Effect of simvastatin and fenofibrate on endothelium in Type 2 diabetes . Statins and fibrates influence endothelial activity and consequently atherogenesis but the mechanisms are not well understood . Twenty Type 2 diabetic patients with dyslipidemia were treated 3 months with simvastatin ( 20 mg daily ) and then 3 months with fenofibrate ( 200 mg daily ) with 2 months of wash-out between the two treatments . Laboratory parameters of oxidative stress , fibrinolysis and endothelial function were evaluated before and at the end of each treatment period . The significant decrease in serum total and LDL-cholesterol concentrations ( P < 0.0001 ) caused by simvastatin was associated with an increase in serum N-acetyl-beta-glucosaminidase activity ( P < 0.001 ) , ascorbic acid ( P < 0.001 ) , plasminogen activator inhibitor ( PAI-1 ) ( P < 0.01 ) , vonWillebrand factor ( P < 0.05 ) , E-selectin ( P < 0.01 ) and vascular endothelial growth factor ( P < 0.05 ) concentrations and with a decrease in plasma glutathione ( P < 0.01 ) levels . Fenofibrate caused a significant decrease in serum triglyceride concentration ( P < 0.0001 ) associated with a decrease in plasma malondialdehyde ( P < 0.001 ) and an increase in plasma PAI-1 ( P < 0.05 ) and P-selectin ( P < 0.05 ) concentrations . We conclude that simvastatin and fenofibrate interact , by different mechanisms , with oxidative stress , a key factor in the modification of fibrinolysis and endothelial function in Type 2 diabetes .

simvastatin

fenofibrate

simvastatin

fenofibrate

ascorbic acid

plasminogen activator inhibitor

vonWillebrand factor

E-selectin

vascular endothelial growth factor

plasma glutathione

serum triglyceride concentration

plasma malondialdehyde

plasma PAI-1

P-selectin

Type 2 diabetes

Twenty


Chronic fatigue syndrome versus neuroendocrineimmune dysfunction syndrome : differential attributions . Since 1988 , when the term chronic fatigue syndrome ( CFS ) was coined , considerable discussion has occurred about stigma associated with this diagnostic term . In particular , patients with CFS have felt that this term trivializes the serious nature of this disorder . A Name Change Work group , appointed by the CFS Coordinating Committee , developed an umbrella term : chronic neuroendocrineimmune dysfunction syndrome ( CNDS ) , and proposed that there would be sub-types under this term , one being CFS . The present study examined attributions of this new umbrella term when compared with CFS . Nurses and physician assistants ( PAs ) were presented a case study of a patient with symptoms of CFS . They were told that the patient had either " chronic fatigue syndrome , " " chronic neuroendocrineimmune dysfunction syndrome , " or " chronic neuroendocrineimmune dysfunction syndrome , which had formerly been called chronic fatigue syndrome . " The different terms led to different attributions , with PA respondents rating the " CNDS " label as more severe . Results suggest that a more medical sounding term ( CNDS ) may lead to attributions that this syndrome is a more serious , disabling illness . The policy implications of these findings are discussed .

syndrome : differential attributions

medical sounding term ( CNDS )

attributions

medical sounding term

attributions

patients with CFS


Is individual peer support a promising intervention for persons with heart failure ? Peer support has been used effectively in a variety of patient populations , but its effectiveness in improving outcomes in persons with chronic heart failure has not been explored . We trained 9 persons with heart failure to mentor other heart failure patients and tested the effectiveness of this approach in a randomized controlled clinical trial . A low proportion ( 37 % ) of the eligible population of hospitalized patients agreed to participate . At the end of the 3-month trial , there was significantly higher heart failure self-care in the intervention group ( P < .05 ) . The only difference in social support was a significant decline in perceived support reciprocity in the intervention group ( F = 5.94 , P = .004 ) . No significant group differences in heart failure readmissions , length of stay , or cost were evident at 90-days , although the heart failure readmission rate was 96 % higher in the intervention group when compared to that in the control group . The reasons for low overall enrollment and high readmission rates in the intervention group require further study . Including additional self-care education by a professional , rather than leaving all the education to the mentor , could strengthen the peer support intervention trialed in this study . Small group meetings may be less intrusive and more desirable for this patient population .

individual peer support

Peer support

mentor other heart failure patients

heart failure self-care

support reciprocity

heart failure readmissions

length of stay

cost

heart failure readmission rate

persons with heart failure

persons with chronic heart failure


Mandibular overdentures supported by two Brånemark , IMZ or ITI implants : a 5-year prospective study . OBJECTIVES The aim of this prospective comparative study was to evaluate the survival rate and the condition of the peri-implant tissues of the IMZ implant system ( two-stage cylindertype ) , the Brånemark implant system ( two-stage screwtype ) and the ITI implant system ( one-stage screwtype ) supporting a mandibular overdenture during a 5-year follow-up period . MATERIAL AND METHODS Three groups of 30 edentulous patients were treated with two endosseous implants in the interforaminal region of the mandible . Clinical and radiographic parameters were evaluated immediately after completion of the prosthetic treatment and after 1 , 2 , 3 , 4 and 5 years of functional loading . RESULTS The five-year survival rate is 98.3 % for the IMZ group , 98.3 % for the Brå group and 100 % for the ITI group . Mean scores on indices for plaque , calculus , gingiva and bleeding were very low at all evaluation periods . Mean marginal bone loss over a period of 5 years , was 1.4 mm for the IMZ group , 0.7 mm for the Brå group and 0.9 mm for the ITI group . CONCLUSION It is concluded that two implants placed in the interforaminal region , connected with a bar , supply a proper base for the support of a mandibular overdenture in the edentulous patient . After 5 years no clinically relevant and statistically significant radiographic changes had developed between the three implant systems .

survival rate


An open and randomized study comparing the efficacy of standard danazol and modified triptorelin regimens for postoperative disease management of moderate to severe endometriosis . OBJECTIVE To compare the efficacy of danazol and triptorelin ( Decapeptyl CR , Ferring , Kiel , Germany ) in the management of moderate and severe endometriosis in terms of symptom control and revised American Fertility Society ( AFS ) score reduction , and to evaluate the hormonal profile of patients treated with triptorelin every 6 weeks . DESIGN Open and randomized trial . SETTING Kwong Wah Hospital , a large public hospital in an urban location ( Hong Kong ) . PATIENT ( S ) Forty patients after their first conservative operation for endometriosis , with surgical confirmation of revised AFS stage III or IV endometriosis . INTERVENTION ( S ) Postoperative 6 months ' therapy of danazol or triptorelin every 6 weeks , postmedical therapy second-look laparoscopy . MAIN OUTCOME MEASURE ( S ) Symptom control and patients ' tolerance during medical therapy , posttherapy revised AFS score , hormonal profile during triptorelin therapy . RESULT ( S ) Pain control was similar between danazol and triptorelin therapy . There was less breakthrough bleeding with triptorelin . More patients failed to complete the whole course of danazol because of its side effects . The revised AFS score at second-look laparoscopy did not show a significant difference between the two medications . Adequate pituitary suppression was observed with injection of triptorelin every 6 weeks . CONCLUSION ( S ) Lengthening of triptorelin administration intervals from 4 weeks to 6 weeks is effective in maintaining a hypoestrogenic state . Patients were more compliant with triptorelin than danazol . Thus , triptorelin injection every 6 weeks is more cost-effective than conventional regimens .

standard danazol

modified triptorelin regimens

danazol

triptorelin

triptorelin

danazol

triptorelin

danazol

triptorelin

triptorelin

danazol

triptorelin

triptorelin

triptorelin

danazol

triptorelin

efficacy

efficacy

symptom control

hormonal profile

posttherapy revised AFS score

Pain control

breakthrough bleeding

side effects .

revised AFS score

Adequate pituitary suppression

hypoestrogenic state .

compliant

moderate to severe endometriosis

Forty

AFS stage III or IV endometriosis


Brain activity correlates differentially with increasing temporal complexity of rhythms during initialisation , synchronisation , and continuation phases of paced finger tapping . Activity in parts of the human motor system has been shown to correlate with the complexity of performed motor sequences in terms of the number of limbs moved , number of movements , and number of trajectories . Here , we searched for activity correlating with temporal complexity , in terms of the number of different intervals produced in the sequence , using an overlearned tapping task . Our task was divided into three phases : movement selection and initiation ( initiate ) , synchronisation of finger tapping with an external auditory cue ( synchronise ) , and continued tapping in absence of the auditory pacer ( continue ) . Comparisons between synchronisation and continuation showed a pattern in keeping with prior neuroimaging studies of paced finger tapping . Thus , activation of bilateral SMA and basal ganglia was greater in continuation tapping than in synchronisation tapping . Parametric analysis revealed activity correlating with temporal complexity during initiate in bilateral supplementary and pre-supplementary motor cortex ( SMA and preSMA ) , rostral dorsal premotor cortex ( PMC ) , basal ganglia , and dorsolateral prefrontal cortex ( DLPFC ) , among other areas . During synchronise , correlated activity was observed in bilateral SMA , more caudal dorsal and ventral PMC , right DLPFC and right primary motor cortex . No correlated activity was observed during continue at P < 0.01 ( corrected , cluster level ) , though left angular gyrus was active at P < 0.05 . We suggest that the preSMA and rostral dorsal PMC activities during initiate may be associated with selection of timing parameters , while activation in centromedial prefrontal cortex during both initiate and synchronise may be associated with temporal error monitoring or correction . The absence of activity significantly correlated with temporal complexity during continue suggests that , once an overlearned timed movement sequence has been selected and initiated , there is no further adjustment of the timing control processes related to its continued production in absence of external cues .

paced finger tapping

continuation

synchronisation

Brain activity

Brain activity correlates

paced finger tapping


The prophylactic effect of valproate on glyceryltrinitrate induced migraine . In this study the human glyceryltrinitrate ( GTN ) model of migraine was for the first time used to test the effect of a prophylactic drug . We chose to test valproate due to its well documented effect as a migraine prophylactic drug . Efficacy of this compound would support the usefulness of the model in prophylactic antimigraine drug development . Twelve patients with migraine without aura were included in a randomized double blind crossover study . Valproate 1000 mg or placebo was given daily , each for a minimum of 13 days . On the last treatment day of each arm a 20 min intravenous infusion of GTN ( 0.25 microg/kg/min ) was given . Headache was registered for 12 h after the infusion and headache intensity was scored on a scale from 0 to 10 . Fulfillment of IHS criteria was recorded for 24 h. The middle cerebral arteries were evaluated by transcranial Doppler and the diameter of the superficial temporal and radial arteries were measured with high frequency ultrasound . GTN evoked migraine fulfilling IHS criteria 1.1 in 6 patients after placebo and in 2 patients after valproate ( P = 0.125 ) . Including additionally 3 patients on placebo and 1 patient on valproate who felt they had suffered a migraine attack , but who had as associated symptoms only photophobia or phonophobia , a significant reduction in the number of patients with induced migraine after valproate was seen ( P = 0.031 ) . Median peak headache intensity was 1 ( range 0-9 ) after valproate compared to 4.5 ( range 0-8 ) after placebo ( P = 0.120 ) . Pretreatment with valproate as compared to placebo reduced the velocity in both middle cerebral arteries after GTN ( left P = 0.021 , right P = 0.031 ) . No effect of valproate was seen in the diameter of the superficial temporal artery ( P = 0.781 ) or the radial artery ( P = 0.367 ) before or after GTN . The study indicates that a prophylactic effect of valproate may be demonstrated using the GTN human migraine model . Although , all headache parameters were reduced after valproate compared to placebo , only one parameter was statistically significantly reduced probably because of the small number of patients . The size of the effect was similar to that of valproate in clinical trials . The GTN model may therefore be a valid tool for testing new prophylactic antimigraine drugs .

valproate

prophylactic drug

valproate

migraine prophylactic drug

Valproate

placebo

GTN

GTN

placebo

valproate

placebo

valproate

valproate

valproate

placebo

valproate

placebo

valproate

valproate

GTN human migraine model

valproate

placebo

GTN

glyceryltrinitrate induced migraine .

Efficacy

Headache

headache intensity

middle cerebral arteries

transcranial Doppler

migraine attack

photophobia

phonophobia

Median peak headache intensity

velocity

middle cerebral arteries

radial artery

GTN human migraine

headache parameters

glyceryltrinitrate induced migraine

Twelve

migraine without aura


Needle versus loop diathermy excision of the transformation zone for the treatment of cervical intraepithelial neoplasia : a randomised controlled trial . OBJECTIVE To determine whether lower rates or incomplete resection of cervical intraepithelial neoplasia ( CIN ) may be achieved by needle excision of the transformation zone ( NETZ ) than with loop excision ( LLETZ ) . DESIGN A prospective randomised controlled trial . SETTING A gynaecological oncology centre and a teaching hospital in West London . POPULATION Four hundred and four women due to receive treatment for suspected CIN . METHODS Women were randomised to receive either LLETZ or NETZ . MAIN OUTCOME MEASURES The study was designed to demostrate a difference in the proportion of women with clear histological margins of 82 % for LLETZ compared to 94 % for NETZ with 90 % power at a 5 % significance level , allowing for absence of CIN in the treatment specimen in 15 % . RESULTS Four randomised women were excluded from the analysis , as they were ineligible for the study . Three hundred and forty-seven ( 87 % ) had CIN in the treatment specimen and could be included in the analysis of excision margins . More women in the NETZ arm had clear histological margins ( 84.8 % vs 75 % , ( P= 0.03 ) . The median volume of specimens in the NETZ arm was 739 mm ( 3 ) larger ( P= 0.33 ) and they were less likely to be removed in multiple pieces ( 2.5 % vs 29.5 % , RR 0.09 , 95 % CI 0.04 to 0.20 ) . Needle excision took longer to perform ( median treatment time 210 vs 90 seconds , P < 0.0001 ) and surgeons more often reported the procedure as 'difficult ' ( 9.5 % vs 3.0 % , RR = 3.17 % , 95 % CI 1.33 to 7.58 ) . No difference in peri-operative or post-operative complication rates could be demonstrated between the two groups . CONCLUSION NETZ is more likely to produce a specimen in one piece and with clear margins compared to LLETZ .

Needle versus loop diathermy excision

loop excision ( LLETZ )

LLETZ

NETZ

LLETZ

NETZ

NETZ

LLETZ

clear histological margins

median volume of specimens

reported the procedure as 'difficult '

cervical intraepithelial neoplasia :


Patterning of pain and power with guided imagery . Using Martha Rogers ' science of unitary human beings , changes in pain and power among 42 patients were examined in relation to the use of a guided imagery modality . Participants were randomly assigned to treatment and control groups and repeated measures MANCOVA was used to detect differences in pain and power over a 4-day period of time . The treatment group 's pain decreased during the last 2 days of the study . No differences in power emerged . Guided imagery appeared to have potential as a useful nursing modality for chronic pain sufferers .

guided imagery

guided imagery modality

control groups

Guided imagery

pain

power

pain

power

pain

power

pain

power


Chemotherapy for patients with non-small cell lung cancer : the surgical setting of the Big Lung Trial . OBJECTIVES The non-small cell lung cancer ( NSCLC ) meta-analysis suggested a survival benefit for cisplatin-based chemotherapy when given in addition to surgery , radical radiotherapy or 'best supportive care ' . However , it included many small trials and trials with differing eligibility criteria and chemotherapy regimens . The aim of the Big Lung Trial was therefore to run a large pragmatic trial to confirm the survival benefits seen in the meta-analysis . METHODS In the surgery setting , a total of 381 patients were randomised to chemotherapy ( C , 192 patients ) or no chemotherapy ( NoC , 189 patients ) . C was three 3-weekly cycles of cisplatin/vindesine , mitomycin/ifosfamide/cisplatin , mitomycin/vinblastine/cisplatin or vinorelbine/cisplatin . RESULTS Chemotherapy was given before surgery in 3 % of patients whilst 97 % received adjuvant chemotherapy . Baseline characteristics were : median age 61 years , 69 % male , 48 % squamous cell , 93 % WHO PS 0-1 , 27 % stage I , 38 % stage II , and 34 % stage III . Complete resection was achieved in approximately 95 % of patients . In the C group , 13 % received no chemotherapy , 21 % one or two cycles , and 64 % all three cycles of their prescribed chemotherapy ( 60 % of the latter with no delays or modification ) . 30 % had grade 3/4 toxicity , mainly haematological , nausea/vomiting and neutropenic fever , and six patients were reported as having a treatment-related death . 198 ( 52 % ) of patients have died , but there is currently no evidence of a benefit in overall survival to the C group : HR 1.02 ( 95 % CI 0.77-1.35 ) , P = 0.90 ) . CONCLUSIONS This trial has failed to observe a survival benefit with adjuvant chemotherapy following complete resection of stage I-III NSCLC . However , the hazard ratio and 95 % confidence intervals are consistent with the previously reported meta-analysis and two large recently reported trials , which suggest a small survival benefit with cisplatin-based chemotherapy .

Chemotherapy

cisplatin-based chemotherapy

surgery

surgery

chemotherapy

no chemotherapy

Chemotherapy

surgery

adjuvant chemotherapy .

no chemotherapy

chemotherapy

adjuvant chemotherapy

cisplatin-based chemotherapy .

survival benefits

Complete resection

death

benefit in overall survival

survival benefit

lung cancer

lung cancer


Single and short-term dosing effects of levocetirizine on adenosine monophosphate bronchoprovocation in atopic asthma . AIMS Adenosine monophosphate ( AMP ) acts indirectly via primed airway mast cells to induce bronchial hyper-responsiveness , which in turn correlates with eosinophilic asthmatic inflammation and atopic disease expression . We evaluated single and short-term dosing effects of a modern histamine H1-receptor antagonist , levocetirizine , given at the usual clinically recommended dose , on the primary outcome of AMP bronchoprovocation . METHODS Fifteen atopic asthmatics were randomized in double-blind , cross-over fashion to receive for 1 week either levocetirizine 5 mg or placebo . There was a 1-week washout period prior to each randomized treatment . The provocative concentration of AMP producing a 20 % fall in FEV1 ( PC20 ) was measured after each washout at baseline and at 4-6 h following the first and last doses of each randomized treatment . RESULTS Baseline mean +/- SEM values after washout prior to each randomized treatment comparing levocetirizine vs placebo were not significantly different for prechallenge FEV1 ( % predicted ) 83 +/- 4 vs 82 +/- 4 , or AMP PC20 ( mg ml ( -1 ) ) 45 +/- 24 vs 45 +/- 22 , respectively . Airway calibre as prechallenge FEV1 for levocetirizine vs placebo was not significantly different following the first dose 86 +/- 4 vs 82 +/- 4 , or the last dose 85 +/- 4 vs 83 +/- 4 , respectively . There were significant improvements ( P < 0.05 ) in AMP PC20 comparing levocetirizine vs placebo following the first dose 123 +/- 73 vs 48 +/- 24 , a 1.4 doubling dilution difference ( 95 % CI 0.8 , 1.9 ) , and the last dose 127 +/- 74 vs 53 +/- 29 , a 1.2 doubling dilution difference ( 95 % CI 0.5 , 2.0 ) . AMP PC20 was also improved ( P < 0.05 ) by the first and last doses of levocetirizine but not placebo , vs respective baseline values , with there being no difference in the degree of protection between first and last doses . CONCLUSIONS Single and short-term dosing with levocetirizine conferred similar improvements in bronchial hyper-responsiveness to AMP challenge , which was unrelated to prechallenge airway calibre . Further studies are indicated to evaluate the longer-term effects of levocetirizine on asthma exacerbations .

levocetirizine

levocetirizine

levocetirizine 5 mg

placebo

levocetirizine

placebo

levocetirizine

placebo

levocetirizine

levocetirizine

eosinophilic asthmatic inflammation

atopic disease expression

mean +/- SEM values

AMP PC20

Airway calibre as prechallenge FEV1

AMP PC20

AMP PC20

bronchial hyper-responsiveness to AMP

asthma exacerbations

Fifteen

atopic asthmatics


[ Comparison of two methods of local anaesthesia prior to transrectal ultrasound-guided prostate biopsies ] . OBJECTIVE To compare the analgesic efficacy of rectal administration of Lidocaïne gel with Lidocaïne periprostatic infiltration prior to transrectal ultrasound-guided prostate biopsies . MATERIAL AND METHODS Between July 2002 and July 2003 , candidates to prostate biopsies were randomised into two groups . In group 1 , 15 ml 2 % Lidocaïne gel was administered intra-rectally 10 minutes prior to biopsies and patients included in group 2 received 10 ml of 1 % Lidocaïne in two périprostatique equivalent injections , 4 minutes prior to prostate biopsies . Pain was assessed with a Visual Analog Scale , during anaesthesia ( VAS 1 ) , during the biopsies procedure ( VAS 2 ) and 30 minutes after them ( VAS 3 ) . RESULTS 308 patients were included in this trial with 156 patients in group 1 and 152 in group 2 . Group 1 experienced statistically less pain for VAS 1 ( 0.1 versus 1.4 , p < 0.0001 ) and VAS 3 ( 0.8 versus 1.4 , p < 0.001 ) but no significative difference could be demonstrated for VAS 2 ( 1.8 versus 2.0 ) . No major complication was noted . CONCLUSION Rectal administration of Lidocaïne gel and infiltration of Lidocaïne lead to a comparable level of anaesthesia during prostatic biopsies procedure . However , the Lidocaïne gel , being both safe and simple , tends to maintain a better comfort of the patient 30 minutes after the end of the biopsies .

local anaesthesia

Lidocaïne gel

Lidocaïne periprostatic infiltration

Lidocaïne gel

administration of Lidocaïne

infiltration of Lidocaïne

Lidocaïne

pain


Effects of pioglitazone and glimepiride on glycemic control and insulin sensitivity in Mexican patients with type 2 diabetes mellitus : A multicenter , randomized , double-blind , parallel-group trial . BACKGROUND Pioglitazone and glimepiride improve glycemic control in patients with type 2 diabetes mellitus by different mechanisms . Pioglitazone is a thiazolidinedione that reduces insulin resistance , and glimepiride is a sulfonylurea insulin secretagogue . OBJECTIVE The goals of this study were to compare changes in measures of glycemic control and insulin sensitivity in Mexican patients with type 2 diabetes who received pioglitazone or glimepiride for 1 year . METHODS This was a multicenter , 52-week , double-blind , parallel-group trial . Patients were randomized to receive monotherapy with either glimepiride ( 2 mg QD initially ) or pioglitazone ( 15 mg QD initially ) . Doses were titrated ( maximal doses : pioglitazone 45 mg , glimepiride 8 mg ) to achieve glycemic targets ( fasting blood glucose < or =7 mmol/L and 1-hour postprandial blood glucose < or =10 mmol/L ) . Insulin sensitivity ( primary end point ) was evaluated in terms of the Homeostasis Model Assessment for Insulin Sensitivity ( HOMA-S ) , the Quantitative Insulin Sensitivity Check Index ( QUICKI ) , and fasting serum insulin ( FSI ) concentrations . Glycemic control was evaluated in terms of glycosylated hemoglobin ( HbA ( 1c ) ) values and fasting plasma glucose ( FPG ) concentrations . Patients were encouraged to maintain their individual diet and exercise regimens throughout the study . RESULTS Two hundred forty-four patients ( 125 women , 119 men ; all but 1 Hispanic ) were randomized to receive pioglitazone ( n = 121 ) or glimepiride ( n = 123 ) . In the intent-to-treat sample , pioglitazone and glimepirede produced comparable reductions in HbA ( 1c ) from baseline to the end of the study ( -0.78 % and -0.68 % , respectively ) . The pioglitazone group had significantly higher HbA ( 1c ) values compared with the glimepiride group after 12 weeks of therapy ( 8.66 % vs 7.80 % ; P = 0.007 ) but had significantly lower values after 52 weeks ( 7.46 % vs 7.77 % ; P = 0.027 ) . Pioglitazone significantly reduced FPG compared with glimepiride ( -0.6 vs 0.6 mmol/L ; P = 0.01 ) . Pioglitazone therapy was associated with significant increases in insulin sensitivity ( reduced insulin resistance ) , whereas glimepiride had no effect . HOMA-S values changed 18.0 % for pioglitazone and -7.9 % for glimepiride ( P < 0.001 ) , QUICKI values changed a respective 0.013 and -0.007 ( P < 0.001 ) , and FSI values were -21.1 and 15.1 pmol/L ( P < 0.001 ) . Both drugs were well tolerated , with pioglitazone associated with more peripheral edema ( number of treatment-emergent cases : 35/121 [ 28.9 % ] vs 17/123 [ 13.8 % ] ; P = 0.005 ) and fewer hypoglycemic episodes ( 19 [ 15.7 % ] vs 38 [ 30.9 % ] ; P = 0.024 ) . The incidence of weight gain was not significantly different between treatment groups . CONCLUSIONS These data suggest that long-term treatment with pioglitazone enhances insulin sensitivity relative to glimepiride in Mexican patients with type 2 diabetes and that pioglitazone may have a more sustained antihyperglycemic effect .

pioglitazone

glimepiride

Pioglitazone

glimepiride

Pioglitazone

glimepiride

pioglitazone

glimepiride

glimepiride

pioglitazone

pioglitazone

glimepiride

pioglitazone

glimepiride

pioglitazone

glimepirede

pioglitazone

glimepiride

Pioglitazone

glimepiride

Pioglitazone

glimepiride

pioglitazone

glimepiride

pioglitazone

glimepiride

pioglitazone

reductions in HbA ( 1c )

HbA ( 1c )

FPG

HOMA-S values

tolerated

peripheral edema

hypoglycemic episodes

weight gain

Mexican

type 2 diabetes mellitus

Two hundred forty-four

women

men

all but 1 Hispanic


Untreated silicone breast implant rupture . Implant rupture is a well-known complication of breast implant surgery that can pass unnoticed by both patient and physician . To date , no prospective study has addressed the possible health implications of silicone breast implant rupture . The aim of the present study was to evaluate whether untreated ruptures are associated with changes over time in magnetic resonance imaging findings , serologic markers , or self-reported breast symptoms . A baseline magnetic resonance imaging examination was performed in 1999 on 271 women who were randomly chosen from a larger cohort of women having cosmetic breast implants for a median period of 12 years ( range , 3 to 25 years ) . A follow-up magnetic resonance imaging examination was carried out in 2001 , excluding women who underwent explantation in the period between the two magnetic resonance imaging examinations ( n = 44 ) . On the basis of these examinations , the authors identified 64 women who had at least one ruptured implant at the first magnetic resonance imaging examination and , for comparison , all women who had intact implants at both examinations ( n = 98 ) . Magnetic resonance images from the two examinations were compared and changes in rupture configuration were evaluated . Comparisons were also made for self-reported breast symptoms occurring during the study period and for changes in serum values of antinuclear antibodies , rheumatoid factor , and cardiolipin antibodies immunoglobulin G and immunoglobulin M. The majority of the women with implant rupture had no visible magnetic resonance imaging changes of their ruptured implants . For 11 implants ( 11 percent ) in 10 women , the authors observed progression of silicone seepage , either as a conversion from intracapsular into extracapsular rupture ( n = 7 ) , as progression of extra-capsular silicone ( n = 3 ) , or as increasing herniation of the silicone within the fibrous capsule ( n = 1 ) ; however , in most cases , these changes were minor . Some changes could be ascribed to trauma , but others seemed spontaneous . There was no increase in levels of autoantibodies during the study period in either study group . Women with untreated implant ruptures reported a significant increase in nonspecific breast changes ( odds ratio , 2.1 ; 95 percent confidence interval , 1.2 to 3.8 ) compared with women without ruptures . On the basis of this first study of women with untreated silicone breast implant rupture , the authors conclude that implant rupture is a relatively harmless condition , which only rarely progresses and gives rise to notable symptoms . Even so , because of a small risk of silicone spread , the authors suggest that women with implant ruptures be followed clinically , if not operated on . Because implant ruptures often occur asymptomatically , any woman with silicone implants , regardless of rupture status , should be evaluated at regular intervals .

implant ruptures

magnetic resonance imaging changes

silicone seepage

levels of autoantibodies

nonspecific breast changes

women

women

( range , 3 to 25 years

women


Evaluation of an aquatics programme on fitness parameters of individuals with a brain injury . The primary objective was to determine the effect of an aquatic exercise programme on the physical fitness of people with a brain injury . A pre-test-post-test randomized-groups design was conducted . Sixteen outpatients with a brain injury were included in the study . Eight participants were assigned to an aquatic exercise group and eight to a control group . The components of physical fitness measured included cardiovascular endurance , body composition , muscular strength and endurance and flexibility . Measurements were taken pre- and post-programme . Results indicated an increase in components of physical fitness for the experimental group but not the control group . Increases in fitness were reported as having a positive impact on the functional capacity of individuals in the exercise group as well as enhancing the individual 's ability to complete activities of daily living successfully . Results indicate that aquatic exercise may positively impact the primary and secondary physical injuries caused by a brain injury .

aquatics programme

aquatic exercise programme

fitness parameters

physical fitness

cardiovascular endurance

body composition

muscular strength

endurance and flexibility

components of physical fitness

functional capacity

primary and secondary physical injuries

brain injury

brain injury

Sixteen

brain injury


Intravenously administered histamine increases choroidal but not retinal blood flow . PURPOSE To determine the effect of intravenously administered histamine on both retinal and choroidal blood flow in humans . METHODS A randomized , double-masked , two-way crossover study was performed in 14 healthy volunteers . Placebo or histamine was administered intravenously in stepwise increasing doses ( 0.08 microg/kg/min , 0.16 microg/kg/min , and 0.32 microg/kg/min ) . Retinal vessel diameters were measured with a retinal vessel analyzer , and retinal venous blood speed was assessed by bi-directional laser Doppler velocimetry . Using these parameters retinal blood flow was calculated . Subfoveal and pulsatile choroidal blood flow were measured with laser Doppler flowmetry and laser interferometry , respectively . RESULTS After infusion of histamine pulsatile choroidal blood flow increased by 5 +/- 3 % , 9 +/- 8 % , and 14 +/- 7 % ( P = 0.001 , ANOVA ) and subfoveolar choroidal blood flow by 8 +/- 11 % , 13 +/- 11 % , and 13 +/- 12 % ( P = 0.003 , ANOVA ) . Retinal arterial and venous vessel diameter significantly increased by 3 +/- 4 % , 2 +/- 4 % , and 3 +/- 5 % ( P = 0.047 , ANOVA ) and 1 +/- 2 % , 3 +/- 2 % , and 3 +/- 2 % ( P = 0.015 , ANOVA ) , respectively . Red blood cell velocity in major retinal veins tended to decrease by -9 +/- 12 % , -9 +/- 20 % , and -13 +/- 12 % , but this effect did not reach levels of significance . Calculated retinal blood flow was not changed by administration of histamine ( -7 +/- 14 % , -4 +/- 20 % , and -8 +/- 12 % , P = 0.28 , ANOVA ) . CONCLUSIONS Intravenous histamine in the selected doses increased choroidal blood flow . Retinal vessels showed a small diameter increase , whereas red blood cell speed decreased , resulting in an unchanged total retinal blood flow . This may result from local differences in the receptor distribution in the posterior part of the eye .

Intravenously administered histamine

intravenously administered histamine

Placebo

histamine

histamine

histamine

Intravenous histamine

Retinal vessel diameters

retinal venous blood speed

retinal blood flow

choroidal blood

pulsatile choroidal blood flow

subfoveolar choroidal blood flow

Calculated retinal blood flow

choroidal blood flow

small diameter increase

red blood cell speed

total retinal blood flow


Predicting the costs of allogeneic sibling stem-cell transplantation : results from a prospective , multicenter , French study . BACKGROUND Allogeneic hematopoietic stem-cell transplantation is a widely used , cost-intensive procedure . Our purpose was to estimate costs and determine cost predictors . METHODS We used data from a prospective French study comparing four doses of immunoglobulins . Resource use of hematopoietic stem-cell transplant recipients during the first 6 months posttransplant , both inpatient and ambulatory costs , in 85 patients from five centers were collected prospectively and costed . Baseline data and clinical events were retrieved . Protocol-driven costs were excluded . Multivariable analysis evaluated the association between costs and patient 's pretransplant status and transplant-related complications . Because of the absence of differences in outcome among the four randomization groups , cost data for all patients were pooled . RESULTS Total costs per patient were the following : mean 76,237 Euros ; standard deviation 32,565 Euros ; median 69,516 Euros ; range 183,758 to 14,761Euros . The major cost driver was hospital days . No association was found between costs and baseline status . The " predictors " of higher costs ( adding an average 20,000 Euros/patient ) were the occurrence of transplant-related complications : graft-versus-host disease and repeated infections that were unpredictable before transplant in this homogeneous group of patients . CONCLUSION Our data highlight the discrepancy between the Diagnosis Related Group prospective payment system and actual costs . The actual cost of geno-identical stem-cell transplantation results from posttransplant complications that can not be predicted prospectively and require ex post cost adjustment .

data from a prospective French study

immunoglobulins

costs

costs

cost predictors

Multivariable analysis

costs

patient 's pretransplant status

transplant-related complications

cost data

Total costs

costs

baseline status

transplant-related complications

repeated infections

actual costs

actual cost


Retroinfusion-supported stenting in high-risk patients for percutaneous intervention and bypass surgery : results of the prospective randomized myoprotect I study . The objective of this study was to assess event-free survival and total treatment costs of retroinfusion-supported stenting in high-risk patients compared to bypass surgery . An increasing number of patients with main-stem and main-stem-equivalent stenosis are treated by stent implantation , which appears to be safe in the short-term follow-up . However , there is a lack of randomized studies comparing conventional bypass surgery with stent implantation , particularly in patients with high risk for both treatments . We here report on the 1-year results of a prospective randomized single-center study in patients with symptomatic main-stem and main-stem-equivalent lesions with substantially increased risk for bypass surgery . Patients where randomized to undergo either percutaneous transluminal coronary angioplasty/stent procedure ( n = 23 ) or bypass surgery ( n = 21 ) . Patients randomized to stent implantation were supported by selective pressure-regulated retroinfusion of the anterior cardiac vein during ischemia . Patients of the stent group and the bypass group did not differ in baseline characteristics , including Parsonnet score and quality-of-life score . Twenty-eight-day mortality and 1-year mortality rate as well as quality-of-life scores were similar in both groups . Event-free survival after 1 year was higher in the bypass group ( 71.4 % vs. 52.3 % ; P = 0.02 ) due to a lower target lesion revascularization rate . With regard to total treatment costs , however , the stent group compared favorably to the bypass group ( 9,346 +/- 807 vs. 26,874 +/- 3,985 euro ) , predominantly as a result of a shorter intensive care and hospital stay . In this first randomized study in high-risk patients for stent implantation and bypass surgery , patients with retroinfusion-supported stent implantation had a similar 1-year outcome and quality of life compared to patients with bypass surgery . Though in the stent group event-free survival was lower and target lesion revascularization rate was higher , retroinfusion-supported stent implantation was associated with substantially lower costs and might be considered as an alternative treatment option in this selected group of high-risk patients .

Retroinfusion-supported stenting

bypass surgery

retroinfusion-supported stenting

bypass surgery

stent implantation

conventional bypass surgery

stent implantation

bypass surgery

stent implantation

stent

bypass

stent implantation

bypass surgery

bypass surgery

event-free survival

total treatment costs

Parsonnet score

quality-of-life score

Twenty-eight-day mortality

1-year mortality rate

quality-of-life scores

Event-free survival

total treatment costs

1-year outcome

quality of life

event-free survival

revascularization rate

lower costs

high-risk

percutaneous intervention

bypass surgery

high-risk patients

patients with high risk

stent group

bypass group

bypass surgery


Public and private heart rate feedback in social phobia : a manipulation of anxiety visibility . According to cognitive behavioural models of social phobia , bodily symptoms are the main source of information concerning social evaluation for social phobics . Experience and perception of bodily symptoms therefore play an important role in social anxiety . In this study we evaluated the effects of anxiety visibility on patients and controls using feedback of veridical heart sounds . A total of 32 social phobics and 32 controls were asked twice to sit in a chair and appear relaxed while being evaluated . Half of the participants heard their heart sounds first via headphones and then via loudspeakers which were also audible to observers . The presentation order of the heart sound was reversed for the other half of the subjects . Social phobics reported substantially more anxiety than controls . Both groups showed habituation in heart rate from the first to the second presentation , and both groups reported perception of a higher heart rate , but only social phobics reported significantly more anxiety and were more worried about their heart rates in the public than in the private condition . These effects were in excess of actual heart rate differences . In conclusion , social phobics worried about the broadcast of a bodily anxiety symptom , whereas controls did not . Information about arousal made public has a strong potential to increase anxiety levels in social phobics .

social phobia

social phobia

social phobics

Social phobics

social phobics

controls

social evaluation

anxiety visibility

heart sound

anxiety

habituation in heart rate

higher heart rate

anxiety

heart rates

actual heart rate differences

bodily anxiety symptom

anxiety levels

social phobia


Six-month trial of on-demand rabeprazole 10 mg maintains symptom relief in patients with non-erosive reflux disease . BACKGROUND Compliance studies have shown that patients with reflux symptoms generally take their medication only when experiencing these symptoms . AIM To evaluate the efficacy of on-demand rabeprazole maintenance therapy in patients with non-erosive reflux disease . METHODS This multicentre , randomized , double-blind , placebo-controlled , withdrawal study compared 6 months of on-demand treatment with rabeprazole 10 mg vs. placebo . Adults with a history of reflux symptoms , a negative endoscopy , and > or = 3 days of moderate to very severe heartburn in the 7 days before enrollment ( N = 535 ) entered 4 weeks of open-label , acute treatment with rabeprazole 10 mg once daily . Patients with complete symptom relief then entered the on-demand phase . The primary end-point was discontinuation due to lack of heartburn control during the on-demand phase . RESULTS Eighty-three percent ( 432 of 523 ) of patients reported complete symptom relief at the end of the acute phase . During on-demand treatment , rates of discontinuation because of inadequate heartburn control were 20 % ( 28 of 139 ) for placebo vs. 6 % ( 16 of 279 ) for rabeprazole ( P < 0.00001 ) . Antacid use was twofold higher in the placebo group vs. the rabeprazole group ( P = 0.0009 ) . CONCLUSIONS Rabeprazole 10 mg once daily is highly effective in acute symptom relief and as on-demand long-term maintenance therapy in non-erosive reflux disease patients .

rabeprazole

rabeprazole

placebo-controlled

rabeprazole

placebo

rabeprazole

placebo

rabeprazole

placebo

rabeprazole

Rabeprazole

symptom relief

reflux disease

efficacy

symptom relief

symptom relief

Antacid use

effective

acute symptom relief

non-erosive reflux disease

patients with reflux symptoms

non-erosive reflux disease

Adults

reflux

heartburn

non-erosive reflux disease


Why distinctive information reduces false memories : evidence for both impoverished relational-encoding and distinctiveness heuristic accounts . Two accounts explain why studying pictures reduces false memories within the Deese-Roediger-McDermott paradigm ( J. Deese , 1959 ; H. L. Roediger & K. B. McDermott , 1995 ) . The impoverished relational-encoding account suggests that studying pictures interferes with the encoding of relational information , which is the primary basis for false memories in this paradigm . Alternatively , the distinctiveness heuristic assumes that critical lures are actively withheld by the use of a retrieval strategy . When participants were given inclusion recall instructions to report studied items as well as related items , they still reported critical lures less often after picture encoding than they did after word encoding . As the impoverished relational-encoding account suggests , critical lures appear less likely to come to mind after picture encoding than they do after word encoding . However , the results from a postrecall recognition test provide evidence in favor of the distinctiveness heuristic .

distinctive information

studying pictures

studying pictures

retrieval strategy .

picture encoding

word encoding .

postrecall recognition test

false memories :

false memories

pictures

critical lures

reported critical lures

critical lures

postrecall recognition

impoverished relational-encoding

distinctiveness heuristic accounts

inclusion recall instructions


Registration accuracy of 153Gd transmission images of the brain . PURPOSE The aim of the study was to determine the accuracy of non-rigid nine-parameter image registrations based on 153Gd transmission computed tomography ( TCT ) images as compared with those based on 99mTc-ethyl cysteinate dimer ( ECD ) images and to assess whether normalised mutual information ( NMI ) or count difference ( CD ) should be used . METHODS TCT and ECD data were acquired in 25 randomly selected patients . Emission images were registered to an ECD template with a CD cost function . The same registration parameters were applied to the transmission images to create a TCT template . All TCT images were registered to the TCT template and the same registration parameters were applied to the ECD images . The procedure was repeated with NMI as cost function . Accuracy of both ECD-based and TCT-based registrations was assessed by comparing the normalisation parameter values and regional activities in the spatially normalised ECD images , using a mixed-model analysis of variance ( ANOVA ) . Scheffe post hoc tests were performed . RESULTS No significant differences were found between ECD/CD , ECD/NMI and TCT/CD , suggesting that ECD registration can be done with either CD or NMI , and that TCT registration using CD is equally as accurate as ECD registration . The accuracy of TCT registration with NMI was lower , with discrepancies occurring in the frontal inferior region and the cerebellum . The analysis of normalisation parameters indicated that z-scaling is underestimated and yz-rotation overestimated with TCT/NMI registration . CONCLUSION We conclude that ECD registrations with CD or NMI are as accurate as TCT registrations with CD and that TCT registrations with NMI should be avoided .

153Gd transmission computed tomography

ECD

TCT

ECD

ECD-based

TCT-based

ECD/CD

ECD/NMI

TCT/CD

ECD

CD

NMI

TCT

TCT

No significant differences

accuracy of TCT registration

lower


Comparison of nitinol tipless stone baskets in an in vitro caliceal model . PURPOSE Tipless stone baskets facilitate caliceal calculi extraction during flexible ureteroscopy . We evaluated the stone capture rate of 9 commercially available tipless stone baskets in an in vitro model using novice and expert operators . MATERIALS AND METHODS The Microvasive Zerotip ( 2.4Fr , 3.0Fr ) , Cook N-Circle ( 2.2Fr , 3.0Fr , 3.2Fr ) , Bard Dimension ( 3.0Fr , Sacred Heart Medical Halo ( 1.9Fr ) , Vantage ( 1.9Fr ) and Circon-ACMI Sur-Catch-NT ( 3.0Fr ) were tested by 3 novice and 3 experienced basket operators . Each operator performed stone extraction of 2 , 5 and 8 mm calculi ( size determined by digital caliper with 3 repetitions of each basket . The time to extraction of the calculus from a convex based test tube caliceal model was recorded . Statistical analysis was performed using repeated measures ANOVA and Fisher 's pairwise comparisons . RESULTS After a learning curve of 27 basket retrievals , there was no significant difference in stone capture times between novice ( 38 +/- 54 seconds ) and expert operators ( 32 +/- 49 seconds , p = 0.174 ) . For total stone capture ( all sizes ) the Sacred Heart Halo resulted in the most rapid stone extraction ( 17 +/- 14 seconds ) by novices and experts , while the Sur-Catch NT resulted in the slowest stone extraction ( 78 +/- 90 , seconds , p = 0.001 ) . The Halo ( 14 +/- 9 seconds ) and Vantage ( 19 +/- 12 seconds ) baskets were significantly faster for 2 mm calculi than the N-Circle ( 73 +/- 60 seconds , p = 0.006 ) , Sur-Catch ( 169 +/- 85 seconds , p = 0.0005 ) and Dimension ( 73 +/- 70 seconds , p = 0.017 ) . The Zerotip functioned well for 2 mm calculi in the hands of expert operators ( 15 +/- 9 seconds ) but not novice operators ( 94 +/- 95 seconds ) . The Sur-Catch NT was significantly slower for 2 mm calculi than the N-Circle ( p = 0.01 ) , Dimension ( p =.03 ) , Halo ( p =.0005 ) , Vantage ( p =.001 ) and Zerotip ( p =.002 ) . For 5 mm calculi the Halo was superior ( 12 +/- 8 seconds ) , while the Zerotip were superior for 8 mm calculi ( 8 +/- 3 seconds ) compared to the N-Circle ( 23 +/- 28 seconds , p = 0.026 ) , Halo ( 26 +/- 18 seconds , p = 0.021 ) and Vantage ( 23 +/- 15 seconds , p = 0.006 ) . CONCLUSIONS The Sacred Heart Halo and Vantage baskets resulted in the most expeditious stone extraction , especially for 2 to 5 mm calculi while the Microvasive Zerotip was optimal for 8 mm calculi . The Sur-Catch NT had the slowest stone capture rate for all stone sizes . Caliceal models of stone basketing may be useful to train novice urology residents and nursing assistants .

nitinol tipless stone baskets

Tipless stone baskets

tipless stone baskets

stone extraction

vitro

stone capture times

rapid stone extraction

most expeditious stone extraction

slowest stone capture rate


Severe complications of 5-fluorouracil and cisplatin with concomitant radiotherapy in inoperable non-metastatic squamous cell oesophageal cancer after intubation -- early termination of a prospective randomised trial .

cisplatin

concomitant radiotherapy

Severe complications


Effect of the dietary approaches to stop hypertension diet and reduced sodium intake on blood pressure control . The authors hypothesized that the Dietary Approaches to Stop Hypertension ( DASH ) diet and reduced sodium intake would control stage 1 hypertension and reduce high-normal blood pressure ( BP ) to optimal levels . Adults with systolic BP 120-159 mm Hg and diastolic BP 80-95 mm Hg were randomly assigned to receive the DASH diet or a typical American ( control ) diet , consuming three different sodium intakes ( higher=142 mmol/d , intermediate=107 mmol/d , and lower=65 mmol/d ) for 30 days each . BP control was defined as systolic BP < 140 mm Hg and diastolic BP < 90 mm Hg . Among subjects with hypertension at baseline , at higher sodium intake the DASH diet increased BP control two-fold over control ( 63 % vs. 32 % ; 95 % confidence interval , 1.4-2.9 ) . Reducing sodium intake in the control diet group increased BP control 2.3-fold ( 74 % vs. 32 % ; 95 % confidence interval , 1.7-3.2 ) . The maximum BP control rate ( 84 % ) was achieved with the DASH/lower sodium diet . BP became normal or optimal in 71 % of persons consuming the control/lower sodium diet and 77 % of persons consuming the DASH/lower sodium diet . Both the DASH diet and reduced sodium intake improved BP control .

reduced sodium intake

DASH diet

typical American ( control ) diet

control/lower sodium diet

DASH/lower sodium diet

blood pressure ( BP )

systolic BP

diastolic BP

increased BP control

increased BP control

maximum BP control rate

BP

BP control

Adults

hypertension


The implications of introducing the symphyseal-fundal height-measurement . A prospective randomized controlled trial .

symphyseal-fundal height-measurement .

implications

symphyseal-fundal height-measurement .

prospective


Effects of two-month vocal exercising with and without spectral biofeedback on student actors ' speaking voice . Twelve student actors ( 6 males , 6 females ) were given voice training for two months . Randomly selected , half of the students ( 3 males , 3 females ) was trained in the traditional way , while the other half was given biofeedback with real-time spectrum analysis . The aim was a ringing voice quality with strong overtones at 3-5 kHz . Text samples read at different loudness levels were recorded before and after training . Fundamental frequency ( F0 ) , sound pressure level ( SPL ) and long-term-average spectrum ( LTAS ) analyses were made . Voice quality was evaluated by two voice trainers . Sound energy at 3-5 kHz increased by 3-4 dB ( 1.5-14.5 dB ) across groups after training . This change , which was slightly larger for the biofeedback ( BF ) group , did not correlate with SPL . F0 increased slightly in the BF group and decreased in the control group . The relative dB level of fundamental decreased significantly more in the BF group probably suggesting a tighter adduction . Voice quality improved in both groups . Visual feedback seems to add some efficacy in voice training . However , there is a danger of hyperfunctional voice production if other sensory feedback is neglected .

two-month vocal exercising

spectral biofeedback

voice training

traditional way

Voice quality

Sound energy at 3-5 kHz

SPL

relative dB level of fundamental

Voice quality

efficacy

( 6 males , 6 females )


The effect of reinforcement or stimulus control to reduce sedentary behavior in the treatment of pediatric obesity . Obese children were randomly assigned to a family-based behavioral treatment that included either stimulus control or reinforcement to reduce sedentary behaviors . Significant and equivalent decreases in sedentary behavior and high energy density foods , increases in physical activity and fruits and vegetables , and decreases in standardized body mass index ( z-BMI ) were observed . Children who substituted active for sedentary behaviors had significantly greater z-BMI changes at 6 ( -1.21 vs. -0.76 ) and 12 ( -1.05 vs. -0.51 ) months , respectively . Substitution of physically active for sedentary behaviors and changes in activity level predicted 6- and 12-month z-BMI changes . Results suggest stimulus control and reinforcing reduced sedentary behaviors are equivalent ways to decrease sedentary behaviors , and behavioral economic relationships in eating and activity may mediate the effects of treatment .

family-based behavioral treatment

sedentary behavior

sedentary behavior

high energy density foods

physical activity

fruits and vegetables

body mass index ( z-BMI )

sedentary behaviors

z-BMI changes

sedentary behaviors

activity level

z-BMI changes

sedentary behaviors

sedentary behaviors

pediatric

obesity

Obese

children


Dihydroergocryptine in the management of senile psycho-organic syndrome . A double-blind , placebo-controlled , randomized study is described of an assessment of the efficacy and relative safety of the ergot alkaloid , dihydroergocryptine , on 52 patients with mild organic brain syndrome over a period of three months using a series of neurophysiological tests . The results indicated that short-term treatment with the alkaloid improved memory impairment . The side-effects were mild and transient in both the dihydroergocryptine and placebo groups and there were no alterations in blood chemistry .

Dihydroergocryptine

placebo-controlled

dihydroergocryptine

dihydroergocryptine

efficacy and relative safety

neurophysiological tests

memory impairment

side-effects

alterations in blood chemistry

senile psycho-organic syndrome .

mild organic brain syndrome


Herpesvirus-like particles in the skin of a saltwater crocodile ( Crocodylus porosus ) .

saltwater crocodile

Crocodylus porosus


The A-V Impulse System reduces deep-vein thrombosis and swelling after hemiarthroplasty for hip fracture . We performed a prospective randomised controlled trial of the A-V Impulse System in 82 patients treated by hemiarthroplasty for subcapital fracture of the femoral neck . The incidence of proximal deep-vein thrombosis as assessed by Doppler ultrasonography was 23 % in the control group and 0 % in those using the device ( p less than 0.01 ) . Calf and thigh circumferences were measured in both groups at seven to ten days after operation . In the treatment group there was a mean relative reduction of postoperative swelling of the thigh by 3.27 cm ( p less than 0.001 ) and of the calf by 1.55 cm ( p less than 0.001 ) . The A-V Impulse System appears to be a safe and effective method of reducing the incidence of proximal deep-vein thrombosis , and of postoperative swelling .

A-V Impulse System

A-V Impulse System

Doppler ultrasonography

safe

postoperative swelling

deep-vein thrombosis

hemiarthroplasty for hip fracture


Human achaete-scute homologue ( hASH1 ) mRNA level as a diagnostic marker to distinguish esthesioneuroblastoma from poorly differentiated tumors arising in the sinonasal tract . Distinction of high-grade esthesioneuroblastomas from other poorly differentiated tumors arising in the nasal cavity is an important diagnostic challenge because it determines patient management and prognosis . The human achaete-scute homologue ( hASH1 ) gene is critical in olfactory neuronal differentiation and is expressed in immature olfactory cells ; therefore , it could have potential use as a diagnostic marker The aim of the present study was to determine the value of hASH1 messenger RNA ( mRNA ) levels in differentiating esthesioneuroblastoma from other poorly differentiated tumors . A real-time polymerase chain reaction assay was developed , permitting the comparative determination of hASH1 mRNA levels in triplicate in a double-blind pilot study including 24 frozen cases of esthesioneuroblastoma and poorly differentiated tumors . All 4 positive cases were esthesioneuroblastomas , and all 19 poorly differentiated tumors were negative . In addition , there was an inverse association between the grade of esthesioneuroblastomas and hASH1 mRNA levels . The hASH1 mRNA level might represent a useful tool for distinguishing esthesioneuroblastoma from poorly differentiated tumors of the sinonasal region .

hASH1 mRNA levels

esthesioneuroblastomas

grade of esthesioneuroblastomas

esthesioneuroblastoma

tumors

esthesioneuroblastomas


Helicobacter pylori eradication in children and adolescents by a once daily 6-day treatment with or without a proton pump inhibitor in a double-blind randomized trial . AIM To evaluate two simplified Helicobacter pylori eradication treatment alternatives for children and adolescents . METHODS Study subjects were identified by enzyme-linked immunosorbent assay and immunoblot in a family screening project . Helicobacter pylori infected 10-21 year olds were offered treatment , individuals with abdominal pain underwent upper endoscopy and those with peptic ulcers were excluded . Participants were randomized to either azithromycin 500 mg daily and tinidazole 500 mg two tablets daily in combination with lansoprasole 30 mg daily for 6 days ( ATL-group ) or with placebo ( ATP-group ) . Urea Breath Test was performed at inclusion and after a minimum of 6 weeks after end of therapy . RESULTS In total , 131 individuals were randomized , of whom 31 ( 24 % ) had undergone upper endoscopy . Full compliance was achieved in 93 % ( 122 of 131 ) . The intention-to-treat eradication rate was 67 % ( 44 of 66 ) and 58 % ( 38 of 65 ) for the ATL- and the ATP-group , respectively . CONCLUSION The double-blind randomized clinical trial did not identify a simplified , successful once daily H. pylori treatment for children and adolescents . Thus , twice daily proton pump inhibitor ( PPI ) -based triple therapies for 7 days remain as the choice of treatment in children . Further , powerful and controlled studies are needed to elucidate the best treatment strategies for H. pylori eradication in this age group .

placebo ( ATP-group )

Urea Breath Test

Helicobacter pylori eradication

Helicobacter pylori eradication

Full compliance

intention-to-treat eradication rate

Helicobacter pylori eradication in

children

and

adolescents

children

adolescents

Helicobacter pylori

abdominal pain

peptic ulcers

31 ( 24 % )

children

adolescents

children


Effect of the motilin agonist KC 11458 on gastric emptying in diabetic gastroparesis . BACKGROUND KC 11458 , a motilin agonist without antibiotic properties , accelerates gastric emptying in animals and healthy humans . AIM To evaluate the acute effects of KC 11458 on gastric emptying in diabetic gastroparesis . METHODS Twenty-nine patients ( 6 type 1 and 23 type 2 ) with gastroparesis underwent assessments of : ( i ) gastric emptying of a solid/liquid meal using scintigraphy , ( ii ) glycaemic control ( blood glucose at 0 , 30 , 60 , 90 and 120 min during the gastric emptying measurement ) and ( iii ) upper gastrointestinal and 'meal-related ' symptoms ( questionnaire ) , at baseline and after treatment with KC 11458 in a dose of 8 mg t.d.s. , or placebo for 8 days . RESULTS KC 11458 had no statistically significant or clinically relevant effect on gastric emptying of either the solid intragastric retention at 100 min ( T100 ) ( P = 0.87 ) or liquid 50 % emptying time ( T50 ) ( P = 0.17 ) components of the meal . KC 11458 slightly worsened ( P = 0.04 ) upper gastrointestinal symptoms when compared with placebo . The magnitude of the change in solid gastric emptying correlated with the change in the blood glucose concentration ( r = 0.49 ; P < 0.05 ) . CONCLUSIONS KC 11458 , in a dose of 8 mg t.d.s . for 8 days , does not accelerate gastric emptying in patients with diabetic gastroparesis . The absence of efficacy may relate to an effect of hyperglycaemia .

KC 11458

KC 11458

KC 11458

KC 11458

placebo

KC 11458

KC 11458

placebo

KC 11458

gastric emptying

gastric emptying

upper gastrointestinal symptoms

solid gastric emptying

blood glucose concentration

gastric emptying

healthy humans .

Twenty-nine

gastroparesis


Gabapentin for the prevention of postoperative pain after vaginal hysterectomy . Gabapentin alleviates and/or prevents acute nociceptive and inflammatory pain both in animals and volunteers , especially when given before trauma . Gabapentin might also reduce postoperative pain . To test the hypothesis that gabapentin reduces the postoperative need for additional pain treatment ( postoperative opioid sparing effect of gabapentin in humans ) , we gave 1200 mg of gabapentin or 15 mg of oxazepam ( active placebo ) 2.5 h prior to induction of anaesthesia to patients undergoing elective vaginal hysterectomy in an active placebo-controlled , double blind , randomised study . Gabapentin reduced the need for additional postoperative pain treatment ( PCA boluses of 50 microg of fentanyl ) by 40 % during the first 20 postoperative hours . During the first 2 postoperative hours pain scores at rest and worst pain score ( VAS 0-100 mm ) were significantly higher in the active placebo group compared to the gabapentin-treated patients . Additionally , pretreatment with gabapentin reduced the degree of postoperative nausea and incidence of vomiting/retching possibly either due to the diminished need for postoperative pain treatment with opioids or because of an anti-emetic effect of gabapentin itself . No preoperative differences between the two groups were encountered with respect to the side effects of the premedication . However , 15 mg oxazepam was more effective in relieving preoperative anxiety than 1200 mg gabapentin .

Gabapentin

Gabapentin

Gabapentin

gabapentin

gabapentin

gabapentin

oxazepam (

active placebo

elective vaginal hysterectomy

Gabapentin

placebo

gabapentin-treated

gabapentin

gabapentin

oxazepam

gabapentin

postoperative pain

acute nociceptive and inflammatory pain

postoperative pain

postoperative pain treatment

pain scores at rest

worst pain score

degree of postoperative

postoperative pain

effective

preoperative anxiety

postoperative pain

vaginal hysterectomy


[ Tension-free laparoscopic versus open inguinal hernia repair ] . AIM During the last decade laparoscopic techniques have been applied to the treatment of inguinal hernia to combine tension-free technique , esthetic , and functional benefits of mini-invasive surgery . Anyway controversy persists regarding the most effective inguinal hernia repair . The aim of this study is to compare the open technique and the laparoscopic approach concerning : complications , recurrences , recovery time and return to usual activity . METHODS A randomized prospective analysis of 121 consecutive inguinal hernia repairs was performed over a 12-month period . Male well-informed patients with primary monolateral inguinal hernia ( ASA I-II ) were divided into 2 groups and consecutively treated ; group A was treated with laparoscopic transabdominal preperitoneal approach ( TAPP ) ( median age 47+/-7 years , 57 patients ) , group B with open mesh herniorrhaphy ( 45+/-6 years , 64 patients ) . RESULTS Complication rate was 5.26 % for group A ( none needed conversion ) and 4.68 % for group B . All complications were considered minor . No recurrences were observed over a 12-month follow-up in both groups . Post-operative hospital stay and return to activity show statistically significant differences . Median post-hospital stay was 1.7 days for group A while it was longer ( 2.9 days ) for group B . Significant difference was observed in the duration of convalescence too ( group A 9.3+/-7.2 days ; group B 12.1+/-7 . 1 days ) . CONCLUSION On the basis of our experience , even if a longer follow-up is needed , the validity of laparoscopic approach to inguinal hernia is confirmed . General anesthesia and higher costs are reasonable compromises for a shorter period of discomfort in patients with a low ASA index and busy job/sport activity .

open inguinal hernia repair ]

inguinal hernia repairs

open mesh herniorrhaphy

inguinal hernia

complications

Complication rate

recurrences

Median post-hospital stay

duration of convalescence

period of discomfort

randomized prospective analysis of

Male


[ Structural and immunohistochemical changes of conjunctiva induced by topical glaucoma medication ] . PURPOSE The topical medication represents the first line therapy for the primary open angle glaucoma . The study is aimed at assessing the structural and immunohistochemical changes of conjunctiva induced by topical glaucoma medication . METHODS For this purpose , we carried out a 40 weeks , prospective , experimental , epidemiological-operational and randomized study enrolling 18 patients ( 36 eyes ) with recently primary open angle glaucoma . The eyes were divided into treatment ( non-selective beta blockers or selective , prostaglandin analogues , topical carbonic anhydrase inhibitors ) in four groups . The assessment was performed by comparison with control group ( 4 patients ) who was instilled with natural tears ( with different preservative ) . Both the cytology and the conjunctival biopsy specimens were investigated by histological exams and immunohistochemistry using different monoclonal antibodies . The study was performed by collaboration with The National Institute of Research and Development in Pathology and Biomedical Sciences- " V. Babes " -Bucharest . RESULTS The morphometric analysis of histological sections of conjunctiva showed the following changes : squamous metaplasia ( significant increases in the thickness and number of epithelial cell layers ) , inflammation ( increase the number of lymphocytes , macrophages and fibroblasts ) and subconjunctival fibrosis . According to the type of medication , we observed the significant increase of subepithelial collagen density and degenerative changes of fibrocytes , the reduction of extracellular matrix and also the up-regulation of antibodies against matrix metalloproteinase and allergic changes . According to structural changes , the immunohistochemistry confirmed the tendency of chronic inflammation . CONCLUSIONS This study revealed important structural and immunohistochemical changes of conjunctiva after topical glaucoma medication . The category and the intensity of these changes are dependent on the sort of therapy and the topical treatment period . The findings showed that benzalkonium chloride ( the most common preservative of antiglaucoma drugs ) is a major factor for conjunctival metaplasia .

topical medication

topical glaucoma medication

control

natural tears

topical glaucoma medication

squamous metaplasia

chronic inflammation .

conjunctiva

18 patients

primary open angle glaucoma

4 patients

natural tears


Long-term quality of life measures after functional endoscopic sinus surgery . BACKGROUND Chronic rhinosinusitis ( CRS ) is a common disease that has a significant impact on quality of life ( QOL ) . The aim of this study was to evaluate the longer-term effects of combined medical and surgical therapy for CRS on overall health status and QOL . METHODS We used a prospective study that utilized the Short-Form 36 Survey at baseline presentation and at a mean time of 3 years post-functional endoscopic sinus surgery to assess the general health status of patients who presented for their initial visitfrom 1996 to 1998 . Of the 200 randomly selected patients , 150 respondents completed follow-up surveys ( a 75 % response rate ) . RESULTS Eighty-nine ( 59.3 % ) women and 61 ( 40.7 % ) men were included in the study . Baseline QOL scores indicated significant differences between patients with CRS and published norms in 6/8 subscale parameters ( role physical , bodily pain , general health , social function , vitality , and mental health ) . Significant improvement in all six categories was maintained at the end of the study period ( p < 0.05 ) with QOL scores within limits of published norms for the general population . CONCLUSION Our data indicate that functional endoscopic sinus surgery , combined with appropriate postoperative care , is effective at maintaining a significant improvement in the overall general health status of patients for at least 3 years after surgical intervention and that the overall scores return to a range of normative values for the general population .

surgical therapy

Short-Form 36 Survey

baseline presentation

endoscopic sinus surgery

endoscopic sinus surgery

Long-term quality of life

quality of life

Baseline QOL scores

role physical , bodily pain

general health

social function

vitality

mental health

QOL scores

Chronic rhinosinusitis ( CRS )

CRS

Eighty-nine ( 59.3 % )

61 ( 40.7 % )

CRS


An evaluation of an adaptive automation system using a cognitive vigilance task . The performance of an adaptive automation system was evaluated using a cognitive vigilance task . Participants responded to the presence of a green " K " in an array of two , five , or nine distractor stimuli during a 40-min vigil . The array with the target stimulus was presented once each minute . Participants EEG was recorded and an engagement index ( EI = 20 x beta/ ( alpha + theta ) ) was derived . In the negative feedback condition , increases in the EI caused the number of stimuli in the array to decrease while decreases in the EI caused the number of stimuli to increase . For the positive feedback condition , increases in the index caused an increase in the array size ( AS ) while decreases caused a decrease in the array size . Each experimental participant had a yoked control partner who received the same pattern of changes in array irrespective of their engagement index . A vigilance decrement was seen only for the positive feedback , experimental group .

adaptive automation system

cognitive vigilance task

adaptive automation system

EEG

engagement index

number of stimuli in the array

EEG

participant had a yoked control partner

experimental group


Concomitant radiochemotherapy vs radiotherapy alone in patients with head and neck cancer : a Hellenic Cooperative Oncology Group Phase III Study . The primary objective of the present randomized phase III trial was to compare the 3-yr survival rate of patients treated with standard fractionated radiotherapy ( RT ) alone or with the same RT concomitantly with cisplatin ( DDP ) or carboplatin ( Cb ) . From January 1995 until July 1999 , 124 patients with histologically proven locally advanced non-nasopharyngeal head and neck cancer ( HNC ) were randomized to receive either RT monotherapy ( 70 Gy , Group A ) or the same RT concomitantly with DDP ( 100 mg/m2 on d 2 , 22 , 42 , Group B ) or Cb ( 7 AUC on d 2 , 22 , 42 , Group C ) . There were no significant differences in complete response rates between patients treated with RT alone or combined chemoradiotherapy . However , median time to progression ( TTP ) and overall survival ( OS ) were significantly longer in patients treated with concomitant chemoradiotherapy . Thus , median TTP was 6.3 , 45.2 , and 17.7 mo in groups A , B , and C respectively ( p = 0.0002 ) . Similarly , median OS was 12.2 , 48.6 , and 24.5 mo , respectively ( p = 0.0003 ) . At 3 yr follow-up , 17.5 % of patients in group A were alive compared to 52 % in group B and 42 % in group C ( p < 0.001 ) . Patients treated with concomitant chemoradiotherapy experienced more frequently severe hematological toxicity . Also , severe nausea/vomiting was more pronounced in group B , as expected . The present study clearly demonstrated that concomitant chemoradiotherapy with platinum analogs significantly prolongs 3-yr survival and median OS in patients with locally advanced HNC compared to conventional RT alone .

Concomitant radiochemotherapy

radiotherapy alone

cisplatin ( DDP )

carboplatin ( Cb )

RT monotherapy

RT concomitantly with DDP

Cb

chemoradiotherapy

concomitant chemoradiotherapy

concomitant chemoradiotherapy

3-yr survival rate

complete response rates

median time to progression ( TTP )

overall survival ( OS )

median TTP

median OS

alive

severe hematological toxicity

severe nausea/vomiting

3-yr survival

median OS


Gonadotropin-releasing hormone agonist with or without raloxifene : effects on cognition , mood , and quality of life .

Gonadotropin-releasing hormone agonist

raloxifene

cognition , mood

, and quality of life .


Randomized , double-blind , placebo-controlled trial of oral sirolimus for restenosis prevention in patients with in-stent restenosis : the Oral Sirolimus to Inhibit Recurrent In-stent Stenosis ( OSIRIS ) trial . BACKGROUND Despite recent advances in interventional cardiology , including the introduction of drug-eluting stents for de novo coronary lesions , the treatment of in-stent restenosis ( ISR ) remains a challenging clinical issue . Given the efficacy of systemic sirolimus administration to prevent neointimal hyperplasia in animal models and to halt and even reverse the progression of allograft vasculopathy , the aim of the present double-blind , placebo-controlled study was to evaluate the efficacy of a 10-day oral sirolimus treatment with 2 different loading regimens for the prevention of recurrent restenosis in patients with ISR . METHODS AND RESULTS Three hundred symptomatic patients with ISR were randomly assigned to 1 of 3 treatment arms : placebo or usual-dose or high-dose sirolimus . Patients received a cumulative loading dose of 0 , 8 , or 24 mg of sirolimus 2 days before and the day of repeat intervention followed by maintenance therapy of 2 mg/d for 7 days . Angiographic restenosis at 6-month angiography was the primary end point of the study . Restenosis was significantly reduced from 42.2 % to 38.6 % and to 22.1 % in the placebo , usual-dose , and high-dose sirolimus groups , respectively ( P=0.005 ) . Similarly , the need for target vessel revascularization was reduced from 25.5 % to 24.2 % and to 15.2 % in the placebo , usual-dose , and high-dose groups , respectively ( P=0.08 ) . The sirolimus blood concentration on the day of the procedure correlated significantly with the late lumen loss at follow-up ( P < 0.001 ) . CONCLUSIONS In patients with ISR , an oral adjunctive sirolimus treatment with an intensified loading regimen before coronary intervention resulted in a significant improvement in the angiographic parameters of restenosis .

placebo-controlled

Sirolimus

placebo

usual-dose or high-dose sirolimus

6-month angiography

restenosis

neointimal hyperplasia

Restenosis

The sirolimus blood concentration

angiographic parameters of restenosis .

in-stent restenosis

ISR

Three hundred

symptomatic patients with ISR


Minocycline safety and tolerability in Huntington disease . Minocycline is an antibiotic with anti-inflammatory and antiapoptotic properties that prolongs survival in a transgenic Huntington disease ( HD ) mouse model . In a double-blind , randomized , placebo-controlled study of minocycline in 60 HD patients , the authors determined that over 8 weeks , minocycline at 100 and 200 mg/day was well tolerated and safe in HD patients . Tolerability and adverse event frequency were similar between treatment and placebo groups .

Minocycline

Minocycline

placebo-controlled

minocycline

minocycline at 100 and 200 mg/day

safety and tolerability

well tolerated and safe

Tolerability

adverse event frequency

Huntington disease

Huntington disease

HD

HD

HD


IV amantadine improves chorea in Huntington 's disease : an acute randomized , controlled study .

IV amantadine

chorea in Huntington 's disease


A randomised comparison of UK genetic risk counselling services for familial cancer : psychosocial outcomes . The aim of the study was to compare psychosocial outcomes for 50 new clinic attendees , referred for cancer genetic counselling to five UK centres . The centres represented England , Scotland and Wales , and were randomly selected from groups ranked by different levels of clinical activity in cancer genetics practice . Questionnaires assessed demographic data , risk perception , mental health and use of health services pre-consultation and at 1 and 12 months follow-up . Satisfaction was measured for attendees and referring doctors at follow-up . A total of 256 unaffected adults fulfilled the study criteria . The five centres varied widely with respect to service organisation and activity , but all had a greater proportion of unaffected attendees with a breast cancer risk ( 61-91 % ) than either a bowel cancer risk ( 0-33 % ) or ovarian cancer risk ( 3-25 % ) . There were no significant differences in the psychosocial data between centres pre-counselling . No significant change over time occurred for any of the centres for risk perception or general psychological distress . There were significant differences between centres in reduction of cancer worry from baseline to 12 months and with the number of women who were recommended to have mammographic surveillance who had not received this . Overall , one-third of women for whom mammography had been recommended had not been screened within 1 year of follow-up . Subsequent attendance at the GP , but not at a hospital , was associated with risk level , but differences between centres could not be analysed . Satisfaction differed significantly between centres for 4 : 14 aspects of service provision and with 3 : 17 items concerning communication ; satisfaction was high overall . Over 90 % of referring doctors were moderately/very satisfied with the service , but 23 % were dissatisfied with waiting times and 19 % with access to preventive treatment . Results differed significantly between centres for doctor 's satisfaction with the provision of referral criteria and prescribing information . In conclusion , there were relatively few significant differences in psychosocial outcomes between centres , considering the wide variation in service organisation and activity . These significant differences were not consistent across the centres , therefore , differences could not be linked to specific aspects of service provision .

UK genetic risk counselling services

cancer genetic counselling

pre-counselling

psychosocial outcomes .

psychosocial outcomes

demographic data

risk perception

mental health

use of health services pre-consultation

Satisfaction

psychosocial data

risk perception

general psychological distress

cancer

Satisfaction

psychosocial outcomes


Once-daily versus twice-daily lamivudine , in combination with zidovudine and efavirenz , for the treatment of antiretroviral-naive adults with HIV infection : a randomized equivalence trial . A randomized , double-blind , double-dummy controlled , multicenter trial was conducted that involved 554 antiretroviral-naive human immunodeficiency virus-infected adults ( plasma HIV type 1 [ HIV-1 ] RNA level , > or=400 copies/mL ; CD4 ( + ) cell count , > 100 cells/mm ( 3 ) ) and compared a 300-mg once-daily ( q.d . ) regimen of lamivudine ( 3TC ) versus a 150-mg twice-daily ( b.i.d . ) regimen of 3TC , combined with zidovudine ( 300 mg b.i.d . ) and efavirenz ( 600 mg q.d . ) , during a 48-week period . Treatments were considered equivalent if the 95 % confidence interval ( CI ) for the difference in proportions of patients achieving an HIV-1 RNA level of < 400 copies/mL was within the bound of -12 % to 12 % . At week 48 of the study , an intent-to-treat analysis in which patients with missing data were considered to have experienced treatment failure showed that the 3TC q.d . and 3TC b.i.d . regimens were equivalent ( HIV-1 RNA level < 400 copies/mL , 178 [ 64 % ] of 278 vs. 174 [ 63 % ] of 276 ; treatment difference , 1 % [ 95 % CI , -7.1 % to 8.9 % ] ; HIV-1 RNA level < 50 copies/mL , 165 [ 59 % ] of 278 vs. 168 [ 61 % ] of 276 ; treatment difference , 1.7 % [ 95 % CI , -9.7 % to 6.6 % ] ) . Median increase above baseline in CD4 ( + ) cell count was similar ( q.d . group , +144 cells/mm ( 3 ) ; b.i.d . group , +146 cells/mm ( 3 ) ) , and the incidences of adverse events , disease progression , and HIV-associated conditions were comparable .

lamivudine ( 3TC )

equivalence

equivalent

HIV-1 RNA level of < 400 copies/mL

failure

antiretroviral-naive

adults

HIV infection

human immunodeficiency virus-infected

adults


A comparison of the effects of anticholinergic and beta 2-agonist and combination therapy on respiratory impedance in COPD . The effects of three different regimens of inhaled bronchodilators on spirometry and respiratory impedance as measured with the technique of forced oscillations were compared in a double-blind crossover study in 22 patients with stable chronic obstructive pulmonary disease ( FEV1 less than 70 percent predicted ) . On three trial days , patients inhaled , in random order , 40 micrograms ipratropium bromide , 200 micrograms fenoterol hydrobromide , or a combination of 40 micrograms ipratropium and 100 micrograms fenoterol from a powder inhaler , followed by a second dose of the same drug after 60 min . The effects were measured at baseline and 20 , 40 , 60 , and 120 min after the first inhalation . No significant decrease in total respiratory resistance at 8 Hz ( Rrs [ 8 ] ) was observed after ipratropium , whereas Rrs ( 8 ) decreased significantly 20 min after fenoterol and 40 min after the combination regimen ( p less than 0.05 ) . All three studied drugs resulted in a significant increase in the reactance ( p less than 0.01 ) and decrease in resonant frequency . Both fenoterol ( delta FEV1 34 percent , p less than 0.0001 ) and the combination regimen ( delta FEV1 38 percent , p less than 0.0001 ) resulted in a significantly larger increase in FEV1 than ipratropium alone ( delta FEV1 17 percent , p less than 0.0001 ) . A second dose of fenoterol and of the combination regimen resulted in a further significant increase in FEV1 after 120 min ( p less than 0.05 ) . A second dose of ipratropium did not result in a further significant increase in FEV1 . The changes in respiratory impedance were qualitatively similar for all three drug regimens , but larger in absolute terms after fenoterol and the combination regimen than after ipratropium . The similar effect of these drugs on the reactance can be explained by an increase in the capacitance of the respiratory system , and in combination with a decrease in frequency dependence of resistance , by assuming a decrease in peripheral airway resistance .

anticholinergic and beta 2-agonist

combination therapy

inhaled bronchodilators

ipratropium bromide

fenoterol hydrobromide

ipratropium

fenoterol

combination regimen

combination regimen

ipratropium

fenoterol

combination regimen

ipratropium

fenoterol

combination regimen

ipratropium

reactance ( p less than 0.01 )

resonant frequency

second dose

capacitance of the respiratory system

COPD

FEV1 less than 70 percent predicted


Rye bran bread intake elevates urinary excretion of ferulic acid in humans , but does not affect the susceptibility of LDL to oxidation ex vivo . BACKGROUND Rye bread contributes an important part of the whole grain intake in the Scandinavian diet . Ferulic acid is the major phenolic compound in rye bran and is an antioxidant in vitro and may , therefore , contribute to cardioprotective effects of whole grain consumption . AIM OF THE STUDY Firstly , to evaluate the bioavailability and potential antioxidative effects in humans of ferulic acid from rye . Secondly , to evaluate urine levels of ferulic acid as a possible biomarker of the ordinary dietary intake of ferulic acid . METHODS We determined the urinary excretion of ferulic acid in 18 postmenopausal women after a dietary intake of rye bran or an inert wheat bran ( control ) in a crossover study ( 2 x 6 weeks with 4 weeks washout ) . The potential antioxidative effect of the rye bran intervention was investigated by measuring low-density lipoprotein ( LDL ) susceptibility to copper oxidation ex vivo . The subjects ingested rye bran enriched breads equivalent to approximately 10.2 mg ferulic acid per day . RESULTS The urinary excretion of ferulic acid averaged approximately 4.8 mg per day during intervention with rye bran breads and approximately 1.9 mg per day on the control breads ( P = 0.002 ) . Rye bran intervention had no influence on lag time or propagation rate of the LDL oxidation ex vivo . CONCLUSIONS The present study demonstrated that ferulic acid from rye bran is bioavailable and that the urinary concentration of ferulic acid reflects the dietary intake of this hydroxycinnamic acid . Within the period of intervention , the elevated ferulic acid did not produce a measurable antioxidative effect on the subjects ' LDL . It is suggested that the determination of ferulic acid in urine is a useful biomarker to assess the intake of ferulic acid from a regular diet .

Rye bran bread intake

Rye bread

dietary intake of rye bran

an inert wheat bran ( control )

rye bran breads

control breads

Rye bran intervention

urinary excretion of ferulic acid

susceptibility of LDL to oxidation

bioavailability

and

potential antioxidative effects

urine levels of ferulic acid

urinary excretion of ferulic acid

urinary excretion of ferulic acid

antioxidative effect

intake of ferulic acid


Caudal neostigmine with bupivacaine produces a dose-independent analgesic effect in children . PURPOSE To evaluate the analgesic efficacy and duration of varying doses of caudal neostigmine with plain bupivacaine and its side effects in children undergoing genito-urinary surgery . METHODS In a randomized double-blind prospective study 80 boys aged two to eight years scheduled for surgical repair of hypospadias were allocated randomly to one of four groups ( n = 20 each ) and received either only caudal 0.25 % plain bupivacaine 0.5 mL.kg ( -1 ) ( Group I ) or 0.25 % plain bupivacaine 0.5 mL.kg ( -1 ) with neostigmine ( Groups II-IV ) in doses of 2 , 3 and 4 microg.kg ( -1 ) respectively . Postoperative pain was assessed for 24 hr using an objective pain score . Blood pressure , heart rate , oxygen saturation , total amount of analgesic consumed and adverse effects were also recorded . RESULTS The duration of postoperative analgesia in Group I ( 5.1 +/- 2.3 hr ) was significantly shorter than in the other three groups ( II -16.6 +/- 4.9 hr ; III - 17.2 +/- 5.5 hr ; IV - 17.0 +/- 5.8 hr ; P < 0.05 ) . Total analgesic ( paracetamol ) consumption was significantly more in Group I ( 697.6 +/- 240.7 mg ) than in the groups receiving caudal neostigmine ( II - 248.0 +/- 178.4 ; III - 270.2 +/- 180.8 and IV -230.6 +/- 166.9 mg ; P < 0.05 ) . Groups II , III and IV were comparable with regards to duration of postoperative analgesia and total analgesic consumption ( P > 0.05 ) . Incidence of nausea and vomiting were comparable in all four groups . No significant alteration in vital signs or any other adverse effects were observed . CONCLUSIONS Caudal neostigmine ( 2 , 3 and 4 microg.kg ( -1 ) ) with bupivacaine produces a dose-independent analgesic effect ( approximately 16-17 hr ) in children as compared to those receiving caudal bupivacaine alone ( approximately five hours ) and a reduction in postoperative rescue analgesic consumption without increasing the incidence of adverse effects .

Caudal neostigmine with bupivacaine

only caudal

plain bupivacaine

( paracetamol )

neostigmine

Caudal neostigmine

bupivacaine

bupivacaine

evaluate

analgesic efficacy and duration

Postoperative pain

objective pain score .

adverse effects

duration of postoperative analgesia

nausea

vomiting

vital signs

analgesic effect

adverse effects

children

children

undergoing genito-urinary surgery .

two to eight


Evaluation of additional amine fluoride/stannous fluoride-containing mouthrinse during supportive therapy in patients with generalized aggressive periodontitis . A randomized , crossover , double-blind , controlled trial . OBJECTIVES The objective of the present randomized controlled trial was to evaluate the efficacy of a mouthrinse containing a combination of AmF/SnF2 in controlling supragingival plaque accumulation and gingival inflammation during a 12-week period in patients affected by generalized aggressive periodontitis ( GAP ) . METHODS Eighteen subjects , six males and 12 females , mean age : 32.2 years , were evaluated . One-half of the patients was either prescribed an AmF/SnF2-containing mouthrinse ( test mouthrinse ) or a control mouthrinse in addition to mechanical plaque control for 12 weeks . After a 2-week wash-out period , the patients received the alternative mouthrinse . Before and after treatment plaque index ( PlI ) , gingival index ( GI ) , angulated bleeding index ( AngBI ) , tooth stain ( GMSI ) , and tongue stain were recorded . RESULTS Test mouthrinse resulted in a statistically significant decrease in PlI ( p = 0.029 ) and GI ( p = 0.017 ) . After treatment , PlI was significantly lower in test compared to control mouthrinse ( p = 0.027 ) . GMSI significantly increased post-treatment for both mouthrinse regimens ( p < 0.001 ) , a significantly higher score being observed for the test compared to control mouthrinse ( p = 0.002 ) . CONCLUSIONS The 12-week use of a AmF/SnF2-containing mouthrinse as an adjunct to conventional mechanical oral hygiene procedures in GAP patients was effective in controlling the amount of supragingival plaque deposits .

AmF/SnF2-containing mouthrinse

control mouthrinse

mechanical plaque control

mouthrinse .

Test mouthrinse

mouthrinse regimens

control mouthrinse

AmF/SnF2-containing mouthrinse

plaque index ( PlI )

gingival index ( GI )

angulated bleeding index ( AngBI )

tooth stain ( GMSI )

tongue stain

PlI

PlI

GMSI

generalized aggressive periodontitis

Eighteen

six

males

females

mean age : 32.2 years

GAP


Risk factors for fracture in a UK population : a prospective cohort study . BACKGROUND Common clinical risk factors for fracture in older women have been identified . To date , most of these risk factors have not been confirmed in a UK population . AIM To confirm the important risk factors for fracture in older women . DESIGN Comprehensive cohort study ( CCS ) with a nested randomized controlled trial . METHODS The CCS included 4292 women aged > 70 years . We assessed potential risk factors for fracture , and followed-up participants for 24 months for incidence of non-vertebral fractures . RESULTS Odds ratios ( ORs ) for predicting any non-vertebral fracture were : previous fracture , 2.67 ( 95 % CI 2.10-3.40 ) ; a fall in the last 12 months , 2.06 ( 95 % CI 1.63-2.59 ) ; and age ( per year increase ) , 1.03 ( 95 % CI 1.01-1.05 ) . ORs for predicting hip fracture were : previous fracture , 2.31 ( 95 % CI 1.31-4.08 ) ; low body weight ( < 58 kg ) , 2.20 ( 95 % CI 1.28-3.77 ) ; maternal history of hip fracture , 1.68 ( 95 % CI 0.85-3.31 ) ; a fall in the last 12 months , 2.92 ( 95 % CI 1.70-5.01 ) ; and age ( per year increase ) , 1.09 ( 95 % CI 1.04-1.13 ) . ORs for predicting wrist fracture were : previous fracture , 2.29 ( 95 % CI 1.56-3.34 ) ; and a fall in the last 12 months , 1.60 ( 95 % CI 1.10-2.31 ) . Being a current smoker was not associated with an increase in risk , and was consistent across all fracture types . DISCUSSION Older women with the clinical risk factors identified in this study should be investigated for osteoporosis or offered preventive treatment .

Risk factors for fracture

cohort study .

risk factors for fracture

risk factors for fracture

Comprehensive cohort study ( CCS )

controlled trial .

CCS

risk factors for fracture

previous fracture

a fall in the last 12 months

age

previous fracture

low body weight

maternal history of hip fracture

a fall in the last 12 months

age

previous fracture

a fall in the last 12 months

current smoker


Ropinirole as a treatment of restless legs syndrome in patients on chronic hemodialysis : an open randomized crossover trial versus levodopa sustained release . OBJECTIVE Restless legs syndrome ( RLS ) is a common neurologic condition characterized by uncomfortable and unpleasant sensations in the legs , occurring primarily at rest , which are usually worse in the evening and are alleviated by movement . RLS is present in 20-40 % of patients with renal failure . This study was a 14-week open , randomized , crossover trial of ropinirole vs. levodopa sustained release ( SR ) in 11 patients with RLS on chronic hemodialysis . METHODS Eleven patients ( 7 men , 4 women ) were enrolled in the study . They received either levodopa SR or ropinirole for 6 weeks , followed by a washout week , then the alternate treatment for 6 weeks . Patients rated the severity of RLS by means of a 6-item questionnaire developed by the International Restless Legs Study Group ( 6-item IRLS ) , by the Clinical Global Impression ( CGI ) scale , and by sleep diaries . RESULTS Under treatment with levodopa SR , 1 patient presented severe vomiting , leading to study discontinuation . The 10 patients who completed the study reported a 33.5 % improvement ( from 16.7 +/- 3.2 to 11.1 +/- 4 ; P < 0.001 ) of the 6-item IRLS scores during levodopa SR treatment and a 73.5 % improvement ( from 16.6 +/- 2.8 to 4.4 +/- 3.8 ; P < 0.001 ) during ropinirole treatment . By the end of the study the mean levodopa SR dosage was 190 mg/d and the mean ropinirole dosage was 1.45 mg/d . Ropinirole was superior to levodopa SR in reducing 6-item IRLS scores ( P < 0.001 ) and in increasing sleep time ( P < 0.001 ) . The patient CGI scale showed a significant difference favoring ropinirole ( P < 0.01 ) . There was no significant carryover or period effect for any outcome measure . Four patients reported a complete reversion of RLS symptoms during ropinirole treatment at doses ranging from 0.25-2 mg/d . CONCLUSIONS These results suggest that ropinirole is more effective than levodopa SR in the treatment of RLS in patients on chronic hemodialysis .

Ropinirole

levodopa sustained release

ropinirole

levodopa sustained release ( SR )

levodopa SR

ropinirole

alternate treatment

Ropinirole

levodopa SR

severity of RLS

severe vomiting

sleep time

CGI scale

RLS symptoms

renal failure

men

women

who completed the study