Use of a DNAemia cut-off for monitoring human cytomegalovirus infection reduces the number of preemptively treated children and young adults receiving hematopoietic stem-cell transplantation compared with qualitative pp65 antigenemia . We performed a randomized trial comparing the use of quantitative DNAemia versus positive antigenemia for starting preemptive antihuman cytomegalovirus ( HCMV ) therapy in hematopoietic stem-cell transplantation ( HSCT ) recipients . In the DNAemia arm , antiviral therapy was initiated on reaching a DNAemia cut-off of 10 000 DNA copies/mL of whole blood , whereas in the antigenemia arm , therapy was started in the presence of a positive antigenemia . The aim of the study was to compare the number of patients treated in the 2 arms . On the whole , 178 patients ( 89 in each arm ) , receiving unmanipulated HSCT from either a relative or an unrelated donor , completed the study . Although the incidence of HCMV infection was comparable in DNAemia and antigenemia arms ( 34 % vs 42 % , respectively , P = .259 ) , the number of patients treated was significantly lower in the DNAemia arm ( 18 % vs 31 % , P = .026 ) . No patient developed HCMV disease . The use of a DNAemia cut-off avoids unnecessary antiviral treatment .

DNAemia cut-off

qualitative pp65 antigenemia

quantitative DNAemia

positive antigenemia

DNAemia

antiviral therapy

DNAemia cut-off

positive antigenemia

unmanipulated HSCT

DNAemia

DNAemia cut-off

antiviral treatment

number of preemptively treated children

HCMV infection

number of patients treated

HCMV disease


Long-term growth hormone treatment in growth hormone deficient adults . Growth hormone treatment in GH-deficient adults has proved beneficial in recent short-term trials , but long-term results have not yet been reported . Thirteen GH-deficient adults ( 4 females , 9 males ; mean ( SEM ) age 26.4 ( 1.7 ) years ) , who had completed 4 months of GH therapy in a double-blind placebo-controlled cross-over study were followed , for further 16.1 ( 0.8 ) months of uninterrupted GH therapy in an open design . A significant mean increase of 1.3 cm in linear height was recorded , whereas body mass index remained unchanged . Mean muscle volume of the thigh , estimated by computerised tomography , increased significantly compared with that of the initial placebo period ( p = 0.01 ) , and a slight decrease was recorded in adipose tissue volume of the thigh ( p = 0.10 ) and subscapular skinfold thickness ( p = 0.10 ) . Still , the muscle to fat ratio of the thigh was significantly lower compared with that of normal subjects ( 72.6/27.4 vs 77.9/22.1 ) ( p less than 0.01 ) . The mean isometric strength of the quadriceps muscles increased significantly during long-term GH therapy ( p less than 0.01 ) , but remained lower compared with that of normal subjects ( 1.66 ( 0.10 ) vs 2.13 ( 0.11 ) Nm/kg body weight ) . Exercise capacity performed on a bicycle ergometer increased significantly after long-term therapy ( p less than 0.05 ) , but still did not reach the values seen in normal subjects ( 22.5 ( 3.4 ) vs 37.4 ( 4.2 ) watt.min.kg-1 . No adverse reactions were recorded during long-term therapy and hemoglobin A1c remained unchanged . These data suggest that long-term GH replacement therapy in GH-deficient adults has beneficial effects on several physiological features which are subnormal in these patients .

Growth hormone treatment

GH therapy

placebo-controlled

GH therapy

placebo

linear height

body mass index

Mean muscle volume of the thigh

adipose tissue volume of the thigh

subscapular skinfold thickness

muscle to fat ratio of the thigh

Exercise capacity

adverse reactions

hemoglobin A1c

growth hormone deficient

adults

GH-deficient adults

Thirteen

GH-deficient adults

females

males

normal


Parenteral amino acid and metabolic acidosis in premature infants . BACKGROUND Aggressive parenteral nutrition ( PN ) including amino acids is recommended for low-birth-weight infants to prevent energy and protein deficit . Their impact on acid-base homeostasis has not been examined . METHODS We investigated the impact of dose and duration of parenteral amino acids , with cysteine , on acid-base parameters in 122 low-birth-weight infants . Premature infants < or=32 weeks , < or=1850 g , and receiving parenteral amino acids at 1.5 g/kg/d for an extended period ( > 24 hours ) , or 3 g/kg/d for a short ( 5 hour ) , extended ( 24 hour ) , or prolonged ( 3-5 days ) duration were included in the study . Data were obtained at age 0-3 days ( n = 43 ) or , when clinically stable , age 3-5 days ( n = 49 ) . Data from 30 infants , matched for birth weight and gestational age , receiving PN during the first 5 days after birth were also obtained . Acidosis was defined as pH < 7.25 . RESULTS Acidosis was evident in all infants between 2 and 5 days after birth . Infants with large patent ductus arteriosus ( PDA ) exhibited significantly ( p < .05 ) lower pH early , had higher blood urea nitrogen levels ( 26 +/- 9 vs 18 + 8 mg/dL ; p < .05 ) , and had greater weight loss ( approximately 17 % of birth weight ) when compared with infants without PDA . Gestational age , weight loss , and patent ductus arteriosus accounted for 65 % of variance in acidosis . CONCLUSIONS Low-birth-weight infants develop metabolic acidosis between 2 and 5 days after birth , irrespective of dose and duration of parenteral amino acid administration . Careful management of parenteral fluids and comorbidities may lower the incidence of acidosis and promote protein accretion .

Parenteral amino acid

parenteral amino acids

cysteine

parenteral amino acids

PN

parenteral amino acid administration

parenteral fluids

Acidosis

lower pH

blood urea nitrogen levels

greater weight loss

Gestational age

weight loss

patent ductus arteriosus


Improvement in sensory impairment and social interaction in young children with autism following treatment with an original Qigong massage methodology . In clinical research , sensory impairment is considered one of the core deficits in autism and is associated with impaired socialization , behavioral disturbances and bowel and sleep problems . The effectiveness of the Cignolini methodology , an original Qigong massage methodology , in treating sensory impairment in young children with autism was evaluated in a small , controlled study . Thirteen children with autism between the ages of three and six received daily treatment according to the methodology for 5 months . Compared with untreated children , treated children experienced significant improvement of their sensory impairment ( p < 0.01 ) , and demonstrated increased social skills ( p < 0.04 ) and basic living skills ( p < 0.02 ) on standardized measures . In addition , all of the children with bowel and sleep abnormalities demonstrated improvement after treatment .

original Qigong massage methodology

sensory impairment

social skills

basic living skills

young children with autism

sensory impairment in young children

Thirteen children

with autism

between the ages of three and six


Effects of low-level laser and plyometric exercises in the treatment of lateral epicondylitis . OBJECTIVE This study was undertaken to compare the effectiveness of a protocol of combination of laser with plyometric exercises and a protocol of placebo laser with the same program , in the treatment of tennis elbow . BACKGROUND DATA The use of low-level laser has been recommended for the management of tennis elbow with contradictory results . Also , plyometric exercises was recommended for the treatment of the tendinopathy . METHODS Fifty patients who had tennis elbow participated in the study and were randomised into two groups . Group A ( n = 25 ) was treated with a 904 Ga-As laser CW , frequency 50 Hz , intensity 40 mW and energy density 2.4 J/cm ( 2 ) , plus plyometric exercises and group B ( n = 25 ) that received placebo laser plus the same plyometric exercises . During eight weeks of treatment , the patients of the two groups received 12 sessions of laser or placebo , two sessions per week ( weeks 1-4 ) and one session per week ( weeks 5-8 ) . Pain at rest , at palpation on the lateral epicondyle , during resisted wrist extension , middle finger test , and strength testing was evaluated using Visual Analogue Scales . Also it was evaluated the grip strength , the range of motion and weight test . Parameters were determined before the treatment , at the end of the eighth week course of treatment ( week 8 ) , and eighth ( week 8 ) after the end of treatment . RESULTS Relative to the group B , the group A had ( 1 ) a significant decrease of pain at rest at the end of 8 weeks of the treatment ( p < 0.005 ) and at the end of following up period ( p < 0.05 ) , ( 2 ) a significant decrease in pain at palpation and pain on isometric testing at 8 weeks of treatment ( p < 0.05 ) , and at 8 weeks follow-up ( p < 0.001 ) , ( 3 ) a significant decrease in pain during middle finger test at the end of 8 weeks of treatment ( p < 0.01 ) , and at the end of the follow-up period ( p < 0.05 ) , ( 4 ) a significant decrease of pain during grip strength testing at 8 weeks of treatment ( p < 0.05 ) , and at 8 weeks follow-up ( p < 0.001 ) , ( 5 ) a significant increase in the wrist range of motion at 8 weeks follow-up ( p < 0.01 ) , ( 6 ) an increase in grip strength at 8 weeks of treatment ( p < 0.05 ) and at 8 weeks follow-up ( p < 0.01 ) , and ( 7 ) a significant increase in weight-test at 8 weeks of treatment ( p < 0.05 ) and at 8 weeks follow-up ( p < 0.005 ) . CONCLUSION The results suggested that the combination of laser with plyometric exercises was more effective treatment than placebo laser with the same plyometric exercises at the end of the treatment as well as at the follow-up . Future studies are needed to establish the relative and absolute effectiveness of the above protocol .

laser with plyometric exercises

placebo laser with the same program

low-level laser

plyometric exercises

904 Ga-As laser CW

plus plyometric exercises

laser or

placebo

strength testing

Visual Analogue Scales

grip strength

range of motion

weight test

pain at rest

pain during middle finger test

pain during grip strength testing

wrist range of motion

grip strength

weight-test

lateral epicondylitis .

tennis elbow .

tennis elbow


A comparison of the laryngeal tube-S and Proseal laryngeal mask during outpatient surgical procedures . BACKGROUND AND OBJECTIVE The Laryngeal Tube Sonda ( LTS ) and the ProSeal Laryngeal Mask Airway ( PLMA ) are two new devices introduced for maintaining the airway during controlled ventilation under general anaesthesia . The present investigation compared their performance in a randomized controlled study . METHODS One hundred ASA I-II patients , aged 18-60 yr undergoing elective minor surgery , were randomized to receive either an LTS ( n = 50 ) or PLMA ( n = 50 ) for airway management . After induction of general anaesthesia , the devices were inserted , its correct placement was verified and airway leak pressure was measured . Ease of insertion , quality of airway seal , fibre-optic view and postoperative pharyngeal morbidity were examined . RESULTS There were no differences in patient characteristics for both groups . First-time and second-time success rates were comparable for both groups ( 86 vs. 88 % and 96 vs. 98 % in LTS and PLMA groups , respectively ) . The airway of one patient in each group could not be managed with these devices after three attempts . Time until delivery of first tidal volume for LTS and PLMA was 24.5 +/- 6.9 and 28.8 +/- 10.3 s. Fixation and manipulation time was 54.9 +/- 15.2 and 73.2 +/- 25 s , respectively ( P < 0.05 ) . Airway seal pressure ( cm H ( 2 ) O ) for LTS and PLMA was 20 +/- 8.6 and 24.1 +/- 10.8 , respectively ( P = 0.04 ) . Patients were questioned on a variety of postoperative pharyngeal morbidities . Only hoarseness was more frequent in the LTS group . CONCLUSIONS Both devices provide a secure airway , are similar in clinical utility and are easy to insert . Better airway seal was detected in the PLMA group .

laryngeal tube-S

Proseal laryngeal mask

Laryngeal Tube Sonda ( LTS )

ProSeal Laryngeal Mask Airway ( PLMA )

LTS

PLMA

Ease of insertion

quality of airway seal

fibre-optic view

postoperative pharyngeal morbidity

airway

Fixation

manipulation

Airway seal pressure

postoperative pharyngeal morbidities

hoarseness

airway seal

outpatient surgical procedures

general anaesthesia

One hundred

ASA I-II patients

18-60 yr

elective minor surgery


A prospective , randomized trial of clear liquids versus low-fat solid diet as the initial meal in mild acute pancreatitis . BACKGROUND & AIMS Patients recovering from mild acute pancreatitis typically receive a clear liquid diet ( CLD ) when ready to initiate oral nutrition . Patient discharge then depends on their successful advancement to solid food . We hypothesized that initiating oral nutrition with a low-fat solid diet ( LFSD ) after mild pancreatitis would be well tolerated and would result in a shorter length of hospitalization ( LOH ) . METHODS Patients with mild pancreatitis were randomized to a CLD or LFSD when they were ready to resume oral nutrition . Decisions about diet advancement and hospital discharge were at the discretion of the medical team , without input from study team members . Patients were monitored daily for recurrence of pain , need to stop feeding , post-refeeding LOH ( primary end point ) , and for 28 days post-refeeding to capture re-admission rates . RESULTS We randomized 121 patients : 66 to CLD and 55 to LFSD . The number of patients requiring cessation of feeding because of pain or nausea was similar in both groups ( 6 % for CLD , 11 % for LFSD ; P = .51 ) . The median LOH after refeeding was identical in both groups ( 1-day interquartile range , 1-2 ; P = .77 ) . Patients in the LFSD arm consumed significantly more calories and grams of fat than those in the CLD arm during their first meal and on study day 1 . There was no difference in the 28-day re-admission rates between the 2 arms . CONCLUSIONS Initiating oral nutrition after mild acute pancreatitis with an LFSD appeared safe and provided more calories than a CLD , but did not result in a shorter LOH .

clear liquid diet ( CLD )

CLD

LFSD

length of hospitalization

pain

need to stop feeding

post-refeeding LOH

re-admission rates

because of pain or

nausea

median LOH after refeeding

calories and grams of fat

28-day re-admission rates

mild acute pancreatitis

LFSD

LOH

mild acute pancreatitis .

mild acute pancreatitis

mild pancreatitis


Codeine/acetaminophen and hydrocodone/acetaminophen combination tablets for the management of chronic cancer pain in adults : a 23-day , prospective , double-blind , randomized , parallel-group study . BACKGROUND Analgesics are an essential component of the treatment of cancer-associated pain . Pharmacologic treatment is usually begun with nonopioid analgesics , most frequently acetaminophen . If pain relief is not achieved , the so-called " weak " opioids , such as codeine and hydrocodone , may be used in combination with acetaminophen . Adverse effects ( AEs ) of the opioids include constipation , somnolence , nausea , and vomiting . Based on the results of a literature search , data comparing the effects of the opioids are lacking . OBJECTIVE The purpose of this study was to compare the analgesic efficacy and tolerability of codeine phosphate versus hydrocodone bitartrate in combination with acetaminophen in the relief of cancer-related pain . METHODS This 23-day , prospective , double-blind , randomized , parallel-group study was conducted at 3 Colombian centers : University Libre , Social Security Institute , and General Hospital of Medellín , Cali , Colombia . Outpatients with cancer were eligible for the study if they were aged > -18 years and had chronic ( duration , > /= 3 months ) moderate to severe cancer-related pain ( score on 10-cm visual analog scale [ VAS ] , > 3 cm [ moderate ] ; score on a 4-point verbal pain-intensity scale , > 1 [ moderate ] ) . Eligible patients were randomly assigned to receive 1 tablet of codeine/acetaminophen ( C/A ) 30/500 mg or hydrocodone/acetaminophen ( H/A ) 5/500 mg PO q4h ( total daily doses , 150/2500 and 25/2500 mg , respectively ) for 23 days . In both groups , if pain intensity was rated as > 3 on the VAS at week 1 or 2 , the dosage was doubled . The primary end point was the proportion of patients who achieved pain relief ( defined as a score of > 1 on a 5-point verbal rating scale [ VRS ] ( 0 = none ; 1 = a little ; 2 = some ; 3 = a lot ; and 4 = complete ) on study days 1 and 2 and weeks 1 , 2 , and 3 . The secondary end point was the proportion of patients in whom pain was decreased ( VAS score , < - 3 cm ) . AEs were self-reported on a 4-point VRS ( 0 = absent ; 1 = mild ; 2 = moderate ; and 3 = severe ) . RESULTS Of the 121 patients who participated , 59 received C/A and 62 received H/A . Of the total number of cases , 59 % were aged 60 to 89 years , and 55 % were men . At baseline , 88 % of the patients described their pain intensity as moderate ; 12 % , severe . Of the patients who received C/A , 58 % responded to the initial dosage of 150/2500 mg/d , and 8 % of the patients responded to the double dosage ; 34 % did not experience pain relief . In patients with H/A , pain was reported as absent or mild in 56 % of patients at the starting dosage of 25/2500 mg/d ; an additional 15 % of the patients responded to the double dosage ; the remaining 29 % of patients did not experience any pain relief . None of the between-group differences in response rates were significant . The most common AEs in the C/A and H/A groups were constipation ( 36 % and 29 % , respectively ) , dizziness ( 24 % and 19 % ) , vomiting ( 24 % and 16 % ) , and dry mouth ( 15 % and 18 % ) , with no significant differences between groups . CONCLUSION In this study , efficacy and tolerability were comparable between C/A and H/A over 23 days of treatment in these patients with moderate or severe , chronic , cancer-related pain .

Codeine/acetaminophen

hydrocodone/acetaminophen combination

acetaminophen

codeine and hydrocodone

combination with acetaminophen

codeine phosphate

hydrocodone bitartrate

acetaminophen

pain relief

analgesic efficacy and tolerability

chronic cancer pain

adults

> -18 years

aged 60 to 89 years

men


Parenteral nutrition and protein sparing after surgery : do we need glucose ? Although capable of inducing an anabolic state after surgery , parenteral nutrition , including glucose , leads to hyperglycemia . Even moderate increases in blood glucose are associated with poor surgical outcome . We examined the hypothesis that amino acids , in the absence of glucose supply , spare protein while preventing hyperglycemia . In this prospective study , 14 patients with colonic cancer were randomly assigned to undergo a 6-hour stable isotope infusion study ( 3 hours of fasting followed by 3-hour infusions of amino acids , Travasol [ Baxter , Montreal , Canada ] 10 % at 0.02 mL.kg ( -1 ) .min ( -1 ) , with or without glucose at 4 mg.kg ( -1 ) .min ( -1 ) ) on the second day after colorectal surgery . Protein breakdown , protein oxidation , protein balance , and glucose production were assessed by stable isotope tracer kinetics using l- [ 1- ( 13 ) C ] leucine and [ 6,6- ( 2 ) H2 ] glucose . Circulating concentrations of glucose , cortisol , insulin , and glucagon were determined . The administration of amino acids increased protein balance from -16+/-4 micromol.kg ( -1 ) .h ( -1 ) in the fasted state to 16+/-3 micromol.kg ( -1 ) .h ( -1 ) . Combined infusion of amino acids and glucose increased protein balance from -17+/-7 to 7+/-5 micromol.kg ( -1 ) .h ( -1 ) . The increase in protein balance during nutrition was comparable in the 2 groups ( P=.07 ) . Combined administration of amino acids and glucose decreased endogenous glucose production ( P=.001 ) and stimulated insulin secretion ( P=.001 ) to a greater extent than the administration of amino acids alone . Hyperglycemia ( blood glucose , 10.1+/-1.9 micromol/L ) occurred only in the presence of glucose infusion . In summary , excluding glucose from a short-term feeding protocol does not diminish the protein-sparing effect of amino acids and avoids hyperglycemia .

surgery

glucose

parenteral nutrition

glucose

amino acids

glucose

isotope infusion

fasting

amino acids

with or without glucose

amino acids

amino acids

glucose

amino acids

glucose

glucose

amino acids

Protein breakdown

protein oxidation

protein balance

glucose production

Circulating concentrations of glucose

cortisol

insulin

glucagon

protein balance

protein balance

protein balance

endogenous glucose production

insulin secretion

Hyperglycemia

protein-sparing effect

hyperglycemia

colonic cancer


Observer variation in the assessment of outcome in traumatic brain injury : experience from a multicenter , international randomized clinical trial . OBJECTIVE Accurate and consistent outcome assessment is essential to randomized clinical trials . We aimed to explore observer variation in the assessment of outcome in a recently completed trial of dexanabinol in head injury and to consider steps to reduce such variation . METHODS Eight hundred sixty-one patients with severe traumatic brain injury who were admitted to 86 centers were included in a multicenter , placebo-controlled , Phase III trial . Outcome was assessed at 3 and 6 months postinjury using the extended Glasgow Outcome Scale ; standardized assessment was facilitated by the use of a structured interview . Before initiation of trial centers , outcome ratings were obtained for sample cases to establish initial levels of agreement . Training sessions in outcome assessment were held , and problems in assigning outcome were investigated . During the trial , a process of central review was established to monitor performance . Interobserver variation was analyzed using the kappa statistic . RESULTS Substantial observer variation was found in the rating of sample cases ( weighted kappa , 0.72 ; confidence interval , 0.68-0.75 ) and in assigning outcome based on completed structured interviews ( weighted kappa , 0.61 ; confidence interval , 0.57-0.64 ) . In the early stages of the trial , a relatively large number of discrepancies ( 29-37 % ) were identified on central review . This number declined as the trial progressed and coincided with investigator training and feedback from central review . Centers with higher enrollment rates showed better performance . CONCLUSION Observer variation in outcome assessment is a significant problem for head injury trials . Consistency can be improved by standardizing procedures , training assessors , and monitoring the quality of assessments and providing feedback to interviewers .

dexanabinol

placebo-controlled

assessment of outcome

outcome assessment

assessment of outcome

extended Glasgow Outcome Scale ;

outcome ratings

Substantial observer variation

outcome

discrepancies

Observer variation

outcome assessment

Consistency

head injury

Eight hundred sixty-one patients

severe traumatic brain injury


The peroxisome proliferator-activated receptor-gamma agonist pioglitazone increases number and function of endothelial progenitor cells in patients with coronary artery disease and normal glucose tolerance . OBJECTIVE Peroxisome proliferator-activated receptor-gamma ( PPAR gamma ) agonists ( thiazolidinediones [ TZDs ] ) are used for the treatment of diabetes . Bone marrow-derived endothelial progenitor cells ( EPCs ) improve vascular function and predict cardiovascular risk . The effect of pioglitazone therapy on EPCs was examined . RESEARCH DESIGN AND METHODS AND RESULTS We performed a prospective , randomized , double-blind study on patients with documented stable coronary artery disease and normal glucose tolerance . Of 54 patients with normal fasting glucose levels , 18 showed impaired glucose tolerance and 36 patients with normal glucose tolerance were randomized to 30-day treatment with pioglitazone ( 45 mg ) or placebo in addition to optimal medical therapy . All patients in the TZD group showed an increase of adiponectin levels as an indicator of compliance ( 11.4 +/- 1.1 to 36.8 +/- 2.1 microg/ml ; P < 0.001 ) . TZD , but not placebo , decreased mean high-sensitivity C-reactive protein to 43 +/- 19 % ( P < 0.05 ) . Pioglitazone increased CD34 ( + ) /kinase insert domain receptor ( + ) EPCs to 142 +/- 9 % and cultured 1,1'-dioctadecyl-3,3,3',3'-tetramethylindocarbocyanine-labeled acetylated LDL ( + ) /lectin ( + ) EPCs to 180 +/- 3 % ( P < 0.05 ) . EPC numbers were not changed in the placebo group . TZD increased the SDF-1-induced migratory capacity to 146 +/- 9 % per EPC number ( P < 0.05 ) and upregulated the clonogenic potential of EPCs , increasing the colony-forming units to 172 +/- 12 % ( P < 0.001 ) . In cultured human EPCs , TZD increased EPC numbers and migration and reduced NADPH-oxidase activity . The TZD effect was reversed by the PPAR gamma antagonist GW9662 and mimicked by treatment with adiponectin . CONCLUSIONS The PPAR gamma agonist pioglitazone increases the number and function of EPCs in patients with coronary artery disease . The effect represents a potential regenerative mechanism in atherosclerosis and is observed in normoglycemic individuals with stable coronary artery disease .

pioglitazone

thiazolidinediones [ TZDs ]

pioglitazone

pioglitazone

placebo

in addition to optimal medical therapy

TZD

TZD

placebo

TZD

TZD

pioglitazone

vascular function

cardiovascular risk .

adiponectin levels

EPC numbers

SDF-1-induced migratory capacity

clonogenic potential of EPCs

colony-forming units

number and function of EPCs


Efficacy and safety of sildenafil in Asian males with erectile dysfunction and cardiovascular risk . OBJECTIVE Assess the effectiveness of sildenafil in Asian males with erectile dysfunction ( ED ) and one or more of the co-morbidities , mild-to-moderate hypertension , dyslipidemia , and diabetes . MATERIAL AND METHOD A six-week , double-blind , randomized , placebo-controlled , multicenter study was carried out in Thailand , Malaysia and Singapore . One hundred and fifty five male subjects were randomized ( 2:1 ) to sildenafil ( n = 104 ) or placebo ( n = 51 ) . Sildenafil was started at 50 mg and increased ( 100 mg ) or decreased ( 25 mg ) at week 2 if necessary . RESULTS On the primary efficacy endpoint , sildenafil-treated subjects had significantly better scores on the International Index of Erectile Function ( IIEF ) questions 3 and 4 than placebo ( p < 0.001 , both questions ) . When accumulated into IIEF domains , all five domains were significant in favor of sildenafil . In addition , sildenafil-treated subjects were more satisfied with treatment and had a higher intercourse success rate . The majority of adverse events were mild in severity ; the most commonly reported treatment-related events were dizziness ( 7.7 % ) and tinnitus ( 2.9 % ) . CONCLUSION Sildenafil ( 25 , 50 , and 100 mg ) was found to be an effective , safe , and well-tolerated treatment for ED in the present study population of Thai , Malaysian , and Singaporean males who also had increased cardiovascular risk

sildenafil

sildenafil

placebo-controlled

sildenafil

placebo

Sildenafil

sildenafil-treated

sildenafil-treated

Efficacy and safety

intercourse success rate

dizziness

tinnitus

Asian

males

erectile dysfunction

cardiovascular risk

males

erectile dysfunction

ED

hypertension

dyslipidemia

diabetes

One hundred and fifty five male


Efficacy of amantadine on quality of life in patients with chronic hepatitis C treated with interferon-alpha and ribavirin : results from a randomized , placebo-controlled , double-blind trial . AIM The aim of this study was to investigate whether amantadine reduces deterioration of quality of life in patients with chronic hepatitis C during and after treatment with interferon-alpha ( IFN-alpha ) and ribavirin . PATIENTS AND METHODS In this randomized , prospective , placebo-controlled , multicenter trial , previously untreated patients with chronic hepatitis C were treated with IFN-alpha plus ribavirin [ 17 ] and randomized for treatment with amantadine ( 200 mg/day , orally , n=136 ) or placebo ( n=131 ) . Quality of life was assessed with the 'Profile of Mood States ' scale and the 'Everyday Life ' questionnaire at baseline , treatment week ( TW ) 8 , TW24 , TW48 , and at follow-up . RESULTS Early during treatment at TW8 , quality of life was not different between patients in the control and the amantadine group . At TW24 , the control group but not the amantadine group , however , showed significant deterioration of the modalities depression , fatigue , and vigor compared with baseline . Especially , nonresponders in the amantadine group showed significantly lower deterioration of depression , anger , mind function , everyday life , and zest for life than those in the placebo group . After treatment , the beneficial effects of amantadine disappeared . CONCLUSION The addition of amantadine to IFN-alpha plus ribavirin combination therapy may reduce deterioration of depression , fatigue , and vigor during treatment but does not affect quality of life after treatment .

amantadine

interferon-alpha and ribavirin

placebo-controlled

placebo-controlled

IFN-alpha plus ribavirin [ 17 ]

amantadine

placebo

amantadine

placebo

amantadine

IFN-alpha plus ribavirin

Efficacy

quality of life

deterioration of quality of life

Quality of life

'Profile of Mood States ' scale

and the 'Everyday Life ' questionnaire

modalities depression

fatigue , and vigor

lower deterioration of depression

anger

mind function

, everyday life , and zest for life

beneficial effects

deterioration of depression

fatigue

vigor

quality of life

chronic hepatitis C

chronic hepatitis C

previously untreated patients

chronic hepatitis C


A randomized placebo-controlled trial comparing the efficacy of etoricoxib 30 mg and ibuprofen 2400 mg for the treatment of patients with osteoarthritis . OBJECTIVE We compared the efficacy of etoricoxib 30 mg to placebo and ibuprofen 2400 mg for the treatment of osteoarthritis ( OA ) of the hip and knee . DESIGN In this 12-week , randomized , double-blind , placebo- and active-comparator-controlled trial , 548 patients ( median age 63 years ) with OA of the hip or knee were randomized to receive placebo , etoricoxib 30 mg q.d. , or ibuprofen 800 mg t.i.d . Demonstration of etoricoxib 's efficacy vs placebo and comparison of its efficacy to ibuprofen were assessed using three co-primary endpoints : Western Ontario and McMaster 's University Osteoarthritis Index ( WOMAC ) Pain Subscale ( WOMAC-PS ) ; WOMAC Physical Function Subscale ( WOMAC-PFS ) ; and Patient Global Assessment of Disease Status ( PGADS ) . Each primary endpoint utilizes a 0-100 mm visual analog scale . To demonstrate comparable efficacy of etoricoxib vs ibuprofen , the 95 % confidence intervals ( CIs ) for the difference in the least squares ( LS ) mean change over 12 weeks for all three co-primary endpoints had to fall within +/-10 mm . Safety and tolerability data were collected throughout the study . RESULTS Mean baseline values for the three co-primary endpoints ranged from 62.52 to 70.14 mm . Both etoricoxib and ibuprofen demonstrated superior ( P < or =0.002 ) efficacy for all primary endpoints . The LS mean ( mm ) changes ( 95 % CI ) over 12 weeks for etoricoxib and ibuprofen , respectively , compared to placebo were given as follows : WOMAC-PS : -11.66 ( -16.31 , -7.01 ) and -7.62 ( -12.30 , -2.94 ) ; WOMAC-PFS : -10.15 ( -14.74 , -5.57 ) and -7.23 ( -11.85 , -2.61 ) ; PGADS : -11.65 ( -16.81 , -6.50 ) and -8.11 ( -13.30 , -2.92 ) . The efficacy of etoricoxib 30 mg was comparable to ibuprofen 2400 mg. All treatments were similarly well tolerated . CONCLUSION Treatment with etoricoxib 30 mg q.d . provides superior efficacy vs placebo and comparable clinical efficacy vs ibuprofen 2400 mg ( 800 mg t.i.d . ) for the treatment of OA of the hip and knee .

placebo-controlled

etoricoxib

ibuprofen

etoricoxib

placebo

ibuprofen

placebo-

placebo

etoricoxib

ibuprofen

etoricoxib 's

placebo

ibuprofen

etoricoxib

ibuprofen

etoricoxib

ibuprofen

etoricoxib

ibuprofen

placebo

etoricoxib

ibuprofen

etoricoxib

placebo

ibuprofen

least squares ( LS ) mean change

Safety and tolerability

data

Mean baseline values

efficacy

WOMAC-PS

WOMAC-PFS

PGADS

efficacy

tolerated

efficacy

osteoarthritis

548 patients

OA of the hip or knee

OA of the hip and knee


Protein ingestion further augments S6K1 phosphorylation in skeletal muscle following resistance type exercise in males . Our objective was to determine the impact of carbohydrate and/or protein ingestion before and after exercise on ribosomal protein S6 kinase ( S6K1 ) and S6 phosphorylation status in human skeletal muscle tissue . Seven healthy , untrained men ( 22.5 +/- 0.9 y ) were randomly assigned to 2 cross-over experiments . Before , immediately after , and 1 h after a single bout of resistance exercise , subjects consumed 0.3 g x kg ( -1 ) carbohydrate with or without 0.3 g x kg ( -1 ) protein hydrolysate ( CHO+PRO and CHO , respectively ) . Muscle biopsies were taken before and immediately after exercise and after 1 and 4 h of postexercise recovery to determine 4E-BP1 , S6K1 ( both T ( 421 ) /S ( 424 ) and T ( 389 ) ) , and S6 phosphorylation status . Following resistance exercise , 4E-BP1 phosphorylation was reduced to a greater extent in the CHO treatment ( -48 +/- 7 % ) than in the CHO+PRO treatment ( -15 +/- 14 % , P < 0.01 ) . During recovery , 4E-BP1 phosphorylation increased in both experiments ( P < 0.01 ) , and tended to be higher in the CHO+PRO test ( P = 0.08 ) . S6K1 phosphorylation at T ( 421 ) /S ( 424 ) substantially increased following exercise and remained elevated during recovery with no differences between treatments . In contrast to the CHO treatment ( -4 +/- 2 % ) , S6K1 phosphorylation at T ( 389 ) was higher following exercise in the CHO+PRO treatment only ( +78 +/- 2 % , P < 0.01 ) . During recovery , S6K1 phosphorylation at T ( 389 ) remained higher in CHO+PRO than in CHO ( P < 0.05 ) . S6 phosphorylation was substantially higher following exercise in the CHO+PRO ( 1.69 +/- 0.35 ) than in the CHO experiment ( 0.45 +/- 0.07 , P < 0.01 ) and remained elevated during recovery ( P < 0.05 ) . We conclude that the availability of dietary protein further enhances phosphorylation of S6K1 during recovery from resistance type exercise .

Protein ingestion

carbohydrate

protein

exercise

resistance exercise

carbohydrate

protein hydrolysate

CHO+PRO

CHO

Muscle biopsies

4E-BP1 phosphorylation

CHO

CHO+PRO

CHO

CHO+PRO

CHO+PRO

CHO

CHO+PRO

CHO

4E-BP1 phosphorylation

4E-BP1 phosphorylation

S6K1 phosphorylation at T ( 389 )

S6 phosphorylation

males

Seven

men

( 22.5 +/- 0.9 y )


The EUROSCAN Study . EUROSCAN Steering Committee .

EUROSCAN

EUROSCAN

EUROSCAN


[ Potentials of monocular augmented reality technology in automobile production ] . INTRODUCTION Augmented reality ( AR ) technologies can enrich the real environment with visual data , which has potential benefits for optimising the operator 's working process . It offers the possibility to provide context-sensitive information independently of the user 's location and position . Data are presented to the dominant eye on a semi-transparent mirror using a head-mounted display ( HMD ) unit that works with retinal laser technology . In this study the potential benefits and drawbacks of this new AR technology were evaluated . MATERIALS AND METHODS 45 participants without any visual impairment were randomly assigned to 3 groups and completed a variety of tasks during a simulated working day . Group 1 received conventional working aids ( paper-based documents ) to support the task processing . Group 2 additionally wore an HMD unit that was switched off . Group 3 wore a functioning HMD without any additional aids . Evaluation was carried out by means of a standardised questionnaire ( BMS ) and a concentration test ( " d2 Aufmerksamkeits-Belastungs-Test " ) . RESULTS No significant differences between the 3 groups were found in terms of mental strain , concentration-test performance and physical or mental complaints reported in a follow-up interview . Around 20 % of the subjects noticed a higher pressure and blurred vision in both eyes as well as headaches . Half of the participants complained about deficiencies concerning the ergonomic hardware design of the AR system . DISCUSSION Changes in objective ophthalmological investigation parameters were not observed . Subjects reported reduced acceptance of the HMD based on non-ophthalmological reasons , for example , the weight of the unit or the length of the cable . However , for some specific working tasks , advantages in process optimisation and operator support were observed .

monocular augmented reality technology

Augmented reality ( AR ) technologies

AR technology

HMD unit that was switched off .

HMD without any additional aids .

mental strain

concentration-test performance

physical or mental complaints

higher pressure

blurred vision in both eyes

headaches

ergonomic hardware design

visual impairment


A pilot study of extended duration peginterferon alfa-2a for patients with hepatitis B e antigen-negative chronic hepatitis B . OBJECTIVES Forty-eight weeks of peginterferon alfa-2a is the approved regimen for chronic hepatitis B ( CHB ) . Standard interferon is more effective for hepatitis B e antigen ( HBeAg ) -negative CHB when given for longer than 1 yr . This study evaluated peginterferon alfa-2a for 60 wk , alone or in combination with lamivudine . METHODS Thirteen patients with HBeAg-negative CHB received peginterferon alfa-2a ( 180 microg/week ) for 60 wk or peginterferon alfa-2a ( 180 microg/week ) for 12 wk followed by 48 wk of peginterferon alfa-2a plus lamivudine . The primary end point , sustained virologic response ( SVR ) , was defined as a reduction in hepatitis B virus deoxyribonucleic acid ( HBV DNA ) of > or=2 log10 copies/mL and HBV DNA < 20,000 copies/mL at 24 wk of follow-up ( week 84 ) . Hepatitis B surface antigen ( HBsAg ) concentrations were analyzed and compared to changes in HBV DNA . RESULTS SVR was achieved by 9/13 patients ( 69 % ) . At week 84 , HBV DNA was undetectable by polymerase chain reaction in 5/13 ( 38 % ) patients , and 3 additional patients had a sustained 2-3 log reduction in HBV DNA . Five patients demonstrated a > 90 % decrease in HBsAg concentration at week 60 , including 3 with undetectable HBV DNA at week 84 and a fourth who met criteria for SVR . CONCLUSIONS Sixty weeks of peginterferon alfa-2a with or without lamivudine resulted in a higher rate of SVR compared to historical controls with HBeAg-negative CHB treated with 48 wk of pegylated interferon . Larger studies are necessary to assess if longer duration therapy is more effective than the standard regimen and results in a greater decline in HBsAg concentration .

peginterferon alfa-2a

peginterferon alfa-2a

peginterferon alfa-2a

peginterferon alfa-2a

peginterferon alfa-2a

peginterferon alfa-2a plus lamivudine .

peginterferon alfa-2a

pegylated interferon .

sustained virologic response ( SVR )

HBV DNA <

HBV DNA .

SVR

HBV DNA

log reduction in HBV DNA .

HBsAg concentration

HBV DNA

SVR .

SVR

chronic hepatitis B

CHB

Thirteen

HBeAg-negative CHB

HBeAg-negative CHB


Clinical benefit with docetaxel plus fluorouracil and cisplatin compared with cisplatin and fluorouracil in a phase III trial of advanced gastric or gastroesophageal cancer adenocarcinoma : the V-325 Study Group . PURPOSE For patients with advanced gastric or gastroesophageal cancer ( AGGEC ) providing clinical benefit with improved palliation is highly desirable . However , a prospective evaluation of clinical benefit in AGGEC patients has never before been reported in a phase III setting . PATIENTS AND METHODS In a multinational trial ( V325 ) , 445 patients were randomly assigned and treated with either docetaxel plus cisplatin and fluorouracil ( DCF ) or cisplatin and fluorouracil ( CF ) . Clinical benefit was prospectively evaluated in this trial as a secondary end point . The primary measure for clinical benefit analysis was time to definitive worsening by one or more categories of Karnofsky performance status ( KPS ) . Secondary clinical benefit end points included time to 5 % definitive weight loss , time to definitive worsening of appetite by one grade , pain-free survival ( defined as time to first appearance of pain ) , and time to first cancer pain-related opioid intake . Clinical benefit assessments were recorded at each clinic visit . RESULTS Clinical benefit assessments were performed in more than 75 % of patients throughout V325 . DCF significantly prolonged time to definitive worsening of KPS compared with CF ( median , 6.1 v 4.8 months ; hazard ratio , 1.38 ; 95 % CI , 1.08 to 1.76 ; log-rank P = .009 ) . Although time to definitive weight loss and time to definitive worsening of appetite favored DCF , the results were not statistically significant . Pain-free survival and time to first cancer pain-related opioid intake were comparable . CONCLUSION To our knowledge , V325 is the first phase III trial to report clinical benefit in AGGEC patients . Clinical benefit was assessed beyond protocol-specific chemotherapy . The addition of D to CF not only significantly improved clinical benefit but also improved quality of life , time to progression , and overall survival compared with CF .

docetaxel plus fluorouracil

cisplatin

cisplatin

fluorouracil

docetaxel plus cisplatin

fluorouracil ( DCF )

cisplatin

fluorouracil ( CF )

CF

DCF

protocol-specific chemotherapy

D

CF

CF

time to definitive worsening

Karnofsky performance status

pain-free survival

( defined as

time to first appearance of pain

time to definitive worsening of KPS

quality of life

, time to progression , and

overall survival


[ Application of tacrolimus and cyclosporine A in HBV-carrying renal transplant recipients ] . OBJECTIVE To compare the long-term effect and safety of tacrolimus ( FK506 ) and cyclosporine ( CsA ) in kidney transplant ( KT ) recipients carrying hepatitis B Virus ( HBV ) . METHODS A total of 109 patients with HBV were randomized into FK506 group ( 52 cases ) and CsA group ( 57 cases ) after KT , and a 2-year-long follow-up of the patients was conducted to record the patient and graft survival , incidence of acute graft rejection and postoperative liver function . RESULTS The 2-year patient/graft survival was 86.0 % /73.7 % and 94.2 % /90.3 % in CsA and FK506 groups , respectively ( P < 0.05 ) , with incidence of acute rejection of 10.5 % and 9.6 % ( P > 0.05 ) , and rate of abnormal liver function of 26.3 % and 15.4 % ( P < 0.05 ) , respectively . Eight patients ( 14.4 % ) in CsA group required a drug conversion but none in FK506 group . The drug conversion resulted in significant reduction of ALT/AST level from 255.13+/-31.38/201.88+/-21.25 U/L to 31.25+/-11.50/25.13+/-9.68 U/L ( P < 0.01 ) . CONCLUSION For HBV-carrying renal transplant recipients , FK506 as the primary choice of immunosuppressant can be more effective and safer than CsA .

tacrolimus

cyclosporine A

tacrolimus ( FK506 )

cyclosporine ( CsA )

CsA

patient and graft survival

incidence of acute graft rejection

postoperative liver function

2-year patient/graft survival

acute rejection

abnormal liver function

ALT/AST level

109 patients


[ Effect of electroacununcture on sex hormone levels in patients with Sjögren 's syndrome ] . OBJECTIVE To observe the effect of electroacupuncture ( EA ) on serum testosterone ( T ) , estradiol ( F2 ) , luteotropic hormone ( LH ) , follicle-stimulating hormone ( FSH ) , progesterone ( P ) , and prolactin ( PRL ) in patients with Sjögren 's Syndrome ( SS ) in order to analyze the correlation between the adjustment effect of EA and changes of hormone levels . METHODS Fifty-seven middle-aged and old women with SS were divided into medication group ( n=27 ) and acupuncture group ( n=30 ) . Patients in acupuncture group were treated with EA ( 80 Hz , 2.5 mA ) of Shenshu ( BL 23 ) , Taixi ( KI 3 ) , Hegu ( LI 4 ) , etc . for 30 min , once every other day , and those of medication group were treated with oral administration of hydroxyl-chloroquine ( 6 mg/kg per day ) , oral transfer agent liquid , Vit B1 , Vit B2 , Vit C , fish-liver oil , one tablet/time , t.i.d. , and pilocarpine ( 20 mg/d ) , continuously for 2 months . Venous blood samples were collected before and after the treatment to examine contents of the abovementioned sex hormones by using electro-chemiluminescent immunoassay ( CLIA ) . RESULTS ( 1 ) Before the treatment , no significant differences were found between two groups in the levels of serum T , E2 , LH , FSH , P and PRL ( P > 0.05 ) . After the treatment , self-comparison of each group showed that serum EF and T contents in acupuncture group increased significantly ( P < 0.01 ) and serum LH content decreased significantly ( P < 0.01 ) ; while in medication group , only serum LH decreased markedly ( P < 0.05 ) in comparison with its basic value of pretreatment . No significant changes were found in serum P , FSH and PRL levels in both groups after the treatment ( P > 0.05 ) . The results suggested that the therapeutic effect of acupuncture group was better than that of medication group in regulating multiple sex hormones . CONCLUSION EA can effectively adjust E2 , T and LH levels in Sjögren 's Syndrome patients and improve most patients ' clinical symptoms , and the therapeutic effect of EA is better than that of medication .

electroacununcture

serum testosterone


Effect of liquid-polish coating on in vivo biofilm accumulation on provisional restorations : part 1 . OBJECTIVE Biofilm accumulation on provisional restorations may affect the surrounding tissues ' integrity . The purpose of this study was to test in vivo biofilm formation on polymethyl methacrylate ( PMMA ) self-cured acrylic resin provisional crowns . METHOD AND MATERIALS Three types of PMMA surfaces were tested : ( 1 ) polished , ( 2 ) polished and coated with bonding agent , and ( 3 ) polished and coated with light-cured liquid polish . After 12 hours in the oral cavity , the crown was removed and examined by confocal laser scanning microscope ( CLSM ) and scanning electron microscope ( SEM ) . RESULTS Biofilm , 250 Mum thick , was observed with CLSM on the polished acrylic surface . Significantly less bacterial accumulation was observed on the crowns coated with bonding agent , whereas no biofilm was observed on the crowns coated with liquid polish ( P < .001 ) . SEM examination confirmed these findings . CONCLUSIONS Bonding resin or liquid polish coatings significantly reduce early biofilm formation , which in turn might affect the overall plaque accumulation on provisional restorations .

liquid-polish coating

polymethyl methacrylate ( PMMA )

crown

confocal laser scanning microscope

scanning electron microscope

in vivo biofilm accumulation

Biofilm accumulation

provisional restorations

Biofilm , 250 Mum thick

bacterial accumulation

biofilm

biofilm formation

provisional restorations :


Eight in-office tooth whitening systems evaluated in vivo : a pilot study . This in vivo pilot study evaluated eight products with hydrogen peroxide ( HP ) concentrations ranging from 15 % to 35 % . The treatment contact time varied from 15 minutes to 60 minutes . Patients were evaluated for color at baseline , immediately after treatment and at one , two , four and six weeks after treatment using a colorimeter , shade guide and photos . All eight products were effective in bleaching teeth . Colorimeter data for deltaE immediately after treatment was 6.77 . At one and six weeks after bleaching , there were 51 % and 65 % reductions in deltaE , respectively .

Eight in-office tooth whitening systems

colorimeter , shade guide and photos

bleaching teeth .

bleaching

deltaE


Predictors of incident depression after hip fracture surgery . OBJECTIVE Depression after hip fracture surgery is prevalent and associated with increased mortality rates and impaired functional recovery . The incidence of new-onset depressive symptoms in patients initially not depressed after hip fracture surgery and their relationship with functional recovery is unknown . METHODS A cohort of 139 nondepressed elderly patients ( > 60 years ) hospitalized for hip fracture surgery were followed up for six months . Clinically significant depressive symptoms were defined as a score of 7 or more on the 15-item Geriatric Depression Scale . RESULTS The authors found a cumulative incidence rate of 20.5 % adjusted for dropouts . Multiple Cox-regression analyses yielded the presence of subthreshold symptoms of depression , anxiety , pain , and cognitive impairment at baseline , the premorbid level of mobility , and a history of ( treated ) depression as risk factors for incident depression ( p < 0.05 ) . A forward , conditional procedure identified postoperative pain ( hazard ratio [ HR ] = 1.32 , 95 % confidence interval [ CI ] : 1.14-1.53 , Wald chi ( 2 ) = 13.57 , df = 1 , p < 0.001 ) and baseline anxiety ( HR = 1.25 , 95 % CI : 1.08-1.44 , Wald chi ( 2 ) = 8.86 , df = 1 , p = 0.003 ) as the strongest independent risk factors . Incident depression was associated with a less favorable outcome at 3 months follow-up . CONCLUSION This exploratory study identified two treatable baseline characteristics that predicted incident depression in nondepressed patients after hip-fracture surgery .

hip fracture surgery

hip fracture surgery

hip fracture surgery

incident depression

15-item Geriatric Depression Scale .

cumulative incidence rate

depression , anxiety

pain

cognitive impairment

postoperative pain

baseline anxiety

Incident depression

incident depression

hip fracture

elderly

> 60 years

hip fracture

hip-fracture


A randomized , controlled trial of a home-based intervention program for children with autism and developmental delay . OBJECTIVE This study aimed to ( 1 ) investigate whether provision of a home-based program in addition to a center-based program improves development in young children with disabilities and coping abilities of their families and ( 2 ) describe the characteristics of children and families who benefit most from the intervention . METHODS Fifty-nine children , aged 3-5 years , with no cerebral palsy , participated in the study . Half of the group was randomized to receive an additional program in their homes . A special education teacher provided 40 visits over 12 months working with the families to help generalize skills to the home environment and assist with their concerns . All children were assessed before and after the intervention , and families completed questionnaires assessing family stress , support , and empowerment on both occasions . Differences in change over time and between the intervention and control group were analyzed by repeated measures and the association between characteristics of children and families with improved outcome by multivariate analysis of variance . RESULTS Change in cognitive development and behavior ( in the centers ) over time favored the children who received the extra intervention ( p = .007 and p = .007 , respectively ) . The groups did not differ on any of the family measures of change . Multivariate analysis of variance revealed more improvement for children in the intervention group from higher than lower stressed families . CONCLUSIONS Results suggest the need for daily reinforcement of skills learned at the center-based program and the importance of involving families , especially those with few resources and relatively high stress .

home-based intervention program

additional program in their homes

family measures of change

autism and developmental delay

young children

Fifty-nine

aged 3-5 years


Should snacks be recommended in obesity treatment ? A 1-year randomized clinical trial . OBJECTIVE To study the effect to recommend no snacks vs three snacks per day on 1-year weight loss . The hypothesis was that it is easier to control energy intake and lose weight if snacks in between meals are omitted . SUBJECTS/METHOD In total 140 patients ( 36 men , 104 women ) , aged 18-60 years and body mass index > 30 kg/m ( 2 ) were randomized and 93 patients ( 27 men , 66 women ) completed the study . A 1-year randomized intervention trial was conducted with two treatment arms with different eating frequencies ; 3 meals/day ( 3M ) or 3 meals and 3 snacks/day ( 3+3M ) . The patients received regular and individualized counseling by dieticians . Information on eating patterns , dietary intake , weight and metabolic variables was collected at baseline and after 1 year . RESULTS Over 1 year the 3M group reported a decrease in the number of snacks whereas the 3+3M group reported an increase ( -1.1 vs +0.4 snacks/day , respectively , P < 0.0001 ) . Both groups decreased energy intake and E % ( energy percent ) fat and increased E % protein and fiber intake but there was no differences between the groups . Both groups lost weight , but there was no significant difference in weight loss after 1 year of treatment ( 3M vs 3+3M=-4.1+/-6.1 vs -5.9+/-9.4 kg ; P=0.31 ) . Changes in metabolic variables did not differ between the groups , except for high-density lipoprotein that increased in the 3M group but not in 3+3M group ( P < 0.033 for group difference ) . CONCLUSION Recommending snacks or not between meals does not influence 1-year weight loss .

snacks

no snacks

three snacks

3 meals/day ( 3M )

3 meals and 3 snacks/day

Information on eating patterns

dietary intake

weight

metabolic variables

number of snacks

energy intake

E % protein and fiber intake

lost weight

weight loss

metabolic variables

high-density lipoprotein

1-year weight loss

obesity

140 patients

men

women

93 patients

men

women


Multitomographic evaluation of the dental effects of two different rapid palatal expansion appliances . Rapid palatal expansion ( RPE ) is widely used in the treatment of transverse maxillary deficiencies . Generally , there are two types of RPE appliances : banded and bonded expanders . The purpose of this prospective study was to compare the dental effects of banded and bonded appliances . The study consisted of 23 patients ( 13 females and 10 males ) with a bilateral maxillary deficiency . Twelve patients ( seven females and five males ) with a mean age of 14.8 +/- 0.3 years were treated with banded RPE and 11 patients ( six females and five males ) with a mean age of 15.1 +/- 0.7 years with bonded RPE . Multitomographic radiographs were taken before ( T0 ) and at the end ( T1 ) of expansion while the patients were wearing an acrylic mandibular appliance in which ball bearings and bars were embedded . Statistical analyses of the measurements at T0 and T1 were undertaken with a paired t-test , and the difference between the groups assesed with a Student 's t-test . In both groups , the angle between the radiographic image of the bar and the axial inclination of the upper first premolar and molar teeth was ( 5.34 and 2.73 degrees for the right premolars , 5.17 and 2.28 degrees for the left premolars , 11.83 and 3.73 degrees for the right molars , and 9.75 and 5.64 degrees for the left molars in the banded and bonded groups , respectively . The distance from the vestibular cortical plate to the palatal root of these teeth ( 1.17 and 1.23 mm for the right premolars , 2.46 and 1.09 mm for the left premolars , 2.75 and 0.64 mm for the right molars , 2.23 and 0.96 mm for the left molars in the banded and bonded groups , respectively ) increased ( both P < 0.01 ) . These increases indicated buccal tipping of the teeth . Comparison of the two groups showed that tipping of the first molar and premolar teeth in the banded group was significantly more than in the bonded group ( P < 0.01 and P < 0.001 , respectively ) .

rapid palatal expansion appliances

Rapid palatal expansion ( RPE )

banded and bonded appliances

banded RPE

bonded RPE

dental effects

dental effects

buccal tipping

transverse maxillary deficiencies .

23 patients

females

males

Twelve patients

seven

females

five

males

mean age of 14.8 +/- 0.3 years

11 patients

six

females

five

males

mean age of 15.1 +/- 0.7 years


Clinical application of C-reactive protein across the spectrum of acute coronary syndromes . BACKGROUND High-sensitivity C-reactive protein ( hsCRP ) is associated with adverse cardiovascular outcomes in acute coronary syndromes ( ACS ) . The ability to formulate recommendations regarding clinical use of hsCRP is limited by a paucity of data regarding several key issues . The purpose of this study was to evaluate hsCRP across the spectrum of ACS . METHODS hsCRP was measured on admission in 3225 patients with ACS . hsCRP concentrations were compared in patients who suffered an adverse cardiac outcome within 10 months of study entry and in patients who had no adverse event . Because of heterogeneity in the relationship between hsCRP and clinical outcomes , evaluation was limited to patients from whom samples were collected within 48 h of symptom onset . RESULTS Patients in the highest quartile of hsCRP compared to those in the lowest quartile were at increased risk of death at 30 days [ adjusted hazard ratio ( adjHR ) 4.6 , P < 0.001 ] and 10 months ( adjHR 3.9 , P < 0.001 ) . In patients with unstable angina/non-ST-elevation myocardial infarction ( STEMI ) , hsCRP > 3 mg/L was associated with increased 10-month mortality ( adjHR 2.3 , P = 0.002 ) , whereas in STEMI a relationship with mortality was seen at hsCRP > 10 mg/L ( adjHR 3.0 , P = 0.008 ) . Increased concentrations of hsCRP were strongly associated with the development of heart failure at 30 days ( adjHR 8.2 , P = 0.001 ) and 10 months ( adjHR 2.6 , P = 0.014 ) . CONCLUSION Increased baseline concentrations of hsCRP are strongly associated with mortality and heart failure across the ACS spectrum . hsCRP measurement should be performed early after presentation and index diagnosis-specific cutpoints should be used .

C-reactive protein

hsCRP

hsCRP

hsCRP

hsCRP

hsCRP

hsCRP

hsCRP

hsCRP

hsCRP

hsCRP

hsCRP concentrations

risk of death

hsCRP

heart failure

baseline concentrations of hsCRP

mortality

heart failure


Effects of alfuzosin 10 mg once daily on sexual function in men treated for symptomatic benign prostatic hyperplasia . We evaluated the effects of extended-release alfuzosin HCl 10 mg once daily ( q.d . ) on sexual function in men with lower urinary tract symptoms associated with benign prostatic hyperplasia ( BPH ) . In a randomized , double-blind , placebo-controlled study of men aged > or = 50 years , after a 28-day placebo run-in period , patients were randomized to receive alfuzosin 10 mg q.d . or matching placebo for 28 days . The mean change from baseline ( day 1 ) in sexual function on day 29 was assessed using the Danish Prostate Symptom Score Sex ( DAN-PSSsex ) questionnaire . A total of 372 patients were randomized to receive alfuzosin ( n=186 ) or placebo ( n=186 ) , with 355 completing the study . At baseline , 64 % of the patients reported erectile dysfunction ( ED ) and 63 % reported ejaculatory dysfunction ( EjD ) . For the 320 patients who completed the DAN-PSSsex , alfuzosin treatment was associated with a significant improvement in the mean change from baseline in erectile function on day 29 compared with placebo ( P=0.02 ) . No significant difference was observed between the two treatment groups in the mean change from baseline in ejaculatory function on day 29 . For patients with ED at baseline , a marginal improvement in erectile function was demonstrated with alfuzosin treatment ( P=0.09 vs placebo ) . For patients with EjD at baseline , the mean change from baseline in ejaculatory function with alfuzosin was comparable to that with placebo . Dizziness was the most common adverse event with alfuzosin treatment ( 5 vs 0 % with placebo ) , with other adverse events reported with comparable frequency in both treatment groups . After 1 month of treatment , alfuzosin 10 mg q.d . significantly improved erectile function in men with lower urinary tract symptoms/ benign prostatic hypertrophy and had no adverse effect on ejaculatory function .

alfuzosin

alfuzosin

placebo-controlled

alfuzosin

or matching placebo

alfuzosin

placebo

sexual function

sexual function

erectile dysfunction ( ED )

ejaculatory dysfunction ( EjD )

erectile function

ejaculatory function

Dizziness

erectile function

men

men

lower urinary tract symptoms

benign prostatic hyperplasia ( BPH )

men

aged > or = 50 years

erectile dysfunction ( ED )

ejaculatory dysfunction ( EjD )


Sodium bicarbonate , N-acetylcysteine , and saline for prevention of radiocontrast-induced nephropathy . A comparison of 3 regimens for protecting contrast-induced nephropathy in patients undergoing coronary procedures . A single-center prospective controlled trial . BACKGROUND Several protective therapies have been developed to prevent contrast-induced nephropathy ( CIN ) . We aimed to investigate the efficacy of sodium bicarbonate by comparing 2 other regimens , including combination of N-acetylcysteine ( NAC ) plus sodium chloride and sodium chloride alone , to prevent CIN in patients undergoing cardiovascular procedures . METHODS We prospectively enrolled 264 patients who were scheduled for cardiovascular procedures and had a baseline creatinine level > 1.2 mg/dL . The patients were assigned 1 of 3 prophylactic regimens : infusion of sodium bicarbonate , sodium chloride , sodium chloride plus oral NAC ( 600 mg bid ) . Contrast-induced nephropathy was defined as an increase in serum creatinine level > 25 % or 0.5 mg/dL after 48 hours . RESULTS There were no significant differences among groups regarding baseline demographic properties and nephropathy risk factors . The change in creatinine clearance was significantly better in the sodium bicarbonate group than other 2 groups ( P = .007 ) . The incidence of CIN was significantly lower in the sodium bicarbonate group ( 4.5 % ) compared with sodium chloride alone ( 13.6 % , P = .036 ) and tended to be lower than in the combination group ( 12.5 % , P = .059 ) . After adjusting the Mehran nephropathy risk score , the risk of CIN significantly reduced with sodium bicarbonate compared with sodium chloride alone ( adjusted risk ratio 0.29 , P = .043 ) . CONCLUSIONS Hydration with sodium bicarbonate provides better protection against CIN than the sodium chloride infusion does alone . Combination therapy of NAC plus sodium chloride did not offer additional benefit over hydration with sodium chloride alone .

Sodium bicarbonate

N-acetylcysteine

saline

sodium bicarbonate

combination of N-acetylcysteine ( NAC )

sodium chloride

sodium chloride

sodium bicarbonate

sodium chloride

sodium chloride plus oral NAC

sodium bicarbonate

sodium bicarbonate

sodium chloride

combination

sodium bicarbonate

sodium chloride

sodium bicarbonate

sodium chloride

sodium chloride alone

radiocontrast-induced nephropathy

contrast-induced nephropathy ( CIN ) .

Contrast-induced nephropathy

nephropathy

risk factors

change in creatinine clearance

incidence of CIN

Mehran nephropathy risk score

risk of CIN

CIN

radiocontrast-induced nephropathy .


A 1.5-year follow-up of an Internet-based intervention for complicated grief . Only recently have psychotherapeutic interventions for complicated grief been developed and evaluated in randomized controlled trials . These trials have reported significant reductions in complicated grief and related symptoms in response to treatment relative to control groups . However , little is known about the long-term outcomes of these treatments . The authors present an evaluation of a 1.5-year follow-up of an Internet-based cognitive-behavioral intervention for complicated grief . Treatment group patients ( n = 22 ) were administered various assessments of complicated grief indicators , including the Impact of Event Scale , the anxiety and depression subscales of the Brief Symptom Inventory , and the SF-12 . Results indicate that the reduction in symptoms of complicated grief observed at posttreatment was maintained at 1.5-year follow-up .

Internet-based intervention

psychotherapeutic interventions

control groups

Impact of Event Scale

symptoms of complicated grief


[ Observation on therapeutic effect of acupuncture on early peripheral facial paralysis ] . OBJECTIVE To observe therapeutic effects of acupuncture at different opportunities on peripheral facial paralysis . METHODS Fifty-two cases were randomly divided into a treatment group ( n=28 ) and a control group ( n=24 ) . The treatment group at the acute stage ( 1-10 days ) were treated with acupuncture at Dicang ( ST 4 ) , Jiache ( ST 6 ) , Yangbai ( GB 14 ) , etc. , with less than 4 points selected on the face and with shallow puncture , and 10 days later electroacupuncture were added at acupoints selected routinely ; the control group were treated with the same methods as the treatment group but acupuncture was not given at the acute stage . RESULTS The cured rate of 78.6 % in the treatment group was significantly higher than 50.0 % in the control group ( P < 0.05 ) . CONCLUSION Early acupuncture is a key for achieving the best therapeutic effect on facial paralysis .

acupuncture

acupuncture

acupuncture at Dicang ( ST 4 )

Jiache ( ST 6 )

Yangbai ( GB 14 )

acupuncture

cured rate

early peripheral facial paralysis ]

peripheral facial paralysis .

Fifty-two cases

facial paralysis .


[ Effect of acupuncture on rehabilitation training of child 's autism ] . OBJECTIVE To observe the effect of acupuncture on rehabilitation training for children 's autism . METHODS Forty autistic children receiving rehabilitation training were divided into a control group and a treatment group , 20 cases in each group . The control group received rehabilitation training including ABA training , the Conductive Education Approach and the training of sensory integration , about 90 sessions for each training ; the treatment group received acupuncture treatment for 60-90 sessions after the rehabilitation training . Their results were detected by the revised Chinese version of Psycho-Educational Profile for autistic and developmentally disabled children ( C-PEP ) . RESULTS The markedly effective rate was 55.0 % in the treatment group and 15.0 % in the control group with a very significant difference between the two groups ( P < 0.01 ) ; the differences before and after training in some projects such as the total score of development , imitation , oral cognition in the treatment group were very significantly different from those in the control group ( P < 0.01 ) . CONCLUSION Acupuncture combined with scientific and effective rehabilitation training has a better therapeutic effect than that of the simple rehabilitation training for child 's autism .

acupuncture

acupuncture

acupuncture treatment

after the rehabilitation training

Acupuncture

simple rehabilitation training

effective rate

therapeutic effect

child 's autism ]

children 's autism .

child 's autism .


Fondaparinux combined with intermittent pneumatic compression vs. intermittent pneumatic compression alone for prevention of venous thromboembolism after abdominal surgery : a randomized , double-blind comparison . BACKGROUND The benefit of combined mechanical and pharmacologic methods for venous thromboembolism prevention after abdominal surgery has not been clearly established . OBJECTIVES To compare the efficacy and safety of fondaparinux in conjunction with intermittent pneumatic compression vs. intermittent pneumatic compression alone in this context . PATIENTS AND METHODS This was a randomized , double-blind , placebo-controlled superiority trial . Patients aged at least 40 years undergoing abdominal surgery were randomized to receive either fondaparinux 2.5 mg or placebo s.c. for 5-9 days , starting 6-8 h postoperatively . All patients received intermittent pneumatic compression . The primary efficacy outcome was venous thromboembolism up to day 10 . The main safety outcomes were major bleeding and all-cause mortality . Follow-up lasted 32 days . RESULTS Of the 1309 patients randomized , 842 ( 64.3 % ) were evaluable for efficacy . The venous thromboembolism rate was 1.7 % ( 7/424 ) in the fondaparinux-treated patients and 5.3 % ( 22/418 ) in the placebo-treated patients ( odds ratio reduction 69.8 % ; 95 % confidence interval 27.9-87.3 ; P = 0.004 ) . Fondaparinux significantly reduced the proximal deep vein thrombosis rate from 1.7 % ( 7/417 ) to 0.2 % ( 1/424 ; P = 0.037 ) . Major bleeds occurred in 1.6 % ( 10/635 ) and 0.2 % ( 1/650 ) of fondaparinux-treated and placebo-treated patients , respectively ( P = 0.006 ) , none being fatal or involving a critical organ . By day 32 , eight patients ( 1.3 % ) receiving fondaparinux and five ( 0.8 % ) receiving placebo had died . CONCLUSIONS In patients undergoing abdominal surgery and receiving intermittent pneumatic compression , fondaparinux 2.5 mg reduced the venous thromboembolism rate by 69.8 % as compared to pneumatic compression alone , with a low bleeding risk as compared to placebo .

placebo-controlled

fondaparinux

placebo

intermittent pneumatic compression

fondaparinux-treated

placebo-treated

Fondaparinux

fondaparinux-treated

placebo-treated

fondaparinux

placebo

pneumatic compression alone

placebo

venous thromboembolism

venous thromboembolism

efficacy

safety

venous thromboembolism up to day 10 .

major bleeding

all-cause mortality

venous thromboembolism rate

proximal deep vein thrombosis rate

Major bleeds

died

venous thromboembolism

low bleeding risk

venous thromboembolism

after abdominal surgery


Statin treatment withdrawal in ischemic stroke : a controlled randomized study . BACKGROUND Pretreatment with statins has been shown to reduce brain injury in cerebral ischemia . In this controlled randomized study , we investigated the influence of statin pretreatment and its withdrawal on the outcome of acute ischemic stroke patients . METHODS From 215 patients admitted within 24 hours of a hemispheric ischemic stroke , 89 patients on chronic statin treatment were randomly assigned either to statin withdrawal for the first 3 days after admission ( n = 46 ) or to immediately receive atorvastatin 20 mg/day ( n = 43 ) . The primary outcome event was death or dependency ( modified Rankin Scale [ mRS ] score > 2 ) at 3 months . Early neurologic deterioration ( END ) and infarct volume at days 4 to 7 were secondary outcome variables . In a secondary analysis , outcome variables were compared with the nonrandomized patients without previous statin therapy ( n = 126 ) . RESULTS Patients with statin withdrawal showed a higher frequency of mRS score > 2 at the end of follow-up ( 60.0 % vs 39.0 % ; p = 0.043 ) , END ( 65.2 % vs 20.9 % ; p < 0.0001 ) , and greater infarct volume ( 74 [ 45 , 126 ] vs 26 [ 12 , 70 ] mL ; p = 0.002 ) compared with the non-statin-withdrawal group . Statin withdrawal was associated with a 4.66 ( 1.46 to 14.91 ) -fold increase in the risk of death or dependency , a 8.67 ( 3.05 to 24.63 ) -fold increase in the risk of END , and an increase in mean infarct volume of 37.63 mL ( SE 10.01 ; p < 0.001 ) after adjusting for age and baseline stroke severity . Compared with patients without previous treatment with statins , statin withdrawal was associated with a 19.01 ( 1.96 to 184.09 ) -fold increase in the risk of END and an increase in mean infarct volume of 43.51 mL ( SE 21.91 ; p = 0.048 ) . CONCLUSION Statin withdrawal is associated with increased risk of death or dependency at 90 days . Hence , this treatment should be continued in the acute phase of ischemic stroke .

Statin treatment

statin pretreatment

statin

statin

atorvastatin

Statin

death

dependency

modified Rankin Scale [ mRS ]

Early neurologic deterioration ( END )

infarct volume

mRS score

infarct volume

death

dependency

END

mean infarct volume

END

mean infarct volume


Are back supports plus education more effective than education alone in promoting recovery from low back pain ? : Results from a randomized clinical trial . STUDY DESIGN Randomized clinical trial . OBJECTIVES To evaluate the effectiveness of a back support plus education versus education alone in promoting recovery from a work-related low back disorder ( WR-LBD ) while simultaneously considering personal , health , and occupational factors and the impact of occupational factors on recovery . SUMMARY OF BACKGROUND DATA No randomized studies of active industrial workers with low back disorders exist regarding the effectiveness of back supports plus education . METHODS A total of 433 actively employed hourly union workers who had a recent diagnosis of a WR-LBD : 1 ) those who wore a specially designed back support plus received education on back health ; and 2 ) those who received education on back health only . Demographic , health , medical , and occupational factors were obtained through interview or abstraction of computer files ; individual ergonomic exposures were measured with a lumbar motion monitor . Outcomes evaluated over a 12-month period included : self-reported measures of back pain , back pain disability level , physical health , mental health , and administrative measures of recurrence , lost work time , and medical care utilization . RESULTS There was no difference between the study groups with respect to mental or physical health , low back pain , back pain disability , neurogenic symptoms , lost work time , likelihood of recurrence of an episode of a back disorder , or other administrative measures of healthcare utilization or lost work time . However , significant decreases in low back pain , low back pain disability , neurogenic symptoms , and an increase in physical health were observed over the 12 months of observation in both study groups . The only occupational variable found to influence was plant group whereby service parts operations workers in the back support plus education group experienced a lower likelihood of WR-LBD recurrence . CONCLUSION Although there was no overall effect on self-reported recovery or administrative measures or lost work time between the study groups , a back support plus health education may have some value in preventing recurrent WR-LBD in industrial workers who work in psychosocial environments and perform manual material handling tasks similar to those found in parts distribution centers .

back supports plus education

education alone

back support plus education

education alone

education on back health only .

back support plus health education

self-reported measures of back pain

mental health

low back pain

neurogenic symptoms

WR-LBD recurrence

low back pain

work-related low back disorder

WR-LBD

active industrial workers

low back disorders


Comparison of the therapeutic efficacy of phonophoresis and iontophoresis using dexamethasone sodium phosphate in the management of patients with knee osteoarthritis . BACKGROUND AND OBJECTIVE Many treatment options , including non-pharmacological and pharmacological measures , have been recommended in the management of osteoarthritis ( OA ) . Among the non-pharmacological approach is physiotherapy , which involves the use of physical modalities like , heat therapy , exercise therapy , electrical stimulation , therapeutic ultrasound , iontophoresis , and phonophoresis . This study was therefore designed to compare the effectiveness of 0.4 % Dexamethasone sodium phosphate ( DEX-P ) phonophoresis ( PH ) with 0.4 % DEX-P iontophoresis ( ION ) therapy in the management of patients with knee joint OA . METHODS Fifty patients ( 19 males and 31 females ) with a mean age of 53.6 +/- 8.9 years were randomly assigned to PH or ION groups with 25 patients in each group . Ultrasound waves of 1 MHz frequency was applied for 5 minutes to the target knee , so also was the direct current for 10 minutes for 10 sessions treatment period . Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) scores , 20 meters ambulatory time , and knee range of motion ( ROM ) were evaluated before and after therapy as the outcome measures . RESULTS At the end of two weeks , significant improvement in total WOMAC scores was observed in 15 ( 60 % ) and 16 ( 64 % ) patients in the PH and ION groups respectively , indicating no significant difference in the improvement rate . Twenty ( 20 ) metres ambulatory time and knee range of motion also improved significantly in both groups , yet these variables showed no significant difference between the two groups . CONCLUSION Both therapeutic modalities were found to be effective and generally well tolerated after 10 treatment sessions . DEX-P phonophoresis was not superior to DEX-P iontophoresis in the treatment of patients with OA of the knee .

phonophoresis

iontophoresis

dexamethasone sodium phosphate

phonophoresis ( PH )

0.4 % DEX-P

iontophoresis ( ION ) therapy

PH

ION

DEX-P

phonophoresis

DEX-P

iontophoresis

20 meters ambulatory time

knee range of motion ( ROM )

WOMAC scores

ambulatory time

knee range of motion

patients with knee osteoarthritis .

patients with OA of the knee .


Prevention of type 2 ( non-insulin-dependent ) diabetes mellitus by diet and physical exercise . The 6-year Malmö feasibility study . From a previously reported 5-year screening programme of 6,956 47-49-year-old Malmö males , a series of 41 subjects with early-stage Type 2 ( non-insulin-dependent ) diabetes mellitus and 181 subjects with impaired glucose tolerance were selected for prospective study and to test the feasibility aspect of long-term intervention with an emphasis on life-style changes . A 5-year protocol , including an initial 6-months ( randomised ) pilot study , consisting of dietary treatment and/or increase of physical activity or training with annual check-ups , was completed by 90 % of subjects . Body weight was reduced by 2.3-3.7 % among participants , whereas values increased by 0.5-1.7 % in non-intervened subjects with impaired glucose tolerance and in normal control subjects ( p less than 0.0001 ) ; maximal oxygen uptake ( ml.min-1.kg-1 ) was increased by 10-14 % vs decreased by 5-9 % , respectively ( p less than 0.0001 ) . Glucose tolerance was normalized in greater than 50 % of subjects with impaired glucose tolerance , the accumulated incidence of diabetes was 10.6 % , and more than 50 % of the diabetic patients were in remission after a mean follow-up of 6 years . Blood pressure , lipids , and hyperinsulinaemia were reduced and early insulin responsiveness to glucose loading preserved . Improvement in glucose tolerance was correlated to weight reduction ( r = 0.19 , p less than 0.02 ) and increased fitness ( r = 0.22 , p less than 0.02 ) . Treatment was safe , and mortality was low ( in fact 33 % lower than in the remainder of the cohort ) . ( ABSTRACT TRUNCATED AT 250 WORDS )

Body weight

maximal oxygen uptake

Glucose tolerance

early insulin responsiveness to glucose

in glucose tolerance

weight reduction

increased fitness


Expectancies , not aroma , explain impact of lavender aromatherapy on psychophysiological indices of relaxation in young healthy women . OBJECTIVES In aromatherapy , lavender aroma is reputed to assist with relaxation . However , while there is much anecdotal evidence to that effect , the empirical literature is very inconsistent . Failure to employ adequate placebos , proper blinding , objective measures , or screening of prior beliefs about aromatherapy means that many previous findings could have been influenced by expectancy biases . The present study sought to establish whether lavender aroma and/or expectancies affect post-stress relaxation . DESIGN A double-blind , 3 ( aroma ) x 3 ( instruction ) x 10 ( time in minutes ) mixed-factorial placebo-controlled trial . METHOD In a laboratory , 96 healthy undergraduate women were exposed to lavender , placebo , or no aroma during physiologically assessed relaxation after an arousing cognitive task . Where an aroma was presented , an instructional priming procedure was used to manipulate participants ' expectancies about the aroma 's likely impact on their ability to relax . RESULTS Results showed no effect of aroma on galvanic skin response during relaxation . However , the nature of instructional prime was associated with relaxation patterns : when expecting the aroma to inhibit them , participants relaxed more ; when expecting facilitation , participants relaxed less . The effect was not seen with regard to self-reported relaxation ( as represented by changes in state anxiety ) and was independent of ratings of attitudes towards aromatherapy . CONCLUSIONS The findings imply that the previous associations of lavender aroma with assisted relaxation may have been influenced by expectancy biases , and that the relevant expectancies are easily manipulable .

lavender aromatherapy

aromatherapy , lavender aroma

placebos

lavender aroma

mixed-factorial placebo-controlled

exposed to lavender

placebo

cognitive task

lavender aroma

aroma on galvanic skin response

relaxation patterns

relaxed

relaxed

self-reported relaxation

attitudes

young

healthy

women

healthy

women


Small-diameter hysteroscopy with Versapoint versus resectoscopy with a unipolar knife for the treatment of septate uterus : a prospective randomized study . STUDY OBJECTIVE To compare 2 procedures for metroplasty : resectoscopy with monopolar knife versus small-diameter hysteroscopy fitted with a Versapoint device . DESIGN Prospective randomized study ( Canadian Task Force classification I ) . SETTING Endoscopic gynecology units at tertiary care university hospitals . PATIENTS One hundred-sixty patients with septate uterus and a history of recurrent abortion or primary infertility undergoing hysteroscopic metroplasty from 2001 to 2005 . INTERVENTIONS Hysteroscopic resection of the uterine septum performed with either a 26F resectoscope with unipolar knife ( 80 women , group A ) or a 5-mm diameter hysteroscope with Versapoint device ( 80 women , group B ) . All patients were managed expectantly , with follow-up lasting 1 year . MEASUREMENTS AND MAIN RESULTS Operative parameters ( operative time , fluid absorption , complications , need for second intervention ) and reproductive outcome parameters ( pregnancy , abortion , term and preterm delivery , modality of delivery , cervical cerclage ) were measured . Operative time and fluid absorption were significantly greater in group A than in group B ( 23.4 +/- 5.7 vs 16.9 +/- 4.7 minutes and 486.4 +/- 170.0 vs 222.1 +/- 104.9 mL , respectively ) . The cumulative complication rate was significantly lower in group B than in group A . No difference in any of the reproductive parameters was observed between the 2 groups : pregnancy and delivery rates were 70 % and 81.6 % in group A vs 76.9 % and 84 % in group B . Nine women ( 18.4 % ) from group B and 8 women ( 16 % ) from group B experienced spontaneous abortions . Most patients ( 54/82 ) delivered by cesarean section without differences according to the hysteroscopic technique used for metroplasty ( 65 % in group A vs 67.7 % in group B ) or to the gestational age ( 65.1 % of term and 68.7 % of preterm deliveries ) . CONCLUSIONS Small-diameter hysteroscopy with bipolar electrode for the incision of uterine septum is as effective as resectoscopy with unipolar electrode regarding reproductive outcome and is associated with shorter operating time and lower complication rate .

resectoscopy with a unipolar knife

resectoscopy with monopolar knife

Hysteroscopic

26F resectoscope with unipolar knife

hysteroscopy

resectoscopy

operative time

fluid absorption

complications

need for second intervention

pregnancy

abortion

Operative time

fluid absorption

cumulative complication rate

reproductive parameters

pregnancy and delivery rates

spontaneous abortions

cesarean section without differences

operating time

complication rate

septate uterus

One hundred-sixty

septate uterus

infertility


[ Stent and surgery for symptomatic carotid stenosis . SPACE study results ] . The SPACE trial compared risk and effectiveness of stent-supported angioplasty ( CAS ) vs carotid endarterectomy ( CEA ) using a noninferiority design in patients with symptomatic stenoses . Intention-to-treat analysis of the entire study population of 1,214 patients showed that primary endpoint events ( ipsilateral stroke or death between randomisation and day 30 ) occurred in 6.92 % of the CAS group and 6.45 % of the CEA group . The 95 % confidence interval ( CI ) of the absolute risk difference ranged from -1.94 % to +2.87 % , therefore the noninferiority was not proven . The same was true for the analysis of protocols . No significant differences between the two treatment methods were found in primary or any of the secondary endpoints . There were also no differences in short-term prevention . The endpoint 'ipsilateral ischemic stroke or vascular death between randomisation and 6 months ' occurred in 7.4 % of the CAS and 6.5 % of the CEA patients ( odds ratio 1.16 , 95 % confidence interval 0.74-1.82 ) . Instent restenoses were significantly more common in the CAS group ( 4.6 % vs 2.2 % , odds ratio 2.14 , 95 % CI 1.10-4.18 ) . Surgery remains the gold standard in treatment of patients with symptomatic carotid artery stenosis . Stent-supported angioplasty can be an alternative only in the hands of an experienced interventionalist with proven low periprocedural complication rate .

Stent and surgery

stent-supported angioplasty ( CAS )

carotid endarterectomy ( CEA )

CAS

CEA

CAS

CEA

CAS

Stent-supported angioplasty

absolute risk difference

short-term prevention

Instent restenoses

periprocedural complication rate


New mini-extracorporeal circulation system ( ECC.O ) is a safe technique in coronary surgery . OBJECTIVES Cardiopulmonary bypass ( CPB ) is known to cause the systemic inflammatory reaction after cardiac surgery . New coated and closed loop circuit systems may reduce this inflammation response and improve the surgical outcome . This study was designed to evaluate the safety and efficacy of the mini-extracorporeal circulation system ( ECC.O ) in CABG patients . DESIGN Forty patients undergoing elective coronary surgery were randomized into two groups , the ECC.O group and the standard CPB group . Routine hemodynamic monitoring and biochemical measurements were registered according to the hospital practice . RESULTS The clinical outcome of the patients was similar in both groups . There were no significant differences between the groups in the duration of intubation following surgery , the length of intensive care unit-stay or the total hospital stay . The haemoglobin level was significantly higher ( p=0.0069 ) during and after the perfusion in the ECC.O group . CONCLUSIONS The ECC.O system can be safely used in CABG patients and it maintains haemoglobin level better than conventional CPB .

Cardiopulmonary bypass ( CPB )

ECC.O group and the

standard CPB group

ECC.O

ECC.O

CPB

inflammation response

improve the surgical outcome

length of intensive care unit-stay

total hospital stay

haemoglobin level

CABG patients

Forty patients

elective coronary surgery

CABG patients


A randomized controlled trial of a health-promotion programme and its effect on ADL dependence and self-reported health problems for the elderly visually impaired . BACKGROUND Ageing with visual impairment is associated with a high degree of disability whereby age-related macular degeneration in particular causes dependence in activities of daily living ( ADL ) even at an early stage . AIMS To compare an activity-based , health-promotion programme with an individual programme , targeting the elderly with age-related macular degeneration concerning the effect on the development of dependence in ADL , general health , and self-reported health problems . METHODS A randomized controlled study with a 28-month follow-up . A total of 229 persons were randomized to the study and 131 ( 57 % ) were followed up ( individual intervention n=69 , health-promotion programme n=62 ) at 28-month . RESULTS The health-promotion group maintained their ADL level despite a significant decrease in visual acuity , while the individual intervention group increased its dependence in ADL . General health systematically dropped to a lower level in both groups , but participants from the health-promotion group reported fewer health problems . There were significantly fewer reports of tiredness and dizziness among the health-promotion participants . CONCLUSION The health-promotion programme seems to have slowed down the disablement process among elderly with decreased vision by enabling them to maintain their ADL level and by reducing self-reported health problems for at least 28 months following intervention .

health-promotion programme

health-promotion programme

individual programme

( individual intervention

health-promotion programme

health-promotion group

individual intervention

health-promotion group

health-promotion

ADL

self-reported health problems

activities of daily living ( ADL )

ADL level

visual acuity

ADL

General health

fewer health problems

tiredness

and dizziness

disablement process

ADL level

reducing self-reported health problems

elderly

visually impaired

age-related macular degeneration


Severe enteropathy among patients with stage II/III colon cancer treated on a randomized trial of bolus 5-fluorouracil/leucovorin plus or minus oxaliplatin : a prospective analysis . BACKGROUND Cases of severe gastrointestinal toxicity were monitored prospectively during NSABP C-07 , a randomized clinical trial of adjuvant therapy for patients with stage II/III colon cancer . METHODS Patients were treated with weekly bolus 5-fluorouracil ( 5-FU ) and leucovorin ( FL ; " Roswell Park Regimen " ) or the same regimen plus oxaliplatin ( FLOX ) . RESULTS Of 1857 patients , 79 ( 4.3 % ) developed a syndrome of bowel wall injury ( BWI , small or large ) characterized by hospitalization for the management of severe diarrhea or dehydration and radiographic or endoscopic evidence of bowel wall thickening or ulceration . Fifty-one ( 64.6 % ) of these adverse events occurred in patients treated with FLOX and 28 ( 35.4 % ) in those treated with FL ( P < .01 ) . Enteric sepsis ( ES ) , characterized by grade 3 or greater diarrhea and grade 4 neutropenia with or without proven bacteremia occurred in 22 patients treated with FLOX , versus 8 in those treated with FL ( P = .01 ) . Patients > 60 years were at higher risk for BWI after treatment with FLOX ( 6.7 % ) versus treatment with FL ( 2.9 % , P < .01 ) . Female patients had a higher incidence of BWI with FLOX ( 9.1 % ) than with FL ( 3.9 % , P < .01 ) . Severe gastrointestinal toxicity usually occurred during the third or fourth week on the first cycle of therapy , required hospitalization , and was managed with fluids , antidiarrheals , and antibiotics . There were 5 deaths ( 0.3 % ) due to enteropathy , 2 related to ES and 3 related to both BWI and ES . Seventy-one percent of patients resumed treatment with FL after recovery . CONCLUSIONS Patients treated with adjuvant FL should be closely monitored for diarrhea and aggressively managed , especially if oxaliplatin has been added to the regimen . Society .

FLOX

FLOX

FL

FLOX

FL

FLOX

FL

FL

adverse events

Enteric sepsis ( ES )

grade 3 or greater diarrhea and grade 4

neutropenia

with or without proven bacteremia

higher risk for BWI

higher incidence of BWI

Severe gastrointestinal toxicity

deaths

diarrhea

patients with stage II/III colon cancer


Injury and illness costs in the Certified Safe Farm study . CONTEXT The Certified Safe Farm ( CSF ) intervention program aims to reduce occupational injuries and illnesses , and promote wellness to reduce health care and related costs to farmers , insurers , and other stakeholders . PURPOSE To evaluate the cost effectiveness of CSF . METHODS Farms ( 316 ) located in a 9-county area of northwestern Iowa were recruited and randomized into intervention and control cohorts . Intervention farms received occupational health screenings , health and wellness screening , education , on-farm safety reviews , and performance incentives . For both cohorts , quarterly calls over 3 years were used to collect self-reported occupational injury and illness information , including costs to the farmers and their insurers . FINDINGS Annual occupational injury and illness costs per farmer paid by insurers were 45 % lower in the intervention cohort ( $ 183 ) than in the control cohort ( $ 332 ) . Although out-of-pocket expenses were similar for both cohorts , combined costs of insurance and out-of-pocket expenses were 27 % lower in the intervention cohort ( $ 374/year per farmer ) compared to the control cohort ( $ 512/year per farmer ) . Within the cohort of intervention farmers , annual occupational injury and illness cost savings were directly associated with on-farm safety review scores . Reported health care costs were $ 237 per farmer in the safest farms ( those farms scoring in the highest tertile ) versus $ 485 per farmer in the least safe farms ( lowest tertile ) . CONCLUSIONS Results suggest that farmers receiving the intervention had lower health care costs for occupational injuries and illnesses than control farmers . These cost savings more than cover the cost of providing CSF services ( about $ 100 per farm per year ) .

intervention

control

Intervention

intervention

intervention

control

intervention

intervention

control

Injury and illness costs

cost effectiveness of CSF

out-of-pocket expenses

health care costs

health care costs

cost savings


Nateglinide reduces carotid intima-media thickening in type 2 diabetic patients under good glycemic control . OBJECTIVE Postprandial hyperglycemia observed in type 2 diabetes mellitus is a risk factor for atherosclerosis . The aim of this study was to investigate the effect of strict glycemic control by nateglinide on common carotid far wall intima-media thickness in type 2 diabetic patients who were already under good glycemic control . METHODS AND RESULTS We performed an open labeled randomized prospective trial on 78 drug-naive type 2 diabetic patients whose HbA1c was less than 6.5 % . Thirty-eight patients were randomly assigned to receive nateglinide ( 270 mg/dL ) and 40 to control group ( no treatment ) . After 12 months , a significant reduction in HbA1c was observed in the nateglinide group , whereas a significant increase of HbA1c was observed in the untreated group . The carotid intima-media thickness at the end of 1-year follow-up was significantly reduced in the nateglinide group compared with the untreated group ( -0.017+/-0.054 mm/year versus 0.024+/-0.066 mm/year , P=0.0064 ) . Whereas nateglinide treatment also reduced triglyceride , highly-sensitive C-reactive protein , and E-selectin , multiple regression analysis identified HbA1c as the only significant independent determinant of the change in carotid intima-media thickness . CONCLUSION In type 2 diabetic patients with good glycemic control , further strict glycemic control by nateglinide results in regression of carotid intima-media thickness .

Nateglinide

strict glycemic control

nateglinide

control group ( no treatment )

untreated

strict glycemic control by nateglinide

carotid intima-media thickening

carotid far wall intima-media thickness

carotid intima-media thickness

carotid intima-media thickness

carotid intima-media thickness

type 2 diabetes


Timing of death and myocardial infarction in patients with non-ST elevation acute coronary syndromes : insights from randomized clinical trials . BACKGROUND Adverse events occur following non-ST elevation acute coronary syndromes ( NSTE ACS ) . However , the timing of these events in relation to index event is less clear . METHODS Accordingly , we evaluated 26,466 NSTE ACS patients from the Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes ( GUSTO-IIb ) , Platelet Glycoprotein IIb/IIIa in Unstable Angina : Receptor Suppression Using Integrilin Therapy ( PURSUIT ) , and Platelet IIb/IIIa Antagonism for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network ( PARAGON ) A and B trials to ascertain the timing of adverse events . Outcomes of interest were death , myocardial infarction ( MI ) , and death or MI at 180 days . Logistic regression modeling for death was used to categorize patients into low- , medium- , and high-risk groups . RESULTS At 6 months , 6.2 % of patients died , 12.1 % had MI , and 15.7 % suffered death or MI . From 15 % to 40 % of these events occurred beyond 30 days . At 6 months , 3 % , 4 % , and 13 % of patients died in low- , medium- , and high-risk groups , respectively . However , the proportion of patients dying beyond 30 days was similar in the three groups ( 44 % , 43 % , and 41 % of death , respectively ) . Similarly , whereas death or MI increased with higher risk ( 11 % , 14 % , and 23 % , respectively ) , the proportion of patients with this event beyond 30 days did not differ in the three strata ( 22 % , 20 % , and 25 % , respectively ) . CONCLUSIONS Our study provides important insights into the timing of adverse events and suggests that the substantial proportion of patients suffer subsequent adverse events after their index NSTE ACS . Thus , these data call for continuous surveillance for these events and efforts beyond the acute phase at increasing adherence to evidence-based therapies to improve the outcomes of these patients .

Platelet Glycoprotein IIb/IIIa

Logistic regression modeling

Timing of death

myocardial infarction

death

myocardial infarction ( MI )

death

MI at 180 days

died

MI

death

MI

proportion of patients dying

death

myocardial infarction

acute coronary syndromes