Split-face comparison of the erbium micropeel with intense pulsed light . BACKGROUND A variety of photorejuvenative techniques have been utilized to reverse the signs of cutaneous photoaging , including ablative and nonablative laser resurfacing as well as light-based devices . OBJECTIVE The purpose of this split-face randomized prospective open-label trial was to determine the effectiveness of sequential erbium : yttrium-aluminum-garnet ( Er : YAG ) laser versus intense pulsed light ( IPL ) for the treatment of mild to moderate facial photodamage . MATERIALS AND METHODS Ten subjects ( ages 35-63 ) with facial dyschromia and rhytides were enrolled . Study patients were randomized to the two treatment arms , Er : YAG ( 3.8 J/cm ( 2 ) , 30 % pattern overlap , 0 % interpulse overlap , 15 microm per pass with no coagulation ) and IPL ( 560-nm filter , 30 J/cm ( 2 ) , 2.4/4.0-ms pulse with 10-ms delay ) , each receiving three sequential treatments spaced 1 month apart . Subjective and blinded physician evaluations were performed at baseline and 4 , 8 , and 20 weeks posttreatment using a nominal scale from 1 to 4 . Erythema and adverse events were assessed 1 week following each treatment . RESULTS Ten female subjects with mild to moderate facial photodamage were treated with one pass of either IPL or Er : YAG in a split-face fashion . Patients received three treatments each spaced 1 month apart . Nine of 10 patients completed the trial ; 1 withdrew due to pain during the second Er : YAG treatment . Baseline subjective and blinded physician dyschromia and rhytid scores revealed no significant difference between the IPL and Er : YAG randomly assigned sides . Up to three IPL or Er : YAG treatments did not result in a significant improvement in rhytid scores . Subjective and blinded physician dyschromia scores improved 26 and 38 % , respectively , 3 months after the final IPL treatment , but only by 7 and 29 % , respectively , with Er : YAG . Subjective global facial appearance scores worsened by 5 % while blinded physician scores improved by 16 % 3 months after 3 Er : YAG treatments , but by 28 and 20 % for IPL , respectively . The overall incidence of adverse events and subsequent downtime was increased for Er : YAG ( 1/10 patients experienced hyperpigmentation , 3/10 exfoliation , 1/10 blistering , and 5/10 discomfort ) compared to IPL ( 1/10 exfoliation and 1/10 discomfort ) , although no permanent side effects were observed with either treatment arm . CONCLUSIONS While low-fluence erbium resurfacing has a modest effect on facial photodamage , patients preferred IPL because it resulted in less downtime . The authors have indicated no significant interest with commercial supporters .

Er : YAG

pattern overlap

interpulse overlap

IPL

pain

overall incidence of adverse events

subsequent downtime

hyperpigmentation

exfoliation

blistering

discomfort

mild to moderate facial photodamage

Ten subjects

( ages 35-63 )

facial dyschromia and rhytides

Ten

female

mild to moderate facial photodamage

Nine of 10 patients completed the trial


Bevacizumab-augmented retinal laser photocoagulation in proliferative diabetic retinopathy : a randomized double-masked clinical trial . PURPOSE To evaluate the additional therapeutic effect of single intravitreal bevacizumab injection on standard laser treatment in the management of proliferative diabetic retinopathy . METHODS A prospective , fellow-eye sham controlled clinical trial was conducted on 80 eyes of 40 high-risk characteristic proliferative diabetic retinopathy type II diabetics . All cases received standard laser treatment according to Early Treatment Diabetic Retinopathy Study protocol . Avastin-assigned eyes received 1.25 mg intravitreal bevacizumab ( Genentech Inc. , San Francisco , CA ) on the first session of their laser treatments . Fluorescein angiography was performed at baseline and at weeks 6 and 16 , and proliferative diabetic retinopathy regression was evaluated in a masked fashion . RESULTS The median age was 52 years ( range : 39-68 ) and 30 % of the participants were male . All patients were followed for 16 weeks . A total of 87.5 % of Avastin-injected eyes and 25 % of sham group showed complete regression at week 6 of follow-up ( p < 0.005 ) . However , at week 16 , PDR recurred in a sizable number of the Avastin-treated eyes , and the complete regression rate in the two groups became identical ( 25 % ; p=1.000 ) ; partial regression rates were 70 % vs 65 % . In the subgroup of Avastin-treated eyes , multivariate analysis identified hemoglobin A1c as the strongest predictor of proliferative diabetic retinopathy recurrence ( p=0.033 ) . CONCLUSIONS Intravitreal bevacizumab remarkably augmented the short-term response to scatter panretinal laser photocoagulation in high-risk characteristic proliferative diabetic retinopathy but the effect was short-lived , as many of the eyes showed rapid recurrence . Alternative dosing ( multiple and/or periodic intravitreal Avastin injections ) is recommended for further evaluation .

Bevacizumab-augmented

retinal laser photocoagulation

intravitreal bevacizumab injection

standard laser treatment

laser treatment

1.25 mg intravitreal bevacizumab

Fluorescein angiography

Avastin-treated

bevacizumab

Avastin

complete regression

PDR

complete regression rate

rapid recurrence


Influence of two different resection techniques ( conventional liver resection versus anterior approach ) of liver metastases from colorectal cancer on hematogenous tumor cell dissemination - prospective randomized multicenter trial . BACKGROUND Surgical hepatic resection remains the treatment of choice for patients with liver metastases from colorectal cancer despite the use of alternative therapeutic strategies . Although this procedure provides long-term survival in a significant number of patients , 50-75 % of the patients develop intra- and/or extrahepatic recurrence . One possible reason for tumor recurrence may be intraoperative hematogenous tumor cell dissemination due to mechanical manipulation of the tumor during hepatic resection . Surgical technique may have an influence on hematogenous tumor cell spread . We hypothesize that hematogenous tumor cell dissemination may be reduced by using the anterior approach technique compared to conventional liver resection . METHODS/DESIGN This is a multi-centre prospective randomized controlled , superiority trial to compare two liver resection techniques of liver metastases from colorectal cancer . 150 patients will be included and randomized intraoperatively after surgical exploration just prior to resection . The primary objective is to compare the anterior approach with the conventional liver resection technique with regard to intraoperative haematogenous tumor cell dissemination . As secondary objectives we examine five year survival rates ( OS and DFS ) , blood loss , duration of operation , requirement of blood transfusions , morbidity rate , prognostic relevance of tumor cell detection in blood and bone marrow and the comparison of tumor cell detection by different detection methods . CONCLUSION This trial will answer the question whether there is an advantage for the anterior approach technique compared to the conventional resection group with regard to tumor cell dissemination . It will also add further information about prognostic differences , safety , advantages and disadvantages of each technique . TRIAL REGISTRATION Current controlled trials - ISRCTN45066244 .

conventional liver resection

anterior approach

Surgical hepatic resection

anterior approach

conventional liver resection technique

anterior approach technique

conventional resection

five year survival rates ( OS and DFS )

blood loss

duration of operation

requirement of blood transfusions

morbidity rate


[ Specific T cell immune response in chronic hepatitis B patients treated with different doses of recombinant hepatitis B vaccine ] . OBJECTIVE To study the specific cellular immunoresponse of peripheral blood lymphocytes in the chronic hepatitis B patients treated with different doses of recombinant hepatitis B vaccine . METHODS Seventy-two chronic hepatitis B patients who did not use any anti-HBV drugs within 6 months were randomized into 3 groups ( 90 micrograms , 60 micrograms , and placebo ) in a ratio of 1:1:1 . The patients in different groups were treated with different doses of recombinant hepatitis B vaccine in combination with IFN alpha 1b 50 micrograms with 3 times a week for 24 weeks . All patients were followed up for 24 weeks ( W24 ) . HBV DNA , HBeAg and liver functions were detected at different time points , and the number of cells that secrete IFN-gamma were detected by ELISPOT . RESULTS There were no significant difference in ELISPOT positive ratio among the 3 groups on baseline detection . At W24 , 12 cases , 12 cases , and 7 cases showed ELISPOT positive in the group of 90 micrograms , 60 micrograms , and placebo . The proportion of patients who were ELISPOT positive was higher in the groups treated with recombinant hepatitis B vaccine ( including the dose of 90 micrograms and 60 micrograms ) than that in the placebo group ( P=0.0446 ) . HBV DNA turned negative in 6/24 of the patients treated with recombinant hepatitis B vaccine ( at both the doses of 90 micrograms and 60 micrograms ) , and HBeAg/Anti-HBe seroconversion or HBeAg became negative in 7/24 of them . In the placebo group , none of the patients showed undetectable HBV DNA , HBeAg/Anti-HBe seroconversion or HBeAg disappearance . At the 24W of follow up , in the patients who were ELISPOT positive , HBV DNA became undetectable in 4 of the patients treated with recombinant hepatitis B vaccine ( at doses of 90 micrograms and 60 micrograms ) , and HBeAg/Anti-HBe seroconversion or HBeAg disappearance were found in 9 of the cases . In the placebo group , none of the cases showed undetectable HBV DNA , and only 1 case had HBeAg/Anti-HBe seroconversion . CONCLUSION The recombinant hepatitis B vaccine may increase the function of specific T lymphocytes in patients with chronic hepatitis B . There were no significant differences between the patients treated with the dose of 90 micrograms and 60 micrograms hepatitis B vaccine .

recombinant hepatitis B vaccine

recombinant hepatitis B vaccine

placebo )

recombinant hepatitis B vaccine

Specific T cell immune response

specific cellular immunoresponse

HBV DNA , HBeAg and liver functions

secrete IFN-gamma

ELISPOT

ELISPOT positive ratio

ELISPOT positive

ELISPOT positive

HBV DNA

HBeAg/Anti-HBe seroconversion or HBeAg

ELISPOT positive

HBV DNA

HBeAg/Anti-HBe seroconversion

HBeAg disappearance

HBV DNA

HBeAg/Anti-HBe seroconversion

function of specific T lymphocytes

chronic hepatitis B patients


[ Effects of Kang Gang Qian Granule ( KGQG ) on clinical and pathological features in chronic hepatitis B patients ] . OBJECTIVE To explore the efficacy of KGQG and its therapeutic mechanisms in chronic hepatitis B patients with liver fibrosis . METHODS 57 chronic hepatitis B patients with liver fibrosis were randomly divided into two groups : 45 cases in KGQG group were treated by KGQG and routine medications ; 12 cases in control group were treated by routine medications only . Serum liver function test results , PCIII , CIV , HA and liver biopsy results of these 57 patients were simultaneously collected and analyzed before and after this intervention . RESULTS KGQG group showed better efficacy over control group in liver function recovery , decrease of serum PCIII , CIV , HA levels and liver pathologic grades ( P 0.05 or 0.01 ) . CONCLUSION The KGQG could effectively ameliorate liver function and facilitate the inhibition and degradation of liver fibrosis in chronic hepatitis B patients , which may be developed as a novel therapeusis to treat this hard-to-cure disease .

Kang Gang Qian Granule ( KGQG )

KGQG

KGQG

KGQG and routine medications

KGQG

KGQG

clinical and pathological features

efficacy

liver function recovery

serum PCIII , CIV , HA levels

liver pathologic grades

chronic hepatitis B

chronic hepatitis B

liver fibrosis

chronic hepatitis B

liver fibrosis

liver fibrosis

chronic hepatitis B


Atrial natriuretic factor inhibits metoclopramide stimulated aldosterone release in man . 1 . Atrial natriuretic factor ( ANF ) has an inhibitory effect on angiotensin II and ACTH stimulated aldosterone secretion in man . The selectivity of this aldosterone suppressing effect of ANF is unclear in man . The present study investigated the effect of ANF on the increase in plasma aldosterone due to metoclopramide in man . 2 . Eight normal male volunteers were studied on three occasions . Metoclopramide ( 10 mg slow i.v . ) was given on all study days and each volunteer was randomised to receive 45 min infusion of either 5 % D-glucose ( placebo ) or ANF ( 99-126 ) 3 or 15 pmol kg-1 min-1 . 3 . Metoclopramide increased plasma aldosterone to approximately 170 % of baseline levels ( P less than 0.01 ) . Concomitant infusion of ANF 3 pmol kg-1 min-1 and 15 pmol kg-1 min-1 significantly attenuated this rise in plasma aldosterone to approximately 130 % ( P less than 0.05 ) and 110 % ( P less than 0.01 ) of baseline values respectively . 4 . It is suggested , in the light of previous findings , that the inhibitory effect of ANF represents a non-selective action of ANF on aldosterone release .

metoclopramide

Metoclopramide

5 % D-glucose

placebo

ANF

pmol

Metoclopramide

ANF 3

aldosterone release

plasma aldosterone

metoclopramide

plasma aldosterone

aldosterone release .

man

man

Eight

normal

male


Long-term retention on treatment with lumiracoxib 100 mg once or twice daily compared with celecoxib 200 mg once daily : a randomised controlled trial in patients with osteoarthritis . BACKGROUND The efficacy , safety and tolerability of lumiracoxib , a novel selective cyclooxygenase-2 ( COX-2 ) inhibitor , has been demonstrated in previous studies of patients with osteoarthritis ( OA ) . As it is important to establish the long-term safety and efficacy of treatments for a chronic disease such as OA , the present study compared the effects of lumiracoxib at doses of 100 mg once daily ( o.d . ) and 100 mg twice daily ( b.i.d . ) with those of celecoxib 200 mg o.d . on retention on treatment over 1 year . METHODS In this 52-week , multicentre , randomised , double-blind , parallel-group study , male and female patients ( aged at least 40 years ) with symptomatic primary OA of the hip , knee , hand or spine were randomised ( 1:2:1 ) to lumiracoxib 100 mg o.d . ( n = 755 ) , lumiracoxib 100 mg b.i.d . ( n = 1,519 ) or celecoxib 200 mg o.d . ( n = 758 ) . The primary objective of the study was to demonstrate non-inferiority of lumiracoxib at either dose compared with celecoxib 200 mg o.d . with respect to the 1-year retention on treatment rate . Secondary outcome variables included OA pain in the target joint , patient 's and physician 's global assessments of disease activity , Short Arthritis assessment Scale ( SAS ) total score , rescue medication use , and safety and tolerability . RESULTS Retention rates at 1 year were similar for the lumiracoxib 100 mg o.d. , lumiracoxib 100 mg b.i.d . and celecoxib 200 mg o.d . groups ( 46.9 % vs 47.5 % vs 45.3 % , respectively ) . It was demonstrated that retention on treatment with lumiracoxib at either dose was non-inferior to celecoxib 200 mg o.d . Similarly , Kaplan-Meier curves for the probability of premature discontinuation from the study for any reason were similar across the treatment groups . All three treatments generally yielded comparable results for the secondary efficacy variables and all treatments were well tolerated . CONCLUSION Long-term treatment with lumiracoxib 100 mg o.d. , the recommended dose for OA , was as effective and well tolerated as celecoxib 200 mg o.d . in patients with OA . TRIAL REGISTRATION clinicaltrials.gov NCT00145301 .

lumiracoxib

celecoxib

lumiracoxib

celecoxib 200 mg o.d .

lumiracoxib

lumiracoxib

celecoxib

lumiracoxib

celecoxib

lumiracoxib

lumiracoxib

celecoxib

lumiracoxib

celecoxib

non-inferiority

1-year retention on treatment rate

Retention rates

retention

tolerated

tolerated

patients with osteoarthritis .

patients with osteoarthritis ( OA ) .


Randomized , controlled trial of Behavioral Family Systems Therapy for Diabetes : maintenance and generalization of effects on parent-adolescent communication . We report a randomized trial of a revised Behavioral Family Systems Therapy for Diabetes ( BFST-D ) intervention . Families of 104 adolescents with diabetes were randomized to standard care ( SC ) or to 6 months of an educational support group ( ES ) or BFST-D. Family communication and problem-solving skills were assessed at 0 , 6 , 12 , and 18 months by independent rating of videotaped family problem-solving discussions . BFST-D improved individual communication of adolescents and mothers , but not fathers . BFST-D significantly improved quality of family interaction compared to SC ( 10 of 12 comparisons ) and ES ( 6 of 12 comparisons ) . Changes in family communication were differentially associated with changes in glycemic control , adherence , and family conflict . BFST-D improved family communication and problem solving relative to SC and modestly relative to ES .

Behavioral Family Systems Therapy

BFST-D

Family communication

problem-solving skills

quality of family interaction

glycemic control

adherence

family conflict

family communication

problem solving

Diabetes :

adolescents

diabetes


Allopurinol improves endothelial function and reduces oxidant-inflammatory enzyme of myeloperoxidase in metabolic syndrome . OBJECTIVE In this study , we tested in patients with metabolic syndrome whether allopurinol through decreasing oxidative stress improves endothelial function , and ameliorates inflammatory state represented by markers of myeloperoxidase , C-reactive protein ( CRP ) and fibrinogen . METHODS In a randomized , double-blind fashion ; subjects with metabolic syndrome were treated with allopurinol ( n = 28 ) or placebo ( n = 22 ) for one month . Before and after treatment , blood samples were collected and the flow-mediated dilation ( FMD ) and isosorbide dinitrate ( ISDN ) -mediated dilation of the brachial artery were performed . RESULTS Baseline clinical characteristics of the allopurinol and placebo groups demonstrated no differences in terms of clinical characteristics , endothelial function and inflammatory markers . After the treatment with allopurinol , FMD was increased from 8.0 +/- 0.5 % to 11.8 +/- 0.6 % ( P < 0.01 ) , but there were no change in the placebo group . In both groups , ISDN-mediated dilation is unaffected by the treatment . As a marker of oxidative stress , allopurinol significantly reduced malondialdehyde . Moreover , myeloperoxidase levels were reduced by the treatment with allopurinol ( 56.1 +/- 3.4 ng/ml vs. 44.4 +/- 2.4 ng/ml , P < 0.05 ) but there were no change in the placebo group . Surprisingly , neither CRP nor fibrinogen levels were affected by the treatment in both groups . CONCLUSION Xanthine oxidoreductase inhibition by allopurinol in patients with metabolic syndrome reduces oxidative stress , improves endothelial function , ameliorates myeloperoxidase levels and does not have any effect on CRP and fibrinogen levels .

Allopurinol

allopurinol

placebo

blood samples

allopurinol

flow-mediated dilation ( FMD )

clinical characteristics

, endothelial function

inflammatory markers

FMD

ISDN-mediated dilation

reduced malondialdehyde

myeloperoxidase levels

CRP nor fibrinogen levels

metabolic syndrome

metabolic syndrome

metabolic syndrome


The dipeptidyl peptidase-4 inhibitor PHX1149 improves blood glucose control in patients with type 2 diabetes mellitus . AIM To determine the efficacy and tolerability of PHX1149 , a novel dipeptidyl peptidase-4 ( DPP4 ) inhibitor , in patients with type 2 diabetes . METHODS This is a multicentre , randomized , double-blind , placebo-controlled , 4-week study in patients with type 2 diabetes with suboptimal metabolic control . Patients with a baseline haemoglobin A ( 1c ) ( HbA ( 1c ) ) of 7.3 to 11.0 % were randomized 1 : 1 : 1 : 1 to receive once-daily oral therapy with either PHX1149 ( 100 , 200 or 400 mg ) or placebo ; patients were on a constant background therapy of either metformin alone or metformin plus a glitazone . RESULTS Treatment with 100 , 200 or 400 mg of PHX1149 significantly decreased postprandial glucose area under the curve AUC ( 0-2 h ) by approximately 20 % ( +0.11 +/- 0.50 , -2.08 +/- 0.51 , -1.73 +/- 0.49 and -1.88 +/- 0.48 mmol/l x h , respectively , for placebo and 100 , 200 and 400 mg ( p = 0.002 , 0.008 and 0.004 vs. placebo ) . Postprandial AUC ( 0-2 h ) of intact glucagon-like peptide-1 , the principal mediator of the biological effects of DPP4 inhibitors , was increased by 3.90 +/- 2.83 , 11.63 +/- 2.86 , 16.42 +/- 2.72 and 15.75 +/- 2.71 pmol/l x h , respectively , for placebo and 100 , 200 and 400 mg ( p = 0.053 , 0.001 and 0.002 vs. placebo ) . Mean HbA ( 1c ) was lower in all dose groups ; the placebo-corrected change in the groups receiving 400 mg PHX1149 was -0.28 % ( p = 0.02 ) . DPP4 inhibition on day 28 was 53 , 73 and 78 % at 24 h postdose in the groups receiving 100 , 200 and 400 mg PHX1149 , respectively . There were no differences in adverse events between PHX1149-treated and placebo subjects . CONCLUSIONS Addition of the DPP4 inhibitor PHX1149 to a stable regimen of metformin or metformin plus a glitazone in patients with type 2 diabetes was well tolerated and improved blood glucose control .

PHX1149 ( 100 , 200 or 400 mg )

placebo

blood glucose control

efficacy and tolerability

Mean HbA ( 1c )

DPP4 inhibition

adverse events

well tolerated

improved blood glucose control .

type 2 diabetes mellitus

type 2 diabetes

type 2 diabetes


Desogestrel and gestodene in oral contraceptives : 12 months ' assessment of carbohydrate and lipoprotein metabolism . We examined the influence on carbohydrate and lipoprotein metabolism of oral contraceptives ( OCs ) containing two new third-generation progestogens , desogestrel and gestodene . This was a prospective randomized study in which monophasic combinations of 20 micrograms ethinyl estradiol ( E2 ) and 150 micrograms desogestrel or 30 micrograms ethinyl E2 plus 75 micrograms gestodene were administered to 15 and 19 healthy women , respectively . An oral glucose tolerance test including measurement of insulin response was performed before treatment and after 3 , 6 , and 12 months of treatment . We also determined fasting plasma concentrations of total cholesterol ; high-density lipoprotein cholesterol , including the subfractions high-density lipoprotein2 cholesterol and high-density lipoprotein3 cholesterol ; low-density lipoprotein cholesterol ; very low-density lipoprotein cholesterol ; and triglycerides . A transient deterioration of glucose tolerance was observed despite unchanged levels of insulin after treatment with both compounds for 3 months . In both groups plasma levels of triglycerides , very low-density lipoprotein cholesterol , and high-density lipoprotein cholesterol increased significantly after 3 months . After 12 months , a significant increase in the high-density lipoprotein cholesterol/total cholesterol ratio was observed in the ethinyl E2-desogestrel group , and no persistent changes in low-density lipoprotein cholesterol could be demonstrated in any of the groups . Our results indicate that treatment with either compound for 12 months has no effect on carbohydrate or lipoprotein metabolism known to increase the risk of cardiovascular disease .

oral contraceptives ( OCs )

progestogens

desogestrel

gestodene

ethinyl estradiol ( E2 )

desogestrel

ethinyl E2 plus 75 micrograms gestodene

carbohydrate and lipoprotein metabolism

oral glucose tolerance test

high-density lipoprotein cholesterol

low-density lipoprotein cholesterol

triglycerides

insulin

plasma levels of triglycerides

low-density lipoprotein cholesterol

carbohydrate or lipoprotein metabolism


Nurse and patient communication profiles in a home-based telehealth intervention for heart failure management . OBJECTIVE This study compared differences in nurse and patient communication profiles between two telehealth modes : telephone and videophone , and evaluated longitudinal changes in communication , nurse perceptions , and patient satisfaction . METHODS Subjects were enrolled in a randomized controlled clinical trial evaluating a 90-day home-based intervention for heart failure . Telephone ( n=14 ) and videophone ( n=14 ) interactions were audio taped and analyzed using the Roter Interaction Analysis System . RESULTS Nurses were more likely to use open-ended questions , back-channel responses , friendly jokes , and checks for understanding on the telephone compared to videophone . Compliments given and partnership were more common on the videophone . Patients were more likely to give lifestyle information and approval comments on the telephone , and used more closed-ended questions on the videophone . Nurses perceptions of the interactions were not different between the telephone and videophone , nor did their perceptions change significantly over the course of the intervention . There were no significant differences in patient satisfaction between the telephone and videophone . CONCLUSIONS The results of this study did not support use of a videophone over the telephone . PRACTICE IMPLICATIONS It is critical to match technologies to patient needs and use the least complex technology possible . When considering use a videophone , health care providers should critically examine the trade-offs between additional complexities with the added value of the visual interaction .

telephone

videophone

Telephone

videophone

Roter Interaction Analysis System

telephone

videophone

telephone

videophone

videophone

videophone

videophone

telephone

videophone

longitudinal changes in communication

nurse perceptions

patient satisfaction

Roter Interaction Analysis System

friendly jokes

checks for understanding

Compliments given and partnership

closed-ended questions

Nurses perceptions of the interactions

perceptions

patient satisfaction


Effect of sport-tinted contact lenses for contrast enhancement on retinal straylight measurements . PURPOSE To investigate the effect of two tinted contact lenses ( CL ) designed for outdoor sports activity on the psychometric determination of retinal straylight using the compensation comparison method . METHODS Thirteen emmetropic subjects were randomly fitted with two different tinted Nike Maxsight ( Bausch & Lomb , Rochester , NY , USA ) CL in one eye , while the contralateral eye was fitted with a clear lens made of the same material ( Optima 38 , Bausch & Lomb ) . Three valid straylight measurements were taken on each eye before and a few minutes after lens insertion , when lens stabilization had occurred . RESULTS The subjects ' mean straylight values were 0.90 +/- 0.09 at baseline and 0.95 +/- 0.10 with the clear Optima 38 CL . Straylight values were 0.97 +/- 0.10 and 1.0 +/- 0.10 log units with the amber and grey-green tinted CL , respectively . Differences in straylight between baseline ( without CL ) and with the clear CL in place were neither statistically significant ( p = 0.066 ) nor was there a significant difference between baseline and the amber CL ( p = 0.052 ) . However , the grey-green CL showed a statistically significant difference from baseline ( p = 0.006 ) . Differences in straylight with the clear CL compared with the grey-green CL were also statistically different from zero ( p = 0.002 ) showing an increased straylight value for the tinted CL . These differences were variable , but consistent for each subject , thus those showing higher or lower changes with one tinted lens tended to show the same trend with the second lens ( r ( 2 ) = 0.736 ) . CONCLUSIONS Despite increases having been found in straylight values with tinted contact lenses , those changes are not likely to induce clinically significant changes in visual function under photopic conditions , even for the grey-green CL , which seems to increase straylight values more significantly than the amber CL . This difference between the tinted CL could suggest a wavelength dependence of straylight values , although this should be investigated further by controlling for pupil size and subjects ' pigmentation , as well as by using neutral density filters .

sport-tinted contact lenses

tinted contact lenses ( CL )

straylight measurements

mean straylight values

Straylight values

straylight value

Thirteen

emmetropic


Teaching picture-to-object relations in picture-based requesting by children with autism : a comparison between error prevention and error correction teaching procedures . BACKGROUND Children who have a combination of language and developmental disabilities with autism often experience major difficulties in learning relations between objects and their graphic representations . Therefore , they would benefit from teaching procedures that minimize their difficulties in acquiring these relations . This study compared two teaching procedures , an error prevention procedure and an error correction procedure , for teaching relations between objects and pictures . METHOD Participants were two groups of children with autism , aged between 3 and 7 years . In the context of picture-to-object requesting , one group was taught using an error correction method and the other group with an error prevention method . The measures for each child were accuracy of correspondences between taught picture and object pairs and accuracy of delayed correspondences in learning outcome tests with all combinations of object and picture pairs presented to them throughout the study . RESULTS The group receiving the error prevention-based teaching made significantly fewer errors during the teaching phases and in their learning outcome test for correspondences between all combinations of pictures and objects . CONCLUSIONS The error prevention teaching procedure would seem to provide a more efficient and ecologically valid method than the error correction procedure for teaching relations between objects and their graphic-based referents . Improvements in the methodology were suggested for providing a stronger basis for comparison between error correction and error prevention teaching methods .

error prevention

error correction teaching procedures .

teaching procedures

an error correction method

an error prevention method .

prevention-based teaching

prevention teaching procedure

errors

children

autism

Children

language and developmental disabilities

autism

children

autism


Pentoxifylline to treat radiation proctitis : a small and inconclusive randomised trial . This prospective randomised controlled study of 40 patients could not show a statistically significant advantage with 6 months of pentoxifylline compared with standard measures for late radiation-induced rectal bleeding . However , a modest benefit can not be excluded and larger randomised placebo-controlled trials with longer durations of pentoxifylline treatment may be justified .

Pentoxifylline

pentoxifylline

placebo-controlled

pentoxifylline

late radiation-induced rectal bleeding

durations of pentoxifylline treatment

radiation proctitis

study of 40 patients


A double-blind randomized clinical evaluation of enamel matrix derivative proteins for the treatment of proximal class-II furcation involvements . OBJECTIVE The aim of the present randomized , double-blind study was to evaluate the clinical response of proximal furcations treated with enamel matrix derivative proteins ( EMD ) . MATERIAL AND METHODS Fifteen patients , each with a pair of contralateral class-II proximal furcation involvements , presenting probing depths ( PDs ) > /=5 mm and bleeding on probing ( BOP ) were selected . The patients were randomly assigned to : control group ( n=15 ) - open flap debridement ( OFD ) +24 % ethylenediaminetetraacetic acid ( EDTA ) conditioning ; test group ( n=15 ) - OFD+24 % EDTA conditioning+EMD application . Plaque index ( PI ) , BOP , PD , gingival margin position ( GMP ) , relative vertical and horizontal clinical attachment level ( RVCAL and RHCAL ) , vertical and horizontal bone level ( VBL and HBL ) and furcation closure were evaluated immediately before and 2 , 4 and 6 months after the surgeries . RESULTS At 6 months , the RVCAL gains of the control and test group were 0.39 +/- 1.00 and 0.54 +/- 0.95 mm , while the RHCAL gains were 1.21 +/- 2.28 and 1.36 +/- 1.26 mm ( p > 0.05 ) . The VBL and HBL gains of the control group were 1.04 +/- 1.12 and 1.00 +/- 1.79 mm , and 0.82 +/- 1.82 and 1.17 +/- 1.38 mm for the test group ( p > 0.05 ) . In addition , a statistical difference was observed in the number of the remaining class-II furcations between the test and control groups ( p < 0.05 ) in this period . CONCLUSION It may be concluded that the use of EMD in proximal furcations did not promote a superior reduction in PD or a gain in clinical and osseous attachment levels , but resulted in a higher rate of class-II to class-I furcation conversion .

enamel matrix derivative proteins

control group

EMD

clinical response

RVCAL gains

RHCAL

VBL and HBL gains

PD

clinical and osseous attachment levels

Fifteen patients

bleeding on probing ( BOP )


Testosterone and gonadotropins but not estrogen associated with spatial ability in women suffering from schizophrenia : a double-blind , placebo-controlled study . The aim of this study was to investigate the association between estrogen and spatial ability tasks in women suffering from schizophrenia . For this purpose , a placebo-controlled , double-blind , three-time cross-over study using 17beta-estradiol combined with norethisterone acetate for replacement therapy and as an adjunct to a naturalistic maintenance antipsychotic treatment was carried out over a period of 8 months . Nineteen women ( mean age=38.0 years , SD=9.9 years ) with schizophrenia hospitalized for the first time or repeatedly were included in the study . Sex hormones - 17beta-estradiol , luteinizing hormone ( LH ) , follicle-stimulating hormone ( FSH ) , prolactin , testosterone , and dehydroepiandrosterone sulfate - were measured and the patients completed a neuropsychological test in the last two active drug and/or placebo phases . Three different spatial ability tasks - spatial orientation , spatial visualization , and flexibility of closure - were measured by a paper-and-pencil test . No association between estrogen and spatial ability was found ; however , in an additional exploratory data analysis , high levels of testosterone , LH , and FSH correlated significantly with performance in the flexibility of closure task . This is the very first study , based on estrogen intervention instead of physiological hormone changes , to examine the association between estrogen and spatial ability in women with schizophrenia .

Testosterone

gonadotropins

placebo-controlled

placebo-controlled

replacement therapy

estrogen

spatial ability

estrogen

spatial ability

Sex hormones

luteinizing hormone ( LH )

follicle-stimulating hormone ( FSH

prolactin

testosterone

dehydroepiandrosterone sulfate

spatial orientation

spatial visualization

flexibility of closure

estrogen

spatial ability

high levels of testosterone

LH

FSH

flexibility of closure

estrogen

spatial ability

women

schizophrenia

women

schizophrenia

Nineteen

women

age=38.0 years

schizophrenia

women

schizophrenia


Intravenous or intramuscular teicoplanin once daily for skin and soft-tissue infections . Teicoplanin is a new glycopeptide antibiotic with potent activity against gram-positive bacteria and pharmacokinetics that allow once daily administration . To study the efficacy and safety of teicoplanin for skin and soft-tissue infections , 75 patients received teicoplanin intravenously ( 38 ) or intramuscularly ( 37 , of which 16 were outpatients ) . Of 62 clinically evaluable patients , 97 percent of teicoplanin iv and 93 percent of teicoplanin im patients were cured or improved . All teicoplanin iv patients and 64 percent of teicoplanin im patients were cured microbiologically at 24-48 hours posttherapy . Persistence of organisms frequently was associated with skin ulcers or abscess cavities and usually had no bearing on clinical outcome . Possible adverse clinical and laboratory reactions caused by teicoplanin occurred in 4 of 38 teicoplanin iv patients ( 11 percent ) and in 8 of 37 teicoplanin im patients ( 22 percent ) . Reactions were mild and resolved with discontinuation of teicoplanin in most cases . In this study , teicoplanin appeared to be safe , efficacious , and convenient for both hospital staff and patients , and potentially cost-effective for the treatment of skin and soft-tissue infections . In particular , teicoplanin appears to be appropriate for outpatient parenteral therapy .

Teicoplanin

teicoplanin

teicoplanin

teicoplanin

teicoplanin

teicoplanin

teicoplanin

teicoplanin

teicoplanin

teicoplanin

skin and soft-tissue infections

efficacy and safety

cured microbiologically

skin ulcers or abscess cavities

mild

safe , efficacious , and convenient

cost-effective

skin and soft-tissue infections

62 clinically evaluable patients


Does surface preparation alter ALA uptake in superficial non-melanoma skin cancer in vivo ? BACKGROUND/PURPOSE Photodynamic therapy ( PDT ) using aminolaevulinic acid ( ALA ) is widely used in the treatment of non-melanoma skin cancer . Surface preparation of the lesion is commonly performed before application of ALA but the extent of the preparation varies from centre to centre and there has been no study of its effects . The purpose of this study was to examine the effects of surface preparation on the local uptake of ALA by recording fluorescence from accumulated protoporphyrin IX ( PPIX ) . METHODS The study was performed on 16 lesions , either superficial basal cell carcinoma ( BCC ) or Bowen 's disease ( BD ) . Each half of the lesion was randomly assigned to ( a ) no surface preparation or ( b ) surface preparation ( randomly allocated to gentle curettage or abrasion with a spatula ) . ALA was left for 4 h ( BCC ) or 6 h ( BD ) . PPIX fluorescence was measured using an excitation wavelength of 405+/-5 nm and emission spectrum recorded using a photodiode array . Spectra were measured ( a ) before and ( b ) after surface preparation , ( c ) immediately before and ( d ) after laser irradiation at 630 nm . RESULTS The ratio of fluorescence after incubation to that before incubation was 6.1+/-1.2 in the non-prepared section . This increased slightly but not significantly to 6.8 +/-1.8 in the prepared section ( P < 0.1 ) . There was no significant difference between curettage and abrasion . There was also no significant difference in outcome after PDT . CONCLUSIONS The clinical assessment agrees with the fluorescence data as no significant difference was seen between prepared and unprepared halves of the lesion 12 months after PDT . Overall our data seem to suggest that for most BCC and BD lesions , surface preparation did not increase ALA uptake .

aminolaevulinic acid ( ALA )

Surface preparation

surface preparation

no surface preparation or

photodiode array

laser irradiation

ALA uptake

uptake of ALA

PPIX fluorescence

ratio of fluorescence after incubation

curettage and abrasion .

ALA uptake


Resource utilization and economic costs of care based on a randomized trial of vacuum-assisted closure therapy in the treatment of diabetic foot wounds . BACKGROUND To evaluate resource utilization and direct economic costs of care for patients treated with negative-pressure wound therapy ( NPWT ) , using the Vacuum-Assisted Closure ( V.A.C . ) system , compared to standard moist wound therapy ( MWT ) . METHODS A total of 162 diabetic patients with post-amputation wounds ( up to the trans-metatarsal level ) entered a 16-week , randomized clinical trial . Patients randomized to V.A.C . ( n = 77 ) received therapy with dressing changes every 48 hours . Control patients ( n = 85 ) received standard MWT . Resource utilization , procedures , and direct costs were calculated and analyzed in this post hoc retrospective study . RESULTS There was no difference between groups for in-patient hospital stay ( number of admissions or length of stay ) . More surgical procedures ( including debridement ) were required in the MWT group ( 120 vs 43 NPWT , P < .001 ) . The average number of dressing changes performed per patient was 118.0 ( range 12-226 ) for MWT versus 41 ( 6-140 ) for NPWT ( P = .0001 ) . The MWT group had 11 ( range 0-106 ) outpatient treatment visits during the study versus 4 ( range 0-47 ) in the NPWT group ( P < .05 ) . The average direct cost per patient treated for 8 weeks or longer ( independent of clinical outcome ) was $ 27,270 and $ 36,096 in the NPWT and MWT groups , respectively . The average total cost to achieve healing was $ 25,954 for patients treated with NPWT ( n = 43 ) compared with $ 38,806 for the MWT group ( n = 33 ) . CONCLUSION Treatment of diabetic patients with post amputation wounds using NPWT resulted in lower resource utilization and a greater proportion of patients obtaining wound healing at a lower overall cost of care when compared to MWT .

vacuum-assisted closure therapy

standard moist wound therapy ( MWT )

V.A.C .

therapy with dressing changes

MWT

MWT

NPWT

MWT

NPWT

MWT

NPWT

NPWT

MWT

NPWT

MWT

resource utilization

direct economic costs

Resource utilization

procedures

direct costs

outpatient treatment visits

average direct cost per patient

average total cost to achieve healing

resource utilization

lower overall cost of care

diabetic foot wounds

diabetic

post-amputation

diabetic

post amputation wounds


Clinical outcome of postoperative adjuvant immunochemotherapy with sizofiran for patients with resectable gastric cancer : a randomised controlled study . Adjuvant immunochemotherapy using the antitumour polysaccharide sizofiran ( SPG ) , an extract from the culture broth of Schizophyllum commune Fries , was prescribed randomly for 386 Japanese patients with resectable gastric cancer . Although the overall survival probability for 5 years did not differ between the SPG and control groups , in 264 patients with curatively resected cancer , the probability to 5 year survival and to recurrence in the sizofiran-administered patients was better than in the controls . In the multivariate analysis , four of six prognostic factors correlated with the prognosis of the 264 patients who underwent curative surgery , that is , nodal involvement ( chi 2 = 21.426 , P = less than 0.0001 ) , age distribution ( chi 2 = 9.262 , P = 0.010 ) , sizofiran administration ( chi 2 = 6.507 , P = 0.011 ) , and primary tumour size ( chi 2 = 9.345 , P = 0.025 ) . Thus , patients with a curatively resected gastric cancer had a better prognosis when sizofiran was prescribed in combination with antitumour drugs .

sizofiran

sizofiran

overall survival probability

recurrence

nodal involvement

age distribution

sizofiran administration

primary tumour size


[ Isometric hip muscle strength in posttraumatic below-knee amputees ] . BACKGROUND/AIM Traumas and war injuries , next to chronic occlusive artery disease and diabetes mellitus-derived complications , are the most frequent cause of the lower limbs amputation . They affect mostly younger population that need a higher level of activities as compared with the elderly . Medical rehabilitation is very significant for the muscle performance improvement in this population providing their social reintegration . The aim of this study was to investigate the effect of below-knee amputation on the hip isometric muscle strength and effect of rehabilitation on improvement of hip muscle strength in below-knee amputees , secondary to war wounding . METHODS Forty below-knee amputees ( after war wounding ) , average age 35.6 +/- 10.6 years , that were included in primary rehabilitation program with prosthetics , were examined . Objective parameters were used to evaluate therapeutical effects . Isometric muscle strength of hip flexors , extensors , abductors and adductors was measured by dynamometer and expressed in Newton ( N ) at admission , control and discharge for each patient . Average length of the treatment was 51 +/- 34.1 days . RESULTS For isometric hip flexors ( t = -1.99346 , p < 0.05 ) , extensors ( t = -4.629073 , p < 0.001 ) , abductors ( t = -4.9408 , p < 0.001 ) and adductors ( t = -2.00228 , p < 0.05 ) , muscle strength was significantly less on the amputated than on nonamputated side . The highest differences in muscle strength between amputated and nonamputated limbs were noted for hip abductors ( 26.6 % ) and extensors ( 23.3 % ) . There was significant improvement of mean values of strength for all examined hip muscles after rehabilitation and prosthetics for both legs in comparison to beginning of the therapy . The hip abductor on the amputated side was for 19.4 % weaker after rehabilitation in comparison to the non-amputated limb . CONCLUSION Decreases of isometric muscle strength in all examined hip muscles were observed , more in the amputated limb . Rehabilitation with prosthetics is a successful method for improving isometric hip muscle strength on the both , amputated and non-amputated limbs in war wounded below-knee amputees .

Medical rehabilitation

below-knee amputees

younger

below-knee amputees

war wounding

Forty

below-knee amputees

after war wounding

35.6 +/- 10.6

war wounded below-knee amputees .


Effect of finasteride treatment on suburethral prostatic microvessel density in patients with hematuria related to benign prostate hyperplasia . INTRODUCTION In the present study we evaluated the effect of short-term finasteride treatment on microvessel density ( MVD ) which is an indicator of prostatic angiogenesis in patients with hematuria secondary to benign prostatic hyperplasia ( BPH ) . MATERIALS AND METHODS 30 patients who were candidates for BPH surgery were prospectively included in the study . All patients had history of gross hematuria and evaluated by ultrasonography and cystoscopy . The patients were randomized two groups before surgery . The treatment group consisted of 13 patients who were given 5 mg finasteride daily for 4 weeks before surgery . The control group consisted of 17 patients who did not receive finasteride before surgery . During surgery , resected suburethral and hyperplastic prostate specimens were sent for histopathologic MVD determination separately . RESULTS Mean MVD in the suburethral portion of prostate was significantly lower in patients treated with finasteride when compared with controls ( 9.08 +/- 5.6 and 13.94 +/- 5.90 , respectively , p < 0.05 ) . Mean MVD for the hyperplastic portion of prostate was similar for the finasteride and control groups ( 14.21 +/- 7.10 and 19.75 +/- 9.73 , respectively , p > 0.05 ) . CONCLUSION The potential role of finasteride on hematuria related to BPH may be the suppressive effect on MVD in the suburethral tissue of prostate .

finasteride

finasteride

5 mg finasteride daily

did not receive finasteride

MVD

30 patients

candidates for BPH surgery


[ The prognostic value of gastric metaplasia in the duodenal mucosa in patients with Helicobacter pylori positive duodenal bulb ulcer ] . The predictive value of gastric metaplasia in the duodenal mucosa in patients Helicobacter pylori-positive patients with duodenal bulb ulcer ( DBU ) was investigated . One hundred and twenty four randomly selected patients with DBU were included in this prospective study . The detection of Helicobacter pylori ( HP ) in the stomach and duodenum was carried out with Giemsa ( using standard visual analogue scale ) , rapid urease test ( standard Jatrox-HP test , Rohm Pharma , Germany ) , and polymerase chain reaction ( PCR ) to detect the specific fragment of ureC HP gene ( Helicopol II , Lytech , Russia ) . Regions of gastric metaplasia of the duodenum were confirmed by periodic acid-Schiff and alcian blue ( Serva ) staining ( pH 1.0 ; 2.5 ) Duodenal ulcer ( DU ) complications were registered within 8 to 10 years . Estimation of the predictive factor ( gastric metaplasia in the duodenum ) was carried out in patients with non-complicated DU ( Group 1 ; n = 73 ) , and with such complications as bleeding , perforation , penetration , pyloroduodenal stenosis ( Group 2 ; n = 51 ) which were revealed within the 8 to 10 years of observation . Gastric metaplasia in the duodenum was found in 64 or 87.7 % of the 73 patients with non-complicated DU and in 5 or 9.8 % of the 51 patients with complicated DU within 8 to 10 years of observation . The following facts about the predictive factor for the prognosis of DU complication were found : the sensitivity of 83.6 % , the specificity of 92.8 % , the predictive accuracy of 88.7 % , the relative risk of the predicted outcome of 7.5 , the relative risk of a different outcome of 0.11 , the odds ration of 65.4 . The study revealed a high and significant ( p < 0.001 ) predictive value of gastric metaplasia in the duodenum as a marker of non-complicated clinical course of DU in HP-positive patients within an 8 to 10-year period .

( gastric metaplasia in the duodenum )

Gastric metaplasia in the duodenum

sensitivity

specificity

predictive accuracy

gastric metaplasia

One hundred and twenty four

patients with DBU

HP-positive patients


A randomized , double-blind , placebo-controlled , multicenter study to evaluate the cardioprotective effects of MC-1 in patients undergoing high-risk coronary artery bypass graft surgery : MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery Trial ( MEND-CABG ) II -- study design and rationale . BACKGROUND Coronary artery bypass graft ( CABG ) surgery is effective in relieving angina and improving survival and quality of life in patients with obstructive coronary artery disease ; however , recurrent angina , myocardial infarction , neurological injury , and death can occur in the perioperative and postoperative period . MC-1 ( pyridoxal 5'-phosphate ) is a novel agent that has shown promise in reducing myocardial necrosis by reducing cellular calcium overload after percutaneous coronary intervention and CABG surgery in high-risk patients undergoing these procedures . METHODS MEND-CABG II is a phase III study evaluating the efficacy and safety of MC-1 in reducing cardiovascular morbidity and mortality after CABG . High-risk patients undergoing CABG surgery will be randomly assigned to receive either MC-1 ( 250 mg/d ) or matching placebo immediately before and continuing for 30 days after the procedure . The primary end point is the occurrence of cardiovascular death or nonfatal myocardial infarction through postoperative day 30 . A total of 3023 patients were enrolled at 130 sites in Canada , the United States , and Germany between October 2006 and September 2007 , with results anticipated shortly after completion of 90-day follow-up in March 2008 . CONCLUSIONS The data from the MEND-CABG II trial will establish whether peri- and postoperative treatment with MC-1 can decrease the short- and intermediate-term morbidity and mortality of high-risk patients undergoing CABG surgery .

placebo-controlled

placebo

Coronary Artery

efficacy

safety

occurrence of cardiovascular death

nonfatal myocardial infarction

short- and intermediate-term morbidity

mortality

obstructive coronary artery disease

3023 patients


New introducer PEG gastropexy does not require prophylactic antibiotics : multicenter prospective randomized double-blind placebo-controlled study . BACKGROUND Peristomal infections are the most common complications of PEG , despite prophylactic antibiotics . The " introducer " PEG-placement technique avoids the sojourn of a PEG catheter through the oropharynx , and hence minimizes the chances of infectious complications . Despite the obvious potential advantage , this technique failed to gain popularity , mainly as a result of other associated risks and complications . Recently , a modified introducer endoscopic PEG-gastropexy technique was shown to be quite safe . The present study is the first study that evaluated the need of prophylactic antibiotics for " introducer " PEG . OBJECTIVE To determine the incidence of peristomal wound infections during the immediate 7-day postprocedure follow-up . DESIGN Prospective , randomized , double-blind , placebo-controlled trial . SETTINGS Multicenter ; a university tertiary-care hospital and a private practice endoscopy clinic . PATIENTS A total of 633 patients undergoing PEG were assessed for inclusion . Ninety-seven patients who had malignant stenotic oropharyngeal stricture were randomized : group I ( 49 patients ) received prophylactic ceftriaxone , and group II ( 48 patients ) received a placebo . Both groups were similar in patient characteristics . INTERVENTIONS Introducer PEG was performed by using the Freka Pexact-15 CH/FR , with the gastric wall nonsurgically sutured to the anterior abdominal wall by use of an endoscope . MAIN OUTCOME MEASUREMENTS The peristomal area was assessed daily for 7 days by using 2 different types of infection scores . RESULTS Clinically significant wound reaction was observed in 1 patient in each group . Wound infection scores were marginally higher in the placebo group , but the differences in the values of infection scores between both the groups were not statistically significant during the 7-day post-PEG follow-up . LIMITATIONS The introducer gastropexy kit is 5 times more expensive than the " pull " PEG . CONCLUSIONS The new introducer PEG-gastropexy technique can be performed safely , without prophylactic antibiotics in patients potentially at high risk of peristomal infectious complications ( those with advanced oropharyngeal malignancy ) ( ClinicalTrials.gov identifier NCT00375414 ) .

New introducer PEG gastropexy

prophylactic ceftriaxone

placebo

placebo

Clinically significant wound reaction

Wound infection scores

values of infection scores

633 patients

Ninety-seven

advanced oropharyngeal malignancy


Post-laparoscopic cholecystectomy pain : effects of intraperitoneal local anesthetics on pain control -- a randomized prospective double-blinded placebo-controlled trial . Postoperative pain after laparoscopic cholecystectomy ( LC ) is generally less than open cholecystectomy ; however , the postoperative shoulder and abdominal pain experienced by patients still causes preventable distress . Intraperitoneal irrigation of the diaphragmatic surface and gallbladder fossa using normal saline , bupivacaine , or lignocaine may effectively control visceral abdominal pain after an LC . Two hundred patients with similar demographics undergoing elective LC were randomized to one of four groups of 50 patients each , including Group A placebo control , Group B with isotonic saline irrigation , Group C with bupivacaine irrigation , and Group D with lignocaine irrigation . All patients received preperitoneal abdominal wall infiltration with 0.25 per cent bupivacaine to control parietal ( somatic ) abdominal pain . The visual analogue and verbal rating pain scores at 0 , 4 , 8 , 12 and 24 hours for both shoulder and abdominal pain were recorded in a prospective double-blind fashion at four points during the first 24 postoperative hours . Analgesia requirements , vital signs , blood glucose , and incidence of nausea and vomiting were also recorded . Patients in each group demonstrated a significant difference in visual analogue and verbal rating pain scores and analgesic consumption when compared with controls . Lignocaine controlled pain significantly better than saline or bupivacaine . Bowel function recovery was similar in all patients , and there were no significant complications . We conclude that intraperitoneal irrigation with either saline , bupivacaine , or lignocaine can significantly reduce visceral abdominal pain after LC . Lignocaine was the most efficacious local anesthetic in this trial and has a high safety profile when used at recommended doses .

anesthetics

saline , bupivacaine

lignocaine

placebo

isotonic saline irrigation

bupivacaine irrigation

lignocaine irrigation

bupivacaine

saline

effects

visceral abdominal pain

visual analogue

and

verbal rating pain scores

analgesic consumption

controlled pain

Bowel function recovery

visceral abdominal pain

Post-laparoscopic cholecystectomy pain

Two hundred

four groups of 50 patients each

parietal ( somatic ) abdominal pain


Determinants of improvement in walking capacity among individuals with chronic stroke following a multi-dimensional exercise program . OBJECTIVE To identify the determinants of improvement in walking capacity following therapeutic exercise in chronic stroke survivors . DESIGN A secondary analysis of data obtained from a prospective , single-blind , randomized controlled intervention trial . SUBJECTS Sixty-three community-dwelling individuals ( mean age = 65 years , age range = 50-87 years ) with a chronic stroke ( post-stroke duration : mean = 5.5 years , range = 1-28 years ) . METHODS Subjects were randomized into a leg exercise group ( n = 32 ) or an arm exercise group ( n = 31 ) . Subjects in each group underwent 3 1-hour exercise sessions per week for 19 weeks . Walking capacity , cardiorespiratory fitness , isometric knee extensor muscle strength , balance ability , and balance confidence were evaluated before and after the interventions . Multiple regression analysis was performed to identify the determinants of improvement in walking capacity . RESULTS After controlling for age , gender , post-stroke duration , and baseline walking capacity , gain in paretic leg muscle strength and peak oxygen consumption remained independently associated with gain in walking capacity ( R2 = 0.229 ) . CONCLUSION Enhancement of cardiorespiratory fitness and paretic leg muscle strength are both significant determinants in improving walking capacity among chronic stroke survivors . However , the rather weak relationship ( R2 = 0.229 ) indicates that other factors not measured in this study may also contribute to the improvement in walking capacity .

multi-dimensional exercise program .

therapeutic exercise

leg exercise

arm exercise

exercise sessions

walking capacity

walking capacity

walking capacity

gain in walking capacity

individuals with chronic stroke

chronic stroke survivors .

Sixty-three

mean age = 65 years

age range = 50-87 years

post-stroke


Enrollment of racial and ethnic minorities in the Prostate , Lung , Colorectal and Ovarian Cancer Screening Trial . BACKGROUND Minority populations in the United States , especially blacks and Hispanics , are generally underrepresented among participants in clinical trials . Here , we report the experience of enrolling ethnic minorities in a large cancer screening trial . METHODS The Prostate , Colorectal , Lung and Ovarian ( PLCO ) Cancer Screening Trial is a multicenter randomized trial designed to evaluate the effectiveness of screening for the PLCO cancers . Subjects were recruited at 10 U.S. centers between 1993 and 2001 . One screening center had a major special recruitment effort for blacks and another center had a major special recruitment effort for Hispanics . RESULTS Among almost 155,000 subjects enrolled in PLCO , minority enrollment was as follows : black ( 5.0 % ) , Hispanic ( 1.8 % ) and Asian ( 3.6 % ) . This compares to an age-eligible population in the combined catchment areas of the PLCO centers that was 14.0 % black , 2.9 % Hispanic and 5.4 % Asian , and an age-eligible population across the U.S. that was 9.5 % black , 6.5 % Hispanic and 3.0 % Asian . About half ( 45 % ) of Hispanics were recruited at the center with the special Hispanic recruitment effort . Seventy percent of blacks were recruited at two centers ; the one with the major special recruitment effort and a center in Detroit whose catchment area was 20 % black among age-eligibles . Blacks , Hispanics and ( non-Hispanic ) whites were all more highly educated , less likely to currently smoke and more likely to get regular exercise than their counterparts in the general population . CONCLUSION Significant efforts were made to recruit racial/ ethnic minorities into PLCO , and these efforts resulted in enrollment levels that were comparable to those seen in many recent cancer screening or prevention trials . Blacks and Hispanics were nonetheless underrepresented in PLCO compared to their levels among age-eligibles in the overall U.S. population or in the aggregate PLCO catchment areas .

screening for the PLCO cancers

special recruitment effort for blacks

recruited

recruited

currently smoke

regular exercise

Hispanics

155,000 subjects enrolled


The effects of strength training on central arterial compliance in middle-aged and older adults . BACKGROUND Contrary to aerobic exercise , strength training ( ST ) is associated with decreased central arterial compliance in young men . It is unknown whether ST , with or without concurrent endurance training , would have a similar effect in older adults with reduced baseline arterial compliance . OBJECTIVE The primary aim of this study was to determine the effect of a ST program on central arterial compliance in middle-aged and older adults . DESIGN Randomized , controlled intervention study in which 37 healthy , sedentary men and women ( 52+/-2 years ) performed 13 weeks of ST ( n=13 ) , ST+aerobic exercise ( n=12 ) or stretching exercises as a control group ( n=12 ) . METHODS Participants were rigorously screened for cardiovascular disease and underwent pre-post testing for carotid arterial compliance ( via simultaneous ultrasound and applanation tonometry ) , carotid-femoral pulse wave velocity , plasma endothelin-1 and angiotensin II concentrations and carotid artery vasoreactivity ( cold pressor test ) . RESULTS ST performed alone , or in conjunction with aerobic exercise , improved maximal muscle strength and increased total lean body mass ( both P < 0.01 ) . No significant changes were observed in carotid artery compliance or carotid-femoral pulse wave velocity following ST or ST+aerobic exercise . Carotid artery compliance increased significantly ( 23 % ) following stretching which may be attributed to a reduction in carotid pulse pressure . No significant changes were observed in plasma vasoconstrictor hormones or carotid artery vasoreactivity following the interventions . CONCLUSION Thirteen weeks of moderate ST two or three times per week does not reduce central arterial compliance in middle-aged and older adults .

strength training

strength training ( ST )

ST

ST

ST+aerobic exercise

aerobic exercise

ST or ST+aerobic exercise

ST

central arterial compliance

central arterial compliance

arterial compliance .

central arterial compliance

carotid arterial compliance

angiotensin II concentrations

carotid artery vasoreactivity

maximal muscle strength

increased total lean body mass

carotid artery compliance

carotid-femoral pulse wave velocity

ST or ST+aerobic exercise

Carotid artery compliance

central arterial compliance

middle-aged

older adults

decreased central arterial compliance

young

reduced baseline arterial compliance

healthy

sedentary

men

women

52+/-2 years

cardiovascular disease

carotid arterial compliance


Benzodiazepine and opioid sedation attenuate the sympathetic response to fiberoptic bronchoscopy . Prophylactic labetalol gave no additional benefit . Results of a randomized double-blind placebo-controlled study . BACKGROUND Hypertension and tachycardia are common during fiber-optic bronchoscopy ( FOB ) , and this may lead to cardiac ischemia . The prophylactic addition of a beta-adrenergic anatagonist might mask this response and prevent the deleterious cardiovascular effects of FOB . METHODS We performed a randomized double-blind placebo-controlled trial of labetalol 10mg iv given with midazolam-alfentanil sedation . We monitored heart rate ( HR ) and systolic/diastolic blood pressure ( SBP/DBP ) throughout the bronchoscopy and calculated the rate-pressure product ( RPP= ( HRxSBP ) /100 ) . One-hundred twenty patients were enrolled . RESULTS In the placebo group , there was no rise in HR , SBP , DBP or RPP , and there was no difference between the placebo and labetalol groups . Adverse events during bronchoscopy were similar in both groups . In a subgroup of patients undergoing interventional bronchoscopy , there was a trend towards lower SBP ( p=0.06 ) . CONCLUSIONS Patients undergoing FOB under adequate midazolam-alfentanil sedation do not develop excessive sympathetic drive that may lead to cardiac stress . The addition of labetalol did not confer additional benefit or risk to the patients . ( ClinicalTrials.gov number , NCT00394537 ) .

Benzodiazepine

opioid sedation

fiber-optic bronchoscopy ( FOB )

beta-adrenergic anatagonist

labetalol

midazolam-alfentanil sedation

fiberoptic bronchoscopy

cardiovascular effects of FOB

HR

SBP , DBP

RPP

Adverse events during bronchoscopy

SBP

fiberoptic bronchoscopy

fiber-optic bronchoscopy ( FOB )

One-hundred twenty

FOB


Effect of intestinal production of equol on menopausal symptoms in women treated with soy isoflavones . OBJECTIVE To evaluate the effect of soy isoflavones on menopausal symptoms in women who do and who do not produce equol , a daidzein metabolite . METHOD A randomized , double-blind , placebo-controlled clinical trial was conducted over 6 months with 96 healthy menopausal women . After taking take 135 mg of isoflavones daily for 1 week , the women in the study group were assigned to the equol-producing ( EP ) or the non-EP group according to the presence or absence of equol in their urine . Menopausal symptoms were evaluated using a modified Kupperman Index . RESULT Compared with the placebo group , the scores for hot flashes and excessive sweating were significantly reduced after 3 months , and the scores for weakness , palpitations , limb paresthesia , and total symptoms after 6 months , in the EP group only . CONCLUSIONS Isoflavone supplementation improves menopausal symptoms only in women with the ability to produce equol .

soy isoflavones

soy isoflavones

placebo-controlled

isoflavones

placebo

Isoflavone supplementation

menopausal symptoms

hot flashes and excessive sweating

weakness

palpitations

limb paresthesia

total symptoms

menopausal symptoms

96 healthy menopausal women .


Clinical trial : exposure to ribavirin predicts EVR and SVR in patients with HCV genotype 1 infection treated with peginterferon alpha-2a plus ribavirin . BACKGROUND The impact of reduced drug exposure on outcomes in patients with chronic hepatitis C has not been determined in routine clinical practice . AIM To examine the impact of exposure to peginterferon alpha-2a and ribavirin on early virological response ( EVR ) and sustained virological response ( SVR ) in treatment-naive patients with HCV genotype 1 infection enrolled in a large expanded access programme . METHODS Eight hundred and ninety-one patients treated for 48 weeks with an initial ribavirin dose of 800 or 1000/1200 mg/day were evaluated . Ribavirin 1000 mg/day ( < 75 kg ) or 1200 mg/day ( > or=75 kg ) and peginterferon alpha-2a 180 microg/week were considered optimal . The impact of reduced drug exposure ( expressed as a percentage of optimal ) on EVR and SVR was evaluated . RESULTS Mean ribavirin exposure in week 0-12 was 70 % and 96 % in patients assigned to ribavirin 800 and 1000/1200 mg/day , respectively . EVR and SVR rates were lower in patients assigned to ribavirin 800 than 1000/1200 mg/day ( EVR , 75 % vs. 84 % , respectively , P < 0.001 ; SVR , 45 % vs. 54 % , respectively , P = 0.011 ) . Furthermore , there was a strong correlation between achievement of EVR and SVR and ribavirin dose over the first 12 weeks expressed either as absolute dose or proportion of optimal dose received ( P < 0.001 for both ) . CONCLUSIONS Ribavirin exposure to week 12 is significantly associated with EVR and SVR in genotype 1 patients . Maintenance of an optimal ribavirin dose is the most important modifiable factor during combination therapy for chronic hepatitis C .

Ribavirin

peginterferon alpha-2a 180

reduced drug exposure

EVR

SVR

Mean ribavirin exposure

EVR

SVR rates

EVR

SVR

HCV genotype 1 infection

chronic hepatitis C

HCV genotype 1 infection

Eight hundred and ninety-one


Effect of radiotherapy on blood lymphocyte population in mammary carcinoma .

radiotherapy

blood lymphocyte population


The interobserver variability of digital rectal examination in a large randomized trial for the screening of prostate cancer . BACKGROUND To analyze to what extent the percentage of suspicious digital rectal examination ( DRE ) findings vary between examiners and to what extent the percentage of prostate cancers ( PCs ) detected in men with these suspicious findings varies between examiners . METHODS In the first screening round of the European Randomized study of Screening for PC ( ERSPC ) Rotterdam , 7,280 men underwent a PSA-determination and DRE of whom 2,102 underwent prostate biopsy ( biopsy indication PSA > or = 4.0 ng/ml and/or suspicious DRE and/or TRUS ) . Descriptive statistics of DRE-outcome per PSA-range were used to determine the observer variability of six examiners . Because this analysis did not correct properly for other predictors of a suspicious DRE ( PSA-level , biopsy indication , TRUS-outcome , prostate volume and age ) , a logistic regression analysis controlling for these explanatory variables was performed as well . RESULTS In 2,102 men biopsied , 443 PCs were detected ( PPV = 21 % ) . For all PSA levels the percentage suspicious DRE varied between examiners from 4 % to 28 % and percentage PC detected in men with a suspicious DRE varied from 18 % to 36 % . Logistic regression analysis showed that three of six examiners considered DRE significantly more often abnormal than others ( ORs 3.48 , 2.80 , 2.47 , P < 0.001 ) . For all examiners the odds to have PC was statistically significantly higher in case of a suspicious DRE ( ORs 2.21-5.96 , P < 0.05 ) . This increased chance to find PC was not significantly observer-dependent . CONCLUSIONS Three of six examiners considered DRE significantly more often suspicious than the others . However , under equal circumstances a suspicious DRE executed by each examiner increased the chance of the presence of PC similarly .

digital rectal examination

digital rectal examination ( DRE )

DRE

DRE

percentage suspicious DRE

percentage PC

DRE

PC

suspicious DRE

PC

DRE

DRE

PC

men

men with a

suspicious DRE


Genital responsiveness in healthy women with and without sexual arousal disorder . INTRODUCTION Most pharmacological treatments that are currently being developed for women with sexual arousal disorder are aimed at remedying a vasculogenic deficit . AIM This study investigated whether pre- and postmenopausal women with sexual arousal disorder are less genitally responsive to visual sexual stimuli than pre- and postmenopausal women without sexual problems . METHOD Twenty-nine medically healthy women with sexual arousal disorder ( 15 premenopausal and 14 postmenopausal ) , diagnosed using the Diagnostic and Statistical Manual of Mental Disorders , 4th Edition ( DSM-IV ) criteria , and 30 age-matched women without sexual problems ( 16 premenopausal and 14 postmenopausal ) were shown sexual stimuli depicting cunnilingus and intercourse . MAIN OUTCOME MEASURE Genital arousal was assessed as vaginal pulse amplitude ( VPA ) using vaginal photoplethysmography . RESULTS Results showed no significant differences between the two groups in mean and maximum VPA , nor in latency of VPA response . CONCLUSION Women with sexual arousal disorder diagnosed according to DSM-IV criteria were not less genitally responsive to visual sexual stimuli than women without such problems . These findings are in line with previous studies . The sexual problems these women report are clearly not related to their potential to become genitally aroused . We argue that the DSM-IV criteria for sexual arousal disorder are in need of revision . In medically healthy women , impaired genital responsiveness is not a valid diagnostic criterion .

vaginal photoplethysmography .

Genital responsiveness

vaginal pulse amplitude ( VPA )

vaginal photoplethysmography

mean and maximum VPA

VPA response

healthy

women

pre- and postmenopausal

women

sexual arousal disorder

Twenty-nine

healthy women

sexual arousal disorder

15 premenopausal

14 postmenopausal

without sexual problems

Women

healthy

women


Comparison of the time required to administer three different fluke and worm combination products to commercial beef cattle at housing . Larger livestock units , a decline in the farm labor force , animal welfare concerns , and a trend toward more selective use of drugs have increased the focus on animal handling , time management , convenience , and compliance in administering veterinary therapeutics . This study was undertaken to quantify and compare the time needed to treat commercial beef cattle with three fluke and worm combination products with different administration profiles . Young beef cattle ( n = 270 ) weighing approximately 400 kg were allocated to batches of five , which were randomly assigned to receive ivermectin + clorsulon injection , ivermectin + closantel injection , or levamisole + triclabendazole oral drench . The mean time needed to administer ivermectin + clorsulon ( single injection ) to five cattle was 31 seconds , which was significantly less than the 100 seconds needed for ivermectin + closantel ( two injections ) and the 126 seconds needed for levamisole + triclabendazole ( P < .001 ) . Such quantitative data can allow for better planning and selection of parasiticide treatment approaches at the farm level .

fluke and worm combination products

ivermectin + clorsulon injection

ivermectin + closantel injection

ivermectin + closantel

levamisole + triclabendazole

time required

mean time needed

planning

selection

commercial beef cattle at housing .

Young beef cattle


Testing three different cancer genetics registry recruitment methods with Hispanic cancer patients and their family members previously registered in local cancer registries in Texas . OBJECTIVE To increase accrual among Hispanics to the Cancer Genetics Network national cancer genetics registry . METHODS Drawing from South Texas cancer registries , 444 Hispanic men and women were randomly assigned to one of three experimental conditions : standard direct-mailed procedures ( X1 ) , X1 plus culturally tailored materials ( X2 ) , and X2 plus interpersonal phone contact ( X3 ) . Participants were also surveyed about the effectiveness of the education materials and the phone contact . A refusal survey was provided for those who declined to join the study . RESULTS A total of 154 individuals joined the Cancer Genetics Network . The X3 condition yielded the greatest accrual ( 43.2 % ) compared to X1 ( 30.9 % ) and X2 ( 29.9 % ; p < 0.05 ) . Tailored materials appeared to have no effect but were highly regarded . The main reasons for not participating were a lack of interest and time requirements . CONCLUSION Interpersonal communication can have a powerful effect on recruitment . However , more research is needed to determine the cost-efficacy of more labor-intensive approaches to registry accrual .

Interpersonal communication

lack of interest and time requirements

cancer

cancer

Cancer

cancer

cancer

men

women

Cancer


Effect of prophylactic transluminal balloon angioplasty on cerebral vasospasm and outcome in patients with Fisher grade III subarachnoid hemorrhage : results of a phase II multicenter , randomized , clinical trial . BACKGROUND AND PURPOSE Cerebral vasospasm continues to be a major cause of poor outcome in patients with ruptured aneurysms . Prophylactic Transluminal Balloon Angioplasty ( pTBA ) appeared to prevent delayed ischemic neurological deficit in a pilot study . A phase II multicenter randomized clinical trial was subsequently designed . METHODS One hundred and seventy patients with Fisher Grade III subarachnoid hemorrhage were enrolled in the study . Of these , 85 patients were randomized to the treatment group and underwent pTBA within 96 hours after subarachnoid hemorrhage . Main end points of the study included the 3-month dichotomized Glasgow Outcome Score ( GOS ) , development of delayed ischemic neurological deficit ( DIND ) , occurrence of Transcranial Doppler ( TCD ) vasospasm , and length of stay in the ICU and hospital . RESULTS The incidence of DIND was lower in the pTBA group ( P=0.30 ) and fewer patients required therapeutic angioplasty to treat DIND ( P=0.03 ) . Overall pTBA resulted in an absolute risk reduction of 5.9 % and a relative risk reduction of 10.4 % unfavorable outcome ( P=0.54 ) . Good grade patients had absolute and relative risk reductions of respectively 9.5 and 29.4 % ( P=0.73 ) . Length of stay in ICU and hospital was similar in both groups . Four patients had a procedure-related vessel perforation , of which three patients died . CONCLUSIONS While the trial is unsuccessful as defined by the primary end point ( GOS ) , proof of concept is confirmed by these results . Fewer patients tend to develop vasospasm after treatment with pTBA and there is a statistically significantly decreased need for therapeutic angioplasty . pTBA does not improve the poor outcome of patients with Fisher grade III subarachnoid hemorrhage .

pTBA

angioplasty

cerebral vasospasm

length of stay in the ICU

incidence of DIND

pTBA

Length of stay in ICU

procedure-related vessel perforation

vasospasm

need for therapeutic angioplasty

One hundred and seventy patients


Evaluation of a device to facilitate female urethral catheterization . Urethral catheterization is a skilled procedure that nurses in hospital settings perform routinely . The opening of the female urethra is located within the vulvar vestibule , making insertion of urinary catheters into females a greater technical challenge than in males . Researchers evaluated whether a new device might decrease the time required for catheter insertion , increase the likelihood of inserting the catheter on the first attempt ( improved accuracy ) , and reduce patient discomfort . Comments about the device from both patients and nurses also are reported .

Urethral catheterization

Evaluation

time required for catheter insertion

reduce patient discomfort

female

females


A simplified 4-site economical intradermal post-exposure rabies vaccine regimen : a randomised controlled comparison with standard methods . BACKGROUND The need for economical rabies post-exposure prophylaxis ( PEP ) is increasing in developing countries . Implementation of the two currently approved economical intradermal ( ID ) vaccine regimens is restricted due to confusion over different vaccines , regimens and dosages , lack of confidence in intradermal technique , and pharmaceutical regulations . We therefore compared a simplified 4-site economical PEP regimen with standard methods . METHODS Two hundred and fifty-four volunteers were randomly allocated to a single blind controlled trial . Each received purified vero cell rabies vaccine by one of four PEP regimens : the currently accepted 2-site ID ; the 8-site regimen using 0.05 ml per ID site ; a new 4-site ID regimen ( on day 0 , approximately 0.1 ml at 4 ID sites , using the whole 0.5 ml ampoule of vaccine ; on day 7 , 0.1 ml ID at 2 sites and at one site on days 28 and 90 ) ; or the standard 5-dose intramuscular regimen . All ID regimens required the same total amount of vaccine , 60 % less than the intramuscular method . Neutralising antibody responses were measured five times over a year in 229 people , for whom complete data were available . FINDINGS All ID regimens showed similar immunogenicity . The intramuscular regimen gave the lowest geometric mean antibody titres . Using the rapid fluorescent focus inhibition test , some sera had unexpectedly high antibody levels that were not attributable to previous vaccination . The results were confirmed using the fluorescent antibody virus neutralisation method . CONCLUSIONS This 4-site PEP regimen proved as immunogenic as current regimens , and has the advantages of requiring fewer clinic visits , being more practicable , and having a wider margin of safety , especially in inexperienced hands , than the 2-site regimen . It is more convenient than the 8-site method , and can be used economically with vaccines formulated in 1.0 or 0.5 ml ampoules . The 4-site regimen now meets all requirements of immunogenicity for PEP and can be introduced without further studies . TRIAL REGISTRATION Controlled-Trials.com ISRCTN 30087513 .

rabies vaccine

purified vero cell rabies vaccine

standard 5-dose

immunogenicity .

geometric mean antibody titres .

high antibody levels

immunogenic

immunogenicity for PEP

rabies vaccine regimen

rabies

Two hundred and fifty-four


Does 3-day course of oral amoxycillin benefit children of non-severe pneumonia with wheeze : a multicentric randomised controlled trial . BACKGROUND WHO-defined pneumonias , treated with antibiotics , are responsible for a significant proportion of childhood morbidity and mortality in the developing countries . Since substantial proportion pneumonias have a viral etiology , where children are more likely to present with wheeze , there is a concern that currently antibiotics are being over-prescribed for it . Hence the current trial was conducted with the objective to show the therapeutic equivalence of two treatments ( placebo and amoxycillin ) for children presenting with non-severe pneumonia with wheeze , who have persistent fast breathing after nebulisation with salbutamol , and have normal chest radiograph . METHODOLOGY This multi-centric , randomised placebo controlled double blind clinical trial intended to investigate equivalent efficacy of placebo and amoxicillin and was conducted in ambulatory care settings in eight government hospitals in India . Participants were children aged 2-59 months of age , who received either oral amoxycillin ( 31-54 mg/Kg/day , in three divided doses for three days ) or placebo , and standard bronchodilator therapy . Primary outcome was clinical failure on or before day- 4 . PRINCIPAL FINDINGS We randomized 836 cases in placebo and 835 in amoxycillin group . Clinical failures occurred in 201 ( 24.0 % ) on placebo and 166 ( 19.9 % ) on amoxycillin ( risk difference 4.2 % in favour of antibiotic , 95 % CI : 0.2 to 8.1 ) . Adherence for both placebo and amoxycillin was > 96 % and 98.9 % subjects were followed up on day- 4 . Clinical failure was associated with ( i ) placebo treatment ( adjusted OR = 1.28 , 95 % CI : 1.01 to1.62 ) , ( ii ) excess respiratory rate of > 10 breaths per minute ( adjusted OR = 1.51 , 95 % CI : 1.19 , 1.92 ) , ( iii ) vomiting at enrolment ( adjusted OR = 1.49 , 95 % CI : 1.13 , 1.96 ) , ( iv ) history of use of broncho-dilators ( adjusted OR = 1.71 , 95 % CI : 1.30 , 2.24 ) and ( v ) non-adherence ( adjusted OR = 8.06 , 95 % CI : 4.36 , 14.92 ) . CONCLUSIONS Treating children with non-severe pneumonia and wheeze with a placebo is not equivalent to treatment with oral amoxycillin . TRIAL REGISTRATION ClinicalTrials.gov NCT00407394 .

oral amoxycillin

placebo

amoxycillin

placebo

amoxicillin

amoxycillin

standard bronchodilator therapy

amoxycillin

amoxycillin

amoxycillin

clinical failure on or before day- 4

Clinical failures

Adherence

Clinical failure

vomiting at enrolment

history of use of broncho-dilators

non-adherence

children

non-severe pneumonia

wheeze

children

non-severe pneumonia

wheeze

children

children

non-severe pneumonia

wheeze


A pilot group therapy for functional memory disorder .

pilot group therapy

functional memory disorder


Omega-3/omega-6 fatty acids for attention deficit hyperactivity disorder : a randomized placebo-controlled trial in children and adolescents . OBJECTIVE The aim of the study was to assess omega 3/6 fatty acids ( eye q ) in attention deficit hyperactivity disorder ( ADHD ) . METHOD The study included a randomized , 3-month , omega 3/6 placebo-controlled , one-way crossover trial with 75 children and adolescents ( 8-18 years ) , followed by 3 months with omega 3/6 for all . Investigator-rated ADHD Rating Scale-IV and Clinical Global Impression ( CGI ) scale were outcome measures . RESULTS A majority did not respond to omega 3/6 treatment . However , a subgroup of 26 % responded with more than 25 % reduction of ADHD symptoms and a drop of CGI scores to the near-normal range . After 6 months , 47 % of all showed such improvement . Responders tended to have ADHD inattentive subtype and comorbid neurodevelopmental disorders . CONCLUSION A subgroup of children and adolescents with ADHD , characterized by inattention and associated neurodevelopmental disorders , treated with omega 3/6 fatty acids for 6 months responded with meaningful reduction of ADHD symptoms .

Omega-3/omega-6 fatty acids

omega 3/6 fatty acids

omega 3/6

placebo-controlled

3 months with omega 3/6 for all

omega 3/6 fatty acids

reduction of ADHD symptoms

drop of CGI scores

ADHD

ADHD

reduction of ADHD symptoms .

children and adolescents .


Immunoenhanced enteral nutrition formulas in head and neck cancer surgery : a prospective , randomized clinical trial . INTRODUCTION Significant malnutrition exists in a high percentage of patients with head and neck cancer . Malnutrition is associated with defects in immune function that may impair the host response to malignancy . Malnutrition and immunosupression make patients highly susceptible to postoperative infections and complications . OBJECTIVES Compare two immunoenhanced enteral nutritions with a control diet , and evaluate the effect in postoperative infections , length of stay and inflammatory markers . PATIENTS A population of 44 patients with oral and laryngeal cancer was enrolled in a randomized trial . At surgery , patients were randomly allocated to three groups : ( group I ) ; patients receiving an arginine-enhanced formula ( group II ) ; patients receiving a standard polymeric formula , and ( group III ) patients receiving an arginine , RNA and omega-3 fatty acids enhanced formula , in an isonitrogenous way . RESULTS The duration of enteral nutrition in the three groups was similar with an average duration of 14,5 +/- 8 days . The length of postoperative stay was similar , with an average of 19,8 +/- 8,5 days . Wound infections and general infections were more frequent in the control group . Fistula rates were not improved in the enhanced diet groups . No significant intergroup differences in the trend of the two plasma proteins ( albumin , transferrin ) , lymphocytes , weight , IL-6 , CPR and TNFalpha were detected . The control group showed the highest levels of TNFalpha at the fourteenth postoperative day . Gastrointestinal tolerance and diarrhoea rate were similar in all the patients . CONCLUSIONS Immunoenhanced enteral nutrition formulas improved the infection rate in the postoperative of head and neck cancer patients . In the fistula rates , we observed that technical problems and nutritional status might have played an equally important role , and therefore the positive effect of immunonutrition in this parameter might have been overestimated .

duration of enteral nutrition

Wound infections and general infections

TNFalpha

cancer

cancer

44 patients

oral and laryngeal cancer

cancer


Predictive validity of a medication adherence measure in an outpatient setting . This study examines the psychometric properties and tests the concurrent and predictive validity of a structured , self-reported medication adherence measure in patients with hypertension . The authors also assessed various psychosocial determinants of adherence , such as knowledge , social support , satisfaction with care , and complexity of the medical regimen . A total of 1367 patients participated in the study ; mean age was 52.5 years , 40.8 % were male , 76.5 % were black , 50.8 % graduated from high school , 26 % were married , and 54.1 % had income < $ 5,000 . The 8-item medication adherence scale was reliable ( alpha=.83 ) and significantly associated with blood pressure control ( P < .05 ) . Using a cutpoint of < 6 , the sensitivity of the measure to identify patients with poor blood pressure control was estimated to be 93 % , and the specificity was 53 % . The medication adherence measure proved to be reliable , with good concurrent and predictive validity in primarily low-income , minority patients with hypertension and might function as a screening tool in outpatient settings with other patient groups .

medication adherence

psychosocial determinants of adherence

knowledge

social support

satisfaction with care

complexity of the medical regimen

blood pressure control

blood pressure control

hypertension

A total of

52.5 years

, 40.8 % were

male


Randomized clinical study comparing Compeed cold sore patch to acyclovir cream 5 % in the treatment of herpes simplex labialis . BACKGROUND Hydrocolloid technology has been proven effective in treating dermal wounds . A previous study showed that a newly developed thin hydrocolloid patch [ Compeed cold sore patch ( CSP ) ] provided multiple wound-healing benefits across all stages of a herpes simplex labialis ( HSL ) outbreak . METHODS An assessment of CSP efficacy and safety was conducted in an international , multicentre , assessor-blinded study , which enrolled 728 subjects with a history of recurrent HSL . Of these , 351 experienced an HSL outbreak and were randomized to use CSP ( n = 179 ) or acyclovir cream 5 % ( n = 172 ) at the onset of symptoms until the lesion healed , for a maximum of 10 days . The primary end point was the subject 's global assessment of therapy ( SGAT ; 0-10 scale ; 0 = no response , 10 = excellent response ) . Multiple secondary end points included clinician-assessed healing time and subject assessment of lesion protection , noticeability and social embarrassment . RESULTS CSP and acyclovir were highly effective ( mean SGAT = 7.89 and 8.00 , respectively ) , with no significant difference observed ( P = 0.65 ) . The difference in healing times between products was not significant ( median , 7.57 days with CSP vs. 7.03 days with acyclovir , P = 0.37 ) . Both treatments were well tolerated . CONCLUSION CSP using hydrocolloid technology provides an efficacious and safe alternative to topical antivirals in treating HSL as a wound while affording additional immediate benefits of wound protection , discretion and relief of social embarrassment .

Compeed cold sore patch

acyclovir cream 5 %

acyclovir cream 5 %

CSP

acyclovir

CSP using hydrocolloid technology

subject 's global assessment of therapy

healing times between products

efficacious and safe

herpes simplex labialis .

herpes simplex labialis

HSL


Effect of esomeprazole triple therapy on eradication rates of Helicobacter pylori , gastric ulcer healing and prevention of relapse in gastric ulcer patients . OBJECTIVES To compare esomeprazole-based triple therapy with esomeprazole alone for the eradication of Helicobacter pylori ( H. pylori ) , healing of ulcer and prevention of relapse in H. pylori-related gastric ulcer ( GU ) diseases . METHODS In this double-blind study , 401 H. pylori-positive patients with more than or equal to two GUs were randomized to : esomeprazole ( 20 mg ) twice daily ( bid ) and amoxicillin ( 1000 mg ) bid and clarithromycin ( 500 mg ) bid ( EAC ) for 1 week , followed by placebo for 3 weeks ( EAC and placebo ) ; EAC for 1 week , followed by esomeprazole ( 20 mg ) once daily ( E20 ) for 3 weeks ( EAC and E20 ) ; or esomeprazole ( 20 mg ) bid and placebo antimicrobials for 1 week , followed by E20 for 3 weeks ( E20 bid and E20 ) . Patients with unhealed GUs at 4 weeks received E20 for an additional 4 weeks . Healed patients were followed up for 12 months . RESULTS Eradication rates at 4 weeks or 8 weeks were 82 % for EAC and E20 , 77 % for EAC and placebo and 9.5 % for E20 bid and E20 ( intention-to-treat analysis ) . Significantly more patients receiving EAC than those receiving esomeprazole alone remained free of GUs during follow-up [ EAC and E20 , 90 % ; EAC and placebo , 87 % ; P=0.0005 for combined group vs. esomeprazole alone [ E20 bid and E20 ( 74 % ) ] . All treatments were well tolerated . CONCLUSION Esomeprazole-based triple therapy is effective for the eradication of H. pylori , healing of GU and prevention of relapse . Esomeprazole monotherapy for 3 weeks after triple therapy may be beneficial in terms of healing .

esomeprazole triple therapy

esomeprazole-based

esomeprazole

amoxicillin

clarithromycin

placebo

esomeprazole

esomeprazole

placebo antimicrobials

Esomeprazole-based

gastric ulcer healing

and prevention of relapse

eradication of Helicobacter pylori ( H.

prevention of relapse

Eradication rates

remained free of GUs

tolerated

effective

eradication of H. pylori ,

healing of GU

and prevention of relapse .

beneficial

gastric ulcer


Science to practice in underserved communities : the effectiveness of school mental health programming . This study examined the effectiveness of a treatment program comprised of several components based on evidence-based treatments ( EBTs ) for disruptive behavior problems delivered to youth participating in a school mental health program in an underserved community in the Appalachian region . Participants were 117 children in kindergarten through 6th grade including 91 children ( 78 % male ) from 5 schools who were consecutively referred to the intervention program and 26 children ( 73 % male ) from 3 schools in which program implementation was delayed for 1 year . Treatment outcome was measured via parent and teacher ratings of child symptoms and functioning . The treatment condition resulted in significant reduction in hyperactivity/impulsivity and early aggressive and delinquent behavior , as well as significant improvement in several other functional domains . Results suggest that EBTs can retain their effectiveness when transported to a community context .

school mental health programming

treatment program

intervention program

EBTs

effectiveness

effectiveness

disruptive behavior problems

youth

children

male

children

male


Atypical recruitment of medial prefrontal cortex in autism spectrum disorders : an fMRI study of two executive function tasks . Recent studies have suggested an uneven profile of executive dysfunction in autism spectrum disorders ( ASD ) . For example , some authors have reported deficits on newly developed tests of executive function sensitive to rostral prefrontal function , despite spared , or even superior , performance on other tests . We investigated the performance of a group of high-functioning participants with ASD ( N=15 ) and an age- and IQ-matched control group ( N=18 ) on two executive function tests , whilst undergoing functional magnetic resonance imaging ( fMRI ) . Behaviourally , there were no significant differences between the two groups . In a classical test of executive function ( random response generation ) , BOLD signal differed between the groups in the cerebellum but not in the frontal lobes . However , on a new test of executive function ( selection between stimulus-oriented and stimulus-independent thought ) , the ASD group exhibited significantly greater signal-change in medial rostral prefrontal cortex ( especially Brodmann Area 10 ) in the comparison of stimulus-oriented versus stimulus-independent attention . In addition , the new test ( but not the classical test ) provided evidence for abnormal functional organisation of medial prefrontal cortex in ASD . These results underline the heterogeneity of different tests of executive function , and suggest that executive functioning in ASD is associated with task-specific functional change .

fMRI

two executive function tests

classical test of executive function

new test of executive function

BOLD signal

autism spectrum disorders :

autism spectrum disorders ( ASD ) .

and

ASD .

ASD


Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma ( MS01 ) : a multicentre randomised trial . BACKGROUND Malignant pleural mesothelioma is almost always fatal , and few treatment options are available . Although active symptom control ( ASC ) has been recommended for the management of this disease , no consensus exists for the role of chemotherapy . We investigated whether the addition of chemotherapy to ASC improved survival and quality of life . METHODS 409 patients with malignant pleural mesothelioma , from 76 centres in the UK and two in Australia , were randomly assigned to ASC alone ( treatment could include steroids , analgesic drugs , bronchodilators , palliative radiotherapy [ n=136 ] ) ; to ASC plus MVP ( four cycles of mitomycin 6 mg/m2 , vinblastine 6 mg/m2 , and cisplatin 50 mg/m2 every 3 weeks [ n=137 ] ) ; or to ASC plus vinorelbine ( one injection of vinorelbine 30 mg/m2 every week for 12 weeks [ n=136 ] ) . Randomisation was done by minimisation , with stratification for WHO performance status , histology , and centre . Follow-up was every 3 weeks to 21 weeks after randomisation , and every 8 weeks thereafter . Because of slow accrual , the two chemotherapy groups were combined and compared with ASC alone for the primary outcome of overall survival . Analysis was by intention to treat . This study is registered , number ISRCTN54469112 . FINDINGS At the time of analysis , 393 ( 96 % ) patients had died ( ASC 132 [ 97 % ] , ASC plus MVP 132 [ 96 % ] , ASC plus vinorelbine 129 [ 95 % ] ) . Compared with ASC alone , we noted a small , non-significant survival benefit for ASC plus chemotherapy ( hazard ratio [ HR ] 0.89 [ 95 % CI 0.72-1.10 ] ; p=0.29 ) . Median survival was 7.6 months in the ASC alone group and 8.5 months in the ASC plus chemotherapy group . Exploratory analyses suggested a survival advantage for ASC plus vinorelbine compared with ASC alone ( HR 0.80 [ 0.63-1.02 ] ; p=0.08 ) , with a median survival of 9.5 months . There was no evidence of a survival benefit with ASC plus MVP ( HR 0.99 [ 0.78-1.27 ] ; p=0.95 ) . We observed no between-group differences in four predefined quality-of-life subscales ( physical functioning , pain , dyspnoea , and global health status ) at any of the assessments in the first 6 months . INTERPRETATION The addition of chemotherapy to ASC offers no significant benefits in terms of overall survival or quality of life . However , exploratory analyses suggested that vinorelbine merits further investigation .

ASC

steroids

analgesic drugs

bronchodilators

palliative radiotherapy

ASC plus MVP

mitomycin

vinblastine

cisplatin

ASC plus vinorelbine

vinorelbine

survival

quality of life

died

non-significant survival benefit

Median survival

survival advantage

median survival

survival benefit

survival

or

quality of life