Pilot study of imiquimod 5 % cream as adjunctive therapy to curettage and electrodesiccation for nodular basal cell carcinoma . BACKGROUND Curettage and electrodesiccation ( C & D ) is a widely used method to treat nodular basal cell carcinoma ( BCC ) . However , residual tumor is present immediately after the procedure in approximately 20 to 40 % of cases . Imiquimod , a topical immune response modifier that targets Toll-like receptor 7 , is currently approved for superficial BCC . OBJECTIVE In a double-blind , vehicle-controlled study , the administration of imiquimod after C & D was investigated to determine if the combination regimen would reduce the frequency of residual tumor compared with C & D alone in patients with nodular BCC . METHODS Twenty patients received three cycles of C & D followed by imiquimod 5 % or vehicle cream once daily for 1 month as adjunctive therapy . The primary end point was the frequency of residual tumor . The secondary end points included the time to heal and cosmetic appearance . RESULTS Twenty patients were randomized to the imiquimod ( n = 10 ) or vehicle ( n = 10 ) treatment group . At 8 weeks , the proportion of patients with residual tumor was substantially decreased with imiquimod therapy ( 10 % ) compared with vehicle ( 40 % ) . Wounds in the vehicle group healed more quickly than those in the imiquimod group , although by 8 weeks , all excision sites were healed . The majority of scars in the control group were atrophic and hypopigmented , whereas most scars in the imiquimod group were flat and slightly pink . CONCLUSION Imiquimod 5 % cream once daily for 1 month as adjunctive therapy after C & D substantially reduced the frequency of residual tumor and improved the cosmetic appearance compared with C & D alone . These preliminary results suggest that further studies to investigate imiquimod adjunctive therapy are warranted .

imiquimod 5 % cream

adjunctive therapy

curettage

electrodesiccation

Curettage

electrodesiccation

C & D

imiquimod

C & D

C & D

imiquimod

vehicle cream

adjunctive therapy

imiquimod

vehicle

imiquimod

vehicle

imiquimod

Imiquimod

C & D

C & D

imiquimod adjunctive therapy

nodular basal cell carcinoma

nodular basal cell carcinoma

BCC

nodular BCC

Twenty


The impact of emotional distress on HIV risk reduction among women . This study evaluated whether 333 seronegative African American female drug users ( aged 18-59 years ) participating in an HIV intervention and with higher levels of emotional distress , specifically symptoms of depression and anxiety , reduced HIV risk behaviors to a lesser extent than those with lower levels of emotional distress . Participants were recruited between June 1998 and January 2001 from inner-city Atlanta ( Georgia , U.S. ) neighborhoods and were randomly assigned to one of two enhanced gender-specific and culturally specific HIV intervention conditions or to the NIDA standard condition . Participants were interviewed at baseline , post-intervention and at 6-month follow-up with a structured questionnaire including information on sociodemographics , sexual and drug-using behavior , and psychosocial characteristics . Despite a significant decline in symptoms of emotional distress during the study period , the women in this sample reported high levels of depressive and anxiety symptoms at baseline and 6-month follow-up . Higher levels of emotional distress were positively associated with post-intervention sexual and drug-taking risk . Women in both enhanced intervention conditions reduced their sexual and drug-taking risks more than women in the standard intervention . Those in the motivation intervention arm experienced a greater reduction in depressive symptoms , accompanied by a greater reduction in sexual risk behavior . Findings suggest the need for effective interventions and mental health resources among subgroups of high-risk women who may be most resistant to behavioral change .

emotional distress

HIV intervention

structured questionnaire

enhanced intervention conditions

standard intervention

motivation intervention

HIV risk reduction

depressive and anxiety symptoms

Higher levels of emotional distress

sexual and drug-taking risks

depressive symptoms

sexual risk behavior


Similar compliance and effect of treatment in chronic hepatitis C resulting from intravenous drug use in comparison with other infection causes . OBJECTIVES There is some reluctance to treat intravenous drug users ( IVDUs ) with chronic hepatitis C ( CHC ) because of presumed lower compliance and response to antiviral therapy . We intended to evaluate the compliance and response to antiviral treatment for CHC in IVDUs compared with non-IVDUs . METHODS A retrospective cohort study -- secondary analysis of the results of a treatment trial -- was performed in Belgium and The Netherlands . A total of 406 previously untreated CHC patients , including 98 ( 24 % ) IVDUs , were studied for compliance ( presentation at the end of treatment ) , complete response ( alanine aminotransferase within normal limits and serum hepatitis C virus polymerase chain reaction negative ) at the end of therapy and sustained virological response ( SVR ) . RESULTS Non-compliance ( 8.2 % ) in IVDUs was not different from non-IVDUs ( 6.8 % ) ( relative risk=1.20 ; 95 % confidence interval=0.55-2.62 ) . Complete response after controlling for hepatitis C virus was similar ( relative risk=1.19 ; 95 % confidence interval=0.89-1.60 ) . Controlling for treatment arm , age , sex , presence of cirrhosis or hepatitis C virus viral load before treatment did not change these results . There was a marginally significant difference in the sustained virological response between IVDUs ( 46.6 % ) and non-IVDUs ( 34.6 % ) ( relative risk=1.35 ; 95 % confidence interval=1.00-1.81 ) , also disappearing after adjusting for genotype . No difference in compliance or sustained virological response was found between active and non-active IVDUs or between IVDU patients in or without a methadone maintenance program . CONCLUSIONS In this group of Benelux patients , IVDUs showed similar compliance and response to treatment with interferon and ribavirin compared with other patients with CHC infection . Therefore , it is no longer justifiable to withhold treatment to chronic hepatitis C patients who use intravenous drugs .

intravenous drug use

antiviral therapy

antiviral treatment for CHC

Non-compliance

Complete response

sustained virological response

similar compliance

response

chronic hepatitis C


Playing on the typewriter , typing on the piano : manipulation knowledge of objects . Two experiments investigated sensory/motor-based functional knowledge of man-made objects : manipulation features associated with the actual usage of objects . In Experiment 1 , a series of prime-target pairs was presented auditorily , and participants were asked to make a lexical decision on the target word . Participants made a significantly faster decision about the target word ( e.g . 'typewriter ' ) following a related prime that shared manipulation features with the target ( e.g . 'piano ' ) than an unrelated prime ( e.g . 'blanket ' ) . In Experiment 2 , participants ' eye movements were monitored when they viewed a visual display on a computer screen while listening to a concurrent auditory input . Participants were instructed to simply identify the auditory input and touch the corresponding object on the computer display . Participants fixated an object picture ( e.g . " typewriter " ) related to a target word ( e.g . 'piano ' ) significantly more often than an unrelated object picture ( e.g . " bucket " ) as well as a visually matched control ( e.g . " couch " ) . Results of the two experiments suggest that manipulation knowledge of words is retrieved without conscious effort and that manipulation knowledge constitutes a part of the lexical-semantic representation of objects .

lexical decision

target word

decision

fixated

manipulation knowledge of words

manipulation knowledge

Participants


Performance of a modified starch hydrophilic matrix for the sustained release of theophylline in healthy volunteers . Two experimental formulations of theophylline with a hydrophilic starch matrix were evaluated for their sustained-release characteristics after single administration in healthy human volunteers . Theo-dur was chosen as a reference sustained-release formulation . In a first study , the extent of absorption was similar for a syrup , for Theo-dur , and for the experimental formulation of theophylline with 70 % drum-dried corn starch as the sustained-release agent ( DDCS-70 ) . The maximal plasma concentration ( Cmax ) was significantly lower , and the time to reach Cmax as well as the time span during which the plasma concentration was at least 75 % of the Cmax were significantly higher for Theo-dur than for the DDCS-70 formulation . A sustained-release profile , as for Theo-dur , was not reached for DDCS-70 . In a second study the influence of the starch : drug ratio on the bioavailability was investigated . The decrease in starch content from 70 to 50 % of the formulation did not improve the plasma concentration-time profile towards a sustained-release profile .

theophylline

Theo-dur

Theo-dur

Theo-dur

maximal plasma concentration ( Cmax )

time to reach Cmax

plasma concentration

plasma concentration-time

healthy volunteers .


Does a first trimester dating scan using crown rump length measurement reduce the rate of induction of labour for prolonged pregnancy ? An uncompleted randomised controlled trial of 463 women . OBJECTIVE To evaluate the effect of a first trimester ultrasound dating scan on the rate of induction of labour for prolonged pregnancy . DESIGN Randomised controlled trial to include 400 women in each arm of the trial . SETTING Participating general practices and a district general teaching hospital . POPULATION Women attending their general practitioner in the first trimester to confirm pregnancy , in whom a first trimester ultrasound scan was not indicated . METHODS Women randomised to the study group ( scan group ) underwent an ultrasound dating scan between 8 and 12 weeks , measuring crown-rump length . The estimated date of delivery ( EDD ) was changed if there was a discrepancy of more than 5 days from the gestation , calculated from the last menstrual period ( LMP ) . For the remaining women ( no-scan group ) , gestation was determined using the LMP . MAIN OUTCOME MEASURES The rate of induction of labour for prolonged pregnancy . RESULTS Due to circumstances beyond the researchers ' control , recruitment was abandoned when 463 women had been enrolled . The EDD was adjusted in 13 ( 5.7 % ) women in the scan group and in 2 ( 0.9 % ) in the no-scan group . There was no difference in the rate of induction for prolonged pregnancy between the scan ( 19 [ 8.2 % ] ) and the no-scan ( 17 [ 7.4 % ] ) groups ( relative risk 1.10 ; 95 % CI 0.59-2.07 ) . CONCLUSIONS Acknowledging the reduced numbers recruited for study , it is concluded that there is no evidence that a first trimester ultrasound dating scan reduces the rate of induction of labour for prolonged pregnancy and may result in a more expensive healthcare strategy .

ultrasound dating scan

ultrasound scan

ultrasound dating scan

ultrasound dating scan

rate of induction of labour

prolonged pregnancy

rate of induction of labour

prolonged pregnancy

rate of induction

prolonged pregnancy

rate of induction of labour

prolonged pregnancy

women

women

Women

first trimester

pregnancy

women


Project Towards No Drug Abuse : long-term substance use outcomes evaluation . OBJECTIVES This paper presents up to 5 years post-program outcomes of Project Towards No Drug Abuse ( Project TND ) , a drug abuse prevention program conducted in South California alternative high school system during years 1994-1999 . METHODS The effects of a 9-session health motivation -- social skills -- decision-making curriculum were evaluated . Twenty-one schools recruited were randomly assigned to standard care ( control ) , classroom only , or a classroom plus semester-long school-as-community component . Last 30-day use of cigarettes , alcohol , marijuana , and hard drugs were assessed at three time intervals : short-term ( year 1 ) , middle-term ( years 2 or 3 ) , and long-term ( years 4 or 5 ) . Multilevel random coefficients modeling were employed to estimate the adjusted levels of substance use . RESULTS Among 1578 baseline subjects , follow-up data were available for 68 % ( year 1 ) , 66 % ( years 2 or 3 ) , and 46 % ( years 4 or 5 ) of subjects , respectively . Results revealed significant positive long-term program effects for hard drug use at year 4 or 5 for the two program interventions ( P = 0.02 ) . CONCLUSIONS Project TND reduced hard drug use in the 46 % who were successfully followed . It is the first program to demonstrate long-term self-reported behavioral effects on hard drug use among high-risk youth by using a school-based , limited-session model .

No Drug Abuse

No Drug Abuse

Twenty-one

youth


Comparison of remifentanil with fentanyl for deep sedation in oral surgery . PURPOSE The aim of this study was to compare recovery for oral surgery patients given a deep sedation regimen of midazolam , propofol , and remifentanil with a standard control of fentanyl in place of remifentanil . MATERIALS AND METHODS This investigation was designed as a randomized , prospective , single-blinded controlled study . Group 1 , the control , received midazolam 0.03 mg/kg , fentanyl 1 microg/kg , and propofol initially at 140 microg/kg/min . Group 2 received midazolam 0.03 mg/kg , remifentanil : propofol ( 1:500 ) given at an initial propofol infusion rate of 40 microg/kg/min . Outcome measures included time to response to verbal command , Aldrete score = 9 , Postanesthesia Discharge Scoring System = 7 , and assessment by the Digit Symbol Substitution Test . RESULTS Forty-seven subjects were entered in the study . Baseline findings were homogenous between the 2 groups . Subjects in group 2 recovered earlier ( P < .005 ) and required less propofol for both the induction ( 0.8 +/- 0.4 versus 1.2 +/- 0.6 mg/kg ; mean +/- SD , P < .01 ) and maintenance of deep sedation ( 46 +/- 9 versus 131 +/- 17 microg/kg/min ; P < .005 ) . There were minor differences in vital signs . CONCLUSIONS This study demonstrated that this remifentanil regimen provided significantly more rapid recovery and used significantly less propofol compared with the fentanyl regimen .

remifentanil

fentanyl

midazolam , propofol

remifentanil

midazolam 0.03 mg/kg

fentanyl 1 microg/kg

propofol

propofol

fentanyl

deep sedation

time to response to verbal command

Aldrete score

= 9

induction

maintenance of deep sedation

rapid recovery

oral surgery patients


The influence of rTMS over the left dorsolateral prefrontal cortex on Stroop task performance . Several studies have demonstrated that repetitive transcranial magnetic stimulation ( rTMS ) can improve cognitive processing . Neuroimaging studies have shown the engagement of the left dorsolateral prefrontal cortex ( DLPFC ) in executive functioning , and more specifically during selective attention . In the present study , the influence of high-frequency rTMS over the left DLPFC on Stroop task performance in healthy female volunteers was investigated . As expected , reaction time on both the incongruent and congruent trials decreased significantly after stimulation , and there was no difference with regard to the Stroop interference effect . Mood remained unchanged after rTMS . Such a pattern is consistent with the role of the left DLPFC in implementing top-down attentional control .

rTMS

Stroop task performance .

high-frequency rTMS

rTMS .

reaction time

Stroop interference effect

Mood

healthy

female


[ Comparison of the efficacy/tolerability ratio of cibenzoline and propafenone in the treatment of ventricular arrhythmia ] . Cibenzoline ( C ) was compared with propafenone ( P ) in 18 adult patients ( 7 women and 11 men ) aged 50 +/- 7 in double-blind , placebo-controlled crossover trial . After a therapeutic wash-out period corresponding to 5 times the half-life of previous anti-arrhythmic drugs , patients with more than 100 premature ventricular contractions ( PVC ) per hour in two 24 hour Holter records obtained at an interval of 7 days were treated in succession and after randomised by C ( 390 mg/day in 3 divided doses ) and P ( 900 mg/day in 3 divided doses ) for a period of two weeks , each active sequence being followed by a two week wash-out period . Efficacy ( based upon the decrease in PVC/hour in a 24 hour Holter ) and tolerability were evaluated at the end of each sequence , with samples drawn at the same times for assay of the study drugs . Three patients dropped out of the trial , 1 with each active drug ( for epigastric pain ) and 1 with dummy . No significant difference was seen between the two drugs regarding the decrease in the total number of PVC/hour in the 15 patients completing the cross-over protocol . A reduction in PVC/hour of more than 70 per cent was seen in 7 patients with C and in 9 patients with P. C was better tolerated than P on the basis of both clinical and electrocardiographic parameters . One patient developed troublesome adverse reactions with C as compared with 4 patients in the case of P. A more than 20 per cent increase in QRS was seen in 7 patients with C and in 10 patients with P , the figures for PR being 2 and 6 patients respectively . One patient showed a proarrhythmic effect with P. Plasma levels of C were significantly higher in responders ( 328 +/- 149 ng/ml ) than in non-responders ( 137 +/- 41 ng/ml , p less than 0.05 ) . No significant difference was found concerning plasma levels of P ( 578 +/- 477 ng/ml compared with 646 +/- 457 ng/ml , p greater than 0.05 ) . In conclusion , the efficacy/tolerability ratio in this population with a low risk of serious rhythm events appeared to be better with C than with P .

cibenzoline

propafenone

Cibenzoline ( C )

propafenone ( P )

placebo-controlled

anti-arrhythmic drugs

C

P

C

C

C

P

C

P .

epigastric pain )

total number of PVC/hour

reduction in PVC/hour

C was better tolerated

adverse reactions

20 per cent increase in QRS

efficacy/tolerability ratio


Effect of micronutrient supplement on health and nutritional status of schoolchildren : study design . OBJECTIVE We tested the hypothesis that supplementation with a micronutrient-fortified beverage improves micronutrient status and physical and mental development in apparently healthy schoolchildren . METHODS The study was carried out in middle-income students in two residential schools that catered to children from a semi-urban population near Hyderabad , India . Included were 869 children who were 6 to 16 y of age in grades 1 to 10 . Because children at each grade were distributed across two classrooms ( clusters ) and were homogeneous , each grade was considered to consist of a matched pair . There were thus 10 pairs available for the study . Classes in each grade were randomized to receive a micronutrient-enriched beverage or a placebo without added micronutrients . The study was double blinded and the duration was 14 mo , with supervised feeding of the micronutrient-enriched beverage . The effect of the micronutrients on the outcome variables growth , biochemical status , mental function , and bone health were assessed . RESULTS The number of matched pairs varied between seven and eight , and the required number of children per treatment group ranged from 32 in the case of bone heath to 177 for body weight . The power of the outcome variables ranged from 74 % to 100 % and was adequate for successful pairing . The effect assessed at the end of supplementation showed that the intervention was beneficial . CONCLUSIONS Designing an intervention , choosing outcome variables , and implementing the protocol in a typical Indian school setting were achieved .

micronutrient supplement

micronutrient-fortified beverage

micronutrient-enriched beverage

placebo without added micronutrients

micronutrient-enriched beverage

micronutrients

supplementation

health and nutritional status

mental function

bone health

beneficial


Paricalcitol capsule for the treatment of secondary hyperparathyroidism in stages 3 and 4 CKD . BACKGROUND The safety and efficacy of paricalcitol injection have been well established for the prevention and treatment of secondary hyperparathyroidism ( SHPT ) in patients with chronic kidney disease ( CKD ) stage 5 . The capsule form of paricalcitol was developed to provide a convenient dosage form for patients with stages 3 and 4 CKD . METHODS Three randomized , placebo-controlled , phase-3 trials were conducted in patients with stages 3 and 4 CKD with SHPT . Enrollment criteria included an estimated glomerular filtration rate between 15 and 60 mL/min/1.73 m2 ( 0.25 and 1.00 mL/s/1.73 m2 ) , an average of 2 consecutive intact parathyroid hormone ( iPTH ) levels greater than 150 pg/mL ( ng/L ) , 2 consecutive serum calcium levels between 8.0 and 10.0 mg/dL ( 2.00 and 2.50 mmol/L ) , and 2 consecutive serum phosphorus levels of 5.2 mg/dL or less ( < or = 1.68 mmol/L ) . Two studies used a thrice-weekly dosing regimen and 1 study used a once-daily dosing regimen for 24 weeks . Dosing was based on serum iPTH , calcium , and phosphorus levels . The primary efficacy end point is 2 consecutive decreases in iPTH levels greater than 30 % from baseline . RESULTS Two hundred twenty patients participated ( n = 107 , paricalcitol ; n = 113 , placebo ) . At least 2 consecutive decreases in iPTH levels of 30 % or greater from baseline occurred in 91 % of paricalcitol versus 13 % of placebo patients ( P < 0.001 ) . Incidences of hypercalcemia , hyperphosphatemia , and elevated calcium-phosphorus product levels were not significantly different between groups . Similarly , no significant differences in urinary calcium and phosphorus excretion or deterioration in kidney function were detected in patients administered paricalcitol compared with placebo . CONCLUSION Paricalcitol capsule was well tolerated and effectively decreased iPTH levels with minimal or no impact on calcium levels , phosphorus balance , and kidney function in patients with stages 3 and 4 CKD .

Paricalcitol capsule

paricalcitol

placebo-controlled

paricalcitol

placebo

Paricalcitol

secondary hyperparathyroidism

safety

efficacy

secondary hyperparathyroidism ( SHPT )

serum calcium levels

serum phosphorus levels

2 consecutive decreases in iPTH levels

decreases in iPTH levels

hypercalcemia

hyperphosphatemia

deterioration in kidney function

secondary hyperparathyroidism

SHPT

Two hundred twenty patients


Randomized , placebo-controlled , double-blind clinical trial evaluating the treatment of plantar fasciitis with an extracoporeal shockwave therapy ( ESWT ) device : a North American confirmatory study . Despite numerous publications and clinical trials , the results of treatment of recalcitrant chronic plantar fasciitis with extracorporeal shockwave therapy ( ESWT ) still remain equivocal as to whether or not this treatment provides relief from the pain associated with this condition . The objective of this study was to determine whether extracorporeal shock wave therapy can safely and effectively relieve the pain associated with chronic plantar fasciitis compared to placebo treatment , as demonstrated by pain with walking in the morning . This was set in a multicenter , randomized , placebo-controlled , double-blind , confirmatory clinical study undertaken in four outpatient orthopedic clinics . The patients , 114 adult subjects with chronic plantar fasciitis , recalcitrant to conservative therapies for at least 6 months , were randomized to two groups . Treatment consisted of approximately 3,800 total shock waves ( +/-10 ) reaching an approximated total energy delivery of 1,300 mJ/mm ( 2 ) ( ED+ ) in a single session versus placebo treatment . This study demonstrated a statistically significant difference between treatment groups in the change from baseline to 3 months in the primary efficacy outcome of pain during the first few minutes of walking measured by a visual analog scale . There was also a statistically significant difference between treatments in the number of participants whose changes in Visual Analog Scale scores met the study definition of success at both 6 weeks and 3 months posttreatment ; and between treatment groups in the change from baseline to 3 months posttreatment in the Roles and Maudsley Score . The results of this study confirm that ESWT administered with the Dornier Epos Ultra is a safe and effective treatment for recalcitrant plantar fasciitis .

placebo-controlled

extracoporeal shockwave therapy

3,800 total shock waves

placebo treatment

ESWT

relief

the pain

safely

effectively relieve the pain

pain

the first few minutes

visual analog scale

Visual Analog Scale scores

Roles and Maudsley Score

safe

effective

plantar fasciitis

recalcitrant chronic plantar fasciitis

four outpatient

adult subjects


Does an educational leaflet improve self-reported adherence to therapy in osteoporosis ? The OPTIMA study . INTRODUCTION Adherence to treatment in osteoporosis remains poor . The aim of this study was to evaluate the effects of an educational leaflet on adherence to medication and to assess the association between adherence and health-related quality of life ( HRQOL ) . METHODS A naturalistic , observational , multi-center , prospective study of 12 months ' follow-up was performed . Consecutive post-menopausal women aged 50 years to 86 years starting treatment with raloxifene according to daily practice were enrolled from 126 primary care offices in Spain . The women were assigned to two study groups . Group A received an educational leaflet with general information about osteoporosis ; group B followed current practice . To assess adherence to medication and HRQOL , the Morisky test and the EuroQoL questionnaire were administered . A total of 745 post-menopausal women ( group A , n=366 ; group B n=379 ) , with a mean age of 62 years , were included . RESULTS Most patients in both study groups showed high adherence to raloxifene at the 3-month visit : 56.3 % vs 62.7 % for groups A and B , respectively ; this proportion at the 12-month visit was 47.4 % ( P=0.15 ) and 52.5 % ( P=0.02 ) , respectively . At baseline , " pain/discomfort " was the dimension showing the highest percentage of women reporting problems : 86.4 % vs 83.2 % in groups A and B , respectively ( P=0.22 ) . HRQOL improved in both groups throughout the study , with an overall mean increment in the EuroQoL visual analog scale ( EQ VAS ) of 9.2 at 12 months ( P < 0.01 ) . Correlations between adherence and HRQOL were weak . After receiving an educational leaflet , young post-menopausal women suffering osteoporosis did not show improvement in adherence to therapy . HRQOL improved at 12-month follow-up under treatment . CONCLUSION No consistent correlation between adherence and HRQOL was found .

educational leaflet

educational leaflet

raloxifene

current practice

raloxifene

educational leaflet

adherence

Adherence

adherence

adherence

adherence to medication

HRQOL

Morisky test

EuroQoL

" pain/discomfort "

HRQOL

EuroQoL visual analog scale ( EQ VAS )

adherence

HRQOL

adherence to therapy .

HRQOL

adherence

HRQOL

osteoporosis

aged 50 years to 86 years

women

mean age of 62 years

post-menopausal


Plasmakinetic prostate resection in the treatment of benign prostate hyperplasia : results of 1-year follow up . AIM In our randomized prospective study , we aimed to evaluate the efficiency of plasmakinetic resection of prostate ( PKRP ) by comparing the preoperative and postoperative results of the transurethral resection of prostate ( TURP ) and PKRP techniques which we administered in patients with benign prostate hyperplasia ( BPH ) in our clinic . METHODS Of 57 patients for whom we thought an operative intervention was necessary , 30 cases in the first group had a TURP and 24 cases in the second group had a PKRP . International prostate symptom scores ( I-PSS ) , uroflowmetry , measurement of residual urine amount and ultrasonography were performed for each patient both preoperatively and postoperatively ( first month and first year ) . Operation times , urethral catheterization times , preoperative and postoperative Hb , Htc and serum Na values of the patients were compared and the complications of the groups were also compared . RESULTS On first month and first year follow up between the groups , there was no significant statistical difference in I-PSS , maximum flow rate , average flow , residual urine and size of the prostate . The decrease in serum Na level was found to be significantly higher in the TURP group ( P < 0.05 ) . The operation times were not significantly different between the groups . While the postoperative catheterization time was 75.7 h in TURP group , it was found to be 42 h in PKRP group and it was clear that catheterization time was significantly shorter ( P < 0001 ) . CONCLUSION It is obvious that PKRP is as efficient as TURP and it has a similar morbidity . In our opinion , PKRP makes a promising treatment for BPH with its advantages , such as early removal of postoperative urethral catheter , a shorter hospital stay and the absence of TUR syndrome risk .

Plasmakinetic prostate resection

transurethral resection of prostate

TURP

PKRP

PKRP

PKRP

uroflowmetry

measurement of

residual urine amount

and ultrasonography

Operation times

urethral catheterization times

preoperative and postoperative Hb

Htc and serum Na values

I-PSS

maximum flow rate

average flow

residual urine and size of the prostate

serum Na level

operation times

postoperative catheterization time

catheterization time

hyperplasia


Sham device v inert pill : randomised controlled trial of two placebo treatments . OBJECTIVE To investigate whether a sham device ( a validated sham acupuncture needle ) has a greater placebo effect than an inert pill in patients with persistent arm pain . DESIGN A single blind randomised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls . Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study . SETTING Academic medical centre . PARTICIPANTS 270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored > or =3 on a 10 point pain scale . INTERVENTIONS Acupuncture with sham device twice a week for six weeks or placebo pill once a day for eight weeks . MAIN OUTCOME MEASURES Arm pain measured on a 10 point pain scale . Secondary outcomes were symptoms measured by the Levine symptom severity scale , function measured by Pransky 's upper extremity function scale , and grip strength . RESULTS Pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups , but changes were not different between the groups ( -0.14 , 95 % confidence interval -0.52 to 0.25 , P = 0.49 ) . Changes in severity scores for arm symptoms and grip strength were similar between groups , but arm function improved more in the placebo pill group ( 2.0 , 0.06 to 3.92 , P = 0.04 ) . Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week on the 10 point arm pain scale in the sham device group than in the placebo pill group ( -0.33 ( -0.40 to -0.26 ) v -0.15 ( -0.21 to -0.09 ) , P = 0.0001 ) and on the symptom severity scale ( -0.07 ( -0.09 to -0.05 ) v -0.05 ( -0.06 to -0.03 ) , P = 0.02 ) . Differences were not significant , however , on the function scale or for grip strength . Reported adverse effects were different in the two groups . CONCLUSIONS The sham device had greater effects than the placebo pill on self reported pain and severity of symptoms over the entire course of treatment but not during the two week placebo run in . Placebo effects seem to be malleable and depend on the behaviours embedded in medical rituals .

placebo pill once a day for eight weeks

Arm pain

10 point pain scale

Pain

10 point arm pain scale

patients with persistent arm pain .


XS0601 reduces the incidence of restenosis : a prospective study of 335 patients undergoing percutaneous coronary intervention in China . BACKGROUND XS0601 , consisting of active ingredients ( Chuangxiongol and paeoniflorin ) , has been shown to inhibit arterial neointimal hyperplasia in animal models and in preliminary human studies . The objective of this study was to evaluate the safety and efficacy of XS0601 in preventing restenosis following percutaneous coronary intervention ( PCI ) . METHODS A multi-center , randomized , double-blind , placebo-controlled trial was conducted . A total of 335 patients were randomized into treatment with the oral administration of XS0601 , or a placebo for 6 months after successful PCI . Angiographic follow-up was scheduled at 6 months , and clinical follow-ups performed at 1 , 3 and 6 months after PCI . The primary end point was angiographic restenosis . The secondary end points were the combined incidence of death , target lesion nonfatal myocardial infarction , repeat angioplasty , and coronary artery bypass graft surgery . RESULTS A total of 308 patients ( 91.9 % ) completed the study and 145 cases ( 47.1 % ) received angiographic follow-up . The restenosis rates were significantly reduced in the XS0601 group as compared with the placebo group ( 26.0 % vs. 47.2 % , P < 0.05 ) , and the minimum lumen diameter ( MLD ) was greater [ ( 2.08 +/- 0.89 ) mm for XS0601 vs. ( 1.73 +/- 0.94 ) mm for placebo , P < 0.05 ] . XS0601 also significantly reduced the combined incidence of major adverse cardiac event ( 10.4 % in the XS0601 group vs. 22.7 % in the placebo group , P < 0.05 ) . The incidence of recurrent angina at 3 and 6 months after PCI was also significantly reduced in XS0601 group ( 7.1 % and 11.0 % ) as compared with those in placebo group ( 19.5 % and 42.9 % ) ( P < 0.05 ) . No significant side effects occurred within the 6-month follow-up period in the XS0601 group . CONCLUSION Administration of XS0601 for 6 months is demonstrated to be safe and effective in reducing restenosis in post-PCI patients .

percutaneous coronary intervention

placebo

coronary artery bypass graft surgery

placebo

placebo

placebo

placebo

angiographic restenosis .

death

restenosis rates

minimum lumen diameter ( MLD )

combined incidence of

major adverse cardiac event

incidence of recurrent angina

percutaneous coronary intervention


Application of ambulatory blood pressure monitoring to clinical therapeutic decisions in hypertension . The antihypertensive efficacies of lisinopril and captopril were compared using office sphygmomanometry and 24-h ambulatory blood pressure monitoring . In a double-blind , prospective , randomly allocated trial , the patients were given increasing doses of captopril at 25-100 mg twice a day or lisinopril at 10-40 mg once a day until a clinical response was achieved or the highest dose was reached . A response was defined as a reduction in diastolic pressure below 90 mmHg or a fall of at least 10 mmHg from baseline . The ambulatory monitoring showed that lisinopril reduced blood pressure from baseline to the final value and maintained the reduction to a greater degree than captopril throughout 24-h periods of observation . The office measurements showed a similar trend , but the intertreatment differences did not reach statistical significance . No first-dose side effects were observed with either drug . Once a day lisinopril appeared to be a more effective antihypertensive regimen than twice a day captopril .

lisinopril

captopril

captopril

lisinopril

captopril

lisinopril

antihypertensive regimen

antihypertensive

clinical response

blood pressure

maintained the reduction

office measurements

hypertension .

the patients


Brain mechanisms of expectation associated with insula and amygdala response to aversive taste : implications for placebo . The experience of aversion is shaped by multiple physiological and psychological factors including one 's expectations . Recent work has shown that expectancy manipulation can alter perceptions of aversive events and concomitant brain activation . Accruing evidence indicates a primary role of altered expectancies in the placebo effect . Here , we probed the mechanism by which expectation attenuates sensory taste transmission by examining how brain areas activated by misleading information during an expectancy period modulate insula and amygdala activation to a highly aversive bitter taste . In a rapid event-related fMRI design , we showed that activations in the rostral anterior cingulate cortex ( rACC ) , orbitofrontal cortex ( OFC ) , and dorsolateral prefrontal cortex to a misleading cue that the taste would be mildly aversive predicted decreases in insula and amygdala activation to the highly aversive taste . OFC and rACC activation to the misleading cue were also associated with less aversive ratings of that taste . Additional analyses revealed consistent results demonstrating functional connectivity among the OFC , rACC , and insula . Altering expectancies of upcoming aversive events are shown here to depend on robust functional associations among brain regions implicated in prior work on the placebo effect .

placebo

placebo

misleading information

highly aversive bitter taste

misleading cue

insula and amygdala activation

aversive ratings of that taste

insula and amygdala

brain areas activated

during an expectancy period


Effects of cooking plant oils on recurrent aphthous stomatitis : a randomized , placebo-controlled , double-blind trial . OBJECTIVE One-third of the total population seems to develop minor recurrent aphthous stomatitis ( RAS ) during their lifetime . However , well-controlled dietary intervention studies to prevent minor RAS are very rare . The objective of the present study was to investigate whether the prevalence of RAS decreased with perilla oil ( rich in alpha-linolenic acid ) . METHODS Thirty subjects ( 8 men and 22 women ) who had minor RAS at least once a month were randomly allocated to a soybean oil group or a perilla oil group in a double-blind manner ( experimental phase ) after a run-in phase of 4 mo during which subjects used a reference oil , the most popular cooking oil in Japan , or a 50/50 mixture of soybean oil and rapeseed oil . During the experimental phase , subjects were asked to use soybean oil or perilla oil as the sole cooking oil for 8 mo . Blood samples were collected at the start and end of the experimental phase for fatty acid analysis of total plasma phospholipid fraction . Occurrence and needed days for healing of minor RAS were recorded during the two phases and compared . RESULTS alpha-Linolenic acid concentrations in the plasma phospholipid fraction increased significantly in both groups during the experimental phase to a similar extent . The prevalence of minor RAS in the experimental phase decreased significantly in both groups compared with the run-in phase to a similar extent , without intergroup differences . CONCLUSION Perilla oil , which is rich in alpha-linolenic acid , was not superior to soybean oil in preventing minor RAS . There was a possibility that avoiding rapeseed oil might be beneficial for prevention of minor RAS .

cooking plant oils

perilla oil

soybean oil

perilla oil

Blood samples

recurrent aphthous stomatitis ( RAS )

Thirty

men

women


CDP571 , a humanized monoclonal antibody to tumour necrosis factor-alpha , for steroid-dependent Crohn 's disease : a randomized , double-blind , placebo-controlled trial . BACKGROUND More than 50 % of patients with Crohn 's disease become either steroid resistant or dependent . Accordingly , development of new treatments for steroid-dependent Crohn 's disease is a research priority . AIM To evaluate CDP571 , a humanized antibody to tumour necrosis factor-alpha , for the treatment of steroid-dependent Crohn 's disease . METHODS Patients with steroid-dependent Crohn 's disease ( n = 271 ) were enrolled in a 36-week , double-blind , placebo-controlled trial . Steroid dependence was defined as use of prednisolone or prednisone ( 15-40 mg/day ) or budesonide ( 9 mg/day ) for > or =8 weeks , a previous failed attempt to decrease or discontinue steroids within 8 weeks of screening , and a Crohn 's Disease Activity Index score of < or =150 points . Patients were randomized to receive intravenous CDP571 10 mg/kg or placebo 8-weekly through to week 32 . Steroids were then tapered using a defined schedule . The primary efficacy endpoint was the percentage of patients with steroid sparing , defined as discontinuation of steroid therapy without a disease flare ( Crohn 's Disease Activity Index score > or =220 points ) at week 36 . RESULTS Steroid sparing occurred in 53 of 181 ( 29.3 % ) CDP571 patients and 33 of 90 ( 36.7 % ) placebo patients ( P = 0.24 ) . Adverse events occurred at similar frequencies in both treatment groups . CONCLUSIONS CDP571 was ineffective for sparing steroids in patients with steroid-dependent Crohn 's disease . CDP571 was well tolerated .

placebo-controlled

placebo-controlled

prednisone

intravenous CDP571 10 mg/kg or placebo

therapy

placebo

Steroid sparing

Adverse events

sparing steroids


Evaluating erectile dysfunction : oral sildenafil versus intracavernosal injection of papaverine . BACKGROUND Intracavernosal injection of vasoactive drugs is an established method of evaluating erectile dysfunction . However , it is invasive and may be associated with pain and priapism . We investigated the use of oral sildenafil as a possible substitute for intracavernosal agents . METHODS Men with erectile dysfunction were randomized into two groups of 25 each . One group of 25 men received injection papaverine initially followed by oral sildenafil , and another 25 received oral sildenafil followed by injection papaverine . Genital self-stimulation was used in both the groups . Penile length and circumference as well as angle of erection , before and after each medication , were recorded . Two days later , the intervention arms were crossed over . Subjective responses were obtained . The effect of medication on each outcome variable was studied by using analysis of variance models in relation to patient , period and medication . RESULTS There was statistically significant improvement from the baseline value in both the arms , i.e injection papaverine and oral sildenafil ( p < 0.001 , p < 0.001 , respectively ) for both penile length and circumference . No significant difference was observed between the two medications in the outcome measures . CONCLCUSION : Oral sildenafil was as effective as injection papaverine in evaluating erectile dysfunction .

Evaluating

Subjective responses

analysis of variance models

penile length and circumference

erectile dysfunction :

Men

erectile dysfunction

two groups of 25 each

men

erectile dysfunction


Perceptual wind-up in the human oesophagus is enhanced by central sensitisation . BACKGROUND Oesophageal acid infusion induces enhanced pain hypersensitivity in non-acid exposed upper oesophagus ( secondary hyperalgesia ) in patients with non-cardiac chest pain , thus suggesting central sensitisation contributes to visceral pain hypersensitivity in functional gut disorders ( FGD ) . Perceptual wind-up ( increased pain perception to constant intensity sensory stimuli at frequencies > or=0.3 Hz ) is used as a proxy for central sensitisation to investigate pain syndromes where pain hypersensitivity is important ( for example , fibromyalgia ) . AIMS Wind-up in central sensitisation induced human visceral pain hypersensitivity has not been explored . We hypothesised that if wind-up is a proxy for central sensitisation induced human visceral pain hypersensitivity , then oesophageal wind-up should be enhanced by secondary hyperalgesia . METHODS In eight healthy volunteers ( seven males ; mean age 32 years ) , perception at pain threshold to a train of 20 electrical stimuli applied to the hand and upper oesophagus ( UO ) at either 0.1 Hz ( control ) or 2 Hz was determined before and one hour after a 30 minute lower oesophageal acid infusion . RESULTS Wind-up occurred only with the 2 Hz train in the UO and hand ( both p=0.01 ) . Following acid infusion , pain threshold decreased ( 17 ( 4 ) % ; p=0.01 ) in the UO , suggesting the presence of secondary hyperalgesia . Wind-up to the 2 Hz train increased in the UO ( wind-up ratio 1.4 ( 0.1 ) to 1.6 ( 0.1 ) ; p=0.03 ) but not in the hand ( wind-up ratio 1.3 ( 0.1 ) and 1.3 ( 0.1 ) ; p=0.3 ) CONCLUSION Enhanced wind-up after secondary oesophageal hyperalgesia suggests that visceral pain hypersensitivity induced by central sensitisation results from increased central neuronal excitability . Wind-up may offer new opportunities to investigate the contribution of central neuronal changes to symptoms in FGD .

electrical stimuli

2 Hz

2 Hz

2 Hz

Perceptual wind-up

Wind-up

pain threshold decreased

Wind-up to the 2 Hz train

UO

human oesophagus

eight

healthy

seven

males

mean age 32 years


Pharmacokinetic and safety evaluation of high-dose combinations of fosamprenavir and ritonavir . High-dose combinations of fosamprenavir ( FPV ) and ritonavir ( RTV ) were evaluated in healthy adult subjects in order to select doses for further study in multiple protease inhibitor ( PI ) -experienced patients infected with human immunodeficiency virus type 1 . Two high-dose regimens , FPV 1,400 mg twice a day ( BID ) plus RTV 100 mg BID and FPV 1,400 mg BID plus RTV 200 mg BID , were planned to be compared to the approved regimen , FPV 700 mg BID plus RTV 100 mg BID , in a randomized three-period crossover study . Forty-two healthy adult subjects were enrolled , and 39 subjects completed period 1 . Due to marked hepatic transaminase elevations , predominantly with FPV 1,400 mg BID plus RTV 200 mg BID , the study was terminated prematurely . For FPV 1,400 mg BID plus RTV 100 mg BID , the values for plasma amprenavir ( APV ) area under the concentration-time profile over the dosing interval ( tau ) at steady state [ AUC ( 0-tau ) ] , maximum concentration of drug in plasma ( C ( max ) ) , and plasma concentration at the end of tau at steady state ( C ( tau ) ) were 54 , 81 , and 26 % higher , respectively , and the values for plasma RTV AUC ( 0-tau ) , C ( max ) , and C ( tau ) were 49 % higher , 71 % higher , and 11 % lower , respectively , than those for FPV 700 mg BID plus RTV 100 mg BID . For FPV 1,400 mg BID plus RTV 200 mg BID , the values for plasma APV AUC ( 0-tau ) , C ( max ) , and C ( tau ) were 26 , 48 , and 32 % higher , respectively , and the values for plasma RTV AUC ( 0-tau ) , C ( max ) , and C ( tau ) increased 4.15-fold , 4.17-fold , and 3.99-fold , respectively , compared to those for FPV 700 mg BID plus RTV 100 mg BID . FPV 1,400 mg BID plus RTV 200 mg BID is not recommended due to an increased rate of marked hepatic transaminase elevations and lack of pharmacokinetic advantage . FPV 1,400 mg BID plus RTV 100 mg BID is currently under clinical evaluation in multiple PI-experienced patients .

fosamprenavir ( FPV )

ritonavir ( RTV )

FPV

RTV

FPV

RTV

FPV

RTV

FPV

RTV

FPV

RTV

FPV

FPV

FPV

RTV

FPV

RTV

FPV

RTV

values for plasma RTV AUC ( 0-tau )

C ( max )

C ( tau )

values for plasma APV AUC ( 0-tau )

plasma RTV AUC ( 0-tau )

C ( max )

C ( tau

lack of pharmacokinetic advantage .

healthy

adult

Forty-two

healthy

adult


[ Effect of Selaginella combined with radiotherapy on nasopharyngeal carcinoma ] . OBJECTIVE To observe the Chinese herbal medicine Selaginella-induced radiosensitization of terminal nasopharyngeal carcinoma ( NPC ) . METHODS Totally 180 patients with NPC were divided equally into 3 groups with the same radiotherapeutic protocols . The patients in group A received radiotherapy alone , those in group B were given daily Selaginella ( 30 g ) prepared into 50 ml decoction during the entire course of radiotherapy , and those in group C had Selaginella 30 g daily in the late course of radiotherapy . RESULTS The complete remission rate of nasopharyngeal primary lesions in groups B and C was significantly higher than that in group A , with also significantly higher complete remission rates of the cervical lymph nodes . The acute toxicity of the skin and mucous membrane was milder in the latter two groups , but the differences were not significant . CONCLUSION Selaginella may induce radiosensitization for terminal NPC and does not increase the acute toxicity of radiotherapy .

Selaginella

radiotherapy

radiotherapy alone

group C had Selaginella 30 g daily

radiotherapy

Selaginella

nasopharyngeal carcinoma

NPC

terminal NPC


Longitudinal quality of life study in patients with metastatic gastric cancer . Analysis modalities and clinical applicability of QoL in randomized phase II trial in a digestive oncology . OBJECTIVES The aim of this study was to compare the longitudinal quality of life ( QoL ) between LV5FU2-irinotecan and LV5FU2 alone or LV5FU2-cisplatin in a randomized Phase II trial in patients with metastatic gastric adenocarcinoma . METHODS Among 134 eligible patients , QLQ-C30 scores were collected and described at each 2 monthly follow-up visit during 6 months . The frequencies of QLQ-C30 score improvement were calculated and mixed models for repeated measurements were applied with or without extreme poorest imputation for missing scores . The " survival " until definitive global health score ( GHS ) deterioration was estimated . RESULTS At the 3rd follow-up , patients with a stable or improved global health ranged from 11 % in the LV5FU2-cisplatin arm to 18 % in the LV5FU2-irinotecan arm . The irinotecan-based-therapy presented 14 to 15 scores with a better QoL . The time until definitive GHS deterioration was globally similar between treatment arms . CONCLUSION This study highlights a better impact of LV5FU2-irinotecan and the interest of QoL assessment in phase II trials to complement the risk-benefit judgement .

LV5FU2 alone

quality of life

QoL

longitudinal quality of life ( QoL )

QLQ-C30 scores

global health

QoL

time until definitive GHS deterioration

QoL assessment


Minimal clinically important change for pain intensity , functional status , and general health status in patients with nonspecific low back pain . STUDY DESIGN Cohort study . OBJECTIVES To estimate the Minimal Clinically Important Change ( MCIC ) of the pain intensity numerical rating scale ( PI-NRS ) , the Quebec Back Pain Disability Scale ( QBPDS ) , and the Euroqol ( EQ ) in patients with low back pain . SUMMARY OF BACKGROUND DATA MCIC can provide valuable information for researchers , healthcare providers , and policymakers . METHODS Data from a randomized controlled trial with 442 patients with low back pain were used . The MCIC was estimated over a 12-week period , and three different methods were used : 1 ) mean change scores , 2 ) minimal detectable change , and 3 ) optimal cutoff point in receiver operant curves . The global perceived effect scale ( GPE ) was used as an external criterion . The effect of initial scores on the MCIC was also assessed . RESULTS The MCIC of the PI-NRS ranged from 3.5 to 4.7 points in ( sub ) acute patients and 2.5 to 4.5 points in chronic patients with low back pain . The MCIC of the QBPDS was estimated between 17.5 to 32.9 points and 8.5 to 24.6 points for ( sub ) acute and chronic patients with low back pain . The MCIC for the EQ ranged from 0.07 to 0.58 in ( sub ) acute patients and 0.09 to 0.28 in patients with chronic low back pain . CONCLUSION Reporting the percentage of patients who have made a MCIC adds to the interpretability of study results . We present a range of MCIC values and advocate the choice of a single MCIC value according to the specific context .

pain intensity

functional status

health status

Euroqol ( EQ )

MCIC of the QBPDS

low back pain

low back pain

low back pain

low back pain


Efficacy and safety of oral conivaptan : a V1A/V2 vasopressin receptor antagonist , assessed in a randomized , placebo-controlled trial in patients with euvolemic or hypervolemic hyponatremia . CONTEXT Hyponatremia [ serum sodium concentration ( [ Na ( + ) ] ) , < 135 mEq/liter ] is the most common fluid and electrolyte abnormality among hospitalized patients . It is frequently caused by the inappropriate release of arginine vasopressin . OBJECTIVE The objective of this study was to evaluate the efficacy and safety of oral conivaptan , a vasopressin V ( 1A ) /V ( 2 ) receptor antagonist , in patients with euvolemic or hypervolemic hyponatremia . DESIGN The study design was a 5-d placebo-controlled , randomized , double-blind study . SETTING The study was performed at a hospital . INTERVENTION Oral conivaptan ( 40 or 80 mg/d ) or placebo was given in two divided doses . PATIENTS Seventy-four patients ( average baseline serum [ Na ( + ) ] , 115 to < 130 mEq/liter ) were studied . MAIN OUTCOME MEASURE The main outcome measure was the change from baseline in serum [ Na ( + ) ] area under the curve . RESULTS The least-squares mean change from baseline in the serum [ Na ( + ) ] area under the curve with conivaptan ( 40 and 80 mg/d ) was 2.0-fold ( P = 0.03 ) and 2.5-fold ( P < 0.001 ) greater , respectively , than that with placebo . The median time to achieve a confirmed increase in serum [ Na ( + ) ] of 4 mEq/liter or more from baseline was 71.7 h for placebo , 27.5 h for 40 mg/d conivaptan ( P = 0.044 ) , and 12.1 h for 80 mg/d conivaptan ( P = 0.002 ) . The mean total times during which patients had a serum [ Na ( + ) ] level of 4 mEq/liter or more above baseline were 46.5 , 69.8 , and 88.8 h ( P = 0.001 ) , respectively . The least-squares mean change in serum [ Na ( + ) ] from baseline to end of treatment was 3.4 mEq/liter for placebo , 6.4 mEq/liter for 40 mg/d conivaptan , and 8.2 mEq/liter for 80 mg/d conivaptan ( P = 0.002 ) . A confirmed normal serum [ Na ( + ) ] ( > /=135 mEq/liter ) or increase of 6 mEq/liter or more was observed in 48 % of patients given placebo , 71 % given 40 mg/d conivaptan , and 82 % given 80 mg/d conivaptan ( P = 0.014 ) . Headache , hypotension , nausea , constipation , and postural hypotension were the most common adverse events . CONCLUSION Oral conivaptan ( 40 and 80 mg/d ) was well tolerated and efficacious in correcting serum [ Na ( + ) ] in hyponatremia .

oral conivaptan

V1A/V2 vasopressin receptor antagonist

placebo-controlled

conivaptan

placebo-controlled

Oral conivaptan

placebo

conivaptan

placebo

placebo

conivaptan

conivaptan

placebo

conivaptan

conivaptan

placebo

conivaptan

conivaptan

conivaptan

Efficacy and safety

efficacy and safety

serum

serum [ Na ( + ) ]

mean change in serum [ Na ( + ) ]

normal serum [ Na ( + ) ]

euvolemic or hypervolemic hyponatremia

hospitalized patients

euvolemic

hypervolemic hyponatremia

Seventy-four


Nasotracheal intubation under curve-tipped suction catheter guidance reduces epistaxis . BACKGROUND Nasotracheal intubation ( NTI ) has greater potential for trauma of nasopharyngeal mucosa than orotracheal intubation . The present study investigated the success rate of NTI and frequency of nasal bleeding using a curve-tipped suction catheter ( CTSC ) to guide nasotracheal tube advancement . METHODS Subjects comprised 131 adult patients who under-went NTI . Subjects were randomly divided into two groups : a ) NTI under CTSC guidance ( G [ + ] group ) . The CTSC ( 14 Fr ) was first inserted through the tracheal tube , with the tip of the CTSC emerging from the distal end of the tube . The curved tip was directed ventrally . Both tracheal tube and CTSC were advanced together through the nasopharynx ; b ) NTI without CTSC guidance ( G [ - ] group ) . The tracheal tube was advanced into the nasal cavity and passed into the pharynx without CTSC guidance . The time required to pass the endotracheal tube through the nasal cavity ( nasal passage time ) , success rate of nasal passage with nasotracheal tube , and the incidence and severity of nasal bleeding were compared . RESULTS Success rate for nasal passage was 100 % in the G ( + ) group ( 62/62 ) and 82.6 % in the G ( - ) group ( 57/69 ; P = 0.0006 ) . Frequency of nasal bleeding was significantly lower in the G ( + ) group ( 21/62 , 33.9 % ) than in the G ( - ) group ( 37/69 , 53.6 % ; P = 0.023 ) . Severity of nasal bleeding was also significantly lower in the G ( + ) group than in the G ( - ) group ( P = 0.030 ) . CONCLUSIONS Nasotracheal intubation under CTSC guidance increases the success rate of airway instrumentation , and also reduces the incidence and severity of epistaxis .

Nasotracheal intubation ( NTI )

curve-tipped suction catheter ( CTSC )

NTI without CTSC guidance

success rate

Success rate for nasal passage

Frequency of nasal bleeding

Severity of nasal bleeding

success rate

incidence and severity

adult

who under-went NTI


The misattribution of salience in delusional patients with schizophrenia . INTRODUCTION Delusions may arise from abnormalities in emotional perception . In this study , we tested the hypothesis that delusional schizophrenia patients are more likely than non-delusional schizophrenia patients and healthy participants to assign affective meanings to neutral stimuli . METHODS Unpleasant , pleasant , and neutral words were randomly presented to three subject groups -- patients with schizophrenia with prominent delusions , patients with schizophrenia without delusions , and healthy participants . Participants performed three tasks : one in which they decided whether a letter string was a word or a non-word ( lexical decision ) and two affective classification tasks in which they judged whether words were 1 ) neutral or unpleasant , or 2 ) neutral or pleasant . RESULTS While there were no significant between-group differences in lexical decision performance , patients with delusions showed selective performance deficits in both affective classification tasks . First , delusional patients were significantly more likely than non-delusional patients and healthy participants to classify words as unpleasant . Second , delusional patients took significantly longer than both other groups to correctly classify neutral words in both affective classification tasks . CONCLUSIONS Taken together , these findings suggest that delusions are associated with the explicit misattribution of salience to neutral stimuli .

neutral or unpleasant

neutral or pleasant

lexical decision performance

selective performance deficits

classify words as unpleasant .

correctly classify neutral words

delusional

schizophrenia

delusional schizophrenia

three

schizophrenia without delusions


A randomized trial of chiropractic and medical care for patients with low back pain : eighteen-month follow-up outcomes from the UCLA low back pain study . STUDY DESIGN Randomized clinical trial . OBJECTIVES To compare the long-term effectiveness of medical and chiropractic care for low back pain in managed care and to assess the effectiveness of physical therapy and modalities among patients receiving medical or chiropractic care . SUMMARY OF BACKGROUND DATA Evidence comparing the long-term relative effectiveness of common treatment strategies offered to low back pain patients in managed care is lacking . METHODS A total of 681 low back pain patients presenting to a managed-care facility were randomized to chiropractic with or without physical modalities , or medical care with or without physical therapy , and followed for 18 months . The primary outcome variables are low back pain intensity , disability , and complete remission . The secondary outcome is participants ' perception of improvement in low back symptoms . RESULTS Of the 681 patients , 610 ( 89.6 % ) were followed through 18 months . Among participants not assigned to receive physical therapy or modalities , the estimated improvements in pain and disability and 18-month risk of complete remission were a little greater in the chiropractic group than in the medical group ( adjusted RR of remission = 1.29 ; 95 % CI = 0.80-2.07 ) . Among participants assigned to medical care , mean changes in pain and disability and risk of remission were larger in patients assigned to receive physical therapy ( adjusted RR = 1.69 ; 95 % CI = 1.08-2.66 ) . Among those assigned to chiropractic care , however , assignment to methods was not associated with improvement or remission ( adjusted RR = 0.98 ; 95 % CI = 0.62-1.55 ) . Compared with medical care only patients , chiropractic and physical therapy patients were much more likely to perceive improvement in their low back symptoms . However , less than 20 % of all patients were pain-free at 18 months . CONCLUSIONS Differences in outcomes between medical and chiropractic care without physical therapy or modalities are not clinically meaningful , although chiropractic may result in a greater likelihood of perceived improvement , perhaps reflecting satisfaction or lack of blinding . Physical therapy may be more effective than medical care alone for some patients , while physical modalities appear to have no benefit in chiropractic care .

medical care

physical therapy

medical

or chiropractic care

physical therapy

chiropractic care

chiropractic

medical and chiropractic care

Physical therapy

low back pain

low back pain intensity

disability

complete remission

low back symptoms

pain

disability

risk of complete remission

mean changes in pain

disability

risk of remission

pain-free

low back pain

low back pain

low back pain

low back pain


Etanercept treatment in adults with established rheumatoid arthritis : 7 years of clinical experience . OBJECTIVE To evaluate safety and efficacy of longterm etanercept treatment in patients with disease modifying antirheumatic drug ( DMARD ) refractory rheumatoid arthritis ( RA ) . METHODS Safety results are reported for 714 patients who received etanercept in one of 7 initial trials or a longterm extension . Efficacy results are reported for 581 patients who enrolled in the extension . RESULTS Of the 714 patients enrolled in the initial trials , 581 ( 81 % ) enrolled in the extension , and 388 ( 54 % ) patients are continuing to receive etanercept therapy . The longest individual treatment was 8.2 years , with 3139 total patient-years of etanercept exposure . Rates of serious adverse events ( overall rate=14.8 events/100 patient-yrs ) , serious infections ( overall rate=4.2 events/100 patient-yrs ) , cancer ( overall rate=1.0 events/100 patient-yrs ) , and deaths ( overall rate=0.7 events/100 patient-yrs ) were stable each year , through 8 years of etanercept exposure . For 356 patients who completed 6 years of etanercept treatment , response rates were ACR20=73 % , ACR50=52 % , ACR70=27 % , DAS28 CRP good response=52 % , and DAS28 CRP remission=37 % of patients . Similar responses occurred in 167 patients who completed Year 7 . Doses of concomitant methotrexate or corticosteroids were reduced in many patients who maintained clinical responses . CONCLUSION The safety profile of etanercept was consistent over time , with rates of adverse events similar to those reported for patients with RA in general . Durable clinical responses were observed in some patients for 7 years or more . The benefit-to-risk ratio for longterm etanercept treatment remains highly favorable .

Etanercept

etanercept

etanercept

etanercept

etanercept

etanercept

safety

efficacy

Rates of serious adverse events

serious infections

cancer

deaths

response rates

Doses

safety profile

rates of adverse events

adults

rheumatoid arthritis :

RA


Resisting good news : reactions to breast cancer risk communication . Many women overestimate their percentage risk of breast cancer , even after they have received careful estimates from health professionals . In 2 experiments with 134 young adult women , 6 variables were explored that might influence such risk perception persistence . In Study 1 , each of the following explanations was unrelated to persistence : public commitment , self-consistency , and unique causal risk models . In Study 2 , two individual difference measures , pessimism and differences in understanding percentages , were unrelated to risk perception persistence . However , providing a " risk anchor " based on downward social comparison processes resulted in better risk acceptance at posttest that persisted at a 2-week follow-up assessment . This article discusses why comparison anchors might be important in risk feedback situations and concludes with recommendations for professionals who wish to provide accurate risk information and have patients adopt that information .

careful estimates

public commitment

self-consistency

unique causal risk models

risk perception

persistence :

risk perception persistence .

risk acceptance

breast cancer risk

young adult

women


The gluten-free , casein-free diet in autism : results of a preliminary double blind clinical trial . This study tested the efficacy of a gluten-free and casein-free ( GFCF ) diet in treating autism using a randomized , double blind repeated measures crossover design . The sample included 15 children aged 2-16 years with autism spectrum disorder . Data on autistic symptoms and urinary peptide levels were collected in the subjects ' homes over the 12 weeks that they were on the diet . Group data indicated no statistically significant findings even though several parents reported improvement in their children . Although preliminary , this study demonstrates how a controlled clinical trial of the GFCF diet can be conducted , and suggests directions for future research .

gluten-free , casein-free diet

GFCF diet

autistic symptoms

urinary peptide levels

improvement

autism :

autism


The effect of random modulation of functional electrical stimulation parameters on muscle fatigue . Muscle contractions induced by functional electrical stimulation ( FES ) tend to result in rapid muscle fatigue , which greatly limits activities such as FES-assisted standing and walking . It was hypothesized that muscle fatigue caused by FES could be reduced by randomly modulating parameters of the electrical stimulus . Seven paraplegic subjects participated in this study . While subjects were seated , FES was applied to quadriceps and tibialis anterior muscles bilaterally using surface electrodes . The isometric force was measured , and the time for the force to drop by 3 dB ( fatigue time ) and the normalized force-time integral ( FTI ) were determined . Four different modes of FES were applied in random order : constant stimulation , randomized frequency ( mean 40 Hz ) , randomized current amplitude , and randomized pulsewidth ( mean 250 micros ) . In randomized trials , stimulation parameters were stochastically modulated every 100 ms in a range of +/-15 % using a uniform probability distribution . There was no significant difference between the fatigue time measurements for the four modes of stimulation . There was also no significant difference in the FTI measurements . Therefore , our particular method of stochastic modulation of the stimulation parameters , which involved moderate ( 15 % ) variations updated every 100 ms and centered around 40 Hz , appeared to have no effect on muscle fatigue . There was a strong correlation between maximum force measurements and stimulation order , which was not apparent in the fatigue time or FTI measurements . It was concluded that a 10-min rest period between stimulation trials was insufficient to allow full recovery of muscle strength .

functional electrical stimulation

rapid muscle fatigue

muscle fatigue

isometric force

force-time integral ( FTI )

fatigue time measurements

FTI measurements

muscle fatigue

fatigue time

FTI measurements

recovery of muscle strength

muscle fatigue

Seven


Prolonged effects of a home-based intervention in patients with chronic illness . BACKGROUND Data on the long-term benefits of nonspecific disease management programs are limited . We performed a long-term follow-up of a previously published randomized trial . METHODS We compared all-cause mortality and recurrent hospitalization during median follow-up of 7.5 years in a heterogeneous cohort of patients with chronic illness initially exposed to a multidisciplinary , home-based intervention ( HBI ) ( n = 260 ) or to usual postdischarge care ( n = 268 ) . RESULTS During follow-up , HBI had no impact on all-cause mortality ( relative risk , 1.04 ; 95 % confidence interval , 0.80-1.35 ) or event-free survival from death or unplanned hospitalization ( relative risk , 1.03 ; 95 % confidence interval , 0.86-1.24 ) . Initial analysis suggested that HBI had only a marginal impact in reducing unplanned hospitalization , with 677 readmissions vs 824 for the usual care group ( mean +/- SD rate , 0.72 +/- 0.96 vs 0.84 +/- 1.20 readmissions/patient per year ; P = .08 ) . When accounting for increased hospital activity in HBI patients with chronic obstructive pulmonary disease during follow-up for 2 years , post hoc analyses showed that HBI reduced readmissions by 14 % within 2 years in patients without this condition ( mean +/- SD rate , 0.54 +/- 0.72 vs 0.63 +/- 0.88 readmission/patient per year ; P = .04 ) and by 21 % in all surviving patients within 3 to 8 years ( mean +/- SD rate , 0.64 +/- 1.26 vs 0.81 +/- 1.61 readmissions/patient per year ; P = .03 ) . Overall , recurrent hospital costs were significantly lower ( 14 % ) in the HBI group ( mean +/- SD , 823 dollars +/- 1642 dollars vs 960 dollars +/- 1376 dollars per patient per year ; P = .045 ) . CONCLUSION This unique study suggests that a nonspecific HBI provides long-term cost benefits in a range of chronic illnesses , except for chronic obstructive pulmonary disease .

home-based intervention

multidisciplinary ,

home-based intervention ( HBI )

usual postdischarge care

HBI

HBI

HBI

HBI

HBI

all-cause mortality

recurrent hospitalization

all-cause mortality

event-free survival from death

unplanned hospitalization

unplanned hospitalization

hospital activity

readmissions

recurrent hospital costs

chronic illness

chronic illness

chronic obstructive pulmonary disease


Web-based weight management programs in an integrated health care setting : a randomized , controlled trial . OBJECTIVE To assess the efficacy of a Web-based tailored behavioral weight management program compared with Web-based information-only weight management materials . RESEARCH METHODS AND PROCEDURES Participants , 2862 eligible overweight and obese ( BMI = 27 to 40 kg/m2 ) members from four regions of Kaiser Permanente 's integrated health care delivery system , were randomized to receive either a tailored expert system or information-only Web-based weight management materials . Weight change and program satisfaction were assessed by self-report through an Internet-based survey at 3- and 6-month follow-up periods . RESULTS Significantly greater weight loss at follow-up was found among participants assigned to the tailored expert system than among those assigned to the information-only condition . Subjects in the tailored expert system lost a mean of 3 +/- 0.3 % of their baseline weight , whereas subjects in the information-only condition lost a mean of 1.2 +/- 0.4 % ( p < 0.0004 ) . Participants were also more likely to report that the tailored expert system was personally relevant , helpful , and easy to understand . Notably , 36 % of enrollees were African-American , with enrollment rates higher than the general proportion of African Americans in any of the study regions . DISCUSSION The results of this large , randomized control trial show the potential benefit of the Web-based tailored expert system for weight management compared with a Web-based information-only weight management program .

Web-based weight management programs

tailored expert system

or

tailored expert system

tailored expert system

tailored expert system

efficacy

Weight change

program satisfaction

weight loss

baseline weight


Evaluation of nonpharmacologic methods of pain and anxiety management for laceration repair in the pediatric emergency department . BACKGROUND Nonpharmacologic interventions , such as distraction , have been shown to be powerful adjuncts in reducing pain and anxiety in children with both acute and chronic painful conditions . There are no controlled studies evaluating these interventions as adjuncts to facilitate completion of painful procedures in the pediatric emergency department ( ED ) . OBJECTIVE We assessed the effectiveness of distraction techniques in reducing the sensory and affective components of pain among pediatric patients undergoing laceration repair in the ED . METHODS Eligible children between 6 and 18 years of age ( N = 240 ) presenting to the ED for laceration repair were randomly assigned to an intervention or control arm . Those assigned to the intervention arm were given a choice of age-appropriate distracters during laceration repair . Quantitative measures of pain intensity , situational anxiety , and pain distress ( as perceived by the parent ) were assessed by using the 7-point Facial Pain Scale , State Trait Anxiety Inventory for Children , and a visual analog scale , respectively , before and after laceration repair . The State Trait Anxiety Inventory for Children was performed in children > or = 10 years of age . RESULTS There was no difference in mean change in Facial Pain Scale scores between the control and the intervention groups in children < 10 years of age . Multivariate analysis in this same age group showed that the intervention was independently associated with a reduction in pain distress as perceived by parents based on the mean change in visual analog scale scores . In older children , the intervention was independently associated with reduction in situational anxiety but not in pain intensity or in parental perception of pain distress . CONCLUSIONS The use of distraction techniques is effective in reducing situational anxiety in older children and lowering parental perception of pain distress in younger children . This technique may have a role in improving the quality of management of procedural pain in a pediatric ED setting .

nonpharmacologic methods

pain and anxiety management

distraction techniques

age-appropriate distracters

distraction techniques

visual analog scale

State Trait Anxiety Inventory

mean change in Facial Pain Scale

reduction in pain distress

situational anxiety

children

acute and chronic painful conditions

children between 6 and 18 years of age

( N = 240

older children


Survey response inducements for registered nurses . The past 20 years have seen an overall decline in survey response rates and an even more pronounced decline in samples of health care professionals . The authors tested the use of a " thank you " or " reminder " postcard as a method by which to stem the tide of declining response rates . The authors conducted a mail and telephone survey of 49,605 registered nurses for the 2000 National Sample Survey of Registered Nurses and sent an extra mailing to a random subsample ( n = 4,968 ) . They then compared response rates for both groups . Contrary to prior research , this study found that reminder postcards did not improve response rates or rates of return . There may be several reasons for this finding , including the general familiarity with , and high saliency of , this research project for the nursing community . These results suggest that even widely accepted best practices for survey methods deserve scrutiny when applied to special subpopulations .

Survey

" thank you " or " reminder " postcard

mail and telephone survey

response

response rates or rates of return .

registered nurses .


A randomized trial of an interim methadone maintenance clinic . BACKGROUND Interim methadone maintenance has been proposed as a method of providing clinically effective services to heroin addicts waiting for treatment in standard comprehensive methadone maintenance programs . METHODS A clinic that provided initial medical evaluation , methadone medication , and AIDS education , but did not include formal drug abuse counseling or other social support services was established in New York City . A sample of 301 volunteer subjects recruited from the waiting list for treatment in the Beth Israel methadone program were randomly assigned to immediate entry into the interim clinic or a control group . RESULTS There were no differences in initial levels of illicit drug use across the experimental and control groups . One-month urinalysis follow-up data showed a significant reduction in heroin use in the experimental group ( from 63 % positive at intake to 29 % positive ) with no change in the control group ( 62 % to 60 % positive ) . No significant change was observed in cocaine urinalyses ( approximately 70 % positive for both groups at intake and follow-up ) . A higher percentage of the experimental group were in treatment at 16-month follow-up ( 72 % vs 56 % ) . CONCLUSIONS Limited services interim methadone maintenance can reduce heroin use among persons awaiting entry into comprehensive treatment and increase the percentage entering treatment .

methadone

methadone

methadone

control group

clinically effective

levels of illicit drug use

reduction in heroin use

cocaine urinalyses

heroin use

heroin addicts


Conventional in vitro fertilization versus intracytoplasmic sperm injection in patients with borderline semen : a randomized study using sibling oocytes . OBJECTIVE To determine whether patients with borderline semen should be treated with conventional IVF or intracytoplasmic sperm injection ( ICSI ) . DESIGN Randomized study . SETTING A university medical center in The Netherlands . PATIENT ( S ) One hundred six couples with borderline semen who were undergoing IVF and ICSI on sibling oocytes . INTERVENTION ( S ) Performing IVF and ICSI on sibling oocytes . MAIN OUTCOME MEASURE ( S ) Fertilization and pregnancy rates . RESULT ( S ) One thousand five hundred eighteen oocytes were collected in 106 oocyte retrievals : 849 oocytes were randomly allocated to ICSI , of which 761 were microinjected , and 669 oocytes were randomly assigned to IVF . In 26 of the 106 patients , there was fertilization only after ICSI and not after IVF ( IVF- group ) . The fertilization rate was 51 % ( 92/182 oocytes ) . In 78 patients , there was fertilization after both IVF and ICSI ( IVF+ group ) ; the fertilization rate was 51 % for both the IVF- and ICSI-treated oocytes ( 271/528 oocytes and 334/658 oocytes , respectively ) . In 2 patients , there was no fertilization after either IVF ( 0/6 oocytes ) or ICSI ( 0/9 oocytes ) . Patients of the IVF+ group had a higher total motile sperm count after preparation than did those of the IVF- group . More high-quality embryos were obtained after ICSI in patients of the IVF+ group . In 101 patients , embryo transfer was performed : 26 in the IVF- group and 75 in the IVF+ group . No significant differences were found with regard to pregnancy rates between those two groups : pregnancy rates were 54 % in the IVF- group and 48 % in the IVF+ group . CONCLUSION ( S ) Performing ICSI on at least some of the oocytes will avoid unnecessary fertilization failure in patients with borderline semen : in this study , 26 of 104 cycles ( 25 % ) were rescued by ICSI .

Conventional in vitro fertilization

intracytoplasmic sperm injection

conventional IVF

IVF

ICSI

IVF

ICSI

microinjected

IVF

ICSI

IVF

IVF

ICSI

IVF-

ICSI-treated

IVF

ICSI

ICSI

IVF+

IVF-

IVF+

IVF-

IVF+

ICSI

ICSI

Fertilization and pregnancy rates .

fertilization rate

total motile sperm count

high-quality embryos

embryo transfer

pregnancy rates

fertilization failure

in patients with borderline semen :

patients with borderline semen

One hundred six couples

borderline semen

In 78 patients

2 patients

101 patients

patients with borderline semen


A crossover study of risperidone in children , adolescents and adults with mental retardation . Risperidone has shown safety and efficacy for aggressive and destructive behaviors in short-term studies . This longer-duration study includes a broad sample . Forty subjects , aged 8-56 years ( mean=22 ) , all with mental retardation and 36 with autism spectrum disorders participated in this 22-week crossover study , with 24 weeks of open maintenance thereafter . Of 40 subjects , 23 ( 57.5 % ) responded fully ( 50 % decrease in Aberrant Behavior Checklist-Community Irritability subscale score ) , while 35 subjects ( 87.5 % ) showed a 25 % decrease . Gender , mood disorder , and antiseizure medications did not alter response . Increased appetite and weight gain were common . Low dose risperidone was effective for aggressive behavior in persons with MR. More long-term studies are needed , incorporating weight control interventions .

risperidone

Risperidone

safety and efficacy

Increased appetite and weight gain

effective

aggressive behavior


Nurse-led cardiac clinics for adults with coronary heart disease . This information on best practice is based on a systematic review of research , published by Blackwell Publishing Asia and conducted by the Centre for Evidence-based Nursing South Australia , a collaborating centre of the Joanna Briggs Institute ( JBI ) . The primary references on which this information is based are provided in the systematic review report available online via Blackwell Synergy www.blackwell-synergy.com and to members of the institute via the web site : www.joannabriggs.edu.au . This information sheet covers the following : Nurse-led education and self-help . Education and motivational interview . Audit and recall . Secondary prevention .

systematic review of research

adults

coronary heart disease


Clinical usefulness of serum prostate specific antigen for the detection of prostate cancer is preserved in men receiving the dual 5alpha-reductase inhibitor dutasteride . PURPOSE We determined whether the decrease in serum PSA seen with 5alpha-reductase inhibitors affects the clinical usefulness of PSA for prostate cancer screening using data from 2 dutasteride benign prostatic hyperplasia studies . MATERIALS AND METHODS A total of 2,802 men 50 years or older with a clinical diagnosis of benign prostatic hyperplasia , no history of prostate cancer , PSA 1.5 to 10 ng/ml , prostate volume 30 cc or greater , an American Urological Association symptom score of 12 or greater and peak urinary flow rate 15 ml per second or less were randomized to 0.5 mg dutasteride daily or matching placebo for 24 months . Increases in PSA from baseline and the maximum increase from nadir to month 24 were compared between the groups and analyzed by prostate cancer status , as determined by PSA driven biopsy and an advised cutoff of more than 4 ng/ml after doubling to correct for dutasteride treatment with sensitivity and specificity calculated for each . RESULTS In placebo treated men without prostate cancer there was an 8.3 % median increase in PSA at month 24 compared with -59.5 % in those who received dutasteride , using doubled values to correct for dutasteride treatment . In those with prostate cancer these changes were 23.8 % and -37.2 % , respectively . Using the upper PSA limit of 4 ng/ml sensitivity for prostate cancer in men receiving dutasteride vs placebo was 0.737 vs 0.804 , while specificity was 0.671 vs 0.578 . Using a PSA increase from nadir of 0.8 ng/ml the sensitivity of dutasteride was 0.548 and its specificity was 0.795 . CONCLUSIONS A doubling factor is effective for maintaining the sensitivity and specificity of PSA for prostate cancer detection in men on dutasteride . Increases in serum PSA in men receiving dutasteride should be considered suspicious and serial PSA measurements should be used to evaluate changes from nadir .

serum prostate specific antigen

5alpha-reductase inhibitors

dutasteride

placebo

dutasteride

dutasteride

dutasteride

placebo

dutasteride

dutasteride

dutasteride

median increase in PSA at month 24

specificity

Using a PSA increase

sensitivity

specificity

PSA

serum PSA

PSA

prostate cancer

men

50 years or older

benign prostatic hyperplasia


Risperidone and adaptive behavior in children with autism . OBJECTIVE To evaluate the impact of risperidone on adaptive behavior in children with autistic disorder who have serious behavior problems and to examine different methods of scoring the Vineland Adaptive Behavior Scales to measure change . METHOD Forty-eight children ( 5 years to 16 years , 5 months ) who showed behavioral improvement during acute treatment with risperidone were followed for 6 months and assessed with the Vineland Scales . RESULTS Raw scores , age-equivalents , and special norm percentile scores all showed significant increases in adaptive behavior in the areas of communication , daily living skills , and socialization ( p < .01 ) . During a period of 6 to 8 months , children gained an average of 7.8 age-equivalent months in the area of socialization , a > 6 % improvement beyond what would be expected based on baseline growth rates . CONCLUSIONS Although limited by the absence of a control group , these results suggest that risperidone may improve adaptive skills in children with autistic disorder accompanied by serious behavioral problems . Vineland age-equivalent scores appear to be most useful in assessing change with treatment over time .

Risperidone

risperidone

risperidone were followed for 6 months

adaptive behavior

improvement

daily living skills

socialization

area of socialization

adaptive skills

children

autism

children

Forty-eight


The effect of a parent-implemented imitation intervention on spontaneous imitation skills in young children with autism . Children with autism exhibit significant deficits in their ability to spontaneously imitate the play actions and descriptive gestures of others . Reciprocal imitation training ( RIT ) is a naturalistic imitation intervention designed to teach spontaneous imitation skills during play . This study assessed the effectiveness of parent-implemented RIT using a multiple-baseline design across three young children with autism and their mothers . After an initial baseline , mothers were taught to implement RIT techniques with their child twice a week for 10 weeks in a clinic setting . Two mothers were taught to use RIT to teach object imitation . The third mother was taught to use RIT to target both object and gesture imitation in a multiple-baseline design across behaviors . Generalization was assessed in the families ' homes at the end of treatment and a 1-month follow-up . Parents learned to use the intervention strategies and their children exhibited increases in spontaneous imitation . These findings replicate the results from previous studies , indicating that RIT is effective for teaching imitation skills to young children with autism in a naturalistic setting and extend the findings to parents .

Reciprocal imitation training ( RIT )

RIT

RIT

RIT

RIT

spontaneous imitation skills

spontaneously imitate

play actions and descriptive gestures

spontaneous imitation skills

effectiveness

learned

spontaneous imitation

imitation skills

young children

autism

Children

autism

three

young children

autism

young children

autism


Antiarrhythmic efficacy of azimilide in patients with atrial fibrillation . Maintenance of sinus rhythm after conversion to sinus rhythm . BACKGROUND Azimilide dihydrochloride ( azimilide ) is an investigational antiarrhythmic drug that has been tested in patients with a variety of arrhythmias . In patients with atrial fibrillation , it has shown excellent efficacy in some previous trials and minimal efficacy in others . METHODS Patients who had symptomatic atrial fibrillation for > 48 hours but < 6 months were eligible for this multicenter , randomized , placebo-controlled clinical trial . Patients were admitted to a hospital and randomly assigned to receive either azimilide 125 mg or a matched placebo twice daily for 3 days and then once daily . Patients who were in sinus rhythm spontaneously or had sinus rhythm restored by electric cardioversion on day 4 were discharged from the hospital . Recurrence of atrial fibrillation was documented by electrocardiogram . In the primary efficacy analysis , time to recurrence in the 2 treatment groups was compared with the log-rank test in the subgroup of patients with structural heart disease . Safety was assessed as deaths , adverse events , and serious adverse events . RESULTS A total of 446 patients were randomized in the study ; 314 were in the subgroup with structural heart disease . The median time to arrhythmia recurrence in both treatment groups with structural heart disease was 13 days , and the difference between treatments was not significant ( P = .4596 , n = 314 ) . The relative risk for recurrence ( placebo : azimilide ) was 1.104 ( 95 % CI 0.849-1.436 ) . There was 1 death in the placebo group and 3 in the azimilide group . CONCLUSIONS Azimilide did not demonstrate clinically important or statistically significant efficacy in reducing the risk for arrhythmia recurrence in patients with structural heart disease who were in atrial fibrillation and converted to sinus rhythm .

azimilide

Azimilide dihydrochloride

azimilide 125 mg

Azimilide

Recurrence of atrial fibrillation

deaths

median time to arrhythmia recurrence

relative risk for recurrence

death

atrial fibrillation

after conversion to sinus rhythm

atrial fibrillation

symptomatic atrial fibrillation

structural heart disease

structural heart disease

structural heart disease

atrial fibrillation

converted to sinus rhythm


A comparison of home measurement and ambulatory monitoring of blood pressure in the adjustment of antihypertensive treatment . BACKGROUND The purpose of this study was to compare home and ambulatory blood pressure ( BP ) in the adjustment of antihypertensive treatment . METHODS After a 4-week washout period , patients whose untreated daytime diastolic ambulatory BP averaged > or = 85 mm Hg were randomized to be treated according to their ambulatory or home BP . Antihypertensive treatment was adjusted at 6-week intervals according to the mean daytime ambulatory diastolic BP or the mean home diastolic BP , depending on the patient 's randomization group . If the diastolic BP stayed above 80 mm Hg , the physician blinded to randomization intensified hypertensive treatment . RESULTS Ninety-eight patients completed the study . During the 24-week follow-up period both systolic and diastolic BP decreased significantly within both groups ( P < .001 ) . At the end of the study , the systolic/diastolic differences between ambulatory ( n = 46 ) and home ( n = 52 ) BP groups in home , daytime ambulatory , night-time ambulatory , and 24-h ambulatory BP changes averaged 2.6/2.6 mm Hg , 0.6/1.7 mm Hg , 1.0/1.4 mm Hg , and 0.6/1.5 mm Hg , respectively ( P range .06 to .75 ) A nonsignificant trend to more intensive drug therapy in the ambulatory BP group and a nonsignificant trend to larger share of patients reaching ( 57.7 % v 43.5 % , P = .16 ) the target pressure in the home BP group was observed due to the 3.8 mm Hg difference in ambulatory and home diastolic BP at randomization . CONCLUSIONS The adjustment of antihypertensive treatment based on either ambulatory or home BP measurement led to good BP control . No significant between-group differences in BP changes were seen at the end of the study . Additional research is needed to provide more conclusive results .

home measurement

ambulatory monitoring

ambulatory or home BP .

intensified hypertensive treatment .

ambulatory or home BP measurement

daytime ambulatory diastolic BP

home diastolic BP

systolic and diastolic BP

BP

ambulatory BP

ambulatory and home diastolic BP

BP


The double-blind sham-controlled study of high-frequency rTMS ( 20 Hz ) for negative symptoms in schizophrenia : negative results . The high-frequency repetitive transcranial magnetic stimulation ( HF-rTMS ) over the prefrontal cortex is a promising method for the treatment of negative symptoms of schizophrenia . Using double-blind sham-controlled parallel design , we evaluated the effect of HF-rTMS over the left dorsolateral prefrontal cortex ( DLPFC ) on negative symptoms in patients with schizophrenia . Sixteen schizophrenia patients with predominantly negative symptoms on stable antipsychotic medication were treated with 20 Hz rTMS ( 90 % of motor threshold , 2000 stimuli per session ) over ten days within 2 weeks with six weeks follow-up . The effect was assessed using PANSS , CGI , MADRS and neuropsychological tests . We failed to find any significant effect of active rTMS . Sham rTMS showed a trend for improvement over time on positive and negative subscales of PANSS and MADRS . Between-group comparisons failed to reveal any significant differences on any rating scales except a positive subscale of PANSS after 8 weeks . Results from our study did not confirm that HF-rTMS over the left DLPCF affects the negative symptoms of schizophrenia and alternative rTMS approaches are discussed .

high-frequency rTMS

HF-rTMS

20 Hz rTMS

rTMS .

rTMS

active rTMS . Sham rTMS

improvement over time

rating scales

positive subscale of PANSS

HF-rTMS

schizophrenia

schizophrenia

schizophrenia

Sixteen

schizophrenia


Evaluation of a novel technique for wound closure using a barbed suture . BACKGROUND Suture knots present several disadvantages in wound closure , because they are tedious to tie and place ischemic demands on tissue . Bulky knots may be a nidus for infection , and they may extrude through skin weeks after surgery . Needle manipulations during knot-tying predispose the surgeon to glove perforation . A barbed suture was developed that is self-anchoring , requiring no knots or slack management for wound closure . The elimination of knot tying may have advantages over conventional wound closure methods . METHODS This prospective , randomized , controlled trial was designed to show that the use of barbed suture in dermal closure of the Pfannenstiel incision during nonemergent cesarean delivery surgery produces scar cosmesis at 5 weeks that is no worse than that observed with conventional closure using 3-0 polydioxanone suture . Cosmesis was assessed by review of postoperative photographs by a blinded , independent plastic surgeon using the modified Hollander cosmesis score . Secondary endpoints included infection , dehiscence , pain , closure time , and other adverse events . RESULTS The study enrolled 195 patients , of whom 188 were eligible for analysis . Cosmesis scores did not significantly differ between the barbed suture group and the control group . Rates of infection , dehiscence , and other adverse events did not significantly differ between the two groups . Closure time and pain scores were comparable between the groups . CONCLUSIONS The barbed suture represents an innovative option for wound closure . With a cosmesis and safety profile that is similar to that of conventional suture technique , it avoids the drawbacks inherent to suture knots .

novel technique

wound closure using a

barbed suture

barbed suture

barbed suture

conventional closure

3-0 polydioxanone suture

conventional suture

Cosmesis

infection

dehiscence

pain

closure time ,

other adverse events

Cosmesis scores

Rates of infection

, dehiscence

adverse events

Closure time and pain scores

cosmesis

safety profile

cesarean


Effects on parental mental health of an education and skills training program for parents of young children with autism : a randomized controlled trial . OBJECTIVE To determine the impact of a parent education and behavior management intervention ( PEBM ) on the mental health and adjustment of parents with preschool children with autism . METHOD A randomized , group-comparison design involving a parent education and counseling intervention to control for nonspecific therapist effects and a control sample was used . Two metropolitan and two rural regions were randomly allocated to intervention groups ( n = 70 ) or control ( n = 35 ) . The parents of consecutive children with autism ( 2 ( 1/2 ) -5 years old ) from the autism assessment services for the intervention regions were then randomly allocated to either a 20-week manual-based parent education and behavior management intervention ( n = 35 ) or a manual-based parent education and counseling intervention ( n = 35 ) . The main outcome measure of parental mental health was the General Health Questionnaire used pre- and postintervention and at 6-month follow-up . RESULTS Both treatments resulted in significant and progressive improvement in overall mental health at follow-up ( F = 2 , 97 , p =.007 ) and mental health significantly improved over time in the 54 % of principal caregivers who had the highest levels of mental health problems . The parent education and behavior management intervention was effective in alleviating a greater percentage of anxiety , insomnia , and somatic symptoms and family dysfunction than parent education and counseling at 6-month follow-up . CONCLUSIONS A 20-week parent education and skills training program for parents of young children newly diagnosed with autism provides significant improvements in parental mental health and adjustment , justifying its addition to early intervention programs at least for parents with mental health problems .

education and skills training program

parental mental health

parental mental health

General Health Questionnaire

mental health

mental health

family dysfunction

parental mental health

parents of young children with autism :


Decompressive craniectomy in traumatic brain injury : the randomized multicenter RESCUEicp study ( www.RESCUEicp.com ) . The RESCUEicp ( Randomized Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of intracranial pressure ) study has been established to determine whether decompressive craniectomy has a role in the management of patients with traumatic brain injury and raised intracranial pressure that does not respond to initial treatment measures . We describe the concept of decompressive craniectomy in traumatic brain injury and the rationale and protocol of the RESCUEicp study .

Decompressive craniectomy

decompressive craniectomy

decompressive craniectomy