dentin and ceramic .

dentin surface treatments

control

desensitizer

disinfectant

saliva

blood

hydrogen peroxide

scanning electron microscopy

Tensile bond strength

tensile bond strength

tensile bond strength


A comparison of the effect of short-term aromatase inhibitor ( letrozole ) and GnRH agonist ( triptorelin ) versus case control on pregnancy rate and symptom and sign recurrence after laparoscopic treatment of endometriosis . PURPOSE To compare the role of an aromatase inhibitor ( letrozole ) with a GnRH agonist ( triptorelin ) versus case control on the pregnancy rate and recurrence of symptoms and signs in patients with endometriosis . METHODS In a prospective randomized clinical trial , after treatment of 144 infertile women in their reproductive age by laparoscopy ( whose endometriosis was confirmed by prior laparoscopy ) , they were divided into 3 groups : group 1 ( 47 cases ) who received letrozole for 2 months , group 2 ( 40 patients ) who were prescribed triptorelin for 2 months and group 3 who were 57 patients in the control group and did not receive any medication . We followed up each group at least for 12 months after their restoration of regular cycle . RESULTS Pregnancy rate was 23.4 % in group 1 , 27.5 % in group 2 , and 28.1 % in group 3 . The results did not show significant differences among the 3 groups . Recurrence rate of endometriosis was 6.4 % in group 1 , 5 % group 2 and 5.3 % in group 3 , which was not statistically significantly different as well . CONCLUSION Pregnancy rate and endometriosis recurrence rate are comparable among the 3 groups .

aromatase inhibitor ( letrozole )

GnRH agonist ( triptorelin )

aromatase inhibitor ( letrozole )

GnRH agonist ( triptorelin )

laparoscopy

endometriosis

laparoscopy

letrozole

triptorelin

control

did not receive any medication

pregnancy rate

symptom and sign recurrence

pregnancy rate

recurrence of symptoms and signs

Pregnancy rate

did not show significant differences

Recurrence rate of endometriosis

Pregnancy rate

endometriosis recurrence rate

endometriosis

infertile

women


[ A prospective randomized study of the radiotherapy volume for limited-stage small cell lung cancer : a preliminary report ] . BACKGROUND AND OBJECTIVE Controversies exists with regard to target volumes as far as thoracic radiotherapy ( TRT ) is concerned in the multimodality treatment for limited-stage small cell lung cancer ( LSCLC ) . The aim of this study is to prospectively compare the local control rate , toxicity profiles , and overall survival ( OS ) between patients received different target volumes irradiation after induction chemotherapy . METHODS LSCLC patients received 2 cycles of etoposide and cisplatin ( EP ) induction chemotherapy and were randomly assigned to receive TRT to either the post- or pre-chemotherapy tumor extent ( GTV-T ) as study arm and control arm , CTV-N included the positive nodal drainage area for both arms . One to 2 weeks after induction chemotherapy , 45 Gy/30 Fx/19 d TRT was administered concurrently with the third cycle of EP regimen . After that , additional 3 cycles of EP consolidation were administered . Prophylactic cranial irradiation ( PCI ) was administered to patients with a complete response . RESULTS Thirty-seven and 40 patients were randomly assigned to study arm and control arm . The local recurrence rates were 32.4 % and 28.2 % respectively ( P = 0.80 ) ; the isolated nodal failure ( INF ) rates were 3.0 % and 2.6 % respectively ( P = 0.91 ) ; all INF sites were in the ipsilateral supraclavicular fossa . Medastinal N3 disease was the risk factor for INF ( P = 0.02 , OR = 14.13 , 95 % CI : 1.47-136.13 ) . During radiotherapy , grade I , II weight loss was observed in 29.4 % , 5.9 % and 56.4 % , 7.7 % patients respectively ( P = 0.04 ) . Grade 0-I and II-III late pulmonary injury was developed in 97.1 % , 2.9 % and 86.4 % , 15.4 % patients respectively ( P = 0.07 ) . Median survival time was 22.1 months and 26.9 months respectively . The 1 to 3-year OS were 77.9 % , 44.4 % , 37.3 % and 75.8 % , 56.3 % , 41.7 % respectively ( P = 0.79 ) . CONCLUSIONS The preliminary results of this study indicate that irradiant the post-chemotherapy tumor extent ( GTV-T ) and positive nodal drainage area did not decrease local control and overall survival while radiation toxicity was reduced . But the current sample size has not met designed requirements , and further investigation is warranted before final conclusions could be drawn .

radiotherapy volume

thoracic radiotherapy ( TRT )

induction chemotherapy

TRT

induction chemotherapy

45 Gy/30 Fx/19 d TRT

EP regimen

EP

local recurrence rates

nodal failure ( INF )

Medastinal N3 disease

grade I , II weight loss

Median survival time

1 to 3-year OS

limited-stage small cell lung cancer

LSCLC

LSCLC patients

Thirty-seven


Clinical massage and modified Proprioceptive Neuromuscular Facilitation stretching in males with latent myofascial trigger points . OBJECTIVES To determine the immediate effects of modified Proprioceptive Neuromuscular Facilitation ( PNF ) stretching ( group I ) versus Myofascial Trigger Point ( MTrP ) therapy plus modified PNF stretching ( group II ) in comparison to a control group receiving no treatment . DESIGN Randomized , assessor-blind , ( 3 x 4 ) mixed-model repeated measures . SETTING University laboratory . PARTICIPANTS Thirty physically active males with tight hamstrings and at least one latent MTrP on muscles innervated by the lumbosacral , sciatic , tibial and common peroneal nerves . MAIN OUTCOME MEASURES Knee range of motion ( ROM ) , stretch perception , pressure pain threshold ( PPT ) and subjective pain intensity . Outcomes were evaluated at baseline , immediately after treatment , at 10 and 30 min . RESULTS Significant changes over time occurred for group II in all outcomes ( p < or = 0.001 ) . Group II also showed lower pain intensity scores than group I immediately post-treatment ( p = 0.045 ) and a strong clinical effect over group I in ROM at all follow-ups ( effect sizes = 0.9-1.0 , p < or = 0.05 ) . Other differences were found between both stretching groups as compared to the control group ( p < or = 0.05 ) . CONCLUSION The results indicate immediate pre- to post-treatment benefits from MTrP therapy combined with modified PNF stretching in young and physically active males with latent MTrPs .

Clinical massage

no treatment

MTrP therapy

modified PNF stretching

Knee range of motion ( ROM )

stretch perception

lower pain intensity scores

clinical effect

ROM

males

latent myofascial trigger points

Thirty

physically active

young

physically active

males


Double-blind , placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device . BACKGROUND A proof-of-concept study suggested that combination therapy with commercial azelastine hydrochloride nasal spray and fluticasone propionate nasal spray significantly improved nasal symptoms of seasonal allergic rhinitis compared with either agent alone . OBJECTIVE To compare an azelastine-fluticasone combination nasal spray administered in a single-delivery device with a commercially available azelastine nasal spray and fluticasone nasal spray . METHODS This 14-day , multicenter , randomized , double-blind study was conducted during the Texas mountain cedar season . After a 5-day placebo lead-in , 610 patients with moderate-to-severe nasal symptoms were randomized to treatment with ( 1 ) azelastine nasal spray , ( 2 ) fluticasone nasal spray , ( 3 ) combination azelastine and fluticasone nasal spray , or ( 4 ) placebo nasal spray . All treatments were given as 1 spray per nostril twice daily . The primary efficacy variable was the change from baseline in the total nasal symptom score ( TNSS ) , consisting of nasal congestion , runny nose , itchy nose , and sneezing . RESULTS All 3 active groups were statistically superior ( P < or= .02 ) to placebo , and the combination was statistically superior ( P < or= .003 ) to either agent alone . The TNSS improved by 28.4 % with combination azelastine-fluticasone , 20.4 % with fluticasone , 16.4 % with azelastine , and 11.2 % with placebo . All 3 treatments were well tolerated . CONCLUSIONS The combination azelastine-fluticasone nasal spray provided statistically significant improvement in the TNSS and additive clinical benefit compared with either agent alone in patients with moderate-to-severe seasonal allergic rhinitis . TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00660517 .

azelastine and fluticasone

azelastine hydrochloride

fluticasone propionate

azelastine-fluticasone

placebo

1 spray per nostril twice daily

azelastine-fluticasone

fluticasone

azelastine

placebo .

azelastine-fluticasone

total nasal symptom score ( TNSS )

TNSS

TNSS

allergic rhinitis

610 patients

moderate-to-severe nasal symptoms


Tracheal soiling with blood during intranasal surgery -- comparison of two endotracheal tubes . Sixty adult patients , ASA Classes I & II , were involved in a study to compare the effectiveness of Mallinckrodt Hi-Lo-Evac tube and Portex blue line tube in preventing soiling of the lower airways during intranasal surgery . The Hi-Lo-Evac tube with and without pack was significantly more effective than the Portex tube with pharyngeal pack ( P less than 0.002 ) and ( P less than 0.01 respectively ) . There was no significant difference when the Hi-Lo-Evac tube was used with or without a pack ( P greater than 0.2 ) . The more effective protection of the lower airways by the Hi-Lo-Evac tube is attributed to the facility of subglottic aspiration during surgery . It is suggested that the Hi-Lo-Evac tube could be used with safety during intranasal surgery in order to reduce postoperative morbidity associated with the use of pharyngeal pack .

intranasal surgery

Mallinckrodt Hi-Lo-Evac tube

Portex blue line tube

effective

safety

postoperative morbidity

Sixty

adult


The effectiveness of a calcium sodium phosphosilicate desensitizer in reducing cervical dentin hypersensitivity : a pilot study . BACKGROUND NovaMin ( NovaMin Technology , Alachua , Fla. ) was introduced into the dental market as a desensitizer in December 2004 . However , to the authors ' knowledge , no researchers yet have evaluated the effectiveness of 100 percent NovaMin powder with NovaMin-containing toothpaste in reducing dentin hypersensitivity compared with the effectiveness of NovaMin-containing toothpaste only and a desensitizing toothpaste containing potassium nitrate as a control . METHODS The authors divided 60 participants randomly into three groups : NovaMin powder with NovaMin-containing toothpaste ( group 1 ) , a placebo powder with NovaMin-containing toothpaste ( group 2 ) and a placebo powder with the control toothpaste ( group 3 ) . The authors used tactile and cold stimuli and a visual analog scale to evaluate participants ' pain at baseline , immediately after powder application and at one week , two weeks and four weeks after powder application . They analyzed data by using Friedman and Wilcoxon signed-rank tests for within-group comparison . They used Kruskal-Wallis and Mann-Whitney U tests for between-group comparison . They considered P < .05 to be statistically significant . RESULTS Groups 1 and 2 showed significant hypersensitivity reduction over baseline at all time points . Group 3 showed significant hypersensitivity reduction at one week onward . Group 1 showed significant improvement compared with groups 2 and 3 , except for response to tactile stimulus at four weeks with group 2 . Between groups 2 and 3 , there were significant differences at two and four weeks . CONCLUSIONS and CLINICAL IMPLICATIONS The use of NovaMin powder and NovaMin-containing toothpaste for hypersensitivity reduction is more effective than the use of a desensitizing toothpaste containing potassium nitrate and fluoride .

NovaMin powder

NovaMin-containing toothpaste

placebo powder

NovaMin-containing toothpaste

control toothpaste

effectiveness

tactile and cold stimuli

visual analog scale

Friedman and Wilcoxon signed-rank tests

hypersensitivity reduction

hypersensitivity reduction

tactile stimulus


Anti-angiogenic effect of tamoxifen combined with epirubicin in breast cancer patients . Vascular endothelial growth factor A ( VEGF-A ) and vascular endothelial growth factor receptor 2 ( VEGFR2 ) are the key factors mediating neo-vascularization . They are often coexpressed in breast cancer . Sex steroids may stimulate angiogenesis via the estrogen receptor ( ER ) pathway . We investigated to compare the effects of the addition of tamoxifen to epirubicin versus epirubicin alone on VEGF and VEGFR2 expression in breast cancer patients . The expression of VEGF and VEGFR2 was assessed on tissue microarray by immunohistochemistry at baseline conditions and after treatments in the case of 191 patients with T2-4 N0-1 breast cancer enrolled in a randomized trial comparing four cycles of single agent epirubicin versus epirubicin plus tamoxifen as primary systemic treatment . Epirubicin alone failed to induce changes in VEGF expression ( P = 0.54 ) , while the addition of tamoxifen to epirubicin resulted in a significant reduction in VEGF expression ( P < 0.001 ) . As a consequence , baseline VEGF had a negative prognostic role in patients who received epirubicin alone but not in patients receiving epirubicin plus tamoxifen ( interaction test P < 0.05 ) . VEGFR2 expression increased at residual tumor histology in both treatment arms , with a lesser extent in patients receiving tamoxifen plus epirubicin . Decrease in VEGFR2 expression was significantly associated with response rate ( P = 0.02 ) . The addition of tamoxifen to epirubicin resulted in a suppression of a key angiogenic pathway . These data suggest a potential synergism of these two drugs .

tamoxifen combined with epirubicin

tamoxifen to epirubicin

epirubicin plus tamoxifen

tamoxifen plus epirubicin

addition of tamoxifen to epirubicin

VEGF and VEGFR2

changes in VEGF expression

VEGF expression

baseline VEGF

VEGFR2 expression

VEGFR2 expression

response rate

breast cancer

T2-4 N0-1 breast cancer


Sunlight exposure or vitamin D supplementation for vitamin D-deficient non-western immigrants : a randomized clinical trial . UNLABELLED Vitamin D deficiency is very common in non-western immigrants . In this randomized clinical trial , vitamin D 800 IU/day or 100,000 IU/3 months were compared with advised sunlight exposure . Vitamin D supplementation was more effective than advised sunlight exposure in improving vitamin D status and lowering parathyroid hormone levels . INTRODUCTION Vitamin D deficiency ( 25-hydroxyvitamin D [ 25 ( OH ) D ] < 25 nmol/l ) is common among non-western immigrants . It can be treated with vitamin D supplementation or sunlight exposure . METHODS To determine whether the effect of vitamin D ( 3 ) supplementation ( daily 800 IU or 100,000 IU/3 months ) or sunlight exposure advice is similar with regard to serum 25 ( OH ) D and parathyroid hormone ( PTH ) concentrations . Randomized clinical trial in 11 general practices in The Netherlands . Non-western immigrants , aged 18-65 years ( n = 232 ) and serum 25 ( OH ) D < 25 nmol/l were randomly assigned to supplementation ( daily 800 IU or 100,000 IU/3 months ) or advice for sunlight exposure for 6 months ( March-September ) . Blood samples were collected at baseline , during treatment ( 3 months , 6 months ) , and at follow-up ( 12 months ) . Statistical analysis was performed with multilevel regression modelling . RESULTS The intention-to-treat analysis included 211 persons . Baseline serum 25 ( OH ) D was 22.5 ± 11.1 nmol/l . After 6 months , mean serum 25 ( OH ) D increased to 53 nmol/l with 800 IU/day , to 50.5 nmol/l with 100,000 IU/3 months , and to 29.1 nmol/l with advised sunlight exposure ( supplementation vs sunshine p < 0.001 ) . Serum PTH decreased significantly in all groups after 3 months , more in the supplementation groups than in the advised sunlight group ( p < 0.05 ) . There was no significant effect on physical performance and functional limitations . CONCLUSION Vitamin D supplementation is more effective than advised sunlight exposure for treating vitamin D deficiency in non-western immigrants .

Sunlight exposure

vitamin D supplementation

Vitamin D

vitamin D

advised sunlight exposure

Vitamin D supplementation

advised sunlight exposure

Baseline serum

mean

vitamin D-deficient


Aztreonam versus gentamicin for short-term prophylaxis in biliary and gastric surgery . Short-term antibiotic prophylaxis was studied in 80 patients undergoing biliary or gastric surgery . The patients were randomized to receive 1 g of aztreonam or 80 mg of gentamicin intravenously 30 minutes before surgery and 8 and 16 hours after surgery . Of samples taken from the abdominal cavity for bacteriologic study , 53 % were culture positive . Wound infections developed in two ( 4.5 % ) of 44 patients receiving aztreonam and in seven ( 19.4 % ) of 36 patients treated with gentamicin . Staphylococcus epidermidis and Enterobacter species were isolated from sites of wound infection in the aztreonam group ; Escherichia coli ( two isolates ) , Pseudomonas aeruginosa ( two isolates ) , Enterobacter species , Klebsiella species , Enterococcus faecalis , and Aeromonas hydrophila were isolated from the gentamicin group . Our data indicate that aztreonam is safe and effective for the prevention of infections following biliary and gastric surgery .

Aztreonam

gentamicin

aztreonam

gentamicin

aztreonam

gentamicin

aztreonam

aztreonam

Wound infections

wound infection

safe and effective


Cost-effectiveness of cognitive-behavioral group therapy for dysfunctional fear of progression in cancer patients . Anxiety and fear are often associated with chronic conditions such as cancer . This paper targets the cost-effectiveness analysis of a cognitive-behavioral group therapy ( CBT ) in comparison to a client-centered , supportive-experiential group therapy ( SET ) in cancer patients with dysfunctional fear of progression . An incremental cost-effectiveness analysis was performed using data from a randomized controlled trial among cancer patients receiving inpatient rehabilitation . The means , 95 % confidence intervals [ 95 % CI ] , incremental cost-effectiveness graphic and acceptability curve were obtained from 1,000 bootstrap replications . A total of 174 patients were included in the economic evaluation . The estimated means [ 95 % CI ] of direct costs and reduction of fear of progression were < euro > 9,045.03 [ 6,359.07 ; 12,091.87 ] and 1.41 [ 0.93 ; 1.92 ] for patients in the SET and < euro > 6,682.78 [ 4,998.09 ; 8,440.95 ] and 1.44 [ 1.02 ; 1.09 ] for patients in the CBT . The incremental cost-effectiveness ratio [ 95 % CI ] amounts to minus < euro > 78,741.66 [ -154,987.20 ; 110,486.32 ] for an additional unit of effect . Given the acceptability curve , there is a 92.4 % chance that the CBT , compared with the SET , is cost-effective without the need of additional costs to payers . Our main result is the superior cost-effectiveness of the cognitive-behavioral intervention program in comparison to the non-directive encounter group for our sample of cancer patients with high levels of anxiety .

cognitive-behavioral group therapy

CBT

cognitive-behavioral intervention

Cost-effectiveness

Anxiety

fear

cost-effectiveness analysis

cost-effectiveness analysis

direct costs

reduction of fear of progression

incremental cost-effectiveness ratio

acceptability curve

cost-effective

cost-effectiveness

anxiety


Randomised , parallel-group , multicentre , multinational phase 2 study comparing edoxaban , an oral factor Xa inhibitor , with warfarin for stroke prevention in patients with atrial fibrillation . The primary objective of this study was to compare the safety of four fixed-dose regimens of edoxaban with warfarin in patients with non-valvular atrial fibrillation ( AF ) . In this 12-week , parallel-group , multicentre , multinational study , 1,146 patients with AF and risk of stroke were randomised to edoxaban 30 mg qd , 30 mg bid , 60 mg qd , or 60 mg bid or warfarin dose-adjusted to a target international normalised ratio of 2.0-3.0 . The study was double-blind to edoxaban dose , but open-label to warfarin . Primary outcomes were occurrence of major and/or clinically relevant non-major bleeding and elevated hepatic enzymes and/or bilirubin . Mean age was 65 +/- 8.7 years and 64.4 % were warfarin-naïve . Whereas major plus clinically relevant non-major bleeding occurred in 3.2 % of patients randomised to warfarin , the incidence of bleeding was significantly higher with the edoxaban 60 mg bid ( 10.6 % ; p=0.002 ) and 30 mg bid regimens ( 7.8 % ; p=0.029 ) , but not with the edoxaban 60 mg qd ( 3.8 % ) or 30 mg qd regimens ( 3.0 % ) . For the same total daily dose of 60 mg , both bleeding frequency and trough edoxaban concentrations were higher in the 30-mg bid group than in the 60-mg qd group . There were no significant differences in hepatic enzyme elevations or bilirubin values among the groups . The safety profiles of edoxaban 30 and 60 mg qd in patients with AF were similar to warfarin . In contrast , the edoxaban bid regimens were associated with more bleeding than warfarin . These results suggest that in this three-month study , edoxaban 30 or 60 mg qd are safe and well-tolerated .

edoxaban

warfarin

edoxaban with warfarin

edoxaban

or warfarin

edoxaban

warfarin .

relevant non-major bleeding

the incidence of bleeding

more bleeding

are safe and well-tolerated


Anxiety disorders in typically developing youth : autism spectrum symptoms as a predictor of cognitive-behavioral treatment . Symptoms of autism spectrum disorder ( ASD ) were assessed ( Social Responsiveness Scale-Parent ( SRS-P ) ; coded in-session behavior ) in typically-developing , anxiety-disordered children ( N = 50 ) treated with cognitive-behavioral therapy ( CBT ) . Study 1 : children with moderate autistic symptomology ( per SRS-P ) were significantly more likely to improve from family CBT ( FCBT ) than individual CBT ( ICBT ; OR = 8.67 ) . Coded behavior did not predict outcome . Study 2 : CBT components were compared by treatment and ASD symptom status . At-home exposure completion was greater in FCBT and there was an interaction in child involvement for treatment and ASD status . Though both treatments reduced anxiety , FCBT outperformed ICBT for children with moderate ASD symptoms , a benefit potentially linked to more at-home exposures and greater child involvement in FCBT .

cognitive-behavioral treatment

At-home exposure completion

anxiety


Promoting imitation in young children with autism : a comparison of reciprocal imitation training and video modeling . The inability to imitate is a salient diagnostic marker for autism . It has been suggested that for children with autism , imitation may be a prerequisite skill that can assist in the development of various skills . Using a multiple baseline design across subjects , the purpose of this research was to determine if two interventions , reciprocal imitation training and video modeling were effective in promoting imitation acquisition in young children with autism . Six boys were matched across various features ( i.e. , age , language , autism severity ) and randomly placed in a treatment condition . Results indicated that all six participants increased their imitation skills to varying degrees in both conditions , and imitation maintained and generalized at higher than baseline levels post treatment .

reciprocal imitation training

video modeling

reciprocal imitation training

video modeling

promoting imitation acquisition

imitation skills

young children

autism

autism .

children

Six

boys


Modest visceral fat gain causes endothelial dysfunction in healthy humans . OBJECTIVES The aim of this study was to determine the impact of fat gain and its distribution on endothelial function in lean healthy humans . BACKGROUND Endothelial dysfunction has been identified as an independent predictor of cardiovascular events . Whether fat gain impairs endothelial function is unknown . METHODS A randomized controlled study was conducted to assess the effects of fat gain on endothelial function . Forty-three normal-weight healthy volunteers were recruited ( mean age 29 years ; 18 women ) . Subjects were assigned to gain weight ( approximately 4 kg ) ( n=35 ) or to maintain weight ( n=8 ) . Endothelial function ( brachial artery flow-mediated dilation [ FMD ] ) was measured at baseline , after fat gain ( 8 weeks ) , and after weight loss ( 16 weeks ) for fat gainers and at baseline and follow-up ( 8 weeks ) for weight maintainers . Body composition was measured by dual-energy X-ray absorptiometry and abdominal computed tomographic scans . RESULTS After an average weight gain of 4.1 kg , fat gainers significantly increased their total , visceral , and subcutaneous fat . Blood pressure and overnight polysomnography did not change after fat gain or loss . FMD remained unchanged in weight maintainers . FMD decreased in fat gainers ( 9.1+/-3 % vs. 7.8+/-3.2 % , p=0.003 ) but recovered to baseline when subjects shed the gained weight . There was a significant correlation between the decrease in FMD and the increase in visceral fat gain ( rho=-0.42 , p=0.004 ) , but not with subcutaneous fat gain ( rho=-0.22 , p=0.15 ) . CONCLUSIONS In normal-weight healthy young subjects , modest fat gain results in impaired endothelial function , even in the absence of changes in blood pressure . Endothelial function recovers after weight loss . Increased visceral rather than subcutaneous fat predicts endothelial dysfunction . ( Fat Gain and Cardiovascular Disease Mechanisms ; NCT00589498 ) .

fat gain

fat gain

fat gain

gain weight

maintain weight

fat gain

endothelial function

Endothelial dysfunction

endothelial function

FMD

FMD

FMD

visceral fat gain

subcutaneous fat gain

endothelial function

blood pressure

Endothelial function

fat

endothelial dysfunction


Changes in sleep quality , but not hormones predict time to postpartum depression recurrence . BACKGROUND Poor sleep quality , dysregulation of hormones and increased inflammatory cytokines are all associated with the risk for postpartum major depression ( PPMD ) . We evaluated change over time in sleep quality and hormones during the first 17 weeks postpartum , as well as a single cytokine measure , and their association with PPMD recurrence . METHODS Participants were pregnant women ( N=56 ) , with past histories of MDD/PPMD but not depressed in their current pregnancy . The Pittsburgh Sleep Quality Index ( PSQI ) and blood samples were collected 8 times during the first 17 weeks postpartum . Estradiol , prolactin and cortisol , and a single measure of IL-6 were assayed . Recurrence was determined by two consecutive 21-item Hamilton Rating Scale for Depression ( HRSD ) scores≥15 and clinician interview . RESULTS In the analyses of time to PPMD recurrence , poor sleep quality , but none of the hormones , was associated with PPMD recurrence ( p < .05 ) after controlling for medication assignment . With every one point increase in PSQI scores across time , a woman 's risk for recurrence increased by approximately 25 % There was no significant association between PSQI scores and IL-6 concentrations in early postpartum ( χ ( 2 ) =0.98 , p=.32 ) . CONCLUSIONS Poor sleep quality across the first 17 weeks post-delivery increases the risk for recurrent PPMD among women with a history of MDD . Changes in the hormonal milieu were not associated with recurrence . Further exploration of the degree to which poor sleep contributes to hormonal and cytokine dysregulation and how they are involved in the pathophysiology of PPMD is warranted .

Pittsburgh Sleep Quality Index ( PSQI )

blood samples

sleep quality

hormones

Pittsburgh Sleep Quality Index

pregnant

women

( N=56 )

women

MDD


Glycerol lidocaine eardrops for the treatment of acute abacterial otitis externa . Inflammations of the external auditory canal number among the most frequently occurring ear-nose-throat diseases . For local treatment , substances from various groups of active ingredients are used as combinations and as single-agent drugs , e.g . antibiotics , glucocorticoids or analgesics [ 1 ] . In the case of acute otitis externa , treatment measures focus on the reduction of pain and swelling . The study described here investigates the efficacy and safety of glycerol lidocaine eardrops for the treatment of acute abacterial otitis externa ( CAS No . for glycerol : 56-81-5 , lidocaine-HCl : 73-78-9 ) . In this double-blind , three-arm study , 105 patients diagnosed with acute abacterial otitis externa were included and randomized to receive either glycerol eardrops , glycerol eardrops with 0.5 % lidocaine , or glycerol eardrops with 2 % lidocaine for seven days . The primary outcome parameter was the change of the five typical clinical symptoms , earache , itching , otorrhea , hearing impairment , and " clogged ear " at Visit 2 ( Day 7 ) based on the initial examination on Day 0 . Both therapy groups treated with a combination of glycerol and lidocaine exhibited definite improvement in overall symptoms after seven days . This improvement differed from the mild reduction of symptoms under treatment with glycerol eardrops alone . Overall improvement of symptoms , expressed by the area under the curve of the baseline-adjusted symptom sum score , yielded a mean value of 10.95 ( standard deviation 27.4 ) for the morning survey of the groups receiving eardrops containing only glycerol ; in comparison , for eardrops containing glycerol and 2 % lidocaine it was 15.71 ( +/- 23.6 ) and for glycerol with 0.5 % lidocaine , 23.16 ( +/- 19.4 ) . No severe adverse events occurred . Five adverse events were documented during the clinical investigation , none of which was considered by the investigators to be related to the study medication . Local therapy with glycerol lidocaine eardrops is a safe , and cost-effective treatment for the widely spread clinical picture of acute abacterial otitis externa . The advantage regarding efficacy of this combination compared with glycerol eardrops must be demonstrated in an adequately powered clinical trial .

Glycerol lidocaine eardrops

antibiotics

glucocorticoids

analgesics

glycerol lidocaine eardrops

glycerol

lidocaine-HCl

glycerol eardrops

glycerol eardrops with 0.5 % lidocaine

glycerol eardrops with 2 % lidocaine

glycerol

lidocaine

glycerol

lidocaine

lidocaine

glycerol

acute abacterial otitis externa

reduction of pain

swelling

acute abacterial otitis externa

earache

itching

otorrhea

hearing impairment

clogged ear

overall symptoms

mild reduction of symptoms

baseline-adjusted symptom sum score

No severe adverse events

adverse events

safe

cost-effective

acute abacterial otitis externa

acute abacterial otitis externa


A randomized study comparing the use of the Ligaclip with bipolar energy to prevent lymphocele during laparoscopic pelvic lymphadenectomy for gynecologic cancer . OBJECTIVE This prospective randomized pilot study compared the use of the Ligaclip ( Ethicon Endo-Surgery , Cincinnati , OH ) with bipolar coagulation in preventing lymphoceles after laparoscopic pelvic lymphadenectomy for gynecologic cancer . STUDY DESIGN Thirty patients with gynecologic malignancy , who had laparoscopic pelvic lymphadenectomy were randomly assigned for lymphadenectomy in 1 side of the pelvis using the Ligaclip , whereas , in the other side , the bipolar coagulation to seal lymphatic vessels was used . RESULTS At ultrasound examination , we detected lymphocele in 10 patients ( 33 % ) . Lymphocele developed in 9 ( 30 % ) patients on the side where laparoscopic pelvic lymphadenectomy was perfomed using bipolar coagulation , and in 1 ( 3.3 % ) patient on the side where laparoscopic pelvic lymphadenectomy was performed using the Ligaclip . Univariate analysis revealed that the Ligaclip 's use compared with electrocoagulation in the laparoscopic pelvic lymphadenectomy is an independent predictive factor for development of lymphocele ( P = .006 ) . CONCLUSION This study demonstrates that the use of the Ligaclip to close lymphatic vessels may reduce the incidence of lymphoceles in patients undergoing laparoscopic pelvic lymphadenectomy .

Ligaclip

lymphadenectomy

Ligaclip

lymphocele

Lymphocele

development of lymphocele

incidence of lymphoceles


[ Study on safety and immunogenicity of oral poliomyelitis attenuated live vaccine ( human diploid cell ) ] . OBJECTIVE To evaluate the safety and Immunogenicity of the Poliomyelitis vaccine ( Human Diploid Cell ) in > or =2 month-old children . METHODS A random , blind and control trial , 1200 healthy children of 2-5 months old in Jiangsu province were administered OPV ( HDC ) vaccine and control vaccines . The antibody was tested by neutralization test . RESULTS After 3 doses of the OPV ( HDC ) vaccine , the systemic reactions were mild . After 1 month of vaccination with 3 doses of the OPV ( HDC ) vaccine , the immune success rates of I , II , III type were 98.28 % , 99.45 % , and 95.71 % respectively , the GMTs of I , II , III type in susceptible children were 1:1243.72 , 1:234.38 and 1:273.10 respectively . CONCLUSIONS The OPV ( HDC ) vaccine was safe and immunogenicity for the children > or =2 months old .

Poliomyelitis vaccine

OPV ( HDC ) vaccine

control vaccines

OPV ( HDC ) vaccine

OPV ( HDC ) vaccine

OPV ( HDC ) vaccine

safety

Immunogenicity

systemic reactions

GMTs of I , II , III type

=2 month-old

children

2-5 months old

OPV ( HDC ) vaccine


[ Effect analysis on non-and-low response infants after revaccinated hepatitis B vaccine ] . OBJECTIVE To evaluate the booster immunization effect to non-and-low response children after 3 doses HepB immunization . METHODS Non-and-low response infants born in 2004 2005 administered 3 doses of HepB at 0 , 1 , 6 months in Guangzhou , Beijing and Zhejiang were divided into 4 groups randomly , and boosted 3 dose of 4 different types of HepB at 0 , 1 , 6 months . RESULTS The GMC of non-and-low response children in group A ( before booster ) , group B ( after 1 dose booster ) and group C ( after 3 dose booster ) were 18.66 mIUml , 88.82 mIU/ml , 178.24 mIU/ml respectively ; the proportion of non-responders in three groups were 20.4 % , 9.1 % , 1.9 % respectively . In 103 non-and-low response children , proportion of titers of more than 100 mIU/ml of group B and group C were 61.2 % and 84.5 % , and there was statistical significant difference ( chi2 = 14.13 , P < 0.01 ) . The GMC after 3 doses revaccination with four kinds of HepB , included 5 microg HepB-Y , 10 microg HepB-Y , l0 microg HepB-CHO , 10 microg HepB-HY were 168.8 mJU/ml , 174.7 mIU/ml , 184.9 mIU/ml , 182.9 mIU/ml respectively . Proportion of titers of more than 100 mIU/ml for four kinds HepB were 79.0 % , 85.7 % , 88.2 % and 84.6 % respectively , and there was no significant difference ( chi2 = 0.75 , 0.05 ) . CONCLUSION There were no different of seroconversion rate between study population received 1 dose and 3 dose booster ( P > 0.05 ) , but high titer was observed after 3 dose booster . The four kinds of HepB , including 5 microg HepB-Y,10 microg HepB-Y , 10 microg HepB-CHO , 10 microg HepB-HY had the same immunization effect after 3 doses revaccination at 0 , 1 , 6 months to non-and-low response children .

hepatitis B vaccine

3 doses of HepB

HepB

revaccination

HepB-Y

HepB-Y

HepB-CHO

HepB-HY

[ Effect analysis

booster immunization effect

proportion of titers

Proportion of titers

seroconversion rate

infants

hepatitis B

infants

2004 2005

children


Reversal of skeletal effects of endocrine treatments in the Intergroup Exemestane Study . The adjuvant use of aromatase inhibitors in breast cancer is associated with adverse effects on bone health . We previously reported a decline in bone mineral density ( BMD ) following the switch from tamoxifen to exemestane in the Intergroup Exemestane Study ( IES ) . Here we report effects of endocrine treatment withdrawal on BMD , bone turnover markers ( BTM ) and fracture rates . 4,724 patients took part in IES , and 206 patients were included in a bone sub-study . BMD and BTM were assessed pre-randomization , during and after the end of treatment ( EOT ) . To evaluate treatment withdrawal effects , 12- and 24-month post EOT BMD results are available for 122 and 126 patients , respectively . Similar patient numbers had BTM measured post EOT . Following treatment withdrawal , the differences in BMD observed between the two endocrine strategies were partially reversed . At 24 months from EOT , spine BMD increased by 1.53 % ( 95 % CI 0.63-2.43 ; p = 0.001 ) after stopping exemestane and fell by 1.93 % ( 95 % CI -2.91 to 0.95 ; p = 0.0002 ) following tamoxifen withdrawal . A similar pattern of changes was observed at the hip . At 2 years post EOT , BMD changes from baseline were similar with both treatment strategies . Corresponding inverse changes in BTM were seen , with an increase following tamoxifen withdrawal and a reduction after exemestane . A higher number of fractures occurred during exemestane treatment , but fracture rates were similar after treatment withdrawal . With the switch strategy used in IES , the on treatment adverse bone effects of exemestane are reversed . Ongoing monitoring of BMD is therefore not routinely required .

aromatase inhibitors

tamoxifen

exemestane

endocrine treatment

tamoxifen

exemestane

exemestane

effects

spine BMD

BMD changes

inverse changes in BTM

number of fractures occurred

fracture rates

adverse bone effects


Alinidine in chronic stable angina : the effect on diastolic perfusion time . The present study has been performed to assess the effects of alinidine on diastolic duration during exercise in chronic coronary artery disease . Twelve male patients with stable effort angina and without previous myocardial infarction were studied . They received alinidine or placebo in a double-blind randomized crossover trial for 3 days after a wash-out period of 4 days . Alinidine was administered at a dosage of 30 mg 3 times a day . At the end of each treatment the patients underwent upright bicycle exercise . Left ventricular time intervals were obtained by means of carotid thermistor plethysmography . Diastolic duration was calculated by subtracting the electromechanical systole from the R-R interval and expressed as a percentage of the cardiac cycle ( % D ) . Alinidine increased both total exercise duration from 246.7 +/- 120.7 to 346.6 +/- 114.1 s ( p less than 0.05 ) and time to 0.1-mV ST segment depression from 98.3 +/- 53 to 187.2 +/- 105 s ( p less than 0.05 ) . Similarly the drug induced a reduction of the rate-pressure product and of the extent of ischemic ST segment depression during exercise . % D was increased by alinidine both at rest and during exercise . A direct linear regression between R-R and % D was found after both alinidine and placebo treatments either at rest or during exercise . Nevertheless , no difference was observed between both slopes and intercepts . Therefore , since the relationship between R-R interval and % D was unaffected by alinidine , it was possible to hypothesize that the changes in diastolic duration were due only to the bradycardic action of the drug .

Alinidine

alinidine

alinidine

placebo

Alinidine

upright bicycle exercise

Alinidine

alinidine

placebo

alinidine

diastolic perfusion time .

ventricular

obtained

Diastolic duration

linear regression

diastolic duration

chronic stable angina

chronic coronary artery disease

Twelve

male

stable effort angina

myocardial infarction


[ Therapy with alpha-interferon in non-Hodgkin 's lymphoma with a low grade of malignancy ( correct title supplied from Table of Contents ) ] .

alpha-interferon


The effect of perindopril and hydrochlorothiazide alone and in combination on blood pressure and on the renin-angiotensin system in hypertensive subjects . The pharmacodynamic effects and acceptability of perindopril ( 4 mg daily ) and hydrochlorothiazide ( 25 mg daily ) given alone or in combination for 1 month were investigated in a double-blind , placebo controlled , parallel group study . The pharmacokinetics of perindopril and its active metabolite perindoprilat and the time course of angiotensin converting enzyme inhibition were studied for 72 h following the last dose of treatment in the two appropriate groups . Similar decreases in blood pressure were seen 24 h after the last dose of perindopril or hydrochlorothiazide ( 11/7 mm Hg supine ) given alone at these doses . The effect of these drugs given together was additive on diastolic blood pressure and synergistic on systolic blood pressure ( 24.5/12.6 mm Hg supine ) taking into account the placebo response . The significant increase in plasma renin activity produced by perindopril alone was potentiated by concurrent administration of hydrochlorothiazide . The formation of perindoprilat was slightly reduced in the group also receiving hydrochlorothiazide and there was a very small reduction in ACE inhibition in this group . Perindopril , whether given alone or in combination with hydrochlorothiazide , was well tolerated and produced no clinically significant change in routine haematology or serum biochemistry . The additive or synergistic effects of perindopril and hydrochlorothiazide on blood pressure must be due to their complementary physiological actions and not to a pharmacokinetic interaction .

perindopril

hydrochlorothiazide

perindopril

hydrochlorothiazide

placebo

perindopril

perindopril

hydrochlorothiazide

perindopril

hydrochlorothiazide

perindoprilat

hydrochlorothiazide

Perindopril

hydrochlorothiazide

perindopril

hydrochlorothiazide

effect

pharmacodynamic effects

pharmacokinetics

blood pressure

diastolic blood pressure

systolic blood pressure

plasma renin activity

perindoprilat

ACE inhibition

well tolerated

hypertensive

two


Effect of thermal stress , restricted feeding and combined stresses ( thermal stress and restricted feeding ) on growth and plasma reproductive hormone levels of Malpura ewes under semi-arid tropical environment . A study was conducted to assess the effect of thermal , nutritional and combined stresses ( thermal and nutritional ) on the growth , oestradiol and progesterone levels during oestrus cycles in Malpura ewes . Twenty-eight adult Malpura ewes were used in the present study . The ewes were randomly allocated into four groups , viz. , GI ( n=7 ; control ) , GII ( n=7 ; thermal stress ) , GIII ( n=7 ; restricted feeding ) and GIV ( n=7 ; combined stress ) . The animals were stall fed with a diet consisting of 60 % roughage and 40 % concentrate . GI and GII ewes were provided with ad libitum feeding while GIII and GIV ewes were provided with restricted feed ( 30 % intake of GI and GII ewes ) to induce nutritional insufficiency . GII and GIV ewes were kept in climatic chamber at 40°C and 55 % RH for 6 h a day between 10:00 and 16:00 hours to induce thermal stress for a period of two oestrous cycles . Parameters studied were body weight , oestrus incidences , plasma oestradiol 17-β , plasma progesterone , conception rate , gestation period , lambing rate , and birth weight of lambs . The results indicate that combined stress significantly ( p < 0.05 ) reduced body weight , oestrus duration , birth weight of lambs , and oestradiol 17-β whereas significantly ( p < 0.05 ) increased oestrus cycle length and progesterone . Furthermore , the results reveal that on comparative basis , ewes were able to better adapt in terms of growth and reproduction to restricted feeding than thermal stress . However , when restricted feeding was coupled with thermal stress it had significant ( p < 0.05 ) influence on body weight , average daily gain , oestradiol 17-β and progesterone concentrations . This showed that combined stress were more detrimental for these reproductive hormones in Malpura ewes under a hot semi-arid environment .

restricted feeding

control )

thermal stress )

restricted feeding )

combined stress )

Twenty-eight

adult


Randomized controlled trial of electro-acupuncture for autism spectrum disorder . OBJECTIVE To study the efficacy , safety , and compliance of short-term electro-acupuncture for children with autism spectrum disorder ( ASD ) . DESIGN Randomized , double-blind , sham-controlled , clinical trial . SUBJECTS AND METHODS Children with ASD were randomly assigned to an electro-acupuncture ( EA ) group ( n=30 ) or a sham electro-acupuncture ( SEA ) group ( n=25 ) matched by age and severity of autism . The EA group received electro-acupuncture for selected acupoints while the SEA group received sham electro-acupuncture to sham acupoints . A total of 12 EA and SEA sessions over four weeks were given . Primary outcome measures included Functional Independence Measure for Children ( WeeFIM ) , Pediatric Evaluation of Disability Inventory ( PEDI ) , Leiter International Performance Scale-Revised ( Leiter-R ) , and Clinical Global Impression-Improvement ( CGI-I ) scale . Secondary outcome measures consisted of Aberrant Behavior Checklist ( ABC ) , Ritvo-Freeman Real Life Scale ( RFRLS ) , Reynell Developmental Language Scale ( RDLS ) , and a standardized parental report . Data were analyzed by the Mann-Whitney test . RESULTS There were significant improvements in the language comprehension domain of WeeFIM ( p=0.02 ) , self-care caregiver assistant domain of PEDI ( p=0.028 ) , and CGI-I ( p=0.003 ) in the EA group compared to the SEA group . As for the parental report , the EA group also showed significantly better social initiation ( p=0.01 ) , receptive language ( p=0.006 ) , motor skills ( p=0.034 ) , coordination ( p=0.07 ) , and attention span ( p=0.003 ) . More than 70 percent of children with ASD adapted to acupuncture easily , while eight percent had poor acupuncture compliance . Mild side effects of minor superficial bleeding or irritability during acupuncture were observed . CONCLUSION A short , four-week ( 12 sessions ) course of electro-acupuncture is useful to improve specific functions in children with ASD , especially for language comprehension and self-care ability .

electro-acupuncture

electro-acupuncture

electro-acupuncture ( EA )

sham electro-acupuncture

Primary outcome measures

Aberrant Behavior Checklist ( ABC )

Ritvo-Freeman Real Life Scale ( RFRLS )

standardized parental report

CGI-I

better

social initiation

( p=0.01 )

receptive language

( p=0.006 )

motor skills ( p=0.034 ) ,

coordination

( p=0.07 )

attention span

adapted to acupuncture easily

poor acupuncture compliance

irritability during acupuncture

autism spectrum disorder .

children

autism spectrum disorder ( ASD )

Children

ASD

age

autism

children

children

ASD


Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia . OBJECTIVE To assess the efficacy of moderate aerobic physical activity with sleep hygiene education to improve sleep , mood and quality of life in older adults with chronic insomnia . METHODS Seventeen sedentary adults aged > or=55 years with insomnia ( mean age 61.6 [ SD±4.3 ] years ; 16 female ) participated in a randomized controlled trial comparing 16 weeks of aerobic physical activity plus sleep hygiene to non-physical activity plus sleep hygiene . Eligibility included primary insomnia for at least 3 months , habitual sleep duration < 6.5h and a Pittsburgh Sleep Quality Index ( PSQI ) score > 5 . Outcomes included sleep quality , mood and quality of life questionnaires ( PSQI , Epworth Sleepiness Scale [ ESS ] , Short-form 36 [ SF-36 ] , Center for Epidemiological Studies Depression Scale [ CES-D ] ) . RESULTS The physical activity group improved in sleep quality on the global PSQI ( p < .0001 ) , sleep latency ( p=.049 ) , sleep duration ( p=.04 ) , daytime dysfunction ( p=.027 ) , and sleep efficiency ( p=.036 ) PSQI sub-scores compared to the control group . The physical activity group also had reductions in depressive symptoms ( p=.044 ) , daytime sleepiness ( p=.02 ) and improvements in vitality ( p=.017 ) compared to baseline scores . CONCLUSION Aerobic physical activity with sleep hygiene education is an effective treatment approach to improve sleep quality , mood and quality of life in older adults with chronic insomnia .

Aerobic exercise

moderate aerobic physical activity

self-reported sleep

quality of life

efficacy

improve sleep , mood

quality of life

older adults

insomnia

Seventeen

adults

> or=55 years

insomnia

61.6 [ SD±4.3 ] years

female

older adults

chronic insomnia


Comparison of three-year clinical outcomes between sirolimus-versus paclitaxel-eluting stents in diabetic patients : prospective randomized multicenter trial . BACKGROUND Three-year follow-up of major adverse cardiovascular event ( MACE ) ( death , nonfatal myocardial infarction , target lesion revascularization ) and the predictors of MACEs in diabetic patients after sirolimus-eluting stent ( SES ) or paclitaxel-eluting stent ( PES ) implantation have not been reported . METHODS Diabetic patients with de novo coronary lesions ( 169 patients with 190 lesions ) were randomly assigned prospectively to either SES or PES . RESULTS Baseline characteristics were similar between the two groups . The rates of MACEs [ 5.9 % ( n = 5 ) in the SES vs. 9.5 % ( n = 8 ) in the PES Group , P = 0.374 ] and definite stent thrombosis [ 1.2 % ( n = 1 ) in the SES vs. 3.6 % ( n = 3 ) in the PES Group , P = 0.368 ] were similar in the two groups during the three-year follow-up . Multivariate logistic analysis showed that insulin treatment was the only independent predictor of MACE [ odds ratio ( OR ) 8.60 , 95 % confidence interval ( CI ) 3.25-22.76 , P < 0.001 ] and target vessel revascularization ( TVR ) ( OR 9.50 , 95 % CI 3.07-29.44 , P < 0.001 ) during the three-year follow-up . CONCLUSIONS The rates of MACEs , TVR , and stent thrombosis during the three-year follow-up were similar in the SES and PES Groups . Insulin treatment was a main predictor of MACEs and TVR during the three-year follow-up after either SES or PES implantation .

sirolimus-eluting stent ( SES )

SES

PES

SES

PES

SES

PES

SES

PES

SES

PES

predictors of MACEs

rates of MACEs

definite stent thrombosis

MACE

target vessel revascularization ( TVR )

rates of MACEs

TVR

stent thrombosis

MACEs

TVR

in diabetic patients

Diabetic

( 169 patients


Oral sucrose as an analgesic drug for procedural pain in newborn infants : a randomised controlled trial . BACKGROUND Many infants admitted to hospital undergo repeated invasive procedures . Oral sucrose is frequently given to relieve procedural pain in neonates on the basis of its effect on behavioural and physiological pain scores . We assessed whether sucrose administration reduces pain-specific brain and spinal cord activity after an acute noxious procedure in newborn infants . METHODS In this double-blind , randomised controlled trial , 59 newborn infants at University College Hospital ( London , UK ) were randomly assigned to receive 0·5 mL 24 % sucrose solution or 0·5 mL sterile water 2 min before undergoing a clinically required heel lance . Randomisation was by a computer-generated randomisation code , and researchers , clinicians , participants , and parents were masked to the identity of the solutions . The primary outcome was pain-specific brain activity evoked by one time-locked heel lance , recorded with electroencephalography and identified by principal component analysis . Secondary measures were baseline behavioural and physiological measures , observational pain scores ( PIPP ) , and spinal nociceptive reflex withdrawal activity . Data were analysed per protocol . This study is registered , number ISRCTN78390996 . FINDINGS 29 infants were assigned to receive sucrose and 30 to sterilised water ; 20 and 24 infants , respectively , were included in the analysis of the primary outcome measure . Nociceptive brain activity after the noxious heel lance did not differ significantly between infants who received sucrose and those who received sterile water ( sucrose : mean 0·10 , 95 % CI 0·04-0·16 ; sterile water : mean 0·08 , 0·04-0·12 ; p=0·46 ) . No significant difference was recorded between the sucrose and sterile water groups in the magnitude or latency of the spinal nociceptive reflex withdrawal recorded from the biceps femoris of the stimulated leg . The PIPP score was significantly lower in infants given sucrose than in those given sterile water ( mean 5·8 , 95 % CI 3·7-7·8 vs 8·5 , 7·3-9·8 ; p=0·02 ) and significantly more infants had no change in facial expression after sucrose administration ( seven of 20 [ 35 % ] vs none of 24 ; p < 0·0001 ) . INTERPRETATION Our data suggest that oral sucrose does not significantly affect activity in neonatal brain or spinal cord nociceptive circuits , and therefore might not be an effective analgesic drug . The ability of sucrose to reduce clinical observational scores after noxious events in newborn infants should not be interpreted as pain relief . FUNDING Medical Research Council .

Oral sucrose

Oral sucrose

sucrose

observational pain scores ( PIPP )

PIPP

newborn infants

infants

neonates

acute noxious

newborn

infants

newborn

infants


A cluster randomised trial to evaluate a physical activity intervention among 3-5 year old children attending long day care services : study protocol . BACKGROUND Young children are not participating in recommended levels of physical activity and exhibit high levels of sedentary behaviour . Childcare services provide access to large numbers of young children for prolonged periods , yet there is limited experimental evidence regarding the effectiveness of physical activity interventions implemented in this setting . The aim of this study is to assess the effectiveness and acceptability of a multi-component physical activity intervention , delivered by childcare service staff , in increasing the physical activity levels of children attending long day care services . METHODS/DESIGN The study will employ a cluster randomised controlled trial design . Three hundred children aged between 3-5 years from twenty randomly selected long day care services in the Hunter Region of New South Wales , Australia will be invited to participate in the trial . Ten of the 20 long day care services will be randomly allocated to deliver the intervention with the remaining ten services allocated to a wait list control group . The physical activity intervention will consist of a number of strategies including : delivering structured fundamental movement skill activities , increasing physical activity opportunities , increasing staff role modelling , providing children with a physical activity promoting indoor and outdoor environment and limiting children 's small screen recreation and sedentary behaviours . Intervention effectiveness will be measured via child physical activity levels during attendance at long day care . The study also seeks to determine the acceptability and extent of implementation of the intervention by services and their staff participating in the study . DISCUSSION The trial will address current gaps in the research evidence base and contribute to the design and delivery of future interventions promoting physical activity for young children in long day care settings . TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12610000087055 .

physical activity intervention

physical activity intervention

wait list control

child physical activity levels

during attendance at long day care

Young children


A randomized trial of genetic and environmental risk assessment ( GERA ) for colorectal cancer risk in primary care : trial design and baseline findings . PURPOSE This paper describes an ongoing randomized controlled trial designed to assess the impact of genetic and environmental risk assessment ( GERA ) on colorectal cancer ( CRC ) screening . METHODS The trial includes asymptomatic patients who are 50-79years and are not up-to-date with CRC screening guidelines . Patients who responded to a baseline telephone survey are randomized to a GERA or Control group . GERA group participants meet with a nurse , decide whether to have a GERA blood test ( a combination of genetic polymorphism and folate ) , and , if tested , receive GERA feedback . Follow-up telephone surveys are conducted at 1 and 6months . A chart audit is performed at 6months . RESULTS Of 2,223 eligible patients , 562 ( 25 % ) have enrolled . Patients who enrolled in the study were significantly younger than those who did not ( p < 0.001 ) . Participants tended to be 50-59years ( 64 % ) , female ( 58 % ) , white ( 52 % ) , married ( 51 % ) , and have more than a high school education ( 67 % ) . At baseline , most participants had some knowledge of CRC screening and GERA , viewed CRC screening favorably , and reported that they had decided to do screening . Almost half had worries and concerns about CRC . CONCLUSIONS One in four eligible primary care patients enrolled in the study . Age was negatively associated with enrollment . Prospective analyses using data for all participants will provide more definitive information on GERA uptake and the impact of GERA feedback .

GERA or

Control group

blood test

polymorphism

folate

GERA

impact

telephone survey

telephone surveys

chart audit

knowledge of CRC screening

worries and concerns

colorectal cancer ( CRC )

asymptomatic patients

GERA or Control group

female

( 58 % )