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Background : Obsessive-compulsive disorder ( OCD ) is a common psychiatric illness in children and adolescents . Previous evidence suggests that fluoxetine is effective in the treatment of OCD in children and adolescents . However , those studies had small sample sizes . As a result , a systematic review , which is a more powerful method to calculate the true effect size , can be applied to examine the efficacy , acceptability and tolerability of fluoxetine in the treatment of OCD in children and adolescents . Objectives : The aims of this study were to review the efficacy , acceptability and tolerability of fluoxetine in the treatment of OCD in children and adolescents . Study appraisal and synthesis methods : The titles and abstract s collected from electronic data bases were evaluated . Then , the full-text versions of relevant studies were thoroughly assessed and extracted . Results : A total of 188 r and omized patients in three RCTs of fluoxetine versus placebo and one RCT of fluoxetine versus citalopram were included in this review . Considering efficacious outcomes , the pooled mean change score of the CY-BOCS in the fluoxetine-treated group was significantly greater than that in the placebo-treated group . Additionally , the CGI-S in the fluoxetine-treated group and the pooled mean change score of the NIMH-OC were also significantly different from those in the placebo-treated group . Limitation : This review included studies with small sample sizes . Conclusions and implication s of key findings : Fluoxetine is associated with a significantly greater reduction in OCD severity , as measured by the CY-BOCS , NIMH-OC and CGI-S , in children and adolescents . Additionally , it is well tolerated in children and adolescents . The acceptability is comparable to that of the placebo-treated group . Nonetheless , further large prospect i ve trials should be conducted to confirm these outcomes
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"It has been suggested that the clinical efficacy of chronic treatment with selective serotonin reuptake inhibitors ( SSRIs ) such as fluoxetine and perhaps all antidepressants is due to their ability to enhance serotonergic activity . The effects of chronic treatment with fluoxetine or tricyclic antidepressants on the L-5-hydroxytryptophan ( 200 mg , L-5-HTP ; PO)–induced increases in plasma cortisol and prolactin ( PRL ) concentrations were studied in patients with major depression or obsessive compulsive disorder ( OCD ) . Administration of L-5-HTP increased plasma cortisol and PRL levels in medicated and unmedicated patients with major depression or OCD . The L-5-HTP – induced cortisol and PRL responses were significantly higher in fluoxetine-treated than in tricyclic-treated or unmedicated major depressed patients . The latter two groups did not differ significantly in their cortisol or PRL responses to L-5-HTP . The L-5-HTP – induced increases in cortisol and PRL in fluoxetine-treated patients with major depression or OCD were not significantly different . The results suggest that fluoxetine , but not tricyclic antidepressants , potentiates 5-HT receptor – mediated stimulation of cortisol and PRL secretion in humans , consistent with available evidence that fluoxetine treatment , but not tricyclic antidepressants , increases central serotonergic activity in patients with MD or OCD by a presynaptic mechanism",
"Rigorously design ed clinical trials have demonstrated the efficacy and safety of fluoxetine in adults with major depressive disorder and obsessive-compulsive disorder ( OCD ) but not in patients below 18 years old . This report describes a r and omized , double-blind , placebo-controlled , fixed-dose ( 20 mg qd ) trial of fluoxetine in 14 children and adolescents with OCD , ages 8 to 15 years old ; the study was 20 weeks long with crossover at 8 weeks . Obsessive-compulsive symptom severity was measured on the Children 's Yale-Brown Obsessive Compulsive Scale ( CY-BOCS ) and the Clinician 's Global Impression-Obsessive Compulsive Disorder scale ( CGI-OCD ) . The CY-BOCS total score decreased 44 % ( N = 7 , p = .003 ) after the initial 8 weeks of fluoxetine treatment , compared with a 27 % decrease ( N = 6 , p = .13 ) after placebo . During the initial 8 weeks , the magnitude of improvement for the fluoxetine group significantly exceeded that for the placebo group as measured by the CGI-OCD ( p = .01 ) but not by the CY-BOCS ( p = .17 ) . The most common drug side effects were generally well tolerated . The results suggest that fluoxetine is a generally safe and effective short-term treatment for children with OCD",
"CONTEXT The serotonin reuptake inhibitors are the treatment of choice for patients with obsessive-compulsive disorder ; however , empirical support for this assertion has been weaker for children and adolescents than for adults . OBJECTIVE To evaluate the safety and efficacy of the selective serotonin reuptake inhibitor sertraline hydrochloride in children and adolescents with obsessive-compulsive disorder . DESIGN R and omized , double-blind , placebo-controlled trial . PATIENTS One hundred eighty-seven patients : 107 children aged 6 to 12 years and 80 adolescents aged 13 to 17 years r and omized to receive either sertraline ( 53 children , 39 adolescents ) or placebo ( 54 children , 41 adolescents ) . SETTING Twelve US academic and community clinics with experience conducting r and omized controlled trials . INTERVENTION Sertraline hydrochloride was titrated to a maximum of 200 mg/d during the first 4 weeks of double-blind therapy , after which patients continued to receive this dosage of medication for 8 more weeks . Control patients received placebo . MAIN OUTCOME MEASURES The Children 's Yale-Brown Obsessive Compulsive Scale ( CY-BOCS ) , the National Institute of Mental Health Global Obsessive Compulsive Scale ( NIMH GOCS ) , and the NIMH Clinical Global Impressions of Severity of Illness ( CGI-S ) and Improvement ( CGI-I ) rating scales . RESULTS In intent-to-treat analyses , patients treated with sertraline showed significantly greater improvement than did placebo-treated patients on the CY-BOCS ( adjusted mean , -6.8vs -3.4 , respectively ; P=.005 ) , the NIMH GOCS ( -2.2 vs -1.3 , respectively ; P=.02 ) , and the CGI-I ( 2.7 vs 3.3 , respectively ; P=.002 ) scales . Significant differences in efficacy between sertraline and placebo emerged at week 3 and persisted for the duration of the study . Based on CGI-I ratings at end point , 42 % of patients receiving sertraline and 26 % of patients receiving placebo were very much or much improved . Neither age nor sex predicted response to treatment . The incidence of insomnia , nausea , agitation , and tremor were significantly greater in patients receiving sertraline ; 12 ( 13 % ) of 92 sertraline-treated patients and 3 ( 3.2 % ) of 95 placebo-treated patients discontinued prematurely because of adverse medical events ( P=.02 ) . No clinical ly meaningful abnormalities were apparent on vital sign determinations , laboratory findings , or electrocardiographic measurements . CONCLUSION Sertraline appears to be a safe and effective short-term treatment for children and adolescents with obsessive-compulsive disorder",
"OBJECTIVE This study assesses the efficacy and tolerability of fluoxetine in the acute treatment of child and adolescent obsessive-compulsive disorder ( OCD ) during a 13-week , double-blind , placebo-controlled study . METHOD Eligible patients aged 7 to 17 ( N = 103 ) were r and omized at a ratio of 2:1 to receive either fluoxetine or placebo . Dosing was initiated at 10 mg daily for 2 weeks , then increased to 20 mg daily . After 4 weeks of treatment , and again after 7 weeks of treatment , non-responders could have their dosage increased by 20 mg daily , for a maximum possible dosage of 60 mg daily . Primary measure of efficacy was improvement in OCD symptoms as measured by the Children 's Yale-Brown Obsessive Compulsive Scale ( CY-BOCS ) . All analyses were intent-to-treat . RESULTS Fluoxetine was associated with significantly greater improvement in OCD as assessed by the CY-BOCS ( p = .026 ) and other measures than was placebo . Fluoxetine was well tolerated and had a rate of discontinuation for adverse events similar to that of placebo ( p = 1.00 ) . CONCLUSIONS Fluoxetine 20 to 60 mg daily was effective and well tolerated for treatment of OCD in this pediatric population",
"ObjectiveS everal controlled trials have demonstrated the efficacy and safety of Fluoxetine in children and adolescents with Obsessive-Compulsive Disorder ( OCD ) , but there is no controlled study on the effectiveness of Citalopram in this group . This report describes the use of Citalopram in comparison with Fluoxetine in childhood-onset OCD . Method This study is a r and omized , double blind , fixed-does ( 20 mg ) trial of Fluoxetine versus Citalopram in 29 children and adolescents ( 17 boys and 12 girls ) with OCD , aged 7–18 years ( mean 13.8 and SD 3.05 ) . The length of study was 6 weeks . Obsessive-Compulsive symptom severity was measured by Yale – Brown Obsessive-Compulsive Scale ( CY-BOCS ) and Clinician ’s Global Impression Scale ( CGI ) . DICA ( Diagnostic Interview of Children and Adolescents ) was used to diagnose the psychiatric disorders . Results Each group showed significant improvement over the baseline as measured by the CY-BOCS ( p CGI ( p = NS ) . The Comparison between two groups showed no significant differences in efficacy and safety of the drugs . Most common adverse effects were headache for Citalopram and tremor for Fluoxetine . Conclusion The results suggest that Citalopram is as safe and effective as Fluoxetine for children and adolescents with OCD . Further studies are needed to replicate our findings",
"There is evidence of the clinical efficacy and safety of clomipramine and the newer selective serotonin reuptake inhibitors ( SSRIs ) for the treatment of obsessive-compulsive disorder ( OCD ) . In the present study , we have compared the efficacy and safety of 40 mg/day of fluoxetine and 150 mg/day of clomipramine in patients with OCD , diagnosed according to DSM-IIIR . A total of 55 patients entered this 8-week , double-blind controlled study . Efficacy for both drugs was comparable . The primary efficacy criterion , the Y-BOCS Total score , did not show any significant differences between treatment arms . Response rate was higher with clomipramine , using a 25 % decrease in Y-BOCS Total score as response threshold , but there were no significant differences between treatment arms using a 35 % threshold . Overall safety and tolerability were good for both drugs , being slightly better for fluoxetine",
"OBJECTIVE It is now well documented that fluoxetine is a viable treatment option for patients with obsessive-compulsive disorder ( OCD ) , and there is a small body of evidence indicating that monoamine oxidase inhibitors may be effective in at least a subset of patients . The authors conducted a 10-week placebo-controlled trial of these two agents in patients who met DSM-III-R criteria for OCD . METHOD Sixty-four subjects were r and omly assigned to receive placebo , phenelzine ( 60 mg/day ) , or fluoxetine ( 80 mg/day ) . These doses were achieved by the end of week 3 of the active phase of the study . Outcomes were assessed with st and ardized instruments to measure OCD , mood , and anxiety . RESULTS Fifty-four patients completed the study . There was a significant difference among the three treatments on one OCD scale , with fluoxetine-treated patients improving significantly more than those in the placebo or phenelzine group . A subgroup of OCD patients with symmetry obsessions did respond to phenelzine . CONCLUSIONS This study provides no evidence to support the use of phenelzine in OCD except possibly for those patients with symmetry or other atypical obsessions . There was also no support for the hypothesis that patients with high levels of anxiety would respond preferentially to phenelzine",
"BACKGROUND One of the few combination approaches to the treatment of obsessive-compulsive disorder ( OCD ) with encouraging support is the addition of an antipsychotic to a serotonin reuptake inhibitor . METHODS The study consisted of a 6-week , placebo-controlled addition of olanzapine 5 - 10 mg ( 6.1 + /- 2.1 mg , mean + /- SD ) to fluoxetine in OCD subjects who were partial or nonresponders to an 8-week , open-label fluoxetine trial ( 40 mg in 43 subjects , 20 mg in 1 subject ) . RESULTS Both the fluoxetine-plus-olanzapine ( n = 22 ) and fluoxetine-plus-placebo ( n = 22 ) groups improved significantly over 6 weeks [ F(3,113 ) = 11.64 , p Yale-Brown Obsessive Compulsive Scale scores with repeated- measures analysis of variance ; however , the treatment x time interaction was not significant for olanzapine versus placebo addition to fluoxetine . CONCLUSIONS These findings indicate no additional advantage of adding olanzapine for 6 weeks in OCD patients who have not had a satisfactory response to fluoxetine for 8 weeks , compared with extending the monotherapy trial",
"We carried out a double-blind , r and omized , parallel-groups clinical trial of fluoxetine ( 20 - 40 mg/day ) and placebo in 11 children with Tourette 's syndrome ( TS ) and associated obsessive-compulsive symptoms ( OCS ) . The treatment period lasted 4 months . No significant differences between treatment groups were observed for measures of OCS . Fluoxetine therapy , however , was associated with a trend toward some improvement in tic severity , attentional abilities , and social functioning . Given these observations and the limitations of this pilot study , which include selection biases , small sample size , and significant placebo effects , the efficacy of fluoxetine in children with TS deserves further larger-scale investigation",
"Abstract Enhanced serotonergic transmission may underlie therapeutic effects of serotonin reuptake inhibitors in obsessive-compulsive disorder . However , such treatment may decrease serotonin receptor responsivity . We investigated whether the serotonin antagonist metergoline would exacerbate or further improve systems in fluoxetine-responsive patients . Pilot results suggested open metergoline produced delayed symptom worsening in fluoxetine-treated patients . Fourteen patients continuing fluoxetine received metergoline and placebo ( double-blind , r and omized ) . Symptom ratings continued for 1 week afterwards . Ten unmedicated patients underwent the same procedures . Symptoms improved 4 h after both metergoline and placebo . The day after metergoline but not placebo , fluoxetine-treated patients had significantly increased anxiety , obsessions and compulsions , abating over several days . Depression was unchanged . Metergoline had no similar delayed effects in unmedicated patients . Metergoline levels were higher in fluoxetine-treated patients . These results , consistent with less conclusive earlier findings , suggest that prolonged changes in brain serotonin function underlie symptom re-emergence following administration of metergoline to fluoxetine-treated patients with obsessive-compulsive disorder",
"In a double-blind , crossover study , 13 fluoxetine-treated patients with obsessive-compulsive disorder were given adjuvant buspirone and placebo for 4 weeks each . There were no significant differences between buspirone and placebo in obsessive-compulsive , depressive , or anxiety symptoms",
"OBJECTIVE This pilot study explored the efficacy and tolerability of paliperidone augmentation of serotonin reuptake inhibitors ( SRIs ) in adults with treatment-resistant obsessive-compulsive disorder ( OCD ) . METHOD Thirty-four patients aged 24 - 67 years ( mean = 43.7 years , SD = 11.4 ) who met DSM-IV criteria for OCD and remained symptomatic following 2 or more past adequate SRI trials ( including their current medication ) were enrolled from May 2008 to March 2012 . Participants were treated for 8 weeks in a double-blind study with either paliperidone ( up to 9 mg/d ) or matching placebo in addition to their SRI . Blinded raters conducted outcome assessment s. The primary outcome , obsessive-compulsive symptom severity , was assessed using the Yale-Brown Obsessive Compulsive Scale ( YBOCS ) . Secondary outcomes included the Clinical Global Impressions-Severity of Illness and -Improvement scales . RESULTS Paliperidone administration result ed in significant baseline-to-posttreatment reductions in obsessive-compulsive symptoms as measured by the YBOCS ( P YBOCS changes ( P = .05 , d = 0.53 ) . In exploratory analyses examining between-group differences , tests for paliperidone superiority relative to placebo were not significant ( P = .14 , d = 0.34 ) ; however , a numerical trend toward significant between-group differences was found , with a reduction of 7.98 points on the YBOCS for the paliperidone group compared to a reduction of 4.02 points for the placebo group . Paliperidone was generally well tolerated and not associated with significant weight gain ( mean [ SD ] weight : paliperidone , pretreatment 84.70 [ 27.08 ] kg , posttreatment 84.84 [ 18.99 ] kg ; vs placebo , pretreatment 77.50 [ 25.33 ] kg , posttreatment 77.43 [ 19.90 ] kg ; P = .21 ) . CONCLUSIONS These results suggest that paliperidone augmentation is well tolerated and has potential efficacy in the short-term treatment of some patients with SRI-resistant OCD . Well-powered , r and omized , controlled studies are necessary to more definitively address the efficacy of this treatment strategy . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00632229",
"OBJECTIVE To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder . METHOD Children ( 7 - 11 years of age ) and adolescents ( 12 - 17 years of age ) meeting DSM-IV criteria for obsessive-compulsive disorder were r and omized to paroxetine ( 10 - 50 mg/day ) or placebo for 10 weeks . The primary efficacy measure was change from baseline in the Children 's Yale-Brown Obsessive-Compulsive Scale ( CY-BOCS ) total score at week 10 last observation carried forward end point . Safety was assessed primarily through adverse event monitoring . RESULTS A total of 207 patients were r and omized to treatment . Of these , 203 were included in the intention-to-treat population . Adjusted mean changes from baseline at week 10 observation carried forward end point in CY-BOCS total score for patients receiving paroxetine and placebo were -8.78 ( SE=0.82 ) and -5.34 points ( SE=0.77 ) , respectively . The adjusted mean difference , -3.45 in favor of paroxetine , was statistically significant ( 95 % confidence interval=-5.60 to -1.29 , p=.002 ) . Adverse events were generally mild to moderate in intensity . A total of 10.2 % ( 10/98 ) of patients in the paroxetine group and 2.9 % ( 3 of 105 ) in the placebo group discontinued treatment because of adverse events . CONCLUSIONS Paroxetine is an effective and generally well-tolerated treatment for obsessive-compulsive disorder in children and adolescents",
"OBJECTIVE To examine the safety and efficacy of fluoxetine in child and adolescent obsessive-compulsive disorder ( OCD ) . METHOD Between 1991 and 1998 , 43 patients were r and omly assigned to fluoxetine or placebo for 8 weeks . Dosing was fixed for the first 6 weeks ( up to 60 mg/day ) and then could be increased to 80 mg/day . Responders entered an 8-week maintenance phase . The primary outcome measures were the Children 's Yale-Brown Obsessive Compulsive Scale ( CY-BOCS ) and the Clinical Global Impression-Improvement ( CGI-I ) scale . Analyses were done on the intent-to-treat sample . RESULTS Fluoxetine patients ( n = 21 ) had significantly lower CY-BOCS scores than placebo patients ( n = 22 ) after 16 ( but not 8) weeks . Fluoxetine responders ( n = 11 ) had significantly lower CY-BOCS scores than placebo responders ( n = 7 ) after an additional 8 weeks of treatment . After 16 weeks , 57 % of fluoxetine ( versus 27 % of placebo ) patients were much or very much improved on the CGI-I scale ( p adverse medication effects . CONCLUSION Fluoxetine was well tolerated and effective for the treatment of child and adolescent OCD , but fluoxetine 's full effect took more than 8 weeks to develop",
"OBJECTIVE To determine the safety and efficacy of fluvoxamine for the treatment of children and adolescents with obsessive-compulsive disorder ( OCD ) with a double-blind , placebo-controlled , multicenter study . METHOD Subjects , aged 8 to 17 years , meeting DSM-III-R criteria for OCD were recruited from July 1991 to August 1994 . After a 7- to 14-day single-blind , placebo washout/screening period , subjects were r and omly assigned to fluvoxamine 50 to 200 mg/day or placebo for 10 weeks . Subjects who had not responded after 6 weeks could discontinue the double-blind phase of the study and enter a long-term , open-label trial of fluvoxamine . Analyses used an intent-to-treat sample with a last-observation-carried-forward method . RESULTS Mean Children 's Yale-Brown Obsessive Compulsive Scale ( CY-BOCS ) scores with fluvoxamine were significantly ( p placebo at weeks 1 , 2 , 3 , 4 , 6 , and 10 . Significant ( p placebo were observed for all secondary outcome measures at all visits . Based on a 25 % reduction of CY-BOCS scores , 42 % of subjects taking fluvoxamine were responders compared with 26 % taking placebo . Forty-six ( 19 fluvoxamine , 27 placebo ) of 120 r and omized subjects discontinued early . Adverse events with a placebo-adjusted rate greater than 10 % were insomnia and asthenia . CONCLUSIONS Fluvoxamine has a rapid onset of action and is well tolerated and efficacious for the short-term treatment of pediatric OCD"
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EXECUTIVE SUMMARY Background Each year , approximately 15 million people worldwide have a stroke ; of these , five million die and another five million are chronically disabled . Stroke recurs in approximately 25 % of patients during the first five years post-stroke ; recurrence may result in death , increased disability or institutionalisation . Modifiable risk factors for recurrent stroke have been identified , and may be addressed by means of behavioural health promotion interventions . Objectives This systematic review sought to establish the effectiveness of secondary prevention behavioural interventions , which address one or more modifiable lifestyle risk factors for recurrent stroke i.e. tobacco use , unhealthy diet , physical inactivity and excessive alcohol consumption . INCLUSION CRITERIA Types of participants The review included studies that had recruited adults ( aged ≥18 years ) who had had a stroke , minor stroke or transient ischaemic attack . Types of intervention The review considered studies that evaluated behavioural lifestyle interventions , design ed to address the prevention of recurrent stroke . Types of outcomes Primary outcomes were concerned with lifestyle behaviour change i.e. tobacco use , diet , physical activity and alcohol consumption , and with change in physiological measures e.g. blood pressure , total cholesterol , and Body Mass Index . Secondary outcome measures included psychological outcomes , learning outcomes and incidence of stroke recurrence . Types of studies Experimental and non-experimental quantitative studies were considered . Search strategy In August 2009 , we search ed All EMB Review s , AMED , ASSIA , British Nursing Index and Archive , CINAHL , Conference Proceedings Citation Index - Science , ProQuest dissertation and theses , EMBASE , MEDLINE , PsycINFO , and bibliographies of retrieved papers . Method ological quality and data extraction Two review authors independently assessed method ological quality using st and ardised critical appraisal instruments from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument , and extracted data using a review -specific data extraction form . Data analysis Where possible , results from the review papers were pooled in statistical meta- analysis using bespoke software based on the system used by the Early Breast Cancer Trialists Collaborative Group . Where statistical pooling was not possible , findings are presented in narrative form . Results Three studies , two RCTs and one quasi-experimental study , involving 581 participants ( baseline ) were included in the review . Two models of service delivery were reported : shared care and nurse-led . Interventions were delivered to groups or in one-to-one consultations . Meta-analyses of the pooled lifestyle data favoured the interventions ( 2p=0.02 ; Note : here and throughout , 2p represents the two-tailed probability ) . In terms of physiological outcomes , the pooled data favoured the interventions ( 2p=0.05 ) , particularly those aim ing to reduce blood pressure and cholesterol levels . The pooled secondary outcomes , including perceived health status and stroke knowledge favoured the interventions ( 2p interventions are effective in terms of affecting positive change in relation to lifestyle behaviours , physiological and secondary outcomes . However , there was insufficient evidence to determine the effect of intervention on incidence of stroke recurrence . Implication s for practice Clinicians should implement stroke secondary prevention interventions which address lifestyle behaviours , physiological factors , psychological outcomes and stroke knowledge . Implication s for research Further large-scale , well- design ed trials are needed to determine the factors that impact on the effectiveness of secondary prevention interventions
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"Background and Purpose — Reduction in the risk of stroke and increase in the speed of hospital presentation after the onset of stroke both depend on the level of knowledge of stroke in the general population . The aim of the present study was to assess baseline knowledge regarding stroke risk factors , symptoms , treatment , and information re sources . Methods — A community-based telephone interview survey was conducted in the Newcastle urban area in Australia . A total of 1278 potential participants between the ages of 18 to 80 were selected at r and om from an electronic telephone directory . A trained telephone interviewer conducted a telephone survey using the Computer-Assisted Telephone Interviewing ( CATI ) program . Results — A total of 822 participants completed the telephone interview . Six hundred three participants ( 73.4 % ) correctly identified the brain as the affected organ in stroke . The most common risk factors for stroke identified by respondents were smoking ( identified by 324 [ 39.4 % ] ) and stress ( identified by 277 [ 33.7 % ] ) . The most common warning sign of stroke described by respondents was “ blurred and double vision or loss of vision in an eye , ” listed by 198 ( 24.1 % ) . A total of 626 ( 76.2 % ) respondents correctly listed ≥1 established stroke risk factor , but only 409 ( 49.8 % ) respondents correctly listed ≥1 warning sign . Conclusions — The level of knowledge in the community of established stroke risk factors , warning signs , and treatment as indicated by this survey suggests that a community-based education program to increase public knowledge of stroke may contribute to reducing the risk of stroke and to increasing the speed of hospital presentation after the onset of stroke",
"OBJECTIVE To evaluate the effectiveness of a treadmill and overground walking program in reducing the disability and h and icap associated with poor walking performance after stroke . DESIGN R and omized , placebo-controlled clinical trial with a 3-month follow-up . SETTING General community . PARTICIPANTS A volunteer sample of 29 ambulatory individuals ( less 2 dropouts ) who were living in the community after having suffered a stroke more than 6 months previously . INTERVENTIONS The experimental group participated in a 30-minute treadmill and overground walking program , 3 times a week for 4 weeks . The control group received a placebo consisting of a low-intensity , home exercise program and regular telephone contact . MAIN OUTCOME MEASURES Walking speed ( over 10 m ) , walking capacity ( distance over 6 min ) , and h and icap ( stroke-adapted 30-item version of the Sickness Impact Profile ) measured by a blinded assessor . RESULTS The 4-week treadmill and overground walking program significantly increased walking speed ( P=.02 ) and walking capacity ( P h and icap ( P=.85 ) compared with the placebo program . These gains were largely maintained 3 months after the cessation of training ( P treadmill and overground walking program was effective in improving walking in persons residing in the community after stroke . This suggests that the routine provision of accessible , long-term , community-based walking programs would be beneficial in reducing disability after stroke",
"A r and om telephone survey on knowledge of stroke was conducted in 1,238 Hong Kong Chinese . Most respondents realized that effective treatment was available , that stroke was preventable and that it could be fatal or disabling . Sudden unilateral limb weakness , sudden speech and language disturbances , and sudden vertigo and clumsiness were better recognized than other warning symptoms of stroke . A slightly better recognition of symptoms of stroke was seen in those with a belief of knowing about stroke , providing a correct description of stroke , those with a positive household history of stroke and those with a better knowledge of potential risk factors . Most respondents would choose desirable actions if stroke was suspected in their family members or themselves . Friends and relatives , newspapers and magazines , and mass media provided the major sources of their knowledge",
"Objective : Despite evidence demonstrating that risk-factor management is effective in reducing recurrent cerebrovascular disease , there are very few structured care programmes for stroke survivors . The aim was to implement and evaluate an integrated care programme in stroke . Methods : 186 patients with stroke were r and omised to either the treatment ( integrated care ) or control ( usual care ) group and were followed up over 12 months . The Integrated Care for the Reduction of Secondary Stroke ( ICARUSS ) model of integrated care involved collaboration between a specialist stroke service , a hospital coordinator and a patient ’s general practitioner . The primary aim was to promote the management of vascular risk factors through ongoing patient contact and education . Results : In the 12 months poststroke , systolic blood pressure ( sBP ) decreased in the treatment group but increased in controls . The group difference was significant , and remained so when age , sex , disability and sBP at discharge were accounted for ( p = 0.04 ) . Treatment patients also exhibited better modification of body mass index ( p = 0.007 ) and number of walks taken ( p controls . Rankin scores indicated significantly reduced disability in treatment patients relative to controls in the year poststroke ( p = 0.003 ) . Conclusions : Through an integrated system of education , advice and support to both patient and GP , the ICARUSS model was effective in modifying a variety of vascular risk factors and therefore should decrease the likelihood or recurrent stroke or vascular event",
"Background and Purpose — The Stroke PROTECT ( Preventing Recurrence Of Thromboembolic Events through Coordinated Treatment ) program systematic ally implements , at the time of acute transient ischemic attack ( TIA ) or ischemic stroke admission , 8 medication/behavioral secondary prevention measures known to improve outcome in patients with cerebrovascular disease . The objective of this study was to determine if the high utilization rates previously demonstrated at hospital discharge were maintained at 90 days after discharge . Methods — Data were prospect ively collected on consecutively encountered ischemic stroke and TIA patients admitted to a university hospital stroke service beginning September 1 , 2002 . PROTECT interventions were initiated before hospital discharge in all PROTECT – target ( underlying stroke mechanism large vessel atherosclerosis or small vessel disease ) and PROTECT – ACS ( At-risk for Coronary Sequelae ) patients . Adherence to program goals was assessed 3 months after discharge . Results — During the period from September 2002 to August 2003 , 144 individuals met criteria for PROTECT intervention . Of the 130 patients ( 90 % ) with available day 90 follow-up data , mean age was 72 ( range , 37 to 95 ) , and 63 % were male . Adherence rates in patients without specific contraindications were 100 % for antithrombotics , 99 % for statins , 92 % for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers , and 80 % for thiazides . Awareness of the importance of calling 911 in response to stroke was 87 % . Adherence to diet and exercise guidelines were 78 % and 70 % , respectively . Of the 24 smokers , tobacco cessation was maintained in 20 ( 83 % ) . Conclusions — High rates of adherence to PROTECT therapies were maintained at 90 days after hospital discharge",
"Background Coronary Heart Disease and Cerebrovascular Disease share many predisposing , modifiable risk factors ( hypertension , abnormal blood lipids and lipoproteins , cigarette smoking , physical inactivity , obesity and diabetes mellitus ) . Lifestyle interventions and pharmacological therapy are recognised as the cornerstones of secondary prevention . Cochrane review has proven the benefits of programmes incorporating exercise and lifestyle counselling in the cardiac disease population . A Cochrane review highlighted as priority , the need to establish feasibility and efficacy of exercise based interventions for Cerebrovascular Disease . Methods A single blind r and omised controlled trial is proposed to examine a primary care cardiac rehabilitation programme for adults post transient ischemic attack ( TIA ) and stroke in effecting a positive change in the primary outcome measures of cardiac risk scores derived from Blood Pressure , lipid profile , smoking and diabetic status and lifestyle factors of habitual smoking , exercise and healthy eating participation . Secondary outcomes of interest include health related quality of life as measured by the Hospital Anxiety and Depression Scale , the Stroke Specific Quality of Life scale and WONCA COOP Functional Health Status charts and cardiovascular fitness as measured by a sub-maximal fitness test . A total of 144 patients , over 18 years of age with confirmed diagnosis of ischaemic stroke or TIA , will be recruited from Dublin community stroke services and two tertiary T.I.A clinics . Exclusion criteria will include oxygen dependence , unstable cardiac conditions , uncontrolled diabetes , major medical conditions , claudication , febrile illness , pregnancy or cognitive impairment . Participants will be block-statified , r and omly allocated to one of two groups using a pre-prepared computer generated r and omisation schedule . Both groups will receive a two hour education class on risk reduction post stroke . The intervention group will receive a 10 week programme of supervised aerobic exercises ( twice weekly ) and individually tailored brief intervention lifestyle counselling . Both groups will be tested on week one and week ten of the programme . Follow-up at 1 year will assess longer term benefits . Analysis will test for significant changes in the key variables indicated . Discussion Application of the Cardiac Rehabilitation paradigm to patients with ischaemic stroke or TIA has not been explored despite the obvious overlap in aetiology . It is hoped the anticipated improvement in vascular risk factors and fitness result ing from such a programme will enhance health and social gain in this population .Trial Registration Current Controlled Trials ISCTRN90272638",
"Background and Purpose — The ability of therapeutic exercise after stroke to improve daily functioning and quality of life ( QOL ) remains controversial . We examined treatment effects on these outcomes in a r and omized controlled trial ( RCT ) of exercise in subacute stroke survivors . Methods — This is a secondary analysis of a single-blind RCT of a 12-week program versus usual care . Baseline , post-treatment and 6-month post-treatment daily functioning and QOL were assessed by Barthel index , Functional Independence Measure , instrumental activities of daily living , Medical Outcomes Study short-form 36-item question naire ( SF-36 ) , and Stroke Impact Scale ( SIS ) . Results — Of 100 r and omized subjects , 93 completed the postintervention assessment , ( mean age 70 ; 54 % male ; 81 % white ; mean Orpington Prognostic Score 3.4 ) , and 80 had 6-month post-treatment assessment . Immediately after intervention , the intervention group improved more than usual care in SF-36 social function ( 14.0 points ; P=0.0051 ) and in SIS ( strength [ 9.2 points ; P=0.0003 ] , emotion [ 5.6 points ; P=0.0240 ] , social participation [ 6.6 points ; P=0.0488 ] , and physical function [ 5.0 points ; P=0.0145 ] ) . Treatment was marginally more effective on Barthel score ( 3.3 points ; P=0.0510 ) , SF-36 ( physical function [ 6.8 points ; P=0.0586 ] , physical role function [ 14.4 points ; P=0.0708 ] ) , and SIS upper extremity function ( 7.2 points ; P=0.0790 ) . Effects were diluted 6 months after treatment ended . Conclusion — This rehabilitation exercise program led to more rapid improvement in aspects of physical , social , and role function than usual care in persons with subacute stroke . Adherence interventions to promote continued exercise after treatment might be needed to continue benefit",
"Smoking cessation treatment is now integrated into many health-care systems and a major research effort is under way to improve current success rates . Until now results from r and omized clinical trials have been reported in many different ways , leading to problems of interpretation . We propose six st and ard criteria comprising the ' Russell St and ard ' ( RS ) . These criteria are applicable to trials of cessation aids where participants have a defined target quit date and there is face-to-face contact with research ers or clinic staff , as follows . ( 1 ) Follow-up for 6 months ( RS6 ) or 12 months ( RS12 ) from the target quit date or the end of a predefined ' grace period ' ; ( 2 ) self-report of smoking abstinence over the whole follow-up period allowing up to five cigarettes in total ; ( 3 ) biochemical verification of abstinence at least at the 6-month or 12-month follow-up point ; ( 4 ) use of an ' intention-to-treat ' approach in which data from all r and omized smokers are included in the analysis unless they have died or moved to an untraceable address ( participants who are included in the analysis are counted as smokers if their smoking status at the final follow-up can not be determined ) ; ( 5 ) following-up ' protocol violators ' and using their true smoking status in the analysis ; and ( 6 ) collecting follow-up data blind to smokers ' allocation to trial group . We believe that these criteria provide the best compromise between practicability and surrogacy for long-term cessation and will enable meaningful comparison between studies . There may be good reasons why other outcome criteria would also be reported , and studies that involve interventions with special groups or where there is no design ated target quit date or face to face contact would need to adapt these criteria accordingly",
"Nir Z , Zolotogorsky Z , Sugarman H : Structured nursing intervention versus routine rehabilitation after stroke . Am J Phys Med Rehabil 2004;83:522–529 . Objective : The goal of this study was to examine the effect of a structured , comprehensive nursing intervention on the course of rehabilitation over the first 6 mos after a first-ever stroke . Design : Intervention ( experimental ) study . The participants were 155 elderly stroke survivors who were admitted to a geriatric rehabilitation department . Stratified r and om sampling generated intervention and control groups . The intervention was design ed to work together with the routine rehabilitation program and consisted of 12 consecutive weekly meetings . The control group received only the routine rehabilitation program . Study variables were measured at entry to study and after 3- and 6-mo intervals . Results : Although there were no significant differences between the two groups at entry to study , at 3 and 6 mos after stroke , the intervention group showed better scores than the control group in functional status ( FIM ™ instrument ) , depression ( Geriatric Depression Scale ) , self-perceived health , self-esteem , and dietary adherence . Conclusion : The nursing intervention had both short- and long-term effects on functional , psychological , and emotional variables . Serious consideration should be given to implementing comprehensive nursing interventions during rehabilitation tailored to meet the specific needs of stroke survivors and their caregivers",
"BACKGROUND AND PURPOSE Many stroke survivors have minimal to moderate neurological deficits but are physically deconditioned and have a high prevalence of cardiovascular problems ; all of these are potentially modifiable with exercise . The purpose s of this r and omized , controlled pilot study were ( 1 ) to develop a home-based balance , strength , and endurance program ; ( 2 ) to evaluate the ability to recruit and retain stroke subjects ; and ( 3 ) to assess the effects of the interventions used . METHODS Twenty minimally and moderately impaired stroke patients who had completed inpatient rehabilitation and who were 30 to 90 days after stroke onset were r and omized to a control group or to an experimental group that received a therapist-supervised , 8-week , 3-times-per-week , home-based exercise program . The control group received usual care as prescribed by the patients ' physicians . Baseline and postintervention assessment s included the Fugl-Meyer Motor Assessment , the Barthel Index of Activities of Daily Living ( ADL ) , the Lawton Scale of Instrumental ADL , and the Medical Outcomes Study -36 Health Status Measurement . Functional assessment s of balance and gait included a 10-m walk , 6-Minute Walk , and the Berg Balance Scale . Upper extremity function was evaluated by the Jebsen Test of H and Function . RESULTS Of 22 patients who met study criteria , 20 completed the study and 2 refused to participate . The experimental group tended to improve more than the control group in motor function ( Fugl-Meyer Upper Extremity : mean change in score , 8 . 4 versus 2.2 ; Fugl-Meyer Lower Extremity : 4.7 versus -0.9 ; gait velocity : median change , 0.25 versus .09 m/s ; 6-Minute Walk : 195 versus 114 ft ; Berg Balance Score : 7.8 versus 5 ; and Medical Outcomes Study -36 Health Status Measurement of Physical Function : 15 . 5 versus 9 ) . There were no trends in differences in change scores by the Jebsen Test of H and Function , Barthel Index , and Lawton Instrumental ADL Scale . CONCLUSIONS This study demonstrated that a r and omized , controlled clinical trial of a poststroke exercise program is feasible . Measures of neurological impairments and lower extremity function showed the most benefit . Effects of the intervention on upper extremity dexterity and functional health status were equivocal . The lasting effects of the intervention were not assessed",
"Objective : To determine levels of satisfaction with information and advice received about stroke disease and relevant issues by community-dwelling stroke survivors . Design : An interview question naire survey . Setting : A family health services authority area in northern Engl and . Subjects : Stroke survivors identified by a valid screening question naire from a stratified r and om sample of 2000 subjects aged 45 years and over . Main outcome measure : Proportion of subjects interviewed responding positively to the question ' Do you think you have received enough advice and information on ... ? ' eighteen topics considered relevant to stroke survivors . Results : The screening process identified 116 stroke survivors , of whom 76 agreed to be interviewed . The majority ( > 80 % ) of patients were satisfied with information and advice received on lifestyle and health promotion issues , incontinence and their current treatment . However , satisfaction was poor for the areas of stroke disease in general , its effects , available services , and legal and financial affairs ( range , 28 - 75 % satisfied ) . Conclusion : Deficits in the provision of adequate information and advice to stroke patients on relevant issues have been identified in this study of a representative sample of community-dwelling stroke survivors . These deficits need to be addressed by those providing care for stroke patients in order to improve patient satisfaction",
"OBJECTIVE To evaluate the effectiveness of the Shanghai Chronic Disease Self-Management Program ( CDSMP ) . METHODS A r and omized controlled trial with six-month follow-up compared patients who received treatment with those who did not receive treatment ( waiting-list controls ) in five urban communities in Shanghai , China . Participants in the treatment group received education from a lay-led CDSMP course and one copy of a help book immediately ; those in the control group received the same education and book six months later . FINDINGS In total , 954 volunteer patients with a medical record that confirmed a diagnosis of hypertension , heart disease , chronic lung disease , arthritis , stroke , or diabetes who lived in communities were assigned r and omly to treatment ( n = 526 ) and control ( n = 428 ) groups . Overall , 430 ( 81.7 % ) and 349 ( 81.5 % ) patients in the treatment and control groups completed the six-month study . Patients who received treatment had significant improvements in weekly minutes of aerobic exercise , practice of cognitive symptom management , self-efficacy to manage own symptoms , and self-efficacy to manage own disease in general compared with controls . They also had significant improvements in eight indices of health status and , on average , fewer hospitalizations . CONCLUSION When implemented in Shanghai , the CDSMP was acceptable culturally to Chinese patients . The programme improved participants ' health behaviour , self-efficacy , and health status and reduced the number of hospitalizations six months after the course . The locally based delivery model was integrated into the routine of community government organizations and community health services . Chinese lay leaders taught the CDSMP courses as successfully as professionals",
"Background and Purpose — Numerous effective strategies for the secondary prevention of cardiovascular events in high-risk patients have now been established . We sought to calculate the cumulative benefit of combining multiple strategies for preventing recurrent events in patients with a history of ischemic stroke or transient ischemic attack . Methods — A comprehensive literature search was undertaken to identify meta-analyses of r and omized controlled trials reporting on the efficacy of secondary prevention strategies . The baseline incidence of vascular events was modeled from the Life Long After Cerebral Ischemia study . Strategies were combined on a multiplicative scale and cumulative risk reductions were computed over a 5-year interval . Results — The combination of 5 proven strategies applied to survivors of an initial stroke or transient ischemic attack — dietary modification , exercise , aspirin , a statin , and an antihypertensive agent — could result in a cumulative relative risk reduction of 80 % . Given a 5-year major cardiovascular event rate of 24 % , this translates to a number needed to treat of about 5 . Further gains would result from applying multimodality therapy over longer intervals and enriching the base strategy with dual antiplatelet therapy , high-dose statins , and more intensive blood pressure – lowering . Even more benefit would be present in high-risk subgroups with the addition , where appropriate , of carotid endarterectomy , moderate intensity oral anticoagulants , glycemic control , and smoking cessation . Conclusions — At least four-fifths of recurrent vascular events in patients with cerebrovascular disease might be prevented by application of a comprehensive , multifactorial approach",
"BACKGROUND AND PURPOSE Little is known about the relative efficacy of supervised versus unsupervised community exercise programs for stroke survivors . This study compared the effectiveness of a 10-week supervised strengthening and conditioning program ( supervised ) with a 1-week supervised instruction program followed by a 9-week unsupervised home program ( unsupervised ) and evaluated retention of changes at 6 months and 1 year after program completion . METHODS Seventy-two subjects retained at baseline ( 27 women , 45 men ; mean+/-SD age , 64.6+/-11.8 years ) were r and omly allocated to receive the supervised or unsupervised program . The primary outcome was walking speed over 6 minutes , and secondary outcome measures were Human Activity Profile , Medical Outcome Study 36-Item Short-Form survey ( SF-36 ) , Physiological Cost Index , and lower extremity muscle strength . RESULTS The 6-minute walking speed increased significantly in both groups and remained significantly improved by 1 year . The Human Activity Profile demonstrated an increasing trend only in the supervised group that was significant by 1 year . The SF-36 Physical Component summary score increased significantly in the supervised group and remained improved by 1 year ; the unsupervised group showed significant improvement at 1 year . Women made greater gains in supervised programs , but men made greater gains in unsupervised programs . CONCLUSIONS Supervised exercise programs and unsupervised programs after initial supervised instruction were both associated with physical benefits that were retained for 1 year , although supervised programs showed trends to greater improvements in self-reported gains . Gender differences require further research",
"Objective : To evaluate risk factor reduction and health-related quality of life following a 10-week cardiac rehabilitation programme in non-acute ischaemic stroke subjects . Design : Single-blinded r and omized control trial . Setting : Outpatient rehabilitation . Subjects : Forty-eight community-dwelling ischaemic stroke patients ( 38 independently mobile , 9 requiring assistance , 1 non-ambulatory ) were r and omly assigned to intervention or control groups by concealed allocation . Intervention : The trial consisted of a 10-week schedule with measures taken at weeks 1 and 10 . Both groups continued usual care ( excluding aerobic exercise ) ; intervention subjects attended 16 cycle ergometry sessions of aerobic-training intensity and two stress-management classes . Main outcome measures : Cardiac risk score ( CRS ) ; VO2 ( mL O2/kg per minute ) and Borg Rate of Perceived Exertion ( RPE ) assessed during a st and ardized ergometry test ; Hospital Anxiety and Depression Scale ( HADS ) ; Frenchay Activity Index ; Fasting Lipid Profiles and Resting Blood Pressure . Results : Group comparison with independent t-tests showed significantly greater improvement at follow-up by intervention subjects than controls in VO2 ( intervention 10.6 ±1.6 to 12.0 ± 2.2 , control 11.1 ±1.8 to 11.1 ±1.9 t=4.734 , P CRS ( intervention 13.4 ±10.1 to 12.4 ±10.5 , control 9.4 ±6.7 to 15.0 ±6.1 t=-2.537 , P RPE rating decreased in intervention subjects ( 13.4 ±12.2 to 12.4 ±2.0 ) and increased in controls ( 13.8 ±1.8 to 14.4 ±1.6 ) ; Mann — Whitney U ( U = 173.5 , P the HADS depression subscale in the intervention group alone ( 5.1 ±3.4 to 3.0 ±2.8 ) ( Wilcoxon signed ranks test Z=-3.278 , P non-acute ischaemic stroke patients can improve their cardiovascular fitness and reduce their CRS with a cardiac rehabilitation programme . The intervention was associated with improvement in self-reported depression ",
"Background and Purpose — Increased knowledge of stroke risk factors in the general population may lead to improved prevention of stroke . The objective of the present study was to assess knowledge of stroke risk factors and to determine factors associated with knowledge . Methods — In a population -based survey , we sent a question naire to r and omly selected residents in Berlin who were ≥50 years of age enquiring about knowledge of stroke risk factors . Knowledge was assessed in an open-ended question . In addition , we enquired about the source of participants ' information . Sociodemographic factors , including age , sex , educational level , and nationality , were also assessed . Results — A total of 28 090 of 75 720 residents ( response rate , 37 % ) responded to the question naire . Of all respondents , 68 % were able to name ≥1 correct stroke risk factor , and 13 % named 4 correct risk factors . The majority of respondents named mass media as source of information ( 82 % ) , followed by family/friends ( 45 % ) and by general physicians ( 20 % ) . In multivariable analysis , increased knowledge of stroke risk factors was significantly associated with younger age , a higher educational level , not living alone , a German nationality , and having received any information about stroke during the last year . However , characteristics of respondents using the respective sources of information varied significantly . Conclusions — Mass media was most frequently named as a source of information about stroke risk factors . Source of information used varied according to population characteristics . Health education programs should take this into account and be adapted accordingly",
"BACKGROUND The study examined the effects of a 12-week health promotion intervention for a predominantly urban African-American population of stroke survivors . DESIGN A pre-test/post-test lag control group design was employed . PARTICIPANTS / SETTING Participants were 35 stroke survivors ( 9 male , 26 female ) recruited from local area hospitals and clinics . MAIN OUTCOME MEASURES Biomedical , fitness , nutritional , and psychosocial measures were employed to assess program outcomes . RESULTS Treatment group made significant gains over lag controls in the following areas : ( 1 ) reduced total cholesterol , ( 2 ) reduced weight , ( 3 ) increased cardiovascular fitness , ( 4 ) increased strength , ( 5 ) increased flexibility , ( 6 ) increased life satisfaction and ability to manage self-care needs , and ( 7 ) decreased social isolation . CONCLUSION A short-term health promotion intervention for predominantly African-American stroke survivors was effective in improving several physiological and psychological health outcomes",
"PURPOSE The purpose of this study was to evaluate the physical and psychosocial effects of an 8-wk community-based functional exercise program in a group of individuals with chronic stroke . METHODS Twenty-five subjects ( mean age 63 yr ) participated in a repeated measures design that evaluated the subjects with two baseline assessment s 1 month apart , one postintervention assessment , and one retention assessment 1 month postintervention . Physical outcome measures assessed were the Berg Balance Test , 12-Minute Walk Test distance , gait speed , and stair climbing speed . Psychosocial measures assessed were the Reintegration to Normal Living Index ( RNL ) and Canadian Occupational Performance Measure ( COPM ) . The 8-wk training consisted of a 60-min , 3 x wk-1 group program that focused on balance , mobility , functional strength , and functional capacity . The program was design ed to be accessible by reducing the need for costly one-on-one supervision , specialized setting s , and expensive equipment . RESULTS Improvements from the exercise program were found for all physical measures and these effects were retained 1-month postintervention . Subjects with lower function improved the most relative to their initial physical status . Significant effects were found for the COPM , but not the RNL Index ; however , subjects with lower RNL improved the most relative to their initial RNL Score . CONCLUSION A short-term community-based exercise program can improve and retain mobility , functional capacity , and balance and result in a demonstrable impact upon the performance of activities and abilities that were considered meaningful to the subjects . Implementation of such community-based programs has potential for improving activity tolerance and reducing the risk for secondary complications common to stroke ( e.g. , falls result ing in fractures and cardiac events ) ",
"Objective : Little is known about the long-term effectiveness after stroke of interventions for behaviour modification and ensuring concordance with therapies . We describe a follow-up study of a previous r and omized controlled trial of a brief period of behaviour modification . The aim of this study was to determine outcomes three years after the initial intervention . Design : Survivors of the original cohort were contacted and asked to attend for follow-up interview , within a geriatric day hospital . This study was carried out in the Geriatric Day Hospital at Stobhill Hospital , Balornock Road , Glasgow . Interventions : Details of risk factor control , including blood pressure , cholesterol levels and diabetic control , were assessed . Question naires used in the initial study were repeated including the Geriatric Depression Scale score , Euroqol Perceived Health Status and Stroke Services Satisfaction Question naire . Main measures : Primary outcome was collective risk factor control . Clinical outcomes including recurrent cerebrovascular events , medication persistence and perceived health status were also recorded . Results : Mean length of follow-up was 3.6 years ( SD 0.43 ) . Of the 205 patients enrolled in the initial study , 102 patients attended for repeat interview ( 49 intervention/53 control ) . There were no significant differences in the percentage of controlled risk factors between groups ( intervention 51.7 % versus control 55.9 % , P = 0.53 ) . Similarities were observed in the number of recurrent clinical events and medication persistence between groups . No overall difference was observed in perceived health status , satisfaction with care or depression scores . Conclusions : Brief intervention with respect to behaviour modification and risk factor control does not appear to have any long-term benefit . These results must be cautiously interpreted in light of the small study number and further research is required",
"Abstract Purpose : This evaluation compared a new self-management program with l and and water exercise ( Moving On after STroke or MOST ) to a st and ard education program ( Living with Stroke or LWS ) . Participants : Of 30 persons with stroke ( average age 68 and 2 years post stroke ) , 18 selected MOST and 12 chose LWS . Sixteen care partners participated . Method : Assessment s at baseline , program completion , and 3-month follow-up included the Reintegration to Normal Living ( RNL ) Index , Activity-specific Balance Confidence ( ABC ) scale , exercise participation , and goal attainment ( for the MOST group ) . Program delivery costs were calculated and focus groups conducted to examine participant expectations and experiences . Results : Social support was an important benefit of both programs , but only MOST participants improved significantly on the RNL ( p ABC ( p short-term personal goals in MOST were achieved , and overall goal attainment was above the expected level . At follow-up , a higher percentage of MOST participants were enrolled in exercise programs ( p self-management programs with exercise are more costly to deliver than st and ard educational programs , these preliminary results indicate that such programs may be more effective in helping persons with stroke and care partners deal with the challenges of living with stroke",
"OBJECTIVES To compare the effects of 3 different exercise training regimens on cardiorespiratory fitness and coronary risk factor reduction in subjects with unilateral stroke . DESIGN A cluster assignment by residential location repeated- measures design . SETTING University-based medical center . PARTICIPANTS Fifty-five subjects with unilateral ischemic stroke were assigned to the following groups : intensity ( n=18 ) , duration ( n=19 ) , and therapeutic exercise ( n=18 ) . INTERVENTION A 14-week intervention with subjects r and omized to 1 of 3 interventions : ( 1 ) moderate intensity , shorter duration ( MISD ) exercise ( gradually increasing exercise intensity while keeping exercise duration constant at 30 min ) , ( 2 ) low-intensity , longer duration ( LILD ) exercise ( gradually increasing duration to 60 min while keeping exercise intensity constant ) , or ( 3 ) conventional therapeutic exercise ( TE ) consisting mainly of strength , balance , and range of motion activities . All groups exercised 3 days per week . MAIN OUTCOME MEASURES Peak oxygen consumption ( VO2peak ) , submaximal oxygen consumption ( VO2 ) , lipid panel , and resting blood pressure . RESULTS The MISD group attained more favorable effects on systolic ( P ) and diastolic blood pressure ( P and total cholesterol ( TC ) ( P MISD ( P triglycerides compared with TE ( P VO2peak and submaximal VO2 in any of the groups . CONCLUSIONS Overall , both MISD and LILD conditions achieved greater clinical and significant gains in coronary risk reduction compared with TE",
"Objective : To assess the rate , degree , and predictors of recovery from a disabled to nondisabled state in patients disabled after recurrent ischemic stroke . Methods : Patients with ischemic stroke enrolled in the Management of Atherothrombosis with Clopidogrel in High Risk Patients ( MATCH ) Study underwent prospect i ve assessment of their modified Rankin score ( mRS ) at 1 , 3 , 6 , 12 , and 18 months after enrollment and after recurrent stroke . Patients disabled ( defined as mRS ≥ 3 ) after recurrence were analyzed for recovery ( defined as mRS Three hundred forty-five ( 54 % ) of 637 patients were disabled after recurrent ischemic stroke ; 115 ( 33 % ) patients had been disabled and 230 ( 66 % ) nondisabled before stroke recurrence . At recurrence , the degree of disability was moderate ( mRS 3 ) in 135 ( 39 % ) patients , severe ( mRS 4 ) in 139 ( 40 % ) , and very severe ( mRS 5 ) in 71 ( 21 % ) . After 12 months ' median follow-up , 117 ( 34 % , 95 % CI : 29 to 39 % ) had recovered : 68 ( 50 % , 42 to 59 % ) of 135 moderately disabled , 45 ( 32 % , 25 to 41 % ) of 139 severely disabled , and 4 ( 6 % , 2 to 14 % ) of 71 very severely disabled ; 70 ( 20.3 % ) patients died . From recurrence , median time to recovery was 6 months ( mRS 3 ) and 18 months ( mRS 4 ) ; 94 % with very severe disability had not recovered at 18 months . Independent predictors of recovery were moderate disability at recurrence ( mRS 3 ) compared with severe ( mRS 4 : hazard ratio [ HR ] 1.5 ; 95 % CI 1.04 to 2.3 ) or very severe disability ( mRS 5 : HR 7.6 ; 2.7 to 20 ) and a nondisabled vs disabled state before recurrence ( HR 4.0 ; 2.3 to 6.8 ) . Conclusions : The rate of recovery from recurrent ischemic stroke was greatest in the first 6 months ; one-third of patients recovered within 12 months . The significant predictors of recovery were a nondisabled state before recurrence and increasing severity of the recurrent stroke",
"OBJECTIVES To examine the effect of exercise on depressive symptoms and the effect of baseline depressive symptoms on the benefits from exercise in stroke survivors who have completed acute rehabilitation . DESIGN Planned secondary analysis of the data from a 9-month r and omized , controlled trial . SETTING Participant homes . PARTICIPANTS One hundred stroke survivors who had completed acute rehabilitation . INTERVENTION A progressive , structured , 3-month physical exercise program . MEASUREMENTS Demographics , stroke characteristics , impairments , functional limitations , the Geriatric Depression Scale , the Stroke Impact Scale , and the Medical Outcomes Study 36-Item Short Form . RESULTS Baseline rates of depressive symptoms and other stroke sequelae were similar between the two arms . Ninety-three participants were assessed immediately after the intervention ( 3 months after enrollment ) , and 80 were assessed 9 months after enrollment . Six ( 14 % ) of the exercise group and 16 ( 35.6 % ) of the usual-care group had depressive symptoms at 3 months ( P = .03 ) . At 9 months , three ( 7.5 % ) of the exercisers had significant depressive symptoms compared with 10 ( 25 % ) who received usual care ( P = .07 ) . Participants with and without baseline depressive symptoms had equivalent treatment-related gains in impairments and functional limitations , but only participants with depressive symptoms had improved quality of life . CONCLUSION Exercise may help reduce poststroke depressive symptoms . Depressive symptoms do not limit gains in physical function due to exercise . Exercise may contribute to improved quality of life in those with poststroke depressive symptoms",
"This paper describes constructing the Assessment of Quality of Life ( AQoL ) instrument ; design ed to measure health-related quality of life ( HRQoL ) , and to be the descriptive system for a multi-attribute utility instrument . Unlike previous utility instruments ' descriptive systems , the AQoL 's has been developed using state-of-the-art psychometric procedures . The result is a descriptive system which emphasizes five different facets of HRQoL and which can cl aim to have construct validity . Based on the WHO 's definition of health a model of HRQoL was developed . Items were written by focus groups of doctors and the research ers . These were administered to a construction sample , comprising hospital patients , and community members chosen at r and om . Final construction was through an iterative process of factor and reliability analyses . The AQoL measures 5 dimensions : illness , independent living , social relationships , physical senses and psychological wellbeing . Each has three items . Exploratory factor analysis showed the dimensions were orthogonal , and each was unidimensional . Internal consistency was α = 0.81 . Structural equation modeling explored its internal structure ; the comparative fit index was 0.90 . These preliminary results indicate the AQoL has the prerequisite qualities for a psychometric HRQoL instrument for evaluation ; replication with a larger sample is needed to verify these findings . Scaling it for economic evaluation using utilities is being undertaken . Respondents have indicated the AQoL is easy to underst and and is quickly completed . Its initial properties suggest it may be widely applicable",
"AIM This paper reports a study evaluating the short-term impact of nursing-led , co-ordinated care after discharge following carotid endarterectomy . BACKGROUND Patient education about stroke risk factors , combined systematic ally with carotid endarterectomy , holds unrealized potential to improve patient outcomes . Nurses are well-placed in the healthcare system to co-ordinate this type of education . METHODS A r and omized controlled trial was conducted between October 2001 and October 2002 . Patients having carotid endarterectomy ( n = 133 ) were r and omized to either the intervention ( n = 66 ) or control group ( n = 67 ) . The intervention consisted of telephone liaison with the patient by a Registered Nurse at 2 , 6 and 12 weeks following carotid endarterectomy , combined with education about stroke risk factor management and structured liaison with the patient 's surgeon and referring general practitioner . While patients allocated to the control group did not receive any postoperative telephone contact directly from the Registered Nurse during the study , their general practitioners received structured postoperative liaison . RESULTS The co-ordinated care postdischarge intervention had a statistically significant positive effect on patient knowledge of stroke warning signs ( P = 0.002 ) , patient self-reported changes to improve lifestyle ( P = 0.006 ) and diet modification ( P vascular surgery patients is needed",
"Objective : To find out if there were any differences in improvement and maintenance of motor function , activity of daily living and grip strength between patients with first-ever stroke receiving two different strategies of physical exercise during the first year after stroke . Design : A longitudinal r and omized controlled stratified trial . Setting : Rehabilitation institutions , community , patients ' homes and nursing homes . Subjects : Seventy-five male and female first-time-ever stroke patients : 35 in an intensive exercise group and 40 in a regular exercise group . Intervention : The intensive exercise group received physiotherapy with focus on intensive exercises in four periods during the first year after stroke . The regular exercise group patients were followed up according to their subjective needs during the corresponding year . Main outcome measures : Motor Assessment Scale , Barthel Index of Activities of Daily Living , and grip strength . Results : Both groups improved significantly up to six months when function stabilized . The groups did not differ significantly on any test occasions . The difference of improvement from admission to discharge was significant in favour of the intensive exercise group , in the Motor Assessment Scale total score ( intensive exercise group 7.5 ; regular exercise group 1.7 , P = 0.01 ) , and in the Barthel Index of Activities of Daily Living total score ( 17.4 versus 8.9 , P = 0.04 ) . Conclusion : Motor function , activities of daily living functions and grip strength improved initially and were maintained during the first year after stroke in all patients irrespective of exercise regime . This indicates the importance of motivation for regular exercise in the first year following stroke , achieved by regular check-ups",
"OBJECTIVE To assess the effects of a community-based exercise program on motor recovery and functional abilities of the paretic upper extremity in persons with chronic stroke . DESIGN R and omized controlled trial . SETTING Rehabilitation research laboratory and a community hall . PARTICIPANTS A sample of 63 people ( > or = 50y ) with chronic deficits result ing from stroke ( onset > or = 1y ) . INTERVENTIONS The arm group underwent an exercise program design ed to improve upper-extremity function ( 1h/session , 3 sessions/wk for 19wk ) . The leg group underwent a lower-extremity exercise program . MAIN OUTCOME MEASURES The Wolf Motor Function Test ( WMFT ) , Fugl-Meyer Assessment ( FMA ) , h and -held dynamometry ( grip strength ) , and the Motor Activity Log . RESULTS Multivariate analysis showed a significant group by time interaction ( Wilks lambda=.726 , P=.017 ) , indicating that overall , the arm group had significantly more improvement than the leg group . Post hoc analysis demonstrated that gains in WMFT ( functional ability ) ( P=.001 ) and FMA ( P=.001 ) scores were significantly higher in the arm group . The amount of improvement was comparable to other novel treatment approaches such as constraint-induced movement therapy or robot-aided exercise training previously reported in chronic stroke . Participants with moderate arm impairment benefited more from the program . CONCLUSIONS The pilot study showed that a community-based exercise program can improve upper-extremity function in persons with chronic stroke . This outcome justifies a larger clinical trial to further assess efficacy and cost effectiveness",
"SIR— Interventions with an educational or counselling component have been reported to be effective in a variety of patient groups to encourage smoking cessation [ 1 ] , lower blood pressure ( BP ) [ 2 , 3 ] , achieve modest reductions in cholesterol [ 4 ] , and promote weight loss [ 5 ] . Evaluation of the impact of education on physical outcomes is lacking in stroke disease , despite evidence that inadequate provision of information may adversely affect compliance with secondary prevention and psychosocial outcomes [ 6 ] . We describe a single-blind r and omised controlled trial of health education and counselling for patients with stroke or transient ischaemic attack ( TIA ) , and its effects on risk factors , satisfaction , mood and perceived health status",
"OBJECTIVES To determine the feasibility and effect of exercise training after stroke . DESIGN R and omized exploratory trial comparing exercise training ( including progressive endurance and resistance training ) with relaxation ( attention control ) . SETTING Interventions were performed in a rehabilitation hospital . PARTICIPANTS Sixty-six independently ambulatory patients ( mean age 72 , 36 men ) without significant dysphasia , confusion , or medical contraindications to exercise training who had completed their usual rehabilitation and had been discharged from hospital . INTERVENTION Both interventions were held three times a week for 12 weeks . Up to seven patients attended each session . MEASUREMENTS The Functional Independence Measure ; Nottingham Extended Activities of Daily Living ; Rivermead Mobility Index ; functional reach ; sit-to-st and ; elderly mobility score ; timed up- and -go ; Medical Outcomes Study 36-Item Short Form Question naire , version 2 ( SF-36 ) ; Hospital Anxiety and Depression Score ; aspects of physical fitness ( comfortable walking speed , walking economy , and explosive leg extensor power ) were measured at baseline , immediately after interventions ( 3 months ) , and 7 months after baseline . RESULTS The median number of intervention sessions attended was 36 ( interquartile range ( IQR ) 30.00 - 36.75 ) for exercise and 36 ( IQR 30.50 - 37.00 ) for relaxation . Adherence to the individual exercises ranged from 94 % to 99 % . At 3 months , role-physical ( an item in SF-36 ) , timed up- and -go , and walking economy were significantly better in the exercise group ( analysis of covariance ) . At 7 months , role-physical was the only significant difference between groups . CONCLUSION Exercise training for ambulatory stroke patients was feasible and led to significantly greater benefits in aspects of physical function and perceived effect of physical health on daily life"
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4116e796-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Our previous systematic review of geriatric assessment ( GA ) in oncology included a literature search up to November 2010 . However , the quickly evolving field warranted an up date . Aims of this review : ( i ) provide an overview of all GA instruments developed and /or in use in the oncology setting ; ( ii ) evaluate effectiveness of GA in predicting/modifying outcomes ( e.g. treatment decision impact , treatment toxicity , mortality , use of care ) . MATERIAL S AND METHODS Systematic review of literature published between November 2010 and 10 August 2012 . English , Dutch , French and German- language articles reporting cross-sectional or longitudinal , intervention or observational studies of GA instruments were included . DATA SOURCES MEDLINE , EMBASE , PsycINFO , CINAHL and Cochrane Library . Two research ers independently review ed abstract s , abstract ed data and assessed the quality using st and ardized forms . A meta- analysis method of combining proportions was used for the outcome impact of GA on treatment modification with studies included in this up date combined with those included in our previous systematic review on the use of GA . RESULTS Thirty-five manuscripts reporting 34 studies were identified . Quality of most studies was moderate to good . Eighteen studies were prospect i ve , 11 cross-sectional and 5 retrospective . Three studies examined treatment decision-making impact and found decisions changed for fewer than half of assessed patients ( weighted percent modification is 23.2 % with 95 % confidence interval ( 20.3 % to 26.1 % ) . Seven studies reported conflicting findings regarding predictive ability of GA for treatment toxicity/complications . Eleven studies examined GA predictions of mortality , and reported that instrumental activities of daily living , poor performance status and more numerous GA deficits were associated with increased mortality risk . Other outcomes could not be meta-analyzed . CONCLUSION Consistent with our previous review , several domains of GA are associated with adverse outcomes . However , further research examining effectiveness of GA on treatment decisions and oncologic outcomes is needed
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[
"BACKGROUND Development of a geriatric screening tool is necessary to identify elderly cancer patients who would benefit from comprehensive geriatric assessment ( CGA ) . We develop and evaluate the G-8 screening tool against various reference tests . PATIENTS AND METHODS Analyses were based on 364 cancer patients aged>70 years scheduled to receive first-line chemotherapy included in a multicenter prospect i ve study . The G-8 consists of seven items from the Mini Nutritional Assessment ( MNA ) question naire and age . Our primary reference test is based on a set of seven CGA scales : Activities Daily Living ( ADL ) , Instrumental ADL , MNA , Mini-Mental State Exam , Geriatric Depression Scale , Cumulative Illness Rating Scale-Geriatrics , and Timed Get Up and Go . We considered the presence of at least one question naire with an impaired score as an abnormal reference exam . Additional reference exams are also discussed . RESULTS The prevalence of being at risk varied from 60 % to 94 % according to the various definitions of the reference test . When considering the primary reference test , a cut-off value of 14 for the G-8 tool provided a good sensitivity estimate ( 85 % ) without deteriorating the specificity excessively ( 65 % ) . CONCLUSION The G-8 shows good screening properties for identifying elderly cancer patients who could benefit from CGA",
"Chemotherapy is associated with toxicity in elderly patients with potentially curable malignancies , posing the dilemma of whether to intensify therapy , thereby improving the cure rate , or de-escalate therapy , thereby reducing toxicity , with consequent risks for under- or overtreatment . Adequate tools to define doses and combinations have not been identified for lymphoma patients . We conducted a prospect i ve trial aim ed to evaluate the feasibility and efficacy of chemotherapy modulated according to a modified comprehensive geriatric assessment ( CGA ) in elderly ( aged ≥70 years ) patients with diffuse large B-cell lymphoma ( DLBCL ) . In June 2000 to March 2006 , 100 patients were stratified using a CGA into three groups ( fit , unfit , and frail ) , and they received a rituximab plus cyclophosphamide , doxorubicin , vincristine , and prednisone modulated in dose and drugs according to comorbidities and activities of daily living ( ADL ) and instrumental ADL scores . Treatment was associated with a complete response rate of 81 % and mild toxicity : grade 4 neutropenia in 14 % , anemia in 1 % , and neurological and cardiac toxicity in 2 % of patients . At a median follow-up of 64 months , 51 patients were alive , with 5-year disease-free , overall , and cause-specific survival rates of 80 % , 60 % , and 74 % , respectively . Chemoimmunotherapy adjustments based on a CGA are associated with manageable toxicity and excellent outcomes in elderly patients with DLBCL . Wide use of this CGA-driven treatment may result in better cure rates , especially in fit and unfit patients",
"Background : Elderly cancer patients form a heterogeneous population in which therapeutic decision-making is often difficult . The aim of this r and omised phase II trial was to evaluate the feasibility and activity of weekly docetaxel/gemcitabine ( DG ) followed by erlotinib after progression ( arm A ) vs erlotinib followed by DG after progression ( arm B ) in fit elderly patients with advanced non small-cell lung cancer ( NSCLC ) . Methods : Elderly chemotherapy-naive patients with stage IIIB/IV NSCLC were selected after a comprehensive geriatric assessment ( socioeconomic , cognitive , depression , ADL and IADL assessment s ) . The primary endpoint was the time to second progression ( TTP2 ) . Overall survival ( OS ) , the time to first progression ( TTP1 ) and safety were secondary endpoints . Results : Between July 2006 and November 2008 , 22 centres enrolled 100 patients . TTP2 was 7.5 and 5.8 months in arm A and arm B , respectively ; TTP1 was 4.7 and 2.7 months ; and the median OS time was 9.4 and 7.1 months ; the respective 1-year survival rates were 36.2 and 31.4 % . There was no major unexpected toxicity . Conclusion : These results suggest that weekly DG , followed by erlotinib , is a promising treatment for fit elderly patients with NSCLC ; the efficacy of the reverse sequence was insufficient to recommend it for EGFR-non-selected patients",
"BACKGROUND Elderly patients with advanced non-small-cell lung cancer ( NSCLC ) may derive similar benefit from platinum-based chemotherapy as younger patients . Quality of life ( QoL ) and comprehensive geriatric assessment ( CGA ) is often advocated to assess benefits and risks . PATIENTS AND METHODS A total of 181 chemotherapy-naive patients [ ≥70 years , performance score ( PS ) of 0 - 2 ] with stage III-IV NSCLC received carboplatin and gemcitabine ( CG ) ( n = 90 ) or carboplatin and paclitaxel ( CP ) ( n = 91 ) every 3 weeks for up to four cycles . Primary end point was change in global QoL from baseline compared with week 18 . Pretreatment CGA and mini geriatric assessment during and after treatment were undertaken . A principal component ( PC ) analysis was carried out to determine the underlying dimensions of CGA and QoL and subsequently related to survival . RESULTS There were no changes in QoL after treatment . The number of QoL responders ( CG arm , 12 % ; CP arm , 5 % ) was not significantly different . CGA items were only associated with neuropsychiatric toxicity . Quality -adjusted survival was not different between treatment arms . The PC analysis derived from nine CGA , six QoL and one PS score indicated only one dominant dimension . This dimension was strongly prognostic , and physical and role functioning , Groningen Frailty Indicator and Geriatric Depression Scale were its largest contributors . CONCLUSIONS Paclitaxel or gemcitabine added to carboplatin did not have a differential effect on global QoL. CGA was associated with toxic effects in a very limited manner . CGA and QoL items measure one underlying dimension , which is highly prognostic",
"Purpose Lung cancer chemotherapy decisions in patients ≥70 years old are complex because of toxicity , comorbidity and the limited data on patient preferences . We examined the relationships between preferences and chemotherapy use in this group of patients . Methods and patients We used a question naire describing four hypothetical lung cancer treatment options . Eighty-three elderly ( ≥70 years old ) lung cancer patients were informed about their diagnosis and therapeutic choices and then asked to choose one of the four options . Patients had previously been included in a prospect i ve study to explore geriatric evaluation in an oncology unit and all had given written informed consent . Results Older patients ( n=83 ) diagnosed with lung cancer ( non-small- and small-cell lung cancer ) from January 2006 to February 2008 were recruited from a single centre . The mean patient age was 77 years ( range : 70–91 ) . Eighty-one patients ( 97.6 % ) were men . Non-small-cell lung cancer ( NSCLC ) was the diagnosis in 63 patients ( 76 % ) . Most patients selected active treatment ( 38.6 % most survival benefit , 18 % less survival benefit ) and 31.3 % selected no active treatment . Elderly lung cancer patients were significantly more likely to accept aggressive treatments despite high reported toxicities . Although most of the patients were symptomatic at diagnosis , the “ symptom relief ” option was chosen less frequently than the options that could prolong survival . Factors significantly related to patients ’ attitude toward chemotherapy were age ( p Elderly lung cancer patients want to be involved in the decision-making process . Survival was the main treatment objective for more than half of the patients in this study . We have not found other published studies about elderly lung cancer patients ’ decisions about chemotherapy",
"As a result of an increasing life expectancy , the incidence of cancer cases diagnosed in the older population is rising . Indeed , cancer incidence is 11-fold higher in persons over the age of 65 than in younger ones . Despite this high incidence of cancer in older patients , solid data regarding the most appropriate approach and best treatment for older cancer patients are still lacking , mostly due to under-representation of these patients in prospect i ve clinical trials . The clinical behaviour of common malignant diseases , e.g. breast , ovarian and lung cancers , lymphomas and acute leukaemias , may be different in older patients because of intrinsic variation of the neoplastic cells and the ability of the tumour host to support neoplastic growth . The decision to treat or not these patients should be based on patients ' functional age rather than the chronological age . Assessment of patients ' functional age includes the evaluation of health , functional status , nutrition , cognition and the psychosocial and economic context . The purpose of this paper is to focus on the influence of age on cancer presentation and cancer management in older cancer patients and to provide suggestions on clinical trial development and methodology in this population",
"PURPOSE To identify Comprehensive Geriatric Assessment ( CGA ) components independently associated with changes in planned cancer treatment . PATIENTS AND METHODS We prospect ively included 375 consecutive elderly patients with cancer ( ELCAPA01 study ) assessed by geriatricians using the CGA . Multivariate analysis was used to identify factors associated with changes in the cancer treatment ( intensification , decrease , or delayed > 2 weeks ) . Change was defined as a difference between the initial treatment proposal and the final treatment selected in a multidisciplinary meeting . RESULTS Mean age was 79.6 years ( st and ard deviation [ SD ] , 5.6 years ) , and 197 ( 52.5 % ) were women . The most common tumor location was the digestive system ( 58.7 % ) . The mean number of comorbidities was 4.2 ( SD , 2.7 ) per patient , and the mean Cumulative Illness Rating Scale for Geriatrics score was 11.8 ( SD , 5.3 ) . After the CGA , the initial cancer treatment plan was modified for 78 ( 20.8 % ) of 375 patients ( 95 % CI , 16.8 to 25.3 ) , usually to decrease treatment intensity ( 63 [ 80.8 % ] of 78 patients ) . By univariate analysis , cancer treatment changes were associated with Eastern Cooperative Oncology Group performance status ≥ 2 ( 73.3 % in the group with changes v 41.1 % in the in the group without changes ; P , dependency for one or more activities of daily living ( ADL ; 59.0 % v 24.2 % ; P malnutrition ( 81.8 % v 51.2 % ; P , cognitive impairment ( 38.5 % v 24.9 % ; P = .023 ) , depression ( 52.6 % v 21.7 % ; P greater number of comorbidities ( mean , 4.8 [ SD , 2.9 ] v 4.0 [ SD , 2.6 ] ; P = .02 ) . By multivariate analysis , factors independently associated with cancer treatment changes were a lower ADL score ( odds ratio [ OR ] , 1.25 per 0.5-point decrease ; CI , 1.04 to 1.49 ; P = .016 ) and malnutrition ( OR , 2.99 ; CI , 1.36 to 6.58 ; P = .007 ) . CONCLUSION Functional status assessed by the ADL score and malnutrition were independently associated with changes in cancer treatment ",
"OBJECTIVE Current chemotherapy protocol s for gastric cancer present high toxicity . The FOLFIRI regimen has shown promising results with elderly colorectal cancer patients and for gastric cancer patients but this is the first report on elderly gastric cancer patients . DESIGN In this multicenter non-r and omized phase II trial , we administered the FOLFIRI chemotherapy protocol ( irinotecan [ 180 mg/m(2 ) ] , fluorouracil [ 5-FU ] [ 400 mg/m(2 ) ] and folinic acid 400 mg/m(2 ) or 200mg/m(2 ) of l-folinic acid ) to patients aged over 70 years with locally-advanced or metastatic gastric cancer combined with Comprehensive Geriatric Assessment ( CGA ) . Responses were assessed at 2 months . RESULTS Forty-two patients received eight cycles of the FOLFIRI regimen , with 82.5 % of patients showing disease control : 10 patients ( 26 % ) showing objective ( partial or complete ) responses and 23 ( 57.5 % ) showing stable disease . One-year overall survival ( OS ) was 41.5 % [ 95%CI 26.5 - 56.0 ] and one-year progression-free survival ( PFS ) was 31.8 % [ 95%CI 18.4 - 46.1 % ] . We observed 10 Grade 3/4 hematologic toxicities with one febrile neutropenia . CGA data demonstrated that geriatric functions were not altered by treatment and that nutritional status improved over treatment . CONCLUSIONS Results show excellent disease control and relatively high survival rates with limited toxicity similar to younger patients indicating that this regimen should be considered as a possible treatment in advanced gastric cancer of the elderly",
"Few data are available to help predict which older cancer patient is at risk of developing chemotherapy-related toxicity . This study was a pilot for a project design ing a predictive risk score . Chemotherapy patients aged 70 years and older were prospect ively enrolled . Chemotherapies were adjusted for their published toxicity . 60 patients were enrolled , 59 were evaluable . Mean dose-intensity was 90.3 % , range 33.3 - 129.0 % . 47 % of the patients experienced grade 4 haematological and /or grade 3 - 4 non-haematological toxicity . Published toxicity ( MAX2 ) , diastolic blood pressure , marrow invasion and lactate dehydrogenase ( LDH ) were all associated with toxicity ( P toxicity . Design ing a composite predictive score to use in assessing the toxicity of multiple chemotherapy regimens therefore appears to be a valid undertaking",
"BACKGROUND The purpose of this study was to determine the relationship of frailty and 6-month postoperative costs . METHODS Subjects aged ≥ 65 years undergoing elective colorectal operations were enrolled in a prospect i ve observational study . Frailty was assessed by a vali date d measure of function , cognition , nutrition , comorbidity burden , and geriatric syndromes . Frailty was quantified by summing the number of positive characteristics in each subject . RESULTS Sixty subjects ( mean age , 75 ± 8 years ) were studied . Inpatient mortality was 2 % ( n = 1 ) . Overall , 40 % of subjects ( n = 24 ) were considered nonfrail , 22 % ( n = 13 ) were prefrail , and 38 % ( n = 22 ) were frail . With advancing frailty , hospital costs increased ( P and costs from discharge to 6-months increased ( P to increased rates of discharge institutionalization ( P and 30-day readmission ( P = .044 ) . CONCLUSIONS A simple , brief preoperative frailty assessment accurately forecasts increased surgical hospital costs and postdischarge to 6-month healthcare costs after colorectal operations in older adults",
"PURPOSE Older adults are vulnerable to chemotherapy toxicity ; however , there are limited data to identify those at risk . The goals of this study are to identify risk factors for chemotherapy toxicity in older adults and develop a risk stratification schema for chemotherapy toxicity . PATIENTS AND METHODS Patients age ≥ 65 years with cancer from seven institutions completed a prechemotherapy assessment that captured sociodemographics , tumor/treatment variables , laboratory test results , and geriatric assessment variables ( function , comorbidity , cognition , psychological state , social activity/support , and nutritional status ) . Patients were followed through the chemotherapy course to capture grade 3 ( severe ) , grade 4 ( life-threatening or disabling ) , and grade 5 ( death ) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events . RESULTS In total , 500 patients with a mean age of 73 years ( range , 65 to 91 years ) with stage I to IV lung ( 29 % ) , GI ( 27 % ) , gynecologic ( 17 % ) , breast ( 11 % ) , genitourinary ( 10 % ) , or other ( 6 % ) cancer joined this prospect i ve study . Grade 3 to 5 toxicity occurred in 53 % of the patients ( 39 % grade 3 , 12 % grade 4 , 2 % grade 5 ) . A predictive model for grade 3 to 5 toxicity was developed that consisted of geriatric assessment variables , laboratory test values , and patient , tumor , and treatment characteristics . A scoring system in which the median risk score was 7 ( range , 0 to 19 ) and risk stratification schema ( risk score : percent incidence of grade 3 to 5 toxicity ) identified older adults at low ( 0 to 5 points ; 30 % ) , intermediate ( 6 to 9 points ; 52 % ) , or high risk ( 10 to 19 points ; 83 % ) of chemotherapy toxicity ( P the risk of chemotherapy toxicity in older adults . Geriatric assessment variables independently predicted the risk of toxicity ",
"Purpose The prevalence of elderly and comorbid patients ( pts ) with malignant lymphoma ( ML ) will steadily increase in future . Elderly patients comprise a heterogeneous population . Comprehensive geriatric assessment ( CGA ) is an established diagnostic tool in geriatric medicine . However , the prognostic value in patients with ML is unclear . We sought to establish a relationship between results of CGA and survival time in patients with ML . Methods Newly diagnosed patients with ML and indication for chemotherapeutical treatment were prospect ively recruited in an observational trial . In addition to usual diagnostic work up , a CGA including activities of daily living ( ADL ) , instrumental activities of daily living ( IADL ) and comorbidities was performed . Association of patients ’ characteristics and results of CGA with survival were analysed according to Kaplan – Meier method and in a multivariate Cox-regression analysis . Results About 143 patients were included , median age was 63 years , 63 patients were women . Median follow-up of surviving patients was 62 months . Sixty-six patients died within this time . Advanced age , poor Karnofsky performance status , dependence in ADL and IADL and presence of severe comorbidity were significantly associated with shorter survival time . In a Cox-regression analysis , IADL ( HR 2.1 ; 95 % CI 1.1–3.9 ) and comorbidity ( HR 1.9 ; 95 % CI 0.9–3.9 ) were independent and strongest associated with survival time . Conclusion Results of CGA , such as IADL and comorbidities , are prognostic variables for survival of patients with ML . Results should be vali date d in homogeneous clinical groups and if confirmed included in diagnostic and therapeutic algorithm",
"OBJECTIVES To test the feasibility and utility of a bedside geriatric assessment ( GA ) to detect impairment in multiple geriatric domains in older adults initiating chemotherapy for acute myelogenous leukemia ( AML ) . DESIGN Prospect i ve observational cohort study . SETTING Single academic institution . PARTICIPANTS Individuals aged 60 and older with newly diagnosed AML and planned chemotherapy . MEASUREMENTS Bedside GA was performed during inpatient exmination for AML . GA measures included the modified Mini-Mental State Examination ; Center for Epidemiologic Studies Depression Scale ; Distress Thermometer , Pepper Assessment Tool for Disability ( includes self- reported activities of daily living ( ADLs ) , instrumental ADLs , and mobility questions ) ; Short Physical Performance Battery ( includes timed 4-m walk , chair st and s , st and ing balance ) ; grip strength , and Hematopoietic Cell Transplantation Comorbidity Index . RESULTS Of 54 participants ( mean age 70.8 ± 6.4 ) eligible for this analysis , 92.6 % completed the entire GA battery ( mean time 44.0 ± 14 minutes ) . The following impairments were detected : cognitive impairment , 31.5 % ; depression , 38.9 % ; distress , 53.7 % ; impairment in ADLs , 48.2 % ; impaired physical performance , 53.7 % ; and comorbidity , 46.3 % . Most were impaired in one ( 92.6 % ) or more ( 63 % ) functional domains . For the 38 participants rated as having good performance status according to st and ard oncologic assessment ( Eastern Cooperative Oncology Performance Scale score ≤1 ) , impairments in individual GA measures ranged from 23.7 % to 50 % . Significant variability in cognitive , emotional , and physical status was detected even after stratification according to tumor biology ( cytogenetic risk group classification ) . CONCLUSION Inpatient GA was feasible and added new information to st and ard oncology assessment , which may be important for stratifying therapeutic risk in older adults with AML",
"The histone deacetylase inhibitor ( HDACi ) valproic acid ( VPA ) has been shown to be active on acute myeloid leukemia ( AML ) and refractory anemia with excess of blasts ( RAEB ) . Thirty-one elderly AML/RAEB patients ( AML n=25 ; RAEB n=6 ) with a high rate of comorbidity were entered in a phase II study with low-dose cytarabine ( Ara-C ) and VPA . Fitness was evaluated by means of the Comprehensive Geriatric Assessment ( CGA ) , including the Cumulative Illness Rating Scale ( CIRS ) score , the self-sufficiency scores of Activity of Daily Living ( ADL ) and Instrumental Activity of Daily Living ( IADL ) . Eight patients obtained a lasting complete remission and 3 other patients obtained hematologic improvement for a total response rate of 35 % . Five of 11 responding patients were relapsed or resistant after a previous treatment with Ara-C. Seven of 11 responding patients were assessed as frail at enrollment and /or had IADL impairment . Grade s 3 and 4 toxicities were mainly hematological . Low-dose Ara-C and VPA is a relatively non-toxic combination with good therapeutic activity in elderly patients with AML/RAEB . This therapeutic approach represents an alternative treatment for patients who can not undergo st and ard induction therapy",
"PURPOSE Factors captured in a geriatric assessment can predict morbidity and mortality in older adults , but are not routinely measured in cancer clinical trials . This study evaluated the implementation of a geriatric assessment tool in the cooperative group setting . PATIENTS AND METHODS Patients age ≥ 65 with cancer , who enrolled on cooperative group cancer trials , were eligible to enroll on Cancer and Leukemia Group B ( CALGB ) 360401 . They completed a geriatric assessment tool before initiation of protocol therapy , consisting of valid and reliable geriatric assessment measures which are primarily self-administered and require minimal re sources and time by healthcare providers . The assessment measures functional status , comorbidity , cognitive function , psychological state , social support , and nutritional status . The protocol specified criteria for incorporation of the tool in future cooperative group trials was based on the time to completion and percent of patients who could complete their portion without assistance . Patient satisfaction with the tool was captured . RESULTS Of the 93 patients who enrolled in this study , five ( 5 % ) met criteria for cognitive impairment and three did not complete the cognitive screen , leaving 85 assessable patients ( median age , 72 years ) . The median time to complete the geriatric assessment tool was 22 minutes , 87 % of patients ( n = 74 ) completed their portion without assistance , 92 % ( n = 78 ) were satisfied with the question naire length , 95 % ( n = 81 ) reported no difficult questions , and 96 % ( n = 82 ) reported no up setting questions . One hundred percent of health care professionals completed their portion . CONCLUSION This brief , primarily self-administered geriatric assessment tool met the protocol specified criteria for inclusion in future cooperative group clinical trials",
"BACKGROUND The aim of this r and omized phase II trial was to evaluate the feasibility and activity of weekly gemcitabine ( G ) followed by erlotinib at disease progression ( arm A ) versus erlotinib followed by G at progression ( arm B ) in vulnerable elderly patients with advanced non small-cell lung cancer ( NSCLC ) , selected on the basis of a comprehensive geriatric assessment ( CGA ) . METHODS Vulnerable elderly chemotherapy-naive patients with stage IIIB/IV NSCLC were selected after a CGA ( socioeconomic , cognitive and emotional status , depression , nutritional status , ADL and IADL assessment s ) . The primary endpoint was the time to second progression ( TTP2 ) . Overall survival ( OS ) , time to first progression ( TTP1 ) and safety were secondary endpoints . RESULTS Between May 2006 and January 2010 , 21 centers enrolled 100 patients , of whom 94 were eligible . TTP2 was 4.3 and 3.5 months in arm A and arm B , respectively ; TTP1 was 2.5 and 2.2 months ; and the median OS time was 4.4 and 3.9 months . The respective one-year survival rates were 27.3 % and 20 % . There was no major unexpected toxicity . CONCLUSION In vulnerable elderly patients with NSCLC not selected for EGFR expression , both strategies were feasible but had modest efficacy . Further studies are needed to identify elderly patients who should receive palliative care only",
"Abstract We conducted a prospect i ve study to compare epirubicin , cyclophosphamide , vinblastine , prednisone and rituximab ( R-miniCEOP ) with cyclophosphamide , doxorubicin , vincristine , prednisone and rituximab ( R-CHOP ) for the treatment of “ fit ” elderly patients with diffuse large B-cell lymphoma ( DLBCL ) . Patients over the age of 65 with stage II – IV DLBCL were screened with a comprehensive geriatric assessment . Patients were r and omized to receive six courses of R-miniCEOP ( n = 114 ) or R-CHOP ( n = 110 ) . Overall , the rate of complete remission was 70 % ( p = 0.466 ) . After a median follow-up of 42 months , 5-year event-free survival ( EFS ) rates were 46 % and 48 % for R-miniCEOP and R-CHOP , respectively ( p = 0.538 ) . Patients older than 72 years and with low-risk disease had a better outcome when treated with R-miniCEOP ( p = 0.011 ) . Overall R-CHOP and R-miniCEOP are similarly effective for elderly “ fit ” patients with DLBCL . The less intense R-miniCEOP may be an acceptable option for the treatment of relatively older patients with low-risk disease"
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4116e7d2-06ff-11f0-808a-c43d1ab1c353
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Congestive heart failure results in clinical signs of edema , shortness of breath , and decreased quality of life . The effective management of patients with congestive heart failure in long term home care setting s is important in reducing rehospitalization , emergency department visits and improving quality of life . Telehealth interventions following hospital discharge in various setting s have been reported in the published literature as having an impact on decreasing emergency department visits , rehospitalization and quality of life . The data on its effectiveness with patients in a long term home health agency program however , is limited
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"BACKGROUND Heart failure treatment guidelines emphasize daily weight monitoring for patients with heart failure , but data to support this practice are lacking . Using a technology-based heart failure monitoring system , we determined whether daily reporting of weight and symptoms in patients with advanced heart failure would reduce rehospitalization and mortality rates despite aggressive guideline -driven heart failure care . METHODS This was a r and omized , controlled trial . Patients hospitalized with New York Heart Association class III or IV heart failure , with a left ventricular ejection fraction receive heart failure program care or heart failure program care plus the AlereNet system ( Alere Medical , Reno , Nev ) and followed-up for 6 months . The primary end point was 6-month hospital readmission rate . Secondary end points included mortality , heart failure hospitalization readmission rate , emergency room visitation rate , and quality of life . RESULTS Two hundred eighty patients from 16 heart failure centers across the United States were r and omized : 138 received the AlereNet system and 142 received st and ard care . Mean age was 59 + /- 15 years and 68 % were male . The population had very advanced heart failure , New York Heart Association class III ( 75 % ) or IV ( 25 % ) , as evidence d by serum norepinepherine levels , 6-minute walk distance and outcomes . No differences in hospitalization rates were observed . There was a 56.2 % reduction in mortality ( P patients with advanced heart failure . Despite no difference in the primary end point of rehospitalization rates , mortality was significantly reduced for patients r and omized to the AlereNet system without an increase in utilization , despite specialized and aggressive heart failure care in both groups",
"BACKGROUND Case management is believed to promote continuity of care and decrease hospitalization rates , although few controlled trials have tested this approach . OBJECTIVE To assess the effectiveness of a st and ardized telephonic case-management intervention in decreasing re source use in patients with chronic heart failure . METHODS A r and omized controlled clinical trial was used to assess the effect of telephonic case management on re source use . Patients were identified at hospitalization and assigned to receive 6 months of intervention ( n = 130 ) or usual care ( n = 228 ) based on the group to which their physician was r and omized . Hospitalization rates , readmission rates , hospital days , days to first rehospitalization , multiple readmissions , emergency department visits , inpatient costs , outpatient re source use , and patient satisfaction were measured at 3 and 6 months . RESULTS The heart failure hospitalization rate was 45.7 % lower in the intervention group at 3 months ( P = .03 ) and 47.8 % lower at 6 months ( P = .01 ) . Heart failure hospital days ( P = .03 ) and multiple readmissions ( P = .03 ) were significantly lower in the intervention group at 6 months . Inpatient heart failure costs were 45.5 % lower at 6 months ( P = .04 ) . A cost saving was realized even after intervention costs were deducted . There was no evidence of cost shifting to the outpatient setting . Patient satisfaction with care was higher in the intervention group . CONCLUSIONS The reduction in hospitalizations , costs , and other re source use achieved using st and ardized telephonic case management in the early months after a heart failure admission is greater than that usually achieved with pharmaceutical therapy and comparable with other disease management approaches",
"Background Telemonitoring of patients with chronic heart failure ( CHF ) is an emerging concept to detect early warning signs of impending acute decompensation in order to prevent hospitalization . Objective The goal of the MOBIle TELemonitoring in Heart Failure Patients Study ( MOBITEL ) was to evaluate the impact of home-based telemonitoring using Internet and mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation . Methods Patients were r and omly allocated to pharmacological treatment ( control group ) or to pharmacological treatment with telemedical surveillance for 6 months ( tele group ) . Patients r and omized into the tele group were equipped with mobile phone – based patient terminals for data acquisition and data transmission to the monitoring center . Study physicians had continuous access to the data via a secure Web portal . If transmitted values went outside individually adjustable borders , study physicians were sent an email alert . Primary endpoint was hospitalization for worsening CHF or death from cardiovascular cause . Results The study was stopped after r and omization of 120 patients ( 85 male , 35 female ) ; median age was 66 years ( IQR 62 - 72 ) . The control group comprised 54 patients ( 39 male , 15 female ) with a median age of 67 years ( IQR 61 - 72 ) , and the tele group included 54 patients ( 40 male , 14 female ) with a median age of 65 years ( IQR 62 - 72 ) . There was no significant difference between groups with regard to baseline characteristics . Twelve tele group patients were unable to begin data transmission due to the inability of these patients to properly operate the mobile phone ( “ never beginners ” ) . Four patients did not finish the study due to personal reasons . Intention-to-treat analysis at study end indicated that 18 control group patients ( 33 % ) reached the primary endpoint ( 1 death , 17 hospitalizations ) , compared with 11 tele group patients ( 17 % , 0 deaths , 11 hospitalizations ; relative risk reduction 50 % , 95 % CI 3 - 74 % , P = .06 ) . Per- protocol analysis revealed that 15 % of tele group patients ( 0 deaths , 8 hospitalizations ) reached the primary endpoint ( relative risk reduction 54 % , 95 % CI 7 - 79 % , P= .04 ) . NYHA class improved by one class in tele group patients only ( P Tele group patients who were hospitalized for worsening heart failure during the study had a significantly shorter length of stay ( median 6.5 days , IQR 5.5 - 8.3 ) compared with control group patients ( median 10.0 days , IQR 7.0 - 13.0 ; P= .04 ) . The event rate of never beginners was not higher than the event rate of control group patients . Conclusions Telemonitoring using mobile phones as patient terminals has the potential to reduce frequency and duration of heart failure hospitalizations . Providing elderly patients with an adequate user interface for daily data acquisition remains a challenging component of such a concept",
"OBJECTIVES We sought to determine whether a multidisciplinary outpatient management program decreases chronic heart failure ( CHF ) hospital readmissions and mortality over a six-month period . BACKGROUND Hospital admission for CHF is an important problem amenable to improved outpatient management . METHODS Two hundred patients hospitalized with CHF at increased risk of hospital readmission were r and omized to a multidisciplinary program or usual care . A study cardiologist and a CHF nurse evaluated each patient and made recommendations to the patient 's primary physician before r and omization . The intervention team consisted of a cardiologist , a CHF nurse , a telephone nurse coordinator and the patient 's primary physician . Contact with the patient was on a prespecified schedule . The CHF nurse followed an algorithm to adjust medications . Patients in the nonintervention group were followed as usual . The primary outcome was the composite of the number of CHF hospital admissions and deaths over six months , compared by using a log transformation t test by intention-to-treat analysis . RESULTS The median age of the study patients was 63.5 years , and 39.5 % were women . There were 43 CHF hospital admissions and 7 deaths in the intervention group , as compared with 59 CHF hospital admissions and 13 deaths in the nonintervention group ( p = 0.09 ) . The quality -of-life score , percentage of patients on target vasodilator therapy and percentage of patients compliant with diet recommendations were significantly better in the intervention group . Cost per patient , in 1998 U.S. dollars , was similar in both groups . CONCLUSIONS This study demonstrates that a six-month , multidisciplinary approach to CHF management can improve important clinical outcomes at a similar cost in recently hospitalized high-risk patients with CHF",
"Remote monitoring ( RM ) of homebound heart failure ( HF ) patients has previously been shown to reduce hospital admissions . We conducted a pilot trial of ambulatory , non-homebound patients recently hospitalized for HF to determine whether RM could be successfully implemented in the ambulatory setting . Eligible patients from Massachusetts General Hospital ( n = 150 ) were r and omized to a control group ( n = 68 ) or to a group that was offered RM ( n = 82 ) . The participants transmitted vital signs data to a nurse who coordinated care with the physician over the course of the 6-month study . Participants in the RM program had a lower all-cause per person readmission rate ( mean = 0.64 , SD ± 0.87 ) compared to the usual care group ( mean = 0.73 , SD ± 1.51 ; P-value = .75 ) although the difference was not statistically significant . HF-related readmission rate was similarly reduced in participants . This pilot study demonstrates that RM can be successfully implemented in non-homebound HF patients and may reduce readmission rates ",
"BACKGROUND Few studies have examined the potential benefits of specialist nurse-led programs of care involving home and clinic-based follow-up to optimise the post-discharge management of chronic heart failure ( CHF ) . OBJECTIVE To determine the effectiveness of a hybrid program of clinic plus home-based intervention ( C+HBI ) in reducing recurrent hospitalisation in CHF patients . METHODS CHF patients with evidence of left ventricular systolic dysfunction admitted to two hospitals in Northern Engl and were assigned to a C+HBI lasting 6 months post-discharge ( n=58 ) or to usual , post-discharge care ( UC : n=48 ) via a cluster r and omization protocol . The co- primary endpoints were death or unplanned readmission ( event-free survival ) and rate of recurrent , all-cause readmission within 6 months of hospital discharge . RESULTS During study follow-up , more UC patients had an unplanned readmission for any cause ( 44 % vs. 22 % : P=0.019 , OR 1.95 95 % CI 1.10 - 3.48 ) whilst 7 ( 15 % ) versus 5 ( 9 % ) UC and C+HBI patients , respectively , died ( P = NS ) . Overall , 15 ( 26 % ) C+HBI versus 21 ( 44 % ) UC patients experienced a primary endpoint . C+HBI was associated with a non-significant , 45 % reduction in the risk of death or readmission when adjusting for potential confounders ( RR 0.55 , 95 % CI 0.28 - 1.08 : P=0.08 ) . Overall , C+HBI patients accumulated significantly fewer unplanned readmissions ( 15 vs. 45 : P recurrent hospital stay ( 108 vs. 459 days : P uptake of beta-blocker therapy ( 56 % vs. 18 % : P adherence to Na restrictions ( P hybrid , C+HBI program of care on hospital utilisation in patients with CHF . Its beneficial effects on recurrent readmission and event-free survival are consistent with those applying either a home or clinic-based approach",
"OBJECTIVE To assess the effect of a telephone intervention to improve quality of life among patients with congestive heart failure ( CHF ) . STUDY DESIGN Prospect i ve r and omized study . METHODS Single-site recruitment of 458 patients using Veterans Health Administration care into a r and omized controlled trial with a 1-year preintervention data collection period and a 1-year intervention and follow-up period . To compensate for imbalanced study groups , propensity scores were included in adjusted models of quality of life , satisfaction with care , inpatient utilization , survival , and costs of care . RESULTS Patients aged 45 to 95 years participated in the study ; 22 % were of Hispanic race/ethnicity , and 7 % were African American . All but 5 were male , consistent with the older population among veterans . At baseline , 40 % were in Goldman Specific Activity Scale class I , 42 % were in class III , 6 % were in class II or IV , and 12 % were unclassified . Patients scored a mean ( SD ) of 14 ( 1.5 ) points below the norm on the physical component score . After the yearlong intervention , no differences in clinical outcomes were noted between the intervention group and the control group . The CHF-related costs were higher for the intervention group , as were overall costs that included the cost of the intervention . Intervention group patients reported better compliance with weight monitoring and exercise recommendations . CONCLUSIONS A risk-stratified intervention for patients with CHF result ed in potential behavioral improvements but no survival benefit . A high-cost high-intensity intervention may be required to improve survival for patients with CHF . Inclusion of the costs of interventions is recommended for future research ers",
"The aim of this study was to determine whether using a teleheath system after discharge from formal home health services would improve clinical outcomes and self-management behaviors . Patients were recruited from 10 home health agencies ( HHAs ) across the United States . All patients used the Health Buddy telehealth system during formal home health services . Patients were r and omly assigned to either the telehealth group or the control group upon discharge from the HHA . Patients in the telehealth group used the Health Buddy for an additional 180 days ; patients in the control group received no further telehealth or home health services . Results show that patients who continued using telehealth beyond the formal episode of care showed greater improvements in respiratory status and activities of daily living . None of the patients who used telehealth during this stage had any hospitalizations or Emergency Department ( ED ) events , while 28.3 % of the control group patients required hospitalization and 26.1 % had at least one ED visit . Telehealth patients were more likely to report that they measured their weights daily , and were more likely to report an increase in diuretic dose following sudden weight gain , ankle swelling , or shortness of breath . We conclude that patients with heart failure may benefit from continued use of telehealth following formal home health services . Results of this study will inform managers and clinicians who are responsible for integrating telehealth into chronic disease protocol",
"This article reports a study that pilot tested the effectiveness of a low-technology structured intervention to st and ardize home healthcare management of patients with heart failure ( HF ) within a home health agency ( HHA ) . The purpose of this study was to use low-technology equipment to improve care for patients with HF enrolled in a home health agency . The 9-week intervention was targeted toward the home health nurses and included telephone and home visits , a teaching tool , digital scales , and a log/notebook filled out by the patients in the study . Patient outcomes included decreased rehospitalization , decreased symptoms of HF , and increased quality of life",
"The purpose of this pilot study was to ( a ) determine the feasibility of providing a heart failure disease management program through an in-home telehealth communication device ( Health Buddy ® ) and ( b ) compare the effectiveness of the Health Buddy ® with traditional home management strategies ( telephonic , home visit ) in achieving selected patient outcomes ( self-efficacy , functional status , depression , and health-related quality of life ) . Ninety participants completed the study through 2 months . Thirty percent of participants were either eliminated prior to or withdrawn after enrollment from the study based on Health Buddy ® issues . A mixed model ANOVA revealed those who received telephonic disease management experienced decreased confidence in their ability to manage their heart failure whereas all other groups experienced increased confidence . Further ANOVA analyses indicated improvement over time with no group differences for functional status , depression , or health-related quality of life . These findings suggest that delivering a disease management program through a telehealth communication device is feasible and may be as effective as traditional methods",
"AIMS Heart failure chiefly affects the elderly , with frequent emergency admissions . Telemonitoring can identify worsening heart failure but previous r and omized trials have enrolled selected patient population s. The Home-HF study examined the impact of home telemonitoring on typical heart failure patients discharged from three acute hospitals in North West London , UK . METHODS AND RESULTS Patients hospitalized with heart failure were r and omized to telemonitoring or usual specialist care . Primary outcome measures were days alive and out of hospital . Secondary outcome measures were number and duration of heart failure hospitalizations , clinic visits , and quality of life . We recruited 182 patients . There was no difference in the primary outcome measure in the two groups , but there were significantly fewer unplanned hospitalizations for heart failure decompensation , and a reduction in clinic and emergency room visits in the telemonitoring group . There was no statistically significant difference in the mean direct health service costs . CONCLUSION Home telemonitoring in a typical elderly population of heart failure patients produces a similar outcome to ' usual ' specialist care , but reduces clinic and emergency room visits and unplanned heart failure rehospitalizations at little additional cost . This method of disease monitoring may allow specialist services to increase the number of patients under their care",
"ABSTRACT This trial compared 3 post-hospitalization nursing care models for reducing congestive heart failure ( CHF ) readmission charges during 180-days of follow-up . Subjects received in-person visits at baseline and 60 days plus 1 of 3 care modalities in the interim : ( a ) video-based home telecare ; ( b ) telephone calls ; and ( c ) usual care . CHF-related read-mission charges were > 80 % lower in the telenursing groups compared to usual care , and these groups also had significantly fewer CHF-related emergency visits . In-person visits were more than 3 times longer than telenursing visits ( p Patient self-care adherence , medications , health status , and satisfaction did not significantly differ between groups . Telenursing can reduce CHF hospitalizations and allow increased frequency of communication with patients",
"Community care for heart failure patients is difficult due to multiple comorbidities , polypharmacy , and advanced age of patients . Studies show that hospital admissions and emergency room visits decrease with increased nursing interventions in home and community setting s. The purpose of this study 1 was to assess the effectiveness of regular telephone interventions by nursing students on outcomes of heart failure patients in the home . Senior students were paired with community nursing staff and assigned 2 heart failure patients to follow up by telephone calls for 12 to 14 weeks . Patients who received telephone interventions had fewer hospital readmissions ( 13 % ) than the comparison group ( 35 % ) . Patients in the telephone intervention group also had fewer overt heart failure symptoms as measured by the Minnesota Living With Heart Failure Question naire",
"Patients with a diagnosis of heart failure , registered at the study practice , were recruited into the study . First , they had a cardiologist 's assessment . They were then r and omised into telemonitored patients who measured pulse , BP , weight and video consulted , and controls",
"Previous studies have found that home-based intervention programs reduce readmission rates for patients with heart failure . Only one previous trial has compared telephone and videophone to traditional care to deliver a home-based heart failure intervention program . The objective of this study was to evaluate the efficacy of a telehealth-facilitated postdischarge support program in reducing re source use in patients with heart failure . Patients at a Midwestern Department of Veterans Affairs Medical Center were r and omized to telephone , videophone , or usual care for follow-up care after hospitalization for heart failure exacerbation . Outcome measures included readmission rates ; time to first readmission ; urgent care clinic visits ; survival ; and quality of life . The intervention result ed in a significantly longer time to readmission but had no effect on readmission rates or mortality . There were no differences in hospital days or urgent care clinic use . All subjects reported higher disease-specific quality of life scores at 1 year . There was evidence of the value of telephone follow-up , but there was no evidence to support the benefit of videophone care over telephone care . Rigorous evaluation is needed to determine which patients may benefit most from specific telehealth applications and which technologies are most cost-effective",
"The purpose of this r and omized field study was to determine the effects of telehomecare on hospitalization , emergency department ( ED ) use , mortality , and symptoms related to sodium and fluid intake , medication use , and physical activity . The sample consists of 284 patients with heart failure . The authors used logistic regression to study the effects of telehomecare on health services utilization and mortality and a general linear model to analyze changes in self-reported symptoms . On average , patients in the telehomecare groups had a lower probability of hospitalizations and ED visits than did patients in the control group . Differences were statistically significant at 60 days but not 120 days . Results show a greater reduction in symptoms for patients using telehomecare compared to control patients . The technology enables frequent monitoring of clinical indices and permits the home health care nurse to detect changes in cardiac status and intervene when necessary"
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4116e80e-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE The aim of this review was to evaluate the conceptual suitability , applicability and psychometric properties of scores used internationally to measure adherence to the Mediterranean diet ( MD ) . DESIGN This was a systematic review to identify original articles that examined some aspects of the conceptual suitability , applicability or psychometric properties of the MD adherence score . Electronic search es were carried out on the international data bases MEDLINE , Scopus , Web of Science and EMBASE ( from January 1980 to 31 December 2015 ) . ELIGIBILITY CRITERIA FOR SELECTING STUDIES The study included original articles that examined some aspects of the conceptual suitability , applicability or psychometric properties of the MD adherence score . The studies where MD adherence scores were administered but did not bring forward any evidence about their performance related to conceptual suitability , applicability or psychometric properties were excluded . DATA EXTRACTION Information relating to the scales was extracted in accordance with the quality criteria defined by the Scientific Advisory Committee of the Medical Outcomes Trust for measurement of health results and the quality criteria recommended by Terwee : ( 1 ) conceptual , ( 2 ) applicability and ( 3 ) psychometric properties . Three authors independently extracted information from eligible studies . RESULTS Twenty-seven studies were identified as meeting the inclusion criteria , yielding 28 MD adherence scores . The results showed that evidence is scarce and that very few scores fulfilled the applicability parameters and psychometric quality . The scores developed by Panagiotakos et al , Buckl and et al and Sotos-Prieto et al showed the highest levels of evidence . CONCLUSIONS Scores measuring adherence to MD are useful tools for identifying the dietary patterns of a given population . However , further information is required regarding existing scores . In addition , new instruments with greater conceptual and method ological rigour should be developed and evaluated for their psychometric properties
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"BACKGROUND Adherence to a Mediterranean diet may improve longevity , but relevant data are limited . METHODS We conducted a population -based , prospect i ve investigation involving 22,043 adults in Greece who completed an extensive , vali date d , food-frequency question naire at base line . Adherence to the traditional Mediterranean diet was assessed by a 10-point Mediterranean-diet scale that incorporated the salient characteristics of this diet ( range of scores , 0 to 9 , with higher scores indicating greater adherence ) . We used proportional-hazards regression to assess the relation between adherence to the Mediterranean diet and total mortality , as well as mortality due to coronary heart disease and mortality due to cancer , with adjustment for age , sex , body-mass index , physical-activity level , and other potential confounders . RESULTS During a median of 44 months of follow-up , there were 275 deaths . A higher degree of adherence to the Mediterranean diet was associated with a reduction in total mortality ( adjusted hazard ratio for death associated with a two-point increment in the Mediterranean-diet score , 0.75 [ 95 percent confidence interval , 0.64 to 0.87 ] ) . An inverse association with greater adherence to this diet was evident for both death due to coronary heart disease ( adjusted hazard ratio , 0.67 [ 95 percent confidence interval , 0.47 to 0.94 ] ) and death due to cancer ( adjusted hazard ratio , 0.76 [ 95 percent confidence interval , 0.59 to 0.98 ] ) . Associations between individual food groups contributing to the Mediterranean-diet score and total mortality were generally not significant . CONCLUSIONS Greater adherence to the traditional Mediterranean diet is associated with a significant reduction in total mortality",
"BACKGROUND Greater adherence to the Mediterranean diet has been associated with a lower incidence of cardiovascular disease and cancer . OBJECTIVE We studied the effect of the Mediterranean diet on total antioxidant capacity ( TAC ) in 3042 participants who had no clinical evidence of cardiovascular disease . DESIGN During 2001 - 2002 , a r and om sample of 1514 men and 1528 women aged 18 - 89 y from the Attica area of Greece was selected . TAC was measured with an immune-diagnostic assay . Food consumption was evaluated with a vali date d food-frequency question naire , and adherence to the Mediterranean diet was assessed on the basis of a diet score that incorporated the inherent characteristics of this diet . RESULTS TAC was positively correlated with diet score . The participants in the highest tertile of the diet score had , on average , 11 % higher TAC levels than did the participants in the lowest tertile , even after adjustment for relevant confounders ( P oxidized LDL-cholesterol concentrations than did the participants in the lowest tertile ( P TAC was positively correlated with the consumption of olive oil ( rho = 0.54 , P = 0.002 ) and of fruit and vegetables ( rho = 0.34 and rho = 0.31 , respectively ; P Mediterranean diet is associated with elevated TAC levels and low oxidized LDL-cholesterol concentrations , which may explain the beneficial role of this diet on the cardiovascular system",
"Objective : To compare the dietary intake of Chinese people living in Pan Yu , Hong Kong , San Francisco and Sydney with respect to cardiovascular health , using the Mediterranean diet score , examining the effects of age , gender , urbanization and acculturation on the diet score . Subjects : A total of 500 men and 510 women in Hong Kong were recruited as a territory-wide stratified r and om sample . Subjects were recruited in response to local advertisements for the other three sites : Pan Yu , 58 men , 95 women ; San Francisco , 166 men , 192 women ; Sydney , 95 men , 73 women . Method : Food-frequency question naire over a 7 week period . A high/healthy score was taken as ≥4 for men and ≥3 for women , representing a dietary pattern beneficial for cardiovascular health . Results : In Hong Kong , more women in the middle age group ( 35–54 ) had a high score than other age groups , and overall more women had high scores than men . In comparing the four geographical regions , Pan Yu had the highest number of subjects with high score , and Hong Kong had the lowest . With the exception of the younger population and men in Hong Kong , the percentage of the population with a high score in all sites is greater than among elderly Greeks consuming a more traditional heart-healthy Mediterranean diet . Conclusion : Considerable variations in Chinese dietary patterns exist with respect to age , gender and geographic location . Overall , the Chinese diet is comparable to the Mediterranean diet and may be expected to have similar health benefits that have been documented for the traditional Mediterranean diet . European Journal of Clinical Nutrition ( 2001 ) 55 ,",
"Epidemiological studies show that adherence to a Mediterranean diet ( MD ) increases longevity ; however , few studies are restricted to Mediterranean population s or explore the effect of a MD pattern that directly incorporates olive oil . Therefore the relationship between adherence to the MD and mortality was studied within the the Spanish cohort of the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC-Spain ) . The EPIC-Spain analysis included 40 622 participants ( 37·7 % males ) aged 29 - 69 years who were recruited from five Spanish regions in 1992 - 1996 . During a mean follow-up of 13·4 years , 1855 deaths were documented : 913 from cancer , 399 from CVD , 425 from other causes and 118 from unknown causes of death . Risk of all-cause and cause-specific mortality was assessed according to the level of adherence to a relative MD ( rMED ) score , measured using an 18-unit scale incorporating nine selected dietary components . A high compared with a low rMED score was associated with a significant reduction in mortality from all causes ( hazard ratio ( HR ) 0·79 ; 95 % CI 0·69 , 0·91 ) , from CVD ( HR 0·66 ; 95 % CI 0·49 , 0·89 ) , but not from overall cancer ( HR 0·92 ; 95 % CI 0·75 , 1·12 ) . A 2-unit increase in rMED score was associated with a 6 % ( P . A high olive oil intake and moderate alcohol consumption contributed most to this association . In this Spanish cohort , following an olive oil-rich MD was related to a significant reduction in all-cause mortality , and reduced the risk of mortality from CVD . These results support the important role that the MD pattern has on reducing mortality in Mediterranean countries",
"Abstract Objective To examine whether adherence to the modified Mediterranean diet , in which unsaturates were substituted for monounsaturates , is associated with longer life expectancy among elderly Europeans . Design Multicentre , prospect i ve cohort study . Setting Nine European countries ( Denmark , France , Germany , Greece , Italy , the Netherl and s , Spain , Sweden , United Kingdom ) . Participants 74 607 men and women , aged 60 or more , without coronary heart disease , stroke , or cancer at enrolment and with complete information about dietary intake and potentially confounding variables . Main outcome measures Extent of adherence to a modified Mediterranean diet using a scoring system on a 10 point scale , and death from any cause by time of occurrence , modelled through Cox regression . Results An increase in the modified Mediterranean diet score was associated with lower overall mortality , a two unit increment corresponding to a statistically significant reduction of 8 % ( 95 % confidence interval 3 % to 12 % ) . No statistically significant evidence of heterogeneity was found among countries in the association of the score with overall mortality even though the association was stronger in Greece and Spain . When dietary exposures were calibrated across countries , the reduction in mortality was 7 % ( 1 % to 12 % ) . Conclusion The Mediterranean diet , modified so as to apply across Europe , was associated with increased survival among older people ",
"OBJECTIVE A Mediterranean diet quality index ( MDQI ) was devised to give an overall assessment of dietary habits and to identify groups at risk . DESIGN The MDQI was based on scores given for selected levels of consumption of selected nutrients and foods . SETTING Mediterranean southern France . SUBJECTS The sample included 473 men and 491 women in three age classes recruited at r and om . RESULTS Only 9.5 % of men , 9.0 % of women , 4.7 % of 20 - 34 year old subjects , 6.6 % of 35 - 54 year old subjects and 14.0 % of 55 - 76 year old subjects were shown to have a healthy diet . However , 10.1 % of men , 8.6 % of women , 19.4 % of 20 - 34 year old subjects , 10.2 % of 35 - 54 year old subjects and 4.6 % of 55 - 76 year old subjects were shown to have a poor diet . There were significantly fewer smokers among subjects with a good diet but the distribution of moderate wine drinkers was comparable between those with a good diet and those with a poor diet . Correspondence analysis associated a healthy diet with 55 - 76 year old men and women living in rural areas , who had received primary schooling only and who were manual workers . Both men and women with a poor MDQI score tended to be young and smokers . In addition , women with a poor MDQI tended to be heavy drinkers and obese . CONCLUSIONS This study showed that the Mediterranean model , which is generally recognized as a healthy diet , appears restricted to older people and to rural areas , whereas urbanized young people depart from it . A nutritional prevention policy targeted at young adults is required to encourage them to adhere to the Mediterranean model . Smoking and drinking showed different distribution patterns in the sample under study",
"Summary . Background : A prospect i ve cohort study with university level participants was initiated to study the effect of Mediterranean diet on health . Aims : The objective of this study was to identify possible lifestyle and socioeconomic variables associated with the consumption of a Mediterranean dietary pattern ( MDP ) . Method : This analysis includes 1587 males and 2260 females . MDP was defined “ a priori ” by summing the st and ardized residuals of nutrients and foods after adjusting a regression model using total energy intake as the independent variable . Multiple regression and non-parametric locally weighted regression models were adjusted with the relative adherence to the MDP as the dependent variable in males and females . Results : Women were more compliant than men with the MDP ( Coefficient regression ( b ) = 4.1 ; Confidence Interval ( CI ) 95 % = 3.2 to 4.9 ) . The compliance with the MDP was significantly poorer among younger participants both in men and women ( p fulfill the traditional MDP ( p = 0.01 in men and p younger and highly educated subjects of the Mediterranean area . A more active life-style is associated with a better compliance with the MDP",
"Mediterranean-style diets provide cardiovascular benefits and increase insulin sensitivity . There is little evidence that adherence to Mediterranean diet may influence the levels of the inflammatory milieu in type 2 diabetes . The aim of this study was to assess whether Mediterranean diet influences both C-reactive protein ( CRP ) and adiponectin in newly diagnosed type 2 diabetes , and whether adherence to Mediterranean diet affects their circulating levels . In a two-arm , single-center trial , 215 men and women with newly diagnosed type 2 diabetes were r and omized to a Mediterranean diet ( n = 108 , 54 males and 54 females ) or a low-fat diet ( n = 107 , 52 males and 55 females ) , with a total follow-up of 8.1 years . At baseline visit and at 1 year , body weight , HOMA index , CRP , and adiponectin and its fractions were assessed . Adherence to the diets was assessed by calculating the Mediterranean-diet score . At 1 year , CPR fell by 37 % and adiponectin rose by 43 % in the Mediterranean diet group , while remaining unchanged in the low-fat diet group . The pattern of adiponectin fractions ( high and non-high molecular weight ) showed a response similar to that of total adiponectin . Diabetic patients with the highest scores ( 6–9 points ) of adherence to Mediterranean diet had lower circulating CRP level and higher circulating total adiponectin levels than the diabetic patients who scored inflammatory milieu of type 2 diabetes",
"In 1994 the European Union BIOMED programme awarded £ 330 000 to a project , coordinated by the UK Cochrane Centre , to identify reports of r and omised controlled trials in general health care journals in Europe . The rationale is that reports of r and omised controlled trials are difficult to identify through sources such as Medline .1 For example , a study of the first six months of Medline for 1993 identified over 400 reports of r and omised controlled trials which were not coded as such , despite having the word r and om or r and omised in the title or abstract .2 A systematic review in 1993 indicated that , on average , search es of Medline identify only 50 % of trials.3 We present here the results of h and search ing the BMJ and the Lancet from 1948 onwards to identify reports of trials . Twenty h and search ers were trained",
"OBJECTIVE To investigate the association of a posteriori dietary patterns with overall survival of older Europeans . DESIGN AND SETTING This is a multi-centre cohort study . Cox regression analysis was used to investigate the association of the prevailing , a posteriori-derived , plant-based dietary pattern with all-cause mortality in a population of subjects who were 60 years or older at recruitment to the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC-Elderly cohort ) . Analyses controlled for all known potential risk factors . SUBJECTS In total , 74,607 men and women , 60 years or older at enrolment and without previous coronary heart disease , stroke or cancer , with complete information about dietary intakes and potentially confounding variables , and with known survival status as of December 2003 , were included in the analysis . RESULTS An increase in the score which measures the adherence to the plant-based diet was associated with a lower overall mortality , a one st and ard deviation increment corresponding to a statistically significant reduction of 14 % ( 95 % confidence interval 5 - 23 % ) . In country-specific analyses the apparent association was stronger in Greece , Spain , Denmark and The Netherl and s , and absent in the UK and Germany . CONCLUSIONS Greater adherence to the plant-based diet that was defined a posteriori in this population of European elders is associated with lower all-cause mortality . This dietary score is moderately positively correlated with the Modified Mediterranean Diet Score that has been constructed a priori and was also shown to be beneficial for the survival of the same EPIC-Elderly cohort",
"Objective To examine whether adherence to the Mediterranean diet was associated with longer telomere length , a biomarker of aging . Design Population based cohort study . Setting Nurses ’ Health Study , an ongoing prospect i ve cohort study of 121 700 nurses enrolled in 1976 ; in 1989 - 90 a subset of 32 825 women provided blood sample s. Participants 4676 disease-free women from nested case-control studies within the Nurses ’ Health Study with telomere length measured who also completed food frequency question naires . Main outcome measure Association between relative telomere lengths in peripheral blood leukocytes measured by quantitative real time polymerase chain reaction and Alternate Mediterranean Diet score calculated from self reported dietary data . Results Greater adherence to the Mediterranean diet was associated with longer telomeres after adjustment for potential confounders . Least squares mean telomere length z scores were −0.038 ( SE 0.035 ) for the lowest Mediterranean diet score groups and 0.072 ( 0.030 ) for the highest group ( P for trend=0.004 ) . Conclusion In this large study , greater adherence to the Mediterranean diet was associated with longer telomeres . These results further support the benefits of adherence to the Mediterranean diet for promoting health and longevity"
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4116e84a-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Health effects of sedentary behaviors ( SB ) may vary depending on their characteristics such as type , purpose , duration , and intensity of the behavior . While a growing number of question naires assess sedentary behaviors , it is unclear which characteristics of SB are measured . The aim of this review was to examine the content of self-report SB question naires . METHODS Three data bases were search ed for sedentary behavior question naires published before January 1st , 2016 . Based on the inclusion criteria , 82 articles out of 1369 were retrieved for a total of 60 question naires . For each question naire , the sedentary behavior characteristics identified were reported and analyzed . RESULTS Most of the question naires assessed the time ( n = 60 ) , posture ( n = 54 ) , purpose ( n = 46 ) and the types ( n = 45 ) of SB performed . Fewer question naires assessed the environment ( n = 20 ) social context ( n = 11 ) , status ( n = 2 ) , and associated behaviors ( n = 2 ) related to sedentary behaviors . All the question naires except two assessed time spent in SB with 17 assessing frequency and 6 assessing breaks in SB . The most frequent characteristics identified in the question naires were the categories of sitting ( 90 % ) , a day ( 95 % ) , watching television ( 65 % ) and using a computer ( 55 % ) . Many characteristics of SB were not measured . CONCLUSIONS By knowing the breadth of SB included in question naires , this review provides support to shape the design of new question naires design ed to reduce the gaps in measuring sedentary behaviors
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"Supplemental digital content is available in the text .",
"INTRODUCTION The short International Physical Activity Question naire ( IPAQ-short ) has frequently been used for national and international comparable physical activity ( PA ) prevalence studies . The purpose of this paper is to describe a Greek version of IPAQ-short ( IPAQ-Gr ) and present its reliability properties in Greek young and healthy adults . METHODS Two hundred and eighteen health science students of the Athens Technological Educational Institute , aged 19 - 29 years , were r and omly selected and participated in the study . An intra-examiner reliability study over time ( 8 and 30 days apart ) was carried out to assess IPAQ-Gr repeatability . An inter-examiner reliability study was also performed to assess the consistency of IPAQ-Gr outcomes between examiners . At the same time , an intra-examiner reliability study using an independent sample of 175 medical students at the University of Ioannina was carried out in order to examine multi-centre IPAQ-Gr reliability . Intra-class correlation coefficients for IPAQ scores and kappa statistics and percent agreement for physical activity classification were used in the analysis . RESULTS Intra-class correlation coefficients ( ICCs ) between day-1 and day-9 assessment s for IPAQ total and vigorous PA were high in all groups examined ( 0.84 to 0.93 ) . ICCs for walking PA , moderate PA and sitting hours were lower , but still good ( 0.69 to 0.81 ) . Repeatability of IPAQ-Gr outcomes after one-month re-administration was high for total and vigorous PA ( 0.87 , 0.81 ) and good for moderate ( 0.66 ) and walking PA ( 0.75 ) . Inter-examiner reliability data showed that all correlations between examiners were greater than 0.70 , up to 0.87 ( paired t-test , p = NS ) , with the exception of moderate PA , where correlations were weaker ( 0.58 to 0.64 ) . Similar results were found when intra-examiner correlations were compared between educational institutes ( multi-centre inter-examiner reliability of IPAQ ) . CONCLUSIONS IPAQ-Gr was found to present acceptable reliability properties in Greek young adults . IPAQ-Gr showed high repeatability values for total and vigorous PA , and good for moderate and walking PA",
"Background There is currently no vali date d question naire available to assess total sedentary time in older adults . Most studies only used TV viewing time as an indicator of sedentary time . The first aim of our study was to investigate the self-reported time spent by older persons on a set of sedentary activities , and to compare this with objective sedentary time measured by accelerometry . The second aim was to determine what set of self-reported sedentary activities should be used to validly rank people ’s total sedentary time . Finally we tested the reliability of our newly developed question naire using the best performing set of sedentary activities . Methods The study sample included 83 men and women aged 65–92 y , a r and om sample of Longitudinal Aging Study Amsterdam participants , who completed a question naire including ten sedentary activities and wore an Actigraph GT3X accelerometer for 8 days . Spearman correlation coefficients were calculated to examine the association between self-reported time and objective sedentary time . The test-retest reliability was calculated using the intraclass correlation coefficient ( ICC ) . Results Mean total self-reported sedentary time was 10.4 ( SD 3.5 ) h/d and was not significantly different from mean total objective sedentary time ( 10.2 ( 1.2 ) h/d , p = 0.63 ) . Total self-reported sedentary time on an average day ( sum of ten activities ) correlated moderately ( Spearman ’s r = 0.35 , p total objective sedentary time . The correlation improved when using the sum of six activities ( r = 0.46 , p The test-retest reliability of the sum of six sedentary activities was 0.71 ( 95 % CI 0.57 - 0.81 ) . Conclusions A question naire including six sedentary activities was moderately associated with accelerometry-derived sedentary time and can be used to reliably rank sedentary time in older persons",
"BACKGROUND Low physical activity ( PA ) is linked to cancer and other diseases prevalent in racial/ethnic minorities and low-income population s. This study evaluated the PA question naire ( PAQ ) used in the Southern Cohort Community Study , a prospect i ve investigation of health disparities between African-American and white adults . METHODS The PAQ was administered upon entry into the cohort ( PAQ1 ) and after 12 - 15 months ( PAQ2 ) in 118 participants ( 40 - 60 year-old , 48 % male , 74 % African-American ) . Test-retest reliability ( PAQ1 versus PAQ2 ) was assessed using Spearman correlations and the Wilcoxon signed rank test . Criterion validity of the PAQ was assessed via comparison with a PA monitor and a last-month PA survey ( LMPAS ) , administered up to 4 times in the study period . RESULTS The PAQ test-retest reliability ranged from 0.25 - 0.54 for sedentary behaviors and 0.22 - 0.47 for active behaviors . The criterion validity for the PAQ compared with PA monitor ranged from 0.21 - 0.24 for sedentary behaviors and from 0.17 - 0.31 for active behaviors . There was general consistency in the magnitude of correlations between the PAQ and PA-monitor between African-Americans and whites . CONCLUSIONS The SCCS-PAQ has fair to moderate test-retest reliability and demonstrated some evidence of criterion validity for ranking participants by their level of sedentary and active behaviors",
"PURPOSE Sitting at work is an emerging occupational health risk . Few instruments design ed for use in population -based research measure occupational sitting and st and ing as distinct behaviors . This study aim ed to develop and vali date brief measure of occupational sitting and physical activity . METHODS A convenience sample ( n = 99 , 61 % female ) was recruited from two medium-sized workplaces and by word-of-mouth in Sydney , Australia . Participants completed the newly developed Occupational Sitting and Physical Activity Question naire ( OSPAQ ) and a modified version of the MONICA Optional Study on Physical Activity Question naire ( modified MOSPA-Q ) twice , 1 wk apart . Participants also wore an ActiGraph accelerometer for the 7 d in between the test and retest . Analyses determined test-retest reliability with intraclass correlation coefficients and assessed criterion validity against accelerometers using the Spearman ρ . RESULTS The test-retest intraclass correlation coefficients for occupational sitting , st and ing , and walking for OSPAQ ranged from 0.73 to 0.90 , while that for the modified MOSPA-Q ranged from 0.54 to 0.89 . Comparison of sitting measures with accelerometers showed higher Spearman correlations for the OSPAQ ( r = 0.65 ) than for the modified MOSPA-Q ( r = 0.52 ) . Criterion validity correlations for occupational st and ing and walking measures were comparable for both instruments with accelerometers ( st and ing : r = 0.49 ; walking : r = 0.27 - 0.29 ) . CONCLUSIONS The OSPAQ has excellent test-retest reliability and moderate validity for estimating time spent sitting and st and ing at work and is comparable to existing occupational physical activity measures for assessing time spent walking at work . The OSPAQ brief instrument measures sitting and st and ing at work as distinct behaviors and would be especially suitable in national health surveys , prospect i ve cohort studies , and other studies that are limited by space constraints for question naire items",
"PURPOSE Past-day recall rather than recall of past week or a usual/typical day may improve the validity of self-reported sedentary time measures . This study examined the test-retest reliability , criterion validity , and responsiveness of the seven-item question naire , Past-day Adults ' Sedentary Time ( PAST ) . METHODS Participants ( breast cancer survivors , n = 90 , age = 33 - 75 yr , body mass index = 25 - 40 kg·m ) in a 6-month r and omized controlled trial of a lifestyle-based weight loss intervention completed the interviewer-administered PAST question naire about time spent sitting/lying on the previous day for work , transport , television viewing , nonwork computer use , reading , hobbies , and other purpose s ( summed for total sedentary time ) . The instrument was administered at baseline , 7 d later for test-retest reliability ( n = 86 ) , and at follow-up . ActivPAL3-assessed sit/lie time in bouts of ≥5 min during waking hours on the recall day was used as the validity criterion measure at both baseline ( n = 72 ) and follow-up ( n = 68 ) . Analyses included intraclass correlation coefficients , Pearson 's correlations ( r ) , and Bl and -Altman plots and responsiveness index . RESULTS The PAST had fair to good test-retest reliability ( intraclass correlation coefficient = 0.50 , 95 % confidence interval [ CI ] = 0.32 - 0.64 ) . At baseline , the correlation between PAST and activPAL sit/lie time was r = 0.57 ( 95 % CI = 0.39 - 0.71 ) . The mean difference between PAST at baseline and retest was -25 min ( 5.2 % ) , 95 % limits of agreement = -5.9 to 5.0 h , and the activPAL sit/lie time was -9 min ( 1.8 % ) , 95 % limits of agreement = -4.9 to 4.6 h. The PAST showed small but significant responsiveness ( -0.44 , 95 % CI = -0.92 to -0.04 ) ; responsiveness of activPAL sit/lie time was not significant . CONCLUSION The PAST question naire provided an easy-to-administer measure of sedentary time in this sample . Validity and reliability findings compare favorably with other sedentary time question naires . Past-day recall of sedentary time shows promise for use in future health behavior , epidemiological , and population surveillance studies"
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There are conflicting data regarding the effect of digoxin use on mortality in patients with atrial fibrillation ( AF ) or with congestive heart failure ( CHF ) . The aim of this meta- analysis was to provide detailed analysis of the currently available study reports . We performed a MEDLINE and a COCHRANE search ( 1993 - 2014 ) of the English literature dealing with the effects of digoxin on all-cause-mortality in subjects with AF or CHF . Only full-sized articles published in peer- review ed journals were considered for this meta- analysis . A total of 19 reports were identified . Nine reports dealt with AF patients , seven with patients suffering from CHF , and three with both clinical conditions . Based on the analysis of adjusted mortality results of all 19 studies comprising 326 426 patients , digoxin use was associated with an increased relative risk of all-cause mortality [ Hazard ratio ( HR ) 1.21 , 95 % confidence interval ( CI ) , 1.07 to 1.38 , P glycosides , digoxin was associated with a 29 % increased mortality risk ( HR 1.29 ; 95 % CI , 1.21 to 1.39 ) in the subgroup of publications comprising 235 047 AF patients . Among 91.379 heart failure patients , digoxin-associated mortality risk increased by 14 % ( HR 1.14 , 95 % CI , 1.06 to 1.22 ) . The present systematic review and meta- analysis of all available data sources suggest that digoxin use is associated with an increased mortality risk , particularly among patients suffering from AF
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"BACKGROUND Although digoxin is effective in the treatment of patients with chronic heart failure who are receiving diuretic agents , it is not clear whether the drug has a role when patients are receiving angiotensin-converting-enzyme inhibitors , as is often the case in current practice . METHODS We studied 178 patients with New York Heart Association class II or III heart failure and left ventricular ejection fractions of 35 percent or less in normal sinus rhythm who were clinical ly stable while receiving digoxin , diuretics , and an angiotensin-converting-enzyme inhibitor ( captopril or enalapril ) . The patients were r and omly assigned in a double-blind fashion either to continue receiving digoxin ( 85 patients ) or to be switched to placebo ( 93 patients ) for 12 weeks . Otherwise , their medical therapy for heart failure was not changed . RESULTS Worsening heart failure necessitating withdrawal from the study developed in 23 patients switched to placebo , but in only 4 patients who continued to receive digoxin ( P relative risk of worsening heart failure in the placebo group as compared with the digoxin group was 5.9 ( 95 percent confidence interval , 2.1 to 17.2 ) . All measures of functional capacity deteriorated in the patients receiving placebo as compared with those continuing to receive digoxin ( P = 0.033 for maximal exercise tolerance , P = 0.01 for submaximal exercise endurance , and P = 0.019 for New York Heart Association class ) . In addition , the patients switched from digoxin to placebo had lower quality -of-life scores ( P = 0.04 ) , decreased ejection fractions ( P = 0.001 ) , and increases in heart rate ( P = 0.001 ) and body weight ( P digoxin carries considerable risks for patients with chronic heart failure and impaired systolic function who have remained clinical ly stable while receiving digoxin and angiotensin-converting-enzyme inhibitors",
"BACKGROUND The Atrial Fibrillation Follow-up Investigation of Rhythm Management trial showed that digoxin was associated with increased mortality in patients with atrial fibrillation . OBJECTIVES To assess the association of digoxin with cardiovascular ( CV ) morbidity and mortality in patients with permanent atrial fibrillation enrolled in the Dutch Rate Control Efficacy in Permanent AF : A Comparison Between Lenient Versus Strict Rate Control II trial as well as to assess the role of digoxin to achieve heart rate targets . METHODS The primary outcome was a composite of CV morbidity and mortality . Secondary outcomes included CV hospitalization and all-cause mortality or heart failure ( HF ) hospitalization . Of the 614 patients , 608 ( 99 % ) completed the dose-adjustment phase . Outcome events were analyzed from the end of the dose-adjustment phase until the end of follow-up . The median follow-up period was 2.9 years ( interquartile range 2.7 - 3.0 years ) . RESULTS In total , 284 patients ( 46.7 % ) used digoxin after the dose-adjustment phase ( median dosage 0.250 mg ; interquartile range 0.0625 - 0.750 mg ) . These patients were more often women , previously admitted for HF , had an increased left ventricular end-systolic diameter , and more often r and omized to strict rate control . By using Cox proportional hazards regression analysis , the use of digoxin was not associated with an increased risk for the primary and secondary outcomes . For the primary outcome , the 3-year estimated cumulative incidence was 12.9 % vs 13.4 % in the digoxin group vs the no-digoxin group ( unadjusted hazard ratio [ HR ] 0.97 ; 95 % confidence interval [ CI ] 0.62 - 1.52 ) . Incidence was 19.4 % vs. 19.5 % for CV hospitalization ( unadjusted HR 1.00 ; 95 % CI 0.69 - 1.45 ) and 6.6 % vs. 9.9 % for all-cause mortality or HF hospitalization ( unadjusted HR 0.62 ; 95 % CI 0.34 - 1.13 ) in the digoxin group vs the no-digoxin group . CONCLUSION The use of digoxin was not associated with increased morbidity and mortality",
"ACCF : American College of Cardiology Foundation ACCP : American College of Chest Physicians ACS : acute coronary syndrome ACT : Atrial arrhythmia Conversion Trial ADONIS : American – Australian – African trial with DronedarONe In atrial fibrillation or flutter for the maintenance of Sinus rhythm AF : atrial fibrillation AHA : American Heart Association AND ROMEDA : ANtiarrhythmic trial with DROnedarone in Moderate-to-severe congestive heart failure Evaluating morbidity DecreAse APHRS : Asia Pacific Heart Rhythm Society aPTT : activated partial thromboplastin time ARB : angiotensin-receptor blocker ARISTOTLE : Apixaban for Reduction In STroke and Other ThromboemboLic Events in atrial fibrillation ATHENA : A placebo-controlled , double-blind , parallel arm Trial to assess the efficacy of dronedarone 400 mg b.i.d . for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter ATRIA : AnTicoagulation and Risk factors In Atrial fibrillation AVERROES : Apixaban VErsus acetylsalicylic acid ( ASA ) to Reduce the Rate Of Embolic Stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment AVRO : A prospect i ve , r and omized , double-blind , Active-controlled , superiority study of Vernakalant vs. amiodarone in Recent Onset atrial fibrillation b.i.d : bis in die ( twice daily ) b.p.m . : beats per minute CABANA : Catheter ABlation vs . ANtiarrhythmic drug therapy for Atrial fibrillation CABG : coronary artery bypass graft CAP : Continued Access to Protect AF CHA2DS2-VASc : Congestive heart failure or left ventricular dysfunction Hypertension , Age ≥75 ( doubled ) , Diabetes , Stroke (doubled)-Vascular disease , Age 65–74 , Sex category ( female ) CHADS2 : Congestive heart failure , Hypertension , Age ≥75 , Diabetes , Stroke ( doubled ) CI : confidence interval CRAFT : Controlled R and omized Atrial Fibrillation Trial CrCl : creatinine clearance DAFNE : Dronedarone Atrial FibrillatioN study after Electrical cardioversion DIONYSOS : R and omized Double blind trIal to evaluate efficacy and safety of drOnedarone ( 400 mg b.i.d . ) vs . amiodaroNe ( 600 mg q.d . for 28 daYS , then 200 mg qd thereafter ) for at least 6 mOnths for the maintenance of Sinus rhythm in patients with atrial fibrillation EAST : Early treatment of Atrial fibrillation for Stroke prevention Trial EHRA : European Heart Rhythm Association ECG : electrocardiogram EMA : European Medicines Agency ERATO : Efficacy and safety of dRonedArone for The cOntrol of ventricular rate during atrial fibrillation EURIDIS : EURopean trial In atrial fibrillation or flutter patients receiving Dronedarone for the maIntenance of Sinus rhythm FAST : atrial Fibrillation catheter Ablation vs . Surgical ablation Treatment FDA : Food and Drug Administration Flec-SL : Flecainide Short-Long trial HAS-BLED : Hypertension , Abnormal renal/liver function , Stroke , Bleeding history or predisposition , Labile INR , Elderly , Drugs/alcohol concomitantly HF-PEF : heart failure with preserved ejection fraction HF-REF : heart failure with reduced ejection fraction HR : hazard ratio HRS : Heart Rhythm Society ICH : intracranial haemorrhage INR : international normalized ratio i.v . : intravenous J-RHYTHM : Japanese RHYTHM management trial for atrial fibrillation LAA : left atrial appendage LoE : level of evidence LVEF : left ventricular ejection fraction MANTRA-PAF : Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation NICE : National Institute for Health and Clinical Excellence NOAC : novel oral anticoagulant NSAID : non-steroidal anti-inflammatory drug NYHA : New York Heart Association OAC : oral anticoagulant or oral anticoagulation o.d . : omni die ( every day ) PALLAS : Permanent Atrial fibriLLAtion outcome Study using dronedarone on top of st and ard therapy PCI : percutaneous coronary intervention PREVAIL : Prospect i ve R and omized EVAluation of the LAA closure device In patients with atrial fibrillation v s. Long-term warfarin therapy PROTECT AF : WATCHMAN LAA system for embolic PROTECTion in patients with Atrial Fibrillation PT : prothrombin time RAAFT : Radio frequency Ablation Atrial Fibrillation Trial RE-LY : R and omized Evaluation of Long-term anticoagulant therapY with dabigatran etexilate ROCKET-AF : Rivaroxaban Once daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in atrial fibrillation RRR : relative risk reduction TE : thromboembolism TIA : transient ischaemic attack t.i.d . : ter in die ( three times daily ) TOE : transoesophageal echocardiogram TTR : time in therapeutic range VKA : vitamin K antagonist Guidelines summarize and evaluate all currently available evidence on a particular issue with the aim of assisting physicians in selecting the best management strategy for an individual patient suffering from a given condition , taking into account the impact on",
"BACKGROUND The role of cardiac glycosides in treating patients with chronic heart failure and normal sinus rhythm remains controversial . We studied the effect of digoxin on mortality and hospitalization in a r and omized , double-blind clinical trial . METHODS In the main trial , patients with a left ventricular ejection fraction of 0.45 or less were r and omly assigned to digoxin ( 3397 patients ) or placebo ( 3403 patients ) in addition to diuretics and angiotensin-converting-enzyme inhibitors ( median dose of digoxin , 0.25 mg per day ; average follow-up , 37 months ) . In an ancillary trial of patients with ejection fractions greater than 0.45 , 492 patients were r and omly assigned to digoxin and 496 to placebo . RESULTS In the main trial , mortality was unaffected . There were 1181 deaths ( 34.8 percent ) with digoxin and 1194 deaths ( 35.1 percent ) with placebo ( risk ratio when digoxin was compared with placebo , 0.99 ; 95 percent confidence interval , 0.91 to 1.07 ; P=0.80 ) . In the digoxin group , there was a trend toward a decrease in the risk of death attributed to worsening heart failure ( risk ratio , 0.88 ; 95 percent confidence interval , 0.77 to 1.01 ; P=0.06 ) . There were 6 percent fewer hospitalizations overall in that group than in the placebo group , and fewer patients were hospitalized for worsening heart failure ( 26.8 percent vs. 34.7 percent ; risk ratio , 0.72 ; 95 percent confidence interval , 0.66 to 0.79 ; P death or hospitalization due to worsening heart failure were consistent with the results of the main trial . CONCLUSIONS Digoxin did not reduce overall mortality , but it reduced the rate of hospitalization both overall and for worsening heart failure . These findings define more precisely the role of digoxin in the management of chronic heart failure",
"BACKGROUND Heart failure is a leading cause of hospital admission and readmission in older adults . The new United States healthcare reform law has created provisions for financial penalties for hospitals with higher than expected 30-day all-cause readmission rates for hospitalized Medicare beneficiaries aged ≥65 years with heart failure . We examined the effect of digoxin on 30-day all-cause hospital admission in older patients with heart failure and reduced ejection fraction . METHODS In the main Digitalis Investigation Group trial , 6800 ambulatory patients with chronic heart failure ( ejection fraction ≤45 % ) were r and omly assigned to digoxin or placebo . Of these , 3405 were aged ≥65 years ( mean age , 72 years ; 25 % were women ; 11 % were nonwhite ) . The main outcome in the current analysis was 30-day all-cause hospital admission . RESULTS In the first 30 days after r and omization , all-cause hospitalization occurred in 5.4 % ( 92/1693 ) and 8.1 % ( 139/1712 ) of patients in the digoxin and placebo groups , respectively , ( hazard ratio { HR } when digoxin was compared with placebo , 0.66 ; 95 % confidence interval { CI } , 0.51 - 0.86 ; P=.002 ) . Digoxin also reduced both 30-day cardiovascular ( 3.5 % vs 6.5 % ; HR , 0.53 ; 95 % CI , 0.38 - 0.72 ; P ) and heart failure ( 1.7 vs 4.2 % ; HR , 0.40 ; 95 % CI , 0.26 - 0.62 ; P ) hospitalizations , with similar trends for 30-day all-cause mortality ( 0.7 % vs 1.3 % ; HR , 0.55 ; 95 % CI , 0.27 - 1.11 ; P=.096 ) . Younger patients were at lower risk of events but obtained similar benefits from digoxin . CONCLUSIONS Digoxin reduces 30-day all-cause hospital admission in ambulatory older patients with chronic systolic heart failure . Future studies need to examine its effect on 30-day all-cause hospital readmission in hospitalized patients with acute heart failure",
"BACKGROUND Some evidence s suggest that the use of digoxin may be harmful inatrial fibrillation ( AF ) patients . The aim of the study was to investigate in a \" real world \" of AF patients receiving vitamin K antagonists ( VKAs ) , the relationship between digoxin use and mortality . METHODS Prospect i ve single-center observational study including 815 consecutive non-valvular AF patients treated with VKAs . Total mortality was the primary outcome of the study . We also performed a sub- analysis considering only cardiovascular ( CV ) deaths . Time in therapeutic range ( TTR ) was used for anticoagulation quality . RESULTS Median follow-up was 33.2months ( 2460 person-years ) ; 171 ( 21.0 % ) patients were taking digoxin . Compared to those without , patients on digoxin were older ( p=0.007 ) , with a clinical history of HF ( p thromboembolic events ( p TTR between the two groups was registered ( p=0.598 ) . During the follow-up , 85 deaths occurred : 47 CV and 38 non-CV deaths ; 35 deaths occurred in digoxin users ( 20.6 % ) . A significant increased rate of total mortality was observed in digoxin-treated patients ( p digoxin was associated with total mortality ( hazard ratio [ HR ] : 2.224 , p CV death ( HR : 4.686 , p digoxin was associated with total mortality ( HR : 2.073 , p=0.0263 ) and CV death ( HR : 4.043 , p=0.004 ) . CONCLUSIONS In AF patients on good anticoagulation control with VKAs , digoxin use was associated with a higher rate of total and CV mortality",
"Background — About half of the 5 million heart failure patients in the United States have diastolic heart failure ( clinical heart failure with normal or near-normal ejection fraction ) . Except for c and esartan , no drugs have been tested in r and omized clinical trials in these patients . Although digoxin was tested in an appreciable number of diastolic heart failure patients in the Digitalis Investigation Group ancillary trial , detailed findings from this important study have not previously been published . Methods and Results — Ambulatory chronic heart failure patients ( n=988 ) with normal sinus rhythm and ejection fraction > 45 % ( median , 53 % ) from the United States and Canada ( 1991 to 1993 ) were r and omly assigned to digoxin ( n=492 ) or placebo ( n=496 ) . During follow-up with a mean length of 37 months , 102 patients ( 21 % ) in the digoxin group and 119 patients ( 24 % ) in the placebo group ( hazard ratio [ HR ] , 0.82 ; 95 % confidence interval [ CI ] , 0.63 to 1.07 ; P=0.136 ) experienced the primary combined outcome of heart failure hospitalization or heart failure mortality . Digoxin had no effect on all-cause or cause-specific mortality or on all-cause or cardiovascular hospitalization . Use of digoxin was associated with a trend toward a reduction in hospitalizations result ing from worsening heart failure ( HR , 0.79 ; 95 % CI , 0.59 to 1.04 ; P=0.094 ) but also a trend toward an increase in hospitalizations for unstable angina ( HR , 1.37 ; 95 % CI , 0.99 to 1.91 ; P=0.061 ) . Conclusions — In ambulatory patients with chronic mild to moderate diastolic heart failure and normal sinus rhythm receiving angiotensin-converting enzyme inhibitor and diuretics , digoxin had no effect on natural history end points such as mortality and all-cause or cardiovascular hospitalizations",
"INTRODUCTION AND OBJECTIVES We aim ed to assess and compare the effect of digoxin on clinical outcomes in patients with atrial fibrillation vs those under beta-blockers or none of these drugs . METHODS AFBAR is a prospect i ve registry study carried out by a team of primary care physicians ( n=777 patients ) . Primary endpoints were survival , survival free of admission due to any cause , and survival free of admission due to cardiovascular causes . The mean follow up was 2.9 years . Four groups were analyzed : patients receiving digoxin , beta-blockers , or digoxin plus beta-blockers , and patients receiving none of these drugs . RESULTS Overall , 212 patients ( 27.28 % ) received digoxin as the only heart control strategy , 184 received beta-blockers ( 23.68 % ) , 58 ( 7.46 % ) were administered both , and 323 ( 41.57 % ) received none of these drugs . Digoxin was not associated with all-cause mortality ( estimated hazard ratio=1.42 ; 95 % confidence interval , 0.77 - 2.60 ; P=.2 ) , admission due to any cause ( estimated hazard ratio=1.03 ; 95 % confidence interval , 0.710 - 1.498 ; P=.8 ) , or admission due to cardiovascular causes ( estimated hazard ratio=1.193 ; 95 % confidence interval , 0.725 - 1.965 ; P=.4 ) . No association was found between digoxin use and all-cause mortality , admission due to any cause , or admission due to cardiovascular causes in patients without heart failure . There was no interaction between digoxin use and sex in all-cause mortality or in survival free of admission due to any cause . However , an association was found between sex and admission due to cardiovascular causes . CONCLUSIONS Digoxin was not associated with increased all-cause mortality , survival free of admission due to any cause , or admission due to cardiovascular causes , regardless of underlying heart failure",
"AIMS Digoxin is recommended for long-term rate control in paroxysmal , persistent , and permanent atrial fibrillation ( AF ) . While some analyses suggest an association of digoxin with a higher mortality in AF , the intrinsic nature of this association has not been examined in propensity-matched cohorts , which is the objective of the current study . METHODS AND RESULTS In Atrial Fibrillation Follow-up Investigation of Rhythm Management ( AFFIRM ) , 4060 patients with paroxysmal and persistent AF were r and omized to rate ( n = 2027 ) vs. rhythm ( n = 2033 ) control strategies . Of these , 1377 received digoxin as initial therapy and 1329 received no digoxin at baseline . Propensity scores for digoxin use were estimated for each of these 2706 patients and used to assemble a cohort of 878 pairs of patients receiving and not receiving digoxin , who were balanced on 59 baseline characteristics . Matched patients had a mean age of 70 years , 40 % were women , and 11 % non-white . During the 3.4 years of the mean follow-up , all-cause mortality occurred in 14 and 13 % of matched patients receiving and not receiving digoxin , respectively [ hazard ratio ( HR ) associated with digoxin use : 1.06 ; 95 % confidence interval ( CI ) : 0.83 - 1.37 ; P = 0.640 ] . Among matched patients , digoxin had no association with all-cause hospitalization ( HR : 0.96 ; 95 % CI : 0.85 - 1.09 ; P = 0.510 ) or incident non-fatal cardiac arrhythmias ( HR : 0.90 ; 95 % CI : 0.37 - 2.23 ; P = 0.827 ) . Digoxin had no multivariable-adjusted or propensity score-adjusted associations with these outcomes in the pre-match cohort . CONCLUSIONS In patients with paroxysmal and persistent AF , we found no evidence of increased mortality or hospitalization in those taking digoxin as baseline initial therapy",
"CONTEXT The Digitalis Investigation Group ( DIG ) trial reported that digoxin provided no overall mortality benefit and only a modest reduction in hospitalizations among patients with heart failure and depressed left ventricular systolic function . The clinical outcomes associated with digoxin therapy at different serum concentrations in the DIG trial have not been assessed . OBJECTIVE To assess variations in serum digoxin concentration ( SDC ) and their association with mortality and hospitalization in patients with heart failure . DESIGN , SETTING , AND PATIENTS Post hoc analysis of the r and omized , double-blinded , placebo-controlled DIG trial , conducted from August 1991 to December 1995 , with the main analysis restricted to men with a left ventricular ejection fraction of 45 % or less ( n = 3782 ) . Patients r and omly assigned to receive digoxin were divided into 3 groups based on SDC at 1 month ( 0.5 - 0.8 ng/mL , n = 572 ; 0.9 - 1.1 ng/mL , n = 322 ; and > or = 1.2 ng/mL , n = 277 ) and compared with patients r and omly assigned to receive placebo ( n = 2611 ) . MAIN OUTCOME MEASURE All-cause mortality at a mean follow-up of 37 months . RESULTS Higher SDCs were associated with increased crude all-cause mortality rates ( 0.5 - 0.8 ng/mL , 29.9 % ; 0.9 - 1.1 ng/mL , 38.8 % ; and > or = 1.2 ng/mL , 48.0 % ; P = .006 for trend ) . Patients with SDCs of 0.5 to 0.8 ng/mL had a 6.3 % ( 95 % confidence interval [ CI ] , 2.1%-10.5 % ) lower mortality rate compared with patients receiving placebo . Digoxin was not associated with a reduction in mortality among patients with SDCs of 0.9 to 1.1 ng/mL ( 2.6 % increase ; 95 % CI , - 3.0 % to 8.3 % ) , whereas patients with SDCs of 1.2 ng/mL and higher had an 11.8 % ( 95 % CI , 5.7%-18.0 % ) higher absolute mortality rate than patients receiving placebo . The association between SDC and mortality persisted after multivariable adjustment ( SDC 0.5 - 0.8 ng/mL hazard ratio [ HR ] 0.80 , 95 % CI , 0.68 - 0.94 ; SDC 0.9 - 1.1 ng/mL HR 0.89 , 95 % CI , 0.74 - 1.08 ; SDC > or = 1.2 ng/mL HR 1.16 , 95 % CI , 0.96 - 1.39 ; and HR of 1.00 [ referent ] for placebo ) . CONCLUSIONS Our findings demonstrate that higher SDCs were associated with increased mortality and suggest that the effectiveness of digoxin therapy in men with heart failure and a left ventricular ejection fraction of 45 % or less may be optimized in the SDC range of 0.5 to 0.8",
"BACKGROUND The use of digitalis is recommended for the treatment of heart failure to reduce hospitalization . Recent data suggest that digitalis treatment may adversely affect survival in women but not in men . We studied patients with left ventricular dysfunction enrolled in the Studies of Left Ventricular Dysfunction ( SOLVD ) to determine whether there was a gender-based survival difference in patients treated with digitalis . METHODS AND RESULTS Symptomatic ( n = 2569 ) and asymptomatic ( n = 4228 ) patients with left ventricular ejection fraction . Digitalis use was assessed at baseline and baseline demographic variables were catalogued and compared . A multivariate analysis , incorporating known covariates of risk for adverse cardiovascular events , was used to examine the association of digitalis with all-cause mortality , cardiovascular death , death from heart failure , and arrhythmic death , with , or without , worsening heart failure in women compared with men . Analysis for an interaction between digitalis and gender on mortality was also performed . No interaction between gender and digitalis treatment on survival was found , and there was no significant difference in the hazard ratios for men and women on digitalis either with respect to all-cause mortality , cardiovascular mortality , heart failure mortality , or arrhythmic death with worsening heart failure . When mortality for arrhythmic death without worsening heart failure was adjusted for the probability of being treated with digitalis ( propensity analysis ) , women fared better than men . CONCLUSION Data from the SOLVD trials suggest that digitalis treatment of heart failure does not result in a difference in survival between men and women . Because a r and omized trial to definitively answer the question is unlikely , and perhaps inappropriate , examination of other heart failure population s for a gender-digitalis interaction is indicated",
"Background —Elevated serum digoxin concentration can cause toxicity , including death . Dronedarone increases digoxin concentration by P-glycoprotein interaction . In Permanent Atrial Fibrillation Outcome Study Using Dronedarone On Top Of St and ard Therapy Trial ( PALLAS ) , dronedarone was associated with both increased cardiovascular death and heart failure in patients with permanent atrial fibrillation . The present analysis examines whether the dronedarone – digoxin interaction might explain these adverse outcomes . Methods and Results —Subgroup analysis was performed to compare outcomes of patients on digoxin at baseline or not . In PALLAS , 1619 patients were r and omized to dronedarone and 1617 to placebo , of whom 544 ( 33.6 % ) and 526 ( 32.5 % ) were receiving digoxin , respectively . Median ( Q1,Q3 ) digoxin serum concentration on day 7 was 1.1 ( 0.7,1.5 ) ng/mL on dronedarone and 0.7 ( 0.5,1.1 ) ng/mL on placebo ( P digoxin , there were 15 ( 8.6%/year ) cardiovascular deaths on dronedarone and 2 ( 1.2%/year ) on placebo ( adjusted hazard ratio , 7.31 ; 95 % confidence interval , 1.66–32.20 ; P=0.009 ) . Among patients not on digoxin , there were 6 cardiovascular deaths on dronedarone ( 1.7%/year ) and 8 on placebo ( 2.2%/year ; adjusted hazard ratio , 0.67 ; 95 % confidence interval , 0.23–1.95 ; P=0.46 ; interaction P value 0.01 ) . In patients on digoxin , there were 11 arrhythmic deaths on dronedarone and none on placebo ; and in patients not on digoxin , there were 2 arrhythmic deaths on dronedarone and 4 on placebo ( P value for interaction 0.002 ) . There was no interaction between baseline digoxin use and the adverse effect of dronedarone on heart failure events . Conclusions —In PALLAS , there was a strong effect of concurrent digoxin use on the adverse effect of dronedarone on cardiovascular death , but not on occurrence of heart failure . Clinical Trial Registration —http://www . clinical trials.gov . Unique identifier : NCT01151137",
"Objective : In heart failure , digitalis increases exercise capacity and reduces morbidity , but has no effect on survival . This raises the suspicion that the inotropic benefits of digitalis may be counteracted by serious adverse effects . Patients with atrial fibrillation ( AF ) were studied to clarify this . Design : In the Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation ( SPORTIF ) III and V studies , 7329 patients with AF at moderate-to-high risk were r and omised to preventive treatment of thromboembolism , either with warfarin or the oral direct thrombin inhibitor ximelagatran . The survival of users and non-users of digitalis was investigated . Results : At baseline , 53.4 % of the study population used digitalis , and these patients had a higher mortality than non-users ( 255/3911 ( 6.5 % ) vs 141/3418 ( 4.1 % ) , p hazard ratio ( HR ) = 1.58 ( 95 % CI 1.29 to 1.94 ) ) . Digitalis users also had more baseline risk factors . After multivariate risk factor adjustment , the increased mortality persisted ( p digitalis , like other inotropic drugs , may increase mortality . This may be concealed in heart failure , but be revealed in patients with AF , who need the rate-reducing effect of digitalis , but do not benefit much from an increased inotropy . Cautious interpretation of the data is m and atory since the patients were not r and omised with respect to digitalis use",
"Previous studies on digoxin use in patients with atrial fibrillation ( AF ) and the risk of all-cause mortality found conflicting results . We conducted a population -based , retrospective , cohort study of patients aged ≥65 years admitted to a hospital with a primary or secondary diagnosis of AF , in Quebec province , Canada , from 1998 to 2012 . The AF cohort was grouped into patients with and without heart failure ( HF ) and into digoxin and no-digoxin users according to the first prescription filled for digoxin within 30 days after AF hospital discharge . We derived propensity score-matched digoxin and no-digoxin treatment groups for the groups of patients with and without HF , respectively , and conducted multivariable Cox proportional hazards regression analyses to determine association between digoxin use and all-cause mortality . The AF propensity score-matched cohorts of patients with and without HF were well balanced on baseline characteristics . In the propensity score-matched HF group , digoxin use was associated with a 14 % greater risk of all-cause mortality ( adjusted hazard ratio 1.14 , 95 % confidence interval 1.10 to 1.17 ) . In the propensity score-matched no-HF group , digoxin use was associated with a 17 % greater risk of all-cause mortality ( adjusted hazard ratio 1.17 , 95 % confidence interval 1.14 to 1.19 ) . In conclusion , our retrospective analyses found that digoxin use was associated with a greater risk for all-cause mortality in patients aged ≥65 years with AF regardless of concomitant HF . Large , multicenter , r and omized controlled trials or prospect i ve cohort studies are required to clarify this issue",
"AIMS In the Digitalis Investigation Group ( DIG ) trial , digoxin reduced mortality or hospitalization due to heart failure ( HF ) in several pre-specified high-risk subgroups of HF patients , but data on protocol -specified 2-year outcomes were not presented . In the current study , we examined the effect of digoxin on HF death or HF hospitalization and all-cause death or all-cause hospitalization in high-risk subgroups during the protocol -specified 2 years of post-r and omization follow-up . METHODS AND RESULTS In the DIG trial , 6800 ambulatory patients with chronic HF , normal sinus rhythm , and LVEF ≤45 % ( mean age 64 years , 26 % women , 17 % non-whites ) were r and omized to receive digoxin or placebo . The three high-risk groups were defined as NYHA class III-IV symptoms ( n = 2223 ) , LVEF 55 % ( n = 2345 ) . In all three high-risk subgroups , compared with patients in the placebo group , those in the digoxin group had a significant reduction in the risk of the 2-year composite endpoint of HF mortality or HF hospitalization : NYHA III-IV [ hazard ratio ( HR ) 0.65 ; 95 % confidence interval ( CI ) 0.57 - 0.75 ; P 55 % ( HR 0.65 ; 95 % CI 0.57 - 0.75 ; P 0.001 ) . Digoxin-associated HRs ( 95 % CI ) for 2-year all-cause mortality or all-cause hospitalization for subgroups with NYHA III-IV , LVEF 55 % were 0.88 ( 0.80 - 0.97 ; P = 0.012 ) , 0.84 ( 0.76 - 0.93 ; P = 0.001 ) , and 0.85 ( 0.77 - 0.94 ; P = 0.002 ) , respectively . CONCLUSIONS Digoxin improves outcomes in chronic HF patients with NYHA class III-IV , LVEF 55 % , and should be considered in these patients",
"BACKGROUND The Digitalis Investigation Group trial reported that treatment with digoxin did not decrease overall mortality among patients with heart failure and depressed left ventricular systolic function , although it did reduce hospitalizations slightly . Even though the epidemiologic features , causes , and prognosis of heart failure vary between men and women , sex-based differences in the effect of digoxin were not evaluated . METHODS We conducted a post hoc subgroup analysis to assess whether there were sex-based differences in the effect of digoxin therapy among the 6800 patients in the Digitalis Investigation Group study . The presence of an interaction between sex and digoxin therapy with respect to the primary end point of death from any cause was evaluated with the use of Mantel-Haenszel tests of heterogeneity and a multivariable Cox proportional-hazards model , adjusted for demographic and clinical variables . RESULTS There was an absolute difference of 5.8 percent ( 95 percent confidence interval , 0.5 to 11.1 ) between men and women in the effect of digoxin on the rate of death from any cause ( P=0.034 for the interaction ) . Specifically , women who were r and omly assigned to digoxin had a higher rate of death than women who were r and omly assigned to placebo ( 33.1 percent vs. 28.9 percent ; absolute difference , 4.2 percent , 95 percent confidence interval , -0.5 to 8.8 ) . In contrast , the rate of death was similar among men r and omly assigned to digoxin and men r and omly assigned to placebo ( 35.2 percent vs. 36.9 percent ; absolute difference , -1.6 percent ; 95 percent confidence interval , -4.2 to 1.0 ) . In the multivariable analysis , digoxin was associated with a significantly higher risk of death among women ( adjusted hazard ratio for the comparison with placebo , 1.23 ; 95 percent confidence interval , 1.02 to 1.47 ) , but it had no significant effect among men ( adjusted hazard ratio , 0.93 ; 95 percent confidence interval , 0.85 to 1.02 ; P=0.014 for the interaction ) . CONCLUSIONS The effect of digoxin therapy differs between men and women . Digoxin therapy is associated with an increased risk of death from any cause among women , but not men , with heart failure and depressed left ventricular systolic function",
"OBJECTIVES The purpose of this study was to determine whether digoxin is effective in patients with chronic , stable mild to moderate heart failure . BACKGROUND Digoxin has been a traditional therapy in heart failure , but method ologic limitations in earlier studies have prevented definitive conclusions regarding its efficacy . METHODS Withdrawal of digoxin ( placebo group , n = 46 ) or its continuation ( digoxin group , n = 42 ) was performed in a prospect i ve , r and omized , double-blind , placebo-controlled multicenter trial of patients with chronic , stable mild to moderate heart failure secondary to left ventricular systolic dysfunction who had normal sinus rhythm and were receiving long-term treatment with diuretic drugs and digoxin . RESULTS Patients withdrawn from digoxin therapy showed worsened maximal exercise capacity ( median change in exercise time -96 s ) compared with that of patients who continued to receive digoxin ( change in exercise time + 4.5 s ) ( p = 0.003 ) . Patients withdrawn from digoxin therapy showed an increased incidence of treatment failures ( p = 0.039 ) ( 39 % , digoxin withdrawal group vs. 19 % , digoxin maintenance group ) and a decreased time to treatment failure ( p = 0.037 ) . In addition , patients who continued to receive digoxin had a lower body weight ( p = 0.044 ) and heart rate ( p = 0.003 ) and a higher left ventricular ejection fraction ( p = 0.016 ) . CONCLUSIONS These data provide strong evidence of the clinical efficacy of digoxin in patients with normal sinus rhythm and mild to moderate chronic heart failure secondary to systolic dysfunction who are treated with diuretics ",
"Background Recent studies of patients with heart failure and of patients receiving intensive care indicate that digoxin may increase mortality if the patient has atrial fibrillation ( AF ) . Objective To study which patients receive digoxin treatment for AF and what the prognosis is for patients given this treatment . Method 2824 patients with AF were studied prospect ively for a mean of 4.6 years . Information about medication was obtained from the local hospital registry . Information about diagnoses , hospitalisations and deaths was obtained from national registries . Propensity score matching and Cox regression was used to account for confounding . Results Factors associated with digoxin use were permanent AF ( hazard ratio ( HR ) = 3.2 , confidence interval ( CI ) 2.7 to 3.9 ) , absence of pacemaker ( HR = 2.3 , CI 1.6 to 3.2 ) , history of heart failure ( HR = 2.0 , CI 1.7 to 2.5 ) , treatment in an internal medicine ward rather than a cardiology ward ( HR = 1.6 , CI 1.3 to 2.0 ) , female sex ( HR = 1.6 , CI 1.3 to 1.9 ) and age ≥80 years ( HR = 1.4 , CI 1.1 to 1.7 ) . More patients with than without digoxin died ( 51 % vs 31 % , p digoxin use could be found for all-cause mortality , myocardial infa rct ion , ischaemic stroke , time to readmission to hospital or days at hospital/year at risk . The only end point significantly associated with digoxin use was pacemaker implantations , which were more common in digoxin-treated patients ( HR = 2.0 , CI 1.2 to 3.4 ) . Conclusion Digoxin is mainly given to an elderly and frailer subset of patients with AF and is thus associated with an increased mortality . When differences in patient characteristics are accounted for digoxin use seems to have a neutral effect on mortality and major cardiovascular events in patients with AF"
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Patients with atrial fibrillation ( AF ) are commonly managed with rhythm control strategy , but the natural history of this common arrhythmia leads itself to progression from paroxysmal to persistent or permanent AF , and recurrences are evident despite rhythm control treatments using cardioversion or catheter ablation . Numerous clinical factors have been associated with outcomes of rhythm control or arrhythmia progression in patients with AF . The more common factors have been used to formulate risk stratification scores , to help predict the outcomes of rhythm control treatments or AF progression . This review article provides an overview on the published clinical risk scores related to outcomes of rhythm control strategy or AF progression
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"Background —Atrioventricular nodal radiofrequency ablation ( AVNA ) with permanent ventricular pacing can be used to control rate in patients with atrial fibrillation ( AF ) . However , long-term outcomes after AVNA are uncertain , especially in light of irreversible pacemaker dependence . Methods and Results —We examined 9122 consecutive patients with AF . The outcomes in 453 patients with AVNA ( 26 % of whom underwent an implantable cardiac defibrillator implant and 37 % underwent cardiac resynchronization therapy implant ) were compared with AF patients without AVNA after propensity score 1:1 matching . During follow-up in the propensity-matched cohort ( 2.41±3.23 years , median 1.23 , quartiles 0.33–3.12 ) , 100 patients died ( yearly rate of death 6.6 % ) . Mode of death was available in 86 % of patients , which was cardiovascular in 67 % of the patients ( related to heart failure in 38 % , sudden death in 5 % , and other cardiovascular reason in 24 % ) and noncardiovascular in 33 % . AVNA in patients with AF was associated with a lower risk of mortality ( odds ratio 0.47 , 95 % confidence interval , 0.29–0.77 ; P=0.003 ) , a lower risk of cardiovascular mortality ( odds ratio = 0.41 , 95 % confidence interval 0.23–0.73 ; P=0.003 ) , and nonsignificant lower risk of stroke and thromboembolic events ( odds ratio = 0.61 , 95 % confidence interval 0.36–1.06 ; P=0.08 ) . Conclusions —In sick AF patients with multiple comorbidities , AVNA with permanent ventricular pacing for rate control seems safe during follow-up and may be associated with lower mortality ",
"Background A prolonged PR interval is known to be a poor prognostic factor in cardiovascular disease . The aim of this study was to investigate the association between PR interval and clinical outcome in patients undergoing radiofrequency catheter ablation ( RFCA ) of atrial fibrillation ( AF ) . Methods and Results We prospect ively included 576 patients with AF ( 75.5 % male , 57.8±11.6 years old , 68.8 % paroxysmal AF ) who underwent RFCA . We analyzed preprocedural sinus rhythm ECGs obtained in the absence of antiarrhythmic drug , and all enrolled patients were categorized into 4 groups based on the quartile values of the PR interval ( 166 , 182 , and 202 ms ) , and were analyzed according to the left atrium ( LA ) volume ( CT ; Computed tomography ) , LA voltage ( NavX ) , and clinical outcome of AF ablation . Based on quartile value of PR interval , the highest quartile of PR interval ( Q4 ; PR ≥202 ms ) was oldest ( P in LA conduction velocity and atrial effective refractory period . Q4 had the greatest LA dimension ( P and volume index ( P lowest LA appendage‐emptying velocity ( P LA voltage ( P of AF recurrence after RFCA of AF ( HR=1.969 , 95 % CI 1.343 to 2.886 , P=0.001 ) . Conclusions The PR interval was closely associated with advanced LA remodeling due to AF , and had a noninvasive significant predictive value of clinical recurrence of AF after RFCA",
"Background —The optimal ablation strategy for persistent atrial fibrillation ( AF ) remains unclear . Methods and Results —This multicentre r and omized study compared circumferential pulmonary vein ablation+linear ablation ( control arm ) versus circumferential pulmonary vein ablation+linear ablation+complex fractionated atrial electrogram ( CFAE ) ablation ( CFAE arm ) in patients with persistent AF . Circumferential pulmonary vein ablation was performed followed by roof and mitral isthmus ablation , before CFAE ablation in the CFAE arm . Ablation strategy was maintained at the first redo procedure . Sixty-five patients were recruited in each arm . The mean age was 61±10 years , 75 % were men , median AF duration was 2 years , 42 % had long-lasting persistent AF , 68 % had associated cardiovascular disease , mean left atrial dimension was 46±6 mm , and median CHA2DS2-VASc score was 2 . Ablation and procedure times were significantly longer in the CFAE arm ( 70±20 versus 55±17 ; 201±35 versus 152±45 minutes ; P , single-procedural success off antiarrhythmic drugs at 12 months ( CFAE : 30/65 [ 46 % ] versus control : 37/65 [ 57 % ] ; P=0.29 ) and multiprocedural success ( CFAE : 51/65 [ 78 % ] versus control : 52/65 [ 80 % ] ; P=1.0 ) were not significantly different . At the first redo procedure , patients in the CFAE arm had a higher incidence of organized atrial tachycardia/flutter ( 24/33 [ 73 % ] versus 11/31 [ 35 % ] ; P=0.005 ) and gap-related macro – re-entrant flutter ( 8/33[24 % ] versus 1/31[3 % ] ; P=0.03 ) . Early recurrence of atrial arrhythmia was an independent predictor of late recurrence . Conclusions —CFAE ablation did not confer incremental benefit when performed in addition to circumferential pulmonary vein ablation and linear ablation . It was associated with a higher incidence of gap-related flutter . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT01711047",
"BACKGROUND The aims of the study are 1 ) to assess antiarrhythmic prophylaxis efficacy during the first 2 months after radiofrequency ablation ( ARF ) due to AF ; 2 ) to define risk factors for early AF recurrence ( EAFR ) after ARF ; 3 ) to determine the long-term follow-up results and risk factors for late AF recurrence ( LAFR ) . METHODS A total number of 210 consecutive patients who had undergone ARF due to AF were analyzed . Patients were r and omized into three groups : Group 1 ( G1 ) , without any anti-arrhythmic drug ( AAD ) ; Group 2 ( G2 ) , with amiodarone or sotalol ; Group 3 ( G3 ) , with last ineffective AAD . The study was design ed to analyze two periods : short-term observation , the first 2 months after ARF ; and at least 2 years of long-term follow-up . RESULTS After 2 months , clinical data were collected from 171 patients ( 123 males , mean age of 50.3 years ; persistent AF in 19.8 % ; lone AF in 36.6 % ) . Sinus rhythm ( SR ) was maintained in 84 ( 49.1 % ) patients ; 35 ( 20.4 % ) patients presented with a single episode of AF , 39 ( 23 % ) patients experienced a reduction in number of AF episodes , and 13 ( 7.5 % ) patients showed no improvement . No predisposing factor for early recurrence was found . After a mean follow-up of 55 months , clinical data were collected in 137 patients , of which 47 ( 34 % ) maintained SR . Those more likely to sustain SR were : males ( 82.9 % vs. 62.2 % ; p = 0.018 ) , younger patients ( 44.8 ± 12.7 vs. 52.5 ± 9.9 ; p = 0.0001 ) , patients with smaller left atrium diameter ( 4.05 ± ± 0.49 cm vs. 4.25 ± 0.51 cm ; p = 0.04 ) , and those without any AF recurrence during the first 2 months after ARF ( 78.7 % vs. 35.6 % ; p LAFR were hypertension ( p persistent AF ( p = 0.014 ) . CONCLUSIONS Antiarrhythmic prophylaxis does not affect the number of AF recurrences during the first 2 months after ablation . SR maintenance during a blanking period after AF ablation is a positive prognostic factor in long-term follow-up . Persistent AF and hypertension are independent risk factors for late AF recurrence after pulmonary vein isolation",
"Aims The choice between initiating a non-vitamin K antagonist oral anticoagulant ( NOAC ) and a vitamin K antagonist ( VKA ) in patients with atrial fibrillation ( AF ) may be challenging . To assist in this decision , we developed a risk score to identify patients for whom a therapeutic benefit of NOACs over VKA is predicted . Methods and results ENGAGE AF-TIMI 48 was a r and omized clinical trial of edoxaban vs. warfarin in 21 105 patients with AF . Cox proportional hazard models identified factors associated with a serious net clinical outcome ( NCO ) of disabling stroke , life-threatening bleeding , and all-cause mortality in VKA naïve patients from the warfarin arm . These were used to develop an integer risk score . Performance was assessed by C-indices and validation by bootstrapping . Kaplan-Meier analyses were stratified by three score categories and treatment arm . Over a median of 2.7 years , 457 NCO events occurred in 2898 patients with a total person-time of 7549.5 years ( 6.05%/year ) . The risk prediction model ( C = 0.693 ) for the NCO was translated into a 17-point integer score , with annualized event rates for the low , intermediate , and high-risk categories in the warfarin arm of 3.5 % , 9.9 % , and 20.8 % , respectively . Therapeutic benefit of higher- and lower-dose edoxaban over warfarin was demonstrated in the high- and intermediate-risk , with equal benefit in the low-risk categories ( P-interaction 0.008 and 0.014 , respectively ) . Conclusion In VKA naive patients with AF , the TIMI-AF score can assist in the prediction of a poor composite outcome and guide selection of anticoagulant therapy by identifying a differential clinical benefit with a NOAC or VKA",
"BACKGROUND Patients with a variety of clinical presentations undergo atrial fibrillation ( AF ) ablation . Long-term ablation success rates can vary considerably . OBJECTIVE The purpose of this study was to develop a clinical scoring system to predict long-term freedom from AF after ablation . METHODS We retrospectively derived the scoring system on a development cohort ( DC ) of 1125 patients undergoing AF ablation and tested it prospect ively in a test cohort ( TC ) of 937 patients undergoing AF ablation . RESULTS The demographics of the DC patients were as follows : age 62.3 ± 10.3 years , male sex 801 ( 71.2 % ) , left atrial size 4.30 ± 0.69 cm , paroxysmal AF 348 ( 30.9 % ) , number of drugs failed 1.3 ± 1.1 , hypertension 525 ( 46.7 % ) , diabetes 100 ( 8.9 % ) , prior stroke/transient ischemic attack 78 ( 6.9 % ) , prior cardioversion 528 ( 46.9 % ) , and CHADS2 score 0.87 ± 0.97 . Multivariate analysis showed 6 independent variables predicting freedom from AF after final ablation : coronary artery disease ( P = .021 ) , atrial diameter ( P = .0003 ) , age ( P = .004 ) , persistent or long-st and ing AF ( P number of antiarrhythmic drugs failed ( P system ( CAAP-AF ) using these 6 variables , with scores ranging from 0 to 13 points . The 2-year AF-free rates by CAAP-AF scores were as follows : 0 = 100 % , 1 = 95.7 % , 2 = 96.3 % , 3 = 83.1 % , 4 = 85.5 % , 5 = 79.9 % , 6 = 76.1 % , 7 = 63.4 % , 8 = 51.1 % , 9 = 53.6 % , and ≥10 = 29.1 % . Ablation success decreased as CAAP-AF scores increased ( P The CAAP-AF score also predicted freedom from AF in the TC . The 2-year Kaplan-Meier AF-free rates by CAAP-AF scores were as follows : 0 = 100 % , 1 = 87.0 % , 2 = 89.0 % , 3 = 91.6 % , 4 = 90.5 % , 5 = 84.4 % , 6 = 70.1 % , 7 = 71.0 % , 8 = 60.7 % , 9 = 68.9 % , and ≥10 = 51.3 % . As CAAP-AF scores increased , 2-year freedom from AF in the TC decreased ( P freedom from AF after ablation in both a DC and a TC of patients undergoing AF ablation . The CAAP-AF score provides a realistic AF ablation outcome expectation for individual patients",
"AIMS Catheter-based atrial fibrillation ( AF ) ablation has become an important therapeutic option in AF patients . Although there has been significant improvent in procedural success , post-procedural AF recurrences are continuing to be a major clinical problem . To the best of our knowledge , the impact of pre-procedural serum uric acid ( SUA ) level , as a pro-oxidant and pro-inflammatory marker , on AF recurrence following cryoballoon-based AF ablation has never been studied before . The objective of this study was to establish whether there is a relationship between levels of SUA and recurrence of paroxysmal AF after catheter ablation . METHODS AND RESULTS A total of 363 patients ( mean age 53.5 ± 11.2 years , 52.6 % male ) with symptomatic paroxysmal AF underwent initial cryoablation procedure . Patients were categorized into quartiles on the basis of their pre-procedural SUA assays and follow-up , and the Kaplan-Meier estimation with a log-rank test was used for the analysis of the influence of SUA on the recurrence of AF . Post-ablation blanking period was observed for 3 months . At a mean follow-up of 19.2 ± 6.1 months , 68 patients ( 18.7 % ) had developed AF recurrence . Atrial fibrillation recurrence rates from the lowest to the highest SUA quartiles were 2.9 , 7.4 , 11.8 , and 77.9 % , respectively ( P pre-ablation SUA level ( HR : 1.96 , 95 % CI : 1.49 - 2.59 , P ) , left atrial diameter ( HR : 1.11 , 95 % CI : 1.04 - 1.19 , P = 0.002 ) and early AF recurrence ( HR : 4.34 , 95 % CI : 1.9 - 9.95 , P = 0.001 ) were independent predictors of AF recurrence after cryoablation . Using a cut-off level of 6.37 , the pre-ablation SUA level predicted AF recurrence during follow-up with a sensitivity of 85.7 % and a specificity of 83.7 % . CONCLUSION In this prospect i ve study of patients with paroxysmal AF undergoing cryoablation , increased pre-ablation SUA levels were associated with a higher rate of AF recurrence . Our results support the role of a pre-ablation pro-inflammatory and pro-oxidant environment in the development of AF recurrence after ablation therapy but suggest that other factors are also important",
"INTRODUCTION Pulmonary vein antrum isolation ( PVAI ) is an accepted treatment for atrial fibrillation ( AF ) refractory to medical therapy . The purpose of this study was to identify the patient , procedural , and follow-up factors associated with arrhythmia recurrences following PVAI . METHODS AND RESULTS Clinical data were prospect ively collected on all 385 consecutive patients who had 530 PVAI ( age 58 ± 11 years , 63 % paroxysmal AF-PAF , follow-up 2.8 ± 1.2 years ) between February 2004 and March 2009 . ECGs were recorded at each follow-up visit with Holter monitoring 1 , 3 , 6 , and 12 months following PVAI and every 6 months thereafter . Recurrences 1 year post-PVAI as very late . Relationship between predictor variables and outcomes was modeled using Cox proportional hazards analysis . Late recurrences occurred in 42 % with a lower rate among PAF versus non-PAF patients ( 39 % vs 56 % , P = 0.001 ) . Of the 256 patients with ≥ 1-year follow-up , 121 ( 47 % ) had no arrhythmia off antiarrhythmic drugs ( AADs ) 1 year post-PVAI ; 36 ( 30 % ) of these had a very late recurrence . In multivariate analysis , non-PAF , hypertension , and prior AAD failure predicted recurrence . When entered into the model , early recurrences remained the only predictor of late recurrences . CONCLUSION Patients with non-PAF , hypertension , and prior failure of multiple AAD were more likely to experience arrhythmia recurrence post-PVAI . Early recurrences were the strongest predictor of late recurrences . Late and very late recurrences following PVAI were common and should be considered when planning long-term AF patient management",
"OBJECTIVES It is uncertain whether gender affects the outcomes of catheter ablation ( CA ) for atrial fibrillation ( AF ) . The objective of the study is to evaluate the efficacy and safety of CA for long-st and ing persistent AF in women . METHODS Between January 2010 and May 2011 , 220 consecutive patients ( 73 females , 33.2 % ) , with long-st and ing persistent AF who underwent CA were prospect ively recruited . Gender-related differences in clinical presentation , periprocedural complications , and outcomes were compared . RESULTS Women were less likely to have lone AF than men ( 27.4 % vs 47.6 % ; P = 0.004 ) . The incidence of rheumatic heart disease was higher in women ( 19.2 % in women vs 1.4 % in men ; P initial ablation success rate than men ( 35.6 % vs 57.1 % ; P = 0.003 ) . Hematomas occurred more often in women ( 6.8 % in women vs 0.7 % in men ; P = 0.027 ) . A Cox regression analysis demonstrated total duration of AF ( per month , hazard ratio [ HR ] 1.003 , confidence interval [ CI ] 1.001 - 1.006 ; P = 0.006 ) and gender ( HR 1.663 , CI 1.114 - 2.485 ; P = 0.013 ) as the independent predictors for recurrence after the first CA . CONCLUSIONS Women and long AF duration were closely related to the recurrence of AF after the first ablation in patients with long-st and ing persistent AF . Women also had a higher risk of vascular complications",
"BACKGROUND Recent studies have suggested an emerging link between obstructive sleep apnea ( OSA ) and atrial fibrillation ( AF ) . Patients with OSA are less likely to remain in sinus rhythm after radiofrequency catheter ablation of AF . OBJECTIVE To evaluate the efficacy of appropriate treatment with continuous positive airway pressure ( CPAP ) on recurrences of AF after ablation . METHODS This study prospect ively included 153 patients ( 128 men ; 60 ± 9 years ) who underwent extensive encircling pulmonary vein isolation for drug refractory AF . The st and ard overnight polysomnographic evaluation was performed 1 week after ablation , and the total duration and the number of central or obstructive sleep apnea or hypopnea episodes were examined . RESULTS Of 153 patients , 116 patients were identified as having OSA . Data regarding the use of CPAP and recurrences of AF were obtained in 82 patients . The remaining 34 patients with OSA were defined as the no-CPAP group . Polysomnography revealed no sleep-disordered breathing in 37 patients . During a mean follow-up period of 18.8 ± 10.3 months , 51 ( 33 % ) patients experienced AF recurrences after ablation . A Cox regression analysis revealed that the left atrial volume ( hazard ratio [ HR ] 1.11 ; 95 % confidence interval [ CI ] 1.01 - 1.23 ; P of CPAP therapy ( HR 0.41 ; 95 % CI 0.22 - 0.76 ; P with AF recurrences during the follow-up period . CONCLUSIONS Patients with untreated OSA have a higher recurrence of AF after ablation . Appropriate treatment with CPAP in patients with OSA is associated with a lower recurrence of AF ",
"BACKGROUND Chronic obstructive pulmonary disease ( COPD ) is a risk factor for atrial fibrillation ( AF ) . The aim of this study was to investigate the impact of COPD on outcomes of catheter ablation in patients with AF in terms of recurrence and quality of life ( QoL ) . METHODS In this prospect i ve study , 550 consecutive patients with symptomatic , medication-refractory AF underwent first catheter ablation . Patients were classified into those with COPD ( group 1 , n = 54 ) and those without COPD ( group 2 , n = 496 ) . Patients were followed up for atrial tachyarrhythmia ( ATa ) recurrence for at least 24 months . The Medical Outcomes Study SF-36 Health Survey was used to assess QoL at baseline and 24 months after ablation . RESULTS After a single ablation , 24 patients in group 1 ( 44.4 % ) and 142 in group 2 ( 28.6 % ) had ATa recurrence during a mean follow-up of 31.4 ± 4.8 months ( P = 0.016 ) . The second ablation was performed in 19 patients ( 35.2 % ) from group 1 and in 109 patients ( 22.0 % ) from group 2 ( P = 0.029 ) . Multivariate logistic analysis showed that nonparoxysmal AF ( P = 0.013 , OR = 1.767 , 95 % CI : 1.129 - 2.765 ) as well as the presence of COPD ( P = 0.029 , OR = 1.951 , 95 % CI : 1.070 - 3.557 ) was the independent predictor for higher ATa recurrence . Moreover , patients in group 1 had significantly lower baseline scores on all SF-36 Health Survey subscales . At 24-month follow-up , both mental component summary and physical component summary scores improved markedly in group 1 and 2 . CONCLUSIONS Although the presence of COPD predicted higher recurrence after single-catheter ablation in AF patients , significant improvements in QoL were observed in the postablation COPD population",
"INTRODUCTION Persistent atrial fibrillation ( persAF ) can occur either as a sustained arrhythmia that has progressed from initially paroxysmal AF or as primary persAF without a history of any spontaneously terminated episode . There is a paucity of data differentiating between the 2 different persAF entities . Thus , we prospect ively evaluated baseline characteristics , electrophysiological features , and ablation outcome in these 2 patient cohorts . METHODS AND RESULTS A total number of 154 consecutive persAF patients ( 63 ± 10 years , f = 42 , longst and ing persAF = 60 ) were characterized in terms of having primary persAF ( P-persAF group ) or persAF that secondarily progressed from paroxysmal AF ( S-persAF group ) . All patients underwent de novo catheter ablation using the stepwise approach . PersAF entities were characterized by detailed patient history , sequential Holter monitoring , and reports of documented modes of AF conversion , respectively . The P-persAF group had a higher number of young patients ( 50 years ) , a shorter AF history , and a higher number of congestive heart failure . The HATCH score did not differ between the groups . Procedural AF termination rate was significantly higher in S-persAF than in P-persAF patients ( n = 55 [ 81 % ] vs. n = 58 [ 68 % ] , P = 0.043 ) . At 1-year follow-up , the arrhythmia-free survival after a single procedure was significantly lower in patients with P-persAF ( 26 % vs. 43 % , P = 0.016 ) . Categorization to P-persAF was the strongest independent predictor of arrhythmia recurrence . CONCLUSIONS P-persAF seems to be a specific arrhythmia entity that is associated with a lower AF-termination rate and a worse outcome after catheter ablation as compared to S-persAF ",
"Background Long-term results after circumferential pulmonary vein isolation ( CPVI ) for the treatment of paroxysmal atrial fibrillation ( PAF ) using a robotic navigation system ( RNS ) have not yet been reported . Objective To evaluate long-term results of patients with PAF after CPVI using RNS . Methods In this study , 200 patients ( n = 151 ( 75.5 % ) male ; median age 62.2 ( 54.7–67.7 ) years ) with PAF were evaluated . In 100 patients , RNS ( RN-group ) was used for CPVI and compared to 100 manually ablated control patients ( MN-group ) . Radiofrequency was used in conjunction with 3D electroanatomic mapping . Power was limited to 30 watts ( W ) at the posterior left atrial ( LA ) wall in the first 49 RNS patients ( RN-group-a ) . After esophageal perforation occurred in one RN-group-a patient , maximum power was reduced to 20 W for the subsequent 51 patients ( RN-group-b ) . Results After a median follow-up of 2 years , single ( 77/100 vs 77/100 , p = 0.89 ) and multiple ( 90/100 vs 93/100 , p = 0.29 ) procedure success rates were comparable between RN-group and MN-group . Single procedure success rate was significantly lower in RN-group-a as compared to RN-group-b ( 65.3 vs 88.2 % , p = 0.047 ) . In RN-group-a patients , procedural times [ 200 ( 170–230 ) vs 152 ( 132–200 ) minutes , p and fluoroscopy times [ 16.6 ( 12.9–21.6 ) minutes vs 13.7 ( 9.5–19 ) minutes , p = 0.043 ] were significantly longer compared to RN-group-b patients . Conclusion Long-term success rate after CPVI using RNS was comparable to manual ablation . Despite a lower power limit of 20 W at the posterior LA wall , single procedure success rate was higher in RN-group-b as compared to RN-group-a . Procedure time and fluoroscopy time decreased , whilst success rate increased with increasing experience in the RN-group",
"BACKGROUND Catheter ablation is now an alternative approach to antiarrhythmic drug therapy for patients with symptomatic atrial fibrillation ( AF ) . We focused on younger patients in whom the prevalence of AF is low , and we sought clinical factors associated with unsuccessful ablation outcomes . METHODS AND RESULTS Among 1983 consecutive symptomatic patients who underwent AF ablation procedures , 95 patients ( 4.8 % ) , age ≤ 40 years , were prospect ively included . Of them , 64 had paroxysmal AF , and the remaining 31 had persistent AF . All patients underwent pulmonary vein isolation and cavotricuspid isthmus ablation . When AF recurred , redo ablations were performed if the patients desired . The mean number of ablation procedures was 1.3 ± 0.6 times per patient . During the follow-up of 40 [ 27.8 - 49.6 ] months , sinus rhythm was maintained in 86 patients ( 90.5 % ) without any antiarrhythmic drugs , but not in the remaining 9 patients ( 9.5 % ) . Low body mass index ( BMI ) and persistent AF were associated with unsuccessful ablation procedures . In multivariate logistic regression analysis , a low BMI had the most significant value , with an odds ratio of 7.33 ( p=0.022 ) . The receiver operating characteristic curve demonstrated a BMI cut point of 22.1 kg/m(2 ) , with an area under the curve of 0.773 . CONCLUSION In symptomatic younger AF patients , a low BMI was an independent clinical factor for unsuccessful AF ablation outcomes",
"BACKGROUND Pre-procedural predictors ( PP ) of atrial fibrillation ( AF ) recurrence ( AFR ) after repeated catheter ablation of AF ( RCAF ) are unknown . The aim of this study was identification of PP of outcome after RCAF . METHODS AND RESULTS In 213 patients ( 73 % male ) with drug-refractory AF ( 47 % paroxysmal AF ; PAF ) RCAF was performed . CHADS2 , CHA2DS2-VASc and ALARMEc ( AF type , Left Atrium size , Renal insufficiency , MEtabolic syndrome , cardiomyopathy ) scores were calculated for each patient . Complete success was defined as no AFR . After RCAF , 125 patients ( 59 % ) were free of atrial flutter or atrial tachycardia ( AFLAT ) on long-term follow-up ( FU ) . The univariate predictors of AFR were : type of AF ( non-PAF vs. PAF , P=0.001 ) , normalized left atrium area ( NLA ≥10.25 vs. NLA estimated glomerular filtration rate ( of AFLAT-free survival after RCAF were non-PAF ( P=0.002 ) and NLA ≥10.25 ( P=0.018 ) . Among combined predictors , only ALARMEc score , and neither CHADS2 or CHA2DS2-VASc , predicted outcome after RCAF ( P CONCLUSIONS RCAF results in a moderate success rate on very long-term FU . Lower success was observed in patients with non-PAF and enlarged LA . ALARMEc score allows for clear description of expected outcome after RCAF"
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4116e908-06ff-11f0-808a-c43d1ab1c353
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Background Intertrigo in the large skin folds is a common problem . There is a plethora of treatments , but a lack of evidence about their efficacy . A nursing guideline on this matter had to be up date d and broadened in scope to other health care professionals . Methods A systematic review was performed . Thirteen data bases were sensitively search ed , supplemented by reference tracking and forward citation search es . All types of empirical research relating to the prevention or treatment of intertrigo were included . Study selection , assessment of bias , data - extraction and analysis were done by two independent review - authors . Results Sixty-eight studies fulfilled the inclusion criteria . Only 4 studies were RCTs and even these had a considerable risk of bias . Study population s were generally small . No studies were found about the prevention of intertrigo . The therapies concerned mostly the topical application of antimycotics , corticosteroids , antibiotics , antiseptics or a combination of these . Besides these pharmaceutical interventions , surgical breast reduction was also studied . Although most study - authors were positive , we could not draw firm conclusions about any of the pharmaceutical interventions . Even patients that received placebo intervention showed improvement . There is weak evidence that reduction mammaplasty may be helpful to treat inframammary intertrigo . All research found had considerable risk of bias , prohibiting firm conclusions . Conclusions There is no evidence at all about the prevention of intertrigo and there is no firm evidence about its treatment . Well design ed studies are needed
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[
"A double-blind , paired comparison study of 3 % amphotericin lotion and placebo is reported . The placebo was as effective as the active drug ( or vice versa ) . There was no acceptance",
" Two hundred and forty five patients with dermatophytoses and cutaneous c and idosis were enrolled in the study ; 122 were r and omized to the once-weekly regimen and 123 to the once-daily regimen . Subjects included both men and women ; the average age was 42 years . There were no statistically significant differences between the two groups with regard to age , sex , race , and body weight distributions . In the group receiving once-weekly fluconazole , there were 58 tinea pedis infections and 77 nonpedis infections ( tinea corporis , tinea cruris , and cutaneous c and idosis ) . In the group receiving once-daily fluconazole , there were 56 tinea pedis infections and 76 nonpedis infections . The duration of infection and total score of signs and symptoms did not differ significantly between the two groups . Patients received treatment until clinical ly cured or up to a maximum of 6 weeks for tinea pedis and 4 weeks for tinea corporis , tinea cruris , or cutaneous c and idosis . Medical history , physical and laboratory examinations , and the clinical diagnosis were recorded . Clinical and mycologic examinations and laboratory testing were performed at baseline and 2 weeks after treatment initiation , and then weekly until clinical ly cured or the maximum duration of treatment allowed was reached . Safety analysis was performed for all patients . Follow-up clinical and mycologic examinations were performed 1 month after the therapy ended . The clinical efficacy was based on cure ( disappearance of all baseline signs and symptoms of infection ) , marked improvement , moderate improvement , failure ( no change or worsening of the signs and symptoms ) , or unevaluable ( most commonly due to protocol evaluations or the absence of an identified pathogen ) . Mycologic efficacy was based on eradication ( absence of pathogen on microscopy and /or culture ) , persistence ( presence of pathogen on microscopy and /or culture ) , superinfection ( absence of pathogen , but with a different fungal pathogen on microscopy and culture associated with clinical disease ) , or unevaluable . Long-term follow-up evaluation included the category relapse , defined as the absence of pathogen at the end of treatment , with the reappearance of that pathogen on microscopy and /or culture at follow-up visit . The culture result determined the efficacy where discrepancies between microscopy and culture findings occurred",
" A total of 594 patients were treated with the new antimycotic agent econazol ( Pevaryl ) . The diagnosis was proven microscopically and on culture except in cases of pityriasis versicolor where it was proven microscopically only . Econazol was given to 130 patients as a 1 % solution , to 128 patients as a 1 % milk , and to 336 patients as a 1 % spray solution . In 333 cases of foot mycosis or eczema marginatum econazol spray powder was given in addition . As measured by the cure rate the spray solution ( 92 % ) was not significantly more effective than the milk ( 89 % ) or the simple solution ( 87 % ) . Criteria for cure included negative microscopy and fungal cultures a week after treatment had ceased as well as clinical cure . A total of 90 % of all cases ( n = 536 ) could be considered as cured microscopically and on culture after an average of 3.6 weeks ( pityriasis versicolor ) and 4.8 weeks ( tinea pedis , manus , inguinocruralis ) . In a further 4.4 % ( n = 26 ) the fungus could be demonstrated microscopically despite a clinical cure and in 7 of these cases culture was also positive . The cure rate was independent of the responsible pathogen . The preparations were tolerated extremely well . In 7 cases , however , transient dermatitic irritations were seen in the inguinocrural region , mainly caused by the simple solution",
"The condition macromastia has not been defined and characterized precisely by the medical community . Whether the patient with hypertrophic breasts is a c and i date for or can be helped by reduction mammaplasty is unclear to both the medical and the lay community . A prospect i ve study of 39 women undergoing reduction mammaplasty surgery was initiated to answer these questions . Patients rated the severity of their somatic pain symptoms and discomfort before reduction mammaplasty and again after complete recovery . The severity of their symptoms and complaints was numerically grade d and analyzed . These data were compared with similar data obtained from 40 \" small-breasted \" women of similar age . Headache , neck pain , back pain , shoulder pain , and bra strap groove pain were present in 60 to 92 percent of patients , and 97 percent of patients had at least three of these pain symptoms preoperatively . All the patients had reduction of their pain symptomatology postoperative , and 25 percent of the study patients had total elimination of pain symptoms by reduction mammaplasty . The postoperative incidence and severity of pain symptoms and discomfort complaints were statistically equivalent to or less than the levels in the control group",
"A double-blind comparative study between 1 % hydrocortisone cream and a combination of 1 % hydrocortisone cream and 2 % miconazole cream has highlighted some of the problems with this type of research in general practice . The collection of adequate patient numbers within a predefined time scale proved a major problem . However , the study demonstrated the safety and efficacy of both these preparations in the treatment of intertrigo",
"30 patients with symmetrical intertriginous c and idiasis were treated with 5-fluorocytosine 10 % cream and nystatin gel using the paired comparison method . The agents were applied twice daily for 2"
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4116e944-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Although calcium is one the simplest and least expensive strategies for preventing osteoporotic fractures calcium supplementation is nevertheless not without controversy ( Kanis 1989 ; Nordin 1990 ) . The Food and Drug Administration in the US has permitted a bone health cl aim for calcium-rich foods , and the NIH in its Consensus Development Process approved a statement that high calcium intake reduces the risk of osteoporosis . OBJECTIVES To assess the effects of calcium on bone density and fractures in postmenopausal women . SEARCH STRATEGY We search ed Cochrane Controlled Register , MEDLINE and EMBASE up to 2001 , and examined citations of relevant articles and proceedings of international meetings . SELECTION CRITERIA Trials that r and omized postmenopausal women to calcium supplementation or usual calcium intake in the diet and reported bone mineral density of the total body , vertebral spine , hip , or forearm or recorded the number of fractures , and followed patients for at least one year were considered for inclusion . DATA COLLECTION AND ANALYSIS Three independent review ers assessed the method ologic quality and extracted data for each trial . For each bone density site ( lumbar spine , total body , combined hip and combined forearm ) , we calculated the weighted mean difference in bone density between treatment and control groups using the percentage change from baseline . We constructed regression models in which the independent variables were year and dose , and the dependent variable was the effect size . This regression was used to determine the years across which pooling was appropriate . Heterogeneity was assessed . For each fracture analysis we calculated a risk ratio . MAIN RESULTS Fifteen trials , representing 1806 participants , were included . Calcium was more effective than placebo in reducing rates of bone loss after two or more years of treatment . The pooled difference in percentage change from baseline was 2.05 % ( 95 % CI 0.24 to 3.86 ) for total body bone density , 1.66 % ( 95 % CI 0.92 to 2.39 ) for the lumbar spine at 2 years , 1.60 % ( 95 % CI 0.78 to 2.41 ) for the hip , and 1.91 % ( 95 % CI 0.33 to 3.50 ) for the distal radius . The relative risk of fractures of the vertebrae was 0.79 ( 95 % CI 0.54 to 1.09 ) ; the relative risk for non-vertebral fractures was 0.86 ( 95 % CI 0.43 to 1.72 ) . REVIEW ER 'S CONCLUSIONS Calcium supplementation alone has a small positive effect on bone density . The data show a trend toward reduction in vertebral fractures , but it is unclear if calcium reduces the incidence of non vertebral fractures
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"The effects of calcium supplementation ( as calcium citrate malate , 1000 mg elemental Ca/d ) with and without the addition of zinc ( 15.0 mg/d ) , manganese ( 5.0 mg/d ) and copper ( 2.5 mg/d ) on spinal bone loss ( L2-L4 vertebrae ) was evaluated in healthy older postmenopausal women ( n = 59 , mean age 66 y ) in a 2-y , double-blind , placebo-controlled trial . Changes ( mean + /- SEM ) in bone density were -3.53 + /- 1.24 % ( placebo ) , -1.89 + /- 1.40 % ( trace minerals only ) , -1.25 + /- 1.46 % ( calcium only ) and 1.48 + /- 1.40 % ( calcium plus trace minerals ) . Bone loss relative to base-line value was significant ( P = 0.0061 ) in the placebo group but not in the groups receiving trace minerals alone , calcium alone , or calcium plus trace minerals . The only significant group difference occurred between the placebo group and the group receiving calcium plus trace minerals ( P = 0.0099 ) . These data suggest that bone loss in calcium-supplemented , older postmenopausal women can be further arrested by concomitant increases in trace mineral intake",
"During a two-year study , we examined the effect of calcium supplementation on postmenopausal bone loss in 43 women in the early postmenopausal period who were assigned to one of three treatment groups : percutaneous 17 beta-estradiol ( combined with progesterone during the second year ) , oral calcium ( 2000 mg daily ) , and placebo . All participants were examined every three months . Bone mineral content in the forearm ( measured by single-photon absorptiometry ) and in the entire body and spine ( measured by dual-photon absorptiometry ) remained constant in the estrogen-treated group but decreased significantly in the groups receiving calcium and placebo . In the calcium-treated group , we observed a tendency toward a slowed loss of compact bone ( in the proximal forearm and total skeleton ) as compared with the placebo group , while the rate of loss of trabecular bone ( the distal forearm and spine ) was the same as in the placebo group . Our preliminary data suggest that calcium supplementation in the dosage we used is not as effective as estrogen therapy for the prevention of early postmenopausal bone loss . Calcium supplementation may have had a minor effect on the loss of cortical bone , but it had no effect on the trabecular bone",
"Postmenopausal bone loss is a major factor in the increasing prevalence of osteoporotic fractures . Evidence is abundant that hormonal replacement therapy prevents the bone loss that follows natural or surgical menopause and reduces the prevalence of osteoporotic fractures in later life [ 1 - 4 ] . However , only about 10 % of American women elect to receive replacement therapy because of attitudes of physicians and patients , the undesirability of menstrual bleeding , and unresolved questions about the relation of the use of estrogen to breast cancer [ 5 ] . Moreover , the duration of hormonal therapy may need to be prolonged because bone loss recurs when therapy is discontinued , yet the incidence of some adverse effects increases with the duration of estrogen use . Safer alternatives to estrogen use have been sought . Epidemiologic and cross-sectional studies have suggested that increasing calcium intake might prevent postmenopausal bone loss , and prospect i ve studies have yielded conflicting results [ 6 - 17 ] . Moreover , some investigators have suggested that effects differ on the various skeletal sites used to determine the rate of bone loss [ 18 ] . We compared the efficacy of calcium augmentation in early postmenopause with calcium augmentation plus hormonal replacement therapy and with placebo . The study had a three-arm , r and omized , parallel design . The patients receiving hormonal replacement therapy were obviously not blinded nor were their physicians , whereas the placebo and calcium groups were double blinded . Methods Healthy , white women between 6 months and 6 years after a natural menopause were recruited to participate in the study . The protocol was approved by the Human Investigation Review Committees of Winthrop-University Hospital and Brookhaven National Laboratory ; written informed consent was obtained from each participant . Participants were recruited by announcements in the local press and in hospital and university publications and through a direct mail campaign . All participants had a history and physical examination . Exclusion characteristics included any disorder known to affect bone metabolism such as glucocorticoid use , gastrointestinal disease , or any chronic illness . Previous or current malignancy was an exclusion characteristic as were absolute contraindications to estrogen replacement or calcium supplements . Absolute contraindications to estrogen replacement therapy included estrogen-dependent neoplasm ( breast or uterus ) , undiagnosed vaginal bleeding , thrombophlebitis or thromboembolism , and acute liver disease . Women with the following problems considered by some investigators to be relative contraindications to estrogen therapy were also excluded : gallbladder disease , history of liver disease , first-degree relatives with breast cancer , and hypertension . Calcium urolithiasis was also an exclusion factor . Women with known osteoporosis or with a vertebral compression fracture were not eligible for the study . One hundred eighteen women entered the study . The women were r and omly assigned to three groups : 1 ) hormonal replacement [ estrogen-progesterone-calcium carbonate ] , 2 ) calcium carbonate , or 3 ) placebo . Assignment to the groups was based on computer-generated r and om numbers provided by the statistician , with stratification for years postmenopause . The women in the hormonal replacement group took conjugated equine estrogens ( Premarin , Wyeth-Ayerst Laboratories , Inc. ; Philadelphia , Pennsylvania ) , 0.625 mg daily for 25 days of the month along with medroxyprogesterone ( Provera , Upjohn ; Kalamazoo , Michigan ) , 10 mg from days 16 to 25 . All women received 400 IU of vitamin D daily in the form of a multivitamin , and calcium supplementation ( as Caltrate , Lederle ; Clifton , New Jersey ) was provided to the two treatment groups . The duration of the study was 2.9 1.1 years ( mean SD ) . A 7-day dietary history was review ed with a nutritionist every 2 months ; calcium was provided as calcium carbonate , 600 mg ( Caltrate ) , and used to supplement the diet to approximate a total daily intake of 1700 mg of elemental calcium ( the mean + 2 SD found by Heaney and colleagues [ 7 ] to result in zero calcium balance in estrogen-deprived women ) . The calcium supplements were taken with meals in divided doses . The placebo appeared identical to the calcium carbonate tablets . No patients took antacids or histamine-2 blockers . All women had a baseline mammogram . Measurements Routine laboratory studies included a complete blood count , urinalysis , and serum fasting calcium , phosphorus , urea nitrogen , creatinine , alkaline phosphatase , cholesterol , and aminotransferase measurements [ 19 , 20 ] . In addition , follicle-stimulating hormone , estradiol , parathyroid hormone , osteocalcin , free thyroxine , and bone alkaline phosphatase were measured , and a urine specimen was collected after an overnight fast for hydroxyproline , calcium , and creatinine determinations , following a 3-day low-hydroxyproline diet [ 21 - 23 ] . Total body calcium was measured annually in the participants , using the delayed neutron activation method at Brookhaven National Laboratory [ 24 , 25 ] . This method uses a whole-body counter to measure the characteristic rays emitted from the neutron capture of Calcium-48 ( natural abundance of 0.187 % ) in the body . The Brookhaven National Laboratory whole-body counter was up grade d in 1987 to use 32 NaI ( T1 ) detectors of 10 cm 10 cm 46 cm positioned symmetrically above and below the patient [ 25 ] . The activated isotope , Calcium-49 , decays with a half-life of 8.72 minutes , emitting a 3.08 MeV characteristic line . More than 99.5 % of the body calcium is contained in the bone [ 26 ] . The method provides total body calcium with a coefficient of variation of about 1.5 % when no substantial change in the body weight occurs during the period of repeated studies . The measurements were made annually . The bone mineral density of the distal radius site was measured using a Lunar Radiation ( Madison , Wisconsin ) single-photon absorptiometer ( SP2 ) . Bone mineral density of the spine ( L2-L4 ) and femur ( neck , trochanter , and Ward triangle ) was measured using a Lunar Radiation DP4 dual-photon absorptiometer . The software version used for the analysis of scans was DP4 Lunar Corporation Version 1.1 . All scans were analyzed using the same software version , which corrects for source decay . Instruments were calibrated daily , and the radioactive source was changed annually . Each measurement was done every 6 months . The coefficient of variation of these measurements was 2 % , except for the Ward triangle ( 2.5 % ) . Activity was measured using activity monitors ( large-scale integrated monitors ) , which were worn about the waist [ 27 ] . The average of 2 weekdays and 1 weekend day was used as an activity score . Activity was measured at baseline and at one other point during the study to ensure that differences among the groups were not due to varied levels of exercise . Statistical Analysis Total body calcium was selected as the primary criterion for efficacy for the following reasons : It measures mass rather than density per unit area ; it measures calcium balance precisely and accurately in the free living state and may be better related to previous studies using the balance technique ; it is more precise than the other measurements ; and it avoids sampling error by measuring the entire skeleton rather than a specific region of the appendicular or axial skeleton . The rate of change in bone mineral was calculated for each woman at each of the sites used in the study . St and ard linear regression procedures were used to estimate the rate of bone mineral change for each woman , and the regression intercept was used as the best estimate of the baseline value . Because some women terminated their participation in the study before others , the rate-of-change data were weighted by the inverse variance to reflect the fit of the regression line for each woman [ 28 ] . Analyses of covariance were done using body mass index , activity scores , cigarette smoking , calcium intake , age , and years postmenopause as covariates . The data reported in this article are based on all women who provided at least three observations for a particular skeletal site . We considered other criteria , such as using data only from women who had participated in the study for at least 2 years , and all data analyses were done for this subgroup as well . The results of these analyses were invariably similar to those reported here and therefore are not presented separately . The mean rates of change in bone mineral for each condition at each site were characterized in terms of both raw units and percentages ; separate analyses were carried out for each . The two indices were similar . Evidence from recent research is substantial that estrogen replacement therapy is effective , whereas the efficacy of calcium supplements is question able . Our expectation was that our data would confirm the efficacy of estrogen-progesterone-calcium therapy , and the critical question was whether or not a beneficial effect of calcium supplements given alone could be shown . A separate one-way analysis of covariance was done for each of the bone mineral measurements to compare the mean rates of change in bone mineral for each of the three conditions . We used two a priori contrasts : the first contrasting women taking estrogen with those receiving calcium and the second comparing women receiving calcium supplements with those on placebo . All P values reported are two-tailed . Results Baseline data for historical data and bone mineral measurements and chemical studies are given in Table 1 . Analysis of variance showed no significant differences in the baseline variables . The initial and final activity scores did not differ significantly . Table 1 . Baseline Values for Patient Characteristics , Bone Mineral Measurements , and Chemical Variables The range of initial daily calcium intake in the overall study group was 150 to 1263 mg ; in the calcium augmentation group , it was 222 to",
"The effect of dietary calcium supplementation on bone mineral content was studied in 40 postmenopausal women with Colles ' fracture . The participants were divided into two groups which were given either placebo or 1 g of calcium per day . The bone mineral content of the femur was determined before and after 1 year of medication . Women with Colles ' fracture were found to have the same mineral content in the femur as age-matched controls without fractures . Calcium supplementation had no significant effect on the bone mineral content",
"A r and omized controlled trial was carried out to determine whether calcium supplementation and load-bearing exercise can increase or maintain bone mass in the elderly . Fifty Chinese women , aged 62–92 years , living in a hostel for the elderly in Hong Kong were r and omized to enter one of four treatment groups : ( I ) calcium supplementation of 800 mg ( as calcium lactate gluconate ) daily ; ( II ) load-bearing exercise four times a week plus a daily placebo tablet ; ( III ) calcium supplementation daily and load-bearing exercise four times a week ; ( IV ) a placebo tablet daily . The interventions went on for 10 months . The bone mineral density ( BMD ) was measured at three sites in the hip ( femoral neck , Ward 's triangle and intertrochanteric area ) and the L2–4 level of the spine . The percentage change in BMD in 10 months was used as the main outcome measurement . The parathyroid hormone level and indices of bone metabolism were also measured before and after 10 months of intervention . The BMD at Ward 's triangle and the intertrochanteric area increased significantly in subjects on calcium supplement ( p on bone loss at any site . However , the results of two-way analysis of variance showed a significant joint effect of calcium supplements and exercise at the femoral neck ( p The parathyroid hormone levels fell significantly in subjects on calcium supplements (p supplement in the form of calcium lactate gluconate was adequately absorbed in elderly Chinese women with a calcium intake of less than 300 mg per day . It was effective in reducing bone loss at the hip , and there may be interaction effects with exercise in maintaining bone density",
"Abstract . Although fluoride salts have been shown to be capable of linearly increasing spinal bone mineral density ( BMD ) in postmenopausal osteoporosis , the effects of this gain in density on the vertebral fracture rate remain controversial . We conducted a 2-year multicenter , prospect i ve , r and omized , double-masked clinical trial in 354 osteoporotic women with vertebral fractures ( mean age 65.7 years ) . They received either fluoride ( 208 patients ) , given as sodium fluoride ( 50 mg/day ) or as monofluorophosphate ( 200 mg/day or 150 mg/day ) , or a placebo ( 146 patients ) . All patients received daily supplements of 1 g of calcium ( Ca ) and 800 IU of vitamin D2 ( D ) . A 1-year open follow-up on Ca-D was obtained in 124 patients . After 2 years the fluoride group and the Ca-D group had increased their lumbar BMD by 10.8 % and 2.4 % respectively ( p = 0.0001 ) . However , the rate of patients with at least one new vertebral fracture , defined by semiquantitative assessment and evaluable on an intention-to-treat basis in 89 % of patients , was similar in the fluoride groups and the Ca-D group . No difference between the three fluoride regimens was found . The percentage of patients with nonvertebral fractures was not different in the fluoride and Ca-D groups ( 1.9 % and 1.4 % respectively for hip fractures ) . A lower limb pain syndrome occurred more frequently in the fluoride groups . In the 124 patients followed for 1 year after cessation of fluoride therapy , the percentage of patients with at least one new vertebral fracture after 36 months was identical to the percentages in the previous fluoride group and the Ca-D group . We conclude that flouride-Ca-D regimen was no more effective that Ca-D supplements for the prevention of new vertebral fractures in women with postmenopausal osteoporosis",
"To study the effect of calcium supplementation on perimenopausal bone loss , 295 women were r and omized into a control group and 2 supplementation groups receiving , respectively , 1000 and 2000 mg elemental calcium/day for a period of 2 yr . We observed a significant decrease in lumbar bone loss in relation to the calcium supplementation ( mean loss after 2 yr of 3.5 % in the control group vs. 1.3 % and 0.7 % in the 1000 and 2000 mg groups , respectively ) , a significant increase in urinary calcium excretion , and a significant decrease in the urinary hydroxyproline/creatine ratio , serum alkaline phosphatase , osteocalcin , and 1,25-dihydroxyvitamin D. The effect of calcium supplementation on lumbar bone loss was significant in the first year of supplementation , but not in the second . However , the urinary hydroxyproline/creatinine ratio and the serum alkaline phosphatase level remained significantly decreased in the treatment groups at the end of the study ; this was not the case for serum osteocalcin . Calcium supplementation did not have a significant effect on metacarpal cortical bone loss . The difference in biochemical parameters between the 2 supplementation groups was small . No significant interaction was observed between the menopausal status of the subjects and the effect of calcium supplementation . We conclude that calcium supplementation retards lumbar bone loss in the first year of calcium supplementation by reducing bone turnover . However , the effect on lumbar bone loss over a longer time span is still uncertain",
"We tested the spine antifracture and bone sparing efficacy of 1.2 g/day of oral calcium as carbonate in two groups of elderly women , one with prevalent fractures ( PF , n = 94 ) on entry and the other without ( NPF , n = 103 ) . It was a prospect i ve r and omized , double-blind , placebo-controlled trial in mostly rural communities in women over age 60 who were living independently and were consuming calcium . We obtained annual lateral spine radiographs and semiannual forearm bone density over 4.3 + /- 1.1 years and determined vertebral fractures by radiographic morphometry augmented by physician assessment . In the PF group , 15 of 53 subjects on calcium had incident fractures , compared with 21 of 41 on placebo ( p = 0.023 , chi2 ) . Calcium did not reduce the rate of incident fractures in the NPF group . Those with a prevalent fracture on entry and not treated with calcium were 2.8 times more likely to experience an incident fracture than all others . Change in the forearm bone mass on placebo in the PF group was -1.24 + /- 2.41%/year compared with + 0.31 + /- 1.80%/year on calcium ( p elderly postmenopausal women with spine fractures and selfselected calcium intakes of , a calcium supplement of 1.2 g/day reduces the incidence of spine fractures and halts measurable bone loss",
"The etiology of age-related bone loss is unclear but both lack of exercise and dietary calcium deficiency have been implicated in its causation . This 2-year r and omized placebo-controlled study was design ed to examine the effects of increased dietary calcium and exercise in 168 women who were more than 10 years postmenopausal . The subjects were r and omized into one of 4 groups : placebo , milk powder containing 1 g of calcium , calcium tablets 1 g/night , and calcium tablets 1 g/night and an exercise regimen . The exercise group aim ed to undertake 4 h of extra weight-bearing exercise per week and were undertaking 10 % more activity than other groups at 2 years . Bone mineral density at the lumbar spine , three hip sites , and two sites of the tibia close to the ankle joint were measured at 6 month intervals . Dietary intake was evaluated by a weighed food record , exercise was evaluated by an exercise diary , and blood and urine sample s were obtained to examine effects on calcium homeostasis . Individual data points were compared using repeated measures ANOVA and least squares regression . Calcium supplementation by either the calcium tablets or the milk powder result ed in cessation of bone loss at the intertrochanteric hip site ( placebo , calcium tablets , calcium and exercise , milk powder -0.81 , + 0.17 , + 0.23 , and + 0.07 % per year , respectively ; p calcium and exercise group had less bone loss at the femoral neck site when compared with calcium supplementation alone ( placebo , calcium tablets , calcium and exercise , milk powder -0.67 , -0.18 , + 0.28 , and -0.18 % per year , respectively ; p calcium and exercise compared with calcium alone ) . There was a significant reduction in the rate of bone loss at the ultradistal site of the tibia ( placebo , calcium tablets , calcium and exercise , milk powder -2.5 , -1.6 , -1.0 , and -1.5 % per year , respectively ; p < 0.05 for all supplementation groups compared with placebo ) . There was no significant bone loss at the spine site in any group . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND The use of calcium supplements slows bone loss in the forearm and has a beneficial effect on the axial bone density of women in late menopause whose calcium intake is less than 400 mg per day . However , the effect of a calcium supplement of 1000 mg per day on the axial bone density of postmenopausal women with higher calcium intakes is not known . METHODS We studied 122 normal women at least three years after they had reached menopause who had a mean dietary calcium intake of 750 mg per day . The women were r and omly assigned to treatment with either calcium ( 1000 mg per day ) or placebo for two years . The bone mineral density of the total body , lumbar spine , and proximal femur was measured every six months by dual-energy x-ray absorptiometry . Serum and urine indexes of calcium metabolism were measured at base line and after 3 , 12 , and 24 months . RESULTS The mean ( + /- SE ) rate of loss of total-body bone mineral density was reduced by 43 percent in the calcium group ( -0.0055 + /- 0.0010 g per square centimeter per year ) as compared with the placebo group ( -0.0097 + /- 0.0010 g per square centimeter per year , P = 0.005 ) . The rate of loss of bone mineral density was reduced by 35 percent in the legs ( P = 0.02 ) , and loss was eliminated in the trunk ( P = 0.04 ) . Calcium use was of significant benefit in the lumbar spine ( P = 0.04 ) , and in Ward 's triangle the rate of loss was reduced by 67 percent ( P = 0.04 ) . Calcium supplementation had a similar effect whether dietary calcium intake was above or below the mean value for the group . Serum parathyroid hormone concentrations tended to be lower in the calcium group , as were urinary hydroxyproline excretion and serum alkaline phosphatase concentrations . CONCLUSIONS Calcium supplementation significantly slowed axial and appendicular bone loss in normal post-menopausal women",
"We report a 4-year r and omized , double-blind , placebo-controlled clinical trial in 236 normal postmenopausal women ( mean age + /- SE , 66.3+/-0.2 years ) who were r and omized to a calcium ( 1600 mg/day as the citrate ) or placebo group . The women were seen every 6 months ; 177 completed the trial . Net percentage changes in each group are given relative to baseline . The differences in net percentage changes ( calcium group minus placebo group ) in medians were : for lumbar spine bone density , 2.0 % ( p proximal femur bone density , 1.3 % ( p = 0.003 ) at year 1 and 1.3 % ( p = 0.015 ) at year 4 ; and for total body bone mineral , 0.4 % ( p = 0.002 ) at year 1 and 0.9 % ( p = 0.017 ) at year 4 . Similar differences at year 4 were : -18.9 % ( p = 0.002 ) for parathyroid hormone ( PTH ) , -11.9 % ( p = 0.026 ) for serum osteocalcin , and -32.2 % ( p = 0.003 ) for urine free pyridinoline . We conclude that long-term administration of calcium supplements to elderly women partially reverses age-related increases in serum PTH level and bone resorption and decreases bone loss . However , the effects on bone loss were weaker than those reported for estrogen , bisphosphonates , or calcitonin therapy , indicating that calcium supplements alone can not substitute for these in treating established osteoporosis . Nonetheless , because of their safety , high tolerance , and low expense , calcium supplements may be a useful preventive measure for elderly postmenopausal women whose bone mineral density values are normal for their age",
"Sixty postmenopausal women were placed in three groups -- control , sex hormone-treated , and CaCO3-treated-- and followed for 2 years . Skeletal mass decreased by 1.18%/year in the control group , 0.15%/year in the hormone group , and 0.22%/year in the CaCO3 group by radiogrammetry ; and 2.88%/year in the control group , 0.73%/year in the hormone group , and 1.83%/year in the CaCO3 group by photon absorptiometry . The treatment groups differed significantly from the control group except for photon absorptiometry in the CaCO3 group . Bone accretion and resorption decreased in the treatment groups as measured by calcium tracer kinetics , resorption more so than accretion . We conclude that [ 1 ] these techniques are sufficiently sensitive to detect age-related bone loss ; [ 2 ] postmenopausal sex-hormone replacement measurably decreases age-related bone loss by suppressing bone turnover , resorption more than accretion ; and [ 3 ] calcium supplements produce the same effect but at the dose we used were slightly less effective",
"OBJECTIVE To determine the rate of bone loss in normal men , and to examine the effects of dietary calcium and cholecalciferol supplementation on bone loss in men . DESIGN Double-blinded , placebo-controlled 3-year trial of supplementation with calcium ( 1000 mg/d ) and cholecalciferol ( 25 micrograms/d ) . SETTING Clinical research center at a university medical facility . SUBJECTS Normal men 30 to 87 years old , recruited from the Portl and community . MEASUREMENTS AND MAIN RESULTS Radial bone mineral content ( assessed by single-photon absorptiometry ) fell by 1.0%/y ( 95 % CI , -1.3 % to 0.7 % ) at a proximal radial site and 1.0%/y ( 95 % CI , -1.4 % to -0.6 % ) at a distal radial site . Vertebral bone mineral content ( assessed by dual-energy quantitative computed tomography ) declined by 2.3%/y ( 95 % CI , -2.8 % to -1.8 % ) . In these healthy men with a high basal dietary calcium intake ( 1159 mg/d ) , calcium and cholecalciferol supplementation did not affect bone loss at any site . CONCLUSIONS Normal men experience a substantial bone loss at both axial and appendicular sites that is not prevented by calcium and vitamin D supplementation in a well-nourished population",
"BACKGROUND Inadequate dietary intake of calcium and vitamin D may contribute to the high prevalence of osteoporosis among older persons . METHODS We studied the effects of three years of dietary supplementation with calcium and vitamin D on bone mineral density , biochemical measures of bone metabolism , and the incidence of nonvertebral fractures in 176 men and 213 women 65 years of age or older who were living at home . They received either 500 mg of calcium plus 700 IU of vitamin D3 ( cholecalciferol ) per day or placebo . Bone mineral density was measured by dual-energy x-ray absorptiometry , blood and urine were analyzed every six months , and cases of nonvertebral fracture were ascertained by means of interviews and verified with use of hospital records . RESULTS The mean ( + /-SD ) changes in bone mineral density in the calcium-vitamin D and placebo groups were as follows : femoral neck , + 0.50+/-4.80 and -0.70+/-5.03 percent , respectively ( P=0.02 ) ; spine,+2.12+/-4.06 and + 1.22+/-4.25 percent ( P=0.04 ) ; and total body , + 0.06+/-1.83 and -1.09+/-1.71 percent ( P calcium-vitamin D and placebo groups was significant at all skeletal sites after one year , but it was significant only for total-body bone mineral density in the second and third years . Of 37 subjects who had nonvertebral fractures , 26 were in the placebo group and 11 were in the calcium-vitamin D group ( P=0.02 ) . CONCLUSIONS In men and women 65 years of age or older who are living in the community , dietary supplementation with calcium and vitamin D moderately reduced bone loss measured in the femoral neck , spine , and total body over the three-year study period and reduced the incidence of nonvertebral fractures",
"This 4-y study investigated the effects of a calcium carbonate supplement on bone loss in 169 women aged 35 - 65 y , r and omly assigned to placebo and treatment ( 1500 mg Ca/d ) groups in a double-blind design . Bone mineral content ( BMC ) and width ( W ) were measured bilaterally on the radius , ulna , and humerus . BMC and BMC /W loss rates were consistently lower in treatment than in control subjects . Loss was significantly reduced in the left and right humerus and the right radius . In premenopausal subjects , only left humerus BMC loss was significantly reduced by Ca supplementation . In postmenopausal treatment subjects , BMC and BMC /W bone loss was reduced in all 12 ( bilateral radius , ulna , and humerus ) of the bone variables measured , 5 at p less than 0.01 and 2 at p less than 0.05 . Ca supplementation counteracted a large portion of the additional bone loss attributable to menopause in this population"
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BACKGROUND An up date d psoriatic arthritis ( PsA ) core outcome set ( COS ) for r and omized controlled trials ( RCTs ) was endorsed at the Outcome Measures in Rheumatology ( OMERACT ) meeting in 2016 . OBJECTIVES To synthesize the evidence on measurement properties of patient reported outcome measures ( PROMs ) for PsA and thereby contribute to development of a PsA core outcome measurement set ( COMS ) as described by the OMERACT Filter 2.0 . METHODS A systematic literature search was performed in EMBASE , MEDLINE and PsycINFO on Jan 1 , 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent review ers rated the quality of studies using the COnsensus based st and ards for the Selection of health Measurement INstruments ( COSMIN ) checklist , and performed a qualitative evidence synthesis . RESULTS Fifty-five studies were included in the systematic review . Forty-four instruments and a total of 89 scales were analyzed . PROMs measuring COS domains with at least fair quality evidence for good validity and reliability ( and no evidence for poor properties ) included the Stockerau Activity Score for PsA ( German ) , Psoriasis Symptom Inventory , visual analogue scale for Patient Global , 36 Item Short Form Health Survey Physical Function subscale , Health Assessment Question naire Disability Index , Bath Ankylosing Spondylitis Functional Index , PsA Impact of Disease question naire , PsA Quality of Life question naire , VITACORA-19 , Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Question naire . CONCLUSIONS At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight m and atory domains of the PsA COS
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"OBJECTIVES This analysis aim ed to confirm the reliability , validity , and responsiveness of the Psoriasis Symptom Diary ( PSD ) using data from two Phase III studies in patients with moderate to severe chronic plaque psoriasis . METHODS Data from two r and omized , double-blind , double-dummy , placebo-controlled , multicenter Phase III studies ( n = 820 ) assessing the efficacy and safety of secukinumab were used . The PSD ( 24-h recall ; 0 - 10 numeric rating scale ) was electronically administered each evening . Test-retest reliability was determined using intraclass correlations . Construct validity hypotheses were evaluated via correlations with the Psoriasis Area and Severity Index ( PASI ) , Investigator 's Global Assessment ( IGA ) , Dermatology Life Quality Index ( DLQI ) , EuroQoL 5-Dimension Health Status Question naire , and Patient Global Impression of Change ( PGIC ) . Discriminating ability and responsiveness were evaluated by estimating mean differences and effect sizes between known groups ( using the PASI and IGA ) . Phase II-derived , anchor-based PGIC thresholds and cumulative distribution function ( CDF ) plots described meaningful change . RESULTS Items on the PSD yielded high intraclass coefficients ( > 0.90 ) . Correlations were in the anticipated direction and by week 12 were moderate to strong ( 0.41 - 0.73 ) in magnitude , demonstrating construct validity . Average PSD item scores differed predictably and significantly between known groups . Responsiveness effect size estimates were moderate to large ( 0.6 - 1.5 ) , and CDF plots showed the percentage of responders to be consistently higher in treatment than in placebo arms across the range of change in PSD scores . CONCLUSIONS The PSD is reliable , valid , and responsive , and represents a valid tool to enhance treatment decisions in patients with moderate to severe plaque psoriasis",
"Plaque psoriasis ( PP ) and psoriatic arthritis ( PsA ) are autoinflammatory chronic conditions associated with skin involvement . Pruritus , or itching , is a prevalent and bothersome symptom in patients with PP and is associated with reduced health-related quality of life . The Worst Itch Numeric Rating Scale ( WI-NRS ) has been developed as a simple , single item with which to assess the patient-reported severity of this symptom at its most intense during the previous 24-hour period . Qualitative research was undertaken to assess the content validity of the WI-NRS . Patients with moderate to severe PP and patients with PsA were recruited from clinical sites in the USA . The qualitative research entailed two-part interviews , which began with concept elicitation to gain underst and ing of patients ' experiences of itching , followed by cognitive debriefing of the WI-NRS to assess the instrument 's underst and ability , clarity , and degree of appropriateness from the patient 's perspective . Twelve patients with PP and 22 with PsA participated in the study . Patients reported that itching was an important and relevant symptom of their psoriatic disease . The WI-NRS was reported to be complete and easy to underst and ; the recall period was considered appropriate , the response scale was familiar , and , overall , the instrument was found to be appropriate for assessing itching severity . Patient responses support the content validity of the WI-NRS . The psychometric properties of the tool will be evaluated in future studies",
"Introduction The novel arthritis-specific Work Productivity Survey ( WPS ) was developed to estimate patient productivity limitations associated with arthritis within and outside the home , which is an unmet need in psoriatic arthritis ( PsA ) . The WPS has been vali date d in rheumatoid arthritis . This report assesses the discriminant validity , responsiveness and reliability of the WPS in adult-onset PsA. Methods Psychometric properties were assessed using data from the RAPID-PsA trial ( NCT01087788 ) investigating certolizumab pegol ( CZP ) efficacy and safety in PsA. WPS was completed at baseline and every 4 weeks until Week 24 . Validity was evaluated at baseline via known-groups defined using first and third quartiles of patients ’ Disease Activity Score 28 based on C-reactive protein ( DAS28(CRP ) ) , Health Assessment Question naire-Disability Index ( HAQ-DI ) , Short Form-36 ( SF-36 ) items and PsA Quality of Life ( PsAQoL ) scores . Responsiveness and reliability were assessed by comparing WPS mean changes at Week 12 in American College of Rheumatology 20 % improvement criteria ( ACR20 ) or HAQ-DI Minimal Clinical ly Important Difference ( MCID ) 0.3 responders versus non-responders , as well as using st and ardized response means ( SRM ) . All comparisons were conducted on the observed cases in the R and omized Set , regardless of the r and omization group , using a non-parametric bootstrap-t method . Results Compared with patients with a better health state , patients with a worse health state had on average 2 to 6 times more household work days lost , more days with reduced household productivity , more days missed of family/social/leisure activities , more days with outside help hired and a significantly higher interference of arthritis per month . Among employed patients , those with a worse health state had 2 to 4 times more workplace days lost , more days with patient workplace productivity reduced , and a significantly higher interference of arthritis on patient workplace productivity versus patients with a better health state . WPS was also responsive to clinical changes , with responders having significantly larger improvements at Week 12 in WPS scores versus non-responders . The effect sizes for changes in productivity in ACR20 or HAQ-DI MCID responders were moderate ( 0.5 < SRM < 0.8 ) or small . Conclusions These analyses demonstrate the validity , responsiveness and reliability of the WPS , as an instrument for the measurement of patient productivity within and outside the home in an adult-onset PsA population",
"Objectives For the measurement of patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the gold st and ard as well as from 100 systematic review s of measurement properties and combined based on sensitivity and precision . The performance of the filters was tested in the gold st and ard as well as in two validation sets , by calculating sensitivity , precision , specificity , and number needed to read . Results We identified 116 studies on measurement properties in the gold st and ard . The sensitive search filter was able to retrieve 113 of these 116 studies ( sensitivity 97.4 % , precision 4.4 % ) . The precise search filter had a sensitivity of 93.1 % and a precision of 9.4 % . Both filters performed very well in the validation sets . Conclusion The use of these search filters will contribute to evidence -based selection of measurement instruments in all medical fields",
"Objective . During OMERACT 8 , delegates selected patient global assessment ( PGA ) of disease as a domain to be evaluated in r and omized controlled trials in psoriatic arthritis ( PsA ) . This study assessed the reliability of the PGA , measured by means of 0–100 mm visual analog scale ( VAS ) , and the additional utility of separate VAS scales for joints ( PJA ) and skin ( PSA ) . Methods . In total , 319 consecutive patients with PsA ( 186 men , 133 women , mean age 51 ± 13 yrs ) were enrolled . PGA , PJA , and PSA were administered at enrolment ( W0 ) and after 1 week ( W1 ) . Detailed clinical data , including ACR joint count , Psoriasis Area and Severity Index ( PASI ) , and Hospital Anxiety and Depression Scale , were recorded . Results . Comparison of W0 and W1 scores showed no significant variations ( intraclass correlation coefficients for PGA 0.87 , PJA 0.86 , PSA 0.78 ) , demonstrating the reliability of the instrument . PGA scores were not influenced by patient anxiety or depression , but were dependent on PJA and PSA ( p = 0.00001 ) . PJA was dependent on the number of swollen and tender joints ( p PSA scores were influenced by the extent of skin psoriasis and by h and skin involvement ( p = 0.00001 ) . Joint and skin disease were found not to correlate in terms of disease activity as evidence d by the swollen joint count compared to PASI ( r = 0.11 ) and by the PJA compared to PSA ( r = 0.38 ) . Conclusion . PGA assessed by means of VAS is a reliable tool related to joint and skin disease activity . Because joint and skin disease often diverge it is suggested that in some circumstances both PJA and PSA are also assessed",
"Objective . To evaluate changes in function as measured by Health Assessment Question naire Disability Index ( HAQ-DI ) and the meaningfulness of the changes , in importance and satisfaction , in patients with psoriatic arthritis ( PsA ) . Methods . HAQ-DI was assessed at baseline and at Weeks 4 , 12 , and 24 in a r and omized double-blind study of 205 patients with active PsA receiving etanercept 25 mg twice weekly or placebo . Concurrently , patients rated the importance of and satisfaction with their change in function on a 7-point scale ( 1 = not at all important/satisfied ; 7 = extremely important/satisfied ) . Mean HAQ-DI improvement corresponding to ratings of minimally ( 2–3 ) or very ( 6–7 ) important or satisfied was determined using a posthoc linear mixed-model analysis . Patient importance ratings were used as an anchor to estimate minimally important difference ( MID ) for HAQ-DI ; distribution-based estimates were also calculated . Results . A total of 161 patients ( 69 placebo ; 92 etanercept ) had ≥ 1 HAQ-DI scores showing improvement from baseline and a corresponding importance or satisfaction rating . HAQ-DI improvements corresponding to importance scale ratings of 2 or 3 were 0.335 ( 95 % CI 0.214 , 0.455 ) and 0.360 ( 95 % CI 0.263 , 0.456 ) , respectively , suggesting an MID of about 0.35 . HAQ-DI improvements corresponding to satisfaction scale ratings of 2 and 3 were 0.293 ( 95 % CI 0.230 , 0.357 ) and 0.360 ( 95 % CI 0.307 , 0.413 ) . For a given change in HAQ-DI , nearly two-thirds of patients indicated a lower rating for satisfaction than for importance . This trial was registered in the Clinical Trials.gov registry ( NCT00317499 ) . Conclusion . Our study suggests the MID for HAQ-DI in PsA is about 0.35 . The results may also provide insight into patient satisfaction with changes in function and expectations for therapy",
"BACKGROUND AND OBJECTIVE It is well established that there are problems with the EQ-5D . This is due to the original scoring methods used and how negative time trade-off ( TTO ) values were treated . A revised scoring method has been published . This article applies this to an inflammatory arthritis cohort . The objective is to examine the impact of a revised scoring system for the EQ-5D ( UK ) TTO on the utility estimates and in the case of rheumatoid arthritis , to explore the impact of using different utility metrics on the incremental cost-effectiveness ratio ( ICER ) results of an economic model . METHODS A total of 504 patients with inflammatory arthritis were rescored using revised EQ-5D scoring , which uses an episodic r and om utility model to deal with negative TTO values . Differences in utility scores were compared and the new mapping coefficients were obtained . These were then used in an economic model to examine the impact on the ICER . RESULTS In rheumatoid arthritis , the overall change is less for the revised EQ-5D scoring than with the original EQ-5D ( TTO ) but greater than the SF-6D : EQ-5D UK -0.22 ( 95 % confidence interval [ CI ] -0.30 to -0.15 ) , revised EQ-5D UK -0.16 ( 95 % CI -0.21 to -0.10 ) and SF-6D -0.08 ( 95 % CI -0.11 to -0.05 ) . A similar trend is seen in the psoriatic arthritis group . The economic model produced different ICERs , when different utility measures were used ; EQ-5D ( TTO ) € 42,402 , SF-6D € 111,788 , and revised EQ-5D ( TTO ) € 57,747 . CONCLUSION In the context of inflammatory arthritis , this article demonstrates that a revised scoring for EQ-5D may have a significant impact on utility estimates and on the output of the economic model",
"Objective To assess the discriminative ability and correlation of the Ankylosing Spondylitis Disease Activity Score ( ASDAS ) and Bath Ankylosing Spondylitis Activity Disease Activity Index ( BASDAI ) with disease activity in axial psoriatic arthritis ( AxPsA ) . Methods Patients with AxPsA were selected from a large prospect i ve cohort study of psoriatic arthritis . Patient and physician global scores were used as constructs of disease activity . Patients were categorised into high and low disease activity states based on patient and physician global assessment scores and physician 's decision to change treatment . Statistical analysis included descriptive statistics , linear and logistic regression . Results 201 patients with AxPsA were included in the study . ASDAS and BASDAI showed good correlation with disease activity as reflected by the patient global score ( correlation coefficients ( r ) for BASDAI 0.84 , ASDAS-B 0.77 , ASDAS-C 0.81 , p physician global score ( r=0.53 for BASDAI , r=0.50 for ASDAS-B , r=0.55 for ASDAS-C , p discriminative ability between high and low disease activity states . However , there were no significant differences between areas under the curve for the models that compared ASDAS with BASDAI for each definition of disease activity state . Conclusions In patients with AxPsA , ASDAS and BASDAI scores show similar good to moderate discriminative ability and correlation with different constructs of disease activity . ASDAS was not superior to BASDAI in its ability to discriminate between high and low disease activity states in",
"The Medical Outcomes Study Short Form-36 ( SF-36 ) is a generic measure of health-related quality of life ( HRQOL ) , vali date d and cross-culturally translated , which has been extensively utilised in rheumatology . In r and omised controlled trials and observational studies , SF-36 provides rich data regarding HRQOL ; but as typically portrayed , patterns of disease and treatment-associated effects can be difficult to discern . “ Spydergrams ” offer a simplified means to visualise complex results across all domains of SF-36 in a single figure : depicting disease and population -specific patterns of decrements in HRQOL compared with age and gender-matched normative data , as well as providing a tool for interpreting complex treatment-associated or longitudinal changes . Utilising spydergrams as a st and ard format to illustrate and report changes in SF-36 across different rheumatic diseases can greatly facilitate analyses and interpretations of clinical trial results , as well as providing patients an accessible means to compare baseline scores and treatment-associated improvements with normative data from individuals without arthritis . Furthermore , SF-6D utility scores based on mean changes across all eight domains of SF-36 are suggested as a quantitative means of summarising changes illustrated by spydergrams , offering a universal metric for cost-effectiveness analyses of therapeutic interventions",
"OBJECTIVE To compare the responsiveness of the Health Assessment Question naire ( HAQ ) , Arthritis Impact Measurement Scale 2 ( AIMS 2 ) , and Medical Outcome Study Short Form Health Survey ( SF-36 ) to changes in articular status and perceived health in out patients with psoriatic arthritis ( PsA ) . METHODS The 3 health status instruments were administered in r and om order on 2 occasions , about 12 - 18 months apart , to 70 patients attending the University of Toronto psoriatic arthritis clinic . St and ardized assessment s of disease activity , disease severity , and general health perceptions were also performed at each clinic visit . To assess responsiveness we used : ( 1 ) linear regression analyses to relate change scores for perceived health , the number of actively inflamed , and damaged joints to change scores for selected dimensions of the HAQ , AIMS 2 , and SF-36 ; ( 2 ) logistic regression analyses to relate both improvement in disease activity and disease progression to health status change scores ; and ( 3 ) st and ardized response means ( SRM ) . RESULTS There were 43 men and 27 women with a mean age of 46 years and arthritis duration of 13 years . Univariate regression analyses showed that the individual instruments were responsive to perceived changes in health , but relatively insensitive to detect changes in articular status . Multivariate regression analyses , in which the common dimensions of the instruments were jointly entered , indicated the SF-36 was equally or more responsive to changes in number of actively inflamed joints , clinical improvement in disease activity , and perceived health than the HAQ and AIMS 2 . The SRM analysis also suggested that the SF-36 was the most responsive . CONCLUSION The SF-36 proved equally or more responsive to short term changes in perceived health and inflammatory disease activity ; however , none of the instruments showed responsiveness to disease progression",
"A psoriatic arthritis ( PsA ) module was convened at OMERACT 8 in order to achieve consensus on the core domains that should be included in r and omized controlled trials and longitudinal observational cohorts of subjects with PsA. Following a plenary session at which current status of measures used to assess PsA were review ed , and discussion at breakout groups , the group achieved consensus on 6 core domains : peripheral joint activity , skin activity , pain , patient global assessment , physical function , and health-related quality of life . In addition the following domains were considered important but not m and atory : spinal disease , dactylitis , enthesitis , fatigue , nail disease , radiography , physician global assessment , and acute-phase reactants . A research agenda was proposed to include development and validation of instruments for the domains where none existed , and in particular further research was recommended for the following areas : magnetic resonance imaging and ultrasound of joints , enthesitis , skin and synovial tissue analysis , and \" participation .",
"Background : The objective of this study was to evaluate the measurement properties of the Psoriasis Symptom Inventory ( PSI ) , an eight-item patient-reported outcome measure for assessing severity of plaque psoriasis symptoms . Methods : In this prospect i ve , r and omized study using data from adults with moderate-to-severe plaque psoriasis , patients completed the PSI , Dermatology Life Quality Index ( DLQI ) , SF-36v2 Acute , and Patient Global Assessment ( PtGA ) . PSI construct validity was assessed using Spearman rank correlations between PSI and DLQI and SF-36 ; test-retest reliability and sensitivity to change were evaluated using PtGA as an anchor . Daily 24-h and weekly 7-day PSI versions were evaluated . Results : Eight US sites enrolled 143 patients ; 139 ( 97.2 % ) completed the study . All symptoms ( itch , redness , scaling , burning , cracking , stinging , flaking , and pain ) were reported across all response options ( not at all severe , mild , moderate , severe , very severe ) . Test-retest reliability was acceptable ( intraclass correlation coefficients range = 0.70–0.80 ) . A priori hypotheses of convergent and discriminant validity were confirmed by correlations of PSI with DLQI items and SF-36 domains . The PSI demonstrated good construct validity and was sensitive to within-subject change ( p PSI is brief , valid , reproducible , and responsive to change and has the potential to be a useful PRO measure in psoriasis clinical trials",
"The objectives of this systematic literature review ( SLR ) were to identify domains and outcome measures used in psoriatic arthritis ( PsA ) studies in the past 5 years , and to compare the measurement of the Outcome Measures in Rheumatology ( OMERACT ) 2006 PsA Core Domain Set in studies published in 2010–2015 vs those published in 2006–2010 . We performed a systematic literature search in two data bases , PubMed and Embase , to identify r and omised controlled trials ( RCTs ) in PsA. We also identified PsA longitudinal observational studies ( LOS ) . Three patient research partners provided input into study conception , and data collection and interpretation . We identified 41 studies representing 22 unique RCTs , 27 LOS and 12 registries . Across all studies , we identified 24 domains and 169 outcome measures . In addition to the PsA Core Domain Set ( 6 domains ) , the following domains were also assessed in more than 30 % of RCTs : acute phase reactants , dactylitis , enthesitis , fatigue and work productivity . We identified a range of 1–15 outcome measures per domain with a mean ( SD ) of 7 ( 4.7 ) per domain . The complete PsA Core Domain Set was assessed in 59 % of RCTs in 2010–2015 compared to 23.5 % RCTs in 2006–2010 . There has been increased measurement of the PsA Core Domain Set in RCTs and LOS in the past 5 years . Numerous additional outcomes were also measured . The PsA Core Domain Set needs an up date to st and ardise PsA outcome assessment s. This SLR will inform the development of an up date d PsA Core Domain Set with patient research partner input"
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4116e9bc-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Following the discovery of an endogenous cannabinoid system and the identification of specific cannabinoid receptors in the central nervous system , much work has been done to investigate the main effects of these compounds . There is increasing evidence that the cannabinoid system may regulate neurodegenerative processes such as excessive glutamate production , oxidative stress and neuroinflammation . Neurodegeneration is a feature common to the various types of dementia and this has led to interest in whether cannabinoids may be clinical ly useful in the treatment of people with dementia . Recent studies have also shown that cannabinoids may have more specific effects in interrupting the pathological process in Alzheimer 's disease . OBJECTIVES To determine from available research whether cannabinoids are clinical ly effective in the treatment of dementia . SEARCH STRATEGY The Specialized Register of the Cochrane Dementia and Cognitive Improvement Group ( CDCIG ) , The Cochrane Library , MEDLINE , EMBASE , PsycINFO , CINAHL and LILACS were search ed on 11 April 2008 using the terms : cannabis or cannabinoid * or endocannabinoid * or cannabidiol or THC or CBD or dronabinol or delta-9-tetrahydrocannabinol or marijuana or marihuana or hashish . The CDCIG Specialized Register contains records from all major health care data bases ( The Cochrane Library , MEDLINE , EMBASE , PsycINFO , CINAHL , LILACS ) as well as from many clinical trials registries and grey literature sources . SELECTION CRITERIA All double-blind and single (rater)-blind r and omized placebo controlled trials assessing the efficacy of cannabinoids at any dose in the treatment of people with dementia . DATA COLLECTION AND ANALYSIS Two review ers independently examined the retrieved studies for inclusion according to the selection criteria . They then independently assessed the method ological quality of selected trials and extracted data where possible . MAIN RESULTS Only one study met the inclusion criteria . The data in the study report were presented in such a way that they could not be extracted for further analysis and there was insufficient quantitative data to vali date the results . AUTHORS ' CONCLUSIONS This review finds no evidence that cannabinoids are effective in the improvement of disturbed behaviour in dementia or in the treatment of other symptoms of dementia . More r and omized double-blind placebo controlled trials are needed to determine whether cannabinoids are clinical ly effective in the treatment of dementia
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"A placebo-controlled crossover design , with each treatment period lasting 6 weeks , was used to investigate effects of dronabinol in 15 patients with a diagnosis of probable Alzhemer 's disease who were refusing food . Eleven patients completed both study periods ; one patient who died of a heart attack 2 weeks before the end of the study was also included in the analysis . The study was terminated in 3 patients : one developed a gr and mal seizure and 2 developed serious intercurrent infections . Body weight of study subjects increased more during the dronabinol treatment than during the placebo periods . Dronabinol treatment decreased severity of disturbed behavior and this effect persisted during the placebo period in patients who received dronabinol first . Adverse reactions observed more commonly during the dronabinol treatment than during placebo periods included euphoria , somnolence and tiredness , but did not require discontinuation of therapy . These results indicate that dronabinol is a promising novel therapeutic agent which may be useful not only for treatment of anorexia but also to improve disturbed behavior in patients with Alzheimer 's disease",
"Rationale Nighttime agitation occurs frequently in patients with dementia and represents the number one burden on caregivers today . Current treatment options are few and limited due to substantial side effects . Objectives The aim of the study was to measure the effect of the cannabinoid dronabinol on nocturnal motor activity . Methods In an open-label pilot study , six consecutive patients in the late stages of dementia and suffering from circadian and behavioral disturbances — five patients with Alzheimer ’s disease and one patient with vascular dementia — were treated with 2.5 mg dronabinol daily for 2 weeks . Motor activity was measured objective ly using actigraphy . Results Compared to baseline , dronabinol led to a reduction in nocturnal motor activity ( P=0.028 ) . These findings were corroborated by improvements in Neuropsychiatric Inventory total score ( P=0.027 ) as well as in subscores for agitation , aberrant motor , and nighttime behaviors ( P side effects were observed . Conclusions The study suggests that dronabinol was able to reduce nocturnal motor activity and agitation in severely demented patients . Thus , it appears that dronabinol may be a safe new treatment option for behavioral and circadian disturbances in dementia",
" Two hundred ten community-dwelling patients with Alzheimer 's disease were examined prospect ively by psychiatrists as part of a longitudinal study . Twenty-five of these patients who were institutionalized during the next 3 years were then matched to 25 patients who were not institutionalized , and the groups were compared . The patients who had been institutionalized had higher scores on st and ardized psychiatric rating scales but not on formal neuropsychological tests of cognition . These results suggest that potentially treatable ( noncognitive ) behavioral and psychiatric symptoms are risk factors for institutionalization , and that treating these symptoms might delay or prevent institutionalization of some patients",
"A method for assessing affect states among older people with Alzheimer 's disease was developed for use in a study design ed to evaluate a special care unit for such residents of a nursing home . The 6-item Philadelphia Geriatric Center Affect Rating Scale was design ed for the use of research and other staff in assessing positive affect ( pleasure , interest , contentment ) and negative affect ( sadness , worry/anxiety , and anger ) by direct observation of facial expression , body movement , and other cues that do not depend on self-report , among 253 demented and 43 nondemented residents . Each affect scale was highly reliable , expressed in estimated portions of a 10-minute observation period when the affect expression occurred . Validity estimates were affirmative in showing discriminant correlations between the positive states and various independent measures of social and other outwardly engaged behavior and between negative states and other measures of depression , anger , anxiety , and withdrawal . Limited support for the two-factor dimensionality of the affect ratings was obtained , although positive and negative affect were correlated , rather than independent . Some hope is offered that the preference and aversions of Alzheimer patients may be better understood by observations of their emotional behaviors and that such methods may lead to a better ability to judge institutional quality",
"BACKGROUND Agitation is a common and distressing symptom in patients with Alzheimer 's disease . Cholinesterase inhibitors improve cognitive outcomes in such patients , but the benefits of these drugs for behavioral disturbances are unclear . METHODS We r and omly assigned 272 patients with Alzheimer 's disease who had clinical ly significant agitation and no response to a brief psychosocial treatment program to receive 10 mg of donepezil per day ( 128 patients ) or placebo ( 131 patients ) for 12 weeks . The primary outcome was a change in the score on the Cohen-Mansfield Agitation Inventory ( CMAI ) ( on a scale of 29 to 203 , with higher scores indicating more agitation ) at 12 weeks . RESULTS There was no significant difference between the effects of donepezil and those of placebo on the basis of the change in CMAI scores from baseline to 12 weeks ( estimated mean difference in change [ the value for donepezil minus that for placebo ] , -0.06 ; 95 % confidence interval [ CI ] , -4.35 to 4.22 ) . Twenty-two of 108 patients ( 20.4 % ) in the placebo group and 22 of 113 ( 19.5 % ) in the donepezil group had a reduction of 30 % or greater in the CMAI score ( the value for donepezil minus that for placebo , -0.9 percentage point ; 95 % CI , -11.4 to 9.6 ) . There were also no significant differences between the placebo and donepezil groups in scores for the Neuropsychiatric Inventory , the Neuropsychiatric Inventory Caregiver Distress Scale , or the Clinician 's Global Impression of Change . CONCLUSIONS In this 12-week trial , donepezil was not more effective than placebo in treating agitation in patients with Alzheimer 's disease . ( Clinical Trials.gov number , NCT00142324 [ Clinical Trials.gov ] . )",
"Controlled clinical trials of the treatment of acute myocardial infa rct ion offer a unique opportunity for the study of the potential influence on outcome of bias in treatment assignment . A group of 145 papers was divided into those in which the r and omization process was blinded ( 57 papers ) , those in which it may have been unblinded ( 45 papers ) , and those in which the controls were selected by a nonr and om process ( 43 papers ) . At least one prognostic variable was maldistributed ( P less than 0.05 ) in 14.0 per cent of the blinded-r and omization studies , in 26.7 per cent of the unblinded-r and omization studies , and in 58.1 per cent of the nonr and omized studies . Differences in case-fatality rates between treatment and control groups ( P less than 0.05 ) were found in 8.8 per cent of the blinded-r and omization studies , 24.4 per cent of the unblinded-r and omization studies , and 58.1 per cent of the nonr and omized studies . These data emphasize the importance of keeping those who recruit patients for clinical trials from suspecting which treatment will be assigned to the patient under consideration"
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4116e9f8-06ff-11f0-808a-c43d1ab1c353
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IMPORTANCE Lowering blood pressure ( BP ) is widely used to reduce vascular risk in individuals with diabetes . OBJECTIVE To determine the associations between BP-lowering treatment and vascular disease in type 2 diabetes . DATA SOURCES AND STUDY SELECTION We search ed MEDLINE for large-scale r and omized controlled trials of BP-lowering treatment including patients with diabetes , published between January 1966 and October 2014 . DATA EXTRACTION AND SYNTHESIS Two review ers independently extracted study characteristics and vascular outcome data . Estimates were stratified by baseline BP and achieved BP , and pooled using fixed-effects meta- analysis . MAIN OUTCOMES AND MEASURES All-cause mortality , cardiovascular events , coronary heart disease events , stroke , heart failure , retinopathy , new or worsening albuminuria , and renal failure . RESULTS Forty trials judged to be of low risk of bias ( 100,354 participants ) were included . Each 10-mm Hg lower systolic BP was associated with a significantly lower risk of mortality ( relative risk [ RR ] , 0.87 ; 95 % CI , 0.78 - 0.96 ) ; absolute risk reduction ( ARR ) in events per 1000 patient-years ( 3.16 ; 95 % CI , 0.90 - 5.22 ) , cardiovascular events ( RR , 0.89 [ 95 % CI , 0.83 - 0.95 ] ; ARR , 3.90 [ 95 % CI , 1.57 - 6.06 ] ) , coronary heart disease ( RR , 0.88 [ 95 % CI , 0.80 - 0.98 ] ; ARR , 1.81 [ 95 % CI , 0.35 - 3.11 ] ) , stroke ( RR , 0.73 [ 95 % CI , 0.64 - 0.83 ] ; ARR , 4.06 [ 95 % CI , 2.53 - 5.40 ] ) , albuminuria ( RR , 0.83 [ 95 % CI , 0.79 - 0.87 ] ; ARR , 9.33 [ 95 % CI , 7.13 - 11.37 ] ) , and retinopathy ( RR , 0.87 [ 95 % CI , 0.76 - 0.99 ] ; ARR , 2.23 [ 95 % CI , 0.15 - 4.04 ] ) . When trials were stratified by mean baseline systolic BP at greater than or less than 140 mm Hg , RRs for outcomes other than stroke , retinopathy , and renal failure were lower in studies with greater baseline systolic BP ( P interaction patients with type 2 diabetes , BP lowering was associated with improved mortality and other clinical outcomes with lower RRs observed among those with baseline BP of 140 mm Hg and greater . These findings support the use of medications for BP lowering in these patients
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"Abstract —To investigate the impact of treatment on cardiovascular mortality and morbidity , we assessed outcomes in patients with hypertension and diabetes who received co-amilozide or nifedipine in the International Nifedipine GITS Study : Intervention as a Goal in Hypertension . Participants had to be 55 to 80 years of age , with hypertension ( ≥150/95 or ≥160 mm Hg ) and at least one additional cardiovascular risk factor . Patients received 30 mg nifedipine once daily or co-amilozide ( 25 mg hydrochlorothiazide and 2.5 mg amiloride ) daily . Doses were doubled if target blood pressures ( Primary ( composite of cardiovascular death , myocardial infa rct ion , heart failure , and stroke ) and secondary outcomes ( composite of primary outcomes , including all-cause mortality and death from vascular and nonvascular causes ) were assessed by means of intent-to-treat analyses . There was no significant difference in the incidence of primary outcomes between nifedipine-treated and co-amilozide – treated patients with diabetes at baseline ( n=1302 ) ( 8.3 % versus 8.4 % ; relative risk , 0.99 , 95 % CI , 0.69 to 1.42;P = 1.00 ) . A significant benefit for nifedipine-treated patients was seen for the composite secondary outcome ( 14.2 % versus 18.7 % ; relative risk , 0.76 , 95 % CI , 0.59 to 0.97;P = 0.03 ) . Among patients without diabetes at baseline ( n=5019 ) , there was a significant difference in the incidence of new diabetes ( nifedipine 4.3 % versus co-amilozide 5.6 % , P = 0.023 ) . Nifedipine GITS once daily is as effective as diuretic therapy in reducing cardiovascular complications in hypertensive diabetics . Nifedipine-treated patients were also less likely to have diabetes or have secondary events ( a composite of all-cause mortality , death from a vascular cause , and death from a nonvascular cause ) than co-amilozide recipients . Our results suggest that nifedipine could be considered as first-line therapy for hypertensive diabetics",
"BACKGROUND The most suitable antihypertensive drug to reduce the risk of cardiovascular disease in patients with hypertension and diabetes is unclear . In prespecified analyses , we compared the effects of losartan and atenolol on cardiovascular morbidity and mortality in diabetic patients . METHODS As part of the LIFE study , in a double-masked , r and omised , parallel-group trial , we assigned a group of 1195 patients with diabetes , hypertension , and signs of left-ventricular hypertrophy ( LVH ) on electrocardiograms losartan-based or atenolol-based treatment . Mean age of patients was 67 years ( SD 7 ) and mean blood pressure 177/96 mm Hg ( 14/10 ) after placebo run-in . We followed up patients for at least 4 years ( mean 4.7 years [ 1.1 ] ) . We used Cox regression analysis with baseline Framingham risk score and electrocardiogram-LVH as covariates to compare the effects of the drugs on the primary composite endpoint of cardiovascular morbidity and mortality ( cardiovascular death , stroke , or myocardial infa rct ion ) . FINDINGS Mean blood pressure fell to 146/79 mm Hg ( 17/11 ) in losartan patients and 148/79 mm Hg ( 19/11 ) in atenolol patients . The primary endpoint occurred in 103 patients assigned losartan ( n=586 ) and 139 assigned atenolol ( n=609 ) ; relative risk 0.76 ( 95 % CI 0.58-.98 ) , p=0.031 . 38 and 61 patients in the losartan and atenolol groups , respectively , died from cardiovascular disease ; 0.63 ( 0.42 - 0.95 ) , p=0.028 . Mortality from all causes was 63 and 104 in losartan and atenolol groups , respectively ; 0.61 ( 0.45 - 0.84 ) , p=0.002 . INTERPRETATION Losartan was more effective than atenolol in reducing cardiovascular morbidity and mortality as well as mortality from all causes in patients with hypertension , diabetes , and LVH . Losartan seems to have benefits beyond blood pressure reduction",
"BACKGROUND Diabetes mellitus is a strong risk factor for cardiovascular and renal disease . We investigated whether the angiotensin-converting-enzyme ( ACE ) inhibitor ramipril can lower these risks in patients with diabetes . METHODS 3577 people with diabetes included in the Heart Outcomes Prevention Evaluation study , aged 55 years or older , who had a previous cardiovascular event or at least one other cardiovascular risk factor , no clinical proteinuria , heart failure , or low ejection fraction , and who were not taking ACE inhibitors , were r and omly assigned ramipril ( 10 mg/day ) or placebo , and vitamin E or placebo , according to a two-by-two factorial design . The combined primary outcome was myocardial infa rct ion , stroke , or cardiovascular death . Overt nephropathy was a main outcome in a sub study . FINDINGS The study was stopped 6 months early ( after 4.5 years ) by the independent data safety and monitoring board because of a consistent benefit of ramipril compared with placebo . Ramipril lowered the risk of the combined primary outcome by 25 % ( 95 % CI 12 - 36 , p=0.0004 ) , myocardial infa rct ion by 22 % ( 6 - 36 ) , stroke by 33 % ( 10 - 50 ) , cardiovascular death by 37 % ( 21 - 51 ) , total mortality by 24 % ( 8 - 37 ) , revascularisation by 17 % ( 2 - 30 ) , and overt nephropathy by 24 % ( 3 - 40 , p=0.027 ) . After adjustment for the changes in systolic ( 2.4 mm Hg ) and diastolic ( 1.0 mm Hg ) blood pressures , ramipril still lowered the risk of the combined primary outcome by 25 % ( 12 - 36 , p=0.0004 ) . INTERPRETATION Ramipril was beneficial for cardiovascular events and overt nephropathy in people with diabetes . The cardiovascular benefit was greater than that attributable to the decrease in blood pressure . This treatment represents a vasculoprotective and renoprotective effect for people with diabetes",
"Summary Background The associations of blood pressure with the different manifestations of incident cardiovascular disease in a contemporary population have not been compared . In this study , we aim ed to analyse the associations of blood pressure with 12 different presentations of cardiovascular disease . Methods We used linked electronic health records from 1997 to 2010 in the CALIBER ( CArdiovascular research using LInked Bespoke studies and Electronic health Records ) programme to assemble a cohort of 1·25 million patients , 30 years of age or older and initially free from cardiovascular disease , a fifth of whom received blood pressure-lowering treatments . We studied the heterogeneity in the age-specific associations of clinical ly measured blood pressure with 12 acute and chronic cardiovascular diseases , and estimated the lifetime risks ( up to 95 years of age ) and cardiovascular disease-free life-years lost adjusted for other risk factors at index ages 30 , 60 , and 80 years . This study is registered at Clinical Trials.gov , number NCT01164371 . Findings During 5·2 years median follow-up , we recorded 83 098 initial cardiovascular disease presentations . In each age group , the lowest risk for cardiovascular disease was in people with systolic blood pressure of 90–114 mm Hg and diastolic blood pressure of 60–74 mm Hg , with no evidence of a J-shaped increased risk at lower blood pressures . The effect of high blood pressure varied by cardiovascular disease endpoint , from strongly positive to no effect . Associations with high systolic blood pressure were strongest for intracerebral haemorrhage ( hazard ratio 1·44 [ 95 % CI 1·32–1·58 ] ) , subarachnoid haemorrhage ( 1·43 [ 1·25–1·63 ] ) , and stable angina ( 1·41 [ 1·36–1·46 ] ) , and weakest for abdominal aortic aneurysm ( 1·08 [ 1·00–1·17 ] ) . Compared with diastolic blood pressure , raised systolic blood pressure had a greater effect on angina , myocardial infa rct ion , and peripheral arterial disease , whereas raised diastolic blood pressure had a greater effect on abdominal aortic aneurysm than did raised systolic pressure . Pulse pressure associations were inverse for abdominal aortic aneurysm ( HR per 10 mm Hg 0·91 [ 95 % CI 0·86–0·98 ] ) and strongest for peripheral arterial disease ( 1·23 [ 1·20–1·27 ] ) . People with hypertension ( blood pressure ≥140/90 mm Hg or those receiving blood pressure-lowering drugs ) had a lifetime risk of overall cardiovascular disease at 30 years of age of 63·3 % ( 95 % CI 62·9–63·8 ) compared with 46·1 % ( 45·5–46·8 ) for those with normal blood pressure , and developed cardiovascular disease 5·0 years earlier ( 95 % CI 4·8–5·2 ) . Stable and unstable angina accounted for most ( 43 % ) of the cardiovascular disease-free years of life lost associated with hypertension from index age 30 years , whereas heart failure and stable angina accounted for the largest proportion ( 19 % each ) of years of life lost from index age 80 years . Interpretation The widely held assumptions that blood pressure has strong associations with the occurrence of all cardiovascular diseases across a wide age range , and that diastolic and systolic associations are concordant , are not supported by the findings of this high-resolution study . Despite modern treatments , the lifetime burden of hypertension is substantial . These findings emphasise the need for new blood pressure-lowering strategies , and will help to inform the design of r and omised trials to assess them . Funding Medical Research Council , National Institute for Health Research , and Wellcome Trust",
"Background : Analyses of the risks of stroke were conducted for subjects with and without diabetes , participating in a r and omized , double‐blind , placebo‐controlled trial of a perindopril‐based blood pressure lowering regimen in 6105 people with prior stroke or transient ischaemic attack ( TIA ) , followed for a median of 3.9 years . Findings : Seven hundred and sixty‐one patients had diabetes at baseline . Diabetes increased the risk of recurrent stroke by 35 % ( 95 % CI 10–65 % ) principally through an effect on ischaemic stroke ( 1.53 , 95 % CI 1.23–1.90 ) . Active treatment reduced blood pressure by 9.5/4.6 mmHg in patients with diabetes and by 8.9/3.9 mmHg in patients without diabetes . The proportional risk reductions achieved for stroke in patients with diabetes , 38 % ( 95 % CI 8–58 % ) , and patients without diabetes , 28 % ( 95 % CI 16–39 % ) , were not significantly different ( p homogeneity = 0.5 ) . The absolute reduction in the risk of recurrent stroke in the patients with diabetes was equivalent to one stroke avoided among every 16 ( 95 % CI 9–111 ) patients treated for 5 years . Conclusions : Diabetes is an important risk factor for stroke in patients with established cerebrovascular disease . Treatment with the ACE inhibitor perindopril with discretionary use of the diuretic indapamide produced reductions in the risk of recurrent stroke in patients with diabetes that were at least as great as those achieved in patients without diabetes",
"OBJECTIVE The Captopril Prevention Project ( CAPPP ) evaluated the effects of an ACE inhibitor-based therapeutic regimen on cardiovascular mortality and morbidity in hypertension . One planned sub analysis of the CAPPP was to evaluate the outcome in the diabetic patient group . RESEARCH DESIGN AND METHODS In the CAPPP , 572 ( 4.9 % of 10,985 hypertensive patients ) had diabetes at baseline and were studied according to a prospect i ve , r and omized , open , blinded , end point trial design . Patients aged 25 - 66 years with diastolic blood pressure > or = 100 mmHg were included and r and omized to receive either captopril or conventional antihypertensive treatment ( diuretics and /or beta-blockers ) . RESULTS The primary end point , fatal and nonfatal myocardial infa rct ion and stroke as well as other cardiovascular deaths , was markedly lower in the captopril than in the conventional therapy group ( relative risk [ RR ] = 0.59 ; P = 0.018 ) . Specifically , cardiovascular mortality , defined as fatal stroke and myocardial infa rct ion , sudden death , and other cardiovascular death , tended to be lower in the captopril group ( RR = 0.48 ; P = 0.084 ) , and no difference was observed between the study groups for stroke ( RR = 1.02 ; P = 0.96 ) . Myocardial infa rct ions were less frequent in the captopril group than in the conventional therapy group ( RR = 0.34 ; P = 0.002 ) . Furthermore , total mortality was lower in the captopril as compared with the conventional therapy group ( RR = 0.54 ; P = 0.034 ) . Patients with impaired metabolic control seemed to benefit the most from ACE inhibitor-based therapy . CONCLUSIONS Captopril is superior to a diuretic/beta-blocker antihypertensive treatment regimen in preventing cardiovascular events in hypertensive diabetic patients , especially in those with metabolic decompensation",
"The Survival and Ventricular Enlargement ( SAVE ) Study demonstrated that long-term administration of the angiotensin-converting enzyme inhibitor captopril to recent survivors of myocardial infa rct ion with left ventricular dysfunction result ed in a reduction in cardiovascular mortality and morbidity . Analysis of multiple subgroups demonstrated that baseline demographics ( older age ) and clinical characteristics ( such as prior MI , history of diabetes or hypertension ) , that have previously been associated with a higher risk of cardiovascular events , were associated with greater end point event rates in SAVE regardless of therapy assignment at the time of r and omization . The effectiveness of captopril therapy in reducing cardiovascular mortality and morbidity was examined in multiple subgroups . Although not all subgroups provided adequate statistical power , the benefits of captopril therapy were relatively uniform in the SAVE study . This indicates that the benefits were not confined to one particular subgroup and conversely that targeting of captopril therapy should be to the broadest group , as defined by SAVE entry criteria , to result in a reduction in cardiovascular mortality and morbidity",
"BACKGROUND Calcium antagonists are a first-line treatment for hypertension . The effectiveness of diltiazem , a non-dihydropyridine calcium antagonist , in reducing cardiovascular morbidity or mortality is unclear . We compared the effects of diltiazem with that of diuretics , beta-blockers , or both on cardiovascular morbidity and mortality in hypertensive patients . METHODS In a prospect i ve , r and omised , open , blinded endpoint study , we enrolled 10,881 patients , aged 50 - 74 years , at health centres in Norway and Sweden , who had diastolic blood pressure of 100 mm Hg or more . We r and omly assigned patients diltiazem , or diuretics , beta-blockers , or both . The combined primary endpoint was fatal and non-fatal stroke , myocardial infa rct ion , and other cardiovascular death . Analysis was done by intention to treat . FINDINGS Systolic and diastolic blood pressure were lowered effectively in the diltiazem and diuretic and beta-blocker groups ( reduction 20.3/18.7 vs 23.3/18.7 mm Hg ; difference in systolic reduction p Fatal and non-fatal stroke occurred in 159 patients in the diltiazem group and in 196 in the diuretic and beta-blocker group ( 6.4 vs 7.9 events per 1000 patient-years ; 0.80 [ 0.65 - 0.99 ] , p=0.04 ) and fatal and non-fatal myocardial infa rct ion in 183 and 157 patients ( 7.4 vs 6.3 events per 1000 patient-years ; 1.16 [ 0.94 - 1.44 ] , p=0.17 ) . INTERPRETATION Diltiazem was as effective as treatment based on diuretics , beta-blockers , or both in preventing the combined primary endpoint of all stroke , myocardial infa rct ion , and other cardiovascular death",
"BACKGROUND It is unknown whether either the angiotensin-II-receptor blocker irbesartan or the calcium-channel blocker amlodipine slows the progression of nephropathy in patients with type 2 diabetes independently of its capacity to lower the systemic blood pressure . METHODS We r and omly assigned 1715 hypertensive patients with nephropathy due to type 2 diabetes to treatment with irbesartan ( 300 mg daily ) , amlodipine ( 10 mg daily ) , or placebo . The target blood pressure was 135/85 mm Hg or less in all groups . We compared the groups with regard to the time to the primary composite end point of a doubling of the base-line serum creatinine concentration , the development of end-stage renal disease , or death from any cause . We also compared them with regard to the time to a secondary , cardiovascular composite end point . RESULTS The mean duration of follow-up was 2.6 years . Treatment with irbesartan was associated with a risk of the primary composite end point that was 20 percent lower than that in the placebo group ( P=0.02 ) and 23 percent lower than that in the amlodipine group ( P=0.006 ) . The risk of a doubling of the serum creatinine concentration was 33 percent lower in the irbesartan group than in the placebo group ( P=0.003 ) and 37 percent lower in the irbesartan group than in the amlodipine group ( P irbesartan was associated with a relative risk of end-stage renal disease that was 23 percent lower than that in both other groups ( P=0.07 for both comparisons ) . These differences were not explained by differences in the blood pressures that were achieved . The serum creatinine concentration increased 24 percent more slowly in the irbesartan group than in the placebo group ( P=0.008 ) and 21 percent more slowly than in the amlodipine group ( P=0.02 ) . There were no significant differences in the rates of death from any cause or in the cardiovascular composite end point . CONCLUSIONS The angiotensin-II-receptor blocker irbesartan is effective in protecting against the progression of nephropathy due to type 2 diabetes . This protection is independent of the reduction in blood pressure it causes",
"The prevalence of hypertension in type 2 diabetics is high , though there is no published data for Switzerl and . This prospect i ve cohort survey determined the frequency of type 2 diabetes mellitus associated with hypertension from medical practitioners in Switzerl and , and collected data on the diagnostic and therapeutic work‐up for cardiovascular risk patients . The Swiss Hypertension And Risk Factor Program ( SHARP ) is a two‐part survey : The first part , I‐SHARP , was a survey among 1040 Swiss physicians to assess what are the target blood pressure ( BP ) values and preferred treatment for their patients . The second part , SHARP , collected data from 20,956 patients treated on any of 5 consecutive days from 188 participating physicians . In I‐SHARP , target BP⩽135/85 mmHg , as recommended by the Swiss Society of Hypertension , was the goal for 25 % of physicians for hypertensives , and for 60 % for hypertensive diabetics ; values > 140/90 mmHg were targeted by 19 % for hypertensives , respectively 9 % for hypertensive diabetics . In SHARP , 30 % of the 20,956 patients enrolled were hypertensive ( as defined by the doctors ) and 10 % were diabetic ( 67 % of whom were also hypertensive ) . Six per cent of known hypertensive patients and 4 % of known hypertensive diabetics did not receive any antihypertensive treatment . Diabetes was not treated pharmacologically in 20 % of diabetics . Proteinuria was not screened for in 45 % of known hypertensives and in 29 % of known hypertensive diabetics . In Switzerl and , most physicians set target BP levels higher than recommended in published guidelines . In this country with easy access to medical care , high medical density and few financial constraints , appropriate detection and treatment for cardiovascular risk factors remain highly problematic",
"Abstract Objective : To determine whether tight control of blood pressure with either a β blocker or an angiotensin converting enzyme inhibitor has a specific advantage or disadvantage in preventing the macrovascular and microvascular complications of type 2 diabetes . Design : R and omised controlled trial comparing an angiotensin converting enzyme inhibitor ( captopril ) with a β blocker ( atenolol ) in patients with type 2 diabetes aim ing at a blood pressure of Setting : 20 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Subjects : 1148 hypertensive patients with type 2 diabetes ( mean age 56 years , mean blood pressure 160/94 mm Hg ) . Of the 758 patients allocated to tight control of blood pressure , 400 were allocated to captopril and 358 to atenolol . 390 patients were allocated to less tight control of blood pressure . Main outcome measures : Predefined clinical end points , fatal and non-fatal , related to diabetes , death related to diabetes , and all cause mortality . Surrogate measures of microvascular and macrovascular disease included urinary albumin excretion and retinopathy assessed by retinal photography . Results : Captopril and atenolol were equally effective in reducing blood pressure to a mean of 144/83 mm Hg and 143/81 mm Hg respectively , with a similar proportion of patients ( 27 % and 31 % ) requiring three or more antihypertensive treatments . More patients in the captopril group than the atenolol group took the allocated treatment : at their last clinic visit , 78 % of those allocated captopril and 65 % of those allocated atenolol were taking the drug ( P Captopril and atenolol were equally effective in reducing the risk of macrovascular end points . Similar proportions of patients in the two groups showed deterioration in retinopathy by two grade s after nine years ( 31 % in the captopril group and 37 % in the atenolol group ) and developed clinical grade albuminuria ≥300 mg/l ( 5 % and 9 % ) . The proportion of patients with hypoglycaemic attacks was not different between groups , but mean weight gain in the atenolol group was greater ( 3.4 kg v 1.6 kg ) . Conclusion : Blood pressure lowering with captopril or atenolol was similarly effective in reducing the incidence of diabetic complications . This study provided no evidence that either drug has any specific beneficial or deleterious effect , suggesting that blood pressure reduction in itself may be more important than the treatment used",
"OBJECTIVE The Appropriate Blood Pressure Control in Diabetes ( ABCD ) Trial is a prospect i ve r and omized blinded clinical trial that compares the effects of intensive versus moderate blood pressure control on the incidence and progression of type 2 diabetic complications . The current article discusses the results of 5.3 years of follow-up of 470 patients with hypertension and evaluates the effects of intensive and moderate blood pressure therapy using nisoldipine versus enalapril as the initial antihypertensive medication for nephropathy , retinopathy , and neuropathy . RESEARCH DESIGN AND METHODS The 470 hypertensive subjects , defined as having a baseline diastolic blood pressure of > or = 90 mmHg , were r and omized to intensive blood pressure control ( diastolic blood pressure goal of 75 mmHg ) versus moderate blood pressure control ( diastolic blood pressure goal of 80 - 89 mmHg ) . RESULTS The mean blood pressure achieved was 132/78 mmHg in the intensive group and 138/86 mmHg in the moderate control group . During the 5-year follow-up period , no difference was observed between intensive versus moderate blood pressure control and those r and omized to nisoldipine versus enalapril with regard to the change in creatinine clearance . After the first year of antihypertensive treatment , creatinine clearance stabilized in both the intensive and moderate blood pressure control groups in those patients with baseline normo- or microalbuminuria . In contrast , patients starting with overt albuminuria demonstrated a steady decline in creatinine clearance of 5 - 6 ml.min-1.1.73 m-2 per year throughout the follow-up period whether they were on intensive or moderate therapy . There was also no difference between the interventions with regard to individuals progressing from normoalbuminuria to microalbuminuria ( 25 % intensive therapy vs. 18 % moderate therapy , P = 0.20 ) or microalbuminuria to overt albuminuria ( 16 % intensive therapy vs. 23 % moderate therapy , P = 0.28 ) . Intensive therapy demonstrated a lower overall incidence of deaths , 5.5 vs. 10.7 % , P = 0.037 . Over a 5-year follow-up period , there was no difference between the intensive and moderate groups with regard to the progression of diabetic retinopathy and neuropathy . In addition , the use of nisoldipine versus enalapril had no differential effect on diabetic retinopathy and neuropathy . CONCLUSIONS Blood pressure control of 138/86 or 132/78 mmHg with either nisoldipine or enalapril as the initial antihypertensive medication appeared to stabilize renal function in hypertensive type 2 diabetic patients without overt albuminuria over a 5-year period . The more intensive blood pressure control decreased all-cause mortality",
"Abstract Objective To investigate whether a low dose of the angiotensin converting enzyme ( ACE ) inhibitor ramipril lowers cardiovascular and renal events in patients with type 2 diabetes who have microalbuminuria or proteinuria . Design R and omised , double blind , parallel group trial comparing ramipril ( 1.25 mg/day ) with placebo ( on top of usual treatment ) for cardiovascular and renal outcomes for at least three years . Setting Multicentre , primary care study conducted mostly by general practitioners in 16 European and north African countries . Participants 4912 patients with type 2 diabetes aged > 50 years who use oral antidiabetic drugs and have persistent microalbuminuria or proteinuria ( urinary albumin excretion 20 mg/l in two consecutive sample s ) , and serum creatinine ≤ 150 μmol/l . Main outcome measures The primary outcome measure was the combined incidence of cardiovascular death , non-fatal myocardial infa rct ion , stroke , heart failure leading to hospital admission , and end stage renal failure . Results Participants were followed for 3 to 6 ( median 4 ) years . There were 362 primary events among the 2443 participants taking ramipril ( 37.8 per 1000 patient years ) and 377 events among the 2469 participants taking placebo ( 38.8 per 1000 patient years ; hazard ratio 1.03 ( 95 % confidence interval 0.89 to 1.20 , P = 0.65 ) ) . None of the components of the primary outcome was reduced . Ramipril lowered systolic and diastolic blood pressures ( by 2.43 and 1.06 mm Hg respectively after two years ) and favoured regression from microalbuminuria ( 20 - 200 mg/l ) or proteinuria ( > 200mg/l ) to normal level ( ) in 1868 participants who completed the study . Conclusions Low dose ( 1.25 mg ) ramipril once daily has no effect on cardiovascular and renal outcomes of patients with type 2 diabetes and albuminuria , despite a slight decrease in blood pressure and urinary albumin . The cardiovascular benefits of a daily higher dose ( 10 mg ) ramipril observed elsewhere are not found with an eightfold lower daily dose",
"BACKGROUND Angiotensin-converting-enzyme ( ACE ) inhibitors have been used for more than a decade to treat high blood pressure , despite the lack of data from r and omised intervention trials to show that such treatment affects cardiovascular morbidity and mortality . The Captopril Prevention Project ( CAPPP ) is a r and omised intervention trial to compare the effects of ACE inhibition and conventional therapy on cardiovascular morbidity and mortality in patients with hypertension . METHODS CAPPP was a prospect i ve , r and omised , open trial with blinded endpoint evaluation . 10,985 patients were enrolled at 536 health centres in Sweden and Finl and . Patients aged 25 - 66 years with a measured diastolic blood pressure of 100 mm Hg or more on two occasions were r and omly assigned captopril or conventional antihypertensive treatment ( diuretics , beta-blockers ) . Analysis was by intention-to-treat . The primary endpoint was a composite of fatal and non-fatal myocardial infa rct ion , stroke , and other cardiovascular deaths . FINDINGS Of 5492 patients assigned captopril and 5493 assigned conventional therapy , 14 and 13 , respectively , were lost to follow-up . Primary endpoint events occurred in 363 patients in the captopril group ( 11.1 per 1000 patient-years ) and 335 in the conventional-treatment group ( 10.2 per 1000 patient-years ; relative risk 1.05 [ 95 % CI 0.90 - 1.22 ] , p=0 - 52 ) . Cardiovascular mortality was lower with captopril than with conventional treatment ( 76 vs 95 events ; relative risk 0.77 [ 0.57 - 1 - 04 ] , p=0.092 ) , the rate of fatal and non-fatal myocardial infa rct ion was similar ( 162 vs 161 ) , but fatal and non-fatal stroke was more common with captopril ( 189 vs 148 ; 1.25 [ 1 - 01 - 1 - 55 ] . p=0.044 ) . INTERPRETATION Captopril and conventional treatment did not differ in efficacy in preventing cardiovascular morbidity and mortality . The difference in stroke risk is probably due to the lower levels of blood pressure obtained initially in previously treated patients r and omised to conventional therapy",
"BACKGROUND Diabetic retinopathy remains a leading cause of visual loss in people of working age . We examined whether c and esartan treatment could slow the progression and , secondly , induce regression of retinopathy in people with type 2 diabetes . METHODS We did a r and omised , double-blind , parallel-group , placebo-controlled trial in 309 centres worldwide . We recruited normoalbuminuric , normotensive , or treated hypertensive people with type 2 diabetes with mild to moderately severe retinopathy and assigned them to c and esartan 16 mg once a day or placebo . After a month , the dose was doubled to 32 mg once per day . Investigators and patients were unaware of the treatment allocation status . Progression of retinopathy was the primary endpoint , and regression was a secondary endpoint . Analysis was by intention to treat . The trial is registered with Clinical Trials.gov , number NCT00252694 . FINDINGS 1905 participants ( aged 37 - 75 years ) were r and omised to c and esartan ( n=951 ) or placebo ( n=954 ) . 161 ( 17 % ) patients in the c and esartan group and 182 ( 19 % ) in the placebo group had progression of retinopathy by three steps or more on the Early Treatment Diabetic Retinopathy Study scale . The risk of progression of retinopathy was non-significantly reduced by 13 % in patients on c and esartan compared with those on placebo ( hazard ratio [ HR ] 0.87 , 95 % CI 0.70 - 1.08 , p=0.20 ) . Regression on active treatment was increased by 34 % ( 1.34 , 1.08 - 1.68 , p=0.009 ) . HRs were not attenuated by adjustment for baseline risk factors or changes in blood pressure during the trial . An overall change towards less severe retinopathy by the end of the trial was observed in the c and esartan group ( odds 1.17 , 95 % CI 1.05 - 1.30 , p=0.003 ) . Adverse events did not differ between the treatment groups . INTERPRETATION Treatment with c and esartan in type 2 diabetic patients with mild to moderate retinopathy might induce improvement of retinopathy",
"Abstract Objective : To determine the relation between systolic blood pressure over time and the risk of macrovascular or microvascular complications in patients with type 2 diabetes . Design : Prospect i ve observational study . Setting : 23 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Participants : 4801 white , Asian Indian , and Afro-Caribbean UKPDS patients , whether r and omised or not to treatment , were included in analyses of incidence ; of these , 3642 were included in analyses of relative risk . Outcome measures : Primary predefined aggregate clinical outcomes : any complications or deaths related to diabetes and all cause mortality . Secondary aggregate outcomes : myocardial infa rct ion , stroke , lower extremity amputation ( including death from peripheral vascular disease ) , and microvascular disease ( predominantly retinal photocoagulation ) . Single end points : non-fatal heart failure and cataract extraction . Risk reduction associated with a 10 mm Hg decrease in up date d mean systolic blood pressure adjusted for specific confounders Results : The incidence of clinical complications was significantly associated with systolic blood pressure , except for cataract extraction . Each 10 mm Hg decrease in up date d mean systolic blood pressure was associated with reductions in risk of 12 % for any complication related to diabetes ( 95 % confidence interval 10 % to 14 % , P myocardial infa rct ion ( 7 % to 14 % , P patients with type 2 diabetes the risk of diabetic complications was strongly associated with raised blood pressure . Any reduction in blood pressure is likely to reduce the risk of complications , with the lowest risk being in those with systolic blood pressure less than 120 mm Hg",
"Objective To compare the effects of two antihypertensive treatment strategies for the prevention of coronary heart disease and other cardiovascular events in the large sub population ( n = 5137 ) with diabetes mellitus in the blood pressure-lowering arm of the Anglo-Sc and inavian Cardiac Outcomes Trial . Methods Patients had either untreated hypertension or treated hypertension . For those with type II diabetes mellitus , inclusion criteria required at least two additional risk factors . Patients were r and omized to amlodipine with addition of perindopril as required ( amlodipine-based ) or atenolol with addition of thiazide as required ( atenolol-based ) . Therapy was titrated to achieve a target blood pressure of less than 130/80 mmHg . Results The trial was terminated early due to significant benefits on mortality and stroke associated with the amlodipine-based regimen . In patients with diabetes mellitus , the amlodipine-based treatment reduced the incidence of the composite endpoint – total cardiovascular events and procedures – compared with the atenolol-based regimen ( hazard ratio 0.86 , confidence interval 0.76–0.98 , P = 0.026 ) . Fatal and nonfatal strokes were reduced by 25 % ( P = 0.017 ) , peripheral arterial disease by 48 % ( P = 0.004 ) and noncoronary revascularization procedures by 57 % ( P coronary heart disease deaths and nonfatal myocardial infa rct ions ( the primary endpoint ) , which were reduced nonsignificantly by 8 % ( hazard ratio 0.92 , confidence interval 0.74–1.15 ) . Conclusion In the large diabetic subgroup in the blood pressure-lowering arm of the Anglo-Sc and inavian Cardiac Outcomes Trial , the benefits of amlodipine-based treatment , compared with atenolol-based treatment , on the incidence of total cardiovascular events and procedures was significant ( 14 % reduction ) and similar to that observed in the total trial population ( 16 % reduction )",
"BACKGROUND Microalbuminuria in diabetes is strongly predictive of nephropathy , end-stage renal disease , and premature cardiovascular morbidity and mortality . Effective preventive therapies are therefore a clinical priority . OBJECTIVE To determine whether the angiotensin-receptor blocker c and esartan compared with placebo affects microalbuminuria incidence or rate of change in albuminuria in type 1 and type 2 diabetes . DESIGN 3 r and omized trials of the DIRECT ( Diabetic Retinopathy C and esartan Trials ) Program . SETTING 309 secondary care centers . PATIENTS 3326 and 1905 patients with type 1 and type 2 diabetes , respectively . Most were normotensive , and all had normoalbuminuria ( median urinary albumin excretion rate , 5.0 microg/min ) . INTERVENTION C and esartan , 16 mg/d increasing to 32 mg/d , versus placebo . Assignment was done central ly using an interactive voice-response system . Patients , caregivers , and research ers were blinded to treatment assignment . During a median follow-up of 4.7 years , 793 patients discontinued therapy and 63 were lost to follow-up . MEASUREMENTS Urinary albumin excretion rate , assessed annually by 2 overnight collection s ; if it was 20 microg/min or greater , then 2 further collection s were done . The primary end point was new microalbuminuria ( 3 or 4 collection s of urinary albumin excretion rate > or=20 microg/min ) . The secondary end point was rate of change in albuminuria . RESULTS Individual and pooled results of the 3 trials showed that c and esartan had little effect on risk for microalbuminuria ( pooled hazard ratio , 0.95 [ 95 % CI , 0.78 to 1.16 ] ; P = 0.60 ) . Pooled results showed that the annual rate of change in albuminuria was 5.53 % lower ( CI , 0.73 % to 10.14 % ; P = 0.024 ) with c and esartan than with placebo . LIMITATIONS Investigators recruited mainly normotensive patients or patients with well-controlled hypertension who were at low overall vascular risk , which result ed in a low rate of microalbuminuria . Studies were powered for retinal and not renal end points . CONCLUSION C and esartan , 32 mg/d , for 4.7 years did not prevent microalbuminuria in mainly normotensive patients with type 1 or type 2 diabetes",
"BACKGROUND Lowering of blood pressure prevents stroke but optimum target levels to prevent recurrent stroke are unknown . We investigated the effects of different blood-pressure targets on the rate of recurrent stroke in patients with recent lacunar stroke . METHODS In this r and omised open-label trial , eligible patients lived in North America , Latin America , and Spain and had recent , MRI-defined symptomatic lacunar infa rct ions . Patients were recruited between March , 2003 , and April , 2011 , and r and omly assigned , according to a two-by-two multifactorial design , to a systolic-blood-pressure target of 130 - 149 mm Hg or less than 130 mm Hg . The primary endpoint was reduction in all stroke ( including ischaemic strokes and intracranial haemorrhages ) . Analysis was done by intention to treat . This study is registered with Clinical Trials.gov , number NCT 00059306 . FINDINGS 3020 enrolled patients , 1519 in the higher-target group and 1501 in the lower-target group , were followed up for a mean of 3·7 ( SD 2·0 ) years . Mean age was 63 ( SD 11 ) years . After 1 year , mean systolic blood pressure was 138 mm Hg ( 95 % CI 137 - 139 ) in the higher-target group and 127 mm Hg ( 95 % CI 126 - 128 ) in the lower-target group . Non-significant rate reductions were seen for all stroke ( hazard ratio 0·81 , 95 % CI 0·64 - 1·03 , p=0·08 ) , disabling or fatal stroke ( 0·81 , 0·53 - 1·23 , p=0·32 ) , and the composite outcome of myocardial infa rct ion or vascular death ( 0·84 , 0·68 - 1·04 , p=0·32 ) with the lower target . The rate of intracerebral haemorrhage was reduced significantly ( 0·37 , 0·15 - 0·95 , p=0·03 ) . Treatment-related serious adverse events were infrequent . INTERPRETATION Although the reduction in stroke was not significant , our results support that in patients with recent lacunar stroke , the use of a systolic-blood-pressure target of less than 130 mm Hg is likely to be beneficial . FUNDING National Institutes of Health-National Institute of Neurological Disorders and Stroke ( NIH-NINDS )",
"BACKGROUND This study was undertaken to determine whether use of the direct renin inhibitor aliskiren would reduce cardiovascular and renal events in patients with type 2 diabetes and chronic kidney disease , cardiovascular disease , or both . METHODS In a double-blind fashion , we r and omly assigned 8561 patients to aliskiren ( 300 mg daily ) or placebo as an adjunct to an angiotensin-converting-enzyme inhibitor or an angiotensin-receptor blocker . The primary end point was a composite of the time to cardiovascular death or a first occurrence of cardiac arrest with resuscitation ; nonfatal myocardial infa rct ion ; nonfatal stroke ; unplanned hospitalization for heart failure ; end-stage renal disease , death attributable to kidney failure , or the need for renal-replacement therapy with no dialysis or transplantation available or initiated ; or doubling of the baseline serum creatinine level . RESULTS The trial was stopped prematurely after the second interim efficacy analysis . After a median follow-up of 32.9 months , the primary end point had occurred in 783 patients ( 18.3 % ) assigned to aliskiren as compared with 732 ( 17.1 % ) assigned to placebo ( hazard ratio , 1.08 ; 95 % confidence interval [ CI ] , 0.98 to 1.20 ; P=0.12 ) . Effects on secondary renal end points were similar . Systolic and diastolic blood pressures were lower with aliskiren ( between-group differences , 1.3 and 0.6 mm Hg , respectively ) and the mean reduction in the urinary albumin-to-creatinine ratio was greater ( between-group difference , 14 percentage points ; 95 % CI , 11 to 17 ) . The proportion of patients with hyperkalemia ( serum potassium level , ≥6 mmol per liter ) was significantly higher in the aliskiren group than in the placebo group ( 11.2 % vs. 7.2 % ) , as was the proportion with reported hypotension ( 12.1 % vs. 8.3 % ) ( P addition of aliskiren to st and ard therapy with renin-angiotensin system blockade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful . ( Funded by Novartis ; ALTITUDE Clinical Trials.gov number , NCT00549757 . )",
"BACKGROUND Microalbuminuria is an early predictor of diabetic nephropathy and premature cardiovascular disease . We investigated whether treatment with an angiotensin-receptor blocker ( ARB ) would delay or prevent the occurrence of microalbuminuria in patients with type 2 diabetes and normoalbuminuria . METHODS In a r and omized , double-blind , multicenter , controlled trial , we assigned 4447 patients with type 2 diabetes to receive olmesartan ( at a dose of 40 mg once daily ) or placebo for a median of 3.2 years . Additional antihypertensive drugs ( except angiotensin-converting-enzyme inhibitors or ARBs ) were used as needed to lower blood pressure to less than 130/80 mm Hg . The primary outcome was the time to the first onset of microalbuminuria . The times to the onset of renal and cardiovascular events were analyzed as secondary end points . RESULTS The target blood pressure ( olmesartan and 71 % taking placebo ; blood pressure measured in the clinic was lower by 3.1/1.9 mm Hg in the olmesartan group than in the placebo group . Microalbuminuria developed in 8.2 % of the patients in the olmesartan group ( 178 of 2160 patients who could be evaluated ) and 9.8 % in the placebo group ( 210 of 2139 ) ; the time to the onset of microalbuminuria was increased by 23 % with olmesartan ( hazard ratio for onset of microalbuminuria , 0.77 ; 95 % confidence interval , 0.63 to 0.94 ; P=0.01 ) . The serum creatinine level doubled in 1 % of the patients in each group . Slightly fewer patients in the olmesartan group than in the placebo group had nonfatal cardiovascular events--81 of 2232 patients ( 3.6 % ) as compared with 91 of 2215 patients ( 4.1 % ) (P=0.37)--but a greater number had fatal cardiovascular events--15 patients ( 0.7 % ) as compared with 3 patients ( 0.1 % ) ( P=0.01 ) , a difference that was attributable in part to a higher rate of death from cardiovascular causes in the olmesartan group than in the placebo group among patients with preexisting coronary heart disease ( 11 of 564 patients [ 2.0 % ] vs. 1 of 540 [ 0.2 % ] , P=0.02 ) . CONCLUSIONS Olmesartan was associated with a delayed onset of microalbuminuria , even though blood-pressure control in both groups was excellent according to current st and ards . The higher rate of fatal cardiovascular events with olmesartan among patients with preexisting coronary heart disease is of concern . ( Funded by Daiichi Sankyo ; Clinical Trials.gov number , NCT00185159 . )",
"AIMS Major guidelines recommend lowering systolic blood pressure ( SBP ) to hypertensives , but evidence is missing whether this is beneficial in ( i ) uncomplicated hypertensives , ( ii ) grade 1 hypertensives , and ( iii ) elderly hypertensives . Providing this missing evidence is important to justify efforts and costs of aggressive therapy in all hypertensives . METHODS AND RESULTS Felodipine Event Reduction ( FEVER ) was a double-blind , r and omized trial on 9711 Chinese hypertensives , in whom cardiovascular outcomes were significantly reduced by more intense therapy ( low-dose hydrochlorothiazide and low-dose felodipine ) achieving a mean of 138 mmHg SBP compared with less-intense therapy ( low-dose hydrochlorothiazide and placebo ) achieving a mean of 142 mmHg . FEVER included older and younger patients , and patients with and without diabetes or cardiovascular disease . In the analyses here reported , Cox regression models assessed outcome differences between more and less-intense treatments in groups of patients with different baseline characteristics . Significant reductions in stroke were found in uncomplicated hypertensives ( -39 % , P = 0.002 ) , in hypertensives with r and omization SBP SBP was lowered by more intense treatment . Significant reductions ( between -29 and -47 % , P = 0.02 to all cardiovascular events and all deaths . Achieving mean SBP values cardiovascular events every 100 patients treated for 3.3 years . CONCLUSIONS These analyses provide strong support , missing so far , to guidelines recommending goal SBP < 140 mmHg in uncomplicated hypertensives , individuals with moderately elevated BP and elderly hypertensives",
"BACKGROUND We investigated whether intensive glycemic control , combination therapy for dyslipidemia , and intensive blood-pressure control would limit the progression of diabetic retinopathy in persons with type 2 diabetes . Previous data suggest that these systemic factors may be important in the development and progression of diabetic retinopathy . METHODS In a r and omized trial , we enrolled 10,251 participants with type 2 diabetes who were at high risk for cardiovascular disease to receive either intensive or st and ard treatment for glycemia ( target glycated hemoglobin level , for dyslipidemia ( 160 mg daily of fenofibrate plus simvastatin or placebo plus simvastatin ) or for systolic blood-pressure control ( target , A subgroup of 2856 participants was evaluated for the effects of these interventions at 4 years on the progression of diabetic retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study Severity Scale ( as assessed from seven-field stereoscopic fundus photographs , with 17 possible steps and a higher number of steps indicating greater severity ) or the development of diabetic retinopathy necessitating laser photocoagulation or vitrectomy . RESULTS At 4 years , the rates of progression of diabetic retinopathy were 7.3 % with intensive glycemia treatment , versus 10.4 % with st and ard therapy ( adjusted odds ratio , 0.67 ; 95 % confidence interval [ CI ] , 0.51 to 0.87 ; P=0.003 ) ; 6.5 % with fenofibrate for intensive dyslipidemia therapy , versus 10.2 % with placebo ( adjusted odds ratio , 0.60 ; 95 % CI , 0.42 to 0.87 ; P=0.006 ) ; and 10.4 % with intensive blood-pressure therapy , versus 8.8 % with st and ard therapy ( adjusted odds ratio , 1.23 ; 95 % CI , 0.84 to 1.79 ; P=0.29 ) . CONCLUSIONS Intensive glycemic control and intensive combination treatment of dyslipidemia , but not intensive blood-pressure control , reduced the rate of progression of diabetic retinopathy . ( Funded by the National Heart , Lung , and Blood Institute and others ; Clinical Trials.gov numbers , NCT00000620 for the ACCORD study and NCT00542178 for the ACCORD Eye study .",
"Analyses of 5-year mortality data from the Hypertension Detection and Follow-up Program ( HDFP ) were performed with stratification according to several baseline traits . The HDFP participants were 10,940 white and black men and women ages 30 - 69 at baseline who were r and omized to either stepped-care ( SC ) or referred-care ( RC ) groups . All-causes mortality rates were lower for the SC than the RC group , both overall and for the 90 - 104 mm Hg stratum , for both cigarette smokers and nonsmokers , and for persons with and without hypercholesterolemia , hyperglycemia , diagnosed diabetes , hyperuricemia , or rapid pulse rate . The SC group also fared better than RC for all strata of body mass index , with an apparent trend toward an inverse relationship between body mass index and degree of benefit . Several of the traits -- cigarette smoking , fasting hyperglycemia , and hyperuricemia -- were associated with significantly higher 5-year mortality rates in both SC and RC participants , in both univariate and multivariate analyses , and a significant U-shaped relationship was recorded between body mass index and mortality for both SC and RC groups . These findings indicate the broad benefit of vigorous antihypertensive stepped-care treatment for hypertensive patients regardless of the presence or absence of the other major risk factors . They also underscore the need for comprehensive management of persons with high blood pressure to control not only their hypertension but also other risk factors associated with negative impact on long-term prognosis",
"The Hypertension Detection and Follow-up Program ( HDFP ) data are reported by diastolic blood pressure ( DBP ) stratum for four race-sex subgroups . For Stratum I ( entry DBP 90–104 mm Hg ) in each of the race-sex subgroups ( black male , black female , white male , and white female ) , Stepped Care ( SC ) participants experienced a reduced mortality as compared to Referred Care ( RC ) . For black males and females in all three entry DBP strata , mortality was lower in the SC than RC . Only in three subgroups did the SC mortality exceed RC : Stratum II ( entry DBP 105–114 mm Hg ) white females and Stratum III ( entry DBP 115 + mm Hg ) white males and females . Possible explanations for these deviant findings are discussed . The HDFP was design ed to determine the difference in total 5-year mortality between SC and RC ; subgroup analyses may be subject to large chance variation and must be interpreted with great caution . The value of vigorous treatment of “ mild ” hypertension ( Stratum I ) in males and females , black and white , and the value of treatment for all blood pressure strata in blacks are confirmed by this analysis",
"BACKGROUND It is not known whether the treatment of patients with asymptomatic left ventricular dysfunction reduces mortality and morbidity . We studied the effect of an angiotensin-converting -- enzyme inhibitor , enalapril , on total mortality and mortality from cardiovascular causes , the development of heart failure , and hospitalization for heart failure among patients with ejection fractions of 0.35 or less who were not receiving drug treatment for heart failure . METHODS Patients were r and omly assigned to receive either placebo ( n = 2117 ) or enalapril ( n = 2111 ) at doses of 2.5 to 20 mg per day in a double-blind trial . Follow-up averaged 37.4 months . RESULTS There were 334 deaths in the placebo group , as compared with 313 in the enalapril group ( reduction in risk , 8 percent by the log-rank test ; 95 percent confidence interval , -8 percent [ an increase of 8 percent ] to 21 percent ; P = 0.30 ) . The reduction in mortality from cardiovascular causes was larger but was not statistically significant ( 298 deaths in the placebo group vs. 265 in the enalapril group ; risk reduction , 12 percent ; 95 percent confidence interval , -3 to 26 percent ; P = 0.12 ) . When we combined patients in whom heart failure developed and those who died , the total number of deaths and cases of heart failure was lower in the enalapril group than in the placebo group ( 630 vs. 818 ; risk reduction , 29 percent ; 95 percent confidence interval , 21 to 36 percent ; P less than 0.001 ) . In addition , fewer patients given enalapril died or were hospitalized for heart failure ( 434 in the enalapril group ; vs. 518 in the placebo group ; risk reduction , 20 percent ; 95 percent confidence interval , 9 to 30 percent ; P less than 0.001 ) . CONCLUSIONS The angiotensin-converting -- enzyme inhibitor enalapril significantly reduced the incidence of heart failure and the rate of related hospitalizations , as compared with the rates in the group given placebo , among patients with asymptomatic left ventricular dysfunction . There was also a trend toward fewer deaths due to cardiovascular causes among the patients who received enalapril",
"BACKGROUND It has recently been reported that the use of calcium-channel blockers for hypertension may be associated with an increased risk of cardiovascular complications . Because this issue remains controversial , we studied the incidence of such complications in patients with non-insulin-dependent diabetes mellitus and hypertension who were r and omly assigned to treatment with either the calcium-channel blocker nisoldipine or the angiotensin-converting-enzyme inhibitor enalapril as part of a larger study . METHODS The Appropriate Blood Pressure Control in Diabetes ( ABCD ) Trial is a prospect i ve , r and omized , blinded trial comparing the effects of moderate control of blood pressure ( target diastolic pressure , 80 to 89 mm Hg ) with those of intensive control of blood pressure ( diastolic pressure , 75 mm Hg ) on the incidence and progression of complications of diabetes . The study also compared nisoldipine with enalapril as a first-line antihypertensive agent in terms of the prevention and progression of complications of diabetes . In the current study , we analyzed data on a secondary end point ( the incidence of myocardial infa rct ion ) in the subgroup of patients in the ABCD Trial who had hypertension . RESULTS Analysis of the 470 patients in the trial who had hypertension ( base-line diastolic blood pressure , > or = 90 mm Hg ) showed similar control of blood pressure , blood glucose and lipid concentrations , and smoking behavior in the nisoldipine group ( 237 patients ) and the enalapril group ( 233 patients ) throughout five years of follow-up . Using a multiple logistic-regression model with adjustment for cardiac risk factors , we found that nisoldipine was associated with a higher incidence of fatal and nonfatal myocardial infa rct ions ( a total of 24 ) than enalapril ( total , 4 ) ( risk ratio , 9.5 ; 95 percent confidence interval , 2.7 to 33.8 ) . CONCLUSIONS In this population of patients with diabetes and hypertension , we found a significantly higher incidence of fatal and nonfatal myocardial infa rct ion among those assigned to therapy with the calcium-channel blocker nisoldipine than among those assigned to receive enalapril . Since our findings are based on a secondary end point , they will require confirmation",
"Context Previously published results of this r and omized , double-blind trial showed that high-risk patients with type 2 diabetic nephropathy had better renal protection if they were treated with irbesartan rather than amlodipine in addition to conventional antihypertensive therapy . Contribution These detailed analyses showed no differences in overall cardiovascular outcomes between patients given irbesartan or amlodipine . Fewer patients given irbesartan had heart failure and fewer patients given amlodipine had heart attacks . Caution s The trial had limited power to detect important differences between groups in mortality or strokes , and most patients received several antihypertensive agents . The Editors Patients with diabetes have an increased risk for cardiovascular complications and death ( 1 ) . Studies that analyzed the effects of inhibition of the reninangiotensin system on the risk for cardiovascular complications included a substantial number of patients with diabetes ( 2 - 5 ) or were done exclusively in patients with diabetes ( 6 - 8 ) . The meta- analysis of these studies ( 9 ) , the analysis of the diabetic cohorts in the Heart Outcomes Prevention Evaluation ( HOPE ) study ( 2 ) , and the Losartan Intervention for Endpoint Reduction in Hypertension ( LIFE ) trial ( 5 ) demonstrated that angiotensin-converting enzyme ( ACE ) inhibitors ( 2 , 9 ) and angiotensin-receptor blockers ( 5 ) had a statistically significant advantage over placebo or alternative agents in decreasing the risk for several cardiovascular events . These studies r and omly assigned few patients with renal involvement and overt proteinuria . Overt proteinuria occurred in fewer than 20 % of the 470 patients in the Appropriate Blood Pressure Control in Diabetes ( ABCD ) trial ( 6 ) , and only 11 % of the 1195 patients in the LIFE trial ( 5 ) . The Captopril Prevention Project ( CAPP ) ( 3 ) and the Swedish Trial in Old Patients with Hypertension-2 ( STOP Hypertension-2 ) ( 4 ) did not state the number of patients with diabetes and overt proteinuria . There were no such patients in the Fosinopril versus Amlodipine Cardiovascular Events Trial ( FACET ) ( 7 ) , and patients with dipstick-positive albuminuria were excluded from the HOPE trial ( 2 ) . Since proteinuria is an independent risk factor for cardiovascular disease ( 10 , 11 ) , the data obtained in the aforementioned trials can not be extrapolated to patients with type 2 diabetes and overt nephropathy . Trials performed in such patients have reported a blood pressureindependent effect of two different angiotensin-receptor blocker agents to protect against nephropathy ( 12 , 13 ) without a change in all-cause mortality . Apart from studies in heart failure , few cardiovascular data exist for receptor blockers compared with either placebo or calcium-channel blockers . We report on the analysis of the cardiovascular end points that were monitored as secondary end points in the Irbesartan Diabetic Nephropathy Trial ( IDNT ) ( 12 ) and assess whether an angiotensin II receptor blocker or a calcium-channel blocker alters the risk for cardiovascular events beyond those observed by blood pressure reduction alone without such agents . Methods Patients The IDNT was a r and omized , double-blind study on the effect of treatment with irbesartan or amlodipine compared with placebo in patients with type 2 diabetic nephropathy . The protocol of this study has been published ( 12 , 14 ) . Entry criteria required that patients be between 30 and 70 years of age and have type 2 diabetes mellitus and overt nephropathy , as evidence d by current treatment for hypertension or by a protein excretion rate of 900 mg/d or greater , serum creatinine level of 89 mol/L ( 1.0 mg/dL ) to 266 mol/L ( 3.0 mg/dL ) in women or of 106 mol/L ( 1.2 mg/dL ) to 266 mol/L ( 3.0 mg/dL ) in men , and baseline seated blood pressure greater than 135/85 mm Hg . The institutional review boards of each center approved the protocol . All patients gave written informed consent . Treatment and R and omization Patients were r and omly assigned central ly by computer to receive treatment with irbesartan , 300 mg/d ( Avapro , Bristol-Myers Squibb , Princeton , New Jersey ) ; amlodipine , 10 mg/d ( Norvasc , Pfizer , New York ) ; or matched placebo . To minimize any center effect , r and omization was blocked by center . All patients had blood pressure controlled to the same blood pressure goal of less than 135/85 mm Hg by using antihypertensive agents other than ACE inhibitors , angiotensin II receptor blocking agents , or calcium-channel blockers . For the analysis of cardiovascular end points , patients were followed to initiation of treatment for end-stage renal failure ( dialysis or renal transplantation ) , reaching a serum creatinine level of 530.4 mol/L ( 6.0 mg/dL ) or higher , death , or administrative censoring in December 2000 . Outcomes We prospect ively established cardiovascular outcomes , defined in the Appendix Table . Appendix Table . Classification for Fatal and Nonfatal Cardiovascular Events Ascertainment of Cardiovascular Events Information about hospitalizations and adverse events were screened at Bristol-Myers Squibb , Princeton , New Jersey , by trained , blinded clinical research associates to identify potential cardiovascular events . Investigators used study forms to report and characterize all cardiovascular outcomes . For all potential events , records , including laboratory values , electrocardiograms , and radiographic reports were obtained for clarification . Since myocardial infa rct ions may go unrecognized , a central electrocardiogram reading center was established at Brigham and Women 's Hospital , Boston , Massachusetts , where two cardiologists review ed every electrocardiogram . Electrocardiography was performed at baseline , 6 months , 12 months , and annually thereafter . A total of 5698 electrocardiograms were review ed at the center . When a new Q-wave infa rct ion was found , the cardiologists asked whether a clinical myocardial infa rct ion was reported . Even when myocardial infa rct ions were not clinical ly reported , these Q-wave infa rct ions were adjudicated as myocardial infa rct ions . Adjudication of Cardiovascular Events Investigators at each center reported cardiovascular events , defined in the Appendix Table . The information on all potential events was referred to one member of the Outcomes Confirmation and Classification Committee ( Appendix ) . If the committee member agreed with the judgment of the center investigator , their combined judgment was accepted . If the center investigator and the committee member differed , the case material was review ed by the membership of the committee , whose decision was accepted . Deaths were adjudicated by a Mortality Committee ( Appendix ) . Each death was review ed by two members of the committee and presented to the membership , whose decision was accepted as final . Statistical Analysis For graphical presentation ( Figure ) and overall testing for statistically significant differences among the three treatment groups , time to the first occurrence of either a specific cardiovascular outcome or one of the composite outcomes was analyzed by product-limit survival curves and the log-rank test ( 15 ) . We used proportional hazards modeling to determine hazard ratios . For the cardiovascular death outcome , which could occur only once , we used the st and ard proportional hazards model ( 16 ) , with treatment assignment as the only independent covariate . For other cardiovascular outcomes , which could occur more than once , we used the And ersonGill formulation of the proportional hazards model ( 17 ) , in which patients are considered at risk for the first event from r and omization to the first event , at risk for the second event from the day following the first event to the second event , and so forth , permitting use of all the data . In accordance with the method of Lee and colleagues ( 18 ) , we used a robust variance estimate that accounts for the possibility of correlation of risk for several events within a patient . We believed that occurrence of a first event of a given type increases the likelihood of a subsequent similar event . Therefore , both treatment assignment and a time-dependent covariate indicating whether the event was the first of its type or a subsequent event were included in these analyses . The time-dependent covariate was statistically significant in each case , confirming the above assumption . There was no statistically significant interaction between treatment and the time-dependent covariatethe effects of treatment assignment were similar for first and subsequent events and inclusion of the time-dependent covariate did not change either the estimates of the treatment effect or their statistical significance s. Figure . Time to first cardiovascular composite event as a function of treatment assignment . P Data management and computations were done by using SAS software for Windows , version 8 ( SAS Institute , Inc. , Cary , North Carolina ) , or S-Plus for Windows , version 6.0 ( Insightful Corp. , Seattle , Washington ) . Statistical tests were two sided . A P value of 0.05 or less , unadjusted for the multiple comparisons , was considered statistically significant . Role of the Funding Sources The funding sources were involved in the data collection but not in the analysis or interpretation or the decision to su bmi t the manuscript for publication . Results The baseline characteristics of the three groups are shown in Table 1 . A flow diagram of the study is shown in the Appendix Figure . Table 1 . Baseline Characteristics Appendix Figure . Flow diagram for the Irbesartan Diabetic Nephropathy Trial . Clinical Management During the study , the blood pressure decreased from the baseline values to 140/77 mm Hg in the irbesartan group , 141/77 mm Hg in the amlodipine group , and 144/80 mm Hg in the placebo group . Blood pressure in the two active treatment groups did not differ ; values in both groups were statistically significantly lower than in the placebo group ( P = 0.001 ) . The distribution of non study drugs used to achieve the target blood pressure was similar",
"OBJECTIVES This was a retrospective analysis to determine the effect of diabetes on outcome in patients with advanced heart failure ( HF ) , and to determine the effect of beta-blockade in patients with HF with and without diabetes mellitus . BACKGROUND In chronic HF the impact on clinical outcomes and therapeutic response of the prevalent comorbid condition diabetes mellitus has not been extensively investigated . METHODS We assessed the impact of diabetes on prognosis and effectiveness of beta-blocker therapy with bucindolol in patients with HF enrolled in the Beta-Blocker Evaluation of Survival Trial ( BEST ) . We conducted a retrospective analysis to examine the prognosis of patients with advanced HF with and without diabetes , and the effect of beta-blocker therapy on mortality and HF progression or myocardial infa rct ion ( MI ) . The data base was the 2,708 patients with advanced HF ( 36 % with diabetes and 64 % without diabetes ) who were r and omized to the beta-blocker bucindolol or placebo in BEST and followed for mortality , hospitalization , and MI for an average of two years . RESULTS Patients with diabetes had more severe chronic HF and more coronary risk factors than patients without diabetes . Diabetes was independently associated with increased mortality in patients with ischemic cardiomyopathy ( adjusted hazard ratio 1.33 , 95 % confidence interval 1.12 to 1.58 , p = 0.001 ) , but not in those with a nonischemic etiology ( adjusted hazard ratio 0.98 , 95 % confidence interval 0.74 to 1.30 , p = 0.89 ) . Compared with patients without diabetes , in diabetic patients beta-blocker therapy was at least as effective in reducing death or HF hospitalizations , total hospitalizations , HF hospitalizations , and MI . Ventricular function and physiologic responses to beta-blockade were similar in patients with and without diabetes . CONCLUSIONS Diabetes worsens prognosis in patients with advanced HF , but this worsening appears to be limited to patients with ischemic cardiomyopathy . In advanced HF beta-blockade is effective in reducing major clinical end points in patients with and without diabetes",
"BACKGROUND Despite treatment , there is often a higher incidence of cardiovascular complications in patients with hypertension than in normotensive individuals . Inadequate reduction of their blood pressure is a likely cause , but the optimum target blood pressure is not known . The impact of acetylsalicylic acid ( aspirin ) has never been investigated in patients with hypertension . We aim ed to assess the optimum target diastolic blood pressure and the potential benefit of a low dose of acetylsalicylic acid in the treatment of hypertension . METHODS 18790 patients , from 26 countries , aged 50 - 80 years ( mean 61.5 years ) with hypertension and diastolic blood pressure between 100 mm Hg and 115 mm Hg ( mean 105 mm Hg ) were r and omly assigned a target diastolic blood pressure . 6264 patients were allocated to the target pressure Felodipine was given as baseline therapy with the addition of other agents , according to a five-step regimen . In addition , 9399 patients were r and omly assigned 75 mg/day acetylsalicylic acid ( Bamycor , Astra ) and 9391 patients were assigned placebo . FINDINGS Diastolic blood pressure was reduced by 20.3 mm Hg , 22.3 mm Hg , and 24.3 mm Hg , in the major cardiovascular events occurred at a mean achieved diastolic blood pressure of 82.6 mm Hg ; the lowest risk of cardiovascular mortality occurred at 86.5 mm Hg . Further reduction below these blood pressures was safe . In patients with diabetes mellitus there was a 51 % reduction in major cardiovascular events in target group Acetylsalicylic acid reduced major cardiovascular events by 15 % ( p=0.03 ) and all myocardial infa rct ion by 36 % ( p=0.002 ) , with no effect on stroke . There were seven fatal bleeds in the acetylsalicylic acid group and eight in the placebo group , and 129 versus 70 non-fatal major bleeds in the two groups , respectively ( p patients with hypertension was associated with a low rate of cardiovascular events . The HOT Study shows the benefits of lowering the diastolic blood pressure down to 82.6 mm Hg . Acetylsalicylic acid significantly reduced major cardiovascular events with the greatest benefit seen in all myocardial infa rct ion . There was no effect on the incidence of stroke or fatal bleeds , but non-fatal major bleeds were twice as common",
"We stratified findings from the Japan Multicenter Investigation for Cardiovascular Diseases-B according to whether or not the patients had diabetes and compared the incidence of cardiac events occurring over a 3-year period between treatment with nifedipine retard and angiotensin converting enzyme ( ACE ) inhibitor . The primary endpoint was the overall incidence of cardiac events ( cardiac death or sudden death , myocardial infa rct ion , hospitalization for angina pectoris or heart failure , serious arrhythmia , and coronary interventions ) , and the secondary endpoints were a composite of other events ( cerebrovascular accidents , worsening of renal dysfunction , non-cardiovascular events , and total mortality ) . The results showed no significant difference in the incidence of the primary endpoint between the nifedipine group ( n=199 ) and the ACE inhibitor group ( n=173 ) in diabetic patients : 15.08 % vs. 15.03 % , relative risk 1.06 , p=0.838 . Also in nondiabetic patients , no significant difference was observed between the former ( n=629 ) and the latter ( n=649 ) : 13.67 % vs. 12.33 % , relative risk 1.04 , p=0.792 . Similar results were obtained for the incidence of the secondary endpoints : in diabetic patients , 5.03 % vs. 5.20 % , relative risk 0.89 , p=0.799 ; in nondiabetic patients , 2.70 % vs. 2.47 % , relative risk 1.07 , p=0.842 . Achieved blood pressure levels were 138/76 and 136/77 mmHg in the nifedipine group and 140/78 and 138/79 mmHg in the ACE inhibitor group in diabetic and nondiabetic patients , respectively . This study showed that nifedipine retard was as effective as ACE inhibitors in reducing the incidence of cardiac events in extremely high-risk hypertensive patients with complications of diabetes and coronary artery disease",
"In diabetic patients long-term treatment with timolol after myocardial infa rct ion was related to a reduction in overall mortality , total cardiac death , sudden death , and nonfatal reinfa rct ion , compared with patients in a placebo group . The analyses were based on 99 diabetic patients in the Norwegian timolol multicenter study . The dosage of timolol was 10 mg twice daily and the follow-up period was 12–33 mo ( mean : 17 mo ) . When analyzing all r and omized patients , there were 14 deaths in the placebo group and 6 deaths in the timolol group , a reduction of 62.8 % ( P The number of nonfatal reinfa rct ions was 10 in the placebo group and 2 in the timolol group , a reduction of 82.7 % ( P inclusion rate , side effects , withdrawals , and timolol-related reduction in mortality and reinfa rct ion , the diabetic patients basically behaved like nondiabetic patients . The data were analyzed retrospectively and should be confirmed by a prospect i ve study . The study also indicates that long-term treatment with timolol may induce slight carbohydrate intolerance",
"BACKGROUND Microalbuminuria and hypertension are risk factors for diabetic nephropathy . Blockade of the renin-angiotensin system slows the progression to diabetic nephropathy in patients with type 1 diabetes , but similar data are lacking for hypertensive patients with type 2 diabetes . We evaluated the renoprotective effect of the angiotensin-II-receptor antagonist irbesartan in hypertensive patients with type 2 diabetes and microalbuminuria . METHODS A total of 590 hypertensive patients with type 2 diabetes and microalbuminuria were enrolled in this multinational , r and omized , double-blind , placebo-controlled study of irbesartan , at a dose of either 150 mg daily or 300 mg daily , and were followed for two years . The primary outcome was the time to the onset of diabetic nephropathy , defined by persistent albuminuria in overnight specimens , with a urinary albumin excretion rate that was greater than 200 microg per minute and at least 30 percent higher than the base-line level . RESULTS The base-line characteristics in the three groups were similar . Ten of the 194 patients in the 300-mg group ( 5.2 percent ) and 19 of the 195 patients in the 150-mg group ( 9.7 percent ) reached the primary end point , as compared with 30 of the 201 patients in the placebo group ( 14.9 percent ) ( hazard ratios , 0.30 [ 95 percent confidence interval , 0.14 to 0.61 ; P average blood pressure during the course of the study was 144/83 mm Hg in the placebo group , 143/83 mm Hg in the 150-mg group , and 141/83 mm Hg in the 300-mg group ( P=0.004 for the comparison of systolic blood pressure between the placebo group and the combined irbesartan groups ) . Serious adverse events were less frequent among the patients treated with irbesartan ( P=0.02 ) . CONCLUSIONS Irbesartan is renoprotective independently of its blood-pressure-lowering effect in patients with type 2 diabetes and microalbuminuria",
"CONTEXT Antihypertensive therapy is well established to reduce hypertension-related morbidity and mortality , but the optimal first-step therapy is unknown . OBJECTIVE To determine whether treatment with a calcium channel blocker or an angiotensin-converting enzyme inhibitor lowers the incidence of coronary heart disease ( CHD ) or other cardiovascular disease ( CVD ) events vs treatment with a diuretic . DESIGN The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ( ALLHAT ) , a r and omized , double-blind , active-controlled clinical trial conducted from February 1994 through March 2002 . SETTING AND PARTICIPANTS A total of 33 357 participants aged 55 years or older with hypertension and at least 1 other CHD risk factor from 623 North American centers . INTERVENTIONS Participants were r and omly assigned to receive chlorthalidone , 12.5 to 25 mg/d ( n = 15 255 ) ; amlodipine , 2.5 to 10 mg/d ( n = 9048 ) ; or lisinopril , 10 to 40 mg/d ( n = 9054 ) for planned follow-up of approximately 4 to 8 years . MAIN OUTCOME MEASURES The primary outcome was combined fatal CHD or nonfatal myocardial infa rct ion , analyzed by intent-to-treat . Secondary outcomes were all-cause mortality , stroke , combined CHD ( primary outcome , coronary revascularization , or angina with hospitalization ) , and combined CVD ( combined CHD , stroke , treated angina without hospitalization , heart failure [ HF ] , and peripheral arterial disease ) . RESULTS Mean follow-up was 4.9 years . The primary outcome occurred in 2956 participants , with no difference between treatments . Compared with chlorthalidone ( 6-year rate , 11.5 % ) , the relative risks ( RRs ) were 0.98 ( 95 % CI , 0.90 - 1.07 ) for amlodipine ( 6-year rate , 11.3 % ) and 0.99 ( 95 % CI , 0.91 - 1.08 ) for lisinopril ( 6-year rate , 11.4 % ) . Likewise , all-cause mortality did not differ between groups . Five-year systolic blood pressures were significantly higher in the amlodipine ( 0.8 mm Hg , P = .03 ) and lisinopril ( 2 mm Hg , P chlorthalidone , and 5-year diastolic blood pressure was significantly lower with amlodipine ( 0.8 mm Hg , P amlodipine vs chlorthalidone , secondary outcomes were similar except for a higher 6-year rate of HF with amlodipine ( 10.2 % vs 7.7 % ; RR , 1.38 ; 95 % CI , 1.25 - 1.52 ) . For lisinopril vs chlorthalidone , lisinopril had higher 6-year rates of combined CVD ( 33.3 % vs 30.9 % ; RR , 1.10 ; 95 % CI , 1.05 - 1.16 ) ; stroke ( 6.3 % vs 5.6 % ; RR , 1.15 ; 95 % CI , 1.02 - 1.30 ) ; and HF ( 8.7 % vs 7.7 % ; RR , 1.19 ; 95 % CI , 1.07 - 1.31 ) . CONCLUSION Thiazide-type diuretics are superior in preventing 1 or more major forms of CVD and are less expensive . They should be preferred for first-step antihypertensive therapy",
"BACKGROUND Long-term administration of angiotensin-converting -- enzyme ( ACE ) inhibitors has been shown to improve survival in patients with symptomatic left ventricular failure and to attenuate left ventricular dilatation in patients with myocardial infa rct ion . We studied whether mortality could be reduced during the 6 months after an acute myocardial infa rct ion with use of the ACE inhibitor enalapril . METHODS At 103 Sc and inavian centers patients with acute myocardial infa rct ions and blood pressure above 100/60 mm Hg were r and omly assigned to treatment with either enalapril or placebo , in addition to conventional therapy . Therapy was initiated with an intravenous infusion of enalapril ( enalaprilat ) within 24 hours after the onset of chest pain , followed by administration of oral enalapril . RESULTS Of the 6090 patients enrolled , 3046 were assigned to placebo and 3044 to enalapril . The life-table mortality rates in the two groups at one and six months were not significantly different ( 6.3 and 10.2 percent in the placebo group vs. 7.2 and 11.0 percent in the enalapril group , P = 0.26 ) . The relative risk of death in the enalapril group was 1.10 ( 95 percent confidence interval , 0.93 to 1.29 ) . Death due to progressive heart failure occurred in 104 patients ( 3.4 percent ) in the placebo group and 132 ( 4.3 percent ) in the enalapril group ( P = 0.06 ) . Therapy had to be changed because of worsening heart failure in 30 percent of the placebo group and 27 percent of the enalapril group ( P less than 0.006 ) . Early hypotension ( systolic pressure less than 90 mm Hg or diastolic pressure less than 50 mm Hg ) occurred in 12 percent of the enalapril group and 3 percent of the placebo group ( P less than 0.001 ) . CONCLUSIONS Enalapril therapy started within 24 hours of the onset of acute myocardial infa rct ion does not improve survival during the 180 days after infa rct ion",
"BACKGROUND Metoprolol can improve haemodynamics in chronic heart failure , but survival benefit has not been proven . We investigated whether metoprolol controlled release/extended release ( CR/XL ) once daily , in addition to st and ard therapy , would lower mortality in patients with decreased ejection fraction and symptoms of heart failure . METHODS We enrolled 3991 patients with chronic heart failure in New York Heart Association ( NYHA ) functional class II-IV and with ejection fraction of 0.40 or less , stabilised with optimum st and ard therapy , in a double-blind r and omised controlled study . R and omisation was preceded by a 2-week single-blind placebo run-in period . 1990 patients were r and omly assigned metoprolol CR/XL 12.5 mg ( NYHA III-IV ) or 25.0 mg once daily ( NYHA II ) and 2001 were assigned placebo . The target dose was 200 mg once daily and doses were up-titrated over 8 weeks . Our primary endpoint was all-cause mortality , analysed by intention to treat . FINDINGS The study was stopped early on the recommendation of the independent safety committee . Mean follow-up time was 1 year . All-cause mortality was lower in the metoprolol CR/XL group than in the placebo group ( 145 [ 7.2 % , per patient-year of follow-up ] ) vs 217 deaths [ 11.0 % ] , relative risk 0.66 [ 95 % CI 0.53 - 0.81 ] ; p=0.00009 or adjusted for interim analyses p=0.0062 ) . There were fewer sudden deaths in the metoprolol CR/XL group than in the placebo group ( 79 vs 132 , 0.59 [ 0.45 - 0.78 ] ; p=0.0002 ) and deaths from worsening heart failure ( 30 vs 58 , 0.51 [ 0.33 - 0.79 ] ; p=0.0023 ) . INTERPRETATION Metoprolol CR/XL once daily in addition to optimum st and ard therapy improved survival . The drug was well tolerated",
"BP is an important determinant of kidney disease among patients with diabetes . The recommended thresholds to initiate treatment to lower BP are 130/80 and 125/75 mmHg for people with diabetes and nephropathy , respectively . We sought to determine the effects of lowering BP below these currently recommended thresholds on renal outcomes among 11,140 patients who had type 2 diabetes and participated in the Action in Diabetes and Vascular disease : preterAx and diamicroN-MR Controlled Evaluation ( ADVANCE ) study . Patients were r and omly assigned to fixed combination perindopril-indapamide or placebo , regardless of their BP at entry . During a mean follow-up of 4.3 yr , active treatment reduced the risk for renal events by 21 % ( P developing microalbuminuria and macroalbuminuria ( both P baseline systolic or diastolic BP . Lower systolic BP levels during follow-up , even to rates of renal events . In conclusion , BP-lowering treatment with perindopril-indapamide administered routinely to individuals with type 2 diabetes provides important renoprotection , even among those with initial BP < 120/70 mmHg . We could not identify a BP threshold below which renal benefit is lost",
"Background The benefits of treating hypertension in elderly diabetic patients , in terms of achieving reductions in cardiovascular morbidity and mortality , have been documented in several recent prospect i ve trials . There has , however , been some controversy regarding the effect of different antihypertensive drugs on the frequency of myocardial infa rct ion in this group of patients . Design STOP Hypertension-2 was a prospect i ve , r and omized , open trial with blinded endpoint evaluation . Methods We studied 6614 elderly patients aged 70–84 years ; 719 of them had diabetes mellitus at the start of the study ( mean age 75.8 years ) . Patients were r and omly assigned to one of three treatment strategies : conventional antihypertensive drugs ( diuretics or β-blockers ) , calcium antagonists , or angiotensin converting enzyme ( ACE ) inhibitors . Results Reduction in blood pressure was similar in the three treatment groups of diabetics . The prevention of cardiovascular mortality was also similar ; the frequency of this primary endpoint did not differ significantly between the three groups . There were , however , significantly fewer ( P = 0.025 ) myocardial infa rct ions during ACE inhibitor treatment ( n = 17 ) than during calcium antagonist treatment ( n = 32 ; relative risk 0.51 , 95 % confidence interval 0.28–0.92 ) ; but a ( non-significant ) tendency to more strokes during ACE inhibitor treatment ( n = 34 compared with n = 29 ; relative risk 1.16 , 95 % confidence interval 0.71–1.91 ) . Conclusion Treatment of hypertensive diabetic patients with conventional antihypertensive drugs ( diuretics , β-blockers , or both ) seemed to be as effective as treatment with newer drugs such as calcium antagonists or ACE inhibitors",
"AIMS The aim of this study was to assess the effect of the angiotensin converting enzyme inhibitor perindopril on cardiovascular events in diabetic patients with coronary artery disease . METHODS AND RESULTS A total of 1502 diabetic patients with known coronary artery disease and without heart failure of 12 218 overall in the EUropean trial on Reduction Of cardiac events with Perindopril in stable coronary Artery ( EUROPA ) disease were r and omized in a double-blinded manner to perindopril 8 mg once daily or placebo . Follow-up was for a median of 4.3 years . The primary end point was cardiovascular death , non-fatal myocardial infa rct ion , and resuscitated cardiac arrest . Perindopril treatment was associated with a non-significant reduction in the primary endpoint in the diabetic population , 12.6 vs. 15.5 % , relative risk reduction 19 % [ ( 95 % CI , -7 to 38 % ) , P=0.13 ] . This was of similar relative magnitude to the 20 % risk reduction observed in the main EUROPA population . CONCLUSION Perindopril tends to reduce major cardiovascular events in diabetic patients with coronary disease in addition to other preventive treatments and the trend towards reduction was of a similar relative magnitude to that observed the general population with coronary artery disease",
"BACKGROUND Although several important studies have been performed in hypertensive type 2 diabetic patients , it is not known whether lowering blood pressure in normotensive ( BP offers any beneficial results on vascular complications . The current study evaluated the effect of intensive versus moderate diastolic blood pressure ( DBP ) control on diabetic vascular complications in 480 normotensive type 2 diabetic patients . METHODS The current study was a prospect i ve , r and omized controlled trial in normotensive type 2 diabetic subjects . The subjects were r and omized to intensive ( 10 mm Hg below the baseline DBP ) versus moderate ( 80 to 89 mm Hg ) DBP control . Patients in the moderate therapy group were given placebo , while the patients r and omized to intensive therapy received either nisoldipine or enalapril in a blinded manner as the initial antihypertensive medication . The primary end point evaluated was the change in creatinine clearance with the secondary endpoints consisting of change in urinary albumin excretion , progression of retinopathy and neuropathy and the incidence of cardiovascular disease . RESULTS The mean follow-up was 5.3 years . Mean BP in the intensive group was 128 + /- 0.8/75 + /- 0.3 mm Hg versus 137 + /- 0.7/81 + /- 0.3 mm Hg in the moderate group , P creatinine clearance ( P = 0.43 ) , a lower percentage of patients in the intensive group progressed from normoalbuminuria to microalbuminuria ( P = 0.012 ) and microalbuminuria to overt albuminuria ( P = 0.028 ) . The intensive BP control group also demonstrated less progression of diabetic retinopathy ( P = 0.019 ) and a lower incidence of strokes ( P = 0.03 ) . The results were the same whether enalapril or nisoldipine was used as the initial antihypertensive agent . CONCLUSION Over a five-year follow-up period , intensive ( approximately 128/75 mm Hg ) BP control in normotensive type 2 diabetic patients : ( 1 ) slowed the progression to incipient and overt diabetic nephropathy ; ( 2 ) decreased the progression of diabetic retinopathy ; and ( 3 ) diminished the incidence of stroke",
"BACKGROUND Patients with congestive heart failure have a high mortality rate and are also hospitalized frequently . We studied the effect of an angiotensin-converting-enzyme inhibitor , enalapril , on mortality and hospitalization in patients with chronic heart failure and ejection fractions less than or equal to 0.35 . METHODS Patients receiving conventional treatment for heart failure were r and omly assigned to receive either placebo ( n = 1284 ) or enalapril ( n = 1285 ) at doses of 2.5 to 20 mg per day in a double-bind trial . Approximately 90 percent of the patients were in New York Heart Association functional classes II and III . The follow-up averaged 41.4 months . RESULTS There were 510 deaths in the placebo group ( 39.7 percent ) , as compared with 452 in the enalapril group ( 35.2 percent ) ( reduction in risk , 16 percent ; 95 percent confidence interval , 5 to 26 percent ; P = 0.0036 ) . Although reductions in mortality were observed in several categories of cardiac deaths , the largest reduction occurred among the deaths attributed to progressive heart failure ( 251 in the placebo group vs. 209 in the enalapril group ; reduction in risk , 22 percent ; 95 percent confidence interval , 6 to 35 percent ) . There was little apparent effect of treatment on deaths classified as due to arrhythmia without pump failure . Fewer patients died or were hospitalized for worsening heart failure ( 736 in the placebo group and 613 in the enalapril group ; risk reduction , 26 percent ; 95 percent confidence interval , 18 to 34 percent ; P less than 0.0001 ) . CONCLUSIONS The addition of enalapril to conventional therapy significantly reduced mortality and hospitalizations for heart failure in patients with chronic congestive heart failure and reduced ejection fractions",
"Background Recent trials question previously accepted low blood pressure targets in type 2 diabetes to reduce complication risk . We explored this question in the DIabetic REtinopathy C and esartan Trials-Protect 2 clinical trial . Methods A total of 1905 normoalbuminuric participants with type 2 diabetes and mild-moderate retinopathy were r and omized to c and esartan or placebo . Participants were normotensive [ untreated , blood pressure ( BP ) The effects of c and esartan on microvascular and macrovascular endpoints alone and in combination were analysed , including subgroup analyses by baseline hypertension status . Results Mean age was 57 ± 8 years , 50 % were men , mean diabetes duration was 9 ± 5 years and baseline HbA1c was 8.2 ± 1.6 % . Mean r and omization BP was 123/75 mmHg in the normotensive , and 139/79 mmHg in the treated hypertensive subgroups . During the median 4.7-year follow-up , achieved systolic pressure on c and esartan was 128 mmHg in baseline normotensive individuals , and 136 mmHg in treated hypertensive patients . C and esartan reduced combined macrovascular and microvascular complication risk ; the age and baseline SBP overall adjusted hazard ratio for c and esartan vs. placebo was 0.85 [ 95 % confidence interval ( CI ) 0.72–0.99 ] , P = 0.040 , reflecting hazard ratios of 0.86 ( 0.66–1.13 ) for baseline normotensive individuals and 0.83 ( 0.68–1.02 ) for hypertensive patients . Hazard ratios were 0.87 ( 0.74–1.04 ) for microvascular and 0.84 ( 0.57–1.25 ) for macrovascular complications , when analysed separately . However , an interaction ( P = 0.06 ) between hypertensive [ hazard ratio 0.67 ( 0.42–1.07 ) ] and normotensive ( 1.45 , 0.71–2.94 ) subgroups was observed for macrovascular events . Conclusion C and esartan modestly reduces vascular complication risk in treated hypertensive diabetic individuals at low risk of cardiovascular disease . Separate analyses of microvascular and macrovascular events suggest that c and esartan may not reduce macrovascular events in normotensive persons with type 2 diabetes . Clinical trial registration : http:// clinical trials.gov/ct2/show/NCT00252694",
"BACKGROUND There is no evidence from r and omized trials to support a strategy of lowering systolic blood pressure below 135 to 140 mm Hg in persons with type 2 diabetes mellitus . We investigated whether therapy targeting normal systolic pressure ( i.e. , participants with type 2 diabetes at high risk for cardiovascular events . METHODS A total of 4733 participants with type 2 diabetes were r and omly assigned to intensive therapy , targeting a systolic pressure of less than 120 mm Hg , or st and ard therapy , targeting a systolic pressure of less than 140 mm Hg . The primary composite outcome was nonfatal myocardial infa rct ion , nonfatal stroke , or death from cardiovascular causes . The mean follow-up was 4.7 years . RESULTS After 1 year , the mean systolic blood pressure was 119.3 mm Hg in the intensive-therapy group and 133.5 mm Hg in the st and ard-therapy group . The annual rate of the primary outcome was 1.87 % in the intensive-therapy group and 2.09 % in the st and ard-therapy group ( hazard ratio with intensive therapy , 0.88 ; 95 % confidence interval [ CI ] , 0.73 to 1.06 ; P=0.20 ) . The annual rates of death from any cause were 1.28 % and 1.19 % in the two groups , respectively ( hazard ratio , 1.07 ; 95 % CI , 0.85 to 1.35 ; P=0.55 ) . The annual rates of stroke , a prespecified secondary outcome , were 0.32 % and 0.53 % in the two groups , respectively ( hazard ratio , 0.59 ; 95 % CI , 0.39 to 0.89 ; P=0.01 ) . Serious adverse events attributed to antihypertensive treatment occurred in 77 of the 2362 participants in the intensive-therapy group ( 3.3 % ) and 30 of the 2371 participants in the st and ard-therapy group ( 1.3 % ) ( P patients with type 2 diabetes at high risk for cardiovascular events , targeting a systolic blood pressure of less than 120 mm Hg , as compared with less than 140 mm Hg , did not reduce the rate of a composite outcome of fatal and nonfatal major cardiovascular events . ( Clinical Trials.gov number , NCT00000620 .",
"The Study on COgnition and Prognosis in the Elderly ( SCOPE ) assessed the effect of c and esartan on cardiovascular outcomes in elderly patients with mild to moderate hypertension . Patients were r and omized to c and esartan 8–16 mg daily ( n = 2477 ) or placebo ( n = 2460 ) . Due to extensive add‐on therapy , blood pressure reduction was only about 3/2 mmHg greater in the c and esartan group than in the control group . Nevertheless , non‐fatal stroke was reduced by 28 % ( p = 0.04 ) in the c and esartan group compared to the control group , and there was a non‐significant 11 % reduction in major cardiovascular events ( p = 0.19 ) . This report provides results in pre‐specified subgroups of patients ( age , gender , diabetes , history of stroke , smoking and cardiovascular risk at r and omization ) . Reductions in major cardiovascular events and stroke with c and esartan‐based therapy were indicated in all subgroups . A significant interaction between treatment and subgroups was found for one pair of subgroups only ; the reduction in major cardiovascular events with c and esartan was greater in patients with a previous stroke ( 64 % reduction , p = 0.004 ) than in those without ( 5 % reduction , p>0.20 ) . In conclusion , this analysis indicates consistent favourable effects of c and esartan‐based therapy on major cardiovascular events and stroke across the different subgroups of patients . However , the benefit was particularly pronounced in patients who entered the study with a previous stroke",
"BACKGROUND Left ventricular dilatation and dysfunction after myocardial infa rct ion are major predictors of death . In experimental and clinical studies , longterm therapy with the angiotensin-converting -- enzyme inhibitor captopril attenuated ventricular dilatation and remodeling . We investigated whether captopril could reduce morbidity and mortality in patients with left ventricular dysfunction after a myocardial infa rct ion . METHODS Within 3 to 16 days after myocardial infa rct ion , 2231 patients with ejection fractions of 40 percent or less but without overt heart failure or symptoms of myocardial ischemia were r and omly assigned to receive doubleblind treatment with either placebo ( 1116 patients ) or captopril ( 1115 patients ) and were followed for an average of 42 months . RESULTS Mortality from all causes was significantly reduced in the captopril group ( 228 deaths , or 20 percent ) as compared with the placebo group ( 275 deaths , or 25 percent ) ; the reduction in risk was 19 percent ( 95 percent confidence interval , 3 to 32 percent ; P = 0.019 ) . In addition , the incidence of both fatal and nonfatal major cardiovascular events was consistently reduced in the captopril group . The reduction in risk was 21 percent ( 95 percent confidence interval , 5 to 35 percent ; P = 0.014 ) for death from cardiovascular causes , 37 percent ( 95 percent confidence interval , 20 to 50 percent ; P less than 0.001 ) for the development of severe heart failure , 22 percent ( 95 percent confidence interval , 4 to 37 percent ; P = 0.019 ) for congestive heart failure requiring hospitalization , and 25 percent ( 95 percent confidence interval , 5 to 40 percent ; P = 0.015 ) for recurrent myocardial infa rct ion . CONCLUSIONS In patients with asymptomatic left ventricular dysfunction after myocardial infa rct ion , long-term administration of captopril was associated with an improvement in survival and reduced morbidity and mortality due to major cardiovascular events . These benefits were observed in patients who received thrombolytic therapy , aspirin , or beta-blockers , as well as those who did not , suggesting that treatment with captopril leads to additional improvement in outcome among selected survivors of myocardial infa rct ion",
"BACKGROUND The objective of the current study was to examine the efficacy and tolerability of the beta-blocker metoprolol succinate controlled release/extended release ( CR/XL ) in patients with diabetes in the Metoprolol CR/XL R and omized Intervention Trial in Chronic Heart Failure ( MERIT-HF ) . METHODS The Cox proportional hazards model was used to calculate hazard ratios ( HR ) for convenience expressed as relative risks ( risk reduction = 1-HR ) , and 95 % confidence intervals ( CI ) . RESULTS The risk of hospitalization for heart failure was 76 % higher in diabetics compared to non-diabetics ( 95 % CI 38 % to 123 % ) . Metoprolol CR/XL was well tolerated and reduced the risk of hospitalization for heart failure by 37 % in the diabetic group ( 95 % CI 53 % to 15 % ) , and by 35 % in the non-diabetic group ( 95 % CI 48 % to 19 % ) . Pooling of mortality data from the Cardiac Insufficiency Bisoprolol Study II ( CIBIS II ) , MERIT-HF , and the Carvedilol Prospect i ve R and omized Cumulative Survival Study ( COPERNICUS ) showed similar survival benefits in patients with diabetes ( 25 % ; 95 % CI 40 % to 4 % ) and without diabetes ( 36 % ; 95 % CI 44 % to 27 % ) ; test of diabetes by treatment interaction was non-significant . Adverse events were reported more often on placebo than on metoprolol CR/XL . CONCLUSIONS Patients with heart failure and diabetes have a much higher risk of hospitalization than patients without diabetes . Regardless of diabetic status , a highly significant reduction in hospitalizations for heart failure was observed with metoprolol CR/XL therapy , which was very well tolerated also by patients with diabetes . Furthermore , the pooled data showed a statistically significant survival benefit in patients with diabetes",
"BACKGROUND Combination therapy with angiotensin-converting-enzyme ( ACE ) inhibitors and angiotensin-receptor blockers ( ARBs ) decreases proteinuria ; however , its safety and effect on the progression of kidney disease are uncertain . Methods We provided losartan ( at a dose of 100 mg per day ) to patients with type 2 diabetes , a urinary albumin-to-creatinine ratio ( with albumin measured in milligrams and creatinine measured in grams ) of at least 300 , and an estimated glomerular filtration rate ( GFR ) of 30.0 to 89.9 ml per minute per 1.73 m(2 ) of body-surface area and then r and omly assigned them to receive lisinopril ( at a dose of 10 to 40 mg per day ) or placebo . The primary end point was the first occurrence of a change in the estimated GFR ( a decline of ≥ 30 ml per minute per 1.73 m(2 ) if the initial estimated GFR was ≥ 60 ml per minute per 1.73 m(2 ) or a decline of ≥ 50 % if the initial estimated GFR was end-stage renal disease ( ESRD ) , or death . The secondary renal end point was the first occurrence of a decline in the estimated GFR or ESRD . Safety outcomes included mortality , hyperkalemia , and acute kidney injury . Results The study was stopped early owing to safety concerns . Among 1448 r and omly assigned patients with a median follow-up of 2.2 years , there were 152 primary end-point events in the monotherapy group and 132 in the combination-therapy group ( hazard ratio with combination therapy , 0.88 ; 95 % confidence interval [ CI ] , 0.70 to 1.12 ; P=0.30 ) . A trend toward a benefit from combination therapy with respect to the secondary end point ( hazard ratio , 0.78 ; 95 % CI , 0.58 to 1.05 ; P=0.10 ) decreased with time ( P=0.02 for nonproportionality ) . There was no benefit with respect to mortality ( hazard ratio for death , 1.04 ; 95 % CI , 0.73 to 1.49 ; P=0.75 ) or cardiovascular events . Combination therapy increased the risk of hyperkalemia ( 6.3 events per 100 person-years , vs. 2.6 events per 100 person-years with monotherapy ; P ) and acute kidney injury ( 12.2 vs. 6.7 events per 100 person-years , P ACE inhibitor and an ARB was associated with an increased risk of adverse events among patients with diabetic nephropathy . ( Funded by the Cooperative Studies Program of the Department of Veterans Affairs Office of Research and Development ; VA NEPHRON-D Clinical Trials.gov number , NCT00555217 . )"
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OBJECTIVE The objective was to develop a clinical practice guideline on the management of neck pain-associated disorders ( NADs ) and whiplash-associated disorders ( WADs ) . This guideline replaces 2 prior chiropractic guidelines on NADs and WADs . METHODS Pertinent systematic review s on 6 topic areas ( education , multimodal care , exercise , work disability , manual therapy , passive modalities ) were assessed using A Measurement Tool to Assess Systematic Review s ( AMSTAR ) and data extracted from admissible r and omized controlled trials . We incorporated risk of bias scores in the Grading of Recommendations Assessment , Development , and Evaluation . Evidence profiles were used to summarize judgments of the evidence quality , detail relative and absolute effects , and link recommendations to the supporting evidence . The guideline panel considered the balance of desirable and undesirable consequences . Consensus was achieved using a modified Delphi . The guideline was peer review ed by a 10-member multidisciplinary ( medical and chiropractic ) external committee . RESULTS For recent-onset ( 0 - 3 months ) neck pain , we suggest offering multimodal care ; manipulation or mobilization ; range-of-motion home exercise , or multimodal manual therapy ( for grade s I-II NAD ) ; supervised grade d strengthening exercise ( grade III NAD ) ; and multimodal care ( grade III WAD ) . For persistent ( > 3 months ) neck pain , we suggest offering multimodal care or stress self-management ; manipulation with soft tissue therapy ; high-dose massage ; supervised group exercise ; supervised yoga ; supervised strengthening exercises or home exercises ( grade s I-II NAD ) ; multimodal care or practitioner 's advice ( grade s I-III NAD ) ; and supervised exercise with advice or advice alone ( grade s I-II WAD ) . For workers with persistent neck and shoulder pain , evidence supports mixed supervised and unsupervised high-intensity strength training or advice alone ( grade s I-III NAD ) . CONCLUSIONS A multimodal approach including manual therapy , self-management advice , and exercise is an effective treatment strategy for both recent-onset and persistent neck pain
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"Abstract Whiplash‐associated disorders are common and incur considerable expense in social and economic terms . There are no known effective treatments for those people whose pain and disability persist beyond 3 months . We conducted a r and omized , assessor‐blinded , controlled trial at two centres in Australia . All participants received 3 advice sessions . In addition the experimental group participated in 12 exercise sessions over 6 weeks . Primary outcomes were pain intensity , pain bothersomeness and function measured at 6 weeks and 12 months . Exercise and advice was more effective than advice alone at 6 weeks for all primary outcomes but not at 12 months . The effect of exercise on the 0–10 pain intensity scale was −1.1 ( 95%CI −1.8 to −0.3 , p = 0.005 ) at 6 weeks and −0.2 ( 0.6 to −1.0 , p = 0.59 ) at 12 months ; on the bothersomeness scale the effect was −1.0 ( −1.9 to −0.2 , p = 0.003 ) at 6 weeks and 0.3 ( −0.6 to 1.3 , p = 0.48 ) at 12 months . The effect on function was 0.9 ( 0.3 to 1.6 , p = 0.006 ) at 6 weeks and 0.6 ( −0.1 to 1.4 , p = 0.10 ) at 12 months . High levels of baseline pain intensity were associated with greater treatment effects at 6 weeks and high levels of baseline disability were associated with greater treatment effects at 12 months . In the short‐term exercise and advice is slightly more effective than advice alone for people with persisting pain and disability following whiplash . Exercise is more effective for subjects with higher baseline pain and disability",
"STUDY DESIGN R and omized clinical trial . OBJECTIVES To examine the effectiveness of cervical traction in addition to exercise for specific subgroups of patients with neck pain . BACKGROUND Cervical traction is frequently used , but its effectiveness has not been adequately examined . Existing studies have failed to target patients most likely to respond . Traction is typically recommended for patients with cervical radiculopathy . A prediction rule has been described to identify a narrower subgroup of patients likely to respond to cervical traction . METHODS Patients with neck pain and signs of radiculopathy were r and omized to 4 weeks of treatment with exercise , exercise with mechanical traction , or exercise with over-door traction . Baseline assessment included subgrouping-rule status . The primary outcome measure ( Neck Disability Index , scored 0 - 100 ) and secondary outcome measure ( neck and arm pain intensity ) were assessed at 4 weeks , 6 months , and 12 months after enrollment . The primary analyses examined 2-way treatment-by-time interactions . Secondary analyses examined validity of the subgrouping rule by adding 3-way interactions . RESULTS Eighty-six patients ( 53.5 % female ; mean age , 46.9 years ) were enrolled in the study . Intention-to-treat analysis found lower Neck Disability Index scores at 6 months in the mechanical traction group compared to the exercise group ( mean difference between groups , 13.3 ; 95 % confidence interval : 5.6 , 21.0 ) and over-door traction group ( mean difference between groups , 8.1 ; 95 % confidence interval : 0.8 , 15.3 ) , and at 12 months in the mechanical traction group compared to the exercise group ( mean difference between groups , 9.8 ; 95 % confidence interval : 0.2 , 19.4 ) . Secondary outcomes favored mechanical traction at several time points . The validity of the subgrouping rule was supported on the Neck Disability Index at the 6-month time point only . CONCLUSION Adding mechanical traction to exercise for patients with cervical radiculopathy result ed in lower disability and pain , particularly at long-term follow-ups . The study protocol was registered at http:// clinical trials.gov ( NCT00979108 )",
"To evaluate the effectiveness of isometric exercises as compared to general exercises in chronic non-specific neck pain . For this r and omised controlled trial total 68 patients ( 34 each group ) with chronic non-specific neck pain were recruited from Alain Poly Clinic and Institute of Physical Medicine & Rehabilitation Dow University of Health Sciences , Karachi between May , 2012 and August , 2012 . Simple r and omisation method was used to assign participants into isometric exercise group and general exercise groups . The isometric exercise group performed exercises for neck muscle groups with a rubber b and and general exercises group performed active range of movement exercises for all neck movements . Patients in both groups received 3 supervised treatment sessions per week for 12 weeks . Visual Analogue Scale ( VAS ) , North wick Park Neck Pain Question naire and goniometer were used to assess pain , disability and neck range of movements at baseline and after 12 weeks . Both interventions showed statistically significant improvements in pain , function and range of movement p = 0.001f or isometric exercise group , p = 0.04 for general exercises group and p = 0.001 for range of movement . However , mean improvements in post intervention VAS score and North wick Park Neck Pain Question naire score was better in isometric exercises group as compared to general exercise group . In conclusion , both interventions are effective in the treatment of chronic non-specific neck pain however ; isometric exercises are clinical ly more effective than general exercises ",
"STUDY DESIGN Systematic review and best evidence synthesis . OBJECTIVES To describe the prevalence and incidence of neck pain and disability in workers ; to identify risk factors for neck pain in workers ; to propose an etiological diagram ; and to make recommendations for future research . SUMMARY OF BACKGROUND DATA Previous review s of the etiology of neck pain in workers relied on cross-sectional evidence . Recently published cohorts and r and omized trials warrant a re- analysis of this body of research . METHODS We systematic ally search ed Medline for literature published from 1980 - 2006 . Retrieved articles were review ed for relevance . Relevant articles were critically appraised . Articles judged to have adequate internal validity were included in our best evidence synthesis . RESULTS One hundred and nine papers on the burden and determinants of neck pain in workers were scientifically admissible . The annual prevalence of neck pain varied from 27.1 % in Norway to 47.8 % in Québec , Canada . Each year , between 11 % and 14.1 % of workers were limited in their activities because of neck pain . Risk factors associated with neck pain in workers include age , previous musculoskeletal pain , high quantitative job dem and s , low social support at work , job insecurity , low physical capacity , poor computer workstation design and work posture , sedentary work position , repetitive work and precision work . We found preliminary evidence that gender , occupation , headaches , emotional problems , smoking , poor job satisfaction , awkward work postures , poor physical work environment , and workers ' ethnicity may be associated with neck pain . There is evidence that interventions aim ed at modifying workstations and worker posture are not effective in reducing the incidence of neck pain in workers . CONCLUSION Neck disorders are a significant source of pain and activity limitations in workers . Most neck pain results from complex relationships between individual and workplace risk factors . No prevention strategies have been shown to reduce the incidence of neck pain in workers",
"In practice the secondary prevention of work-related upper extremity ( WRUE ) symptoms generally targets biomechanical risk factors . Psychosocial risk factors have also been shown to play an important role in the development of WRUE symptom severity and future disability . The addition of a stress management component to biomechanically focused interventions may result in greater improvements in WRUE symptoms and functional limitations than intervening in the biomechanical risk factors alone . Seventy office workers with WRUE symptoms were r and omly assigned to an ergonomics intervention group ( assessment and modification of work station and stretching exercises ) or a combined ergonomic and job stress intervention group ( ergonomic intervention plus two 1-h workshops on the identification and management of workplace stress ) . Baseline , 3- and 12-month follow-up measures of observed ergonomic risks and self-reported ergonomic risks , job stress , pain , symptoms , functional limitation , and general physical and mental health were obtained from all participants . While both groups experienced significant decreases in pain , symptoms , and functional limitation from baseline to three months with improvements continuing to 12 months post baseline , no significant differences between groups were observed for any outcome measures . Findings indicate that the additional two-session job stress management component did not significantly enhance the short- or long-term improvements brought about by the ergonomic intervention alone",
"Background : To date , optimal strategies for the management of patients with cervical radiculopathy remain elusive . Preliminary evidence suggests that a multimodal treatment program consisting of manual therapy , exercise , and cervical traction may result in positive outcomes for patients with cervical radiculopathy . However , limited evidence exists to support the use of mechanical cervical traction in patients with cervical radiculopathy . Objective : The purpose of this study was to examine the effects of manual therapy and exercise , with or without the addition of cervical traction , on pain , function , and disability in patients with cervical radiculopathy . Design : This study was a multicenter r and omized clinical trial . Setting : The study was conducted in orthopedic physical therapy clinics . Patients : Patients diagnosed with cervical radiculopathy ( N=81 ) were r and omly assigned to 1 of 2 groups : a group that received manual therapy , exercise , and intermittent cervical traction ( MT EXTraction group ) and a group that received manual therapy , exercise , and sham intermittent cervical traction ( MTEX group ) . Intervention : Patients were treated , on average , 2 times per week for an average of 4.2 weeks . Measurements : Outcome measurements were collected at baseline and at 2 weeks and 4 weeks using the Numeric Pain Rating Scale ( NPRS ) , the Patient-Specific Functional Scale ( PSFS ) , and the Neck Disability Index ( NDI ) . Results : There were no significant differences between the groups for any of the primary or secondary outcome measures at 2 weeks or 4 weeks . The effect size between groups for each of the primary outcomes was small ( NDI=1.5 , 95 % confidence interval [CI]=−6.8 to 3.8 ; PSFS=0.29 , 95 % CI=−1.8 to 1.2 ; and NPRS=0.52 , 95 % CI=−1.8 to 1.2 ) . Limitations : The use of a nonvali date d clinical prediction rule to diagnose cervical radiculopathy and the lack of a control group without treatment were limitations of this study . Conclusions : The results suggest that the addition of mechanical cervical traction to a multimodal treatment program of manual therapy and exercise yields no significant additional benefit to pain , function , or disability in patients with cervical radiculopathy",
"Objectives The authors ' goals were to compare the effectiveness of manual therapy ( MT ; mainly spinal mobilization ) , physical therapy ( PT ; mainly exercise therapy ) , and continued care by the general practitioner ( GP ; analgesics , counseling and education ) over a period of 1 year . Methods One hundred eighty-three patients suffering for at least 2 weeks from nonspecific neck pain were r and omized to receive a 6-week treatment strategy of MT once a week , PT twice a week , or GP care once every 2 weeks . The primary outcome measures were perceived recovery , severity of physical dysfunctioning , pain intensity , and functional disability . Results The differences between groups considered over 1 year were statistically significant ( repeated measurements analyses P Neck Disability Index ( P=0.06 ) . Higher improvement scores were observed for MT for all outcomes , followed by PT and GP care . The success rate , based on perceived recovery after 13 weeks , was 72 % for MT , which was significantly higher than the success rate for continued GP care ( 42 % , P=0.001 ) but not significantly higher compared with PT treatment ( 59 % , P=0.16 ) . The difference between PT and GP approached statistical significance ( P=0.06 ) . After 1 year the success rates were 75 % , 63 % , and 56 % , respectively , and no longer significantly different . Conclusions Short-term results ( at 7 weeks ) have shown that MT speeded recovery compared with GP care and , to a lesser extent , also compared with PT . In the long-term , GP treatment and PT caught up with MT , and differences between the three treatment groups decreased and lost statistical significance at the 13-week and 52-week follow-up",
"Objective : To compare the effectiveness of a 12-month home-based combined strength training and stretching programme against stretching alone in the treatment of chronic neck pain . Design : A r and omized follow-up study . Participants : One hundred and one patients with chronic non-specific neck pain were r and omized in two groups . Intervention : The strength training and stretching group was supported by 10 group training sessions and the stretching group was instructed to perform stretching exercises only as instructed in one group session . Main outcome measurements : Neck pain , disability , neck muscle strength and mobility of cervical spine were measured before and after the intervention . Results : No significant differences in improvement in neck pain and disability were found between the two training groups . Mean ( SD ) pain decreased from 64 ( 17 ) mm by 37 ( 95 % confidence interval ( CI ) 44 to 30 ) mm in the strength training and stretching group , and from 60 ( 17 ) mm by 32 ( 39 to 25 ) mm in the stretching group . The improvements in disability were significant in both groups ( P changes in neck strength and mobility were minor . Training adherence decreased over time from the targeted three sessions a week , ending up at 1.1 ( 0.7 ) times a week for strength training and stretching group and 1.4 ( 0.8 ) times a week for stretching group . Conclusions : No statistically significant differences in neck pain and disability were observed between the two home-based training regimens . Combined strength training and stretching or stretching only were probably as effective in achieving a long-term improvement although the training adherence was rather low most of the time",
"Chronic neck pain is a major public health problem with very few evidence -based complementary treatment options . This study aim ed to test the efficacy of 12 weeks of a partner-delivered home-based cupping massage , compared to the same period of progressive muscle relaxation in patients with chronic non-specific neck pain . Patients were r and omly assigned to self-directed cupping massage or progressive muscle relaxation . They were trained and asked to undertake the assigned treatment twice weekly for 12 weeks . Primary outcome measure was the current neck pain intensity ( 0–100 mm visual analog scale ; VAS ) after 12 weeks . Secondary outcome measures included pain on motion , affective pain perception , functional disability , psychological distress , wellbeing , health-related quality of life , pressure pain thresholds and adverse events . Sixty one patients ( 54.1±12.7 years ; 73.8%female ) were r and omized to cupping massage ( n = 30 ) or progressive muscle relaxation ( n = 31 ) . After treatment , both groups showed significantly less pain compared to baseline however without significant group differences . Significant effects in favor of cupping massage were only found for wellbeing and pressure pain thresholds . In conclusion , cupping massage is no more effective than progressive muscle relaxation in reducing chronic non-specific neck pain . Both therapies can be easily used at home and can reduce pain to a minimal clinical ly relevant extent . Cupping massage may however be better than PMR in improving well-being and decreasing pressure pain sensitivity but more studies with larger sample s and longer follow-up periods are needed to confirm these results . Trial Registration Clinical Trials.gov",
"BACKGROUND Recent studies have shown that a transcutaneous electrical nerve stimulation ( TENS ) and interferential current ( IFC ) application reduces pain in subjects with musculoskeletal disorders . However there are no clinical trials evaluating or comparing the muscle relaxation generated for these devices . PURPOSE To compare the muscle relaxation of the upper trapezius induced by the application of TENS and IFC in females with chronic nonspecific neck discomfort . METHODS Sixty-four females between 18 and 40 years of age and a history of nonspecific neck discomfort were r and omly assigned to a TENS or an IFC group . The women in the TENS ( N = 32 ; mean age 22 years ) and IFC ( N = 32 , mean age 23 years ) group were su bmi tted to current application during 3 consecutive days and were assessed by electromyography ( EMG ) in different times aim ing to quantify the muscular tension of the upper trapezius . A visual analogue scale ( VAS ) was used as pain measure at baseline ( before TENS or IFC application ) and at the end of the study . RESULTS At baseline , demographic , pain , and EMG assessment data were similar between groups . Those in the IFC group had a significant trapezius relaxation after 3 IFC applications when compared to baseline and intermediate evaluations ( P TENS group ( P > 0.05 ) . In relation to pain relief , both groups showed an improvement at the end of the study when compared to baseline ( both , P IFC as TENS application ( P IFC induced the upper trapezius relaxation after 3 sessions in females with neck discomfort , but the TENS application did not change the muscular tension . However , these results should be carefully interpreted due to the lack of differences between groups . A significant pain decrease was found in the subjects of both groups , however , only the IFC application presented a clinical ly important improvement",
"Objective : To investigate whether an exercise intervention shown to increase aerobic capacity , would also lead to less musculoskeletal pain ; improved work ability , productivity , and perceived physical exertion ; and less sick leave . Methods : Sixty-seven construction workers were r and omized into an exercise group training 3 × 20 minutes per week and a control group . Question naires and text messages were completed before and after the 12-week intervention . Results : No significant changes were found in musculoskeletal pain , work ability , productivity , perceived physical exertion , and sick leave with the intervention . Question naires and text messages provided similar results of pain and work ability . Conclusions : Although the intervention improved aerobic capacity , it was not successful in improving musculoskeletal pain and other work-related factors . A detectable improvement presumably requires a more multifaceted intervention , larger sample size , or longer follow-up . Text messages may be a convenient data - collection method in future studies",
"BACKGROUND Evidence suggests that brief physiotherapy programmes are as effective for acute whiplash-associated disorders as more comprehensive programmes ; however , whether this also holds true for chronic whiplash-associated disorders is unknown . We aim ed to estimate the effectiveness of a comprehensive exercise programme delivered by physiotherapists compared with advice in people with a chronic whiplash-associated disorder . METHODS PROMISE is a two group , pragmatic r and omised controlled trial in patients with chronic ( > 3 months and to receive either the comprehensive exercise programme ( 20 sessions ) or advice ( one session and telephone support ) . Sealed opaque envelopes were used to conceal allocation . The primary outcome was pain intensity measured on a 0 - 10 scale . Outcomes were measured at baseline , 14 weeks , 6 months , and 12 months by a masked assessor . Analysis was by intention to treat , and treatment effects were calculated with linear mixed models . The trial is registered with the Australian New Zeal and Clinical Trials Registry , number ACTRN12609000825257 . FINDINGS 172 participants were allocated to either the comprehensive exercise programme ( n=86 ) or advice group ( n=86 ) ; 157 ( 91 % ) were followed up at 14 weeks , 145 ( 84 % ) at 6 months , and 150 ( 87 % ) at 12 months . A comprehensive exercise programme was not more effective than advice alone for pain reduction in the participants . At 14 weeks the treatment effect on a 0 - 10 pain scale was 0·0 ( 95 % CI -0·7 to 0·7 ) , at 6 months 0·2 ( -0·5 to 1·0 ) , and at 12 months -0·1 ( -0·8 to 0·6 ) . CNS hyperexcitability and symptoms of post-traumatic stress did not modify the effect of treatment . We recorded no serious adverse events . INTERPRETATION We have shown that simple advice is equally as effective as a more intense and comprehensive physiotherapy exercise programme . The need to identify effective and affordable strategies to prevent and treat acute through to chronic whiplash associated disorders is an important health priority . Future avenues of research might include improving underst and ing of the mechanisms responsible for persistent pain and disability , investigating the effectiveness and timing of drugs , and study of content and delivery of education and advice . FUNDING The National Health and Medical Research Council of Australia , Motor Accidents Authority of New South Wales , and Motor Accident Insurance Commission of Queensl and",
"BACKGROUND CONTEXT Evidence -based clinical practice guidelines ( CPGs ) for the management of patients with acute mechanical low back pain ( AM-LBP ) have been defined on an international scale . Multicenter clinical trials have demonstrated that most AM-LBP patients do not receive CPG-based treatments . To date , the value of implementing full and exclusively CPG-based treatment remains unclear . PURPOSE To determine if full CPGs-based study care ( SC ) results in greater improvement in functional outcomes than family physician-directed usual care ( UC ) in the treatment of AM-LBP . STUDY DESIGN / SETTING A two-arm , parallel design , prospect i ve , r and omized controlled clinical trial using blinded outcome assessment . Treatment was administered in a hospital-based spine program outpatient clinic . PATIENT SAMPLE Inclusion criteria included patients aged 19 to 59 years with Quebec Task Force Categories 1 and 2 AM-LBP of 2 to 4 weeks ' duration . Exclusion criteria included \" red flag \" conditions and comorbidities contraindicating chiropractic spinal manipulative therapy ( CSMT ) . OUTCOME MEASURES PRIMARY OUTCOME improvement from baseline in Rol and -Morris Disability Question naire ( RDQ ) scores at 16 weeks . SECONDARY OUTCOMES improvements in RDQ scores at 8 and 24 weeks ; and in Short Form-36 ( SF-36 ) bodily pain ( BP ) and physical functioning ( PF ) scale scores at 8 , 16 , and 24 weeks . METHODS Patients were assessed by a spine physician , then r and omized to SC ( reassurance and avoidance of passive treatments , acetaminophen , 4 weeks of lumbar CSMT , and return to work within 8 weeks ) , or family physician-directed UC , the components of which were recorded . RESULTS Ninety-two patients were recruited , with 36 SC and 35 UC patients completing all follow-up visits . Baseline prognostic variables were evenly distributed between groups . The primary outcome , the unadjusted mean improvement in RDQ scores , was significantly greater in the SC group than in the UC group ( p=.003 ) . Regarding unadjusted mean changes in secondary outcomes , improvements in RDQ scores were also greater in the SC group at other time points , particularly at 24 weeks ( p=.004 ) . Similarly , improvements in SF-36 PF scores favored the SC group at all time points ; however , these differences were not statistically significant . Improvements in SF-36 BP scores were similar between groups . In repeated- measures analyses , global adjusted mean improvement was significantly greater in the SC group in terms of RDQ ( p=.0002 ) , nearly significantly greater in terms of SF-36 PF ( p=.08 ) , but similar between groups in terms of SF-36 BP ( p=.27 ) . CONCLUSIONS This is the first reported r and omized controlled trial comparing full CPG-based treatment , including spinal manipulative therapy administered by chiropractors , to family physician-directed UC in the treatment of patients with AM-LBP . Compared to family physician-directed UC , full CPG-based treatment including CSMT is associated with significantly greater improvement in condition-specific functioning",
"Objective : To compare the effects of an isolated application of cervical spine thrust joint manipulation vs. the application of cervical , cervico-thoracic junction and thoracic manipulation on neck pain , disability and cervical range of motion in chronic neck pain . Design : R and omized clinical trial . Setting : Clinical practice . Participants : Eighty-two patients ( 41 females ) with chronic mechanical neck pain . Interventions : Patients were r and omly assigned to a cervical spine manipulation group or a full manipulative group who received mid-cervical , cervico-thoracic and thoracic joint manipulations . Measurements : Neck pain intensity ( 11-point numeric pain rating scale ) , self-reported disability ( Neck Disability Index ) and cervical range of motion were collected at baseline and one week after the intervention by an assessor blinded to the allocation of the patients . Results : A significant Group * Time interaction for Neck Disability Index ( P = 0.022 ) , but not for neck pain ( P = 0.612 ) , was found : patients in the full manipulative group exhibited greater reduction in disability than those who received the cervical spine manipulation alone , whereas both groups experienced similar decreases in neck pain . Patients in both groups experienced similar increases in cervical range of motion ( P > 0.4 ) . No effect of gender was observed ( P > 0.299 ) . Conclusions : In patients with chronic mechanical neck pain , manipulation of the cervical and thoracic spine leads to a greater reduction in disability at one week than after manipulation of the cervical spine alone , whereas changes in pain and range of motion are not affected differently",
"OBJECTIVE The objective of the study was to investigate clinical effects of low-level laser therapy ( LLLT ) in patients with acute neck pain with radiculopathy . DESIGN Double-blind , r and omized , placebo-controlled study . SETTING The study was carried out between January 2005 and September 2007 at the Clinic for Rehabilitation at the Medical School , University of Bel grade , Serbia . PATIENTS AND INTERVENTION Sixty subjects received a course of 15 treatments over 3 weeks with active or an inactivated laser as a placebo procedure . LLLT was applied to the skin projection at the anatomical site of the spinal segment involved with the following parameters : wavelength 905 nm , frequency 5,000 Hz , power density of 12 mW/cm(2 ) , and dose of 2 J/cm(2 ) , treatment time 120 seconds , at whole doses 12 J/cm(2 ) . OUTCOME MEASURES The primary outcome measure was pain intensity as measured by a visual analog scale . Secondary outcome measures were neck movement , neck disability index , and quality of life . Measurements were taken before treatment and at the end of the 3-week treatment period . RESULTS Statistically significant differences between groups were found for intensity of arm pain ( P = 0.003 , with high effect size d = 0.92 ) and for neck extension ( P = 0.003 with high effect size d = 0.94 ) . CONCLUSION LLLT gave more effective short-term relief of arm pain and increased range of neck extension in patients with acute neck pain with radiculopathy in comparison to the placebo procedure",
"& NA ; Dysfunction in the motor system is a feature of persistent whiplash associated disorders . Little is known about motor dysfunction in the early stages following injury and of its progress in those persons who recover and those who develop persistent symptoms . This study measured prospect ively , motor system function ( cervical range of movement ( ROM ) , joint position error ( JPE ) and activity of the superficial neck flexors ( EMG ) during a test of cranio‐cervical flexion ) as well as a measure of fear of re‐injury ( TAMPA ) in 66 whiplash subjects within 1 month of injury and then 2 and 3 months post injury . Subjects were classified at 3 months post injury using scores on the neck disability index : recovered ( 30 ) . Motor system function was also measured in 20 control subjects . All whiplash groups demonstrated decreased ROM and increased EMG ( compared to controls ) at 1 month post injury . This deficit persisted in the group with moderate/severe symptoms but returned to within normal limits in those who had recovered or reported persistent mild pain at 3 months . Increased EMG persisted for 3 months in all whiplash groups . Only the moderate/severe group showed greater JPE , within 1 month of injury , which remained unchanged at 3 months . TAMPA scores of the moderate/severe group were higher than those of the other two groups . The differences in TAMPA did not impact on ROM , EMG or JPE . This study identifies , for the first time , deficits in the motor system , as early as 1 month post whiplash injury , that persisted not only in those reporting moderate/severe symptoms at 3 months but also in subjects who recovered and those with persistent mild symptoms",
"STUDY DESIGN R and omized clinical trial . OBJECTIVE To investigate the short-term effects of thoracic spine thrust manipulation combined with cervical spine nonthrust manipulation ( experimental group ) versus cervical spine nonthrust manipulation alone ( comparison group ) in individuals with mechanical neck pain . BACKGROUND Research has demonstrated improved outcomes with both nonthrust manipulation directed at the cervical spine and thrust manipulation directed at the thoracic spine in patients with neck pain . Previous studies have not determined if thoracic spine thrust manipulation may increase benefits beyond those provided by cervical nonthrust manipulation alone . METHODS Sixty-four participants with mechanical neck pain were r and omized into 1 of 2 groups , an experimental or comparison group . Both groups received 2 treatment sessions of cervical spine nonthrust manipulation and a home exercise program consisting of active range-of-motion exercises , and the experimental group received additional thoracic spine thrust manipulations . Outcome measures were collected at baseline and at a 1-week follow-up , and included the numeric pain rating scale , the Neck Disability Index , and the global rating of change . RESULTS Participants in the experimental group demonstrated significantly greater improvements ( P numeric pain rating scale and Neck Disability Index at the 1-week follow-up compared to those in the comparison group . In addition , 31 of 33 ( 94 % ) participants in the experimental group , compared to 11 of 31 participants ( 35 % ) in the comparison group , indicated a global rating of change score of + 4 or higher at the 1-week follow-up , with an associated number needed to treat of 2 . CONCLUSION Individuals with neck pain who received a combination of thoracic spine thrust manipulation and cervical spine nonthrust manipulation plus exercise demonstrated better overall short-term outcomes on the numeric pain rating scale , the Neck Disability Index , and the global rating of change",
"Background Healthcare decision makers face challenges when using guidelines , including underst and ing the quality of the evidence or the values and preferences upon which recommendations are made , which are often not clear . Methods GRADE is a systematic approach towards assessing the quality of evidence and the strength of recommendations in healthcare . GRADE also gives advice on how to go from evidence to decisions . It has been developed to address the weaknesses of other grading systems and is now widely used internationally . The Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence ( DECIDE ) consortium ( http://www.decide-collaboration.eu/ ) , which includes members of the GRADE Working Group and other partners , will explore methods to ensure effective communication of evidence -based recommendations targeted at key stakeholders : healthcare professionals , policymakers , and managers , as well as patients and the general public . Surveys and interviews with guideline producers and other stakeholders will explore how presentation of the evidence could be improved to better meet their information needs . We will collect further stakeholder input from advisory groups , via consultations and user testing ; this will be done across a wide range of healthcare systems in Europe , North America , and other countries . Targeted communication strategies will be developed , evaluated in r and omized trials , refined , and assessed during the development of real guidelines . Discussion Results of the DECIDE project will improve the communication of evidence -based healthcare recommendations . Building on the work of the GRADE Working Group , DECIDE will develop and evaluate methods that address communication needs of guideline users . The project will produce strategies for communicating recommendations that have been rigorously evaluated in diverse setting s , and it will support the transfer of research into practice in healthcare systems globally",
"This study investigated effectiveness of manual therapy ( MT ) with transcutaneous electrical nerve stimulation ( TENS ) to reduce pain intensity in patients with mechanical neck disorder ( MND ) . A r and omized multi-centered controlled clinical trial was performed in 12 Primary Care Physiotherapy Units in Madrid Region . Ninety patients were included with diagnoses of subacute or chronic MND without neurological damage , 47 patients received MT and 43 TENS . The primary outcome was pain intensity measured in millimeters using the Visual Analogue Scale ( VAS ) . Also disability , quality of life , adverse effects and sociodemographic and prognosis variables were measured . Three evaluations were performed ( before , when the procedure finished and six months after ) . Seventy-one patients ( 79 % ) completed the follow-up measurement at six months . In more than half of the treated patients the procedure had a clinical ly relevant \" short term \" result after having ended the intervention , when either MT or TENS was used . The success rate decreased to one-third of the patients 6 months after the intervention . No differences can be found in the reduction of pain , in the decrease of disability nor in the quality of life between both therapies . Both analyzed physiotherapy techniques produce a short-term pain reduction that is clinical ly relevant",
"BACKGROUND CONTEXT This is the first study to systematic ally evaluate the value of a longer treatment period for massage . We provide a framework of how to conceptualize an optimal dose in this challenging setting of nonpharmacologic treatments . PURPOSE The aim was to determine the optimal dose of massage for neck pain . STUDY DESIGN / SETTING Two-phase r and omized trial for persons with chronic nonspecific neck pain . Primary r and omization to one of five groups receiving 4 weeks of massage ( 30 minutes 2x/or 3x/wk or 60 minutes 1x , 2x , or 3x/wk ) . Booster r and omization of participants to receive an additional six massages , 60 minutes 1x/wk , or no additional massage . PATIENT SAMPLE A total of 179 participants from Group Health and the general population of Seattle , WA , USA recruited between June 2010 and August 2011 were included . OUTCOME MEASURES Primary outcomes self-reported neck-related dysfunction ( Neck Disability Index ) and pain ( 0 - 10 scale ) were assessed at baseline , 12 , and 26 weeks . Clinical ly meaningful improvement was defined as greater than or equal to 5-point decrease in dysfunction and greater than or equal to 30 % decrease in pain from baseline . METHODS Clinical ly meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations ( GEEs ) . Secondary analyses for the continuous outcomes used linear GEEs . RESULTS There were no observed differences by primary treatment group at 12 or 26 weeks . Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks ( dysfunction : relative risk [RR]=1.56 [ 1.08 - 2.25 ] , p=.018 ; pain : RR=1.25 [ 0.98 - 1.61 ] , p=.077 ) , but those were nonsignificant at 26 weeks ( dysfunction : RR=1.22 [ 0.85 - 1.74 ] ; pain : RR=1.09 [ 0.82 - 1.43 ] ) . Subgroup analysis by primary and booster treatments found the booster dose only effective among those initially r and omized to one of the 60-minute massage groups . CONCLUSIONS \" Booster \" doses for those initially receiving 60 minutes of massage should be incorporated into future trials of massage for chronic neck pain",
"Spinal Manipulation ( SM ) has been purported to decrease pain and improve function in subjects with non-specific neck pain . Previous research has investigated which individuals with non-specific neck pain will be more likely to benefit from SM . It has not yet been proven whether or not the effectiveness of thoracic SM depends on the specific technique being used . This double-blind r and omized trial has compared the short-term effects of two thoracic SM maneuvers in subjects with chronic non-specific neck pain . Sixty participants were distributed r and omly into two groups . One group received the Dog technique ( n = 30 ) , with the subject in supine position , and the other group underwent the Toggle-Recoil technique ( n = 30 ) , with the participant lying prone , T4 being the targeted area in both cases . Evaluations were made of self-reported neck pain ( Visual Analogue Scale ) ; neck mobility ( Cervical Range of Motion ) ; and pressure pain threshold at the cervical and thoracic levels ( C4 and T4 spinous process ) and over the site described for location of tense b and s of the upper trapezius muscle . Measurements were taken before intervention , immediately afterward , and 20 min later . Both maneuvers improved neck mobility and mechanosensitivity and reduced pain in the short term . No major or clinical differences were found between the groups . In the between-groups comparison slightly better results were observed in the Toggle-Recoil group only for cervical extension ( p = 0.009 ) , right lateral flexion ( p = 0.004 ) and left rotation ( p < 0.05 )",
"Study Design . R and omized clinical trial . Objective . To assess the effectiveness of manual physical therapy and exercise ( MTE ) for mechanical neck pain with or without unilateral upper extremity ( UE ) symptoms , as compared to a minimal intervention ( MIN ) approach . Summary of Background Data . Mounting evidence supports the use of manual therapy and exercise for mechanical neck pain , but no studies have directly assessed its effectiveness for UE symptoms . Methods . A total of 94 patients referred to 3 physical therapy clinics with a primary complaint of mechanical neck pain , with or without unilateral UE symptoms , were r and omized to receive MTE or a MIN approach of advice , motion exercise , and subtherapeutic ultrasound . Primary outcomes were the neck disability index , cervical and UE pain visual analog scales ( VAS ) , and patient-perceived global rating of change assessed at 3- , 6- , and 52-weeks . Secondary measures included treatment success rates and post-treatment healthcare utilization . Results . The MTE group demonstrated significantly larger reductions in short- and long-term neck disability index scores ( mean 1-year difference −5.1 , 95 % confidence intervals ( CI ) −8.1 to −2.1 ; P = 0.001 ) and short-term cervical VAS scores ( mean 6-week difference −14.2 , 95 % CI −22.7 to −5.6 ; P = 0.001 ) as compared to the MIN group . The MTE group also demonstrated significant within group reductions in short- and long-term UE VAS scores at all time periods ( mean 1-year difference −16.3 , 95 % CI −23.1 to −9.5 ; P = 0.000 ) . At 1-year , patient perceived treatment success was reported by 62 % ( 29 of 47 ) of the MTE group and 32 % ( 15 of 47 ) of the MIN group ( P = 0.004 ) . Conclusion . An impairment-based MTE program result ed in clinical ly and statistically significant short- and long-term improvements in pain , disability , and patient-perceived recovery in patients with mechanical neck pain when compared to a program comprising advice , a mobility exercise , and subtherapeutic ultrasound",
"Objective . To investigate the effect of workplace neck/shoulder strength training with and without regular supervision on neck/shoulder pain and headache among office workers . Method . A 20-week cluster r and omized controlled trial among 351 office workers was r and omized into three groups : two training groups with the same total amount of planned exercises three times per week ( 1 ) with supervision ( 3WS ) throughout the intervention period , ( 2 ) with minimal supervision ( 3MS ) only initially , and ( 3 ) a reference group ( REF ) . Main outcome is self-reported pain intensity in neck and shoulder ( scale 0–9 ) and headache ( scale 0–10 ) . Results . Intention-to-treat analyses showed a significant decrease in neck pain intensity the last 7 days in 3MS compared with REF : −0.5 ± 0.2 ( P 0.07 ) . Intensity of headache the last month decreased in both training groups : 3WS versus REF : −1.1 ± 0.2 ( P ( P 0.001 ) . Additionally , days of headache decreased 1.0 ± 0.5 in 3WS and 1.3 ± 0.5 in 3MS versus REF . There were no differences between the two training groups for any of the variables . Conclusion . Neck/shoulder training at the workplace reduced neck pain and headache among office workers independently of the extent of supervision . This finding has important practical implication s for future workplace interventions",
"Objectives . This study investigated long-term effects and implementation processes of workplace strength training for musculoskeletal disorders . Methods . 333 and 140 laboratory technicians from private and public sector companies , respectively , replied to a 3-year follow-up question naire subsequent to a 1-year r and omized controlled trial ( RCT ) with high-intensity strength training for prevention and treatment of neck , shoulder , and arm pain . Being a natural experiment , the two participating companies implemented and modified the initial training program in different ways during the subsequent 2 years after the RCT . Results . At 3-year follow-up the pain reduction in neck , shoulder , elbow , and wrist achieved during the first year was largely maintained at both companies . However , the private sector company was rated significantly better than the public sector company in ( 1 ) training adherence , ( 2 ) training culture , that is , relatively more employees trained at the workplace and with colleagues , ( 3 ) self-reported health changes , and ( 4 ) prevention of neck and wrist pain development among initially pain-free employees . Conclusions . This natural experiment shows that strength training can be implemented successfully at different companies during working hours on a long-term basis with lasting effects on pain in neck , shoulder , and arm",
"Background This systematic review up date d and extended the \" UK evidence report \" by Bronfort et al. ( Chiropr Osteopath 18:3 , 2010 ) with respect to conditions/ interventions that received an ' inconclusive ’ or ' negative ’ evidence rating or were not covered in the report . Methods A literature search of more than 10 general medical and specialised data bases was conducted in August 2011 and up date d in March 2013 . Systematic review s , primary comparative studies and qualitative studies of patients with musculoskeletal or non-musculoskeletal conditions treated with manual therapy and reporting clinical outcomes were included . Study quality was assessed using st and ardised instruments , studies were summarised , and the results were compared against the evidence ratings of Bronfort . These were either confirmed , up date d , or new categories not assessed by Bronfort were added . Results 25,539 records were found ; 178 new and additional studies were identified , of which 72 were systematic review s , 96 were r and omised controlled trials , and 10 were non-r and omised primary studies . Most ' inconclusive ’ or ' moderate ’ evidence ratings of the UK evidence report were confirmed . Evidence ratings changed in a positive direction from inconclusive to moderate evidence ratings in only three cases ( manipulation/mobilisation [ with exercise ] for rotator cuff disorder ; spinal mobilisation for cervicogenic headache ; and mobilisation for miscellaneous headache ) . In addition , evidence was identified on a large number of non-musculoskeletal conditions not previously considered ; most of this evidence was rated as inconclusive . Conclusions Overall , there was limited high quality evidence for the effectiveness of manual therapy . Most review ed evidence was of low to moderate quality and inconsistent due to substantial method ological and clinical diversity . Areas requiring further research are highlighted",
"Summary Fear of movement plays and important role in individuals with subacute whiplash‐associated disorders and it should be directly targeted in treatment . ABSTRACT Fear and avoidance of activity may play a role in fostering disability in whiplash‐associated disorders ( WAD ) . This study examined the role of fear after WAD and assessed the effectiveness of 3 treatments targeting fear . People still symptomatic from WAD grade I‐II injuries approximately 3 months previously ( n = 191 ) completed question naires ( eg , Neck Disability Index [ NDI ] ) and were r and omized to 1 of the treatments : ( 1 ) informational booklet ( IB ) describing WAD and the importance of resuming activities , ( 2 ) IB + didactic discussion s ( DD ) with clinicians reinforcing the booklet , and ( 3 ) IB + imaginal and direct exposure desensitization ( ET ) to feared activities . DD and ET participants received three 2‐hour treatment sessions . Absolute improvements in NDI were in predicted direction ( ET = 14.7 , DD = 11.9 , IB = 9.9 ) . ETs reported significantly less posttreatment pain severity compared with the IB ( Mean = 1.5 vs 2.3 , P groups . Reduction in fear was the most important predictor of improvement in NDI ( β = 0.30 , P by reductions in pain ( β = 0.20 , P = .003 ) and depression ( β = 0.18 , P = .004 ) . The mediational analysis confirmed that fear reduction significantly mediated the effect of treatment group on outcome . Results highlight the importance of fear in individuals with subacute WAD and suggest the importance of addressing fear via exposure therapy and /or educational interventions to improve function",
"Study Design . Parallel-group r and omized controlled trial . Objective . Establish the short-term effectiveness of chiropractic therapy for spinal pain compared with a sham intervention and explore the predictors of chiropractic treatment satisfaction . Summary of Background Data . Chiropractic treatment is widely used for spinal pain . However , a lack of sound evidence precludes conclusions about the effectiveness of chiropractic for spinal pain . Methods . Participants were adults experiencing spinal pain , r and omized to receive 2 treatments of chiropractic or sham therapy . Participants and outcome assessors were blinded to group allocation . Primary outcomes at 2 weeks were pain intensity ( 0–10 scale ) and function ( 0–40 Functional Rating Index ) . Secondary outcomes were global change , minimum acceptable outcome , and treatment satisfaction . Treatment effects were estimated with linear mixed models for the primary outcomes . We used logistic regression to identify differences in the secondary outcomes and explore for predictors of treatment satisfaction . Results . One hundred eighty three participants ( chiropractic , n = 92 ; sham , n = 91 ) were recruited and included in the analyses . Participants receiving chiropractic therapy reported greater improvements in pain ( mean difference , 95 % confidence interval [ CI ] = 0.5 [ 0.1–0.9 ] ) , physical function ( mean difference [ 95 % CI ] = 2.1 [ 0.3–4.0 ] ) , and were more likely to experience global improvement ( 48 % vs. 24 % , P = 0.01 ) and treatment satisfaction ( 78 % vs. 56 % , P minimally acceptable outcome ( 34 % sham vs. 29 % chiropractic , P = 0.42 ) . Awareness of treatment assignment and achieving minimally important improvement in pain intensity were associated with chiropractic treatment satisfaction . Conclusion . Short-term chiropractic treatment was superior to sham ; however , treatment effects were not clinical ly important . Awareness of treatment assignment and clinical ly important reductions in pain were associated with chiropractic treatment satisfaction . Level of Evidence :",
"INTRODUCTION whiplash is a frequent post traumatic pathology caused by muscle , tendon and capsular elements over stretching . The authors conducted a short term prospect i ve r and omised study to test the effectiveness of a multi wave High Power Laser Therapy ( HPLT ) versus conventional simple segmental physical rehabilitation ( PT ) included in Italian tariff nomenclature performance physiotherapy Study Design : prospect i ve r and omised study ( Level II ) . MATERIAL AND METHODS the authors identified 135 homogeneous patients with whiplash grade 1 - 2 of the Quebec Task Force classification ( QTFC ) . INAIL , the Italian National Workers Insurance , based in Milan , was reliable source for identifying patients . All patients with whiplash injuries grade 1 or 2 QTFC , were eligible for the study , starting from April 28 2010 to September 30 2010 . Patients referred to a Coordinator ( C.M. ) who applied the inclusion and exclusion criteria . Patients who agreed to participate were r and omly assigned to one of the two treatment groups . Date s for initial treatment session were arranged , including cervical spine X-ray , and assessment . Each patient gave informed consent for participation and agreed to adopt only the study treatment for 6 weeks . Group A ( 84 patients ) was treated with High Power Laser Therapy ( HPLT ) , Group B ( 51 patients ) received conventional simple segmental physical rehabilitation ( PT ) . During the treatment period , no other electro-medical therapy , analgesics or anti-inflammatory drugs were allowed . All patients were assessed at baseline ( T0 ) and at the end of the treatment period ( T1 ) using a Visual Analogical Scale ( VAS ) , ( T2 ) the date of return to work was registered afterwards . RESULTS there was a reduction in VAS pain scores at T1 . Group A ( VAS = 20 ) Group B ( VAS = 34,8 ) ( p = 0.0048 ) . Laser treatment allowed quick recovery and return to work ( T2 ) . Group A after 48 days against 66 days of Group B ( p=0.0005 ) . CONCLUSIONS results suggest that High Power Laser Therapy - is an effective treatment in patients with whiplash injury , compared to conventional simple segmental physical rehabilitation",
"UNLABELLED Studies regarding self-management of persistent neck pain are infrequent . OBJECTIVE to compare treatment effects of ( a ) a multi-component pain and stress self-management group intervention ( PASS ) and ( b ) individually administered physical therapy ( IAPT ) for patients with persistent musculoskeletal tension-type neck pain . METHODS Persons seeking physical therapy treatment due to persistent tension-type neck pain at nine primary health care centers in Sweden were r and omly assigned to either PASS or IAPT . Before treatment ( baseline ) and at 10- and 20-weeks the participants completed a self- assessment question naire comprising : the Self-Efficacy Scale , the Neck Disability Index , the Coping Strategies Question naire , the Hospital Anxiety and Depression Scale , the Fear-Avoidance Beliefs Question naire and questions regarding neck pain , analgesics and utilization of health care . Intention-to-treat analyses were performed using repeated measures analysis of variance between baseline , 10-week and 20-week follow-up . RESULTS One hundred and fifty six participants were included ( PASS n=77 , IAPT n=79 ) . On average participants receiving PASS attended seven treatment sessions and participants receiving IAPT 11 sessions over the 20-week follow-up period . Repeated measures ANCOVA showed significant time x group interaction effects for ability to control pain ( p self-efficacy regarding pain-interfering activities ( p=0.005 ) , disability due to neck pain ( p=0.001 ) and levels of catastrophic thinking ( p PASS had a better effect than IAPT in the treatment of persistent musculoskeletal tension-type neck pain regarding coping with pain , in terms of patients ' self-reported pain control , self-efficacy , disability and catastrophizing , over the 20-week follow-up",
"Study Design . A r and omized controlled trial with 3 and 6 months follow-up . Objective . To compare the effectiveness of acupuncture with simulated acupuncture in patients with subacute and chronic whiplash-associated disorders . Summary of Background Data . Acupuncture is widely used for the treatment of neck and other musculoskeletal pain , and there is some evidence supporting its effectiveness for short-term pain relief . The effectiveness of acupuncture in the treatment of whiplash-associated disorders is not clear . Methods . A total of 124 patients between 18 and 65 years with chronic ( 85 % ) or subacute whiplash-associated disorders ( Grade I or II ) were r and omly allocated to real or simulated electroacupuncture treatment for 12 sessions during a 6-week period . Both treatments involved skin penetration with acupuncture needles and were provided by a single university-trained acupuncturist in a University Clinic in Sydney , Australia . Primary outcome measures were pain intensity ( 10-cm visual analog scale ) , disability ( Neck Disability Index ) , and health-related quality of life ( SF-36 ) . Secondary outcomes were patient-specific activity scales , and the McGill Pain Rating Index . Results . Mean initial pain intensity for all participants was 5.6 cm . Participants receiving the real electroacupuncture treatment had significantly greater reduction in pain intensity at 3 and 6 months , 0.9 cm ( P = 0.05 ) and 1.3 cm ( P = 0.007 ) , respectively , in comparison to the sham electro-acupuncture group . After adjustment for baseline status , there was no significant reduction in disability , or improvement in health-related quality of life . There was an improvement in the activity scales of a similar size to the reduction in pain , but no difference in the McGill Index . Conclusion . Real electroacupuncture was associated with a significant reduction in pain intensity over at least 6 months . This reduction was probably not clinical ly significant . There was no improvement in disability or quality of life",
"Abstract Purpose We conducted a systematic review to critically appraise and synthesize literature on the effectiveness of work disability prevention ( WDP ) interventions in workers with neck pain , whiplash-associated disorders ( WAD ) , or upper extremity disorders . Methods We search ed electronic data bases from 1990 to 2012 . R and om pairs of independent review ers critically appraised eligible studies using the Scottish Intercollegiate Guidelines Network criteria . Scientifically admissible studies were summarized and synthesized following best- evidence synthesis methodology . Results Of the 6,359 articles retrieved , 16 r and omized controlled trials were eligible for critical appraisal and five were admissible . We found that a return-to-work coordination program ( including workplace-based work hardening ) was superior to clinic-based work hardening for persistent rotator cuff tendinitis . Workplace high-intensity strength training and workplace advice had similar outcomes for neck and shoulder pain . Mensendieck/Cesar postural exercises and strength and fitness exercises had similar outcomes for non-specific work-related upper limb complaints . Adding a brief job stress education program to a workplace ergonomic intervention was not beneficial for persistent upper extremity symptoms . Adding computer-prompted work breaks to ergonomic adjustments and workplace education benefited workers ’ recovery from recent work-related neck and upper extremity complaints . Conclusions At present , no firm conclusions can be drawn regarding the effectiveness of WDP interventions for managing neck pain , WAD , and upper extremity disorders . Our review suggests a return-to-work coordination program is more effective than clinic-based work hardening . Also , adding computer-prompted breaks to ergonomic and workplace interventions benefits workers ’ recovery . The current quality of evidence does not allow for a definitive evaluation of the effectiveness of ergonomic interventions",
"Objectives : The aim of this study was to compare the effect on self-rated pain , disability , and self-efficacy of 3 interventions for the management of chronic whiplash-associated disorders : physiotherapist-led neck-specific exercise ( NSE ) , physiotherapist-led NSE with the addition of a behavioral approach , or Prescription of Physical Activity ( PPA ) . Material s and Methods : A total of 216 volunteers with chronic whiplash-associated disorders participated in this r and omized , assessor blinded , clinical trial of 3 exercise interventions . Self-rated pain/pain bothersomeness ( Visual Analogue Scale ) , disability ( Neck Disability Index ) , and self-efficacy ( Self-Efficacy Scale ) were evaluated at baseline and at 3 and 6 months . Results : The proportion of patients reaching substantial reduction in pain bothersomness ( at least 50 % reduction ) was more evident ( P substantial pain reduction . Reduction of disability was also larger in the 2 neck-specific exercise groups at both 3 and 6 months ( P Self-efficacy was only improved in the NSE group without a behavioral approach ( P=0.02 ) . However , there were no significant differences in any outcomes between the 2 physiotherapist-led NSE groups . Discussion : NSE result ed in superior outcomes compared with PPA in this study , but the observed benefits of adding a behavioral approach to the implementation of exercise in this study were inconclusive",
"Study Design . R and omized parallel-group trial with 1-year follow-up . Objective . To evaluate whether education of patients communicated orally by a specially trained nurse is superior to giving patients a pamphlet after a whiplash injury . Summary of Background Data . Long-lasting pain and physical disability after whiplash injuries are related to both serious personal suffering and huge socio-economic costs . Pure educational interventions after such injuries seem generally as effective as more costly interventions , but it is unknown if the way advice is communicated is of any importance . Methods . Participants with relatively mild complaints after car collisions were recruited from emergency departments and GPs . A total of 182 participants were r and omized to either : ( 1 ) a 1 hour-educational session with a specially trained nurse , or ( 2 ) an educational pamphlet . Outcome parameters were neck pain , headache , disability , and return to work . Recovery was defined as scoring pain 0 or 1 ( 0–10 point scale ) and not being off sick at the time of the follow-ups . Results . After 3 , 6 , and 12 months 60 % , 58 % , and 66 % , respectively of the participants had recovered . Group differences were nonsignificant on all outcome parameters , even though the outcome tended to be better for the group receiving personal advice . Conclusion . Prognosis did not differ between patients who received personal education and those who got a pamphlet . However , a systematic tendency toward better outcome with personal communicated information was observed and the question how patients should be educated to reduce the risk of chronicity after whiplash is worth further investigation , since no treatment have been proven to prevent long-lasting symptoms , and all forms of advice or educational therapy are so cheap that even a modest effect justifies its use",
"Purpose To determine the time-wise effect of specific resistance training on neck pain among industrial technicians with frequent neck pain symptoms . Methods Secondary analysis of a parallel-group cluster r and omized controlled trial of 20 weeks performed at two large industrial production units in Copenhagen , Denmark . Women with neck pain > 30 mm VAS ( N = 131 ) were included in the present analysis . The training group ( N = 77 ) performed specific resistance training for the neck/shoulder muscles three times a week , and the control group ( N = 54 ) received advice to stay active . Participants of both groups registered neck pain intensity ( 0–100 mm VAS ) once a week . Results Neck pain intensity was 55 mm ( SD 23 ) at baseline . There was a significant group by time interaction for neck pain ( F-value 2.61 , P differences in neck pain reached significance after 4 weeks ( 11 mm , 95 % CI 2 to 20 ) . The time-wise change in pain showed three phases ; a rapid decrease in the training group compared with the control group during the initial 7 weeks , a slower decrease in pain during the following weeks ( week 8–15 ) , and a plateau during the last weeks ( week 16–20 ) . Adherence to training followed a two-phase pattern , i.e. weekly participation rate was between 70–86 % during the initial 7 weeks , dropping towards 55–63 % during the latter half of the training period . Conclusion Four weeks of specific resistance training reduced neck pain significantly , but 15 weeks is required to achieve maximal pain reduction . The time-wise change in pain followed a three-phase pattern with a rapid effect during the initial 7 weeks followed by a slower but still positive effect , and finally a plateau from week 15 and onwards . Decreased participation rate may explain the decreased efficacy during the latter phase of the intervention",
"Purpose Although there is growing evidence in favour of the bio-psychosocial approach to the treatment of persistent neck pain , it is question ed whether treating psychological factors can improve patient perceptions of disability , pain and quality of life . This r and omised , controlled study with 12 months ’ follow-up was conducted to evaluate the efficacy of adding cognitive-behavioural principles to exercises for chronic neck pain . Methods Eighty patients were r and omly assigned to the usual neck exercises plus cognitive-behavioural treatment ( PTcb group , 40 subjects ) or to treatment based on neck exercises alone ( PT group , 40 subjects ) . Before treatment ( T1 ) , at the end of treatment ( T2 ) and 12 months later ( T3 ) , all of the patients completed a booklet including the Neck Pain and Disability Scale , a numerical rating scale , and the Short-Form Health Survey Question naire ( SF-36 ) . Results The present trial failed to demonstrate its primary end point : the pre- and post-treatment difference in total NPDS scores was not statistically different between groups . Disability improved similarly in both groups over time , remaining stable until T3 in the PTcb group and slightly increasing at the same time in the PT group . Pain trends were comparable , with both groups showing an improvement between T1 and T2 , and a slight worsening between T2 and T3 . There were significant increases in all of the SF-36 domains except for health in general , and vitality in both groups by the end of treatment . SF-36 showed a between-group difference only for the physical activity domain ( 10.4 ; 95 % CI 2.4–18.5 ) . Conclusion Disability , pain and quality of life improved at the end of treatment in both groups , without differences between them",
"Background and ObjectiveS ince oxidative stress plays a pathogenetic role in chronic neck pain ( CNP ) , we investigated whether a combination of α-lipoic acid ( ALA ) and superoxide dismutase ( SOD ) might improve pain control and the efficacy of physiotherapy ( “ multimodal therapy ” ) in patients with CNP . Setting This study was conducted in the Rehabilitation Unit of the Department of Surgical and Oncological Sciences at the University Policlinic in Palermo , Italy . Design and Patients This was a prospect i ve , r and omized , open study in out patients .Intervention Patients r and omly received either physiotherapy alone ( group 2 ; n = 45 ) or a combination of ALA 600 mg and SOD 140 IU daily in addition to physiotherapy ( group 1 ; n = 51 ) , for 60 days . Pain was assessed by a visual analogue scale ( VAS ) and a modified Neck Pain Question naire ( mNPQ ) . Treatment compliance and safety were also evaluated . Results Both groups experienced a significant reduction in the VAS and mNPQ scores after 1 month ; however , while no further improvement was observed in group 2 at 60 days , group 1 showed a further VAS reduction ( p their neck pain was improved ( p compliance with prescribed physiotherapy ( p = 0.048 ) . No drug reaction was observed . Conclusion Use of ALA/SOD in combination with physiotherapy may be a useful approach to CNP , being antioxidants that act on nerve inflammation and disease progression . Clinical Rehabilitation ImpactThese preliminary observations suggest that some interesting goals ( better pain control and physical wellbeing ) can be achieved by multimodal therapy in CNP patients",
"Ketorolac tromethamine injected intramuscularly ( IM ) has been shown to be an effective analgesic in treating patients with acute musculoskeletal pain in the emergency department ( ED ) . The authors compare the efficacy of a single dose of IM ketorolac to osteopathic manipulative treatment ( OMT ) as delivered in the ED for the management of acute neck pain . A r and omized clinical trial was conducted in three EDs . A convenience sample of 58 patients with acute neck pain of less than three weeks ' duration were enrolled . Subjective measures of pain intensity on an 11-point numerical rating scale were gathered from patients immediately before treatment and one hour afterward . Subjects received either OMT or 30 mg , IM ketorolac . Subjects ' perceived pain relief was also recorded at one hour after treatment on a subjective 5-point pain relief scale . Twenty-nine patients received IM ketorolac , and 29 patients received OMT . Although both groups showed a significant reduction in pain intensity , 1.7+/-1.6 ( P OMT reported a significantly greater decrease in pain intensity ( P=.02 [ 95 % CI , 0.2 - 1.9 ] ) . When comparing pain relief at one hour posttreatment , there was no significant difference between the OMT and ketorolac study groups ( P=.10 ) . The authors found that , at one hour posttreatment , OMT is as efficacious as IM ketorolac in providing pain relief and significantly better in reducing pain intensity . The authors conclude that OMT is a reasonable alternative to parenteral nonsteroidal anti-inflammatory medication for patients with acute neck pain in the ED setting",
"Objectives This 40-week workplace physical training RCT investigated the effect of soccer and Zumba , respectively , on muscle pain intensity and duration , work ability , and rating of perceived exertion ( RPE ) during work among female hospital employees . Methods 107 hospital employees were cluster-r and omized into two training groups , and a control group . The training was conducted outside working hours as two-three 1-h sessions per week for the first 12 weeks , and continued as one-two 1-h sessions per week for the last 28 weeks . Muscle pain intensity and duration , work ability , and RPE during work were measured at baseline and after 12 and 40 weeks . Results After 12 weeks , both the soccer ( −1.9 , 95 % CI , −3.0 , −0.8 , P = 0.001 ) and the Zumba group ( −1.3 , 95 % CI , −2.3 , −0.3 , P = 0.01 ) reduced the pain intensity ( on a scale from 0 to 10 ) in the neck-shoulder region ( eta squared = 0.109 ) , whereas only the soccer group ( −1.9 , 95 % CI , −3.2 , −0.7 , P = 0.002 , eta squared = 0.092 ) showed a reduction after 40 weeks referencing the control group . After 40 weeks , both the soccer ( -16.4 days , 95 % CI , −29.6 , −3.2 , P the Zumba group ( -16.6 days , 95 % CI , −28.9 , −4.2 , P reduced the pain duration during the past 3 months in the neck-shoulder region ( eta squared = 0.077 ) . No significant effects on intensity or duration of pain in the lower back , RPE during work or work ability were found . Conclusions The present study indicates that workplace initiated soccer and Zumba training improve neck-shoulder pain intensity as well as duration among female hospital employees . Trial Registration International St and ard R and omized Controlled Trial Number Register IS RCT N 61986892",
"Background Neck pain in adults is common and a leading cause of physical disability . Recently , a guideline was developed for the management of non-specific neck pain ( NSNP ) with an aim to improve the quality of the delivery of chiropractic care . One key guideline recommendation is to undertake multimodal care for patients with NSNP . The aim of this pilot study is to determine the feasibility of implementing a multifaceted knowledge translation intervention by promoting the use of multimodal care by chiropractors managing patients with NSNP . Methods / design The design is a cluster-r and omized controlled pilot and feasibility trial . Chiropractors in private practice in Canada will be approached to participate in the study . Thirty consenting chiropractors will be r and omized to receive either a theory-based educational intervention in the experimental group or simply a printed copy of the guideline in the control group . Each chiropractor will recruit five neck pain patients ( a total of 150 patients ) into the study . Development of the multifaceted intervention was informed by the results of a related qualitative study based on the Theoretical Domains Framework and consists of a series of three webinars , two online case scenarios , a self-management video on Brief Action Planning , and a printed copy of the practice guideline . Primary feasibility outcomes for both chiropractors and patients include rates of ( 1 ) recruitment , ( 2 ) retention , and ( 3 ) adherence to the intervention . A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors ’ compliance with guideline recommendations ( e.g. exercise and self-care prescriptions ) at study onset and at 3 months . Secondary outcomes include scores of behavioural constructs ( level of knowledge and self-efficacy ) for recommended multimodal care . Clinical outcomes include pain intensity and neck pain-specific disability . Analyses from this study will focus on generating point estimates and corresponding 95 % confidence intervals for parameters of a priori interest ( recruitment , retention , adherence , pain intensity , Neck Disability Index ) . Discussion Results of this study will inform the design of a larger cluster-r and omized controlled trial aim ed at evaluating the effectiveness of the theory-based tailored intervention and increasing the use of multimodal care by chiropractors managing patients with NSNP.Trial registration https:// clinical trials.gov/ ,",
"Introduction Return to work following an occupational injury is a multifactoral process although many traditional clinic-based rehabilitation programs do not appreciate the importance of workplace factors . A r and omized controlled trial was conducted to investigate the effect of workplace-based rehabilitation program on the return to work outcome of work-related rotator cuff disorder , which is based on the therapeutic use of actual work facilities and work environment . Methods A total of 103 workers were recruited and r and omly assigned into Clinic-based Work Hardening ( CWH ) or Workplace-based Work Hardening ( WWH ) groups . The CWH group were given traditional generic work hardening training while WWH group received workplace-based work hardening training with rehabilitative principles of athletic rotator cuff pathology , biomechanics and specific job activities . Results After four weeks , a higher return to work rate was obtained in WWH group compared to CWH group ( 71.4 % vs. 37 % , p lowering of self-reported shoulder problems and functional work capabilities in the WWH group versus the CWH group . Conclusion Workplace-based rehabilitation program appeared to be more effective in facilitating the return to work process of the injured worker as assessed immediately following intervention . In particular this approached was associated with many of the psychosocial workplace factors related to separation from the work routine . The influence of peer group and /or employer could be minimized . This initial attempt with rotator cuff injuries appears promising however long-term outcome needs to be determined",
"The efficacy of low-level laser therapy ( LLLT ) in myofascial pain syndrome ( MPS ) seems controversial . A prospect i ve , double-blind , r and omized controlled trial was conducted in patients with chronic MPS in the neck to evaluate the effects of low-level 830-nm gallium arsenide aluminum ( Ga – As – Al ) laser therapy . The study group consisted of 64 MPS patients . The patients were r and omly assigned into two groups . In group 1 ( n = 32 ) , Ga – As – Al laser treatment was applied over three trigger points bilaterally for 2 min over each point once a day for 15 days during a period of 3 weeks . In group 2 ( n = 32 ) , the same treatment protocol was given , but the laser instrument was switched off during applications . All patients in both groups performed daily isometric exercise and stretching exercises for cervical region . Parameters were measured at baseline and after 4 weeks . All patients were evaluated with respect to pain ( at rest , movement , and night ) and assessed by visual analog scale , measurement of active range of motion using an inclinometer and a goniometer , and the neck disability index . In both groups , statistically significant improvements were detected in all outcome measures compared with baseline ( p no significant differences were obtained between the two groups ( p > 0.05 ) . In conclusion , although the laser therapy has no superiority over placebo groups in this study , we can not exclude the possibility of effectivity with another treatment regimen including different laser wavelengths and dosages ( different intensity and density and /or treatment interval )",
"The aim was to determine the effect of one weekly hour of specific strength training within working hours , performed with the same total training volume but with different training frequencies and duration s , or with different levels of supervision , on compliance , muscle health and performance , behavior and work performance . In total , 573 office workers were cluster-r and omized to : 1 WS : one 60-min supervised session/week , 3 WS : three 20-min supervised sessions/week , 9 WS : nine 7-min supervised sessions/week , 3 MS : three 20-min sessions/week with minimal supervision , or REF : a reference group without training . Outcomes were diary-based compliance , total training volume , muscle performance and question naire-based health , behavior and work performance . Comparisons were made among the WS training groups and between 3 WS and 3 MS . If no difference , training groups were collapsed ( TG ) and compared with REF . Results demonstrated similar degrees of compliance , mean(range ) of 39(33 - 44)% , and total training volume , 13.266(11.977 - 15.096)kg . Musculoskeletal pain in neck and shoulders were reduced with approx . 50 % in TG , which was significant compared with REF . Only the training groups improved significantly their muscle strength 8(4 - 13)% and endurance 27(12 - 37)% , both being significant compared with REF . No change in workability , productivity or self-rated health was demonstrated . Secondary analysis showed exercise self-efficacy to be a significant predictor of compliance . Regardless of training schedule and supervision , similar degrees of compliance were shown together with reduced musculoskeletal pain and improved muscle performance . These findings provide evidence that a great degree of flexibility is legitimate for companies in planning future implementation of physical exercise programs at the workplace . Clinical Trials.gov , number NCT01027390",
"BACKGROUND CONTEXT Neck pain , common among the elderly population , has considerable implication s on health and quality of life . Evidence supports the use of spinal manipulative therapy ( SMT ) and exercise to treat neck pain ; however , no studies to date have evaluated the effectiveness of these therapies specifically in seniors . PURPOSE To assess the relative effectiveness of SMT and supervised rehabilitative exercise , both in combination with and compared to home exercise ( HE ) alone for neck pain in individuals ages 65 years or older . STUDY DESIGN / SETTING R and omized clinical trial . PATIENT SAMPLE Individuals 65 years of age or older with a primary complaint of mechanical neck pain , rated ≥3 ( 0 - 10 ) for 12 weeks or longer in duration . OUTCOME MEASURES Patient self-report outcomes were collected at baseline and 4 , 12 , 26 , and 52 weeks after r and omization . The primary outcome was pain , measured by an 11-box numerical rating scale . Secondary outcomes included disability ( Neck Disability Index ) , general health status ( Medical Outcomes Study Short Form-36 ) , satisfaction ( 7-point scale ) , improvement ( 9-point scale ) , and medication use ( days per week ) . METHODS This study was funded by the US Department of Health and Human Services , Health Re sources and Services Administration . Linear mixed model analyses were used for comparisons at individual time points and for short- and long-term analyses . Blinded evaluations of objective outcomes were performed at baseline and 12 weeks . Adverse event data were collected at each treatment visit . RESULTS A total of 241 participants were r and omized , with 95 % reporting primary outcome data at all time points . After 12 weeks of treatment , the SMT with home exercise group demonstrated a 10 % greater decrease in pain compared with the HE-alone group , and 5 % change over supervised plus home exercise . A decrease in pain favoring supervised plus HE over HE alone did not reach statistical significance . Compared with the HE group , both combination groups reported greater improvement at week 12 and more satisfaction at all time points . Multivariate longitudinal analysis incorporating primary and secondary patient-rated outcomes showed that the SMT with HE group was superior to the HE-alone group in both the short- and long-term . No serious adverse events were observed as a result of the study treatments . CONCLUSIONS SMT with HE result ed in greater pain reduction after 12 weeks of treatment compared with both supervised plus HE and HE alone . Supervised exercise sessions added little benefit to the HE-alone program",
"Background Specific strength training can reduce neck and shoulder pain in office workers , but the optimal combination of exercise frequency and duration remains unknown . This study investigates how one weekly hour of strength training for the neck and shoulder muscles is most effectively distributed . Methods A total of 447 office workers with and without neck and /or shoulder pain were r and omly allocated at the cluster-level to one of four groups ; 1 × 60 ( 1WS ) , 3 × 20 ( 3WS ) or 9 × 7 ( 9WS ) min a week of supervised high-intensity strength training for 20 weeks , or to a reference group without training ( REF ) . Primary outcome was self-reported neck and shoulder pain ( scale 0–9 ) and secondary outcome work disability ( Disability in Arms , Shoulders and H and s ( DASH ) ) . Results The intention-to-treat analysis showed reduced neck and right shoulder pain in the training groups after 20 weeks compared with REF . Among those with pain ≥3 at baseline ( n=256 ) , all three training groups achieved significant reduction in neck pain compared with REF ( p a baseline pain rating of 3.2 ( SD 2.3 ) in the neck among neck cases , 1WS experienced a reduction of 1.14 ( 95 % CI 0.17 to 2.10 ) , 3WS 1.88 ( 0.90 to 2.87 ) and 9WS 1.35 ( 0.24 to 2.46 ) which is considered clinical ly significant . DASH was reduced in 1WS and 3WS only . Conclusion One hour of specific strength training effectively reduced neck and shoulder pain in office workers . Although the three contrasting training groups showed no statistical differences in neck pain reduction , only 1WS and 3WS reduced DASH . This study suggests some flexibility regarding time-wise distribution when implementing specific strength training at the workplace",
"Objective To evaluate the effectiveness of treatment with collar or physiotherapy compared with a wait and see policy in recent onset cervical radiculopathy . Design R and omised controlled trial . Setting Neurology outpatient clinics in three Dutch hospitals . Participants 205 patients with symptoms and signs of cervical radiculopathy of less than one month ’s duration Interventions Treatment with a semi-hard collar and taking rest for three to six weeks ; 12 twice weekly sessions of physiotherapy and home exercises for six weeks ; or continuation of daily activities as much as possible without specific treatment ( control group ) . Main outcome measures Time course of changes in pain scores for arm and neck pain on a 100 mm visual analogue scale and in the neck disability index during the first six weeks . Results In the wait and see group , arm pain diminished by 3 mm/week on the visual analogue scale ( β=−3.1 mm , 95 % confidence interval −4.0 to −2.2 mm ) and by 19 mm in total over six weeks . Patients who were treated with cervical collar or physiotherapy achieved additional pain reduction ( collar : β=−1.9 mm , −3.3 to −0.5 mm ; physiotherapy : β=−1.9 , −3.3 to −0.8 ) , result ing in an extra pain reduction compared with the control group of 12 mm after six weeks . In the wait and see group , neck pain did not decrease significantly in the first six weeks ( β=−0.9 mm , −2.0 to 0.3 ) . Treatment with the collar result ed in a weekly reduction on the visual analogue scale of 2.8 mm ( −4.2 to −1.3 ) , amounting to 17 mm in six weeks , whereas physiotherapy gave a weekly reduction of 2.4 mm ( −3.9 to −0.8 ) result ing in a decrease of 14 mm after six weeks . Compared with a wait and see policy , the neck disability index showed a significant change with the use of the collar and rest ( β=−0.9 mm , −1.6 to −0.1 ) and a non-significant effect with physiotherapy and home exercises . Conclusion A semi-hard cervical collar and rest for three to six weeks or physiotherapy accompanied by home exercises for six weeks reduced neck and arm pain substantially compared with a wait and see policy in the early phase of cervical radiculopathy . Trial registration Clinical trials NCT00129714",
"QUESTION Are postural exercises delivered by Mensendieck/Cesar therapists more effective in decreasing pain , reducing disability and improving health-related quality of life in visual display unit workers with early non-specific work-related upper limb disorders than strength and fitness exercises delivered by physiotherapists ? DESIGN R and omised trial with concealed allocation and intention-to-treat analysis . PARTICIPANTS Eighty-eight ( 6 drop-outs ) visual display unit workers with early non-specific work-related upper limb disorders . INTERVENTION One group received 10 weeks of postural exercises while the other group received 10 weeks of strength and fitness exercises . OUTCOME MEASURES Pain was measured with a 10-cm visual analogue scale , disability was measured with the Disabilities of Arm , Shoulder and H and question naire , and health-related quality of life was measured with the Short Form-36 . Number of participants experiencing upper limb complaints was also collected . Outcome measures were collected at baseline and again at 3 , 6 , and 12 months . RESULTS There was no significant difference in decrease in pain between the groups at 3 months ( 0.6 cm , 95 % CI 0.0 to 1.2 ) , 6 months ( 0.2 , 95 % CI -0.3 to 0.7 ) , or at 12 months ( 0.1 , 95 % CI -0.6 to 0.8 ) . Differences between the groups in upper limb complaints , disability , and health related quality of life were also small and not significant at any measurement occasion . CONCLUSION Postural exercises did not result in a better outcome than strength and fitness exercises . However , 55 % of visual display unit workers with early non-specific work-related upper limb disorders reported being free of complaints one year after both interventions were commenced . TRIAL REGISTRATION IS RCT N15872455",
"Objectives Little is known about the effectiveness of therapeutic massage , one of the most popular complementary medical treatments for neck pain . A r and omized controlled trial was conducted to evaluate whether therapeutic massage is more beneficial than a self-care book for patients with chronic neck pain . Methods Sixty-four such patients were r and omized to receive up to 10 massages over 10 weeks or a self-care book . Follow-up telephone interviews after 4 , 10 , and 26 weeks assessed outcomes including dysfunction and symptoms . Log-binomial regression was used to assess whether there were differences in the percentages of participants with clinical ly meaningful improvements in dysfunction and symptoms ( ie , > 5-point improvement on the Neck Disability Index ; > 30 % improvement from baseline on the symptom bothersomeness scale ) at each time point . Results At 10 weeks , more participants r and omized to massage experienced clinical ly significant improvement on the Neck Disability Index [ 39 % vs. 14 % of book group ; relative risk (RR)=2.7 ; 95 % confidence interval ( CI ) , 0.99 - 7.5 ] and on the symptom bothersomeness scale ( 55 % vs. 25 % of book group ; RR=2.2 ; 95 % CI , 1.04 - 4.2 ) . After 26 weeks , massage group members tended to be more likely to report improved function ( RR=1.8 ; 95 % CI , 0.97 - 3.5 ) , but not symptom bothersomeness ( RR=1.1 ; 95 % CI , 0.6 - 2.0 ) . Mean differences between groups were strongest at 4 weeks and not evident by 26 weeks . No serious adverse experiences were reported . Conclusions This study suggests that massage is safe and may have clinical benefits for treating chronic neck pain at least in the short term . A larger trial is warranted to confirm these results",
"Background Previous studies have shown positive effects of physical exercise at the workplace on musculoskeletal disorders . However , long-term adherence remains a challenge . The present study evaluates long-term adherence and effects of a workplace strength training intervention on back , neck and upper extremity pain among laboratory technicians . Methods Cluster-r and omized controlled trial involving 537 industrial laboratory technicians . Subjects were r and omized at the cluster level to one of two groups : training group 1 ( TG1 , n = 282 ) performing supervised strength training from February to June 2009 ( round one ) or training group 2 ( TG2 , n = 255 ) performing supervised strength training from August to December 2009 ( round two ) . The outcome measures were changes in self-reported pain intensity ( 0–9 ) in the back , neck and upper extremity as well as Disability of the Arm , Shoulder and H and ( DASH , 0–100 ) . Results Regular adherence , defined as at least one training session per week , was achieved by around 85 % in both groups in the supervised training periods . In the intention-to-treat analyses there were significant group by time effects for pain in the neck , right shoulder , right h and and lower back and DASH - result ing in significant reductions in pain ( mean 0.3 to 0.5 ) and DASH ( mean 3.9 ) in the scheduled training group compared to the reference group . For TG1 there were no significant changes in pain in round two , i.e. they maintained the pain reduction achieved in round one . Subgroup analyses among those with severe pain ( > = 3 on a scale of 0–9 ) showed a significant group by time effect for pain in the neck , right shoulder , upper back and lower back . For these subgroups the pain reduction in response to training ranged from 1.1 to 1.8 . Conclusions Specific strength training at the workplace can lead to significant long-term reductions in spinal and upper extremity pain and DASH . The pain reductions achieved during the intensive training phase with supervision appears to be maintained a half year later",
"Background Although leisure-time physical activity is important for health , adherence to regular exercise is challenging for many adults . The workplace may provide an optimal setting to reach a large proportion of the adult population needing regular physical exercise . This study evaluates the effect of implementing strength training at the workplace on non-specific neck and shoulder pain among industrial workers . Methods Cluster-r and omized controlled trial involving 537 adults from occupations with high prevalence of neck and shoulder pain ( industrial production units ) . Participants were r and omized to 20 weeks of high-intensity strength training for the neck and shoulders three times a week ( n = 282 ) or a control group receiving advice to stay physically active ( n = 255 ) . The strength training program followed principles of progressive overload and periodization . The primary outcome was changes in self-reported neck and shoulder pain intensity ( scale 0 - 9 ) . Results 85 % of the participants followed the strength training program on a weekly basis . In the training group compared with the control group , neck pain intensity decreased significantly ( -0.6 , 95 % CI -1.0 to -0.1 ) and shoulder pain intensity tended to decrease ( -0.2 , 95 % CI -0.5 to 0.1 , P = 0.07 ) . For pain-cases at baseline ( pain intensity > = 3 ) the odds ratio - in the training group compared with the control group - for being a non-case at follow-up ( pain intensity High-intensity strength training relying on principles of progressive overload can be successfully implemented at industrial workplaces , and results in significant reductions of neck and shoulder pain . Trial registration NCT01071980",
"OBJECTIVES This study evaluated the effects on work-related neck and upper-limb disorders among computer workers stimulated ( by a software program ) to take regular breaks and perform physical exercises . Possible effects on sick leave and productivity were studied as well . A r and omized controlled design was used with cluster r and omization . Altogether 268 computer workers with complaints in the neck or an upper limb from 22 office locations were r and omized into a control group , one intervention group stimulated to take extra breaks and one intervention group stimulated to perform exercises during the extra breaks during an 8-weekperiod . Question naires were administered before and after the intervention , and questions were generated by the software during the intervention period . Computer usage was recorded online . RESULTS The data on self-reported recovery suggested a favorable effect ; more subjects in the intervention groups than in the control group reported recovery ( 55 % versus 34 % ) from their complaints and fewer reported deterioration ( 4 % versus 20 % ) . However , a comparison between the reported pre- and postintervention scores on the severity and frequency of the complaints showed no significant differences in the change among the three groups . No effects on sick leave were observed . The subjects in the intervention groups showed higher productivity . CONCLUSIONS The use of a software program stimulating workers to take regular breaks contributes to perceived recovery from neck or upper-limb complaints . There seems to be no additional effects from performing physical exercises during these breaks",
"Background Evidence suggests that to facilitate physical activity sedentary people may adhere to one component of exercise prescriptions ( intensity , duration or frequency ) without adhering to other components . Some experts have provided evidence for determinants of adherence to different components among healthy people . However , our underst and ing remains scarce in this area for patients with neck or low back pain . The aims of this study are to determine whether patients with neck or low back pain have different rates of adherence to exercise components of frequency per week and duration per session when prescribed with a home exercise program , and to identify if adherence to both exercise components have distinct predictive factors . Methods A cohort of one hundred eighty-four patients with chronic neck or low back pain who attended physiotherapy in eight primary care centers were studied prospect ively one month after intervention . The study had three measurement periods : at baseline ( measuring characteristics of patients and pain ) , at the end of physiotherapy intervention ( measuring characteristics of the home exercise program ) and a month later ( measuring professional behaviors during clinical encounters , environmental factors and self-efficacy , and adherence behavior ) . Results Adherence to duration per session ( 70.9 % ± 7.1 ) was more probable than adherence to frequency per week ( 60.7 % ± 7.0 ) . Self-efficacy was a relevant factor for both exercise components ( p total number of exercises prescribed was predictive of frequency adherence ( p . Professional behaviors have a distinct influence on exercise components . Frequency adherence is more probable if patients received clarification of their doubts ( adjusted OR : 4.1 ; p duration adherence is more probable if they are supervised during the learning of exercises ( adjusted OR : 3.3 ; p to exercise prescription frequency and duration components have distinct levels and predictive factors . We recommend additional study , and advise that differential attention be given in clinical practice to each exercise component for improving adherence",
"Background Continuous neck and shoulder pain is a common musculoskeletal complaint . Physical exercise can reduce pain symptoms , but compliance to exercise is a challenge . Exercise-specific self-efficacy has been found to be a predictor of participation in preplanned exercise . Little is known about the influence of exercise-specific self-efficacy on compliance to workplace physical exercise . Purpose To determine the influence of exercise-specific self-efficacy on compliance to specific strength exercises during working hours for laboratory technicians . Methods We performed a cluster-r and omized controlled trial , including laboratory technicians from two industrial production units in Copenhagen , Denmark . The participants were r and omized to supervised specific strength exercises for the neck and shoulder muscles for 20 minutes three times a week ( n = 282 ) or to a reference group ( n = 255 ) . The participants answered baseline and follow-up questions regarding self-efficacy and registered all exercises in a diary . Results Overall compliance to exercises was 45 % . Compliance in company A ( private sector ) differed significantly between the three self-efficacy groups after 20 weeks . The odds ratio of compliance was 2.37 for moderate versus low self-efficacy , and 2.93 for high versus low self-efficacy . No significant difference was found in company B ( public sector ) or in the intervention group as a whole . Conclusion We did not find self-efficacy to be a general statistically significant predictor of compliance to exercises during 20 weeks , but found self-efficacy to be a predictor of compliance in a private sector setting . Workplace-specific differences might be present and should be taken into account",
"STUDY DESIGN R and omized clinical trial . OBJECTIVE To compare the short-term effects of upper cervical and upper thoracic high-velocity low-amplitude ( HVLA ) thrust manipulation to nonthrust mobilization in patients with neck pain . BACKGROUND Although upper cervical and upper thoracic HVLA thrust manipulation and nonthrust mobilization are common interventions for the management of neck pain , no studies have directly compared the effects of both upper cervical and upper thoracic HVLA thrust manipulation to nonthrust mobilization in patients with neck pain . METHODS Patients completed the Neck Disability Index , the numeric pain rating scale , the flexion-rotation test for measurement of C1 - 2 passive rotation range of motion , and the craniocervical flexion test for measurement of deep cervical flexor motor performance . Following the baseline evaluation , patients were r and omized to receive either HVLA thrust manipulation or nonthrust mobilization to the upper cervical ( C1 - 2 ) and upper thoracic ( T1 - 2 ) spines . Patients were reexamined 48-hours after the initial examination and again completed the outcome measures . The effects of treatment on disability , pain , C1 - 2 passive rotation range of motion , and motor performance of the deep cervical flexors were examined with a 2-by-2 mixed-model analysis of variance ( ANOVA ) . RESULTS One hundred seven patients satisfied the eligibility criteria , agreed to participate , and were r and omized into the HVLA thrust manipulation ( n = 56 ) and nonthrust mobilization ( n = 51 ) groups . The 2-by-2 ANOVA demonstrated that patients with mechanical neck pain who received the combination of upper cervical and upper thoracic HVLA thrust manipulation experienced significantly ( P reductions in disability ( 50.5 % ) and pain ( 58.5 % ) than those of the nonthrust mobilization group ( 12.8 % and 12.6 % , respectively ) following treatment . In addition , the HVLA thrust manipulation group had significantly ( P passive C1 - 2 rotation range of motion and motor performance of the deep cervical flexor muscles as compared to the group that received nonthrust mobilization . The number needed to treat to avoid an unsuccessful outcome was 1.8 and 2.3 at 48-hour follow-up , using the global rating of change and Neck Disability Index cut scores , respectively . CONCLUSION The combination of upper cervical and upper thoracic HVLA thrust manipulation is appreciably more effective in the short term than nonthrust mobilization in patients with mechanical neck pain . LEVEL OF EVIDENCE Therapy , level 1b",
"Abstract Patients with chronic whiplash associated disorders present with varied sensory , motor and psychological features . In this first instance it was question ed whether a multimodal program of physical therapies was an appropriate management to be broadly prescribed for these patients when it was known that some would have sensory features suggestive of a notable pain syndrome . A r and omised controlled trial was conducted with 71 participants with persistent neck pain following a motor vehicle crash to explore this question . Participants were r and omly allocated to receive either a multimodal physiotherapy program ( MPT ) or a self‐management program ( SMP ) ( advice and exercise ) . In the r and omisation process , participants were stratified according to the presence or not of widespread mechanical or cold hyperalgesia . The intervention period was 10 weeks and outcomes were assessed immediately following treatment . Even with the presence of sensory hypersensitivity in 72.5 % of subjects , both groups reported some relief of neck pain and disability ( Neck Disability Index ) and it was superior in the group receiving multimodal physiotherapy ( p = 0.04 ) . Post‐hoc observations however suggested that relief was marginal in the subgroup with both widespread mechanical and cold hyperalgesia . Further research is required to test the validity of this sub‐group observation and to test the effect of the intervention in the long term",
"Background .Neck and low back pain are leading causes of morbidity and health care utilization . However , little is known about the characteristics that differentiate those who seek from those who do not seek health care for their pain . Objectives .The objectives of this study were to : 1 ) describe health care utilization for neck and back pain ; 2 ) determine the characteristics of individuals seeking health care for neck and back pain ; and 3 ) identify the characteristics of patients who consult medical doctors , chiropractors , or both . Design . Population -based cross-sectional mailed survey . Subjects . Subjects were r and omly selected adults from the Saskatchewan Health Insurance and Registration File . Measures .Demographic , socio-economic , general health , comorbidity , health-related- quality -of-life , pain severity and health care utilization data were collected . The main outcome was whether subjects with prevalent neck or low back pain visited a health care provider in the previous month . Results .Twenty-five percent of individuals with neck or low back pain visited a health care provider . Seeking health care was associated with disabling neck or back pain , digestive disorders , worse bodily pain and worse physical-role-functioning . Compared with medical patients , fewer chiropractic patients lived in rural areas or reported arthritis , but they reported better social and physical functioning . More patients consulting both providers reported disabling neck or back pain . Conclusions .Individuals seeking care for neck or back pain have worse health status than those who do not seek care . Patients consulting chiropractors alone report fewer comorbidities and are less limited in their activities than those consulting medical doctors",
"UNLABELLED The aim of this study was to evaluate the effectiveness of qigong compared with exercise therapy and no treatment . Elderly patients with chronic neck pain ( > 6 months ) were r and omly assigned to qigong or exercise therapy ( each 24 sessions over a period of 3 months ) or to a waiting list control . Patients completed st and ardized question naires at baseline and after 3 and 6 months . The main outcome measure was average neck pain on the visual analogue scale after 3 months . Secondary outcomes were neck pain and disability ( NPAD ) and quality of life ( SF-36 ) . One hundred seventeen patients ( age , 76 + /- 8 years , 95 % women ) were included in the intention-to-treat analysis . The average duration of neck pain was 19.0 + /- 14.9 years . After 3 months , no significant differences were observed between the qigong group and the waiting list control group ( visual analogue scale mean difference , -11 mm [ CI , -24.0 ; 2.1 ] , P = .099 ) or between the qigong group and the exercise therapy group ( -2.5 mm [ - 15.4 ; 10.3 ] , P = .699 ) . Results for the NPAD were similar ( qigong vs waiting list -6.7 ( -15.4 ; 2.1 ) , P = .135 ; qigong vs exercise therapy 2.3 ( -6.2 ; 10.8 ) ; P = .600 ) . We found no significant effect after 3 months of qigong or exercise therapy compared with no treatment . Further studies should include outcomes more suitable to elderly patients , longer treatment , and patients with less chronic pain . PERSPECTIVE In a r and omized controlled study , we evaluated whether a treatment of 24 qigong sessions over a period of 3 months is ( 1 ) superior to no treatment and ( 2 ) superior to the same amount of exercise therapy in elderly patients ( age , 76 + /- 8 years , 95 % women ) with long-term chronic neck pain ( 19.0 + /- 14.9 years ) . After 3 and 6 months , we found no significant differences for pain , neck pain , disability , and quality of life among the 3 groups",
"BACKGROUND Little is known about the effectiveness of treatments for acute whiplash injury . We aim ed to estimate whether training of staff in emergency departments to provide active management consultations was more effective than usual consultations ( Step 1 ) and to estimate whether a physiotherapy package was more effective than one additional physiotherapy advice session in patients with persisting symptoms ( Step 2 ) . METHODS Step 1 was a pragmatic , cluster r and omised trial of 12 NHS Trust hospitals including 15 emergency departments who treated patients with acute whiplash associated disorder of grade s I-III . The hospitals were r and omised by clusters to either active management or usual care consultations . In Step 2 , we used a nested individually r and omised trial . Patients were r and omly assigned to receive either a package of up to six physiotherapy sessions or a single advice session . R and omisation in Step 2 was stratified by centre . Investigator-masked outcomes were obtained at 4 , 8 , and 12 months . Masking of clinicians and patients was not possible in all steps of the trial . The primary outcome was the Neck Disability Index ( NDI ) . Analysis was intention to treat , and included an economic evaluation . The study is registered IS RCT N33302125 . FINDINGS Recruitment ran from Dec 5 , 2005 to Nov 30 , 2007 . Follow-up was completed on Dec 19 , 2008 . In Step 1 , 12 NHS Trusts were r and omised , and 3851 of 6952 eligible patients agreed to participate ( 1598 patients were assigned to usual care and 2253 patients were assigned to active management ) . 2704 ( 70 % ) of 3851 patients provided data at 12 months . NDI score did not differ between active management and usual care consultations ( difference at 12 months 0·5 , 95 % CI -1·5 to 2·5 ) . In Step 2 , 599 patients were r and omly assigned to receive either advice ( 299 patients ) or a physiotherapy package ( 300 patients ) . 479 ( 80 % ) patients provided data at 12 months . The physiotherapy package at 4 months showed a modest benefit compared to advice ( NDI difference -3·7 , -6·1 to -1·3 ) , but not at 8 or 12 months . Active management consultations and the physiotherapy package were more expensive than usual care and single advice session . No treatment-related serious adverse events or deaths were noted . INTERPRETATION Provision of active management consultation did not show additional benefit . A package of physiotherapy gave a modest acceleration to early recovery of persisting symptoms but was not cost effective from a UK NHS perspective . Usual consultations in emergency departments and a single physiotherapy advice session for persistent symptoms are recommended . FUNDING NIHR Health Technology Assessment programme",
"& NA ; Regular physical exercise is a cornerstone in rehabilitation programs , but adherence to comprehensive exercise remains low . This study determined the effectiveness of small daily amounts of progressive resistance training for relieving neck/shoulder pain in healthy adults with frequent symptoms ; 174 women and 24 men working at least 30 h per week and with frequent neck/shoulder pain were r and omly assigned to resistance training with elastic tubing for 2 or 12 minutes per day 5 times per week , or weekly information on general health ( control group ) . Primary outcomes were changes in intensity of neck/shoulder pain ( scale 0 to 10 ) , examiner‐verified tenderness of the neck/shoulder muscles ( total tenderness score of 0 to 32 ) , and isometric muscle strength at 10 weeks . Compared with the control group , neck/shoulder pain and tenderness , respectively , decreased 1.4 points ( 95 % confidence interval −2.0 to −0.7 , p group , muscle strength increased 2.0 Nm ( 95 % confidence interval 0.5 to 3.5 Nm , p = 0.01 ) in the 2‐minute group and 1.7 Nm ( 95 % confidence interval 0.2 to 3.3 Nm , p = 0.02 ) in the 12‐minute group . In conclusion , as little as 2 minutes of daily progressive resistance training for 10 weeks results in clinical ly relevant reductions of pain and tenderness in healthy adults with frequent neck/shoulder symptoms . Trial registration : www.is rct n.org/IS RCT N60264809 . In generally healthy adults with frequent neck/shoulder muscle pain , as little as 2 minutes of daily progressive resistance training reduces pain and tenderness",
"Objectives This study aim ed to evaluate the effects of an exercise programme focusing on muscle stretching and endurance training on the 12-month incidence of neck pain in office workers . Methods A 12-month prospect i ve cluster-r and omised controlled trial was conducted in healthy office workers with lower-than-normal neck flexion movement or neck flexor endurance . Participants were recruited from 12 large-scale enterprises . A total of 567 healthy office workers were r and omly assigned at the cluster level into either intervention ( n=285 ) or control ( n=282 ) groups . Participants in the intervention group received an exercise programme that included daily stretching exercise and twice-a-week muscle endurance training . Those in the control group received no intervention . The primary outcome measure was the 12-month incidence of neck pain , and the secondary outcome measures were pain intensity , disability level , and quality of life and health status . Analyses were performed using the Cox proportional hazard models . Results Over the 12-month follow-up , 12.1 % of participants in the intervention group and 26.7 % in the control group developed incident neck pain . Hazard rate ratios showed a protective effect of the exercise programme for neck pain ( HR=0.45 , 95 % CI 0.28 to 0.71 ) after adjusting for biopsychosocial factors . There was no significant difference in pain intensity , disability and quality of life and health status between those who reported incident neck pain in the intervention and control groups . Conclusions The exercise programme reduced incident neck pain and increased neck flexion movement for office workers with lower-than-normal neck flexion movement",
"OBJECTIVE To examine the annual incidence of acute whiplash injuries after road traffic crashes in a geographic catchment area in Northern Sweden during the period 2000 - 2009 . DESIGN Descriptive epidemiology determined by prospect ively collected data from a defined population . SETTING The study was conducted at a public hospital in Sweden . PARTICIPANTS The population of the hospital 's catchment area ( 136,600 inhabitants in 1999 and 144,500 in 2009 ) . METHODS At the emergency department , all injured persons ( approximately 11,000 per year ) were asked to answer a question naire about the injury incident . Data from the medical records also were analyzed . From 2000 - 2009 , 15,506 persons were injured in vehicle crashes . Persons who were subject to an acute neck injury within whiplash-associated disorder grade s 1 - 3 were included . The overall and annual incidences were calculated as incidence . Age , gender , type of injury event , and direction of impact were described . The incidences were compared with national statistics on insurance cl aims from 2003 , 2007 , and 2008 to detect changes in the proportions of cl aims . MAIN OUTCOME MEASURES The annual incidence of acute whiplash injuries . Secondary outcome measures were types of injury events , age and gender distribution , changes in the proportion of rear-end crashes during 2000 - 2009 , and changes in the proportion of insurance cl aims during 2003 - 2008 . RESULTS During 2000 - 2009 , 3297 cases of acute whiplash injury were encountered . The overall incidence was 235/100,000/year . The average yearly increase in incidence was 1.0 % . Women comprised 51.9 % and men 48.1 % of the injured . Car occupants ( 86.4 % ) and bicycle riders ( 6.1 % ) were most frequently injured . The proportion of rear-end crashes decreased from 55 % to 45 % from 2000 - 2009 . The proportion of insurance cl aims significantly decreased between 2003 and 2008 ( P < .0001 , χ(2 ) test ) . CONCLUSION The incidence of emergency department visits attributable to acute whiplash injuries after road traffic crashes have been relatively stable during the past decade in our area , except in 2007 and 2008 , when a peak occurred",
"BACKGROUND CONTEXT Although the use of deep heat therapy is widespread , there is scant literature available on its effectiveness in treating back or neck pain . PURPOSE The purpose of this study was to determine the efficacy of microwave diathermy to treat nonspecific chronic neck pain . DESIGN The study was design ed as a double-blind , r and omized controlled trial . PATIENT SAMPLE The patient sample consisted of 149 patients with nonspecific chronic neck pain in a hospital of the And alusian Public Health Care System , Spain OUTCOME MEASURES The study outcome measures are as follows : at baseline , pain intensity ( using a visual analogue scale ) , disability ( Neck Disability Index ) , and health-related quality of life ( 36-item short form health survey [ SF-36 ] ) ; at 3 weeks , baseline measures and patients ' perceived overall outcome and satisfaction with the treatment ; and at 6 months , 3-week measures , therapeutic co- interventions , and adherence to exercises . METHODS Patients were allocated r and omly to three groups . The first group received continuous microwave diathermy , the second group was administered pulsed microwaves , and the third group ( the control group ) received unplugged microwaves . All three groups received the same general treatment : range of motion , isometric exercises , and transcutaneous electrical nerve stimulation . RESULTS The three groups had reduced pain and disability , and improvement was seen in some dimensions of the SF-36 . However , there were no differences found in any of the parameters measured among the three therapeutic groups . CONCLUSIONS Microwave diathermy does not provide additional benefit to a treatment regimen of chronic neck pain that already involves other treatment approaches",
"OBJECTIVE To evaluate the effect of neck coordination exercise on sensorimotor function in women with neck pain compared with best-available treatment and sham treatment . DESIGN Observer-blinded r and omized controlled trial with short-term and 6-month follow-ups . SUBJECTS Women with chronic non-specific neck pain were r and omized to 3 groups : neck coordination exercise with a novel training device ; strength training for the neck and shoulders ; or massage . Each group had 36 participants . METHODS The intervention period was 11 weeks with 22 individually supervised sessions . Primary outcomes were postural sway measures and precision of goal -directed arm movements . Secondary outcomes were range of motion for the neck , peak speed of axial rotation , and neck pain . A repeated measures multivariate analysis of variance ( MANOVA ) was conducted separately on the primary outcomes for the short-term and 6-month evaluations and on the sensorimotor secondary outcomes for the 6-month effect . The 6-month effect on pain was analysed with a repeated measures analysis of variance ( ANOVA ) . RESULTS No significant treatment effects in favour of neck coordination exercise were found for short-term or 6-month evaluations . CONCLUSION Neck coordination exercise is no better than strength training and massage in improving sensorimotor function . Further research should investigate the use of cut-offs for sensorimotor dysfunctions prior to proprioceptive or coordinative training",
"STUDY DESIGN R and omized controlled trial . Objective To determine if force magnitude during posterior-to-anterior mobilization affects immediate and short-term outcomes in patients with chronic , nonspecific neck pain . BACKGROUND The optimal dose of mobilization to effectively treat patients with neck pain is not known . METHODS Patients with neck pain of at least 3 months in duration ( n = 64 ) were r and omized to receive a single treatment of posterior-to-anterior mobilization applied with 30 N or 90 N of mean peak force ( 3 sets of 30 seconds ) or a placebo ( detuned laser ) on the spinous process at the painful spinal level . Pressure pain threshold , pain measured with a visual analog scale ( range , 0 - 100 mm ) , cervical range of motion , and spinal stiffness at the painful spinal level ( measured with a custom device and normalized as a percentage of C7 stiffness ) were assessed before , immediately after , and at a mean ± SD follow-up of 4.0 ± 1.8 days following treatment . Repeated- measures analysis of covariance and Bonferroni-adjusted post hoc tests determined group differences for each outcome measure after treatment and at follow-up . RESULTS At follow-up , the 90-N group had less pain than the 30-N group ( mean difference , 11.3 mm ; 95 % confidence interval : 0.1 , 22.6 mm ; P = .048 ) and lower stiffness than the placebo group ( mean difference , 17.5 % ; 95 % confidence interval : 4.2 % , 30.9 % ; P = .006 ) . These differences were not present immediately after treatment . There were no significant between-group differences in pressure pain threshold or range of motion after treatment or at follow-up . CONCLUSION A specific dose of mobilization , in terms of applied force , appears necessary for reducing stiffness and potentially pain in patients with chronic neck pain . Changes were not observed immediately after mobilization , suggesting that its effects are not directly mechanical . TRIAL REGISTRATION Australian and New Zeal and Clinical Trials Registry ( http://www.anzctr.org.au/ ) : ACTRN12611000374965 . LEVEL OF EVIDENCE Therapy , level 1b-",
"To evaluate the role of manual therapy with exercise regime versus exercise regime alone in the management of non-specific chronic neck pain . In this 62 subjects r and omized controlled trial 31 subjects in group A received manual therapy ( manipulation ) with supervised exercise regime whilst 31 subjects in group B performed only supervised exercise regime for the period of 3 weeks . Both groups had a home exercise program consisted of strengthening exercises for neck/scapuluar stability , stretching and general range of motion exercises for neck with advice regarding posture awareness and correction for 3 months . The results suggested significant reduction in pain intensity level in both groups ; over 3 weeks and 12 weeks ' time period in relation to baseline on visual analog scale ( p=0.001 ) . Similarly , statistically significant improvements noticed in Neck Disability Index ( NDI ) ( p=0.0001 ) in both groups while looking at baseline data with reference to 12 weeks ' time period . On closer inspection , the manual therapy ( manipulation ) with exercise regime appeared as a favorable treatment preference compared with exercise regime alone",
"STUDY DESIGN Secondary analysis of a r and omized clinical trial ( RCT ) . OBJECTIVES To perform a secondary analysis on the treatment arm of a larger RCT to determine differences in treatment outcomes , adverse reactions , and effect sizes between patients who received cervical thrust manipulation and those who received only nonthrust manipulation as part of an impairment-based , multimodal treatment program of manual physical therapy ( MPT ) and exercise for patients with mechanical neck pain . BACKGROUND A treatment regimen of MPT and exercise has been effective in patients with mechanical neck pain . Limited research has compared the effectiveness of cervical thrust manipulations and nonthrust mobilizations for this patient population , and no studies have investigated the added benefit of cervical thrust manipulations as part of an overall MPT treatment plan . METHODS Treatment outcomes from 47 patients in the treatment arm of a larger RCT , with a primary complaint of mechanical neck pain , were analyzed . Twenty-three patients ( 49 % ) received cervical thrust manipulations as part of their MPT treatment , and 24 patients ( 51 % ) received only cervical nonthrust mobilizations . All patients received up to 6 clinic sessions , twice weekly for 3 weeks , and a home exercise program . Primary outcome measures were the Neck Disability Index ( NDI ) , 2 visual analog scales for cervical and upper extremity pain , and a 15-point global rating of change scale . Blinded outcome measurements were collected at baseline and at 3- , 6- and 52-week follow-ups . RESULTS Consistent with the larger RCT , both subgroups in this secondary analysis demonstrated improvement in short- and long-term pain and disability scores . Low statistical power ( beta adverse reactions were reported by patients in either subgroup . CONCLUSIONS Clinical ly meaningful and statistically significant improvements in both subgroups of patients over time suggest that cervical thrust manipulation , as part of the MPT treatment plan , did not influence the results of the treatment arm of the larger RCT from which this study was drawn . Although no between-group differences can be identified , the small observed effect sizes in this study may benefit future studies with sample size estimation for larger RCTs and indicate the need to incorporate clinical prediction rule criteria as a means to improve statistical power . LEVEL OF EVIDENCE Therapy , level 4",
"UNLABELLED A r and omized controlled trial comparing manipulation with mobilization for recent onset neck pain . OBJECTIVE To determine whether neck manipulation is more effective for neck pain than mobilization . DESIGN R and omized controlled trial with blind assessment of outcome . SETTING Primary care physiotherapy , chiropractic , and osteopathy clinics in Sydney , Australia . PARTICIPANTS Patients ( N=182 ) with nonspecific neck pain less than 3 months in duration and deemed suitable for treatment with manipulation by the treating practitioner . INTERVENTIONS Participants were r and omly assigned to receive treatment with neck manipulation ( n=91 ) or mobilization ( n=91 ) . Patients in both groups received 4 treatments over 2 weeks . MAIN OUTCOME MEASURE The number of days taken to recover from the episode of neck pain . RESULTS The median number of days to recovery of pain was 47 in the manipulation group and 43 in the mobilization group . Participants treated with neck manipulation did not experience more rapid recovery than those treated with neck mobilization ( hazard ratio=.98 ; 95 % confidence interval , .66 - 1.46 ) . CONCLUSIONS Neck manipulation is not appreciably more effective than mobilization . The use of neck manipulation therefore can not be justified on the basis of superior effectiveness",
"Objective : Coping is shown to affect outcomes in chronic pain patients ; however , few studies have examined the role of coping in the course of recovery in whiplash-associated disorders ( WAD ) . The purpose of this study was to determine the predictive value of coping style for 2 key aspects of WAD recovery , reductions in neck pain , and in disability . Methods : A population -based prospect i ve cohort study design was used to study 2986 adults with traffic-related WAD . Participants were assessed at baseline , 6 weeks , and 4 , 8 , and 12 months postinjury . Coping was measured at 6 weeks using the Pain Management Inventory , and neck pain recovery was assessed at each subsequent follow-up , using a 100 mm visual analogue scale ( VAS ) . Disability was assessed at each follow-up using the Pain Disability Index ( PDI ) . Pain recovery was defined as a VAS score of 0 to 10 ; disability recovery was defined as a PDI score of 0 to 4 . Data analysis used multivariable Cox proportional hazards models . Results : Those using high versus low levels of passive coping at 6 weeks postinjury experienced 28 % slower pain recovery and 43 % slower disability recovery . Adjusted hazard rate ratios for pain recovery and disability recovery were 0.72 ( 95 % CI , 0.59 - 0.88 ) and 0.57 ( 95 % CI , 0.41 - 0.78 ) , respectively . Active coping was not associated with recovery of neck pain or disability . Conclusions : Passive coping style predicts neck pain and self-assessed disability recovery . It may be beneficial to assess and improve coping style early in WAD",
"Purpose Health and safety training program has been applied to prevent work-related musculoskeletal disorders ( MSDs ) in workplace . We evaluated the effectiveness of participatory training and didactic training programs on MSD prevention among frontline workers in Shenzhen , China . Methods The authors r and omly assigned 918 workers from intervention factories to receive participatory training ( intervention group ) , and 907 workers from intervention factories and 1,654 workers from control factories to receive didactic training ( control_1 group , control_2 group , respectively ) from June 1 , 2008 to November 30 , 2009 . Participants were asked to report experience of ache , pain or discomfort in 10 body parts at baseline and 1 year after training . Data were analyzed to compare the MSD prevalence 1 year before and 1 year after training in different groups from 2009 to 2010 . Results The follow-up rate was 61 % ( 2,120/3,479 ) at 1 year after training . In the year after training , there were no statistically significant changes in the proportion of workers who reported MSD in any body part . MSD prevalence rates in the intervention group reduced from 16.8 to 9.9 % for lower extremities ( χ2 = 13.102 , p upper back , lower back , neck , shoulder and elbow in the intervention group and for all 10 body parts in two control groups . Conclusions Overall , the training programs did not seem to prevent the occurrence of MSD among frontline workers . However , participatory training might be effective to reduce MSD in the lower extremities and wrist and finger",
"Study Design . R and omized controlled trial using mixed methods . Objective . To evaluate the relative effectiveness of high-dose supervised exercise with and without spinal manipulation and low-dose home exercise for chronic neck pain . Summary of Background Data . Neck pain is a common global health care complaint with considerable social and economic impact . Systematic review s have found exercise therapy ( ET ) to be effective for neck pain , either alone or in combination with spinal manipulation . However , it is unclear to what extent spinal manipulation adds to supervised exercise or how supervised high-dose exercise compares with low-dose home exercise . Methods . Two hundred and seventy patients with chronic neck pain were studied at an outpatient clinic . Patients were r and omly assigned one of the following interventions : ( 1 ) high-dose supervised strengthening exercise with spinal manipulation ( exercise therapy combined with spinal manipulation therapy [ ET + SMT ] ) , ( 2 ) high-dose supervised strengthening exercise ( ET ) alone , or ( 3 ) low-dose home exercise and advice ( HEA ) . The primary outcome was patient-rated pain at baseline and at 4 , 12 , 26 , and 52 weeks . Secondary measures were disability , health status , global perceived effect , medication use , and satisfaction . Results . At 12 weeks , there was a significant difference in patient-rated pain between ET + SMT and HEA ( 1.3 points , P patient-rated pain at 52 weeks ( ET + SMT vs. HEA , 0.2 points , P > 0.05 ; ET vs. HEA , 0.3 points , P > 0.05 ) , linear mixed model analyses incorporating all time points yielded a significant advantage for the 2 supervised exercise groups ( ET + SMT vs. HEA , P = 0.03 ; ET vs. HEA , P = 0.02 ) . Similar results were observed for global perceived effect and satisfaction . Conclusion . Supervised strengthening exercise with and without spinal manipulation performed similarly , yielding better outcomes than home exercise particularly in the short term . Various stakeholders ' perspectives should be considered carefully when making recommendations regarding these therapies , taking into account side effects , preferences , and costs",
"OBJECTIVE To determine whether the Feldenkrais method is an effective intervention for chronic neck/scapular pain in patients with visual impairment . DESIGN R and omized controlled trial with an untreated control group . SETTING Low vision center . PARTICIPANTS Patients ( N=61 ) with visual impairment ( mean , 53.3 y ) and nonspecific chronic ( mean , 23.8 y ) neck/scapular pain . INTERVENTIONS Participants were r and omly assigned to the Feldenkrais method group ( n=30 ) or untreated control group ( n=31 ) . Patients in the treatment group underwent one 2-hour Feldenkrais method session per week for 12 consecutive weeks . MAIN OUTCOME MEASURES Blind assessment of perceived pain ( visual analog scale [ VAS ] ) during physical therapist palpation of the left and right occipital , upper trapezius , and levator scapulae muscle areas ; self-assessed degree of pain on the Visual , Musculoskeletal , and Balance Complaints question naire ; and the Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain scale . RESULTS Patients undergoing Feldenkrais method reported significantly less pain than the controls according to the VAS and Visual , Musculoskeletal , and Balance Complaints question naire ratings at posttreatment follow-up and 1-year follow-up . There were no significant differences regarding the Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain scale ratings . CONCLUSIONS Feldenkrais method is an effective intervention for chronic neck/scapular pain in patients with visual impairment",
"Prospect i ve single cohort study . To evaluate the NDI by comparison with the SF36 health Survey Question naire . The NDI is a simple ten-item question naire used to assess patients with neck pain . The SF36 measures functional ability , well being and the overall health of patients . It is used as a gold st and ard in health economics to assess the health utility , gain and economic impact of medical interventions . One hundred and sixty patients with neck pain attending the spinal clinic completed self- assessment question naires . A second question naire was completed in 34 patients after a period of 1–2 weeks . The internal consistency of the NDI and SF36 was calculated using Cronbach ’s alpha . The test – retest reliability was assessed using the Bl and and Altman method . The concurrent validity of the NDI with respect to the SF-36 was assessed using Pearson correlations . Both question naires showed robust internal consistency : Cronbach ’s alpha for the NDI scale was acceptable ( 0.864 , 95 % confidence limits 0.825–0.894 ) though slightly smaller than that of the SF36 . The correlations between each item of the NDI scores and the total NDI score ranged from 0.447 to 0.659 , ( all with P The test – retest reliability of the NDI was high ( intra-class correlation 0.93 , 95 % confidence limits 0.86–0.97 ) and comparable with the best values found for SF36 . The correlations between NDI and SF36 domains ranged from −0.45 to −0.74 ( all with P < 0.001 ) . We have shown that the NDI has good reliability and validity and that it compares well with the SF36 in the spinal surgery out patient setting",
"OBJECTIVE The purpose of this study was to investigate the immediate and long-term effects of a 1-year multimodal program with the addition of 2 different traction approaches on the pain , function , disability , and nerve root function in patients with discogenic cervical radiculopathy ( CR ) . This study also attempted to identify the optimal traction angle based on the maximum recovery of the peak-to-peak amplitude of the flexor carpi radialis ( FCR ) H-reflex . METHODS This r and omized clinical trial with one-year follow-up included a total of 216 ( 101 female ) patients with unilateral lower discogenic CR were r and omly assigned to 1 of 3 groups . The st and ard care group ( C ) received the multimodal program ( pain relief methods , muscle strengthening , and thoracic spine manipulation ) . The ventroflexion traction group ( A ) received the same multimodal program as group C , with added traditional ventroflexion traction . The novel traction group ( B ) received the same multimodal program as group C in addition to a flexor carpi radialis ( FCR ) H-reflex-based traction method . Primary outcomes were the Neck Disability Index ( NDI ) and secondary outcomes included neck pain , arm pain , and the amplitude and latency of the H-reflex . Patients were assessed at 3 intervals ( pre-treatment , 4 weeks post-treatment , and the 1-year follow-up ) . RESULTS The mixed linear model with repeated measures indicated a significant group × time effect in favor of the novel cervical traction group ( B ) for measures of NDI ( F = 412.6 , P .0005 ) , neck pain ( F = 108.9 , P .0005 ) , arm pain ( F = 91.3 , P ) , H- reflex amplitude ( F = 207.7 , P .0005 ) , and H-reflex latency ( F = 58.9 P added improved NDI , neck pain , arm pain , and the amplitude and latency of FCR H-reflex for a group of patients with chronic discogenic CR",
"Abstract Thoracic spine manipulation has been shown to be effective for the management of neck pain . The purpose of this study was to investigate the immediate effect of a T3–T4 spinal thrust manipulation on autonomic nervous system activity in subjects with chronic cervical pain . An additional aim was to determine if the manipulation result ed in an immediate pain relief in patients with chronic neck pain when compared to a placebo intervention . One hundred subjects with chronic neck pain were r and omly assigned to receive either a thoracic thrust manipulation or a placebo intervention . The Friedman 's test was used to evaluate the change in pupil diameter within both groups . The Wilcoxen signed-ranks test was used to explore pupil changes over time and to make paired comparisons of the pupil change between the groups . The Mann – Whitney U test was used to compare the change in pain perception for the chronic cervical pain group subjects receiving either the thrust manipulation or the placebo intervention . The results demonstrated that manipulation did not result in a change in sympathetic activity . Additionally , there was no significant difference in the subject 's pain perception ( P=0.961 ) when comparing the effects of the thrust manipulation to the placebo intervention within this group of subjects with chronic neck pain . The clinical impression of this study is that manipulation of the thoracic spine may not be effective in immediately reducing pain in patients with chronic neck pain",
"BACKGROUND The optimal type of exercise protocol in the physical rehabilitation of non-specific neck pain has not yet been established . Furthermore , the role of fear-avoidance belief in the maintenance of pain and disability has been highlighted . Research indicates that exercise may be a means to reduce fear-avoidance belief , but evidence is scarce . AIM To compare the effect of two different exercise programs on pain , strength and fear-avoidance belief . DESIGN R and omized clinical trial . SETTING A specialized outpatient hospital clinic in Denmark . POPULATION Twenty-three men and 60 women on sick leave due to non-specific neck pain . METHODS Participants were r and omized to either general physical activity ( GPA group ) or GPA and additional strength training of the neck and shoulder ( SST group ) . The primary outcome was pain intensity . Secondary outcomes were muscle strength of the neck and shoulder and fear-avoidance belief . RESULTS Pain was significantly reduced within groups with a median of -1 ( IQR : -3 to 0 , P Changes in strength did not differ between groups . Both groups experienced significant increases in neck flexion strength of 14.7 N ( IQR : -1 to 28.4 , P=0 . 001 ) in the SST group and 6.9 N ( IQR : -4.9 to18.6 , P=0.014 ) in the GPA group . Furthermore , the SST group achieved an increase of 18.6 N ( IQR : -2.6 to 69.7 , P=0.005 ) in neck extension . Fear-avoidance beliefs improved with 6 ( IQR : 3 to 12 , P subjects severely disabled by non-specific neck pain , there is no additional improvement on pain or muscle strength when neck exercises are given as a home-based program with a minimum of supervision . However , strength training of the painful muscles seems to be effective in decreasing fear-avoidance beliefs",
"Abstract And ersen , CH , And ersen , LL , Pedersen , MT , Mortensen , P , Karstad , K , Mortensen , OS , Zebis , MK , and Sjøgaard , G. Dose-response of strengthening exercise for treatment of severe neck pain in women . J Strength Cond Res 27(12 ) : 3322–3328 , 2013—Specific strength training is shown to relieve neck pain in office workers . The purpose of this study is to evaluate the effectiveness of specific strength training in women with severe neck pain and to analyze the dose – response relationship between training adherence and pain reduction . One hundred eighteen untrained women with severe neck pain ( > 30 mm VAS pain ) were included from a larger study , in which the subjects were r and omized to 20-week specific strength training for the neck/shoulders or to a control group . In the intention-to-treat analysis , the training group experienced greater pain relief than the control group ( p decreased pain by 35 mm VAS ( 95 % confidence interval : −26 to −44 ) from baseline to follow-up corresponding to a 70 % reduction . In the dose – response analyses , participants with medium and high training adherence showed better pain relief than the control group and those with low adherence ( p decrease from baseline in the medium and high adherence groups was 37 mm VAS ( 28–46 mm ) and 33 mm VAS ( 24–43 mm ) , respectively . Specific strength training reduces pain intensity in women with severe neck pain , and 1–2 training sessions per week for 20 weeks ( ∼30 training sessions ) seems sufficient for optimal pain relief ",
"Our purpose was to compare the effectiveness of three manual therapy techniques : high velocity , low amplitude ( HVLA ) , mobilization ( Mob ) and sustained natural apophyseal glide ( SNAG ) in patients with chronic neck pain ( CNP ) . The r and omized controlled trial included patients with mechanically reproducible CNP , who were r and omized to the treatment group . Outcome measures were the Visual Analogue scale ( VAS ) , Neck Disability Index ( NDI ) , Global Rating of Change ( GROC ) and Cervical Range of Motion ( CROM ) . Two-way repeated measures analysis of variance compared outcomes at baseline , at the end of treatment and 1 , 2 and 3 months after treatment . A total of 51 subjects completed the trial . No significant differences were found between HVLA , Mob and SNAG at the end of treatment and during the follow-up in any of the analysed outcomes . There were no differences in satisfaction for all techniques . The results lead to the conclusion that there is no long-term difference between the application of HVLA , Mob and SNAG in pain , disability and cervical range of motion for patients with CNP",
"UNLABELLED Chronic neck pain is a common medical complaint partly mediated by psychosocial distress and having a high socioeconomic impact . There is preliminary evidence that stress reduction by meditation might be beneficial in chronic pain syndromes . We aim ed to evaluate the effectiveness of an 8-week meditation program ( jyoti meditation ) in patients with chronic neck pain by means of a r and omized clinical trial . Eighty-nine patients ( aged 49.7 ± 10.5 years , 73 female ) with chronic neck pain who scored > 40 mm on a 100-mm visual analog scale and had concomitant increased perceived stress were r and omized to an 8-week meditation program ( jyoti meditation ) with weekly 90-minute classes ( n = 45 ) or to a home-based exercise program ( n = 44 ) with a wait list offer for meditation . Both groups were instructed to practice at home . Outcomes were assessed at baseline and after 8 weeks . Primary outcome measure was change of mean pain at rest ( visual analog scale score ) from baseline to week 8 . Secondary outcomes included pain at motion , functional disability , pain-related bothersomeness , perceived stress , quality of life , and psychological outcomes . Patients had neck pain for a mean of 11 years . Eighteen patients in the meditation group and 16 patients in the exercise group were lost to follow-up . Meditation training significantly reduced pain when compared to the exercise group after 8 weeks ( reduction of 45.5 ± 23.3 mm to 21.6 ± 17.2 mm in the meditation group , and 43.8 ± 22.0 mm to 37.7 ± 21.5 mm in the exercise group ; mean difference : 13.2 mm [ 95 % confidence interval : 2.1 , 24.4 ; P = .02 ] ) . Pain-related bothersomeness decreased more in the meditation group ( group difference 11.0 mm [ 95 % confidence interval : 1.0 , 21.0 ; P = .03 ] ) . No significant treatment effects were found for pain at motion , psychological scores , and quality of life , although the meditation group showed nonsignificant greater improvements compared to the exercise group . In conclusion , meditation may support chronic pain patients in pain reduction and pain coping . Further well- design ed studies including more active control comparisons and longer-term follow-up are warranted . PERSPECTIVE This article presents the results of a r and omized controlled trial on the clinical effects of an 8-week meditation program or self-care exercise in patients with chronic neck pain . Meditation reduced pain at rest but not disability and might be a useful treatment option for pain management of chronic neck pain",
"OBJECTIVES To determine if an educational intervention in the acute stage of whiplash injury may improve the recovery rate . METHODS Consecutive subjects were r and omized to one of two treatment groups : educational intervention or usual care . The intervention group received an educational pamphlet based on the current evidence . The control group did not receive these material s but received usual emergency department care and a st and ard nondirected discharge information sheet . Both groups underwent follow-up by telephone interview at two weeks and three months . The primary outcome measure of recovery was the patient 's response to the question , \" How well do you feel you are recovering from your injuries ? \" RESULTS A total of 112 subjects agreed to participate . Age , gender , precollision employment level and health , initial symptoms , collision parameters , and emergency treatments were similar between the groups . At two weeks postcollision , 7.3 % in the treatment group reported recovery compared with 8.8 % in the control group ( absolute risk difference , -1.5 % ; 95 % confidence interval = -12.6 % to 9.7 % ) . At three months postcollision , 21.8 % in the treatment group reported complete recovery compared with 21.0 % in the control group ( absolute risk difference , 0.8 % ; 95 % confidence interval = -14.4 % to 16.0 % ) . At three months , there were no clinical ly or statistically significant differences between groups in severity of remaining symptoms , limitations in daily activities , therapy use , medications used , lost time from work , or litigation . CONCLUSIONS An evidence -based educational pamphlet provided to patients at discharge from the emergency department is no more effective than usual care for patients with grade 1 or 2 whiplash-associated disorder",
"Myofascial pain syndrome ( MPS ) of the trapezius muscle is one of the main causes of neck pain . In this r and omized , double-blind study , we evaluated the effects of high-intensity laser therapy ( HILT ) in female patients with chronic MPS of the trapezius muscle . The patients were assigned to two groups . The HILT group was treated with HILT and exercise , and the sham therapy group was treated with placebo HILT and exercise . The patients were assessed for pain , cervical active range of motion , disability , and quality of life . Evaluations were performed before treatment ( week 0 ) and after treatment ( weeks 4 and 12 ) . Both groups showed significant improvement in all parameters at weeks 4 and 12 . However , in a comparison of the percentage changes in the parameters at weeks 4 and 12 relative to pretreatment values , the HILT group showed greater improvement in pain scores , the neck disability index , and several subparts of the short-form 36 health survey ( SF-36 ) ( physical functioning , role limitations due to physical functioning , bodily pain , general health perceptions , social functioning , and role limitations due to emotional problems ) than did the sham therapy group . We conclude that HILT is an effective therapeutic method in the treatment of patients with chronic MPS of the trapezius muscle",
"Summary This r and omised trial showed that multiprofessional stratified management had no effect beyond usual care in reducing transition rates to chronicity in patients with acute whiplash . ABSTRACT Acute whiplash is a heterogeneous disorder that becomes persistent in 40 % to 60 % of cases . Estimates of recovery have not changed in recent decades . This r and omized , single‐blind , controlled trial tested whether multidisciplinary individualized treatments for patients with acute whiplash ( could reduce the incidence of chronicity at 6 mo by 50 % compared to usual care . Participants ( n = 101 ) were recruited from accident and emergency centres and the community . It was hypothesized that better recovery rates were achievable if the heterogeneity was recognised and patients received individualised interventions . Patients r and omized to pragmatic intervention ( n = 49 ) could receive pharmaceutical management ( ranging from simple medications to opioid analgesia ) , multimodal physiotherapy and psychology for post‐traumatic stress according to their presentations . The treatment period was 10 wks with follow‐up at 11 weeks and 6 and 12‐months . The primary outcome was neck pain and disability ( Neck Disability Index ( NDI ) ) . Analysis revealed no significant differences in frequency of recovery ( NDI ≤8 % ) between pragmatic and usual care groups at 6 months ( OR 95 % , CI = 0.55 , 0.23–1.29 ) , P = 0.163 ) or 12 mo ( OR 95 % , CI = 0.65 , 0.28–1.47 , P = 0.297 ) . There was no improvement in current nonrecovery rates at 6 mo ( 63.6 % , pragmatic care ; 48.8 % , usual care ) , indicating no advantage of the early multiprofessional intervention . Baseline levels of pain and disability had a significant bearing on recovery both at 6 and 12 mo in both groups , suggesting that future research focus on finding early effective pain management , particularly for the subgroup of patients with initial high levels of pain and disability , towards improving recovery rates",
"Abstract This r and omized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders ( WAD ) . The setting was a single university centre and 4 physiotherapy practice s in Queensl and , Australia . Eighty patients with chronic WAD ( > 3 months ) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013 . The interventions were 6 weeks of dry-needling to posterior neck muscles ( n = 40 ) and exercise or sham dry-needling and exercise ( n = 40 ) . The primary outcomes of the Neck Disability Index ( NDI ) and self-rated recovery were measured at baseline , 6 and 12 weeks , 6 and 12 months by a blinded assessor . Analysis was intention to treat . An economic evaluation was planned but missing data deemed further analysis unwarranted . Seventy-nine patients ( 99 % ) were followed up at 6 weeks , 78 ( 98 % ) at 12 weeks , 74 ( 93 % ) at 6 months , and 73 ( 91 % ) at 12 months . The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks . The treatment effects were small and not clinical ly worthwhile . At 6 weeks , the treatment effect on the 0 - 100 NDI was −0.3 ( 95 % confidence interval −5.4 to 4.7 ) , 12 weeks −0.3 ( −5.2 to 4.9 ) , 6 months −4.4 ( −9.6 to −0.74 ) , and 12 months −3.8 ( −9.1 to −0.5 ) . There was no effect for self-rated recovery . In patients with chronic WAD , dry-needling and exercise has no clinical ly worthwhile effects over sham dry-needling and exercise",
"Evidence supports exercise-based interventions for the management of neck pain , however there is little evidence of its superiority over usual physiotherapy . This study investigated the effectiveness of a group neck and upper limb exercise programme ( GET ) compared with usual physiotherapy ( UP ) for patients with non-specific neck pain . A total of 151 adult patients were r and omised to either GET or UP . The primary measure was the Northwick Park Neck pain Question naire ( NPQ ) score at six weeks , six months and 12 months . Mixed modelling identified no difference in neck pain and function between patients receiving GET and those receiving UP at any follow-up time point . Both interventions result ed in modest significant and clinical ly important improvements on the NPQ score with a change score of around 9 % between baseline and 12 months . Both GET and UP are appropriate clinical interventions for patients with non-specific neck pain , however preferences for treatment and targeted strategies to address barriers to adherence may need to be considered in order to maximise the effectiveness of these approaches",
"Objective . In a cohort of primary care patients with chronic neck pain , to determine whether specific neck stabilization exercises , in addition to general neck advice and exercise , provide better clinical outcome at 6 weeks than general neck advice and exercise alone . Methods . This was a multicenter r and omized controlled trial in 4 physical therapy departments . Seventy-four participants ( mean age 51.3 yrs ) were r and omized to specific neck stabilization exercises with a general neck advice and exercise program ( n = 37 ) or a general neck advice and exercise program alone ( n = 37 ) . They attended a 1-hour clinical examination , followed by a maximum of 4 treatment sessions . Assessment s were undertaken at baseline , 6 weeks , and 6 months . The primary outcome was the Neck Pain and Disability Scale ( NPDS ) . Analysis was by intention to treat . Results . Seventy-one ( 96 % ) participants received their allocated intervention . There was 91 % followup at 6 weeks and 92 % followup at 6 months . The mean ( SD ) 6-week improvement ( reduction ) in NPDS score was 10.6 ( 20.2 ) for the specific exercise program and 9.3 ( 15.7 ) for the general exercise program . There were no significant between-group differences in the NPDS at either 6 weeks or 6 months . For secondary outcomes , participants in the specific exercise group were less likely to be taking pain medication at 6-week followup ( p = 0.02 ) . There were no other significant between-group differences . Conclusion . Adding specific neck stabilization exercises to a general neck advice and exercise program did not provide better clinical outcome overall in the physical therapy treatment of chronic neck pain",
"Objective : To determine the efficacy of Sustained Natural Apophyseal Glides ( SNAGs ) with and without Isometric Exercise Training Program ( IETP ) in Non-specific Neck Pain ( NSNP ) Methods : This r and omized control trial of one year duration was conducted at out-patient department of Physiotherapy and Rehabilitation , Khyber Teaching Hospital ( KTH ) Peshawar , Pakistan from July 2012 to June 2013 . The sample of 102 patients of NSNP were r and omly selected through simple r and om sampling technique , and placed into two groups . The SNAGs manual physical therapy technique with IETP was applied on 51 patients in group A and SNAGs manual physical therapy techniques was applied alone on 51 patients in group B. The duration of intervention was 6 weeks , at 4 times per week . The Neck Disability Index ( NDI ) and Visual Analog Scale ( VAS ) for neck pain were assessment tools used for all patients before and after 6 weeks of physical therapy intervention . All the patients were assessed through NDI and VAS before intervention and at the completion of 6 weeks program . The data of all 102 was analyzed by SPSS-20 and statistical test was applied at 95 % level of significance determine the efficacy of both the treatments interventions and compare with each other . Results : The patients in group A , treated with SNAGs and followed by IETP for 6 weeks , demonstrated more improvement in pain and physical activity as assessed by VAS ( p=0.013 ) and NDI ( p=0.003 ) , as compared to the patients treated with SNAGS alone , as pain and function assessed by VAS ( p=0.047 ) and NDI ( p=0.164 ) . In group A the NDI score improved from 40 to 15 and VAS from 7 to 4 , while in group B the NDI score improved from 42 to 30 and VAS from 7 to 4 . Conclusion : Patients with non-specific neck pain treated with SNAGs manual physical therapy techniques and followed by IETP was more effective in reduction of pain and enhancement of function , as compared to those patients treated with SNAGs manual physical therapy techniques alone",
"OBJECTIVE To explore perceptions of spinal manipulative therapy and exercise among adults aged 65 years and older with chronic neck pain . DESIGN Mixed methods study embedded within a r and omized clinical trial . SUBJECTS/ PATIENTS Interviews were conducted with 222 of 241 r and omized clinical trial participants . They had a mean age of 72.2 years and they had neck pain of moderate severity and of 6 years mean duration . METHODS Semi-structured interviews were conducted at the completion of the 12 week intervention phase , during which participants received spinal manipulative therapy and exercise interventions . Interviews explored determinants of satisfaction with care , whether or not therapy was worthwhile , and what was liked and disliked about treatment . Interviews were recorded and transcribed ; content analysis was used to identify themes within responses . RESULTS Participants placed high value on their relationships with health care team members , supervision , individualized care , and the exercises and information provided as treatment . Change in symptoms did not figure as prominently as social and process-related themes . Percpetions of age , activities , and co-morbities influenced some seniors ' expectations of treatment results , and comorbidities impacted perceptions of their ability to participate in active care . CONCLUSION Relationship dynamics should be leveraged in clinical encounters to enhance patient satisfaction and perceived value of care",
"Abstract Currently , large levels of practice variability exist regarding the clinical deactivation of trigger points . Manual physical therapy has been identified as a potential means of resolving active trigger points ; however , to date the ideal treatment approach has yet to be eluci date d. The purpose of this clinical trial was to compare the effects of two manual treatment regimens on individuals with upper trapezius trigger points . Sixty patients , 19–38 years of age with non-specific neck pain and upper trapezius trigger points , were r and omized into one of two , 4 week physical therapy programs . One group received muscle energy techniques while the second group received an integrated neuromuscular inhibition technique ( INIT ) consisting of muscle energy techniques , ischemic compression , and strain – counterstrain ( SCS ) . Outcomes including a visual analog pain scale ( VAS ) , the neck disability index ( NDI ) , and lateral cervical flexion range of motion ( ROM ) were collected at baseline , 2 and 4 weeks after the initiation of therapy . Results revealed large pre – post-effect sizes within the INIT group ( Cohen 's d = 0.97 , 0.94 and 0.97 ) . Additionally , significantly greater improvements in pain and neck disability and lateral cervical flexion ROM were detected in favor of the INIT group ( 0.29–0.57 , 0.57–1.12 and 0.29–0.57 ) at a 95 % CI respectively . The findings of this study indicate the potential benefit of an integrated approach in deactivating upper trapezius trigger points . Further research should be performed to investigate the long-term benefits of the current treatment approach",
"PURPOSE This trial was design ed to evaluate the optimal dose of massage for individuals with chronic neck pain . METHODS We recruited 228 individuals with chronic nonspecific neck pain from an integrated health care system and the general population , and r and omized them to 5 groups receiving various doses of massage ( a 4-week course consisting of 30-minute visits 2 or 3 times weekly or 60-minute visits 1 , 2 , or 3 times weekly ) or to a single control group ( a 4-week period on a wait list ) . We assessed neck-related dysfunction with the Neck Disability Index ( range , 0–50 points ) and pain intensity with a numerical rating scale ( range , 0–10 points ) at baseline and 5 weeks . We used log-linear regression to assess the likelihood of clinical ly meaningful improvement in neck-related dysfunction ( ≥5 points on Neck Disability Index ) or pain intensity ( ≥30 % improvement ) by treatment group . RESULTS After adjustment for baseline age , outcome measures , and imbalanced covariates , 30-minute treatments were not significantly better than the wait list control condition in terms of achieving a clinical ly meaningful improvement in neck dysfunction or pain , regardless of the frequency of treatments . In contrast , 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction ( relative risk = 3.41 and 4.98 , P = .04 and .005 , respectively ) and pain intensity ( relative risk = 2.30 and 2.73 ; P = .007 and .001 , respectively ) . CONCLUSIONS After 4 weeks of treatment , we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain . Clinicians recommending massage and research ers study ing this therapy should ensure that patients receive a likely effective dose of treatment",
"OBJECTIVE Strain-counterstrain is an osteopathic technique which is widely used for treating mobility restrictions in the neck . We aim ed to investigate whether a single strain-counterstrain intervention is more effective than a sham intervention in improving restricted cervical range of motion in patients with neck pain . METHODS 61 adult patients with neck pain and restricted cervical mobility were r and omly allocated to receive either a single strain-counterstrain intervention or a sham treatment . After outcome measurement all patients received full individualized osteopathic treatment . Mobility of the cervical spine was measured by a blinded observer using the Cervical Range of Motion ( CROM ) tool . In addition , patients rated pain intensity and assessed the treatment effect . The main outcome measure was the sum of changes in mobility restriction ( in % ) after treatment compared to normal mobility . RESULTS All patients completed the study . Mobility restriction decreased by 2.0 % ( SD 6.9 % ) in the group receiving strain-counterstrain treatment and 0.6 % ( SD 5.7 % ) in the group receiving sham treatment ( mean difference 1.5 % , 95 % confidence interval -1.7 to 4.8 % ; p=0.35 ) . There were no significant differences between groups for secondary outcomes . After receiving the full osteopathic treatment the group initially receiving strain-counterstrain improved by another 4.2 % ( 7.0 % ; p=0.003 ) and the group initially receiving sham by another 5.6 % ( SD 6.8 % ; p Strain-counterstrain as a single intervention did not have immediate effects on mobility and pain over a sham treatment . Future studies should probably focus on the investigation of full osteopathic treatment",
"Long 's manipulation ( LM ) is a representative Chinese manipulation approach incorporating both spinal manipulation and traditional Chinese massage ( TCM ) techniques . This r and omized controlled trial ( RCT ) aim ed to compare the immediate and short-term relative effectiveness of LM to TCM on patients with chronic neck pain . Patients were r and omly assigned to either LM group or TCM group . LM group was treated with Long 's manipulation , while the TCM group received TCM therapy . Patients attended 8 sessions of treatment ( one session every three days ) . Outcome measures included neck disability ( Northwick Park Neck Pain Question naire ; NPQ ) , pain intensity ( Numeric Pain Rating Scale ; NPRS ) , patient perceived satisfaction of care ( PPS ) ( 11-point scale ) , craniovertebral angle ( CV angle ) and cervical range of motion ( ROM ) . A blinded assessor performed assessment at baseline , immediate after treatment and 3 months post treatment . LM group achieved significantly greater improvement than TCM group in pain intensity ( p ( p = 0.049 ) and satisfaction ( p improvements in CV angle and most of cervical ROM between groups ( p = 0.169 ∼ 0.888 ) with an exception of flexion at 3-month follow-up ( p = 0.005 ) . This study shows that LM could produce better effects than TCM in relieving pain and improving disability in the management of patients with chronic mechanical neck pain",
"OBJECTIVE To determine the immediate effects on both pain and active range of motion ( ROM ) of the unilateral posteroanterior ( PA ) mobilization technique on the painful side in mechanical neck pain patients presenting with unilateral symptoms . DESIGN Triple-blind , r and omized controlled trial . SETTING Outpatient physical therapy , institutional clinic . PARTICIPANTS Patients ( N=60 ) , 2 physical therapists , and 1 assessor involved in this study . INTERVENTIONS The patients were r and omly allocated into either preferred or r and om mobilization group by using an opaque concealed envelope . The first therapist performed the screening , assessing , prescribing the spinal level(s ) , and the grade of mobilization . The second therapist performed the mobilization treatment according to their allocated group stated in an envelope . The assessor who was blind to the group allocation conducted the measurements of pain and active cervical ROM . MAIN OUTCOME MEASURES Pain intensity , active cervical ROM , and global perceived effect were measured at baseline and 5 minutes posttreatment . RESULTS After mobilization , there were no apparent differences in pain and active cervical ROM between groups . However , within-group changes showed significant decreases in neck pain at rest and pain on most painful movement ( P increase in active cervical ROM after mobilization on most painful movement ( P=0.002 ) . CONCLUSIONS The results of this study did not provide support for the preference of the unilateral PA mobilization on the painful side to the r and om mobilization",
"OBJECTIVES To examine the clinical effectiveness of a stepped care approach over a 12-month period after an acute whiplash injury ; to estimate the costs and cost-effectiveness of each strategy including treatments and subsequent health-care costs ; and to gain participants ' perspective on experiencing whiplash injury , NHS treatment , and recovery within the context of the Managing Injuries of the Neck Trial ( MINT ) . DESIGN Two linked , pragmatic , r and omised controlled trials . In Step 1 , emergency departments ( EDs ) were cluster r and omised to usual care advice ( UCA ) or The Whiplash Book advice (WBA)/active management advice . In Step 2 , participants were individually r and omised to either a single session of advice from a physiotherapist or a physiotherapy package of up to six sessions . An economic evaluation and qualitative study were run in parallel with the trial . SETTING Twelve NHS trusts in Engl and comprising 15 EDs . PARTICIPANTS People who attended EDs with an acute whiplash injury of whiplash-associated disorder grade s I-III were eligible for Step 1 . People who had attended EDs with whiplash injuries and had persistent symptoms 3 weeks after ED attendance were eligible for Step 2 . INTERVENTIONS In Step 1 , the control intervention was UCA and the experimental intervention was a psycho-educational intervention ( WBA/active management advice ) . In Step 2 the control treatment was reinforcement of the advice provided in Step 1 and the experimental intervention was a package of up to six physiotherapy treatments . MAIN OUTCOME The primary outcome was the Neck Disability Index ( NDI ) , which measures severity and frequency of pain and symptoms , and a range of activities including self-care , driving , reading , sleeping and recreation . Secondary outcomes included the mental and physical health-related quality -of-life ( HRQoL ) subscales of the Short Form question naire-12 items ( SF-12 ) and the number of work days lost . RESULTS A total of 3851 patients were recruited to Step 1 of the trial . 1598 patients attending EDs were r and omised to UCA , and 2253 were r and omised to WBA/active management . Outcome data were obtained at 12 months for 70 % and 80 % of participants at Step 1 and Step 2 , respectively . The majority of people recovered from the injury . Eighteen per cent of the Step 1 cohort had late whiplash syndrome . There was no statistically or clinical ly significant difference observed in any of the outcomes for participants attending EDs r and omised to UCA or active management advice [ difference in NDI 0.5 , 95 % confidence interval ( CI ) -1.8 to 2.8 ] . In Step 2 the physiotherapy package result ed in improvements in neck disability at 4 months compared with a single advice session , but these effects were small at the population level ( difference in NDI -3.2 , 95 % CI -5.8 to -0.7 ) . The physiotherapy package was accompanied by a significant reduction in the number of work days lost at 4-month follow-up ( difference -40.2 , 95 % CI -44.3 to -35.8 ) . CONCLUSIONS MINT suggests that enhanced psycho-educational interventions in EDs are no more effective than UCA in reducing the burden of acute whiplash injuries . A physiotherapy package provided to people who have persisting symptoms within the first 6 weeks of injury produced additional short-term benefits in neck disability compared with a single physiotherapy advice session . However , from a health-care perspective , the physiotherapy package was not cost-effective at current levels of willingness to pay . Both experimental treatments were associated with increased cost with no discernible gain in health-related quality of life . However , an important benefit of the physiotherapy package was a reduction in work days lost ; consequently , the intervention may prove cost-effective at the societal level . TRIAL REGISTRATION Current Controlled Trials IS RCT N33302125 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 16 , No. 49 . See the HTA programme website for further project information",
"BACKGROUND Mechanical neck pain is a common condition that affects an estimated 70 % of persons at some point in their lives . Little research exists to guide the choice of therapy for acute and subacute neck pain . OBJECTIVE To determine the relative efficacy of spinal manipulation therapy ( SMT ) , medication , and home exercise with advice ( HEA ) for acute and subacute neck pain in both the short and long term . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00029770 ) SETTING 1 university research center and 1 pain management clinic in Minnesota . PARTICIPANTS 272 persons aged 18 to 65 years who had nonspecific neck pain for 2 to 12 weeks . INTERVENTION 12 weeks of SMT , medication , or HEA . MEASUREMENTS The primary outcome was participant-rated pain , measured at 2 , 4 , 8 , 12 , 26 , and 52 weeks after r and omization . Secondary measures were self-reported disability , global improvement , medication use , satisfaction , general health status ( Short Form-36 Health Survey physical and mental health scales ) , and adverse events . Blinded evaluation of neck motion was performed at 4 and 12 weeks . RESULTS For pain , SMT had a statistically significant advantage over medication after 8 , 12 , 26 , and 52 weeks ( P ≤ 0.010 ) , and HEA was superior to medication at 26 weeks ( P = 0.02 ) . No important differences in pain were found between SMT and HEA at any time point . Results for most of the secondary outcomes were similar to those of the primary outcome . LIMITATIONS Participants and providers could not be blinded . No specific criteria for defining clinical ly important group differences were prespecified or available from the literature . CONCLUSION For participants with acute and subacute neck pain , SMT was more effective than medication in both the short and long term . However , a few instructional sessions of HEA result ed in similar outcomes at most time points . PRIMARY FUNDING SOURCE National Center for Complementary and Alternative Medicine , National Institutes of Health",
"Purpose To investigate whether a work-site strength-training program has a positive effect on self-reported psychosocial workplace factors and job satisfaction . Methods We conducted a r and omized controlled trial among laboratory technicians implementing neck and shoulder exercises for pain relief , with 199 participants in the training group and 228 in the control group . Influence at work , sense of community , time pressure , and job satisfaction were measured with the Copenhagen Psychosocial Question naire at baseline and post-intervention after 20 weeks . Results There was no statistically significant change in any of the four variables in the training group from baseline to follow-up ( all p ≥ 0.39 ) . When we used MANOVA to test for between-group effects over time , we did not find any statistically significant result ( all p > 0.14 ) . Conclusions This study does not provide evidence for an effect of a work-site strength-training program on self-reported psychosocial workplace factors and job satisfaction ",
"Objective To observe the clinical effect of acupuncture in treating cervical spondylosis with different syndrome types . Methods One hundred and seventeen patients were r and omized into the treated group : ( 59 cases ) , treated with normal acupuncture , and the control group ( 58 cases ) , treated with sham acupuncture , operated once every other day , 9 times in total ( in 18 days ) as one therapeutic course , and a succeeding 3-month follow-up study was carried out after terminating the therapy . The efficacy of treatment was evaluated with the Northwick Park Neck Pain Question naire ( NPQ ) and Visual Analogue Scale ( VAS ) , and the scores gained in patients with different syndrome types were analyzed with a general linear model . Results The NPQ and VAS : scores showed a linear decreasing tendency in both groups at the time of ending treatment and the 1st month of follow-up , but showed a secondary curve increasing tendency in the 3rd month of follow-up . Multivariate analysis showed the difference was of statistical significance ( P VAS score ( P NPQ score ( P>0.05 ) . Conclusion Acupuncture shows : good immediate effect in treating cervical spondylosis , but its long-term effect is not satisfactory . The difference in syndrome type may have some impact on the effects of acupuncture in alleviating pain , but exerts no evident influence on the comprehensive effect",
"STUDY DESIGN R and omized clinical trial . OBJECTIVE To compare the effectiveness of cervical spine thrust manipulation to that of Kinesio Taping applied to the neck in individuals with mechanical neck pain , using self-reported pain and disability and cervical range of motion as measures . BACKGROUND The effectiveness of cervical manipulation has received considerable attention in the literature . However , because some patients can not tolerate cervical thrust manipulation , alternative therapeutic options should be investigated . METHODS Eighty patients ( 36 women ) were r and omly assigned to 1 of 2 groups : the manipulation group , which received 2 cervical thrust manipulations , and the tape group , which received Kinesio Taping applied to the neck . Neck pain ( 11-point numeric pain rating scale ) , disability ( Neck Disability Index ) , and cervical-range-of-motion data were collected at baseline and 1 week after the intervention by an assessor blinded to the treatment allocation of the patients . Mixed-model analyses of variance were used to examine the effects of the treatment on each outcome variable , with group as the between-subjects variable and time as the within-subjects variable . The primary analysis was the group-by-time interaction . RESULTS No significant group-by-time interactions were found for pain ( F = 1.892 , P = .447 ) or disability ( F = 0.115 , P = .736 ) . The group-by-time interaction was statistically significant for right ( F = 7.317 , P = .008 ) and left ( F = 9.525 , P = .003 ) cervical rotation range of motion , with the patients who received the cervical thrust manipulation having experienced greater improvement in cervical rotation than those treated with Kinesio Tape ( P cervical spine range of motion for flexion ( F = 0.944 , P = .334 ) , extension ( F = 0.122 , P = .728 ) , and right ( F = 0.220 , P = .650 ) and left ( F = 0.389 , P = .535 ) lateral flexion . CONCLUSION Patients with mechanical neck pain who received cervical thrust manipulation or Kinesio Taping exhibited similar reductions in neck pain intensity and disability and similar changes in active cervical range of motion , except for rotation . Changes in neck pain surpassed the minimal clinical ly important difference , whereas changes in disability did not . Changes in cervical range of motion were small and not clinical ly meaningful . Because we did not include a control or placebo group in this study , we can not rule out a placebo effect or natural changes over time as potential reasons for the improvements measured in both groups . LEVEL OF EVIDENCE Therapy , level 1b",
"Study Design . R and omized controlled trial . Objective . To evaluate whether qigong is more effective than no treatment and not inferior to exercise therapy . Summary of Background Data . Lifetime prevalence of chronic neck pain is close to 50 % . Qigong is often used by patients , although , the evidence is still unclear . Methods . Patients ( aged 20–60 years ) with chronic neck pain ( visual analog scale , VAS ≥40 mm ) were r and omized to 1 ) qigong or 2 ) exercise therapy ( 18 sessions over 6 months ) or 3 ) waiting list ( no treatment ) . At baseline and after 3 and 6 months , patients completed st and ardized question naires assessing neck pain ( VAS ) , neck pain and disability , and quality of life ( Short Form SF-36 question naire , SF-36 ) . The primary endpoint was average pain in the last 7 days on VAS at 6-month follow-up . Statistical analysis included generalized estimation equation models adjusted for baseline values and patient expectation . Results . A total of 123 patients ( aged 46 ± 11 years , 88 % women ) suffering from chronic neck pain for 3.2 ( SD ± 1.6 ) years were included . After 6 months , a significant difference was seen between the qigong and waiting list control groups ( VAS mean difference : −14 mm [ 95 % CI = −23.1 to −5.4 ] , P = 0.002 ) . Mean improvements in the exercise group were comparable to those in the qigong group ( difference between groups −0.7 mm [ CI = −9.1 to 7.7 ] ) but failed to show statistical significance ( P = 0.092 ) . Neck pain and disability , and SF-36 results also yielded superiority of qigong over no treatment and similar results in the qigong and exercise therapy groups . Conclusion . Qigong was more effective than no treatment in patients with chronic neck pain . Further studies could be design ed without waiting list control and should use a larger sample to clarify the value of qigong compared to exercise therapy",
"The Scottish Intercollegiate Guidelines Network ( SIGN ) develops evidence based clinical guidelines for the NHS in Scotl and . The key elements of the methodology are ( a ) that guidelines are developed by multidisciplinary groups ; ( b ) they are based on a systematic review of the scientific evidence ; and ( c ) recommendations are explicitly linked to the supporting evidence and grade d according to the strength of that evidence . Until recently , the system for grading guideline recommendations was based on the work of the US Agency for Healthcare Research and Quality ( formerly the Agency for Health Care Policy and Research ) . 1 2 However , experience over more than five years of guideline development led to a growing awareness of this system 's weaknesses . Firstly , the grading system was design ed largely for application to questions of effectiveness , where r and omised controlled trials are accepted as the most robust study design with the least risk of bias in the results . However , in many areas of medical practice r and omised trials may not be practical or ethical to undertake ; and for many questions other types of study design may provide the best evidence . Secondly , guideline development groups often fail to take adequate account of the method ological quality of individual studies and the overall picture presented by a body of evidence rather than individual studies or they fail to apply sufficient judgment to the overall strength of the evidence base and its applicability to the target population of the guideline . Thirdly , guideline users are often not clear about the implication s of the grading system . They misinterpret the grade of recommendation as relating to its importance , rather than to the strength of the supporting evidence , and may therefore fail to give due weight to low grade recommendations . # # # # Summary points A revised system of determining levels of evidence and grade s",
"Purpose : To evaluate whether long-term neck and upper body exercises conducted in economical community-based outpatient clinic and home-based setting s could improve health-related quality of life (HRQoL)for individuals affected by chronic neck pain . The effect of baseline HRQoL and neck pain values on training adherence was also studied . Methods : Subjects ( n = 101 , 91 women/10 men , mean age 41.0 ± 9.5 years ) with chronic non-specific neck pain were r and omized to a combined strength-training and stretching-exercise group ( CSSG , n = 49 ) or to a stretching exercise group ( SG , n = 52 ) . HRQoL was assessed at baseline and after 12 months using the R AND -36 question naire . Comparisons between groups were performed using bootstrap-type analysis of covariance . The impact of HRQoL and neck pain values on training adherence , determined using participants ’ exercise logs , was studied using generalized estimating equations . Results : CSSG showed significant improvements in five and SG in four of eight of the HRQoL dimensions . There were no significant differences between the groups . Adherence to long-term training was only slightly affected by baseline-assessed HRQoL and neck pain values . Conclusions : The two training protocol s were feasible and equally effective in improving HRQoL. Baseline HRQoL and pain values had only a minor effect on training adherence . Implication s for Rehabilitation Long-term strength training and stretching are effective in improving HRQoL in people with chronic neck pain . Baseline HRQoL and neck pain values have little effect on training adherence",
"Objective : The aim of this study was to evaluate a tailored physical activity protocol performed in a work environment with a group of female workers employed in manual precision tasks to reduce upper limb pain . Methods : Sixty female subjects were r and omly assigned to an intervention group or a control group . The IG was administered of a 6-month , twice-a-week , tailored exercise program , whereas the CG received no intervention . Results : The IG showed a reduction on shoulder pain accompanied by increases on the range of motion measures . In addition , reductions in upper limb pain and neck disability were detected with concomitant increases in grip strength . Conclusions : This study indicated positive effects of a tailored workplace exercise protocol in female workers exposed to moderate risk for work-related musculoskeletal disorders , showing clinical ly meaningful reductions of pain symptoms and disability on upper limb and neck regions",
"& NA ; The purpose of the study was to examine the effects of a workplace physical exercise intervention on the perceived intensity of headache and the intensity of symptoms in the neck and shoulders , as well as on the extension and flexion strength of the upper extremities . The study was a cluster r and omized controlled trial . The cross‐over design consisted of physical exercise intervention ( 15 weeks ) and no‐intervention ( 15 weeks ) . The subjects ( n=53 ) were office workers ( mean age 46.6 ( SD 8.4 ) ) who reported headache ( n=41 ) symptoms in the neck ( n=37 ) or shoulders ( n=41 ) , which had restricted their daily activities during the last 12 months . Pain symptoms were measured using the Borg CR10 scale and muscular strength with a 5RM test . Statistical analyses were based on linear mixed models . Physical exercise intervention result ed in a slight , but statistically significant , decrease in the intensity of headache and neck symptoms , as well as an increase in the extension strength of the upper extremities . The mean decrease in headache during the 5‐week period was 0.64 CR10 ( 95 % CI 0.28–1.00 ) ( P=0.001 ) or 49 % ( 95 % CI 22–77 ) , and 0.42 CR10 ( 95 % CI 0.11–0.72 ) ( P=0.002 ) or 49 % ( 95 % CI 13–85 ) in the intensity of neck symptoms . The mean increase in the extension strength of the upper extremities was 1.3 kg ( 95 % CI 0.5–2.1 ) ( P=0.001 ) or 4 % ( 95 % CI 1–6 ) . The intervention had no effect on the intensity of shoulder symptoms or the flexion strength of the upper extremities . Specific exercise may be clinical ly important to alleviate headache and neck symptoms ",
"Purpose . To determine the immediate effects of the central posteroanterior ( PA ) mobilization technique on both pain and active cervical range of motion in patients with mechanical neck pain presenting with central or bilateral symptoms . Methods . A r and omized controlled trial was conducted in 60 patients who were r and omly allocated into either ‘ central PA ’ or ‘ r and om ’ mobilization group . Two physical therapists and one assessor participated . Outcome measures included neck pain at rest , pain on the most painful movement , and active cervical range of motion taken before and immediately 5 min after the mobilization treatment . Results . Significant reductions in pain at rest and on the most painful movement were noted within-group comparisons ( p ‘ central PA ’ mobilization group obtained a significantly greater reduction in pain on the most painful movement than the ‘ r and om ’ mobilization group ( p active cervical range of motion . However , the differences in the means of pain reduction between both mobilization techniques were modest ( central PA mobilization technique for treating patients with central or bilateral mechanical neck pain is therefore arguably",
"OBJECTIVE We evaluated the inter-rater reliability ( IRR ) of assessing the quality of evidence ( QoE ) using the Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) approach . STUDY DESIGN AND SETTING On completing two training exercises , participants worked independently as individual raters to assess the QoE of 16 outcomes . After recording their initial impression using a global rating , raters grade d the QoE following the GRADE approach . Subsequently , r and omly paired raters su bmi tted a consensus rating . RESULTS The IRR without using the GRADE approach for two individual raters was 0.31 ( 95 % confidence interval [ 95 % CI ] = 0.21 - 0.42 ) among Health Research Methodology students ( n = 10 ) and 0.27 ( 95 % CI = 0.19 - 0.37 ) among the GRADE working group members ( n = 15 ) . The corresponding IRR of the GRADE approach in assessing the QoE was significantly higher , that is , 0.66 ( 95 % CI = 0.56 - 0.75 ) and 0.72 ( 95 % CI = 0.61 - 0.79 ) , respectively . The IRR further increased for three ( 0.80 [ 95 % CI = 0.73 - 0.86 ] and 0.74 [ 95 % CI = 0.65 - 0.81 ] ) or four raters ( 0.84 [ 95 % CI = 0.78 - 0.89 ] and 0.79 [ 95 % CI = 0.71 - 0.85 ] ) . The IRR did not improve when QoE was assessed through a consensus rating . CONCLUSION Our findings suggest that trained individuals using the GRADE approach improves reliability in comparison to intuitive judgments about the QoE and that two individual raters can reliably assess the QoE using the GRADE system",
"PURPOSE The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance , muscle strength gains , and neck/shoulder pain in office workers . METHODS A 1-yr r and omized controlled intervention trial was done with three groups : specific resistance training ( SRT , n = 180 ) , all-round physical exercise ( APE , n = 187 ) , and reference intervention ( REF , n = 182 ) with general health counseling . Physical tests were performed and question naires answered at pre- , mid- , and postintervention . The main outcome measures were compliance , changes in maximal muscle strength , and changes in intensity of neck/shoulder pain ( scale 0 - 9 ) in those with and without pain at baseline . RESULTS Regular participation was achieved by 54 % , 31 % , and 16 % of those of the participants who answered the question naire in SRT ( 78 % ) , APE ( 81 % ) , and REF ( 80 % ) , respectively , during the first half of the intervention period , and decreased to 35 % , 28 % and 9 % , respectively , during the second half . Shoulder elevation strength increased 9 - 11 % in SRT and APE ( P Participants with neck pain at baseline decreased the intensity of neck pain through SRT , from 5.0 + /- 0.2 to 3.4 + /- 0.2 ( P pain over the 1-yr period in REF compared with SRT and APE ( P shoulder elevation strength , were more effective than REF to decrease neck pain among those with symptoms at baseline , and prevent development of shoulder pain in those without symptoms at baseline",
"OBJECTIVE This study is aim ed to assess the efficacy of traditional acupuncture for chronic neck pain in patients by comparing the differences in symptoms , dysfunctions and quality of life . METHODS The study used a two-arm , single-blinded , r and omised controlled design . The patients were r and omised to the study group and control group , who respectively received traditional acupuncture and placebo treatment . The Northwick Park Neck Pain Question naire ( NPQ ) , visual analogue scale ( VAS ) , Short Form ( 36 ) Health Survey ( SF-36 ) and doctor 's judgement were applied for measuring effectiveness . The patients ' effectiveness outcome was assessed , respectively , before the intervention , immediately after the intervention , at the end of the first month of follow-up and at the end of the third month of follow-up . The statistical analysis was done on Statistical Package for Social Sciences ( SPSS ) v13 , which included comparison of demographic and clinical homogeneity , the repeated measures approach based on the general linear model ( GLM ) for effectiveness assessment and the sum rank test for doctors ' subjective efficacy judgement . RESULTS Totally , 190 patients were recruited and 178 patients ( 88 in the study group and 90 in the control group ) completed the intervention and follow-up assessment . The scores of NPQ , VAS and SF-36 were improved after the intervention and during follow-up ( P effectiveness outcome in NPQ , VAS and in the VT , SF and MH domains of SF-36 ( P Traditional acupuncture can relieve pain intensity and improve the quality of daily life with a relative long-term clinical efficacy in patients with chronic neck pain",
"BACKGROUND AND OBJECTIVES Upper extremity musculoskeletal disorders ( MSD ) are very common in regular computer users and leading cause of work related illness . The objective of the present study is to evaluate effectiveness of yogic exercises in the improvement of symptoms of MSDs of upper limbs . MATERIAL S AND METHODS 60 study participants were r and omly divided into two groups that is yoga with counselling and only counselling group for 12 weeks . Symptom severity and functional status were assessed using the self administered Boston Carpal Tunnel Question naire and pre design ed symptom question naire before and after intervention . RESULTS There was significant reduction in symptom severity score ( P = 0.002 ) and improvement in functional status score in yoga with counselling group when compared to only counselling group . There is also a significant decrease in self reported symptoms like CT myalgia symptom ( P = 0.019 ) and improvement in weakness . CONCLUSION The present study showed a yoga based regimen is more effective than counselling alone in relieving symptoms of computer related musculoskeletal disorders",
"UNLABELLED Yoga has been found effective in the treatment of chronic low back pain . We aim ed to evaluate the effectiveness of Iyengar yoga in chronic neck pain by means of a r and omized clinical trial . Seventy-seven patients ( aged 47.9 ± 7.9 , 67 female ) with chronic neck pain who scored > 40 mm on a 100-mm visual analog scale ( VAS ) were r and omized to a 9-week Iyengar yoga program with weekly 90-minute classes ( n = 38 ) or to a self-care/exercise program ( n = 38 ) . Patients were examined at baseline and after 4 and 10 weeks . The primary outcome measure was change of mean pain at rest ( VAS ) from baseline to week 10 . Secondary outcomes included pain at motion , functional disability , quality of life ( QOL ) , and psychological outcomes . Twelve patients in the yoga group and 11 patients in the self-care/exercise group were lost to follow-up , with higher study nonadherence in the self-care group ( 5 versus 10 patients ) . Mean pain at rest was reduced from 44.3 ± 20.1 to 13.0 ± 11.6 at week 10 by yoga and from 41.9 ± 21.9 to 34.4 ± 21.1 by self-care/exercise ( group difference : -20.1 , 95 % confidence interval : -30.0 , -10.1 ; P was reduced from 53.4 ± 18.5 to 22.4 ± 18.7 at week 10 by yoga and from 49.4 ± 22.8 to 39.9 ± 21.5 by self-care/exercise ( group difference : -18.7 , 95 % confidence interval : -29.3 , -8.1 ; P . Significant treatment effects of yoga were also found for pain-related apprehension , disability , QOL , and psychological outcomes . Sensitivity analyses suggested minimal influence of dropout rates . Both programs were well tolerated . In this preliminary trial , yoga appears to be an effective treatment in chronic neck pain with possible additional effects on psychological well-being and QOL . The effectiveness of yoga in chronic neck pain should be further tested by comparative effectiveness studies with longer observation periods . PERSPECTIVE This article presents the results of a r and omized controlled trial on the clinical effects of a 9-week yoga program or self-care exercise in patients with chronic neck pain . Yoga led to superior pain relief and functional improvements and might be a useful treatment option for chronic neck pain",
"Background A clinical prediction rule ( CPR ) purported to identify patients with neck pain who are likely to respond to thoracic spine thrust manipulation has recently been developed , but has yet to be vali date d. Objective The purpose of this study was to examine the validity of this CPR . Design This was a multi-center r and omized clinical trial . Methods One hundred forty patients with a primary report of neck pain were r and omly assigned to receive either 5 sessions of stretching and strengthening exercise ( exercise-only group ) or 2 sessions of thoracic spine manipulation and cervical range of motion exercise followed by 3 sessions of stretching and strengthening exercise ( manipulation + exercise group ) . Data on disability and pain were collected at baseline , 1 week , 4 weeks , and 6 months . The primary aim ( treatment group × time × status on the prediction rule ) was examined using a linear mixed model with repeated measures . Time , treatment group , and status on the rule , as well as all possible 2-way and 3-way interactions , were modeled as fixed effects , with disability ( and pain ) as the dependent variable . Effect sizes were calculated for both pain and disability at each follow-up period . Results There was no 3-way interaction for either disability or pain . A 2-way ( group × time ) interaction existed for both disability and pain . Pair-wise comparisons of disability demonstrated that significant differences existed at each follow-up period between the manipulation + exercise group and the exercise-only group . The patients who received manipulation exhibited lower pain scores at the 1-week follow-up period . The effect sizes were moderate for disability at each follow-up period and were moderate for pain at the 1-week follow-up . Limitations Different exercise approaches may have result ed in a different outcome . Conclusions The results of the current study did not support the validity of the previously developed CPR . However , the results demonstrated that patients with mechanical neck pain who received thoracic spine manipulation and exercise exhibited significantly greater improvements in disability at both the short- and long-term follow-up periods and in pain at the 1-week follow-up compared with patients who received exercise only",
"Context Neck pain is common among primary care patients . Evidence on the effectiveness of therapies for neck pain is limited . A previous r and omized , controlled trial suggested benefits from manual therapy and physical therapy . Contribution This r and omized , controlled trial of manual therapy , physical therapy , and continued care by a doctor confirms the superiority of manual therapy and physical therapy over continued care . At 7 weeks , 68.3 % of patients in the manual therapy group reported resolved or much improved pain , compared with 50.8 % of patients in the physical therapy group and 35.9 % of patients in the continued care group . Clinical Implication s Primary care physicians should consider manual therapy when treating patients with neck pain . The Editors Neck pain is a common problem in the general population , with point prevalences between 10 % and 15 % ( 1 - 3 ) . It is most common at approximately 50 years of age and is more common in women than in men ( 1 , 2 , 4 - 6 ) . Neck pain can be severely disabling and costly , and little is known about its clinical course ( 7 - 9 ) . Limited range of motion and a subjective feeling of stiffness may accompany neck pain , which is often precipitated or aggravated by neck movements or sustained neck postures . Headache , brachialgia , dizziness , and other signs and symptoms may also be present in combination with neck pain ( 10 , 11 ) . Although history taking and diagnostic examination can suggest a potential cause , in most cases the pathologic basis for neck pain is unclear and the pain is labeled nonspecific . Conservative treatment methods that are frequently used in general practice include analgesics , rest , or referral to a physical therapist or manual therapist ( 12 , 13 ) . Physical therapy may include passive treatment , such as massage , interferential current , or heat applications , and active treatment , such as exercise therapies . Physical therapists can specialize in passive manual ( or h and s-on ) techniques , including mobilization or manipulation ( high-velocity thrust techniques ) , also referred to as manual therapy ( 14 - 19 ) . According to the International Federation of Orthopedic Manipulative Therapies , Orthopedic manipulative ( manual ) therapy is a specialization within physical therapy and provides comprehensive conservative management for pain and other symptoms of neuro-musculo-articular dysfunction in the spine and extremities ( unpublished data ) . Today , many different manual therapy approaches are applied by various health professionals , including medical doctors , physical therapists , massage therapists , manual therapists , chiropractors , and osteopathic doctors . Review s of trials involving manual therapy or physical therapy show that most interventions in these categories are characterized by a combination of passive and active components ( 20 - 23 ) . Although a combination of manual therapy or physical therapy that includes exercises appears to be effective for neck pain , these therapies have not been studied in sufficient detail to draw firm conclusions , and the method ologic quality of most trials on neck pain is rather low ( 20 - 23 ) . Koes and colleagues ( 24 , 25 ) performed a r and omized trial on back and neck pain and found promising results for manual therapy and physical therapy in subgroup analyses of patients with neck pain . In our r and omized , controlled trial , we compared the effectiveness of manual therapy , physical therapy , and continued care by a general practitioner in patients with nonspecific neck pain . Methods Patients Patients with nonspecific neck pain whose clinical presentation did not warrant referral for further diagnostic screening were referred to one of four research centers by 42 general practitioners for study selection . We excluded patients whose history , signs , and symptoms suggested a potential nonbenign cause ( including previous surgery of the neck ) or evidence of a specific pathologic condition , such as malignancy , neurologic disease , fracture , herniated disc , or systemic rheumatic disease . Two research assistants who were experienced physical therapists and were blinded to treatment allocation performed physical examinations at baseline and follow-up . They used st and ardized inclusion and exclusion criteria and performed a short neurologic examination ( Appendix Table 1 ) and range-of-motion assessment . The eligibility criteria were age between 18 and 70 years , pain or stiffness in the neck for at least 2 weeks , neck symptoms reproducible during physical examination , willingness to adhere to treatment and measurement regimens , no physical therapy or manual therapy for neck pain during the previous 6 months , no involvement in litigation , and written informed consent . Patients with concurrent headaches , nonradicular pain in the upper extremities , and low back pain were not excluded , but neck pain had to be the main symptom for all patients . R and om Assignment and Data Collection All patient data were collected before r and omization . Patients were assigned to a treatment group on the basis of block r and omization after prestratification for symptom severity ( severity scores age ( and , mainly for practical reasons , research center ( four local centers ) . R and omized permuted blocks of six patients were generated for each stratum by using a computer-generated r and om-sequence table . A research er who was not involved in the project prepared opaque , sequentially numbered sealed envelopes that contained folded cards indicating one of the three interventions . Interventions The intervention period lasted 6 weeks . Patients were allowed to perform exercises at home and to continue medication prescribed at baseline or use over-the-counter analgesics . Other co- interventions were discouraged but were registered if they occurred . Within the boundaries of the protocol , treatment could be reassessed and adapted to the patient 's condition . The specific treatment characteristics were registered at each visit . A maximum number of visits was set for each intervention group ; however , the patients did not have to complete this maximum number if symptoms had resolved . Manual Therapy Our approach to manual therapy was eclectic and incorporated several techniques used in western Europe , North America , and Australia , including those described by Cyriax , Kaltenborn , Maitl and , and Mennel ( 15 , 16 , 19 ) . In our trial , manual therapy ( defined as the use of passive movements to help restore normal spinal function ) included h and s-on muscular mobilization techniques ( aim ed at improving soft tissue function ) , specific articular mobilization techniques ( to improve overall joint function and decrease any restrictions in movement at single or multiple segmental levels in the cervical spine ) , and coordination or stabilization techniques ( to improve postural control , coordination , and movement patterns by using the stabilizing cervical musculature ) ( 26 ) . Joint mobilization is a form of manual therapy that involves low-velocity passive movements within or at the limit of joint range of motion ( 27 ) . Manual therapists must undergo extensive training to be able to skillfully perform mobilization techniques ( 15 , 19 ) . Spinal manipulations ( low-amplitude , high-velocity thrust techniques ) were not included in this protocol . Forty-five minute treatment sessions were scheduled once per week , for a maximum of six treatments . Six experienced manual therapists acknowledged by the Netherl and s Manual Therapy Association performed the treatment . Physical Therapy The physical therapists used a combination of several treatment options , but active exercise therapies were the cornerstone of their strategy . Active exercise therapy involves participation by the patient and includes active exercises ( to improve strength or range of motion ) , postural exercises , stretching , relaxation exercises , and functional exercises . Manual traction or stretching , massage , or physical therapy methods , such as interferential current or heat applications , could precede the exercise therapy . Specific manual mobilization techniques were not included in this protocol . Thirty-minute treatment sessions were scheduled twice per week for a maximum of 12 treatments . The treatment was performed by five experienced physical therapists . We prevented cross-contamination with manual therapy by choosing physical therapists who were not manual therapy specialists . Continued Care by a General Practitioner Each patient in this group received st and ardized care from his or her general practitioner , including advice on prognosis , advice on psychosocial issues , advice on self-care ( heat application , home exercises ) , advice on ergonomics ( for example , size of pillow , work position ) , and encouragement to await further recovery . The treatment protocol was similar to the practice guidelines for low back pain issued by the Dutch College of General Practitioners ( 28 ) . Patients received an educational booklet containing ergonomic advice and exercises ( 29 ) . Medication , including paracetamol or nonsteroidal anti-inflammatory drugs , was prescribed on a time-contingent basis if necessary . Ten-minute follow-up visits , scheduled every 2 weeks , were optional , and referral during the intervention period was discouraged . Outcome Measures Data were collected at the research center after 3 and 7 weeks . At 7 weeks , treatment results were expected to be maximal . The patients were repeatedly asked not to reveal any information about their treatment allocation to the research assistants . The success of blinding was evaluated at 7 weeks . Primary outcome measures focused on perceived recovery , pain , and functional disability . Patients rated perceived recovery on a 6-point ordinal transition scale , ranging from much worse to completely recovered . Success was defined a priori as completely recovered or much improved ( 30 ) . In addition , on the basis of the systematic assessment of spinal mobility , palpation , and pain reported by"
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INTRODUCTION Frail older people are often unable to undertake high-intensity exercise programmes . Chair-based exercises ( CBEs ) are used as an alternative , for which health benefits are uncertain . OBJECTIVE To examine the effects of CBE programmes for frail older people through a systematic review of existing literature . METHOD A systematic search was performed for CBE-controlled trials in frail population s aged ≥65 years published between 1990 and February 2011 in electronic data bases . Quality was assessed using the Jadad method . RESULTS The search identified 164 references : with 42 duplicates removed , 122 review ed , 116 excluded , and 6 analysed . 26 outcome measures were reported measuring 3 domains : mobility and function , cardiorespiratory fitness , mental health . All studies were of low method ological quality ( Jadad score ≤2 ; possible range 0 - 5 ) . Two studies showed no benefit , and four reported some evidence of benefit in all three domains . No harmful effects were reported ; compliance was generally good . CONCLUSION The quality of the evidence base for CBEs is low with inconclusive findings to clearly inform practice . A consensus is required on the definition and purpose of CBEs . Large well- design ed r and omised controlled trials to test the effectiveness of CBE are justified
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"Background : There is no single generally accepted clinical definition of frailty . Previously developed tools to assess frailty that have been shown to be predictive of death or need for entry into an institutional facility have not gained acceptance among practising clinicians . We aim ed to develop a tool that would be both predictive and easy to use . Methods : We developed the 7-point Clinical Frailty Scale and applied it and other established tools that measure frailty to 2305 elderly patients who participated in the second stage of the Canadian Study of Health and Aging ( CSHA ) . We followed this cohort prospect ively ; after 5 years , we determined the ability of the Clinical Frailty Scale to predict death or need for institutional care , and correlated the results with those obtained from other established tools . Results : The CSHA Clinical Frailty Scale was highly correlated ( r = 0.80 ) with the Frailty Index . Each 1-category increment of our scale significantly increased the medium-term risks of death ( 21.2 % within about 70 mo , 95 % confidence interval [ CI ] 12.5%–30.6 % ) and entry into an institution ( 23.9 % , 95 % CI 8.8%–41.2 % ) in multivariable models that adjusted for age , sex and education . Analyses of receiver operating characteristic curves showed that our Clinical Frailty Scale performed better than measures of cognition , function or comorbidity in assessing risk for death ( area under the curve 0.77 for 18-month and 0.70 for 70-month mortality ) . Interpretation : Frailty is a valid and clinical ly important construct that is recognizable by physicians . Clinical judgments about frailty can yield useful predictive information",
"Based on the growing body of evidence implicating an important role for myogenic regulatory factors ( MRFs ) in the adaptive responses of skeletal muscle to mechanical load , we tested the hypothesis that protein concentrations of MRFs as well as cell cycle proteins ( i.e. , cyclins and cyclin-dependent kinase inhibitors ) would be altered after heavy leg resistance exercise ( RE ) . Because we and others , however , have shown a blunted adaptive response to long-term resistance training in older ( O ) women [ females ( F ) ] compared with men ( M ) , we also tested the hypothesis that these myogenic responses to RE would be influenced by age and gender . Twenty-two younger ( Y ) adults ( 20 - 35 yr , 11 YF , 11 YM ) and 20 O adults ( 60 - 75 yr , 9 OF , 11 OM ) consented to vastus lateralis muscle biopsy before and 24 h after a bout of RE using a regimen known to induce myofiber hypertrophy when performed 2 - 3 days/wk for several weeks ( 3 sets of 80 % one-repetition maximum for squat , leg press , and knee extension ) . Protein concentrations of MRFs ( MyoD , myogenin , myf-6 ) , cyclin D1 , cyclin B1 , alpha-actin , and the cyclin-dependent kinase inhibitor p27kip were determined by immunoblotting . Data were analyzed by using age x gender x load repeated- measures ANOVA . Myogenin expression was 44 % higher ( P reduction in p27kip ( 20 % ; P Levels of cyclin D1 , cyclin B1 , MyoD , myf-6 , and alpha-actin were not influenced by age , gender , or loading . We report a novel finding in humans of markedly higher myogenin protein content in older sedentary muscle . The results do not , however , support the hypothesis that myogenic protein expression is altered 24 h after RE , irrespective of age or gender . Although the time point of postexercise muscle biopsy could be viewed as too early to capture maximal effects for most of these proteins , the significant decline in p27kip concentration found in OF suggests that mechanical load may provide one means of overcoming the inhibitory influence of p27kip",
"Objective : To assess the cost effectiveness of a community based exercise programme as a population wide public health intervention for older adults . Design : Pragmatic , cluster r and omised community intervention trial . Setting : 12 general practice s in Sheffield ; four r and omly selected as intervention population s , and eight as control population s. Participants : All those aged 65 and over in the least active four fifths of the population responding to a baseline survey . There were 2283 eligible participants from intervention practice s and 4137 from control practice s. Intervention : Eligible subjects were invited to free locally held exercise classes , made available for two years . Main outcome measures : All cause and exercise related cause specific mortality and hospital service use at two years , and health status assessed at baseline , one , and two years using the SF-36 . A cost utility analysis was also undertaken . Results : Twenty six per cent of the eligible intervention practice population attended one or more exercise sessions . There were no significant differences in mortality rates , survival times , or admissions . After adjusting for baseline characteristics , patients in intervention practice s had a lower decline in health status , although this reached significance only for the energy dimension and two composite scores ( p incremental average QALY gain of 0.011 per person in the intervention population result ed in an incremental cost per QALY ratio of € 17 174 ( 95 % CI = € 8300 to € 87 120 ) . Conclusions : Despite a low level of adherence to the exercise programme , there were significant gains in health related quality of life . The programme was more cost effective than many existing medical interventions , and would be practical for primary care commissioning agencies to implement",
"Objective : To evaluate the effect of a musical exercise programme on mood state and cognitive function in women with dementia . Design : R and omized controlled trial . Setting : Public Psychiatric Hospital Rekem , Belgium . Patients : Twenty-five patients with dementia . Interventions : Fifteen patients attended exercise training for three months , which consisted of daily physical exercises supported by music for 30 min/session . They were compared with a group of 10 control patients , who received an equal amount of attention through daily conversation . Main measures : The effect on cognition was measured by the Mini-Mental State Examination ( MMSE ) and the Amsterdam Dementia Screening Test 6 ( ADS 6 ) . Behaviour was evaluated with the abbreviated Stockton Geriatric Rating Scale ( BOP scale ) . The assessment s were made before , after six weeks of intervention and immediately after the three-month experimental period . Results : The exercise group showed a significant improvement in cognition . This was documented by an increased MMSE mean score of 12.87 - 15.53 , and by a higher median score , rising from 10 to 14 points , on the subset ‘ fluency ’ ( ADS 6 test ) . The control group showed no significant improvement , either on the MMSE ( mean score of 10.80 -11.00 ) or on the fluency subtest of the ADS 6 ( median scores were 6.5 - 7 points ) . The effects on behavioural changes were not significant . Conclusion : The present study suggests a beneficial effect of cognition using a music-based exercise programme in a group of patients with moderate to severe dementia . Further studies are needed to confirm these findings",
"OBJECTIVE The purpose of this pilot was to determine whether a strength and flexibility program in frail long-term care facility ( LTC ) residents would result in improved function . DESIGN A prospect i ve , r and omized , controlled , semicrossover trial was design ed with participants assigned either to group exercise ( EX ) or recreational therapy ( C ) . In the EX group , the intervention continued for 1 year . In the C group , recreation continued for 6 months ; these controls were then crossed over to the same exercise intervention as the EX group and followed for an additional 6 months . Functional outcomes were measured at baseline and 3 , 6 , 9 , and 12 months for both groups . SETTING A LTC facility , which included both assisted living ( AL ) and nursing home ( NH ) residents . PARTICIPANTS Twenty frail residents ( 5 from NH , 15 from AL ) aged 75 to 99 years at one LTC facility . INTERVENTION After r and om group assignment , the EX group met 1 hour three times per week . An exercise physiologist and LTC staff conducted sessions which included seated range of motion ( ROM ) exercises and strength training using simple equipment such as elastic resistance b and s ( therab and s ) and soft weights . The C group met three times per week and participated in activities such as painting during the first 6 months , before crossing over to exercise . MEASUREMENTS AND METHODS Objective measures of physical and cognitive function were obtained at baseline and 3 , 6 , 9 , and 12 months using the timed get-up- and -go test ( TUG ) , Berg balance scale , physical performance test ( PPT ) , and mini-mental status exam ( MMSE ) . Because we were interested in the impact of exercise on multiple endpoints and to protect the type I error rate , a global hypothesis test was used . RESULTS There was a significant overall impact across the four measures of the exercise intervention ( P = 0.013 ) . Exercise benefit as indicated by the difference between exercise and control conditions showed exercise decreased TUG by 18 seconds , which represents an effect size ( in st and ard deviation units ) of 0.50 , increased PPT scores by 1.3 , with effect size = 0.40 , increased Berg scores by 4.8 , with effect size of 0.32 , and increased MMSE by 3.1 , with effect size = 0.54 . Except for the Berg , 90 % confidence intervals on these exercise effects excluded 0 . CONCLUSION Frail elderly in a LTC facility were able to participate and benefit from a strength training program . The program was delivered with low-cost equipment by an exercise physiologist and LTC staff . The advantage of such a program is that it provides recreational and therapeutic benefits ",
"OBJECTIVES To examine the influence of regular participation in chair exercises on postoperative deconditioning in respect of selected physiological , psychological and anthropometric variables . DESIGN Quasi-experimental , non-r and omised control group pre-test/post-test design where test group ( N = 20 ) and control group ( N = 10 ) were not equivalent because r and om selection and assignment were not possible . SUBJECTS Patients discharged from an orthopaedic ward 8 - 10 days after hip surgery who were cognitively competent ( mean score on Mini-Mental State Examination 26 ( SD 3.5 ) ) , sedentary ( mean score on Habitual Physical Activity Question naire for the Elderly 7.4 ( SD 3.3 ) ) women aged 70 years and above ( mean 80 ( SD 6.6 ) years ) . SETTING Hip fracture patients admitted to a multidisciplinary geriatric hospital for further medical observation . MEASUREMENTS Abstract ion of medical records provided information about co-morbidities and question naires assessed demographic , affective and cognitive function . Physiological , psychological and anthropometric status was measured pre- and post-intervention . RESULTS Data revealed high variability , suggesting that the effect of the independent variable was obscured by the heterogeneity of the cohort . Both groups improved similarly in grip strength , and in levels of depression and confidence . Body composition data explained the weight maintenance as a consequence of significant gains in fat-free mass in the experimental group . The significant change in systolic blood pressure and heart rate over the exercise and recovery period suggested that the 6-week period of moderate-intensity exercise was adequate to stimulate cardiovascular adaptations . CONCLUSIONS Whether or not the submaximal chair exercise regimen was of optimal benefit remains unclear . However , the intervention did appear to have contributed to the maintenance of the physical condition of older women temporarily disabled as a result of a fracture and subsequent hip surgery",
"Eighty-two patients aged > or = 70 years with heart failure were r and omized to a gentle , seated exercise program or to usual care . Six-minute walk distance and quality of life did not change between groups , but daily activity as measured by accelerometry increased in the exercise group relative to the control group",
"The purpose of this study was to determine the influence of simple , progressive lower body exercise training , focusing on strength and power , on functional abilities in frail older adults . Twenty-five residents of a long-term care facility ( 75 - 94 yrs ) participated in this r and omized controlled trial of 10-wks duration . The exercise group ( Ex , n = 18 ) underwent simple , progressive lower body resistance exercises , specifically aim ed at improving muscle power , 3 times/wk ; the control subjects ( Con , n = 7 ) maintained their usual daily activities . Knee extensor strength and power were measured on an isokinetic dynamometer ( 180 degrees/s ) , and functional performance was assessed from a 6-m walk timed test , a 30-s chair st and , and an 8-ft up- and -go timed test , before and after the 10-wk intervention period . Significant increases were found in the Ex group for eccentric ( 44 % ) and concentric ( 60 % ) average power ( p functional test : the 8-foot up- and -go , chair st and , and walk time improved by 31 % , 66 % , and 33 % , respectively ( p No significant change occurred in the Con group . In conclusion , simple progressive exercise training , even in the 10th decade , increases muscle power and is associated with an improved performance of functional activities using the trained muscles"
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Background The immediate post concussion assessment and cognitive testing ( ImPACT ) is the most widely used concussion assessment tool . Despite its popularity , it is unclear if validation studies for the ImPACT test covered all aspects of validity to support its widespread use in research and clinical practice . Objective The purpose of this report is to review literature surrounding the validity and the utility of the ImPACT test . Data sources and appraisal A systematic review of relevant studies in PubMed , CINAHL , and PsycINFO was carried out . Studies were evaluated using the STROBE ( strengthening the reporting of observational studies in epidemiology ) or the STARD ( st and ards for reporting of diagnostic accuracy ) criteria . Results The literature search yielded 5968 studies . Sixty-nine studies met the inclusion criteria and were included in the qualitative review . Although the convergent validity of ImPACT was supported , evidence of discriminant and predictive validity , diagnostic accuracy and responsiveness was inconclusive . The utility of the ImPACT test after acute symptom resolution was sparse . The review found many factors influenced the validity and utility of ImPACT scores . Conclusion Clinicians must consider the benefit of ImPACT testing for their patients on a case-by-case scenario and must take the psychometric properties of the test into account when interpreting results
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"Background Neurocognitive testing has been endorsed as a “ cornerstone ’ of concussion management by recent Vienna and Prague meetings of the Concussion in Sport Group . Neurocognitive testing is important given the potential unreliability of athlete self-report after injury . Relying only on athletes'ormalities after injury . Study Design Case control study ; Level of evidence , 3 . Methods High school and college athletes with a diagnosed concussion were tested 2 days after injury . Postinjury neurocognitive performance ( Immediate Postconcussion Assessment and Cognitive Testing ) and symptom ( postconcussion symptom ) scores were compared with preinjury ( baseline ) scores and with those of an agex and education-matched noninjured athlete control group . “ Abnormal ” test performance was determined statistically with Reliable Change Index scores . Results Sixty-four percent of concussed athletes reported a significant increase in symptoms , as judged by postconcussion symptom scores , compared with preinjury baseline at 2 days after injury . Eighty-three percent of the concussed sample demonstrated significantly poorer neurocognitive test results relative to their own baseline performance . The addition of neurocognitive testing result ed in a net increase in sensitivity of 19 % . Ninety-three percent of the sample had either abnormal neurocognitive test results or a significant increase in symptoms , relative to their own baseline ; 30 % of a control group demonstrated either abnormalities in neurocognitive testing or elevated symptoms , as judged by postconcussion symptom scores . For the concussed group , use of symptom and neurocognitive test results result ed in an increased yield of 29 % overreliance on symptoms alone . In contrast , 0 % of the control group had both symptoms and abnormal neurocognitive testing . Conclusion Reliance on patients ’ self-reported symptoms after concussion is likely to result in underdiagnosis of concussion and may result in premature return to play . Neurocognitive testing increases diagnostic accuracy when used in conjunction with self-reported symptoms",
"This study explored the diagnostic utility of the composite scores of Immediate Post-Concussion Assessment and Cognitive Testing ( ImPACT ) and Post Concussion Symptom Scale scores ( PCSS ) . Recently concussed high school athletes ( N=72 ) were tested within 72 h of sustaining a concussion , and data were compared to non-concussed high school athletes with no history of concussion ( N=66 ) . Between-groups MANOVA revealed a significant multivariate effect of concussion on test performance ( p ImPACT composite scores , as well as the PCSS to classify concussion status . One discriminant function was identified that consisted of the Visual Memory , Processing Speed , and Impulse Control composite scores PCSS , which correctly classified 85.5 % of the cases . Approximately 82 % of participants in the concussion group and 89 % of participants in the control group were correctly classified . Using these data , the sensitivity of ImPACT was 81.9 % , and the specificity was 89.4 % . As part of a formal concussion management program , ImPACT is a useful tool for the assessment of the neurocognitive and neurobehavioral sequelae of concussion , and can also provide post-injury cognitive and symptom data that can assist a practitioner in making safer return to play decisions",
"Computerized neurocognitive assessment tools ( NCATs ) are increasingly used for baseline and post-concussion assessment s. To date , NCATs have not demonstrated strong test-retest reliabilities . Most studies have used non-military population s and different method ologies , complicating the determination of the utility of NCATs in military population s. The test-retest reliability of four NCATs ( Automated Neuropsychological Assessment Metrics 4 [ ANAM4 ] , CNS-Vital Signs , CogState , and Immediate Post-Concussion Assessment and Cognitive Test [ ImPACT ] ) was investigated in a healthy active duty military sample . Four hundred and nineteen Service Members were r and omly assigned to take one NCAT and 215 returned after approximately 30 days for retest . Participants deemed to have inadequate effort during one or both testing sessions , according to the NCATs scoring algorithms , were removed from analyses . Each NCAT had at least one reliability score ( intraclass correlation ) in the \" adequate \" range ( .70-.79 ) , only ImPACT had one score considered \" high \" ( .80-.89 ) , and no scores met \" very high \" criteria ( .90-.99 ) . However , overall test-retest reliabilities in four NCATs in a military sample are consistent with reliabilities reported in the literature and are lower than desired for clinical decision-making",
"Objectives This study aim ed to develop and vali date prognostic criteria to identify children at risk for persistence of mild traumatic brain injury ( MTBI ) impairment . Methods A prospect i ve cohort study was conducted among 11- to 17-year-old emergency department ( ED ) patients admitted for MTBI . The Immediate Postconcussion Assessment and Cognitive Testing neurocognitive test was administered during hospitalization and at routine clinic follow-up ( ImPACT © ) . Logistic regression and receiver operating characteristic ( ROC ) analyses were used to develop prognostic criteria for MTBI-related impairment in 1 group and vali date the criteria in a second group . Mild traumatic brain injury – related impairment was defined as any impairment ( symptom score > 8 or 12 or The derivation and validation cohorts were 42 and 21 patients ( median age , 14 years ; 71.4 % male ) . Using the mean of the validation cohort patients ’ 4 neurocognitive deficit composite percentiles at baseline , a cut point of less than 39 percentile had high sensitivity ( 0.89 ) and specificity ( 0.80 ) and an area under the ROC curve of 0.85 in predicting the presence of any impairment at follow-up ; it discriminated equally well in the validation cohort . A cut point of less than 27 percentile had good sensitivity ( 0.67 ) and specificity ( 0.67 ) and area under the ROC curve of 0.67 in predicting the presence of severe impairment in the derivation cohort at follow-up ; it discriminated equally well in the validation cohort . Conclusions This is the first study demonstrating prognostic criteria that may greatly help physicians identify patients who would benefit from structured follow-up care after MTBI",
"OBJECTIVE : The purpose of this study was to compare concussion rates and recovery times for athletes wearing newer helmet technology compared to traditional helmet design . METHODS : This was a three-year , prospect i ve , naturalistic , cohort study . Participants were 2,141 high school athletes from Western Pennsylvania . Approximately half of the sample wore the Revolution helmet manufactured by Riddell , Inc. ( n = 1,173 ) and the remainder of the sample used st and ard helmets ( n = 968 ) . Athletes underwent computerized neurocognitive testing through the use of ImPACT at the beginning of the study . Following a concussion , players were reevaluated at various time intervals until recovery was complete . RESULTS : In the total sample , the concussion rate in athletes wearing the Revolution was 5.3 % and in athletes wearing st and ard helmets was 7.6 % [ & khgr;2 ( 1 , 2 , 141 ) = 4.96 , P relative risk estimate was 0.69 ( 95 % confidence interval = 0.499– 0.958 ) . Wearing the Revolution helmet was associated with approximately a 31 % decreased relative risk and 2.3 % decreased absolute risk for sustaining a concussion in this cohort study . The athletes wearing the Revolution did not differ from athletes wearing st and ard helmets on the mechanism of injury ( e.g. , head-to-head strike ) , on-field concussion markers ( e.g. , amnesia or loss of consciousness ) , or on-field presentation of symptoms ( e.g. , headaches , dizziness , or balance problems ) . CONCLUSION : Recent sophisticated laboratory research has better eluci date d injury biomechanics associated with concussion in professional football players . This data has led to changes in helmet design and new helmet technology , which appears to have beneficial effects in reducing the incidence of cerebral concussion in high school football players",
"Context With increasing knowledge and research about concussion , there have been few objective studies that have used neuropsychological domain scores and postural stability to assess concussion . Objective To evaluate the recovery curve of athletes who incur sport-related concussion from repeated serial testing of neuropsychological and posturography testing . Design A prospect i ve epidemiological model was used for the course of the study . Setting Division I intercollegiate athletics . Participants Athletes participating in football , soccer , basketball , softball , and cheerleading . Main Outcome Measures Neuropsychological scores and posturography measures were obtained preseason and serially at day 1 , day 2 , day 3 , and day 10 postconcussion . Control participants were tested at the same intervals . Neuropsychological scores were converted to st and ards score and then into domains of attention , learning , speed of information processing , concentration , memory , and verbal fluency . Analysis of covariance with the baseline test as the covariate was used to analyze the data with univariate post hoc tests performed . Results Significant group differences were found for self reported symptoms ( P = 0.001 ) , speed of information processing ( P = 0.005 ) , mean stability ( P = 0.002 ) , and vestibular function ( P = 0.003 ) between injured and control participants . A group , by day , planned comparison found that speed of information processing and composite balance measures demonstrated significant differences through day 10 postinjury , while symptoms and the vestibular ratio remained significant only through day 3 . Conclusions The concussion recovery curve demonstrated short-term neuropsychological and posturography deficits following injury . A comprehensive approach to concussion management should be used to assess the injury and make return-to-play decisions",
"OBJECTIVE Neuropsychological ( NP ) testing has been used for several years as a way of detecting the effects of sport-related concussion in order to aid in return-to-play determinations . In addition to st and ard pencil- and -paper tests , computerized NP tests are being commercially marketed for this purpose to professional , collegiate , high school , and elementary school programs . However , a number of important questions regarding the clinical validity and utility of these tests remain unanswered , and these questions present serious challenges to the applicability of NP testing for the management of sport-related concussion . Our purpose is to outline the criteria that should be met in order to establish the utility of NP instruments as a tool in the management of sport-related concussion and to review the degree to which existing tests have met these criteria . DATA SOURCES A comprehensive literature review of MEDLINE and PsychLit from 1990 to 2004 , including all prospect i ve , controlled studies of NP testing in sport-related concussion . DATA SYNTHESIS The effects of concussion on NP test performance are so subtle even during the acute phase of injury ( 1 - 3 days postinjury ) that they often fail to reach statistical significance in group studies . Thus , this method may lack utility in individual decision making because of a lack of sensitivity . In addition , most of these tests fail to meet other psychometric criteria ( eg , adequate reliability ) necessary for this purpose . Finally , it is unclear that NP testing can detect impairment in players once concussion-related symptoms ( eg , headache ) have resolved . Because no current guideline for the management of sport-related concussion allows a symptomatic player to return to sport , the incremental utility of NP testing remains question able . CONCLUSIONS / RECOMMENDATIONS Despite the theoretic rationale for the use of NP testing in the management of sport-related concussion , no NP tests have met the necessary criteria to support a clinical application at this time . Additional research is necessary to establish the utility of these tests before they can be considered part of a routine st and ard of care , and concussion recovery should be monitored via the st and ard clinical examination and subjective symptom checklists until NP testing or other methods are proven effective for this purpose",
"OBJECTIVES To prospect ively examine the relationship of sport-related concussion with depression and neurocognitive performance and symptoms among male and female high school and college athletes . A secondary objective was to explore age and sex differences . DESIGN Pretest , multiple posttest , repeated- measures design . SETTING Laboratory . PARTICIPANTS High school and collegiate athletes ( N=75 ) with a diagnosed concussion . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Beck Depression Inventory-II and computerized neurocognitive test battery ( Immediate Post-concussion Assessment and Cognitive Test ) , which includes concussion symptoms ( Post-concussion Symptom Scale ) at baseline and at 2 , 7 , and 14 days postinjury . RESULTS Concussed athletes exhibited significantly higher levels of depression from baseline at 2 days ( P≤.001 ) , 7 days ( P=.006 ) , and 14 days postconcussion ( P=.04 ) . Collegiate athletes demonstrated a significant increase in depression at 14 days postconcussion than did high school athletes ( P=.03 ) . There were no sex differences in depression levels . Neurocognitive decrements at 14 days were supported for reaction time ( P=.001 ) and visual memory ( P=.001 ) . Somatic depression at 7 days postconcussion was related to slower reaction time at 7 days postconcussion . Somatic depression at 14 days postinjury was related to lower visual memory scores at 14 days postinjury . CONCLUSIONS Although not clinical ly significant , athletes experienced increased depression scores up to 14 days after concussion that coincided with neurocognitive decrements in reaction time and visual memory . Somatic depression appears to be most salient with regard to lower neurocognitive performance . Mood assessment s after concussion are warranted to help monitor and enhance recovery",
"The purpose of the current study was to explore potential differences in pre- and post-concussion performance on a computerized neurocognitive concussion test between African American and White high-school and collegiate student-athletes . A prospect i ve case-control design was used to compare baseline and 2- and 7-day post-concussion computerized neurocognitive performance and symptoms between 48 White and 48 African American athletes matched for age , gender , and concussion history . The Immediate Post-Concussion Assessment Cognitive Test ( ImPACT ) version 2.0 ( NeuroHealth System , LLC , Pittsburgh , PA , USA ) computer software program was used to assess neurocognitive function ( i.e. , verbal and visual memory , motor processing speed , and reaction time ) and concussion symptoms . Regardless of race/ethnicity , there were significant decrements in computerized neurocognitive performance and increased symptoms following a concussion for the entire sample . African Americans and Whites did not differ significantly on baseline or post-concussion verbal memory , visual memory , reaction time , and total reported symptoms . However , African American participants were 2.4 × more likely to have at least one clinical ly significant cognitive decline on ImPACT at 7 days post-concussion and scored lower at 7 days post-concussion compared with baseline on processing speed than White participants . The authors concluded that the baseline ImPACT test was culturally equivalent and construct valid for use with these two racial/ethnic groups . However , in contrast , the findings support deleterious performance for the African American athletes compared with the White athletes on the ImPACT post-concussion evaluation that is of critical clinical relevance and warrants further research",
"The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted",
"Background Recent concussion management guidelines have suggested that athletes with mild ( grade 1 ) concussions may be returned to play if asymptomatic for 15 minutes . The purpose of this study was to assess the utility of a current concussion management guideline in classifying and managing mild concussion . Hypothesis High school athletes diagnosed with a grade 1 concussion will demonstrate measurable decline in neuropsychological functioning that persists during the 1st week of recovery . Study Design Prospect i ve study design ed to evaluate neuropsychological functioning both prior to and following concussion . Methods Forty-three high school athletes completed neuropsychological test performance and symptom ratings prior to the season and at two times during the 1st week following mild concussion . Results Thirty-six hours after injury , mildly concussed high school athletes demonstrated a decline in memory ( P self-reported symptoms ( P Athletes with grade 1 concussion demonstrated memory deficits and symptoms that persisted beyond the context in which they were injured . These data suggest that current grade 1 return-to-play recommendations that allow for immediate return to play may be too liberal . Clinical Relevance A reconsideration of current concussion grading systems appears to be warranted",
"OBJECTIVE The long-term impact of sports-related concussion is uncertain . Several studies using traditional neuropsychological measures have found a relationship between a previous history of concussion and reduced cognitive abilities . In contrast , studies using computerized neuropsychological measures have typically found no relationship between concussion history and cognition . In the present study , we examined the association between a self-reported concussion history and cognition using traditional and computer-based neuropsychological tests . METHODS A computerized neuropsychological battery was administered to a sample of 858 collegiate male athletes . Of this sample , 298 athletes reported a history of concussion . A traditional neuropsychological battery was administered to a separate sample of 479 male collegiate athletes , 187 of whom reported a history of concussion . Finally , both a computerized and a traditional neuropsychological battery were administered to a third distinct sample of 175 male collegiate athletes , 57 of whom reported a history of concussion . Concussion history was assessed via self-report . None of the athletes had been concussed in the 6 months before testing . RESULTS No significant association was found between self-reported concussion history and performance on either computerized or traditional neuropsychological tests . CONCLUSION Findings suggest that athletes who report a distant history of concussion have minimal enduring neurocognitive deficits . Given conflicting findings in the literature , prospect i ve studies that attempt to identify moderating factors are necessary to help determine who is at risk for long-term cognitive difficulties after concussion",
"OBJECTIVE To identify predictors of prolonged symptoms in athletes who sustain concussions . STUDY DESIGN This was a multicenter prospect i ve cohort study of patients in 2 sport concussion clinics . Possible predictors of prolonged symptoms from concussion were compared in 2 groups , those whose symptoms resolved within 28 days and those whose symptoms persisted beyond 28 days . C and i date predictor variables were entered into a logistic regression model that was used to generate aORs . RESULTS A total of 182 patients met the inclusion criteria during the study period . The mean patient age was 15.2 ± 3.04 years . More than one-third of the patients ( n = 65 ) underwent computerized neurocognitive testing on their initial visit . On univariate analyses , Post-Concussion Symptom Scale ( PCSS ) score and all composite scores on computerized neurocognitive testing were apparently associated with prolonged symptom duration . Sex , age , loss of consciousness at time of injury , and amnesia at time of injury were not associated with prolonged symptom duration . After adjusting for potential confounding , only total PCSS score was associated with the odds of suffering prolonged symptoms . CONCLUSION Further efforts to develop clinical tools for predicting which athletes will suffer prolonged recoveries after concussion should focus on initial symptom score",
"Background : The relevance of headache to outcome after sports-related concussion is poorly understood . Hypotheses : High school athletes reporting headache approximately 1 week after injury will have significantly more other concussion symptoms and will perform more poorly on neuropsychological tests than athletes not experiencing headache . Study Design : Prospect i ve cohort study . Methods : Study participants included 109 high school athletes who had sustained concussion and who were divided into two groups : those reporting headache 7 days after injury and those reporting no headaches . The two groups were compared regarding on-field markers of concussion severity at the time of injury and symptoms and neurocognitive test results collected via ImPACT , a computerized neuropsychological test battery and postconcussion symptom scale , at a mean of 6.8 days after injury . Results : Athletes reporting posttraumatic headache demonstrated significantly worse performance on reaction time and memory ImPACT neurocognitive composite scores . These athletes also reported significantly more symptoms other than headache and were more likely to have demonstrated on-field antero grade amnesia . Conclusions : Findings suggest that any degree of postconcussion headache in high school athletes 7 days after injury is likely associated with an incomplete recovery after concussion",
"Objective : Following the Second International Conference on Concussion in Sport in 2005 , a summary agreement statement was published that introduced new terminology for sport-related concussions . This new classification system is binary ( ie , “ simple ” versus “ complex ” concussions ) . Athletes who are slow to recover ( ie , > 10 days ) are classified as having complex concussions . The purpose of this study was to determine if high school football players , retrospectively classified as having a simple or a complex concussion , could be differentiated in the first 48 after injury on the basis of symptom reporting or neuropsychological testing . Design : Case-control study . Setting : Pennsylvania high school football programs . Participants : The total sample consisted of 114 concussed high school football players who were identified through a 3 year prospect i ve cohort study . Interventions : All completed a computerized neuropsychological screening evaluation within 72 hours of injury . They were followed clinical ly until they recovered and were cleared to return to play . They were classified retrospectively as having a simple ( n = 55 ) or complex ( n = 59 ) concussion based on their recovery times . Main Outcome Measurements : Neurocognitive test performance and symptom ratings . Results : Within 72 hours after injury , athletes with complex concussions performed more poorly on neuropsychological testing and reported more symptoms than those with simple concussions . Athletes with complex concussions who were slow to recover were 18 times more likely to have 3 unusually low neuropsychological test scores than those with simple concussions ( 95 % CI = 2.3 - 144.9 ) . Athletes with previous concussions did not recover more slowly . Conclusions : This study provides evidence that supports and refutes the clinical usefulness of the new simple-complex concussion classification system",
"Objective : To determine whether exposure to repetitive head impacts over a single season negatively affects cognitive performance in collegiate contact sport athletes . Methods : This is a prospect i ve cohort study at 3 Division I National Collegiate Athletic Association athletic programs . Participants were 214 Division I college varsity football and ice hockey players who wore instrumented helmets that recorded the acceleration-time history of the head following impact , and 45 noncontact sport athletes . All athletes were assessed prior to and shortly after the season with a cognitive screening battery ( ImPACT ) and a subgroup of athletes also were assessed with 7 measures from a neuropsychological test battery . Results : Few cognitive differences were found between the athlete groups at the preseason or postseason assessment s. However , a higher percentage of the contact sport athletes performed more poorly than predicted postseason on a measure of new learning ( California Verbal Learning Test ) compared to the noncontact athletes ( 24 % vs 3.6 % ; p cognitive measures ( ImPACT Reaction Time and Trails 4/B ) , poorer performance was significantly associated with higher scores on several head impact exposure metrics . Conclusion : Repetitive head impacts over the course of a single season may negatively impact learning in some collegiate athletes . Further work is needed to assess whether such effects are short term or persistent",
"Primary objective : The purpose of this study was to investigate the relationship between soccer heading and computerized neurocognitive performance and symptoms in female and male youth soccer players . Research design : Cross-sectional and prospect i ve design . Methods and procedures : A total of 63 ( 27 females , 36 males ) youth soccer players aged 13–18 years ( M = 15.89 , SD = 1.17 ) participated in the study . Participants completed the Immediate Post-concussion Assessment and Cognitive Test ( ImPACT ) and symptom report . Main outcomes : Computerized neurocognitive performance ( e.g. , verbal and visual memory , motor processing , and reaction time ) and symptoms . Results : There were no differences in neurocognitive performance or symptoms among low- , moderate- , and high-exposure header groups . The current sample outperformed the 10th percentile norms for neurocognitive and symptom scores . Males headed the ball more frequently and reported lower verbal and visual memory and motor processing speed scores than females . Conclusion : The current findings did not support a relationship between soccer heading and computerized neurocognitive performance and symptoms . The research ers suggest that any purported effects of soccer heading in youth are subtle and may affect only a small number of athletes . The reported sex differences in heading exposure warrant further attention",
"OBJECT The authors investigated return-to-play duration for initial and recurrent concussion in the same season in 2 teams of junior ( 16 - 21-year-old ) ice hockey players during a regular season . METHODS The authors conducted a prospect i ve cohort study during 1 junior regular season ( 2009 - 2010 ) of 67 male fourth-tier ice hockey players ( mean age 18.2 ± 1.2 years [ SD ] , range 16 - 21 years ) from 2 teams . Prior to the start of the season , every player underwent baseline assessment s that were determined using the Sideline Concussion Assessment Tool 2 ( SCAT2 ) and the Immediate Post-Concussion Assessment and Cognitive Test ( ImPACT ) . The study protocol also required players who entered the study during the season to complete a baseline SCAT2 and ImPACT . If the protocol was not followed , the postinjury test results of a player without true baseline test results were compared with previously established age- and sex-matched group normative levels . Each game was directly observed by a physician and at least 1 neutral nonphysician observer . Players suspected of suffering a concussion were evaluated by the physician during the game . If a concussion was diagnosed , the player underwent clinical evaluation at the physician 's office within 24 hours . The return-to-play decision was based on clinical evaluation guided by the Zurich return-to-play protocol ( contained in the consensus statement of international expert opinion at the 3rd International Conference on Concussion in Sport held in Zurich , November 2008 ) . This clinical evaluation and return-to-play protocol was augmented by the 2 tests ( SCAT2 and ImPACT ) also recommended by the Zurich consensus statement , for which baseline values had been obtained . RESULTS Seventeen players sustained a physician-observed or self-reported , physician-diagnosed concussion during a physician-observed ice hockey game . The mean clinical return-to-play duration ( in 15 cases ) was 12.8 ± 7.02 days ( median 10 days , range 7 - 29 days ) ; the mean number of physician office visits by players who suffered a concussion ( 15 cases ) was 2.1 ± 1.29 ( median 1.5 visits ) . Five of the 17 players who sustained a concussion also suffered a recurrent or second concussion . One of the 5 individuals who suffered a repeat concussion sustained his initial concussion in a regular season game that was not observed by a physician , and as a result this single case was not included in the total of 21 concussions . This initial concussion of the player was identified during baseline testing 2 days after the injury and was subsequently medically diagnosed and treated . The mean interval between the first and second concussions in these 5 players was 78.6 ± 39.8 days ( median 82 days ) , and the mean time between the return-to-play date of the first and second concussions was 61.8 ± 39.7 days ( median 60 days ) . CONCLUSIONS The mean rates of return to play for single and recurrent concussions were higher than rates cited in recent studies involving sport concussions . The time interval between the first and second concussions was also greater than previously cited . This difference may be the result of the methodology of direct independent physician observation , diagnosis , and adherence to the Zurich return-to-play protocol",
"OBJECT The objective of this study was to measure the incidence of concussion ( scaled relative to number of athlete exposures ) and recurrent concussion within 2 teams of fourth-tier junior ice hockey players ( 16 - 21 years old ) during 1 regular season . METHODS A prospect i ve cohort study called the Hockey Concussion Education Project was conducted during 1 junior ice hockey regular season ( 2009 - 2010 ) involving 67 male fourth-tier ice hockey players ( mean age 18.2 ± 1.2 years , range 16 - 21 years ) from 2 teams . Prior to the start of the season , every player underwent baseline assessment s using the Sideline Concussion Assessment Tool 2 ( SCAT2 ) and the Immediate Post-Concussion Assessment and Cognitive Test ( ImPACT ) . The study protocol also required players who entered the study during the season to complete baseline SCAT2 and ImPACT testing . If the protocol was not followed , the postinjury test results of a player without true baseline test results would be compared against previously established age and gender group normative levels . Each regular season game was observed by a qualified physician and at least 1 other neutral nonphysician observer . Players who suffered a suspected concussion were evaluated at the game . If a concussion diagnosis was made , the player was subsequently examined in the physician 's office for a full clinical evaluation and the SCAT2 and ImPACT were repeated . Based on these evaluations , players were counseled on the decision of when to return to play . Athlete exposure was defined as 1 game played by 1 athlete . RESULTS Twenty-one concussions occurred during the 52 physician-observed games ( incidence 21.5 concussions per 1000 athlete exposures ) . Five players experienced repeat concussions . No concussions were reported during practice sessions . A concussion was diagnosed by the physician in 19 ( 36.5 % ) of the 52 observed games . One of the 5 individuals who suffered a repeat concussion sustained his initial concussion in a regular season game that was not observed by a physician , and as a result this single case was not included in the total of 21 total concussions . This initial concussion of the player was identified during baseline testing 2 days after the injury and was subsequently medically diagnosed and treated . CONCLUSIONS The incidence of game-related concussions ( per 100 [ corrected ] athlete exposures ) in these fourth-tier junior [ corrected ] ice hockey players was 7 [ corrected ] times higher than [ corrected ] previously reported in the literature . This difference may be the result of the use of st and ardized direct physician observation , diagnosis , and subsequent treatment . The results of this study demonstrate the need for follow-up studies involving larger and more diverse sample groups to reflect generalizability of the findings . These follow-up studies should involve other contact sports ( for example football and rugby ) and also include the full spectrum of gender , age , and skill levels ",
"STUDY DESIGN Prospect i ve cohort . OBJECTIVES To identify the prevalence of neurocognitive and balance deficits in collegiate football players 48 hours following competition . BACKGROUND Neurocognitive testing , balance assessment s , and subjective report of symptoms are a commonly used test battery in examining athletes when concussion is suspected . Previous literature suggests many concussions go unreported . Little research exists examining the prevalence of neurocognitive or balance deficits in athletes who do not report concussion-like symptoms to a health care provider . METHODS Forty-five Division IA collegiate football players participated in this study . Preseason baseline scores using the Balance Error Scoring System , the Immediate Post-Concussion Assessment and Cognitive Testing , and the Postconcussion Symptom Scale were compared to posttest results obtained 48 hours following a game . Prevalence of symptoms was analyzed and reported . RESULTS Thirty-two ( 71 % ) of the 45 athletes tested demonstrated at least 1 deficit in either the Postconcussion Symptom Scale , Balance Error Scoring System , or at least 1 composite score of the Immediate Post-Concussion Assessment and Cognitive Testing . Nineteen of the 32 subjects demonstrated a change in 2 or more categories of neurocognitive and balance function . CONCLUSION In a cohort of football players tested 48 hours following their last game of the season , who did not seek medical attention related to a concussion , a significant number demonstrated limitations in neurocognitive and balance performance , suggesting that further research may need to be performed to improve recognition of an athlete 's deficits and to improve the ability to assess concussion . LEVEL OF EVIDENCE Differential diagnosis/symptom prevalence , level 3b",
"OBJECTIVE There is continuing controversy regarding predictors of poor outcome following mild traumatic brain injury ( mTBI ) . This study aim ed to prospect ively examine the influence of preinjury factors , injury-related factors , and postinjury factors on outcome following mTBI . METHOD Participants were 123 patients with mTBI and 100 trauma patient controls recruited and assessed in the emergency department and followed up 1 week and 3 months postinjury . Outcome was measured in terms of reported postconcussional symptoms . Measures included the ImPACT Post-Concussional Symptom Scale and cognitive concussion battery , including Attention , Verbal and Visual memory , Processing Speed and Reaction Time modules , pre- and postinjury SF-36 and MINI Psychiatric status ratings , VAS Pain Inventory , Hospital Anxiety and Depression Scale , PTSD Checklist-Specific , and Revised Social Readjustment Scale . RESULTS Presence of mTBI predicted postconcussional symptoms 1 week postinjury , along with being female and premorbid psychiatric history , with elevated HADS anxiety a concurrent indicator . However , at 3 months , preinjury physical or psychiatric problems but not mTBI most strongly predicted continuing symptoms , with concurrent indicators including HADS anxiety , PTSD symptoms , other life stressors and pain . HADS anxiety and age predicted 3-month PCS in the mTBI group , whereas PTSD symptoms and other life stressors were most significant for the controls . Cognitive measures were not predictive of PCS at 1 week or 3 months . CONCLUSIONS Given the evident influence of both premorbid and concurrent psychiatric problems , especially anxiety , on postinjury symptoms , managing the anxiety response in vulnerable individuals with mTBI may be important to minimize ongoing sequelae"
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BACKGROUND Early enteral feeding practice s are potentially modifiable risk factors for necrotising enterocolitis in very preterm or very low birth weight ( VLBW ) infants . Observational studies suggest that conservative feeding regimens , including slowly advancing enteral feed volumes , reduce the risk of necrotising enterocolitis . However , slow feed advancement may delay establishment of full enteral feeding and be associated with metabolic and infectious morbidities secondary to prolonged exposure to parenteral nutrition . OBJECTIVES To determine the effect of slow rates of enteral feed advancement on the incidence of necrotising enterocolitis , mortality , and other morbidities in very preterm or VLBW infants . SEARCH METHODS We used the st and ard search strategy of the Cochrane Neonatal Review Group Specialised Register . We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL 2014 , Issue 8) , MEDLINE , EMBASE , and CINAHL ( to September 2014 ) , conference proceedings , and previous review s. SELECTION CRITERIA R and omised or quasi-r and omised controlled trials that assessed the effect of slow ( up to 24 ml/kg per day ) versus faster rates of advancement of enteral feed volumes upon the incidence of necrotising enterocolitis in very preterm or VLBW infants . DATA COLLECTION AND ANALYSIS Two review authors independently assessed trial eligibility and risk of bias and undertook data extraction . We analysed the treatment effects in the individual trials and reported the risk ratio and risk difference for dichotomous data and mean difference for continuous data , with respective 95 % confidence intervals . We used a fixed-effect model in meta-analyses and explored the potential causes of heterogeneity in sensitivity analyses . MAIN RESULTS We identified six r and omised controlled trials in which a total of 618 infants participated . Most participants were stable preterm infants of birth weight between 1000 g and 1500 g. Few participants were extremely preterm , extremely low birth weight , or growth-restricted . The trials typically defined slow advancement as daily increments of 15 ml/kg to 20 ml/kg and faster advancement as 30 ml/kg to 35 ml/kg . Meta-analyses did not detect statistically significant effects on the risk of necrotising enterocolitis ( typical risk ratio ( RR ) 0.96 , 95 % confidence interval ( CI ) 0.55 to 1.70 ) or all-cause mortality ( typical RR 1.57 , 95 % CI 0.92 to 2.70 ) . Infants who had slow advancement took significantly longer to regain birth weight ( reported median differences 2 to 6 days ) and to establish full enteral feeding ( 1 to 5 days ) . AUTHORS ' CONCLUSIONS The available trial data suggest that advancing enteral feed volumes at daily increments of 30 ml/kg to 35 ml/kg does not increase the risk of necrotising enterocolitis in very preterm or VLBW infants . Advancing the volume of enteral feeds at slow rates result ed in several days delay in regaining birth weight and establishing full enteral feeds . The applicability of these findings to extremely preterm , extremely low birth weight , or growth-restricted infants is limited . Further r and omised controlled trials in these population s may be warranted to resolve this uncertainty
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"Background : The interrelations between early enteral feeding , necrotising enterocolitis ( NEC ) , and nosocomial sepsis ( NS ) remain unclear . Objective : To evaluate the effect of age at the introduction of enteral feeding on the incidence of NS and NEC in very low birthweight ( VLBW Methods : Data were collected on the pattern of enteral feeding and perinatal and neonatal morbidity on all VLBW infants born in one centre during 1995–2001 . Enteral feeding was compared between infants with and without NS and /or NEC . Results : The study sample included 385 infants . Of these , 163 ( 42 % ) developed NS and 35 ( 9 % ) developed NEC . Enteral feeding was started at a significantly earlier mean ( SD ) age in infants who did not develop nosocomial sepsis ( 2.8 ( 2.6 ) v 4.8 ( 3.7 ) days , p = 0.0001 ) . Enteral feeding was introduced at the same age in babies who did or did not develop NEC ( 3.1 ( 2 ) v 3.7 ( 3 ) days , p = 0.28 ) . Over the study period , the mean annual age at the start of enteral feeding fell consistently , and this correlated with the mean annual incidence of NS ( r2 = 0.891 , p = 0.007 ) . Multiple logistic regression analysis showed age at start of enteral feeding , respiratory distress syndrome , and birth weight to be the most significant predictors of risk of NS ( p = 0.0005 , p = 0.024 , p = 0.011 ) . Conclusions : Early enteral feeding was associated with a reduced risk of NS but no change in the risk of NEC in VLBW infants . These findings support the use of early enteral feeding in this high risk population , but this needs to be confirmed in a large r and omised controlled trial",
"OBJECTIVE To compare the effects of continuous versus intermittent feeding on gastrointestinal tolerance and growth in very low birth weight ( VLBW ) infants . STUDY DESIGN In a r and omized , controlled trial conducted at 3 neonatal units , 70 premature infants with a gestational age 24 to 29 weeks and birth weight were assigned to 1 of 3 feeding methods : continuous nasogastric feeding , intermittent nasogastric feeding , or intermittent orogastric feeding . Feeding was initiated within 30 hours of birth . Daily enteral and parenteral volumes , caloric and protein intakes , growth , enteral intolerance , and clinical complications were recorded . Cox regression analysis was used to determine primary outcome , the time to achieve full enteral feeding . RESULTS The continuously fed infants achieved full enteral feeding significantly faster than the intermittently fed infants ( hazard ratio [ HR ] = 1.86 ; 95 % confidence interval [ CI ] = 1.07 to 3.22 ) . In stratified analysis according to birth weight , the improvement was even more pronounced in the smallest infants , those with birth weight Growth rate was significantly faster in the continuously fed infants ( P = .002 ) . CONCLUSION In VLBW infants , continuous feeding seems to be better than intermittent feeding with regard to gastrointestinal tolerance and growth",
"In a prospect i ve multicentre study on 926 preterm infants formally assigned to their early diet , necrotising enterocolitis developed in 51 ( 5.5 % ) . Mortality was 26 % in stringently confirmed cases . In exclusively formula-fed babies confirmed disease was 6 - 10 times more common than in those fed breast milk alone and 3 times more common than in those who received formula plus breast milk . Pasteurised donor milk seemed to be as protective as raw maternal milk . Among babies born at more than 30 weeks ' gestation confirmed necrotising enterocolitis was rare in those whose diet included breast milk ; it was 20 times more common in those fed formula only . Other risk factors included very low gestational age , respiratory disease , umbilical artery catheterisation , and polycythaemia . In formula-fed but not breast-milk-fed infants , delayed enteral feeding was associated with a lower frequency of necrotising enterocolitis . With the fall in the use of breast milk in British neonatal units , exclusive formula feeding could account for an estimated 500 extra cases of necrotising enterocolitis each year . About 100 of these infants would die",
"The National Institute of Child Health and Human Development conducts and supports research on all stages of human development from preconception to adulthood in order to better underst and the health of children , youths , adults , families , and communities . Health and human development information is made easily available on the site with a simple A to Z list , along with clinical trials and health education campaign information . Links to clinical trials , news releases , publications , and related web sites are also available , as well as information on research being conducted at present and supported by the National Institute of Child Health and Human Development",
"OBJECTIVE To evaluate whether the mean gastric residual volume ( GRV ) and green gastric residuals ( GR ) themselves are significant predictors of feeding intolerance in the early enteral feeding advancement in extremely low birth weight ( ELBW ; DESIGN Ninety-nine ELBW infants were fed following a st and ardized protocol ( day 3 - -14 ) . At 48 hours of age , milk feeding was started ( 12 mL/kg/d increments , 12 meals per day ) . GR were checked before each feeding , and a GRV up to 2 mL/3 mL in infants less-than-or-equal750 g/>750 g was tolerated . In cases of increased GRV , feedings were reduced or withheld . The color of GR was assessed as clear , milky , green-clear , green-cloudy , blood-stained , or hemorrhagic . Multiple regression analysis was used to study the effect of the mean GRV and the color of GR on the feeding volume on day 14 ( V14 ) . RESULTS The median V14 was 103 mL/kg/d ( 0 - -166 ) . V14 increased with an increasing percentage of milky GR , whereas the mean GRV and the color green did not have a significant effect . CONCLUSIONS 1 ) Early enteral feeding could be established in ELBW infants . The critical GRV seems to be above 2 mL/3 mL because there was no significant negative correlation between the mean GRV and V14 . 2 ) Green GR were not negatively correlated with V14 and should not slow down the advancement of feeding volumes in absence of other clinical signs and symptoms",
"We sought to describe neonatal morbidities and therapeutic interventions in very low-birth-weight ( VLBW ) and extremely low-birth-weight ( ELBW ) infants cared for in Spanish hospitals . We preformed a prospect i ve collection of data covering the perinatal period until discharge by the SEN1500 network . This network , set up by the Spanish Society of Neonatology , targets VLBW and ELBW infants ( 400 to 1500 g ) admitted to neonatal units in Spanish hospitals . Data were recorded in electronic form and controlled for possible errors or inconsistencies before analysis . We report data for 8836 neonates admitted to 48 neonatal units from January 2002 to December 2005 . Prenatal steroids were given to significantly more newborns in 2003 to 2005 ( 79.4 % ) than in 2002 ( 73.4 % ) , although the remaining perinatal data examined failed to significantly vary . Delivery was by cesarean section in 69.8 % of cases but significantly lower ( 35.9 % ) for infants under a postmenstrual age of 26 weeks . Hyaline membrane disease was diagnosed in 53.9 % of the newborns and bronchopulmonary dysplasia ( BPD ) in 10.46 % . Mechanical ventilation was employed in 69.1 % , surfactant in 50.3 % , and steroids for BPD in 5.3 % . Intraventricular hemorrhage grade s 3 to 4 ( 8.1 % ) and cystic leukomalacia ( 2.6 % ) were the most relevant brain ultrasonography findings . Rates of early- and late-onset septicemia were 5 % and 29.4 % , respectively . Further diagnoses were necrotizing enterocolitis ( NEC ; 6.9 % ) and persistent ductus arteriosus ( PDA ; 24.2 % ) ; 40.6 % of the cases of NEC and 15.3 % of those of PDA required surgery . In addition , 26.6 % of the newborns required supplementary oxygen at 28 days of life . The number of newborns who had not recovered their birth weight at this age fell from 3.1 % in 2002 to 1.5 % in 2005 . Rates of prenatal steroid use , cesarean delivery , and main morbidities were comparable to figures cited for other patient series , although our BPD rate was among the lowest reported and nosocomial sepsis rate among the highest"
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The aim of this systematic review was to assess the effect of diet on changes in parameters describing the body size phenotype of metabolically healthy obese subjects . The data bases Medline , Scopus , Web of Knowledge and Embase were search ed for clinical studies carried out between 1958 and June 2016 that reported the effect of dietary intervention on BMI , blood pressure , concentration of fasting triglyceride ( TG ) , high density lipoprotein cholesterol ( HDL-C ) , fasting glucose level , the homoeostatic model assessment of insulin resistance ( HOMA-IR ) and high sensitivity C-Reactive Protein ( hsCRP ) in metabolically healthy , obese subjects . Twelve clinical studies met inclusion criteria . The combined analyzed population consists of 1827 subjects aged 34.4 to 61.1 with a BMI > 30 kg/m2 . Time of intervention ranged from eight to 104 weeks . The baseline characteristics related to lipid profile were more favorable for metabolically healthy obese than for metabolically unhealthy obese . The meta-analyses revealed a significant associations between restricted energy diet and BMI ( 95 % confidence interval ( CI ) : −0.88 , −0.19 ) , blood pressure ( systolic blood pressure ( SBP ) : −4.73 mmHg ; 95 % CI : −7.12 , −2.33 ; and diastolic blood pressure ( DBP ) : −2.75 mmHg ; 95 % CI : −4.30 , −1.21 ) and TG ( −0.11 mmol/l ; 95 % CI : −0.16 , −0.06 ) . Changes in fasting glucose , HOMA-IR and hsCRP did not show significant changes . Sufficient evidence was not found to support the use of specific diets in metabolically healthy obese subjects . This analysis suggests that the effect of caloric restriction exerts its effects through a reduction in BMI , blood pressure and triglycerides in metabolically healthy obese ( MHO ) patients
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"BACKGROUND There are few prospect i ve data on the prognosis of insulin-sensitive and insulin-resistant normal-weight ( NW ) or obese individuals . OBJECTIVES The estimated liver fat content , incidences of hyperglycemia and cardiovascular disease , and all-cause and cardiovascular mortality rates were investigated in a population -based cohort of 1658 individuals who were categorized according to BMI and insulin resistance as defined by HOMA-IR values ≥2.5 and the presence of metabolic syndrome . DESIGN This was a prospect i ve cohort study with a 9-y follow-up . Anthropometric values , blood pressure , and blood metabolic variables were measured , and information on vital status was collected from demographic files at follow-up . RESULTS A total of 137 of 677 NW individuals ( 20 % ) were classified as insulin resistant and normal weight ( IR-NW ) , and 72 of 330 obese individuals ( 22 % ) were classified as insulin sensitive and obese ( IS-obese ) . Incidences of diabetes , impaired fasting glucose , and cardiovascular events were 0.4 % , 6.3 % , and 3.3 % , respectively , in insulin-sensitive and normal-weight ( IS-NW ) individuals ( reference category ) ; 5.8 % , 10.2 % , and 6.6 % , respectively , in IR-NW individuals ; and 5.6 % , 8.3 % , and 8.3 % , respectively , in IS-obese individuals . In a multiple logistic regression model , risks of incident hyperglycemia and cardiovascular events increased in both groups compared with in the reference category [ HR ( 95 % CI ) : 2.54 ( 1.42 , 4.55 ) and 1.98 ( 0.86 , 4.54 ) in IR-NW subjects ; 2.16 ( 1.01 , 4.63 ) and 2.76 ( 1.05 , 7.28 ) in IS-obese subjects ] . The estimated liver fat content significantly increased during follow-up only in the IR-NW group in the same model . Cardiovascular mortality was 2 - 3-fold higher in IR-NW and IS-obese than in IS-NW individuals in a Cox regression model . CONCLUSIONS Our data refute the existence of healthy obese phenotypes because IS-obese individuals showed increased cardiometabolic risk . The existence of unhealthy NW phenotypes is supported by their increased risk of incident hyperglycemia , fatty liver , cardiovascular events , and death",
"CONTEXT Gut microbiota , which acts collectively as a fully integrated organ in the host metabolism , can be shaped by long-term dietary interventions after a specific diet . OBJECTIVE The aim was to study the changes in microbiota after 1 year 's consumption of a Mediterranean diet ( Med diet ) or a low-fat , high-complex carbohydrate diet ( LFHCC diet ) in an obese population . DESIGN Participants were r and omized to receive the Med diet ( 35 % fat , 22 % monounsaturated ) and the LFHCC diet ( 28 % fat , 12 % monounsaturated ) . SETTING AND PARTICIPANTS The study was conducted in 20 obese patients ( men ) within the Coronary Diet Intervention With Olive Oil and Cardiovascular Prevention ( CORDIOPREV ) study , an ongoing prospect i ve , r and omized , opened , controlled trial in patients with coronary heart disease . MAIN OUTCOME MEASURE We evaluated the bacterial composition and its relationship with the whole fecal and plasma metabolome . RESULTS The LFHCC diet increased the Prevotella and decreased the Roseburia genera , whereas the Med diet decreased the Prevotella and increased the Roseburia and Oscillospira genera ( P = .028 , .002 , and .016 , respectively ) . The abundance of Parabacteroides distasonis ( P = .025 ) and Faecalibacterium prausnitzii ( P = .020 ) increased after long-term consumption of the Med diet and the LFHCC diet , respectively . The changes in the abundance of 7 of 572 metabolites found in feces , including mainly amino acid , peptide , and sphingolipid metabolism , could be linked to the changes in the gut microbiota . CONCLUSIONS Our results suggest that long-term consumption of the Med and LFHCC diets exerts a protective effect on the development of type 2 diabetes by different specific changes in the gut microbiota , increasing the abundance of the Roseburia genus and F. prausnitzii , respectively"
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The objective of this systematic review was to compare the effectiveness of individualized patient education interventions to st and ardized patient education interventions on the rate of readmission , performance of specific health behaviours , depression , anxiety , and cognition during the post-hospital discharge recovery period following cardiovascular surgery . DESIGN AND DATA SOURCES R and omized controlled trials that included study participants who underwent their first bypass and /or valve replacement surgery ; were eighteen years of age or older ; and were recovering in the community . REVIEW METHODS For all data analyzed , data was entered based on the principle of intention to treat . To be included in a given comparison , outcome data had to have been available for at least 80 % of those who were r and omized . Assessment of statistical heterogeneity was tested . Generic inverse variance methods based on r and om effects models were used to pool effect estimates across included studies . RESULTS Seventeen trials involving 2624 study participants where individualized patient education was the primary interventional intent was included in this review . Four studies that included 930 participants reported on hospital readmissions . The sources of bias that remain unclear or were judged as containing high risk of bias most frequently across included trials were blinding of outcome assessment , incomplete outcome data , and selective reporting . An effect of the individualized patient education in reducing hospital readmission rates ( Mean Difference : -1.28 , 95 % CI -1.87 to -0.68 , p ) , depression ( Mean Difference : -23.32 , 95 % CI -23.70 to -22.95 , p ) , and anxiety ( Mean Difference : -19.34 , 95 % CI -20.46 to -18.23 , p performance of specific health behaviours ( Mean Difference : 3.45 , 95 % CI 3.27 - 3.63 , p ) and cognition ( Mean Difference : 11.17 , 95 % CI 10.66 - 11.68 , p the readmission rates . However , a major limitation notes in the current body of evidence relates to the small number of or even lacking number of trials for clinical ly important outcomes . As well , the individualized patient education intervention is effective in promoting statistically significant changes in quality of life , performance of health behaviours , depression , and anxiety
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"& NA ; Cardiovascular diseases cause more disability and economic loss in industrialized nations than any other group of diseases . In previous work [ Nurs Res 49 ( 2000a ) 1 ] , most coronary artery bypass graft patients ( CABG , N=225 ) reported unrelieved pain and received inadequate analgesics . This study proposed to evaluate a preadmission education intervention to reduce pain and related activity interference after CABG surgery . Patients ( N=406 ) were r and omly assigned to ( a ) st and ard care or ( b ) st and ard care+pain booklet group . Data were examined at the preadmission clinic and across days 1–5 after surgery . Outcomes were pain‐related interference ( BPI‐I ) , pain ( MPQ‐SF ) , analgesics ( chart ) , concerns about taking analgesics ( BQ‐SF ) , and satisfaction ( American Pain Society‐POQ ) . The impact of sex was explored related to primary and secondary outcomes . The intervention group did not have better overall pain management although they had some reduction in pain‐related interference in activities ( t(355)=2.54 , P more pain and pain‐related interference in activities than men . The booklet was rated as helpful , particularly by women . In conclusion , the intervention did not result in a clinical ly significant improvement in pain management outcomes . In future , an intervention that considers sex‐specific needs and also involves educating the health professionals caring for these patients may influence these results",
"The effectiveness of in-hospital self-care patient education , delivered to patients following heart surgery , is question able , as evidence indicates individuals are not able to absorb and /or retain information at this time . In the absence of adequate instruction , individuals will not have the relevant information to engage in specific self-care behaviors , result ing in the onset of complications and /or hospital readmissions . The purpose of this pilot study was to collect preliminary evidence to demonstrate the impact of an individualized education intervention given above and beyond usual care , delivered , at two points in time , following hospital discharge . A r and omized controlled trial was used in which 34 patients were r and omly assigned to one of two groups . Chi-square analyses to examine differences between groups on complications and hospital readmission rates were conducted . Findings point to the impact of the intervention in reducing the number of hospital readmissions and complications at 3 months following hospital discharge",
"AIMS To test the effect of education and support by a nurse on self-care and re source utilization in patients with heart failure . METHODS A total of 179 patients ( mean age 73 , 58 % male , NYHA III-IV ) hospitalized with heart failure were evaluated prospect ively . Patients were r and omized to the study intervention or to ' care as usual ' . The supportive educative intervention consisted of intensive , systematic and planned education by a study nurse about the consequences of heart failure in daily life , using a st and ard nursing care plan developed by the research ers for older patients with heart failure . Education and support took place during the hospital stay and at a home visit within a week of discharge . Data were collected on self-care abilities , self-care behaviour , readmissions , visits to the emergency heart centre and use of other health care re sources . RESULTS Education and support from a nurse in a hospital setting and at home significantly increases self-care behaviour in patients with heart failure . Patients from both the intervention and the control group increased their self-care behaviour within 1 month of discharge , but the increase in the intervention group was significantly more after 1 month . Although self-care behaviour in both groups decreased during the following 8 months , the increase from baseline remained statistically significant in the intervention group , but not in the control group . No significant effects on re source utilization were found . CONCLUSIONS Intensive , systematic , tailored and planned education and support by a nurse results in an increase in patients ' self-care behaviour . No significant effects were found on use of health care re sources . Additional organisational changes , such as longer follow-up and the availability of a heart failure specialist would probably enhance the effects of education and support",
"AIMS AND OBJECTIVES The aim of this study was to assess the effect of a supportive educational intervention developed based on the Orem 's self-care theory on the self-care ability of patients with myocardial infa rct ion . BACKGROUND Patients with cardiovascular disease suffer from the lack of knowledge about the disease and consequently are not able to fulfil their own self-care needs . DESIGN This was a r and omised controlled trial conducted in 2012 . METHODS We recruited a r and om sample of 66 patients with myocardial infa rct ion who had been recently discharged from coronary care unit . The study setting was two university hospitals located in Khorasan , Iran . Patients were r and omly allocated to either the experimental or the control groups . Patients in the experimental group received education , support , and counselling while patients in the control group received no intervention . We employed a demographic question naire and the Myocardial Infa rct ion Self-Care Ability Question naire for data collection and spss version 16.00 for data analysis . FINDINGS After the study , patients in the experimental group had higher levels of self-care knowledge , motivation and skills compared to the pre study readings and the control group . CONCLUSION The supportive educational intervention developed based on the Orem 's self-care theory can improve nonhospitalised patients ' self-care ability and positively affect public health outcomes . Consequently , using the developed programme for providing follow-up care to nonhospitalised patients is recommended . RELEVANCE TO CLINICAL PRACTICE Having the ability to develop caring systems based on the nursing theories is a prerequisite to st and ard nursing practice . Identifying patients ' educational needs is a fundamental prerequisite to patient education . Our findings revealed that the supportive educational intervention developed based on the Orem 's self-care theory can help health care providers identify and fulfil patients ' self-care needs",
"AIMS To investigate the long-term benefits of a six-week comprehensive cardiac rehabilitation programme on physical activity , psychological well-being and quality of life in patients with coronary heart disease . BACKGROUND Cardiac rehabilitation ( CR ) in short term improves exercise capacity and quality of life in patients with cardiac disease . However , the long-term benefits of CR are inconclusive . DESIGN A prospect i ve CR programme with repeated measures follow-up over 12 months . METHODS A six-week outpatient cardiac rehabilitation programme was conducted including 147 patients with coronary heart disease . Patients completed the physical activity energy expenditure ( seven-day recall activity ) , MacNew Heart Disease Health-Related Quality of Life ( MacNew ) and Hospital Anxiety and Depression scale ( HADs ) at baseline , six weeks , six and 12 months . RESULTS One hundred and five ( 71 % ) patients ( 76 male ) mean age of 61.8 ( SD 9.7 ) completed the four-measurement points . Analysis of variance revealed that total energy expenditure ( F ( 2 , 231 ) = 131 , p HADs ( F ( 2 , 237 ) = 19.3 , p depression score ( F ( 2 , 235 ) = 21.06 , p anxiety score ( F ( 2,237 ) = 17.02 , p MacNew ( F ( 2 , 197 ) = 77.02 , p Depression was independently explained in 22 % of the variance in quality of life at 6 or 12 months . The energy expenditure was significantly higher for men compared to women ( F ( 1 , 103 ) = 31 , p cardiac rehabilitation programme is beneficial in improving quality of life , physical activity status , anxiety and depression . These benefits were maintained at 12 months . Elevated levels of depression were associated with impaired quality of life . RELEVANCE TO CLINICAL PRACTICE All relevant health care staff should be aware of the benefits of CR and routinely refer and encourage patients with cardiac disease to attend a cardiac rehabilitation programme . Depression and anxiety intervention strategies should be incorporated in cardiac rehabilitation programmes",
"OBJECTIVE To test the efficacy of an information intervention upon emotional recovery following coronary artery bypass surgery . METHODS R and omized trial . Video information was combined with individualized information sessions carried out by nurses at admission and at discharge from the hospital . The video was shown pre-operatively and again during the session at admission . Patients were helped to express their questions and worries and congruent information and support was provided . Control group patients received st and ardized information and no video . Recordings were made at baseline , discharge from hospital and during a 2 years follow-up period . RESULTS One hundred and nine patients were r and omized to the intervention or the control groups . A MANOVA was used to test of the variance of the outcome variables at each time point . At discharge intervention patients reported less anxiety ( p = 0.046 ) and better subjective health ( p = 0.005 ) . They reported better subjective health during the whole follow-up period ( 0.040 > or = p > or = 0.000 ) , less anxiety up to 1 year ( 0.042 > or = p > or = 0.004 ) , and less depression from 6 months to 2 years following discharge ( 0.023 > or = p > or = 0.004 ) . CONCLUSION The effects of the intervention probably relate to the combined use of the video and patient centered information sessions . PRACTICE IMPLICATION S The intervention can easily be implemented in clinical practice and nurses strongly identified with its principles",
"For this study a r and omized clinical trial was design ed to test the effects of an early home recovery information intervention on physical functioning , psychological distress , and symptom frequency 1 month following coronary artery bypass graft surgery ( CABG ) . Recovery outcomes were compared between two groups : those receiving an audiotape of information on expected physical sensations and their management ( Cardiac Home Information Program [ CHIP ] ) in addition to the usual care , and those receiving the usual cardiac discharge information protocol . A nonprobability sample of 180 patients ( 84 women and 96 men ; mean age = 62 years ) was equally distributed between the two study groups . When controlling for age , comorbidity , and cardiac functional status , the results showed positive effects on physical functioning in women and psychological distress , vigor and fatigue in men . Consistent with other studies , women had worse physical functioning and more symptom frequency than men . These findings indicate that the CHIP intervention is an effective method to prepare CABG patients for home recovery",
"OBJECTIVE The purpose of this study was to determine the effectiveness of an information and support telephone intervention for reducing anxiety in patients who have undergone coronary artery bypass graft surgery and their partners . DESIGN The study is a r and omized controlled trial . Intervention began at discharge ; 6 telephone calls were made to patients and partners over 7 weeks . Primary outcome was Beck Anxiety Inventory measured at baseline in hospital , at home on day 3 , week 4 , and week 8 . SAMPLE The subjects were 131 patients who have undergone elective coronary artery bypass graft surgery and their partners . RESULTS Patients ' anxiety was moderate to severe the day before discharge . It was significantly lower in the treatment group than in the control group at day 2 at home . Partners always had lower anxiety than patients . A more sustained decrease in anxiety in the partner treatment group was found at both day 2 and week 4 . CONCLUSION Intervention effect is in the early period after discharge-- the time most affected by reduced lengths of stay",
"The purpose of this trial was to determine the effectiveness of advanced practice nursing support on cardiac surgery patients ’ during the first 5 weeks following hospital discharge . Patients ( N = 200 ) were r and omly allocated to two groups : ( a ) an intervention group who received telephone calls from an advanced practice nurse ( APN ) familiar with their clinical condition and care needs , twice during the first week following discharge then weekly thereafter for 4 weeks , and ( b ) a usual care group . Measures of health-related quality of life ( HRQL ) , symptom distress , satisfaction with recovery care , and unexpected health care contacts were obtained at 5 weeks following discharge . There were no significant group differences in HRQL , unexpected contacts with the health care system , or symptom distress . The provision of APN support via telephone followup after cardiac surgery is feasible . However , further r and omized trials of single and multicomponent APN interventions are needed to prove effectiveness",
"OBJECTIVE The objective of this study was to evaluate the effects of a home-based intervention program ( HBIP ) on anxiety and depression 6 months after coronary artery bypass grafting ( CABG ) . METHODS In a prospect i ve r and omized controlled trial , 203 elective CABG patients were included . An HBIP structured for respondents in the intervention group was performed 2 and 4 weeks after surgery . Anxiety and depression symptoms were measured by the Hospital Anxiety and Depression Scale ( HADS ) in both patient groups before surgery , 6 weeks after surgery , and 6 months after surgery . RESULTS A total of 185 patients completed the study : 93 patients in the intervention group and 92 patients in the control group . On 6-week and 6-month follow-ups , significant improvements in anxiety and depression symptoms were found in both groups . These improvements did not differ significantly between the groups . However , in a predefined subgroup of patients with anxiety and /or depression symptoms at baseline ( n=65 ) , improvement was significantly larger in the intervention group ( n=29 ) than in the control group ( n=36 ) after 6 months ( P Patients experiencing high levels of psychological distress before CABG surgery benefited from a structured informational and psychological HBIP . Implementation of psychological screens of patients scheduled for CABG might serve to identify patients experiencing anxiety and /or depression . These patients could then be targeted to receive individualized HBIP",
"HeartCare is an Internet-based information and support service for patients recovering at home from coronary artery bypass graft ( CABG ) surgery . The system is design ed to meet the nursing challenges in health information to support needs of CABG patients . HeartCare ( a ) provides information and support , tailored to patients ' individual and changing recovery needs during CABG recovery , ( b ) makes recovery information more accessible for timely use by patients , and ( c ) extends the scope of nursing services to CABG patients from hospital through home . An ongoing r and omized controlled study is underway to evaluate the clinical outcomes of patients ' use of the HeartCare system and to examine its acceptance as a usable re source for postCABG patients who have limited previous computer experience",
"BACKGROUND Approximately 30 % of patients undergoing coronary artery bypass graft ( CABG ) procedures have diabetes and , as such , are at increased risk for postoperative complications and a lengthy recovery . OBJECTIVE To test the feasibility of an in-home early recovery management intervention to improve physical and psychosocial functioning in the diabetic CABG population . METHODS This pilot study was a 2-group , r and omized , experimental study . The 6-week in-home early recovery intervention was delivered by way of a device called the Health Buddy ( Health Hero Network , Redwood City , CA ) . Subjects were 49 diabetic patients who had undergone a first-time CABG procedure . RESULTS Although no statistical differences between groups were found , descriptively , the intervention group 's baseline means on Medical Outcomes Study Short Form-36 subscales measuring physical functioning were lower but improved to levels comparable with that of the control group . Improvements in psychosocial functioning were comparable between the 2 groups . CONCLUSION This in-home telehealth intervention may have promise for improving functioning outcomes in high-risk CABG patients with diabetes . However , weaknesses of the intervention and the need for a more focused , directive intervention were identified",
"AIM The aim of the study was to test the effect of an audiotape giving concrete objective information and strategies to reduce symptoms , psychological distress and enhance physical functioning in patients having coronary artery bypass grafts . BACKGROUND The period following hospital discharge is stressful for patients having coronary artery bypass grafts . Evident-based interventions are needed to improve outcomes in Thai population s following coronary artery bypass graft surgery . METHODS A r and omized controlled trial was conducted during 2004 - 2005 . A sample of 120 Thai patients having coronary artery bypass grafts was r and omly assigned to an intervention group or a control group . The intervention group was given an information audiotape the day prior to hospital discharge , and encouraged to listen to it as many times as necessary . Participants were interviewed using vali date d instruments predischarge and at 2 weeks and 4 weeks after discharge . FINDINGS Participants in the intervention group had statistically significantly fewer symptoms of shoulder , back or neck pain and lack of appetite , and increased physical activity after discharge , compared to the control group . This effect remained statistically significant after controlling for age , gender , co-morbidity and presurgical cardiac functional status . However , no statistically significant difference in psychological distress was observed . CONCLUSION Nurses can use an audiotape containing preparatory information to improve outcomes for patients having coronary artery bypass grafts during the few weeks after discharge from hospital . Further studies are recommended to improve its effect on psychological distress",
"The purpose of this study was to investigate the impact of a supportive-educative telephone program on the levels of knowledge and anxiety of patients undergoing coronary artery bypass graft surgery during the first 6 weeks after hospital discharge . With a posttest-only control group design , the first 74 patients scheduled , between September 1986 and February 1987 , for coronary artery bypass graft surgery in a large , western Canadian teaching hospital were r and omly assigned to either an experimental or a control group . The effect of the intervention , which was implemented by a cardiac rehabilitation nurse specialist , was assessed by a knowledge test and a state anxiety inventory . Data were collected without knowledge of the participants ' group assignment . As hypothesized , data analysis with independent t tests revealed a statistically significant ( p less than 0.05 ) difference between the knowledge level of the experimental and the control group in the areas of coronary artery disease , diet , medications , physical activity restrictions , exercise , and rest . A statistically significant difference between the state anxiety level of the experimental and the control group was also evident , as was a statistically significant inverse relationship between participants ' knowledge and anxiety levels . From these findings , several implication s and recommendations for nursing practice and research have been generated",
"This article presents considerations for the design and testing of electronic interventions to improve recovery outcomes in cardiac patients . A brief description of the design and testing of 2 telehealth interventions for cardiac patients is provided : HeartCare and E-CHANGE . The HeartCare project was a r and omized trial of a home support program for patients after coronary artery bypass graft surgery . E-CHANGE is an Internet-based home support program design ed to increase lifestyle exercise after a cardiac event . Lessons learned from these 2 projects regarding design considerations , system use , effectiveness , and research challenges are discussed . Methods to promote the preservation of nursing values in electronic systems are described , as well nursing roles in the use of computer-assisted care",
"Background : The ‘ Fit For Surgery ’ programme was based on previous studies suggesting improvement in risk factors contributing to coronary disease while patients wait for cardiac surgery . Aim : To evaluate our nurse-led programme in a r and omised controlled trial with 188 patients . Methods : Patients listed for coronary artery bypass surgery with at least one poorly controlled risk factor were r and omised to st and ard care or the intervention which provided lifestyle counselling and preparation for surgery at monthly intervals . Primary outcome measurements were anxiety , blood pressure , cholesterol , length of stay and body mass index . Costs of the intervention were also collected . Results : For both groups blood pressure and total cholesterol improved ( Blood pressure mm Hg ( Control − 9.11 ( CI − 4.89 , − 13.33 ) ; Intervention − 13.02 ( CI − 8.76 , − U17.29 ) both p ) ; total cholesterol ( Control − 0.20 ( CI − 0.03 , − 0.37 ) p = 0.02 , Intervention − 0.18 ( CI − 0.02 , − 0.34 ) p = 0.03 ) . However there were no significant differences between the groups . Cost minimization analysis showed that the total costs were less in the intervention group due to fewer admissions ( total costs £ 10,754 ( 3746 ) v £ 13,047 ( 5835 ) , CI − 3743 , − 843 ; p = 0.002 ) . Conclusions : The nurse-led programme did not appear to reduce risk factors prior to coronary artery bypass surgery . However , the intervention appears to reduce overall healthcare utilization ",
"Common concerns with the traditional protocol ( TP ) for cardiac rehabilitation include suboptimal program participation , poor facilitation of independent exercise , the use of costly continuous electrocardiographic ( ECG ) monitoring , and lack of insurance reimbursement . To address these concerns , a reduced cost-modified protocol ( MP ) was developed to promote independent exercise . Eighty low- to moderate-risk cardiac patients were r and omized to a TP ( n = 42 ) or a MP ( n = 38 ) and were compared over 6 months on program participation , exercise adherence , cardiovascular outcomes , and program costs . During month 1 , patients followed identical regimens , including 3 ECG-monitored exercise sessions/week , with encouragement to achieve > /=5 thirty-minute sessions/week . In week 5 , the TP continued with a facility-based regimen including 3 exercise sessions/week for 6 months and used ECG monitoring the initial 3 months . The MP discontinued ECG monitoring in week 5 and were gradually weaned to an off-site exercise regimen that was complemented with educational support meetings and telephone follow-up . Compared with TP patients , MP patients had higher rates of off-site exercise over 6 months ( p = 0.05 ) , and total exercise ( on site + off site ) during the final 3 months ( p = 0.03 ) . Also , MP patients were less likely to drop out ( p = 0.05 ) . Both protocol s promoted comparable improvements in maximal oxygen uptake ( p blood lipids ( p hemodynamic measurements ( p cost $ 738 less/patient than the TP and required 30 % less staff ( full-time equivalents ) . These results suggest that a reduced cost MP was as effective as an established TP in improving physiologic outcomes while demonstrating higher rates of exercise adherence and program participation . Thus , the MP or a similar protocol has applicability to hospitals with large capitated or managed care population s to provide cost-effective cardiovascular risk reduction to patients",
"Background and objective The educational aspect of oral anticoagulant treatment is considered a possible cause of variability in anticoagulation levels . The aim of this prospect i ve study was to investigate whether the time spent in the therapeutic range ( TSTR ) by patients taking oral anticoagulants could be improved by two different , consecutive educational approaches on the crucial aspects of oral anticoagulant therapy . Design and methods Between May and June 2004 , vali date d interviews were conducted with 240 patients ( 128 male and 112 female , mean age 50 ± 12 years ) enrolled in the study . Three months later , the patients were r and omly allocated to three groups . A course that focused on the questions in the interview was followed by the first group ( n = 80 ) ; a brochure containing the correct answers to questions was given to the second ( n = 81 ) ; nothing was provided for the third ( n = 79 ) . Results A significant difference was found in the TSTR between the quarters preceding and following the interview . Mean TSTR increase was 13 % . Patients that were r and omly selected to attend the educational course , read a brochure or do nothing showed similar TSTR percentages in the quarter following the interview . A good control of the anticoagulant therapy ( TSTR > 70 % ) was maintained , with no significant variation during the following three-quarters . Interpretation and conclusions A two-step educational approach for patients on long-term oral anticoagulation does not improve TSTR percentages in the short term",
"BACKGROUND Coronary artery bypass graft ( CABG ) surgery is performed more frequently in individuals who are older and sicker than in previous years . Increased patient acuity and reduced hospital length of stays leave individuals ill prepared for their recovery . OBJECTIVES To test the feasibility of a peer support program and determine indicators of the effects of peer support on recovery outcomes of individuals following CABG surgery . METHODS AND RESULTS A pre-post test pilot r and omized clinical trial design enrolled men and women undergoing first-time nonemergency CABG surgery at a single site in Ontario . Patients were r and omly assigned to either usual care or peer support . Patients allocated to usual care ( n=50 ) received st and ard preoperative and postoperative education . Patients in the peer support group ( n=45 ) received individualized education and support via telephone from trained cardiac surgery peer volunteers for eight weeks following hospital discharge . Most ( 93 % ) peer volunteers believed they were prepared for their role , with 98 % of peer volunteers initiating calls within 72 h of the patient 's discharge . Peer volunteers made an average of 12 calls , less than 30 min in duration over the eight-week recovery period . Patients were satisfied with their peer support ( n=45 , 98 % ) . The intervention group reported statistical trends toward improved physical function ( physical component score ) ( t [89]=-1.6 ; P=0.12 ) role function ( t [93]=-1.9 ; P=0.06 ) , less pain ( t [93]=1.30 ; P=0.20 ) and improved cardiac rehabilitation enrollment ( chi2=2.50 , P=0.11 ) . CONCLUSIONS These preliminary results suggest that peer support may improve recovery outcomes following CABG . Data from the present pilot trial also indicate that a home-based peer support intervention is feasible and an adequately powered trial should be conducted",
"Two thous and patients undergoing coronary artery bypass grafting with cardiopulmonary bypass were prospect ively studied to compare the influence of age on the incidence of neurologic , cardiac , and other complications . Postoperative neurologic events were found in 56 ( 2.8 % ) patients , with an incidence in patients > or = 75 years ( 8.9 % ) more than twice that of patients 65 to 74 ( 3.6 % ) and nine times larger than in patients or = 75 years compared with those Patients with postoperative neurologic events had a ninefold increase in mortality--35.7 % versus 4.0 % . Logistic regression analysis demonstrate the most important predictors of a postoperative neurologic event to be age , preoperative neurologic abnormality , recent myocardial infa rct ion , and duration of cardiopulmonary bypass . The risk of neurologic complications increases disproportionately to the risk of cardiac complications in the elderly undergoing coronary artery bypass grafting with cardiopulmonary bypass . Despite neurologic improvement ( 32 of 56 patients ) , a postoperative neurologic event was second only to low cardiac output state as the postoperative complication most highly associated with in-hospital death . These results are important for decisions regarding selection of c and i date s for coronary artery bypass grafting and for prediction of surgical outcome",
"In a trial to evaluate the effectiveness of a nurse-directed intervention design ed to help patients decrease dietary intake of fat , quit or decrease smoking , and increase exercise , 138 women who underwent coronary artery bypass surgery were r and omized to receive special intervention ( SI ) or usual care ( UC ) . The SI group received a behavioral program based on self-efficacy theory in the home 2 weeks after discharge with regular follow-up . The UC group received routine medical care . Risk factors and lifestyle behaviors were measured at baseline and 1 year after surgery in 116 ( 84 % ) women ( SI = 59 , UC = 57 ) . The SI group decreased their total fat intake from a mean of 38 % of calories at baseline to 35 % at 1 year , while the UC group increased it from 36 % to 38 % . The prevalence of smoking decreased from 24 % at baseline to 8 % at 1 year in the SI group and from 19 % to 14 % in the UC group . At follow-up , the quit rate in those smoking at baseline was 64 % in the SI group , with no new smokers , and 55 % in the UC group , with three new smokers . Both groups reported improvement in exercise , with the proportion of women reporting participation in some form of regular exercise slightly higher in the SI group than in the UC group , 54 % and 51 % , respectively",
"BACKGROUND Depression is commonly reported as a consequence of coronary artery bypass grafting surgery . It is the most important barrier to proper treatment of cardiac patients , causing failure in accepting the condition , decreasing the motivation in following the therapeutic recommendations , and negatively affecting the patients ' function and quality of life . OBJECTIVE ( S ) The objective of this study was to investigate the effects of a PRECEDE-based educational program on depression , general health , and quality of life in coronary artery bypass grafting surgery patients . METHODS The experimental study included 54 post-bypass surgery patients in Isfahan Cardiovascular Research Center . The patients were r and omly assigned to intervention and comparison groups ( 27 patients in each ) . The data were collected using four question naires ( Cardiac Depression Scale , General Health Question naire-12 , SF-36 , and a PRCEDE-based question naire to measure predisposing , reinforcing , enabling factors , and self-help behaviors ) . All subjects were pre-tested . The intervention , consisting of nine educational sessions per week ( 60 - 90min each ) was implemented . The patients were followed for 2 months post-intervention and post-tested at the end of the second month . RESULTS Following the educational intervention , the mean scores of predisposing factors , enabling factors , reinforcing factors and self-helping behaviors were significantly increased in the intervention group , compared to the comparison group ( p The mean score for depression in the comparison group ( 104.5±30.4 ) and intervention group ( 112.8±21.9 ) decreased significantly following educational intervention , but the change was more pronounced in the intervention group compared with the control group ( 66.2±22 vs. 89.2±27.8 ) . The difference between the two groups on the basis of general health was statistically significant ( p ) . Improvements in quality of life on the basis of physical function ( p role limitations result ing from emotional status ( p mental health ( p educational program based on the PRECEDE Model on decreasing depression level , improving general health , and increasing quality of life in coronary artery bypass grafting surgery patients",
"Shortened hospitalizations following cardiac surgery necessitate re-evaluation of how pertinent information for self-care management and reduction of coronary artery disease risk factors can be incorporated into an effective inpatient cardiac patient teaching program . This study investigated the effect of three different teaching approaches ( i.e. , an inpatient teaching program , a postdischarge telephone follow-up program , and a postdischarge group teaching program ) among 90 patients who had undergone coronary artery bypass graft surgery . Teaching outcomes were evaluated in this study by use of the Heart Disease Management Question naire and Cardiac Surgical Patient Teaching Satisfaction Inventory . Analyses of the data revealed similar patient teaching outcomes regardless of the type of teaching intervention the participant received . Findings supported the effectiveness of the inpatient teaching protocol which focused on \" survival skills \" for self-care management postdischarge . The findings are important in the re design of teaching programs which are efficient yet meaningful to the patient within today 's health care environment . Additional findings indicated that patients who had longer lengths of stay and those with more vessels bypassed were the least satisfied with their teaching . Further implication s for nurses involved in patient teaching are discussed",
"Objective : To investigate the long-term effect of exp and ed cardiac rehabilitation on a composite end-point , consisting of cardiovascular death , myocardial infa rct ion or readmission for cardiovascular disease , in patients with coronary artery disease . Design : Single-centre prospect i ve r and omized controlled trial . Setting : University hospital . Subjects : Two hundred and twenty-four patients with acute myocardial infa rct ion or undergoing coronary artery by-pass grafting . Intervention : Patients were r and omized to exp and ed cardiac rehabilitation ( a one-year stress management programme , increased physical training , staying at a ‘ patient hotel ’ for five days after the event , and cooking sessions ) , or to st and ard cardiac rehabilitation . Main measures : Data on cardiovascular death , myocardial infa rct ion , readmission for cardiovascular disease and days at hospital for cardiovascular reasons were obtained from national registries of the Swedish National Board of Health and Welfare . Results : The primary end-point occurred in 121 patients altogether ( 54 % ) . The number of cardiovascular events were reduced in the exp and ed rehabilitation group compared with the st and ard cardiac rehabilitation ( 53 patients ( 47.7 % ) versus 68 patients ( 60.2 % ) ; hazard ratio 0.69 ; P = 0.049 ) . This was mainly because of a reduction of myocardial infa rct ions in the exp and ed rehabilitation group . During the five years 12 patients ( 10.8 % ) versus 23 patients ( 20.3 % ) ; hazard ratio 0.47 ; P = 0.047 had a myocardial infa rct ion . Days at hospital for cardiovascular reasons were significantly reduced in patients who received exp and ed cardiac rehabilitation ( median 6 days ) compared with st and ard cardiac rehabilitation ( median 10 days ; P = 0.02 ) . Conclusion : Exp and ed cardiac rehabilitation after acute myocardial infa rct ion or coronary artery bypass grafting reduces cardiovascular morbidity and days at hospital for cardiovascular reasons",
"Coronary artery bypass ( CAB ) patients are older increasingly more often than before . Effectiveness of cardiac rehabilitation among the elderly is not yet adequately known about . The purpose was to describe short-term ( 3-month ) , intermediate ( 6-month ) , and long-term ( 12-month ) effects of health counseling , guidance , and adjustment education in groups on health , health behaviors , and functional abilities among older CAB patients . The study population was r and omized to an intervention group ( IG=49 ) and a control group ( CG=68 ) . Prior to CAB , intervention included one guidance and counseling group session and four sessions within 12 months following CAB . Intervention had positive effects on exercise activities , use of alcohol , and functional abilities among all participants , and on frequency of eating visible fat , fresh greens and vegetables among men . The intervention was effective with some exercise activities and functional abilities persisting for at least 1 year following CAB . Similar interventions may be arranged for older people . Health care professionals need to guide and encourage older people in their efforts to participate in them",
"OBJECTIVE The purpose of this study is to determine the impact of a home communication intervention ( HCI ) for ischemic heart failure Coronary Artery Bypass Graft ( CABG ) patients > /= 65 years of age on self-efficacy , coronary artery disease risk factor modification and functioning posthospitalization . DESIGN A r and omized clinical trial with repeated measures was used . SAMPLE A sub sample of ischemic heart failure CABG surgery patients ( n = 35 ) was drawn from the parent study of 180 CABG patients . RESULTS HCI participants ( n = 18 ) had significantly higher adjusted mean self-efficacy scores [ F(1 , 29 ) = 6.40 , P adjusted mean levels of functioning ( physical , general health , mental , and vitality functioning ) compared with the routine care group ( n = 17 ) , using repeated measures analysis of covariance with baseline scores as covariates . There were also significant effects of time on bodily pain and role emotional functioning . Significantly higher exercise adherence ( t = 3.09 , P reported stress ( t = 3.77 , P HCI intervention with more tailored strategies for vulnerable subgroups of CABG patients",
"BACKGROUND . Comprehensive preventive education for heart patients is effective in reducing cardiac events . However , very dem and ing counselling protocol s can not easily be implemented as an integral part of clinical practice in hospitals . AIM . To evaluate whether recurrent preventive group education for coronary artery bypass grafting patients affects the resistance of LDL against oxidation and the classical risk factors for coronary heart disease . METHODS . A prospect i ve , controlled study with one-year follow-up was carried out in Southern Finl and . Coronary artery bypass patients were allocated late ( S 18 months ) after the operation in the intervention and control groups . RESULTS . Seventy two patients ( 65 men and 7 women ) completed the study . Twelve-hour group education on healthy life-style had a significant ( 25 % , P = 0.01 ) but transient positive effect on the resistance of LDL against oxidation . There was a trend towards increased physical activity in the intervention group . The impact of education on patients ' weight was also more consistent ( 1.2 kg at 12 months , P fibrinogen and serum lipids were small . CONCLUSIONS . Repeated group education applied as an economically feasible part of specialist care had only small positive effects on patients ' risk factors . There was a significant , but transient , increase in the resistance of LDL against oxidation . However , effective lipid lowering drug treatment is indicated for most coronary artery bypass patients rather than repeated health education alone",
"AIMS AND OBJECTIVES The aim of this study was to determine how discharge training and counselling provided to patients , who had undergone coronary artery bypass graft ( CABG ) surgery , had effects on patients ' self-care ability and on the problems encountered after discharge . The objectives were to help patients develop self-care behaviour to deal more comfortably with the problems caused by the disease and , hopefully , to reduce the number of problems they may encounter . BACKGROUND CABG surgery patients needing to manage various aspects of their self-care at home often find these tasks very difficult to carry out effectively . Discharge training and counselling services help patients undergoing CABG to develop self-care behaviours . DESIGN The study was prospect i ve and quasi-experimental . METHODS The intervention and control groups consisted of 57 patients who were given discharge training and counselling by a research er and 52 patients who were given routines by a nurse , respectively . The intervention group began receiving discharge training and counselling on the day of hospitalization . These were provided according to their individual knowledge needs and patients were given a booklet developed for training purpose s. Data were collected by research er using the Personal Information Form , the Self-Care Agency Scale . RESULTS It was found that the intervention group had a higher mean self-care score than the control group and experienced fewer problems following discharge compared with patients in the control group . CONCLUSION The discharge training and counselling services given to patients in the intervention group had a positive impact on the self-care ability of these patients and on alleviating the problems they encountered . RELEVANCE TO CLINICAL PRACTICE As discharge training and counselling services had a positive impact on the self-care and alleviation of the problems that patients encounter after being discharged , we recommend application of these services and the usage of the training booklet for CABG patients",
"OBJECTIVE To evaluate the effectiveness of a nurse led shared care programme to improve coronary heart disease risk factor levels and general health status and to reduce anxiety and depression in patients awaiting coronary artery bypass grafting ( CABG ) . DESIGN R and omised controlled trial . SETTING Community , January 1997 to March 1998 . STUDY GROUPS 98 ( 75 male ) consecutive patients were recruited to the study within one month of joining the waiting list for elective CABG at Glasgow Royal Infirmary University NHS Trust . Patients were r and omly assigned to usual care ( control ; n = 49 ) or a nurse led intervention programme ( n = 49 ) . INTERVENTION A shared care programme consisting of health education and motivational interviews , according to individual need , was carried out monthly . Care was provided in the patients ' own homes by the community based cardiac liaison nurse alternating with the general practice nurse at the practice clinic . OUTCOME MEASURES Smoking status , obesity , physical activity , anxiety and depression , general health status , and proportion of patients exceeding target values for blood pressure , plasma cholesterol , and alcohol intake . RESULTS Compared with patients who received usual care , those participating in the nurse led programme were more likely to stop smoking ( 25 % v 2 % , p = 0.001 ) and to reduce obesity ( body mass index > 30 kg/m2 ) ( 16.3 % v 8.1 % , p = 0.01 ) . Target systolic blood pressure improved by 19.8 % compared with a 10.7 % decrease in the control group ( p = 0.001 ) and target diastolic blood pressure improved by 21.5 % compared with 10.2 % in the control group ( p = 0.000 ) . However , there was no significant difference between groups in the proportion of patients with cholesterol concentrations exceeding target values . There was a significant improvement in general health status scores across all eight domains of the 36 item short form health survey with changes in difference in mean scores between the groups ranging from 8.1 ( p = 0.005 ) to 36.1 ( p Levels of anxiety and depression improved ( p time spent being physically active ( p nurse led shared care intervention was shown to be effective for improving care for patients on the waiting list for CABG",
"This experimental study examined the effectiveness of a psychoeducational intervention delivered over 12 weeks . The sample was comprised of 38 coronary artery bypass graft ( CABG ) surgery patient-family member caregiver dyads who completed all six data collection points . Experimental and control groups did not differ in emotional health , functional health status , or satisfaction . Differences in the number of self-reported complications/symptoms were not in the predicted direction . Improvement occurred in clinical , functional , and emotional outcomes ; however , several symptoms , such as fatigue and pain , persisted . Family caregivers reported more depressive symptoms than patients preoperatively and at later stages of recovery . Implication s include the need for instruction about the recovery trajectory and adequate preparation and support of home health nurses and family caregivers",
"BACKGROUND & OBJECTIVE Evidence s suggest that relaxation therapy may improve psychological outcomes in heart patients . We evaluated the effect of progressive muscular relaxation ( PMR ) training in decreasing anxiety and improving quality of life among anxious patients after coronary artery bypass graft surgery ( CABG ) . METHODS This study was an open uncontrolled trial . The sample included 110 anxious patients referred to the cardiac rehabilitation clinic of Tehran Heart Center , Tehran , Iran , during six weeks after coronary artery bypass graft ( CABG ) . Patients were allocated to receive both exercise training and lifestyle education plus relaxation therapy ( relaxation group ; n=55 ) or only exercise training beside lifestyle education ( control group or the recipient of usual care group ; n=55 ) . Duration of the relaxation therapy was 6 wk and in the case of usual care was 8 wk . Both the groups were followed up one month after completion of intervention . Anxiety and quality of life in the two treatment groups were compared . RESULTS There were no significant differences in overall QOL , state anxiety and trait anxiety scores between the two groups before intervention . Significant reductions in state anxiety ( P trait anxiety ( P high state anxiety and a low quality of life than men in the two groups before intervention . After intervention , there was no difference between men and women in the relaxation group . INTERPRETATION & CONCLUSION Our findings show that progressive muscular relaxation training may be an effective therapy for improving psychological health and quality of life in anxious heart patients",
"Tobacco smoking is a major risk factor for cardiovascular disease [ 1 ] . Smokers who quit reduce their coronary heart disease morbidity and mortality rates , even after the onset of clinical disease . Smokers who quit after a myocardial infa rct ion have lower reinfa rct ion rates and longer survival than do those who continue to smoke [ 2 ] . The relation between smoking and the outcome of coronary artery bypass graft surgery is less well studied , but in one study , smokers who quit after surgery had better survival , fewer attacks of angina , and fewer hospitalizations during a 10-year period [ 3 , 4 ] . Pathologic and angiographic studies show less late saphenous vein graft occlusion in smokers who quit after surgery than in those who do not [ 5 , 6 ] . Neither the pattern nor predictors of smoking cessation after coronary artery bypass graft surgery have been well studied . The operation may induce smoking cessation , because myocardial infa rct ion and newly diagnosed coronary artery disease do so [ 2 , 7 - 9 ] . Approximately one third of smokers quit smoking after having a myocardial infa rct ion [ 2 , 9 , 10 ] . Patients scheduled for coronary bypass surgery , like patients who have myocardial infa rct ion , face a potentially life-threatening event related to coronary heart disease , one requiring hospitalization for at least 1 week . However , coronary bypass surgery is often elective , whereas myocardial infa rct ion may be an unexpected complication of an undiagnosed condition . Consequently , patients may be less motivated to stop smoking after bypass surgery than they are after myocardial infa rct ion . In a r and omized trial of coronary artery bypass surgery , 25 % of smokers assigned to surgery stopped smoking in the year after the operation , and smoking rates remained constant for the next 5 years [ 11 ] . Two newer studies reported higher cessation rates ( 31 % and 55 % ) [ 12 , 13 ] . None of these studies vali date d self-reported smoking status at follow-up or identified factors associated with nonsmoking . Even less is known about the success of smoking interventions in patients having coronary bypass surgery . In-hospital intervention boosts the cessation rate after myocardial infa rct ion [ 10 , 14 ] , but whether it will do so after bypass surgery is unknown . To determine this , we developed a smoking cessation program for in patients recovering from coronary artery bypass surgery and tested its effectiveness in a r and omized , controlled trial . We chose this approach because patients who undergo coronary bypass surgery spend a median of 11 days in the hospital after surgery [ 15 ] . During this time , they are not permitted to smoke , can be easily reached by an intervention team , and may be highly motivated to quit . We reasoned that we could take advantage of this period of enforced nonsmoking to teach smokers the skills to remain abstinent after discharge . We also tried to identify factors associated with sustained nonsmoking to guide future intervention efforts . Methods Recruitment and R and omization This trial was conducted in the postoperative cardiac surgery unit at Massachusetts General Hospital . During 1 year ending 1 July 1987 , we review ed the charts of all 672 patients scheduled for coronary artery bypass surgery by six participating surgeons ( 82 % of all such procedures ) . A research nurse recruited patients who met eligibility criteria : those who had smoked at least 1 pack of cigarettes in the past 6 months , lived in eastern Massachusetts or Rhode Isl and , spoke English , and were not too ill to participate . We included both current smokers and recent ( Of 672 patients scheduled for the surgery , 152 ( 23 % ) were current smokers or had quit within 6 months . Of 120 patients meeting eligibility criteria , 93 ( 78 % ) agreed to participate . Reasons for refusals were insufficient time to collect baseline data ( n = 8) , too much stress ( n = 6 ) , no desire to quit ( n = 6 ) , or perceived ability to quit without assistance ( n = 3 ) . Patients were r and omly assigned to control or intervention groups after surgery . Intervention began when the patient was physically able to participate , generally on the fourth day after operation . Four participants were lost before r and omization ( surgery was canceled for 3 and 1 died ) , and 89 patients were r and omly assigned to control or intervention groups . Two patients , one in each group , died before discharge , when outcome was first assessed . This report is based on the 87 patients ( 43 controls , 44 patients receiving the intervention ) who were discharged alive . Intervention The intervention was a smoking cessation and relapse prevention program adapted from the American Lung Association 's In Control program , which teaches cognitive and behavioral smoking cessation techniques [ 16 ] . We used edited portions of the videotape and manual to produce a st and ardized , three-session program delivered by the study nurse to individual patients . Family members were encouraged to attend . Total counseling time was 60 minutes . One week after discharge , the nurse called each participant to offer support and brief counseling . Patients in the control group received usual postoperative care , including brief advice not to smoke as part of a group lecture . In patients were not permitted to smoke by hospital policy . Assessment Patients completed a baseline data form before surgery . It assessed demographic factors ( age , sex , ethnic background , education , and employment status ) , functional status [ 17 ] , smoking history ( pack-years and daily cigarette consumption ) , degree of nicotine addiction [ 18 ] , current symptoms of nicotine withdrawal [ 19 ] , previous attempts to quit smoking ( number of attempts , duration , difficulty , and method ) , level of social support for nonsmoking , percentage of household members and friends who smoke , knowledge and attitudes about smoking and heart disease ( 15 items ) , duration of nonsmoking before surgery , intention to quit after surgery , and confidence in their ability to quit . Charts were review ed for medical history , severity of heart disease ( frequency of angina attacks , number of myocardial infa rct ions , previous bypass surgery or angioplasty , left ventricular function on angiogram , and number of coronary vessels occluded and bypassed ) , and hospital course ( length of stay and occurrence of 12 complications ) . The primary outcome variable was smoking behavior , assessed by self-report and vali date d by saliva cotinine assay [ 20 ] . Smoking status was monitored at hospital discharge and 2 weeks and 2 , 4 , 8 , and 12 months later . It was also assessed in September 1992 , a median of 5.5 years after discharge ( range , 60 to 72 months ) . At 1 and 5.5 years , self-reported nonsmoking was vali date d by saliva cotinine assay [ 20 ] . Sample s were obtained by mail , a method previously shown to accurately identify smokers and nonsmokers [ 21 ] . Individuals who did not provide saliva sample s or whose cotinine concentrations were more than 20 ng/mL were considered smokers [ 22 ] . Death certificate data were review ed to identify patients lost to follow-up . Eighty patients ( 92 % ) were alive 1 year after discharge , and smoking status was determined in all of them . Seventy patients ( 80 % ) were alive at 5.5 years , and smoking status was assessed in 66 ( 94 % ) . More than 90 % of follow-up information was obtained by telephone . If this was not possible , patients were sent a written form . Other variables assessed at follow-up were nicotine withdrawal symptoms , attitudes and beliefs about smoking , confidence in the ability to quit , health status , and functional status . We also monitored co interventions , including attendance at a cardiac rehabilitation or smoking cessation program , interim hospitalization , and use of nicotine gum . ( Transdermal nicotine was not available during the study period . ) Data Analysis Two outcome rates were calculated : continuous nonsmoking ( no smoking since hospital discharge ) and current nonsmoking ( no smoking for the past week ) [ 23 ] . Following st and ard practice , patients lost to follow-up and patients whose reports of nonsmoking were not vali date d biochemically were counted as smokers when calculating cessation rates [ 23 ] . We excluded these patients and repeated the calculations . To identify factors associated with smoking cessation , we compared smokers and nonsmokers 1 and 5.5 years after surgery . To minimize misclassification of smoking status in these analyses , we excluded patients lost to follow-up and nonsmokers whose self-report was not vali date d biochemically . We compared differences in proportions and means between groups using chi-square tests and Student t-tests , respectively . Variables associated with nonsmoking at the P control and intervention groups at study entry or during hospitalization ( Table 3 ) . The typical participant was a middle-aged , white man with a high school education who smoked 1.5 packs each day and had a 58 pack-year smoking history . Participants had made an average of 2.5 attempts to quit smoking , but only 14 % had attended a formal program . Although 79 % of patients had been told to abstain from cigarettes before surgery , 48 % smoked in the week before admission and 15 % smoked in the hospital before surgery . In contrast , 38 % abstained from tobacco for more than 1 month before admission and 19 % did not smoke for more than 3 months . As a group , participants knew that smoking contributed to their heart disease and believed that they would benefit from quitting . They were strongly motivated to quit smoking after surgery and expected some difficulty but were confident of success . They felt strong social support for",
"CONTEXT Depressive symptoms commonly follow coronary artery bypass graft ( CABG ) surgery and are associated with less positive clinical outcomes . OBJECTIVE To test the effectiveness of telephone-delivered collaborative care for post-CABG depression vs usual physician care . DESIGN , SETTING , AND PARTICIPANTS Single-blind effectiveness trial at 7 university-based and community hospitals in or near Pittsburgh , Pennsylvania . Participants were 302 post-CABG patients with depression ( 150 , intervention ; 152 , usual care ) and a comparison group of 151 r and omly sample d post-CABG patients without depression recruited between March 2004 and September 2007 and observed as out patients until June 2008 . INTERVENTION Eight months of telephone-delivered collaborative care provided by nurses working with patients ' primary care physicians and supervised by a psychiatrist and primary care physician from this study . MAIN OUTCOME MEASURES Mental health-related quality of life ( HRQL ) measured by the Short Form-36 Mental Component Summary ( SF-36 MCS ) at 8-month follow-up ; secondary outcome measures included assessment of mood symptoms ( Hamilton Rating Scale for Depression [ HRS-D ] ) , physical HRQL ( SF-36 PCS ) , and functional status ( Duke Activity Status Index [ DASI ] ) ; and hospital readmissions . RESULTS The intervention patients reported greater improvements in mental HRQL ( all P 0.5 - 6.0 ) , physical functioning ( DASI : Delta , 4.6 points ; 95 % CI , 1.9 - 7.3 ) , and mood symptoms ( HRS-D : Delta , 3.1 points ; 95 % CI , 1.3 - 4.9 ) ; and were more likely to report a 50 % or greater decline in HRS-D score from baseline ( 50.0 % vs 29.6 % ; number needed to treat , 4.9 [ 95 % CI , 3.2 - 10.4 ] ) than usual care patients ( P . Men with depression were particularly likely to benefit from the intervention ( SF-36 MCS : Delta , 5.7 points ; 95 % CI , 2.2 - 9.2 ; P = .001 ) . However , the mean HRQL and physical functioning of intervention patients did not reach that of the nondepressed comparison group . CONCLUSION Compared with usual care , telephone-delivered collaborative care for treatment of post-CABG depression result ed in improved HRQL , physical functioning , and mood symptoms at 8-month follow-up . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00091962"
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CONTEXT Despite the recognized distressing symptom of fatigue in children with cancer , little information is available to assist in the selection of an instrument to be used to measure fatigue . OBJECTIVES The objectives of this study were to 1 ) describe the instruments that have been used to measure cancer-related fatigue in children and adolescents and 2 ) summarize the psychometric properties of the most commonly used instruments used to measure fatigue in children and adolescents with cancer . METHODS Five major electronic data bases were systematic ally search ed for studies using a fatigue measurement scale in a population of children or adolescents with cancer . Fatigue scales used in those studies were included in the review . RESULTS From a total of 1753 articles , 25 were included . We identified two main fatigue measurement instruments used in a pediatric oncology population : 1 ) the Fatigue Scale-Child/Fatigue Scale-Adolescent and the proxy report versions for parents and staff and 2 ) the PedsQL ™ Multidimensional Fatigue Scale . These two scales show similar attributes with reasonably good internal consistency and responsiveness . CONCLUSION Either the Fatigue Scale or PedsQL Multidimensional Fatigue Scale can be incorporated into clinical research . Future research should focus on identifying specific fatigue measures more suited to different purpose s such as comparative trials or identification of high-risk groups
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"The purpose of this study was to investigate the relationships between clinical factors ( including haemoglobin value , chemotherapeutic agents , and corticosteroid use ) and changing patterns of fatigue before and for the next 10 days following the start of a new round of chemotherapy in children with cancer . A prospect i ve longitudinal design was used to collect data from 48 paediatric oncology patients who were about to begin a new round of chemotherapy and their parents . Fatigue levels were assessed using multidomain question naires with three categories of patient self-report ( including ‘ General Fatigue ’ , ‘ Sleep/Rest Fatigue ’ , and ‘ Cognitive Fatigue ’ ) and four categories of parent proxy-report ( including ‘ Lack of Energy ’ , ‘ Unable to Function ’ , ‘ Altered Sleep ’ , and ‘ Altered Mood ’ ) . The findings suggest that fatigue from both patient self-report and parent proxy-report changed significantly over time . The major findings from this study are that patients have more problems with fatigue in the first few days after the start of a cycle of chemotherapy . Corticosteroid use and haemoglobin value were associated with significant increases in fatigue that were sustained for several days and reached the highest level of fatigue at day 5 for those receiving concurrent steroids . The association of chemotherapeutic agents with fatigue varied between patient self-report and parent report , but the type of chemotherapeutic agents used was not associated with most changes in fatigue",
"The Memorial Symptom Assessment Scale ( MSAS ) is a new patient-rated instrument that was developed to provide multidimensional information about a diverse group of common symptoms . This study evaluated the reliability and validity of the MSAS in the cancer population . R and omly selected in patients and out patients ( n = 246 ) with prostate , colon , breast or ovarian cancer were assessed using the MSAS and a battery of measures that independently evaluate phenomena related to quality of life . Symptom prevalence in the 218 evaluable patients ranged from 73.9 % for lack of energy to 10.6 % for difficulty swallowing . Based on a content analysis , three symptoms were deleted and two were added ; the revised scale evaluates 32 physical and psychological symptoms . A factor analysis of variance yielded two factors that distinguished three major symptom groups and several subgroups . The major groups comprised psychological symptoms ( PSYCH ) , high prevalence physical symptoms ( PHYS H ) , and low prevalence physical symptoms ( PHYS L ) . Internal consistency was high in the PHYS H and PSYCH groups ( Cronback alpha coefficients of 0.88 and 0.83 , respectively ) , and moderate in the PHYS L group ( alpha = 0.58 ) . Although the severity , frequency and distress dimensions were highly intercorrelated , canonical correlations and other analyses demonstrated that multidimensional assessment ( frequency and distress ) augments information about the impact of symptoms . High correlations with clinical status and quality of life measures support the validity of the MSAS and indicate the utility of several subscale scores , including PSYCH , PHYS , and a brief Global Distress Index . The MSAS is a reliable and valid instrument for the assessment of symptom prevalence , characteristics and distress . It provides a method for comprehensive symptom assessment that may be useful when information about symptoms is desirable , such as clinical trials that incorporate quality of life measures or studies of symptom epidemiology",
"The aim of this research is to examine the experience and impact of chemotherapy-related fatigue in recently diagnosed pediatric oncology patients . A repeated- measures , within-subjects , mixed ( quantitative plus qualitative ) design was used to prospect ively assess fatigue during early chemotherapy cycles and to compare fatigue to depressive symptoms . Parental interviews collected concurrently were analyzed for descriptions of the child 's fatigue and mood states and for strategies to cope with fatigue . Results indicated a significant correlation between fatigue and depression , but qualitative analyses suggested that the 2 phenomena may be unique and distinguishable . Qualitative analyses of parent interviews also identified specific strategies that were frequently used in response to high levels of fatigue . The findings illustrate the significant impact of chemotherapy-related fatigue in children being treated for cancer . The study also provides guidance for the assessment of fatigue and related symptoms and identifies specific strategies for coping with fatigue",
"Few studies have attempted to describe the experience of symptoms in young children with cancer . This is due , in part , to the lack of vali date d symptom assessment scales for this patient population . The objective of this study was to evaluate the reliability and validity of a revised Memorial Symptom Assessment Scale ( MSAS ) in patients aged 7 - 12 as an instrument for the assessment of symptoms in young children with cancer . The MSAS ( 7 - 12 ) was administered to 149 children ( in patients and out patients ) who were undergoing treatment at either the Royal Marsden NHS Trust , London , United Kingdom or The Children 's Hospital at Westmead , Sydney , Australia . Validity was evaluated by comparison with the medical record , parental report , and concurrent assessment on visual analogue scales for selected symptoms . The data provide evidence of the reliability and validity of MSAS ( 7 - 12 ) and demonstrate that children with cancer as young as 7 years can report clinical ly relevant and consistent information about their symptom experience . Young children with cancer experience multiple symptoms . Approximately one-third had experienced lethargy and /or pain and /or insomnia during the 48 hours prior to the completion of MSAS ( 7 - 12 ) . The completion rate for MSAS ( 7 - 12 ) was high and the majority of children completed the instrument in a short period of time and with little difficulty . The instrument appears to be age appropriate and may be helpful to older children unable to independently complete MSAS ( 10 - 18 ) . Systematic symptom assessment may be useful in future epidemiological studies of symptoms and in cancer chemotherapy drug trials",
"This prospect i ve , two-site , r and omized , controlled pilot study assessed the feasibility of an enhanced physical activity ( EPA ) intervention in hospitalized children and adolescents receiving treatment for a solid tumor or for acute myeloid leukemia ( AML ) , and assessed different statistical techniques to detect the intervention 's sleep and fatigue outcomes . Twenty-nine patients ( 25 with a solid tumor and 4 with AML ) participated . Data were collected from actigraph ; patient , parent , and staff nurse reports of patient fatigue ; parent sleep diaries ; and patient charts . The intervention was successfully implemented 85.4 % of the scheduled times . We used two different statistical methods to analyze the longitudinal data . Using an ANOVA model , sleep was significantly more efficient in the experimental arm than in the control arm when daily differences from baseline sleep efficiency values were averaged and compared ( F=4.17 , P=0.053 ) . However , in a mixed model ( repeated measures ) analysis , sleep duration ( F=0.54 , P=0.47 ) and sleep efficiency ( F=0.04 , P=0.85 ) were not seen to differ between study arms . We conclude that an inpatient intervention of EPA can be delivered to children and adolescents receiving chemotherapy . Our findings identify design and statistical considerations for a future effectiveness study of the EPA intervention in hospitalized pediatric oncology patients",
"This experimental , r and omized controlled study was conducted for children with cancer who are 7 to 12 years of age and receiving chemotherapy treatment to detect the impact of appropriate nursing interventions on decreasing the fatigue syndrome . The research sample is composed of a total of 60 children with cancer , with 30 children being included in the experimental group and 30 children included in the control group with their mothers . In the experimental group , after the 7th to 10th day of the chemotherapy treatment , throughout a week , the research er conducted the effective nursing interventions every day for 45 to 60 minutes . In the control group , routine nursing interventions were carried out . The experimental and control group children 's mean scores for the Fatigue Scale-Child and those of mothers for Fatigue Scale-Parent were compared . A statistically significant difference was found between the Fatigue Scale-Child and Fatigue Scale-Parent mean scores of the experimental and the control group children ( P fatigue of children with cancer can be reduced by implementing appropriate nursing interventions",
"BACKGROUND Fatigue is described as one of the most distressing symptoms of cancer therapy ; yet it has received limited clinical attention . Children are suffering from a symptom that is under-diagnosed during their treatment . AIM The aim of this study is : ( a ) to assess the change in fatigue scores during cancer treatment according to children 's perspectives , and ( b ) to describe the possible causes of fatigue from children 's points of view . SAMPLE AND METHODS The present study is part of an ongoing prospect i ve study . The research group consisted of 40 ( n = 40 ) children aged 7 - 12 years with cancer who are being followed up in the oncology clinic of a Greek children 's hospital . After parental consent was obtained , data were collected using the Child Fatigue Scale and a sociodemographic data form . RESULTS The children with cancer reported a statistically significant increase in fatigue scores during their treatment ( F = 6.846 , P = 0.003 ) . Gender was the only demographic factor associated with a significant increase in the fatigue scores ( F = 4.857 , P = 0.034 ) . CONCLUSIONS Cancer treatment was found significantly to increase children 's fatigue levels . Medical procedures and the hospital environment seemed to be major causative factors of the fatigue experienced by children with cancer during their treatment"
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BACKGROUND Although supervised exercise therapy ( SET ) provides significant symptomatic benefit for patients with intermittent claudication ( IC ) , it remains an underutilized tool . Widespread implementation of SET is restricted by lack of facilities and funding . Structured home-based exercise therapy ( HBET ) with an observation component ( e.g. , exercise logbooks , pedometers ) and just walking advice ( WA ) are alternatives to SET . This is the second up date of a review first published in 2006 . OBJECTIVES The primary objective was to provide an accurate overview of studies evaluating effects of SET programs , HBET programs , and WA on maximal treadmill walking distance or time ( MWD/T ) for patients with IC . Secondary objectives were to evaluate effects of SET , HBET , and WA on pain-free treadmill walking distance or time ( PFWD/T ) , quality of life , and self-reported functional impairment . SEARCH METHODS The Cochrane Vascular Information Specialist search ed the Cochrane Vascular Specialised Register ( December 16 , 2016 ) and the Cochrane Central Register of Controlled Trials ( 2016 , Issue 11 ) . We search ed the reference lists of relevant studies identified through search es for other potential trials . We applied no restriction on language of publication . SELECTION CRITERIA We included parallel-group r and omized controlled trials comparing SET programs with HBET programs and WA in participants with IC . We excluded studies in which control groups did not receive exercise or walking advice ( maintained normal physical activity ) . We also excluded studies comparing exercise with percutaneous transluminal angioplasty , bypass surgery , or drug therapy . DATA COLLECTION AND ANALYSIS Three review authors ( DH , HF , and LG ) independently selected trials , extracted data , and assessed trials for risk of bias . Two other review authors ( MvdH and JT ) confirmed the suitability and method ological quality of trials . For all continuous outcomes , we extracted the number of participants , mean outcome , and st and ard deviation for each treatment group through the follow-up period , if available . We extracted Medical Outcomes Study Short Form 36 outcomes to assess quality of life , and Walking Impairment Question naire outcomes to assess self-reported functional impairment . As investigators used different scales to present results of walking distance and time , we st and ardized reported data to effect sizes to enable calculation of an overall st and ardized mean difference ( SMD ) . We obtained summary estimates for all outcome measures using a r and om-effects model . We assessed the quality of evidence using the GRADE approach . MAIN RESULTS For this up date , we included seven additional studies , making a total of 21 included studies , which involved a total of 1400 participants : 635 received SET , 320 received HBET , and 445 received WA . In general , SET and HBET programs consisted of three exercise sessions per week . Follow-up ranged from six weeks to two years . Most trials used a treadmill walking test to investigate effects of exercise therapy on walking capacity . However , two trials assessed only quality of life , functional impairment , and /or walking behavior ( i.e. , daily steps measured by pedometer ) . The overall method ological quality of included trials was moderate to good . However , some trials were small with respect to numbers of participants , ranging from 20 to 304.SET groups showed clear improvement in MWD/T compared with HBET and WA groups , with overall SMDs at three months of 0.37 ( 95 % confidence interval [ CI ] 0.12 to 0.62 ; P = 0.004 ; moderate- quality evidence ) and 0.80 ( 95 % CI 0.53 to 1.07 ; P MWD of approximately 120 and 210 meters in favor of SET groups . Data show improvements for up to six and 12 months , respectively . The HBET group did not show improvement in MWD/T compared with the WA group ( SMD 0.30 , 95 % CI -0.45 to 1.05 ; P = 0.43 ; moderate- quality evidence ) .Compared with HBET , SET was more beneficial for PFWD/T but had no effect on quality of life parameters nor on self-reported functional impairment . Compared with WA , SET was more beneficial for PFWD/T and self-reported functional impairment , as well as for some quality of life parameters ( e.g. , physical functioning , pain , and physical component summary after 12 months ) , and HBET had no effect . Data show no obvious effects on mortality rates . Thirteen of the 1400 participants died , but no deaths were related to exercise therapy . Overall , adherence to SET was approximately 80 % , which was similar to that reported with HBET . Only limited adherence data were available for WA groups . AUTHORS ' CONCLUSIONS Evidence of moderate and high quality shows that SET provides an important benefit for treadmill-measured walking distance ( MWD and PFWD ) compared with HBET and WA , respectively . Although its clinical relevance has not been definitively demonstrated , this benefit translates to increased MWD of 120 and 210 meters after three months in SET groups . These increased walking distances are likely to have a positive impact on the lives of patients with IC . Data provide no clear evidence of a difference between HBET and WA . Trials show no clear differences in quality of life parameters nor in self-reported functional impairment between SET and HBET . However , evidence is of low and very low quality , respectively . Investigators detected some improvements in quality of life favoring SET over WA , but analyses were limited by small numbers of studies and participants . Future studies should focus on disease-specific quality of life and other functional outcomes , such as walking behavior and physical activity , as well as on long-term follow-up
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"OBJECTIVE : To assess the acute metabolic and cardiovascular responses to walking exercise at an intensity corresponding to the heart rate of claudication pain onset and to investigate the effects of a 12-week walking training program at this intensity on walking capacity . METHODS : Twenty-nine patients with intermittent claudication were r and omly allocated to the walking training ( n = 17 ) or control ( CO , n = 12 ) group . The walking training group performed an acute exercise session comprising 15 × 2-min bouts of walking at the heart rate of claudication pain onset , with 2-min interpolated rest intervals . The claudication symptoms and cardiovascular and metabolic responses were evaluated . Walking training was then performed at the same intensity twice each week for 12 weeks , while the control group engaged in twice weekly stretching classes . The claudication onset distance and total walking distance were evaluated before and after the interventions . Brazilian Registry Clinical Trials : RBR-7M3D8W . RESULTS : During the acute exercise session , the heart rate was maintained within tight limits . The exercise intensity was above the anaerobic threshold and > 80 % of the heart rate peak and VO2peak . After the exercise training period , the walking exercise group ( n = 13 ) showed increased claudication onset distance ( 309±153 vs. 413±201 m ) and total walking distance ( 784±182 vs. 1,100±236 m ) compared to the control group ( n = 12 ) ( p CONCLUSION : Walking exercise prescribed at the heart rate of claudication pain onset enables patients with intermittent claudication to exercise with tolerable levels of pain and improves walking performance",
"BACKGROUND This prospect i ve , r and omized controlled clinical trial determined whether an optimal exercise program length exists to efficaciously change claudication onset time ( COT ) and peak walking time ( PWT ) in patients with peripheral artery disease and claudication . METHODS The study r and omized 142 patients to supervised exercise ( n = 106 ) or a usual care control group ( n = 36 ) , with 80 completing the exercise program and 27 completing the control intervention . The exercise program consisted of intermittent walking to nearly maximal claudication pain 3 days per week . COT and PWT were the primary outcomes obtained from a treadmill exercise test at baseline and bimonthly during the study . RESULTS After exercise , changes in COT ( P PWT ( P exercise program , COT and PWT increased from baseline to month 2 ( P .05 ) . When changes were expressed per mile walked during the first 2 months , middle 2 months , and final 2 months of exercise , COT and PWT only increased during the first 2 months ( P gains in COT and PWT occur rapidly within the first 2 months of exercise rehabilitation and are maintained with further training . The clinical significance is that a relatively short 2-month exercise program may be preferred to a longer program to treat claudication because adherence is higher , costs associated with personnel and use of facilities are lower per patient , and more patients can be trained for a given amount of personnel time and re source utilization",
"BACKGROUND In patients with intermittent claudication , a supervised walking exercise program increases peak exercise performance and community-based functional status . Patients with peripheral arterial disease also have muscle weakness in the affected extremity that may contribute to the walking impairment . However , the potential benefits of training modalities other than walking exercise , such as strength training , have not been critically evaluated in this patient population . The present study tested the hypothesis that a strength training program would be as effective as treadmill walking exercise and that combinations of strengthening and walking exercise would be more effective than either alone in improving exercise performance . METHODS AND RESULTS Twenty-nine patients with disabling claudication were r and omized to 12 weeks of supervised walking exercise on a treadmill ( 3 h/wk at a work intensity sufficient to produce claudication ) , strength training ( 3 h/wk of resistive training of five muscle groups of each leg ) , or a nonexercising control group . Grade d treadmill testing was performed to maximally tolerated claudication pain to define changes in peak exercise performance . After 12 weeks , patients in the treadmill training program had a 74 + /- 58 % increase in peak walking time as well as improvements in peak oxygen consumption ( VO2 ) and the onset of claudication pain . Patients in the strength-trained group had a 36 + /- 48 % increase in peak walking time but no change in peak VO2 or claudication onset time . Control subjects had no changes in any of these measures over the 12-week period . After the first 12 weeks , patients in the initial walking exercise group continued for 12 more weeks of supervised treadmill training . This result ed in an additional 49 + /- 53 % increase in peak walking time ( total of 128 + /- 99 % increase over the 24 weeks ) . After the initial 12 weeks , patients in the strength-trained group began 12 weeks of supervised treadmill training , and patients in the control group participated in a 12-week combined program of strengthening and treadmill walking exercise . The combined strength and treadmill training program and treadmill training after 12 weeks of strength training result ed in increases in peak exercise performance similar to those observed with 12 weeks of treadmill training alone . CONCLUSIONS A supervised treadmill walking exercise program is an effective means to improve exercise performance in patients with intermittent claudication , with continued improvement over 24 weeks of training . In contrast , 12 weeks of strength training was less effective than 12 weeks of supervised treadmill walking exercise . Finally , strength training , whether sequential or concomitant , did not augment the response to a walking exercise program",
"Background Few medical therapies improve lower extremity functioning in people with lower extremity peripheral artery disease ( PAD ) . Among people with PAD , we studied whether a group-mediated cognitive behavioral intervention promoting home-based unsupervised exercise prevented mobility loss and improved functional performance compared to control . Methods and Results One hundred ninety-four PAD participants were r and omized . During months 1 to 6 , the intervention group met weekly with other PAD participants and a facilitator . Group support and self-regulatory skills were used to help participants adhere to walking exercise . Ninety-percent of exercise was conducted at or near home . The control group attended weekly lectures . During months 6 to 12 , each group received telephone contact only . Primary outcomes have been reported . Here we compare changes in exploratory outcomes of mobility loss ( the inability to climb a flight of stairs or walk one-quarter mile without assistance ) , walking velocity , and the Short Physical Performance Battery . Compared to controls , fewer participants r and omized to the intervention experienced mobility loss at 6-month follow-up : 6.3 % versus 26.5 % , P=0.002 , odds ratio=0.19 ( 95 % CI=0.06 to 0.58 ) and at 12-month follow-up : 5.2 % versus 18.5 % , P=0.029 , odds ratio=0.24 ( 95 % CI=0.06 to 0.97 ) . The intervention improved fast-paced 4-m walking velocity at 6-month follow-up ( P=0.005 ) and the Short Physical Performance Battery at 12-month follow-up ( P=0.027 ) , compared to controls . Conclusions In exploratory analyses , a group-mediated cognitive behavioral intervention promoting unsupervised walking exercise prevented mobility loss and improved functioning at 6- and 12-month follow-up in PAD patients . Clinical Trial Registration URL : http:// clinical trials.gov . Unique identifier : NCT00693940",
"PURPOSE A pilot study was conducted to test the feasibility of supervised treadmill exercise training to improve functioning in study participants with peripheral arterial disease who did not have classical symptoms of intermittent claudication . METHODS For this study , 32 men and women with peripheral arterial disease but no symptoms of claudication were r and omized to exercise training or usual care . The intervention was a 12-week supervised treadmill walking program . Outcomes included 6-minute walk distance , maximum treadmill walking distance , and 4-meter walking velocity . Participant-reported community walking ability was measured with the Walking Impairment Question naire ( WIQ ) . Inflammatory blood factor levels also were measured . RESULTS Altogether , 25 participants who completed follow-up testing were included in intention-to-treat analyses . Of 24 participants ( 58 % ) r and omized to exercise , 14 completed the entire exercise training program . The participants r and omized to the intervention showed greater improvement in their WIQ walking speed score than the control subjects ( P = .05 ) . The participants r and omized to the intervention showed improvements in their 6-minute walk distance ( 1134 + /- 347 vs 1266 + /- 295 feet ; P = .03 ) , maximal treadmill walking distance ( 389 + /- 248 vs 585 + /- 293 feet ; P WIQ distance score ( 52.3 + /- 29.1 vs 63.1 + /- 25.1 ; P = .002 ) , and WIQ speed score ( 48.7 + /- 26.8 vs 59.7 + /- 22.7 ; P = .008 ) . The participants r and omized to the control condition showed improvements in maximal treadmill walking distance ( 362 + /- 180 vs 513 + /- 237 feet ; P = .014 ) . There were no significant changes in the inflammatory blood factors after exercise . CONCLUSIONS This pilot study demonstrated that a supervised treadmill walking program may be feasible and may improve functioning for individuals with peripheral arterial disease who do not have classical symptoms of intermittent claudication . Further study is needed with a larger sample to identify optimal exercise methods that improve lower extremity functioning in men and women with peripheral arterial disease who do not have intermittent claudication",
"Patients with atherosclerotic peripheral arterial disease ( PAD ) of the lower extremities have impaired walking ability due to exercise-induced muscle ischemia and the result ant pain of intermittent claudication . To evaluate the benefit of exercise training as a treatment for patients with PAD , as well as possible mechanisms associated with improvement , we r and omly assigned 19 men with disabling claudication to treated and control groups . Treatment consisted of supervised treadmill walking ( 1 hr/day , 3 days/wk , for 12 weeks ) with progressive increases in speed and grade as tolerated . Grade d treadmill testing was performed to maximal toleration of claudication pain on entry and after 12 weeks of training to define changes in peak exercise performance . After 12 weeks , treated subjects had increased their peak walking time 123 % , peak oxygen consumption 30 % , and pain-free walking time 165 % ( all p less than 0.05 ) . Control subjects had no change in peak oxygen consumption , but after 12 weeks , peak walking time increased 20 % ( p less than 0.05 ) . In treated subjects , maximal calf blood flow ( measured by a plethysmograph ) increased 38 + /- 45 % ( p less than 0.05 ) , but the change in flow was not correlated to the increase in peak walking time . Elevated plasma concentrations of acylcarnitines have been associated with the functional impairment of PAD and may reflect the metabolic state of ischemic skeletal muscle . In treated subjects , a 26 % decrease in resting plasma short-chain acylcarnitine concentration was correlated with improvement in peak walking time ( r = -0.78 , p less than 0.05 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE Exercise advice is the main treatment for symptom relief in the UK for patients with mild to moderate Intermittent Claudication ( IC ) . Would a weekly exercise and motivation class for 6 months offer adjuvant benefit over written and verbal exercise advice alone ? PATIENTS AND METHODS Fifty-nine patients attending a regional vascular centre for whom IC was the main factor affecting mobility were r and omised to either exercise advice alone ( n=30 ) or exercise advice with a once a week 45 min supervised exercise/motivation class ( n=29 ) . The mean age was 68 years . Baseline and 6-month assessment included a Quality of Life Question naire -- the Short-Form-36 , the Charing Cross Symptom Specific Claudication Question naire ( CCCQ ) and treadmill walking distance ( 3.5 km/h 12 % ) . RESULTS At 6-month follow-up the supervised exercise group had improved their treadmill walking by 129 % compared to 69 % in the advice alone group ( p=0.001 ) . This significant improvement was maintained at the subsequent 9 and 12-month follow-up assessment s. By the 9-month stage the advice only group CCCQ score had improved 16 % from baseline , while the supervised exercise group had a significantly better 43 % improvement in base line score ( p Self reported frequency of walks was higher in the exercise class group being significant for improvement in CCCQ score . CONCLUSION A weekly , supervised exercise and motivation class for a 6-month period provides a significant improvement in patients ' symptoms , quality of life , and distance walked compared with advice alone and this improvement continues after attendance at class has ceased",
"Background : Although only a small percentage of patients with peripheral arterial disease ( PAD ) have claudication , many more suffer from atypical leg symptoms . Purpose : This pilot trial evaluated a risk-factor modification program to improve walking ability in patients with PAD and leg symptoms other than intermittent claudication . Methods : Patients 18 years or older with an ankle-brachial index ( ABI ) of 0.50 to 0.89 completed a baseline assessment of current walking ability , physical activity level , health-related quality of life , glycosylated hemoglobin values , and fasting lipid profiles . Patients were r and omized to usual care ( control group ) versus usual care plus an educational intervention on risk-factor management ( intervention group ) . We compared functional outcomes between and within groups using the Student ’s t test and control and intervention group outcomes at 12 weeks using analysis of covariance with the baseline value as the covariate . Results : We r and omized 50 patients into two treatment arms . There was no difference in the mean age of patients in each group . At baseline , mean ABI for the control versus the intervention group was 0.72 ( SD=0.10 ) and 0.75 ( SD=0.10 ) , respectively , and mean stair-climbing values did not differ between groups . At 12 weeks , mean stair-climbing values were 40.2 ( SD=30.2 ) for the control and 61.2 ( SD=32.8 ) for the intervention group . The difference in adjusted mean walking distance between groups at 12 weeks was not significant . Analysis of covariance associated assignment to the intervention versus the control arm with a significant increase at 12 weeks in the ABI ( p=.008 ) and stair-climbing ability ( p=.02 ) . Conclusions : Patients in the intervention group improved objective measures of blood flow and reported stair-climbing ability",
"IMPORTANCE Clinical practice guidelines state there is insufficient evidence to support advising patients with peripheral artery disease ( PAD ) to participate in a home-based walking exercise program . OBJECTIVE To determine whether a home-based walking exercise program that uses a group-mediated cognitive behavioral intervention , incorporating both group support and self-regulatory skills , can improve functional performance compared with a health education control group in patients with PAD with and without intermittent claudication . DESIGN , SETTING , AND PATIENTS R and omized controlled clinical trial of 194 patients with PAD , including 72.2 % without classic symptoms of intermittent claudication , performed in Chicago , Illinois between July 22 , 2008 , and December 14 , 2012 . INTERVENTIONS Participants were r and omized to 1 of 2 parallel groups : a home-based group-mediated cognitive behavioral walking intervention or an attention control condition . MAIN OUTCOMES AND MEASURES The primary outcome was 6-month change in 6-minute walk performance . Secondary outcomes included 6-month change in treadmill walking , physical activity , the Walking Impairment Question naire ( WIQ ) , and Physical and Mental Health Composite Scores from the 12-item Short-Form Health Survey . RESULTS Participants r and omized to the intervention group significantly increased their 6-minute walk distance ( [ reported in meters ] 357.4 to 399.8 vs 353.3 to 342.2 for those in the control group ; mean difference , 53.5 [ 95 % CI , 33.2 to 73.8 ] ; P .001 ) , maximal treadmill walking time ( intervention , 7.91 to 9.44 minutes vs control , 7.56 to 8.09 ; mean difference , 1.01 minutes [ 95 % CI , 0.07 to 1.95 ] ; P = .04 ) , accelerometer-measured physical activity over 7 days ( intervention , 778.0 to 866.1 vs control , 671.6 to 645.0 ; mean difference , 114.7 activity units [ 95 % CI , 12.82 to 216.5 ] ; P = .03 ) , WIQ distance score ( intervention , 35.3 to 47.4 vs control , 33.3 to 34.4 ; mean difference , 11.1 [ 95 % CI , 3.9 to 18.1 ] ; P = .003 ) , and WIQ speed score ( intervention , 36.1 to 47.7 vs control , 35.3 - 36.6 ; mean difference , 10.4 [ 95 % CI , 3.4 to 17.4 ] ; P = .004 ) . CONCLUSION AND RELEVANCE A home-based walking exercise program significantly improved walking endurance , physical activity , and patient-perceived walking endurance and speed in PAD participants with and without classic claudication symptoms . These findings have implication s for the large number of patients with PAD who are unable or unwilling to participate in supervised exercise programs . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00693940",
"The aim of this study was to develop and pilot a group education programme for promoting walking in people with intermittent claudication . Patient focus groups ( n=24 ) and literature review s were conducted to inform the development of the education programme , which involves a three-hour group-based education workshop and follow-up telephone support . A pilot study was subsequently conducted in which 23 new patients ( Rutherford category 1–3 ) were r and omly assigned to usual care ( control ) or usual care plus the education programme . Outcomes were assessed at baseline and six weeks including daily steps ( tri-axial accelerometer ) , walking capacity ( six-minute walk test and Gardner treadmill test ) , and quality of life ( Intermittent Claudication Question naire [ ICQ ] ) . Exit interviews were conducted to assess the acceptability and usefulness of the programme . Compared with controls , the intervention group had superior walking capacity and quality of life at six weeks . Mean differences in six-minute walk distance , treadmill maximum walking distance and ICQ score were 44.9 m ( 95 % confidence interval [ CI ] , 6.9 to 82.9 ) , 173 m ( 95 % CI , 23 to 322 ) , and −10.6 ( 95 % CI , −18.9 to −2.3 ) , respectively . The daily step count did not differ between groups . The exit interviews indicated that participants valued attending the programme , that it gave them a greater underst and ing of their condition , and that they had been walking more for exercise since attending . The results suggest that the education programme is feasible , acceptable , and potentially useful for improving walking capacity and quality of life . A fully-powered trial exploring clinical and cost effectiveness is needed . TRIAL REGISTRATION NUMBER : IS RCT N06733130 ( http://www.controlled-trials.com )",
"Background PAD is a disabling , chronic condition of the lower extremities that affects approximately 8 million people in the United States . The purpose of this study was to determine whether an innovative home-based walking exercise program for patients with peripheral artery disease ( PAD ) improves self-efficacy for walking , desire for physical competence , satisfaction for physical functioning , social functioning , and acceptance of PAD related pain and discomfort . Methods The design was a 6-month r and omized controlled clinical trial of 194 patients with PAD . Participants were r and omized to 1 of 2 parallel groups : a home-based group-mediated cognitive behavioral walking intervention or an attention control condition . Results Of the 194 participants r and omized , 178 completed the baseline and 6-month follow-up visit . The mean age was 70.66 ( ±9.44 ) and was equally represented by men and women . Close to half of the cohort was African American . Following 6-months of treatment , the intervention group experienced greater improvement on self-efficacy ( p = .0008 ) , satisfaction with functioning ( p = .0003 ) , pain acceptance ( p = .0002 ) , and social functioning ( p = .0008 ) than the control group ; the effects were consistent across a number of potential moderating variables . Change in these outcomes was essentially independent of change in 6-minute walk performance . Trial registration [ Clinical Trials.gov Identifier : NCT00693940",
"Objectives : Patients with peripheral artery disease have walking impairment , greater thrombotic risk , and are often treated with exercise training . We sought to determine the effect of a 3-month-long exercise program on clot strength among patients with peripheral artery disease and intermittent claudication . Methods : Twenty-three symptomatic peripheral artery disease patients were r and omly assigned to a walking exercise program or to an attention control group who performed light resistance exercise . We investigated the effect of exercise training on clot strength and time to clot formation was assessed by thromboelastography . Results : After 3 months of exercise , clot strength ( maximal amplitude ) and time to clot formation ( R ) did not change significantly from baseline , even after improvements in claudication onset time ( p peak walking time ( p in clot formation parameters were not significantly different between groups . Among the 10 individuals demonstrating a reduction in clot strength ( reduced maximal amplitude ) , one was a smoker ( 10 % ) compared to 9 of 13 non-responders ( 69 % ) whose maximal amplitude was unchanged or increased ( p = 0.0097 ) . Conclusion : In this ancillary study , a 12-week walking program improved ambulatory function in peripheral artery disease patients with claudication , but does not modify clot strength or time to clot formation . Larger studies are needed to confirm these hypothesis generating findings and to determine whether a different amount or type of exercise may induce a change in clotting in this patient population",
"BACKGROUND Supervised treadmill-walking exercise programs have been proven to be a highly effective in improving walking distance in peripheral arterial disease ( PAD ) patients with lifestyle-limiting claudication . Limited information is available on the contributions of central cardiorespiratory functions for improving these patients ' walking capacity with exercise training . METHODS This study r and omized 28 participants ( 21 men ; age , 65.6 years ; 92.7 % smoking history , 36.6 % with diabetes ) with lifestyle-limiting PAD-related claudication to 3 hours/week of supervised exercise training for 12 weeks , using arm-ergometry ( n = 10 ) or treadmill-walking ( n = 10 ) vs a usual-care control group ( n = 8) . Cardiorespiratory function measurements were assessed before and after training at a submaximal workload and at the onset of claudication ( pain-free walking distance [ PFWD ] ) and at maximal walking distance [ ( MWD ] ) . Changes in these functions from baseline were analyzed among the groups with analysis of covariance . Associations between variables were determined by Pearson 's partial correlations . RESULTS The mean baseline demographic , medical , and exercise variables were similar among the groups . There were similar significant differences in the submaximal double product ( heart rate × systolic blood pressure ) and at MWD , ventilatory threshold , ventilatory oxygen uptake ( VO(2 ) ) at onset of claudication , and VO(2 ) peak in response to training in both exercise groups vs the control group . Statistically significant , moderate correlations ( r = 0.60 - 0.68 ) were found between changes in all cardiorespiratory variables and changes in PFWD or MWD . CONCLUSION Improvements in cardiorespiratory function after arm-ergometry or treadmill-training were significantly associated with improvements in both PFWD and MWD , providing supporting evidence of systemic contributions to exercise training-related improvements in walking capacity seen in patients with claudication",
"OBJECTIVE The efficacy of polestriding exercise ( walking with modified ski poles with a movement pattern similar to cross-country skiing ) to increase exercise tolerance of persons with intermittent claudication pain caused by peripheral arterial disease was tested in this 24-week prospect i ve r and omized clinical trial . METHODS The study was conducted in a Department of Veterans Affairs Hospital with 52 individuals who gave written informed consent and were r and omized into either a polestriding exercise ( n = 27 ; age , 65.5 + /- 7.0 years ; ankle brachial index , 0.64 + /- 0.25 ) or nonexercise control ( n = 25 ; age , 68.6 + /- 8.9 years ; ankle brachial index , 0.69 + /- 0.14 ) group ( P > .05 for all comparisons ) . The polestriding exercise program consisted of supervised training three times per week for 4 weeks , two times per week for 8 weeks , one time per week for 4 weeks , biweekly for 4 weeks and unsupervised training for 4 weeks . Starting in week 5 , subjects took their poles home with instructions to repeat the most recent supervised training walk at an appropriate and convenient location near their residence . This was referred to as unsupervised but directed exercise . Subjects were provided with a personal log book for documenting unsupervised exercise sessions . With both supervised and unsupervised exercise , subjects were expected to complete a total of four 30-minute to 45-minute polestriding exercise sessions per week . The main outcome measures were exercise duration on symptom-limited incremental treadmill test , Walking Impairment Question naire , rating of perceived leg pain at baseline , 4 , 8 , 12 , 16 , and 24 weeks , and constant work-rate treadmill exercise tests at baseline and at 4 , 12 , and 24 weeks . RESULTS Polestriding significantly ( P exercise tolerance on the constant work-rate and incremental treadmill tests . Ratings of perceived claudication pain were significantly less after the polestriding training program . Subject perceived distance and walking speed scores on the Walking Impairment Question naire improved in the polestriding trained group only ( P polestriding training significantly improves quantitative and qualitative measures of the exercise tolerance of persons limited by intermittent claudication pain",
"Objective —Peripheral artery disease ( PAD ) is characterized by impaired blood flow to the lower extremities , causing claudication and exercise intolerance . The mechanism(s ) by which exercise training improves functional capacity is not understood . This study tested the hypothesis that in PAD patients who undergo supervised exercise training , increases in capillary density ( CD ) in calf muscle take place before improvements in peak oxygen uptake ( VO2 ) . Methods and Results —Thirty-five PAD patients were r and omly assigned to 12 weeks of directly supervised or home-based exercise training . Peak VO2 testing and gastrocnemius muscle biopsies were performed at baseline and after training . CD ( endothelial cells/mm2 ) was measured using immunofluorescence staining . After 3 weeks of directly supervised training , patients had an increase in CD ( 216±66 versus 284±77 , P increase in peak VO2 . However , after 12 weeks , peak VO2 increased ( 15.3±2.8 versus 16.8±3.8 , P CD remained increased over baseline , but there were no changes in markers of oxidative capacity . Within subjects , CD was related to peak VO2 before and after directly supervised training . Conclusion —Changes in CD in ischemic muscle with training may modulate the response to training , and those changes precede the increase in VO2",
"The aims of the study were to determine whether heart rate variability ( HRV ) measured at rest and during exercise could be altered by an exercise training programme design ed to increase walking performance in patients with peripheral arterial disease . Forty-four volunteers were r and omised into 12 weeks of either : supervised walking training twice weekly for 30 min at 75 % VO2peak ( SU ) , home-based walking training sessions : twice weekly , 30 min per week ( HB ) or no exercise ( CT ) . HRV measures were calculated from a 5-min resting ECG . Each patient then underwent maximal , grade d exercise treadmill testing . All measures were repeated after 12 weeks . The SU group showed significantly ( p maximal walking time ( MWT ) but no change in VO2peak . There were no statistically significant changes in any of the measures of HRV in any group . Effect sizes for change in HRV measures were all very small and in some cases negative . Improved walking performance was not accompanied by central cardiorespiratory or neuroregulatory adaptations in the present study . The lack of any change in HRV was possibly due to either the low intensity or discontinuous nature of exercise undertaken . Key pointsIt is known that exercise can positively influence heart rate variability in some cardiac patients .It is known that exercise can increase walking performance in peripheral vascular disease patients .Exercise training improved walking performance in peripheral vascular disease patients but HRV was unaltered . This may be due to low overall physiological dem and s on the cardiovascular system or the intermittent nature of the exercise",
"OBJECTIVE To derive formulae to predict the likely 12-month health-related quality of life outcome following different treatments for intermittent claudication ( IC ) . DESIGN A prospect i ve , r and omized , controlled study . MATERIAL S One hundred and seventy-one unselected patients with stable IC were sequentially r and omized to invasive therapy , supervised physical training or observation . Hierarchical analysis was used to identify significant predictors of outcome . RESULTS The strongest outcome predictors were baseline values of the respective outcome variables in all groups . No more than two significant secondary predictors were identified for each outcome variable and no outcome variable was a predictor of any other outcome variable . Result ing prediction equations achieved between 61 and 90 % concordance with improvement ( 75 % considered adequate ) , with best prediction for invasive therapy and poorest for observation . Suggested cutpoints for the various endpoints in the three groups had sensitivities ranging between 65 and 100 % and false positive rates between 5 and 50 % . CONCLUSIONS The derived equations adequately predicted improvement on the various outcome variables in invasive therapy and supervised physical training , and may serve as aids in selecting patients likely to benefit most from a particular treatment strategy . The uniqueness of the outcome variables underscores the importance of implementing a comprehensive set of endpoints relevant to the impacts of the condition",
"Supervised , hospital-based exercise rehabilitation programs are effective for improving functional status for patients with claudication due to peripheral arterial occlusive disease . However , it has been suggested that unsupervised , home-based exercise programs , which have been relatively little evaluated , would be equally efficacious as compared with hospital-based programs . The authors tested the hypothesis that a hospital-based exercise rehabilitation program would improve treadmill exercise perfor mance more than a home-based program . Of 20 consecutively enrolled patients with claudication , 10 were r and omly placed into a supervised , hospital-based program and 10 into an unsupervised , home-based program for a three-month period . Exercise perfor mance was evaluated by treadmill testing using a grade d protocol . In addition , func tional status was evaluated by the Walking Impairment Question naire ( WIQ ) and the Medical Outcomes Study SF-20 question naire ( MOS ) . Patients in the hospital-based program were treated with treadmill walking three times a week for one hour/visit . Patients in the home-based program were instructed to walk at least three times a week and were contacted weekly to provide encouragement and to record compliance with ( continued on next page ) the program . Patients in the hospital-based group improved peak walking time by 137 % , pain-free walking time by 150 % , and peak oxygen consumption by 19 % ( all P walking distance and speed according to WIQ data ( both P MOS physical functioning score in the hospital-based group improved by 20 percentage points ( P exercise performance measured on the treadmill . Improvement in the ability to walk on the treadmill was greater in the hospital-based than the home- based program ( P ability to walk distances was the only question naire measure that improved in persons who received the home-based program ( P improving treadmill exercise performance than an unsupervised , home-based program",
"Background — Claudication is a common and disabling symptom of peripheral artery disease that can be treated with medication , supervised exercise ( SE ) , or stent revascularization ( ST ) . Methods and Results — We r and omly assigned 111 patients with aortoiliac peripheral artery disease to receive 1 of 3 treatments : optimal medical care ( OMC ) , OMC plus SE , or OMC plus ST . The primary end point was the change in peak walking time on a grade d treadmill test at 6 months compared with baseline . Secondary end points included free-living step activity , quality of life with the Walking Impairment Question naire , Peripheral Artery Question naire , Medical Outcomes Study 12-Item Short Form , and cardiovascular risk factors . At the 6-month follow-up , change in peak walking time ( the primary end point ) was greatest for SE , intermediate for ST , and least with OMC ( mean change versus baseline , 5.8±4.6 , 3.7±4.9 , and 1.2±2.6 minutes , respectively ; P Although disease-specific quality of life as assessed by the Walking Impairment Question naire and Peripheral Artery Question naire also improved with both SE and ST compared with OMC , for most scales , the extent of improvement was greater with ST than SE . Free-living step activity increased more with ST than with either SE or OMC alone ( 114±274 versus 73±139 versus −6±109 steps per hour ) , but these differences were not statistically significant . Conclusions — SE results in superior treadmill walking performance than ST , even for those with aortoiliac peripheral artery disease . The contrast between better walking performance for SE and better patient-reported quality of life for ST warrants further study . Clinical Trial Registration — URL : http:// clinical trials.gov/ct/show/NCT00132743?order=1 . Unique identifier : NCT00132743",
"Background — This prospect i ve , r and omized , controlled clinical trial compared changes in exercise performance and daily ambulatory activity in peripheral artery disease patients with intermittent claudication after a home-based exercise program , a supervised exercise program , and usual-care control . Methods and Results — Of the 119 patients r and omized , 29 completed home-based exercise , 33 completed supervised exercise , and 30 completed usual-care control . Both exercise programs consisted of intermittent walking to nearly maximal claudication pain for 12 weeks . Patients wore a step activity monitor during each exercise session . Primary outcome measures included claudication onset time and peak walking time obtained from a treadmill exercise test ; secondary outcome measures included daily ambulatory cadences measured during a 7-day monitoring period . Adherence to home-based and supervised exercise was similar ( P=0.712 ) and exceeded 80 % . Both exercise programs increased claudication onset time ( P peak walking time ( P home-based exercise increased daily average cadence ( P0.05 ) . The changes in claudication onset time and peak walking time were similar between the 2 exercise groups ( P>0.05 ) , whereas the change in daily average cadence was greater with home-based exercise ( P home-based exercise program , quantified with a step activity monitor , has high adherence and is efficacious in improving claudication measures similar to a st and ard supervised exercise program . Furthermore , home-based exercise appears more efficacious in increasing daily ambulatory activity in the community setting than supervised exercise . Clinical Trial Registration — URL : http://www . Clinical Trials . Gov . Unique identifier : NCT00618670",
"PURPOSE : The purpose of this study was to compare the effects of a 24-week walking with poles rehabilitation program with a traditional 24-week walking program on physical function in patients with peripheral arterial disease ( PAD ) . METHODS : Patients with PAD ( n = 103 , age = 69.7 ± 8.9 years , ankle-brachial index were r and omized into a rehabilitation program of traditional walking ( n = 52 ) or walking with poles ( n = 51 ) . Patients exercised 3 times per week for 24 weeks . Exercise endurance was measured by time walked on a constant work rate treadmill test at 6 , 12 , and 24 weeks . Perceived physical function was measured by the Medical Outcomes Study Short Form-36 and Walking Impairment Question naire . Tissue oxygenation was measured using near-infrared spectroscopy . RESULTS : Patients assigned to the traditional walking group walked longer at 24 weeks than those assigned to the pole walking group ( 21.10 ± 17.07 minutes and 15.02 ± 12.32 minutes , respectively , P = .037 ) . There were no differences between the groups in tissue oxygenation . However , there was a significant lengthening of time for which it took to reach minimum tissue oxygenation values ( P in perceived physical function as measured by the Physical Function subscale on the Medical Outcomes Study Short Form-36 or perceived walking distance as measured by the Walking Distance subscale on the Walking Impairment Scale . CONCLUSIONS : Traditional walking was superior to walking with poles in increasing walking endurance on a constant work rate treadmill test for patients with PAD",
"This was a r and omized clinical trial to determine whether Nordic pole walking ( NPW ) is more effective in improving walking distance than a st and ard home exercise programme ( HEP ) in patients with intermittent claudication",
"PURPOSE The effects of upper-limb ( arm cranking ) and lower-limb ( leg cranking ) exercise training on walking distances in patients with intermittent claudication was assessed . METHODS Sixty-seven patients ( 33 to 82 years old ) with moderate to severe intermittent claudication were recruited , and the maximum power generated during incremental upper- and lower-limb ergometry tests was determined , as were pain-free and maximum walking distances ( by using a shuttle walk test ) . Patients were r and omly assigned to an upper-limb training group ( n = 26 ) or a lower-limb training group ( n = 26 ) . An additional untrained group ( n = 15 ) was recruited on an ad hoc basis in parallel with the main trial by using identical inclusion criteria . This group was subsequently shown to possess a similar demographic distribution to the two exercise groups . Supervised training sessions were held twice weekly for 6 weeks . RESULTS Both training programs significantly improved the maximum power generated during the incremental upper- and lower-limb ergometry tests ( P central cardiovascular function that was independent of the training mode . More importantly , pain-free and maximum walking distances also improved in both training groups ( P upper-limb exercise training may result , in part , from systemic cardiovascular effects rather than localized metabolic or hemodynamic changes . CONCLUSION Carefully prescribed upper-limb exercise training can evoke a rapid symptomatic improvement in patients with claudication , while avoiding the physical discomfort experienced when performing lower-limb weight-bearing exercise",
"OBJECTIVE Determine the efficacy of a home-based walking intervention to improve walking ability and quality of life in people with diabetes and peripheral arterial disease ( PAD ) . RESEARCH DESIGN AND METHODS We conducted a r and omized , controlled , single-blind trial within university-affiliated clinics in our local community . We r and omized 145 participants ( 45 women ) with diabetes and PAD to our intervention — a 6-month behavioral intervention targeting levels of readiness to engage in routine walking for exercise — versus attention control . Our primary outcome was 6-month change in maximal treadmill walking distance . Secondary outcomes included 3-month change in maximal walking distance , lower limb function ( i.e. , walking impairment scores ) , quality of life ( Medical Outcomes Short Form Survey ) , exercise behaviors , depressive symptoms , and self-efficacy at 3 and 6 months . RESULTS The mean age of participants was 66.5 ( SD 10.1 ) years . Intervention and control groups did not differ significantly in 6-month change in maximal treadmill walking distance ( average [ SE ] 24.5 [ 19.6 ] meters vs. 39.2 [ 19.6 ] meters ; P = 0.60 ) . Among secondary outcomes , for the intervention and control groups , respectively , average walking speed scores increased by 5.7 [ 2.2 ] units and decreased by 1.9 [ 2.8 ] units ( P = 0.03 ) ; the mental health quality of life subscale score increased by 3.2 [ 1.5 ] and decreased by 2.4 [ 1.5 ] units ( P = 0.01 ) . CONCLUSIONS A home-based walking intervention did not improve walking distance but did improve walking speed and quality of life in people with diabetes and PAD . Clinicians should consider recommending home-based walking therapy for such patients",
"Background This prospect i ve , r and omized , controlled clinical trial compared changes in primary outcome measures of claudication onset time ( COT ) and peak walking time ( PWT ) , and secondary outcomes of submaximal exercise performance , daily ambulatory activity , vascular function , inflammation , and calf muscle hemoglobin oxygen saturation ( StO2 ) in patients with symptomatic peripheral artery disease ( PAD ) following new exercise training using a step watch ( NEXT Step ) home‐exercise program , a supervised exercise program , and an attention‐control group . Methods and Results One hundred eighty patients were r and omized . The NEXT Step program and the supervised exercise program consisted of intermittent walking to mild‐to‐moderate claudication pain for 12 weeks , whereas the controls performed light resistance training . Change scores for COT ( P PWT ( P 6‐minute walk distance ( P=0.028 ) , daily average cadence ( P=0.011 ) , time to minimum calf muscle StO2 during exercise ( P=0.025 ) , large‐artery elasticity index ( LAEI ) ( P=0.012 ) , and high‐sensitivity C‐reactive protein ( hsCRP ) ( P=0.041 ) were significantly different among the 3 groups . Both the NEXT Step home program and the supervised exercise program demonstrated a significant increase from baseline in COT , PWT , 6‐minute walk distance , daily average cadence , and time to minimum calf StO2 . Only the NEXT Step home group had improvements from baseline in LAEI , and hsCRP ( P . Conclusions NEXT Step home exercise utilizing minimal staff supervision has low attrition , high adherence , and is efficacious in improving COT and PWT , as well as secondary outcomes of submaximal exercise performance , daily ambulatory activity , vascular function , inflammation , and calf muscle StO2 in symptomatic patients with PAD . Clinical Trial Registration URL : Clinical Trials.gov . Unique Identifier : NCT00618670",
"OBJECTIVES Supervised exercise training ( SET ) is recommended for patients with intermittent claudication ( IC ) . The optimal exercise programme has not been identified , and the potential adverse effects of exercise on these patients warrant consideration . Calpain proteases have been linked with tissue atrophy following ischaemia-reperfusion injury . High calpain activity may therefore cause muscle wasting in claudicants undergoing SET , and skeletal muscle mass ( SMM ) is integral to healthy ageing . This study assesses the impact of ( 1 ) treadmill-based SET alone ; and ( 2 ) treadmill-based SET combined with resistance training on pain-free walking distance ( PFWD ) , SMM , and calpain activity . METHODS Thirty-five patients with IC were r and omised to 12 weeks of treadmill only SET ( group A ) , or combined treadmill and lower-limb resistance SET ( group B ) . PFWD via a 6-minute walking test , SMM via dual energy X-ray absorptiometry , and calpain activity via biopsies of gastrocnemius muscles were analysed . RESULTS Intention-to-treat analyses revealed PFWD improved within group A ( 160 m to 204 m , p = .03 ) , but not group B ( 181 m to 188 m , p = .82 ) . There was no between group difference ( p = .42 ) . Calpain activity increased within group A ( 1.62 × 10(5 ) fluorescent units [ FU ] to 2.21 × 10(5 ) FU , p = .05 ) , but not group B. There was no between group difference ( p = .09 ) . SMM decreased within group A ( -250 g , p = .11 ) and increased in group B ( 210 g , p = .38 ) ( p = .10 between groups ) . Similar trends were evident for per protocol analyses , but , additionally , change in SMM was significantly different between groups ( p = .04 ) . CONCLUSIONS Neither exercise regimen was superior in terms of walking performance . Further work is required to investigate the impact of the calpain system on SMM in claudicants undertaking SET ",
"Background and Objective : Type 2 diabetes is one of the main causes of peripheral vascular disease . The beneficial effects of exercise on glucose homeostasis include a marked stimulation of blood glucose utilization during and after its performance . The objective of this study was to determine the effects of a program of 3 physical therapy modalities on blood circulation in patients with type 2 diabetes with peripheral arterial disease . Subjects and Method : A r and omized controlled trial was undertaken . Sixty-eight patients with type 2 diabetes with Leriche-Fontaine stage I or IIa peripheral arterial disease were r and omly assigned to an exercise or placebo group . For 20 weeks , the exercise group underwent treatment comprising 3 exercises at proximal , medium , and distal segments of the lower limbs , and the placebo group received sham treatment with disconnected ultrasound equipment . Peripheral arterial disease was determined by evaluating the ankle/brachial index ( ABI ) , Doppler flow velocity , blood parameters , cardiovascular risk score , and heart rate during exercise test . Results : After 20 weeks of treatment , significant differences between groups were found in the following : right ( P ABI ; Doppler flow velocity ( cm/s ) in the right ( P posterior tibial artery and in the right ( P dorsalis pedis artery ; and fibrinogen ( P hemoglobin ( P cholesterol ( P high-density lipoprotein cholesterol ( P HbA1c ( P low-density lipoprotein cholesterol values ( P physical therapy modalities improves ABI , Doppler flow velocity , and blood parameters in patients with type 2 diabetes",
"OBJECTIVES To evaluate effects of a structured home-based exercise program on functional capacity and quality of life ( QoL ) in patients with intermittent claudication ( IC ) after 1-year follow-up , and to compare these results with those from a concurrent control group who received supervised exercise training ( SET ) . DESIGN Comparative longitudinal cohort study . SETTING Referral center . PARTICIPANTS Patients ( N=142 ) with IC . INTERVENTIONS Structured home-based exercise training or SET . MAIN OUTCOME MEASURES The maximum ( pain-free ) walking distance and the ankle-brachial index ( ABI ) ( at rest and postexercise ) were measured at baseline and after 6 and 12 months ' follow-up . Additionally , QoL was evaluated using a self-administered question naire consisting of the Euroqol-5D ( scale 0 - 1 ) , rating scale ( scale 0 - 100 ) , Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ; scale 0 - 100 ) , and the Vascular Quality of Life Question naire ( VascuQol ; scale 1 - 7 ) . Comparison of the groups was performed with adjustment for the nonr and omized setting using propensity scoring . RESULTS One hundred forty-two patients with IC started the structured home-based exercise program , of whom 95 ( 67 % ) completed 12 months ' follow-up . The mean relative improvement compared with baseline was statistically significant after 12 months ' follow-up for the maximum and pain-free walking distance ( 342 % , 95 % confidence interval [ CI ] , 169 - 516 ; P ABI postexercise ( mean change , .06 ; 95 % CI , .01-.10 ; P=.02 ) . For the QoL outcomes , the improvement compared with baseline was statistically significant after 12 months for the VascuQol ( mean change , .42 ; 95 % CI , .20-.65 ; P SF-36 physical functioning ( mean change , 5.17 ; 95 % CI , .77 - 9.56 ; P=.02 ) . Compared with the structured home-based exercise program , patients in the control group showed significantly better results in the mean relative improvement of maximum and pain-free walking distance and change in the ABI at rest after 12 months ' follow-up . CONCLUSIONS Structured home-based exercise training is effective in improving both functional capacity and QoL in patients with IC and may be considered as a feasible and valuable alternative toSET , since supervised exercise programs are not often available",
"OBJECTIVES The main aims of treatment in patients with intermittent claudication ( IC ) are to improve the clinical indicators of lower limb ischaemia and patients ' quality of life ( QoL ) . The aims of this study were assess the clinical and cost effectiveness of a supervised exercise programme ( SEP ) in patients with IC . DESIGN Non-r and omised , controlled trial . SETTING University teaching hospital . PATIENTS AND METHODS Two groups of patients with IC were studied . Seventy patients were sequentially recruited before and after the establishment of a Supervised Exercise Programme at our unit . Thirty-seven patients ( median age 69 years , 26 men ) received conservative medical therapy ( CMT ) and 33 patients ( median age 67 years , 22 men ) received CMT plus a 3 month SEP of graduated physical exercise for sixty minutes , three times each week . Patients were assessed prior to and at 6 months following treatment . At each assessment patient reported walking distances ( PRWD ) , treadmill claudication and maximal distances ( ICD and MWD ) , ankle brachial pressure indices ( ABPI ) pre & post exercise and patient reported QoL using the SF36 question naire were assessed . RESULTS Prior to intervention the two groups were well matched . Following treatment , CMT patients demonstrated no significant change in PRWD or ICD but did record a small but significant improvement in MWD . CMT was also associated with a negative effect size in the SF36 index and in 7 of the 8 SF36 QoL domains , effect size > -0.5 for the domains of Physical Function and Emotional Role . SEP patients demonstrated significant improvement in PRWD , ICD and MWD . SEP was associated with a positive effect size in the SF36 index and in 2 SF36 QoL domains but a negative effect size in a further 2 domains . However , all QoL effect sizes following SEP were 0.5 for the SF36 domains of Physical Function , Physical Role , Emotion Role and SF36 index . SEP result ed in a 0.027 quality adjusted life year ( QALY ) gain over CMT in the first year post-treatment thus the cost/QALY gained of SEP is pound1780 at 1 year . CONCLUSIONS Compared to CMT , SEP increases walking distances , improves QoL and is a highly cost-effective treatment for IC",
"The effects of 14-day physical exercise or iloprost treatment ( 0.5 - 2 ng/Kg/min ) on endogenous nitric oxide production and neutrophil adhesion were evaluated in 20 patients with peripheral arterial occlusive disease ( Fontaine Stage II ) . Peripheral venous blood sample s and 4-h urine sample s were collected before , immediately after 14 days of therapy and 7 - 10 days after therapy in order to evaluate neutrophil adhesion , nitrite/nitrate and cGMP excretion rates . A longer pain free walking distance was observed after exercise , compared to iloprost ( > 500 m in 3/10 subjects ) . Urinary nitrite/nitrate , as well as cGMP concentrations , significantly increased after exercise . Nitrite/nitrate excretion rate inversely correlated to neutrophil adhesion . No variations were observed in these parameters in iloprost treated patients . The improvement in claudication and the transient increase in urinary nitrite/nitrate suggest a possible nitric oxide-dependent mechanism for the clinical efficacy of physical exercise . The results from the present and previous observations indicate that , besides pharmacological treatments , a regular aerobic exercise improves peripheral arterial occlusive disease",
"PURPOSE To determine if improvements in physical function and peripheral circulation after 6 months of exercise rehabilitation could be sustained over a subsequent 12-month maintenance exercise program in older patients with intermittent claudication . METHODS Seventeen patients r and omized to exercise rehabilitation and 14 patients r and omized to usual care control completed this 18-month study . Patients exercised three times per week during the first 6 months of a progressive exercise program , followed by two times per week during the final 12 months of a maintenance program . Patients were studied at baseline , 6 months , and 18 months during the study . RESULTS Eighteen months of exercise rehabilitation increased the initial claudication distance by 373 meters ( 189 % ) ( P absolute claudication distance by 358 meters ( 80 % ) ( P walking economy by 11 % ( P 6-minute walk distance by 10 % ( P daily physical activity by 31 % , and maximal calf blood flow by 18 % ( P exercise rehabilitation ( P = NS ) , and were significantly greater than the changes in the control group throughout the study ( P Improvements in claudication distances , walking economy , 6-minute walk distance , physical activity level , and peripheral circulation after 6 months of exercise rehabilitation are sustained for an additional 12 months in older patients with intermittent claudication using a less frequent exercise maintenance program",
"OBJECTIVE To compare the effect of two training programmes and advice to exercise at home on physiological adaptations in patients with peripheral arterial disease ( PAD ) . DESIGN 30 patients with a typical history of PAD and intermittent claudication were r and omised to either an upper body strength training programme ( UBST ) , a dynamic ( walking , cycling , circuit ) conventional exercise rehabilitation programme ( CER ) , or advice to ' walk as much as possible at home ' ( CONT ) . Before and after intervention groups performed a st and ard grade d treadmill exercise test ( GTET ) and a 6-minute walk test ( SMWT ) to determine peak physiological parameters and walking distances . Maximal walking distance ( MWD ) , pain-free walking distance ( PFWD ) , peak oxygen uptake ( VO2 ) , heart rate and perceived pain were measured . RESULTS MWD on the GTET increased significantly in the CER group compared with the CONT and UBST groups ( 93.9 + /- 79 % v. 7.0 + /- 19.8 % v. 7.3 + /- 46 % ; CER v. UBST v. CONT p = 0.003 ) . Similarly , peak VO2 increased with CER compared with the CONT and UBST groups ( 28.4 + /- 20 v. -6.2 + /- 15 v. -1.0 + /- 21 % ; CER v. UBST v. CONT p = 0.004 ) . During the SMWT the CER and UBST groups improved in PFWD compared with the CONT group ( 37 + /- 47 % v. 27 + /- 71 % v. -30 + /- 29 % ; CER v. UBST v. CONT p = 0.03 ) , and perceived pain decreased in the CER group compared with the UBST group ( -24 + /- 39 % v. 27 + /- 48 % ; CER v. UBST p = 0.01 ) . CONCLUSION CER improves physiological parameters and walking distances more than UBST does . CER is effective within 6 weeks . Verbal encouragement to exercise is an ineffective form of management",
"The purpose of this study was to examine the effects of a 6-month exercise program on submaximal walking economy in individuals with peripheral arterial disease and intermittent claudication ( PAD-IC ) . Participants ( n = 16 ) were r and omly allocated to either a control PAD-IC group ( CPAD-IC , n = 6 ) which received st and ard medical therapy , or a treatment PAD-IC group ( TPAD-IC ; n = 10 ) which took part in a supervised exercise program . During a grade d treadmill test , physiological responses , including oxygen consumption , were assessed to calculate walking economy during submaximal and maximal walking performance . Differences between groups at baseline and post-intervention were analyzed via Kruskal – Wallis tests . At baseline , CPAD-IC and TPAD-IC groups demonstrated similar walking performance and physiological responses . Postintervention , TPAD-IC patients demonstrated significantly lower oxygen consumption during the grade d exercise test , and greater maximal walking performance compared to CPAD-IC . These preliminary results indicate that 6 months of regular exercise improves both submaximal walking economy and maximal walking performance , without significant changes in maximal walking economy . Enhanced walking economy may contribute to physiological efficiency , which in turn may improve walking performance as demonstrated by PAD-IC patients following regular exercise programs",
"Objective : The aim of this study was to evaluate the effectiveness of a supervised exercise program ( SEP ) plus at home nonsupervised exercise therapy ( non-SET ) on functional status , quality of life ( QoL ) and hemodynamic response in post-lower-limb bypass surgery patients . Results : One hundred and seventeen patients were r and omized to an intervention ( n = 57 ) or a control group ( n = 60 ) . A new individual SEP was design ed for patients with peripheral arterial disease ( PAD ) and applied to the studied subjects of the intervention group who also continued non-SET at home , whereas those assigned to the control group received just usual SEP according to a common cardiovascular program . The participants of the study were assessed by a 6-min walking test ( 6 MWT ) , an ankle-brachial index ( ABI ) , and the Medical Outcomes Study Short Form-36 ( SF-36 ) of QoL at baseline , at 1 and 6 months after surgery . A significant improvement was observed in the walked distance in the intervention group after 6 months compared with the control group ( p higher QoL score in the physical and mental component of SF-36 ( p new SEP and non-SET at home has yielded significantly better results in walking distance and QoL in the intervention group than in the controls",
"Background We studied whether a 6‐month group‐mediated cognitive behavioral ( GMCB ) intervention for peripheral artery disease ( PAD ) participants , which promoted home‐based walking exercise , improved 6‐minute walk and other outcomes at 12‐month follow‐up , 6 months after completing the intervention , compared to a control group . Methods and Results We r and omized PAD participants to a GMCB intervention or a control group . During phase I ( months 1 to 6 ) , the intervention used group support and self‐regulatory skills during weekly on‐site meetings to help participants adhere to home‐based exercise . The control group received weekly on‐site lectures on topics unrelated to exercise . Primary outcomes were measured at the end of phase I. During phase II ( months 7 to 12 ) , each group received telephone contact . Compared to controls , participants r and omized to the intervention increased their 6‐minute walk distance from baseline to 12‐month follow‐up , ( from 355.4 to 381.9 m in the intervention versus 353.1 to 345.6 m in the control group ; mean difference=+34.1 m ; 95 % confidence interval [CI]=+14.6 , + 53.5 ; P speed score ( from 36.1 to 46.5 in the intervention group versus 34.9 to 36.5 in the control group ; mean difference = + 8.8 ; 95 % CI=+1.6 , + 16.1 ; P=0.018 ) . Change in the WIQ distance score was not different between the 2 groups at 12‐month follow‐up ( P=0.139 ) . Conclusions A weekly on‐site GMCB intervention that promoted home‐based walking exercise intervention for people with PAD demonstrated continued benefit at 12‐month follow‐up , 6 months after the GMCB intervention was completed . Clinical Trial Registration URL : Clinical Trials.gov . Unique identifier : NCT00693940",
"This r and omized trial proposed to determine if there were differences in calf muscle StO2 parameters in patients before and after 12 weeks of a traditional walking or walking-with-poles exercise program . Data were collected on 85 patients who were r and omized to a traditional walking program ( n = 40 ) or walking-with-poles program ( n = 45 ) of exercise training . Patients walked for 3 times weekly for 12 weeks . Seventy-one patients completed both the baseline and the 12-week follow-up progressive treadmill tests ( n = 36 traditional walking and n = 35 walking-with-poles ) . Using the near-infrared spectroscopy measures , StO2 was measured prior to , during , and after exercise . At baseline , calf muscle oxygenation decreased from 56 ± 17 % prior to the treadmill test to 16 ± 18 % at peak exercise . The time elapsed prior to reaching nadir StO2 values increased more in the traditional walking group when compared to the walking-with-poles group . Likewise , absolute walking time increased more in the traditional walking group than in the walking-with-poles group . Tissue oxygenation decline during treadmill testing was less for patients assigned to a 12-week traditional walking program when compared to those assigned to a 12-week walking-with-poles program . In conclusion , the 12-week traditional walking program was superior to walking-with-poles in improving tissue deoxygenation in patients with PAD",
"BACKGROUND The first-line intervention for intermittent claudication is usually supervised exercise therapy ( SET ) . The literature describes a range of exercise programs varying in setting , duration , and content . The purpose of the present study was to examine the exercise protocol s offered and to identify the impact of the intensity of the SET programs ( in terms of frequency , duration , and type of exercise ) on improvements in walking distance ( response ) in the first 3 months . The present study is part of the Exercise Therapy in Peripheral Arterial Disease ( EXITPAD ) study , a multicenter r and omized clinical trial comparing the effects of SET provided by regional physiotherapists , with or without daily feedback , on the level of activities with the effects of walking advice . METHODS The analysis included patients r and omized to receive SET with or without feedback . The physical therapists administering the SET were asked to fill out therapy evaluation sheets stating frequency , duration , and type of exercises . The relationship between training volume and the impact on walking distance was explored by dividing training volume data into tertiles and relating them to the median change in maximum walking distance at 3 and 12 months . RESULTS Data of 169 patients were included in the analysis . A SET program consisting of at least two training sessions per week each lasting over 30 minutes , during the first 3 months of a 1-year program tailored to individual patients ' needs led to better results in terms of walking distance after 3 and 12 months than the other variants . The results of our analysis dividing training volume into tertiles suggest that there is a relationship between training volume and improvement in walking distance and that at least 590 minutes of training should be offered in the first 3 months . No differences were found between program involving only walking and a combination of exercises , nor between individual and group training . CONCLUSION A SET programs consisting of at least two training sessions a week , each lasting over 30 minutes , should be offered during the first 3 months of the SET program to optimize improvement in terms of maximum walking distance",
"Purpose : Peripheral arterial disease ( PAD ) is a chronic , progressive disease with a significant cardiovascular and cerebrovascular risk burden and a considerable impact on functional capacity and quality of life ( QoL ) . Exercise programmes result in significant improvements in walking distances but long-term effects are uncertain . The aim of this study was to assess the one-year effects of participation in a 12-week supervised exercise programme on functional capacity and QoL for PAD patients . Methods : Patients were r and omly allocated to a control ( n = 16 ) or an exercise ( n = 28 ) group . Data regarding functional capacity ( Walking Impairment Question naire WIQ ) , disease-specific QoL ( Intermittent Claudication Question naire ICQ ) and generic QoL ( SF-36 ) were collected at baseline , 12 weeks and 1 year . Results : At 12 weeks , there was a trend towards improved QoL in both groups , with a tendency for greater improvement in the exercise group ( p = 0.066 ) and a trend towards improved functional capacity ( WIQ Stair-climbing p = 0.093 ) in the exercise group . At 1 year , ICQ scores in the exercise group were considerably better than those in the control group ( p = 0.058 ) , reflecting improved QoL and maintenance of benefits . Conclusions : Participation in a supervised exercise programme results in improvements in functional capacity and QoL at 1 year post-participation . Implication s for Rehabilitation Peripheral arterial disease has a considerable impact on functional capacity and quality of life Functional capacity and quality of life are improved in patients with peripheral arterial disease up to 1 year post-participation in supervised exercise Improvements at 1 year are reduced from those noted immediately following an exercise",
"OBJECTIVE To examine the influence of peripheral arterial disease ( PAD ) on heart rate variability ( HRV ) in patients , and to examine the influence of an intense long-term ( 12 months ) exercise program on HRV in PAD patients . METHODS This study involved ambulatory patients attending a local hospital and university center . Participants were twenty-five patients with diagnosed PAD and intermittent claudication and 24 healthy , age-matched adults . Interventions involved r and om allocation of PAD patients to 12 months of conservative medical treatment ( Conservative ) or medical treatment with supervised treadmill walking ( Exercise ) . The main outcome measures were time- and frequency-domain , nonlinear HRV measures during supine rest , and maximal walking capacity prior to and following the intervention . RESULTS Despite significantly worse walking capacity ( 285 ± 190 m vs 941 ± 336 m ; P , Exercise patients exhibited a significantly greater improvement in walking capacity ( 183 % ± 185 % vs 57 % ± 135 % ; P = .03 ) with similar small nonsignificant changes in HRV compared with Conservative patients . CONCLUSIONS The current study demonstrated that PAD patients exhibited similar resting HRV to healthy adults with 12 months of intense supervised walking producing similar HRV changes to that of conservative medical treatment . The greater walking capacity of healthy adults and PAD patients following supervised exercise does not appear to be associated with enhanced HRV",
"PURPOSE The purpose of this r and omized trial was to compare the efficacy of a low-intensity exercise rehabilitation program vs a high-intensity program in changing physical function , peripheral circulation , and health-related quality of life in peripheral arterial disease ( PAD ) patients limited by intermittent claudication . METHODS Thirty-one patients r and omized to low-intensity exercise rehabilitation and 33 patients r and omized to high-intensity exercise rehabilitation completed the study . The 6-month exercise rehabilitation programs consisted of intermittent treadmill walking to near maximal claudication pain 3 days per week at either 40 % ( low-intensity group ) or 80 % ( high-intensity group ) of maximal exercise capacity . Total work performed in the two training regimens was similar by having the patients in the low-intensity group exercise for a longer duration than patients in the high-intensity group . Measurements of physical function , peripheral circulation , and health-related quality of life were obtained on each patient before and after the rehabilitation programs . RESULTS After the exercise rehabilitation programs , patients in the two groups had similar improvements in these measures . Initial claudication distance increased by 109 % in the low-intensity group ( P absolute claudication distance increased by 61 % ( P peak oxygen uptake , ischemic window , and health-related quality of life . CONCLUSION The efficacy of low-intensity exercise rehabilitation is similar to high-intensity rehabilitation in improving markers of functional independence in PAD patients limited by intermittent claudication , provided that a few additional minutes of walking is accomplished to elicit a similar volume of exercise",
"BACKGROUND The prothrombotic , hypofibrinolytic state that develops in patients with intermittent claudication ( IC ) upon walking due to ischemia-reperfusion injury ( IRI ) of the leg muscles may contribute to the high incidence of life- and limb-threatening thrombotic events observed in this patient group . Treatments , such as angioplasty , that obtund the IRI also ameliorate the procoagulant diathesis . The effect on this diathesis of supervised exercise and cilostazol , both of which provide symptomatic benefit in IC , but without significantly obtunding IRI , is unknown . METHODS Thirty-four patients ( 27 men and 7 women ; median age , 67 years ; range , 63 - 72 years ) were r and omized to receive best medical therapy ( BMT ) plus supervised exercise ( n = 9 ) , BMT plus cilostazol ( n = 9 ) , BMT plus supervised exercise plus cilostazol ( n = 7 ) , or BMT alone ( n = 9 ) in a 2 x 2 factorial design . Thrombin-antithrombin complex and prothrombin fragments 1 and 2 , both markers of thrombin generation ; plasminogen activator inhibitor antigen and tissue plasminogen activator antigen , both markers of fibrinolysis ; ankle-brachial pressure index ( ABPI ) ; and initial and absolute claudication distance ( ACD ) were measured at baseline and then 3 and 6 months after r and omization . RESULTS At 6 months , when compared with receiving BMT only , supervised exercise and cilostazol result ed in improvements in ABPI of 18 % and 13 % and in ACD of 40 % and 64 % , respectively . The effects on ABPI and ACD of combining supervised exercise and cilostazol were additive . Supervised exercise , cilostazol , and supervised exercise combined with cilostazol had no significant effect on any of the four hemostatic markers . CONCLUSIONS Treatment of IC by supervised exercise or cilostazol results in significant improvements in ABPI and ACD but has no demonstrable effect on the prothrombotic diathesis . This suggests that supervised exercise and cilostazol , unlike angioplasty , are unlikely to have a long-term beneficial effect on the thrombotic risks faced by these patients",
"This study aims to evaluate the reliability of repeated grade d workload treadmill testing ( G-test ; 2 mph ; 0 % grade , increasing 2 % every 2 min ) and to compare the reliability of a constant workload treadmill protocol ( C-test ; 2 mph ; 12 % grade ) versus the grade d workload treadmill protocol in patients with intermittent claudication , studied longitudinally . A clinical trial investigating an orally stable prostacycline derivative that included 330 patients with intermittent claudication was performed . The trial employed three active treatment groups and one placebo group . Because there were no significant inter-group differences at baseline or after treatment , data from all groups were pooled for the evaluation of treadmill test reliability . Treadmill data were obtained from a 2-week run-in phase where three G-tests were performed , as well as from the beginning and the end of a 3-month double-blind phase where a G-test and a C-test were performed in r and om order . Treadmill test reliability was described through test process-related and between-subject variances and also using variance-derived parameters such as the reliability coefficient ( RC ) and the relative precision ( RP ) . A higher value for the RC and a lower value for the RP indicate that the test variability is predominantly due to between-subject variance and not to test process-related variance . Estimates of variance were described for both the maximal or absolute claudication distance ( ACD ) and the initial claudication distance ( ICD ) with each treadmill test . Reliability estimates are reported for the total study sample and for patients with baseline claudication distances diseased claudicants . Theoretical considerations suggest that reliability measures may differ in these subgroups . With repeated testing during the run-in phase for the measure of ACD , the G-test had an RC of 0.952 and an RP of 21.9 % . With the comparison of both test protocol s in the entire study population for the measurement of ACD , the G-test had an RC of 0.902 and an RP of 31.3 % , while the C-test had an RC of 0.876 and an RP of 35.2 % . The results for ICD on the G-test were an RC of 0.809 and an RP of 43.7 % , while the C-test had an RC of 0.737 and an RP of 51.3 % . The reliability of the ACD measurement for RC and RP was numerically superior to those for the ICD for both protocol s. In patients with a baseline ACD , the RC for ACD on the G-test was 0.827 and the RP was 41.4 % . In contrast , on the C-test the RC decreased to 0.250 and the RP increased to 86.6 % . These changes in RC and RP were due to a marked decrease in the between-subject variance , demonstrating the inability of the C-test to separate appropriately the different claudication distances in population s with highly limited baseline claudication distances . During a run-in phase , the G-test has excellent test characteristics . During the longitudinal phase of a trial , the reliability of G-tests and C-tests are comparable in the entire study population . However , in patients with low claudication distances , the G-test should be given preference over the C-test",
"OBJECTIVE The purpose of the study was to examine the effects of a 12-month exercise program on lower limb mobility ( temporal-spatial gait parameters and gait kinematics ) , walking performance , peak physiological responses , and physical activity levels in individuals with symptoms of intermittent claudication due to peripheral arterial disease ( PAD-IC ) . METHODS Participants ( n = 21 ) with an appropriate history of PAD-IC , ankle-brachial pressure index ( ABI ) Participants were r and omly allocated to either a control PAD-IC group ( CPAD-IC ) ( n = 11 ) that received st and ard medical therapy and a treatment PAD-IC group ( TPAD-IC ) ( n = 10 ) , which also took part in a 12-month supervised exercise program . A further group of participants ( n = 11 ) free of PAD ( ABI > 0.9 ) and who were non-regular exercisers were recruited from the community to act as age and mass matched controls ( CON ) . Lower limb mobility was determined via two-dimensional video motion analysis . A grade d treadmill test was used to assess walking performance and peak physiological responses to exercise . Physical activity levels were measured via a 7-day pedometer recording . Differences between groups were analyzed via repeated measures analysis of variance ( ANOVA ) . RESULTS The 12-month supervised exercise program had no significant effect on lower limb mobility , peak physiological responses , or physical activity levels in TPAD-IC compared with CPAD-IC participants . However , the TPAD-IC participants demonstrated significantly greater walking performance ( 171 % improvement in pain free walking time and 120 % improvement in maximal walking time compared with baseline ) . CONCLUSION The results of this study confirm that a 12-month supervised exercise program will result in improved walking performance , but does not have an impact on lower limb mobility , peak physiological responses , or physical activity levels of PAD-IC patients",
"PURPOSE This study was performed to test the effectiveness of a formal supervised exercise program against a home-based exercise program for both walking ability and quality of life endpoints . METHODS Patients with arterial claudication were r and omized to either a 12-week supervised exercise program ( SUPEX ) with weekly lectures relating to peripheral vascular disease or to a home exercise group ( HOMEX ) who attended an identical lecture program and received weekly exercise instruction . The study population included 29 men and 26 women , with a mean age of 69.1 + /- 8.1 years . Forty-seven patients completed the 12-week program , 46 were available for testing at completion , and 38 for 6-month testing . Claudication pain time ( CPT ) and maximum walking time ( MWT ) on a progressive treadmill exercise test were assessed at baseline , program completion , and 6 months . The Medical Outcomes Study Short Form-36 ( SF-36 ) was administered at these intervals to assess effects on quality of life . RESULTS Each group improved ( p CPT and MWT at the completion of the 12-week program , which was sustained at the 6-month follow-up . Increase in HOMEX CPT from baseline ( 3.6 + /- 2.73 minutes ) to 6-month follow-up ( 6.6 + /- 3.17 minutes ) was less than for the SUPEX group ( 3.8 + /- 2.74 to 11.2 + /- 4.02 minutes , respectively ) ; similar results were obtained for MWT . At both completion and 6 months , there was a significant intergroup difference for CPT and MWT ( p health perception based on the SF-36 demonstrated improvement ( p Physical Function Subscale , Bodily Pain Subscale , and Physical Composite Score . There were no between-group differences on the subsets of the SF-36 at the three assessment intervals . CONCLUSIONS Supervised exercise programs provide superior increased walking ability in the noninterventional therapy of arterial claudication , and both supervised and home based exercise therapy result in improved SF-36 functional measures . The lack of intergroup differences in these measures may be a result of the high degree of interaction with healthcare providers in the HOMEX group . Although a supervised program results in optimal walking benefits , a highly structured home-based program provides similar functional improvement and may be a satisfactory alternative for patients with lesser walking requirements",
"PURPOSE The purpose of this investigation was to evaluate the efficacy of PoleStriding exercise ( a form of walking that uses muscles of the upper and lower body in a continuous movement similar to cross-country skiing ) and vitamin E ( alpha-tocopherol ) to improve walking ability and perceived quality of life ( QOL ) of patients with claudication pain secondary to peripheral arterial disease ( PAD ) . METHODS Fifty-two subjects were r and omized into four groups : PoleStriding with vitamin E ( N = 13 ) , PoleStriding with placebo ( N= 14 ) , vitamin E without exercise ( N= 13 ) , and placebo without exercise ( N = 12 ) . The dose of vitamin E was 400 IU daily . Only the PoleStriding with vitamin E and PoleStriding with placebo groups received PoleStriding instruction and training . Assignment to vitamin E or placebo was double blind . Subjects trained three times weekly for 30 - 45 min ( rest time excluded ) . Individuals in vitamin E and placebo groups came to the laboratory biweekly for ankle blood-pressure measurements . RESULTS Results of this r and omized clinical trial provide strong evidence that PoleStriding significantly ( P exercise tolerance on the constant work-rate and incremental treadmill tests . Ratings of perceived claudication pain were significantly less after the PoleStriding training program ( P= 0.02 ) . In contrast , vitamin E did not have a statistically significant effect on the subjects ' ratings of perceived leg pain ( P= 0.35 ) or treadmill walking duration ( P= 0.36 ) . Perceived distance and walking speed ( Walking Impairment Question naire ) and perceived physical function ( R and Short Form-36 ) improved in the PoleStriding trained group only ( P PoleStriding effectively improved the exercise tolerance and perceived QOL of patients with PAD . Little additional benefit to exercise capacity was realized from vitamin E supplementation",
"BACKGROUND In this r and omized trial we compared two treadmill trainings , based on exercises performed to moderate claudication pain vs pain-free training , with respect to their effects on walking ability and endothelial function . METHODS A total of sixty patients with stable intermittent claudication were r and omized to the pain-free treadmill training ( repetitive intervals to onset of claudication pain ) or moderate treadmill training ( repetitive intervals to moderate claudication pain ) . In both groups exercises were performed 3 times a week for 3 months . Changes in flow mediated dilatation ( FMD ) and treadmill walking performance as well as plasma levels of C-reactive protein ( hs-CRP ) and fibrinogen were assessed before and after the program . RESULTS Fifty-two patients completed the training program . Post-training maximal walking time was prolonged by 100 % ( p pain-free walking time by 120 % ( p FMD increased by 56 % ( p levels of hs-CRP and fibrinogen were seen after treadmill program in either group . CONCLUSIONS Both pain-free treadmill training and the moderate treadmill training have similar efficacy on walking ability in patients with claudication . The improvement of post-training FMD indicates systemic effect of both treadmill programs on endothelial function . Both programs appear to be safe therapeutic modes , since none of them escalates the inflammation . Pain-free treadmill training seems useful and effective therapeutic option for patients with claudication",
"PURPOSE To compare clinical success , functional capacity , and quality of life during 12 months after revascularization or supervised exercise training in patients with intermittent claudication . MATERIAL S AND METHODS This study had institutional review board approval , and all patients gave written informed consent . Between September 2002 and September 2005 , 151 consecutive patients who presented with symptoms of intermittent claudication were r and omly assigned to undergo either endovascular revascularization ( angioplasty-first approach ) ( n = 76 ) or hospital-based supervised exercise ( n = 75 ) . The outcome measures were clinical success , functional capacity , and quality of life after 6 and 12 months . Clinical success was defined as improvement in at least one category in the Rutherford scale above the pretreatment level . Significance of differences between the groups was assessed with the unpaired t test , chi(2 ) test , or Mann-Whitney U test . To adjust outcomes for imbalances of baseline values , multivariable regression analysis was performed . RESULTS Immediately after the start of treatment , patients who underwent revascularization improved more than patients who performed exercise in terms of clinical success ( adjusted odds ratio [ OR ] , 39 ; 99 % confidence interval [ CI ] : 11 , 131 ; P signs of ipsilateral symptoms at 6 months compared with patients in the exercise group ( adjusted OR , 0.4 ; 99 % CI : 0.2 , 0.9 ; P functional capacity and quality of life scores increased after 6 and 12 months , but no significant differences between the groups were demonstrated . CONCLUSION After 6 and 12 months , patients with intermittent claudication benefited equally from either endovascular revascularization or supervised exercise . Improvement was , however , more immediate after revascularization",
"OBJECTIVES To compare the effect of unsupervised exercise , supervised exercise and intermittent pneumatic foot and calf compression ( IPC ) on the claudication distance , lower limb arterial haemodynamics and quality of life of patients with intermittent claudication . METHODS Thirty-four eligible patients with stable intermittent claudication were r and omised to IPC ( n = 13 , 3h/d for 6 months ) , supervised exercise ( n = 12 , three hourly sessions/week for 6 months ) or unsupervised exercise ( n = 9 ) . In each patient , initial claudication distance ( ICD ) , absolute claudication distance ( ACD ) , resting ankle brachial pressure index ( ABPI ) , and resting hyperaemic calf arterial inflow were measured before , 6 weeks , 6 months and 1 year after r and omisation . Quality of life was assessed with the short form (SF)-36 , walking impairment ( WIQ ) and intermittent claudication question naires ( ICQ ) . RESULTS Compared with unsupervised exercise , both IPC and supervised exercise , increased ICD and ACD , up to 2.83 times . IPC increased arterial inflow ( p ABPI . Supervised exercise decreased arterial inflow and increased ABPI ( p Unsupervised exercise had no effect on arterial inflow or ABPI . IPC improved significantly the ICQ score and the speed score of the WIQ , while supervised exercise improved the WIQ claudication severity score . At 1 year clinical effectiveness of supervised exercise and IPC was largely preserved . CONCLUSIONS IPC , by augmenting leg perfusion , achieved improvement in walking distance comparable with supervised exercise . Long-term results in a larger number of patients will provide valuable information on the optimal treatment modality of intermittent claudication",
"In a non-r and omized , open-label study results after a structured institution-based peripheral arterial occlusive disease ( PAD ) rehabilitation program were compared with the results of training at home . Three groups were compared : group 1 ( n = 19 ) PAD rehabilitation ; group 2 ( n = 19 ) PAD rehabilitation + clopidogrel 75 mg once daily ; group 3 ( n = 21 ) home-based training . The training period was 3 months for all groups , which was followed by a 3-month observation phase ( without prescribed training ) . The rehabilitation program consisted of 3 training hours per week . Background variables , demographics , and baseline claudication distances were comparable between groups . After 3 months of training the absolute claudication distances ( ACD ) improved by 82.7 % , 131.4 % , and 5.4 % for groups 1 , 2 and 3 . The initial claudication distances ( ICD ) changed by 163.8 % , 200.6 % , and 44.4 % , respectively . All changes , except the ACD result for group 3 , were statistically significant ( p 0.05 ) . Structured training groups ( 1 and 2 ) performed significantly better than group 3 ( p 0.05 ) . When results from groups 1 and 2 were pooled , ACDs changed from 493.3 218.1 to 1026.0 468.9 m , 546.0 378.8 m [ 95 % CI 417.8 - 674.2 m ] ; p 0.05 . ICDs improved from 175.3 110.8 m to 493.1 326.7 m , 320.8 315.9 m [ 95 % CI 213.9 - 427.7 m ] ; p 0.05 . The difference between the pooled mean results of the structured training groups and the results of group 3 amounted to 474.3 m [ 95 % CI 270.2 - 678.4 m ] and 242.4 m [ 95 % CI 99.0 - 385.7 m ] , for ACD and ICD , respectively . Structured , supervised PAD rehabilitation is a highly efficacious treatment for intermittent claudication and may be regarded as the present gold st and ard among conservative treatment options",
"PURPOSE This study was performed to test the efficacy of a supervised , hospital-based exercise program compared with a home-based exercise program involving minimal supervision , for both walking ability and quality of life measures in patients with exercise-limiting intermittent leg claudication . METHODS Twenty-one patients were assigned r and omly to 12 weeks of supervised exercise or to a home-based exercise group . After 12 weeks the participants in the supervised group transitioned to a home-based program . Both groups were then reevaluated at the end of 24 weeks . The initial claudication distance ( ICD ) and absolute claudication distance ( ACD ) on progressive treadmill exercise was measured at baseline , 12 weeks , and 24 weeks . Additionally , self-reported quality of life status was evaluated using the MOS SF-36 question naire . RESULTS Each group improved ( P ACD from baseline to 12 weeks , which was sustained at the 24-week follow-up . Both groups experienced similar long-term improvements ( P ACD ( 521.5 + /- 253.4 meters to 741.9 + /- 365.6 meters for the supervised group , 532.2 + /- 263.5 meters to 715.0 + /- 394.4 meters in the home group , P not significant , between groups ) . The supervised group experienced a greater improvement ( P ICD after 12 weeks than the home group but not at 24 weeks . The on-site group also experienced significant improvements in ICD after 24 weeks ( P self-reported physical function or mental health as assessed by the MOS SF-36 . CONCLUSION A structured exercise program was more effective in improving the ICD over a 24-week period than a less formal , home-based program . However , if patients are screened properly and receive adequate instruction , a home-based program can be a safe , low-cost alternative providing similar long-term ( 24 weeks ) exercise benefits in ACD",
"OBJECTIVES to compare the effect of surgery , exercise and simple observation on maximum exercise power in claudicants . DESIGN prospect i ve , r and omised study . METHODS a total of 264 unselected claudicants were r and omised to supervised exercise training , invasive treatment ( open surgical or endovascular procedures ) or observation . One year treatment outcomes were analysed on an intention to-treat basis . RESULTS invasively treated patients showed a significant improvement in maximum walking power , stopping distance , post-ischaemic blood flow and big toe pressure at one year . Patients r and omised to physical exercise training or to the control group did not improve in any outcome measure . CONCLUSION invasive treatment increased walking capacity , leg blood pressure and flow . Supervised physical exercise training offered no therapeutic advantage compared to untreated controls",
"OBJECTIVES To determine if the use of a plantar flexion device ( Step It pedal ) in a newly developed exercise programme is of benefit to patients with peripheral arterial disease . DESIGN Prospect i ve feasibility trial with patients r and omised to either st and ard care or the Step It exercise programme plus st and ard care . SETTING Physiotherapy Department at Cumberl and Infirmary , Carlisle , UK . PARTICIPANTS Patients were identified from the vascular team 's referral list . In total , 42 patients agreed to take part ; 18 in the control group and 24 in the intervention group . INTERVENTIONS Eligible participants were r and omised and received either st and ard care or took part in a plantar flexion resistance exercise programme , involving the Step It pedal , for a period of 12 weeks . MAIN OUTCOME MEASURES Maximum walking distance , claudication distance and ankle brachial pressure index . RESULTS Eighty-three percent of patients completed the study . Improvements in median distance to claudication symptoms and maximum walking distance were observed in the intervention group but not in the control group . Nine out of 15 ( 60 % ) participants in the control group and 14 out of 20 ( 70 % ) participants in the intervention group improved their walking distance . Ankle brachial pressure index remained virtually unchanged in both groups . CONCLUSIONS Due to the variability of patients ' fitness in the sample , it can not be concluded whether use of the Step It pedal has additional benefits to patients over st and ard care . However , the study completion rate implies that patients with peripheral arterial disease are receptive to undertaking exercise programmes",
"Mika P , Spodaryk K , Cencora A , Unnithan VB , Mika A : Experimental model of pain-free treadmill training in patients with claudication . Am J Phys Med Rehabil 2005;84:756–762 . Objective : Treadmill training in claudication is often based on walking exercise to a pain threshold or longer to the maximum muscle pain of the lower limbs . This kind of exercise may cause an inflammatory response . The purpose of this study was to determine whether pain-free treadmill training using walking exercise to 85 % of the distance to onset of claudication pain can significantly improve pain-free walking distance in patients with intermittent claudication and to evaluate whether this kind of program may induce an inflammatory response leading to the progression of atherosclerosis . Design : A total of 98 patients aged 50–70 yrs with stable intermittent claudication were r and omized into a supervised treadmill training program or a comparison group . Patients in the treatment group participated in 12 wks of supervised treadmill training . We examined the effects of 12 wks of pain-free treadmill training on pain-free walking distance , total leukocyte count , neutrophil count , and microalbuminuria in patients with claudication . Results : A total of 80 participants completed the program . Exercise rehabilitation increased the time to onset of claudication pain by 119.2 % , from 87.4 ± 38 m to 191.6 ± 94.8 m ( P in total leukocyte count , neutrophil count , or microalbuminuria after 12 wks of treadmill exercise ( P > 0.05 ) Conclusion : A pain-free training program can be used in the treatment of claudication as a low-risk program , increasing walking ability without potential harmful effects of ischemia – reperfusion injury",
"BACKGROUND To explore the efficacy of cycle training in the treatment of intermittent claudication , the present study compared performance and physiologic effects of cycle training with more conventional treadmill walking training in a group of patients with claudication . METHOD Forty-two individuals with peripheral arterial disease and intermittent claudication ( 24 men , 18 women ) were stratified by gender and the presence or absence of type 2 diabetes mellitus and then r and omized to a treadmill ( n = 13 ) , cycle ( n = 15 ) , or control group ( n = 14 ) . Treadmill and cycle groups trained three times a week for 6 weeks , whereas the control group did not train during this period . Maximal and pain-free exercise times were measured on grade d treadmill and cycle tests before and after training . RESULTS Treadmill training significantly improved maximal and pain-free treadmill walking times but did not improve cycle performance . Cycle training significantly improved maximal cycle time but did not improve treadmill performance . However , there was evidence of a stronger cross-transfer effect between the training modes for patients who reported a common limiting symptom during cycling and walking at baseline . There was also considerable variation in the training response to cycling , and a subgroup of responsive patients in the cycle group improved their walking performance by more than the average response observed in the treadmill group . CONCLUSION These findings suggest that cycle exercise is not effective in improving walking performance in all claudication patients but might be an effective alternative to walking in those who exhibit similar limiting symptoms during both types of exercise",
"Platelet function and levels of vascular adhesion molecule-1 ( VCAM-1 ) were investigated in 24 patients with peripheral arterial disease at Fontaine stage II undergoing a 2 weeks treatment with iloprost ( 0.5 - 2 ng/kg/h i.v . infused , 6 h/day ) or a 2 weeks supervised physical training , r and omly assigned . Patients were studied before ( T0 ) and after ( T14 ) treatments and 10 days later ( T24 ) . The adhesion of washed platelets to fibrinogen coated microwells was reduced after treatment both with iloprost ( 1.9+/-0.4 vs 6.8+/-0.7 % ; T24 vs T0 ; M+/-SEM ; p adhesion to human plasma coated microwells was reduced only after treatment with iloprost ( 1.9+/-0.8 vs 5.8+/-0.9 ; p expression of fibrinogen receptor ( glycoprotein IIb/IIIa ) on platelets , measured by flow-cytometry was also reduced after iloprost treatment ( 17.1+/-1.5 vs 31.8+/-4.8 AU ; p of platelet thromboxane A2 metabolite 2,3-dinor-thromboxane B2 decreased only in patients treated with iloprost ( 154.7+/-97.9 vs 256.2+/-106.4 pg mg creatinine(-1 ) ; p plasma VCAM-1 was lower in patients who were treated with iloprost ( 827.7+/-77.4 vs 999.0+/-83.8 ng ml(-1 ) ; p iloprost and physical exercise seem to act on reversible phenomena such as the expression of adhesion molecules or ex vivo adhesion , whereas only iloprost reduces thromboxane A2 bio synthesis in vivo . This anti-platelet activity seems to be extended in time and to be associated with an improvement in vascular function",
"OBJECTIVE This cohort study was conducted to determine the effect on walking distances of supervised exercise therapy provided in a community-based setting . METHODS The study included all consecutive patients presenting at the vascular outpatient clinic with intermittent claudication , diagnosed by a resting ankle brachial index The exclusion criterion was the inability to walk the baseline treadmill test for a minimum of 10 m. The intervention was a supervised exercise therapy in a community-based setting . A progressive treadmill test at baseline and at 1 , 3 , and 6 months of follow-up measured initial claudication distance and absolute claudication distance . Changes were calculated using the mean percentages of change . RESULTS From January through October 2005 , 93 consecutive patients with claudication were eligible . Overall , 37 patients discontinued the supervised exercise therapy program . Eleven stopped because of intercurrent diseases , whereas for 10 , supervised exercise therapy did not lead to adequate improvement and they underwent a vascular intervention . Three patients quit the program , stating that they were satisfied with the regained walking distance and did not require further supervised exercise therapy . Ten patients were not motivated sufficiently to continue the program , and in three patients , a lack of adequate insurance coverage was the reason for dropping out . Data for 56 patients were used and showed a mean percentage increase in initial claudication distance of 187 % after 3 months and 240 % after 6 months . The mean percentage of the absolute claudication distance increased 142 % after 3 months and 191 % after 6 months . CONCLUSION Supervised exercise therapy in a community-based setting is a promising approach to providing conservative treatment for patients with intermittent claudication",
"BACKGROUND Supervised exercise training ( SET ) is recommended as initial treatment to improve walking capacity in peripheral arterial disease ( PAD ) patients with intermittent claudication . Various mechanisms by which SET yields beneficial effects are postulated , however data regarding its influence on angiogenesis are scarce . Thus , we design ed a prospect i ve r and omized controlled trial to study the impact of SET on markers of angiogenesis and endothelial function in PAD . METHODS Forty PAD patients were r and omized to SET on top of best medical treatment ( SET+BMT ) for 6 months versus best medical treatment ( BMT ) only . Endothelial progenitor cells ( EPC ) were assessed by whole-blood flow cytometry ( co-expression of CD34 + CD133 + KDR+ ) and cell culture assays ( endothelial cell-colony forming units , circulating angiogenic cells , migration assay ) at baseline , 3 , 6 and 12-months after inclusion . Changes of plasma levels of asymmetric dimethylarginine ( ADMA ) , vascular endothelial growth factor ( VEGF ) , stromal cell-derived factor-1 ( SDF-1 ) and maximum walking distance were determined . RESULTS EPC - measured by flow cytometric and cell culture techniques - increased significantly upon training paralleled by a significant decrease of ADMA when compared to the BMT group ( p beneficial effect of SET on EPC diminished , but maximum walking distance was significantly improved compared to baseline and controls ( p VEGF and SDF-1 plasma levels in time course . CONCLUSIONS SET increases circulating EPC counts and decreases ADMA levels reflecting enhanced angiogenesis and improved endothelial function , which might contribute to cardiovascular risk reduction",
"Introduction : Peripheral atherosclerotic disease ( PAD ) is a condition characterized by low functional capacity which is associated with impaired free living , ambulation and low exercise tolerance . The purpose of this r and omized controlled study was to evaluate whether changes in maximal walking time are associated with adaptations in cardiovascular function following supervised exercise",
"OBJECTIVE This r and omized controlled trial investigated the effects of upper- and lower-limb aerobic exercise training on disease-specific functional status and generic health-related quality of life ( QOL ) in patients with intermittent claudication . METHODS The study recruited 104 patients ( mean age , 68 years ; range , 50 - 85 ) from the Sheffield Vascular Institute . Patients were r and omly allocated to groups that received upper-limb ( ULG ) or lower-limb ( LLG ) aerobic exercise training , or to a nonexercise control group . Exercise was performed twice weekly for 24 weeks at equivalent limb-specific relative exercise intensities . Main outcome measures were scores on the Walking Impairment Question naire ( WIQ ) for disease-specific functional status , the Medical Outcomes Study Short Form version 2 ( SF-36v2 ) , and European Quality of Life Visual Analog Scale ( EQ-VAS ) for health-related QOL . Outcomes were assessed at baseline , and at 6 , 24 , 48 , and 72 weeks . RESULTS After 6 weeks , improvements in the perceived severity of claudication ( P = .023 ) and stair climbing ability ( P = .011 ) vs controls were observed in the ULG , and an improvement in the general health domain of the SF-36v2 vs controls was observed in the LLG ( P = .010 ) . After 24 weeks , all four WIQ domains were improved in the ULG vs controls ( P ≤ .05 ) , and three of the four WIQ domains were improved in the LLG ( P health-related QOL domains were apparent in the ULG . CONCLUSIONS These findings support the use of alternative , relatively pain-free forms of exercise in the clinical management of patients with intermittent claudication",
"Expansion of the capillary network , or angiogenesis , occurs following endurance training . This process , which is reliant on the presence of VEGF ( vascular endothelial growth factor ) , is an adaptation to a chronic mismatch between oxygen dem and and supply . Patients with IC ( intermittent claudication ) experience pain during exercise associated with an inadequate oxygen delivery to the muscles . Therefore the aims of the present study were to examine the plasma VEGF response to acute exercise , and to establish whether exercise training alters this response in patients with IC . In Part A , blood was collected from patients with IC ( n=18 ) before and after ( + 20 and + 60 min post-exercise ) a maximal walking test to determine the plasma VEGF response to acute exercise . VEGF was present in the plasma of patients ( 45.11+/-29.96 pg/ml ) and was unchanged in response to acute exercise . Part B was a training study to determine whether exercise training altered the VEGF response to acute exercise . Patients were r and omly assigned to a treatment group ( TMT ; n=7 ) that completed 6 weeks of high-intensity treadmill training , or to a control group ( CON ; n=6 ) . All patients completed a maximal walking test before and after the intervention , with blood sample s drawn as for Part A. Training had no effect on plasma VEGF at rest or in response to acute exercise , despite a significant increase in maximal walking time in the TMT group ( 915+/-533 to 1206+/-500 s ; P=0.009 ) following the intervention . The absence of a change in plasma VEGF may reflect altered VEGF binding at the endothelium , although this can not be confirmed by the present data",
"CONTEXT Neither supervised treadmill exercise nor strength training for patients with peripheral arterial disease ( PAD ) without intermittent claudication have been established as beneficial . OBJECTIVE To determine whether supervised treadmill exercise or lower extremity resistance training improve functional performance of patients with PAD with or without claudication . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled clinical trial performed at an urban academic medical center between April 1 , 2004 , and August 8 , 2008 , involving 156 patients with PAD who were r and omly assigned to supervised treadmill exercise , to lower extremity resistance training , or to a control group . MAIN OUTCOME MEASURES Six-minute walk performance and the short physical performance battery . Secondary outcomes were brachial artery flow-mediated dilation , treadmill walking performance , the Walking Impairment Question naire , and the 36-Item Short Form Health Survey physical functioning ( SF-36 PF ) score . RESULTS For the 6-minute walk , those in the supervised treadmill exercise group increased their distance walked by 35.9 m ( 95 % confidence interval [ CI ] , 15.3 - 56.5 m ; P distance walked by 12.4 m ( 95 % CI , -8.42 to 33.3 m ; P = .24 ) compared with the control group . Neither exercise group improved its short physical performance battery scores . For brachial artery flow-mediated dilation , those in the treadmill group had a mean improvement of 1.53 % ( 95 % CI , 0.35%-2.70 % ; P = .02 ) compared with the control group . The treadmill group had greater increases in maximal treadmill walking time ( 3.44 minutes ; 95 % CI , 2.05 - 4.84 minutes ; P walking impairment distance score ( 10.7 ; 95 % CI , 1.56 - 19.9 ; P = .02 ) ; and SF-36 PF score ( 7.5 ; 95 % CI , 0.00 - 15.0 ; P = .02 ) than the control group . The resistance training group had greater increases in maximal treadmill walking time ( 1.90 minutes ; 95 % CI , 0.49 - 3.31 minutes ; P = .009 ) ; walking impairment scores for distance ( 6.92 ; 95 % CI , 1.07 - 12.8 ; P = .02 ) and stair climbing ( 10.4 ; 95 % CI , 0.00 - 20.8 ; P = .03 ) ; and SF-36 PF score ( 7.5 ; 95 % CI , 0.0 - 15.0 ; P = .04 ) than the control group . CONCLUSIONS Supervised treadmill training improved 6-minute walk performance , treadmill walking performance , brachial artery flow-mediated dilation , and quality of life but did not improve the short physical performance battery scores of PAD participants with and without intermittent claudication . Lower extremity resistance training improved functional performance measured by treadmill walking , quality of life , and stair climbing ability . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00106327",
"OBJECTIVE To analyze the effects of strength training ( ST ) in walking capacity in patients with intermittent claudication ( IC ) compared with walking training ( WT ) effects . METHODS Thirty patients with IC were r and omized into ST and WT . Both groups trained twice a week for 12 weeks at the same rate of perceived exertion . ST consisted of three sets of 10 repetitions of whole body exercises . WT consisted of 15 bouts of 2-minute walking . Before and after the training program walking capacity , peak VO(2 ) , VO(2 ) at the first stage of treadmill test , ankle brachial index , ischemic window , and knee extension strength were measured . RESULTS ST improved initial claudication distance ( 358 + /- 224 vs 504 + /- 276 meters ; P total walking distance ( 618 + /- 282 to 775 + /- 334 meters ; P VO(2 ) at the first stage of treadmill test ( 9.7 + /- 2.6 vs 8.1 + /- 1.7 mL.kg(-1).minute ; P ischemic window ( 0.81 + /- 1.16 vs 0.43 + /- 0.47 mm Hg minute meters(-1 ) ; P = .04 ) , and knee extension strength ( 19 + /- 9 vs 21 + /- 8 kg and 21 + /- 9 vs 23 + /- 9 ; P Strength increases correlated with the increase in initial claudication distance ( r = 0.64 ; P = .01 ) and with the decrease in VO(2 ) measured at the first stage of the treadmill test ( r = -0.52 ; P = .04 and r = -0.55 ; P = .03 ) . Adaptations following ST were similar to the ones observed after WT ; however , patients reported lower pain during ST than WT ( P ST improves functional limitation similarly to WT but it produces lower pain , suggesting that this type of exercise could be useful and should be considered in patients with IC",
"Objective : To assess the effect of pain-free treadmill training on changes of plasma fibrinogen , haematocrit , lipid profile , and walking ability in patients with claudication . Design : R and omized control trial . Methods : Sixty-eight patients with peripheral obstructive arterial disease and intermittent claudication ( Fontaine stage II ) were r and omly assigned into the treadmill training ( repetitive intervals to onset of claudication pain , three times a week ) or a control group ( no change in physical activity ) over 3 months . Both groups performed treadmill test to assess pain-free walking time ( PFWT ) and maximal walking time ( MWT ) and had blood analyses [ for haematocrit , fibrinogen , triglycerides , and cholesterol : total , high-density lipoprotein ( HDL ) and low-density lipoprotein ( LDL ) ] done at baseline and after 6 and 12 weeks of the study . Results : Total and LDL cholesterol levels in the training group decreased ( p Significant ( p ( 19 % ) in the training group but changes of all these lipids were insignificant in the control group over the 3 months . Haematocrit and fibrinogen changes were insignificant in both groups . PFWT was prolonged by 109 % and MWT increased by 54 % in the training group ( p pain-free treadmill training parallels with progressive normalization of lipid profiles in patients with claudication",
"OBJECTIVES To identify a stable biochemical marker of disease severity in patients with intermittent claudication and to use these findings to assess the effect of therapeutic exercise training . DESIGN Case-control study : prospect i ve r and omised-controlled trial of exercise training . MATERIAL S AND METHODS Plasma fibrinogen , serum amyloid A protein ( SAA ) , C-reactive protein ( CRP ) and urinary albumin-creatinine ratio ( ACR ) were measured in 67 claudicants and 15 controls . Twenty-two patients were r and omised to supervised exercise training and 17 r and omised to observation . Subjects were review ed at 3 , 6 and 12 months . RESULTS The median ( interquartile range ) baseline fibrinogen was 3.7 g/l ( 3.3 - 4.25 ) in claudicants and 3.5 g/l ( 2.9 - 3.95 ) in controls ( p = 0.045 ) ; CRP was 4.7 mg/l ( 2.2 - 9.0 ) and 2.1 mg/l ( 1.0 - 2.8 ) , respectively ( p SAA was 72 mg/l ( 35 - 132 ) and 30 mg/l ( 20 - 89 ) ( p = 0.0009 ) . Claudicants showed an increased urinary ACR following treadmill exercise ( Wilcoxon , p Exercise training reduced SAA at 6 months , CRP at 3 months and progressively attenuated the post-exercise increase in ACR . No similar changes were found in controls . CONCLUSIONS Repetitive low- grade inflammatory events in claudicants lead to elevation of serum acute-phase proteins . Exercise training is associated with symptomatic improvement and reduction inflammatory markers . The concern that exercise has adverse systemic effects therefore seems to be unjustified",
"Because individuals with claudication pain secondary to peripheral arterial disease ( PAD ) are limited in both walking speed and duration , the benefits of walking exercise may be insufficient to yield a cardiovascular training effect . The objectives of this analysis were to determine whether polestriding exercise training , performed by persons with PAD , would improve exercise endurance , elicit a cardiovascular training benefit , and improve quality of life ( QoL ) . Persons ( n = 49 ) whose claudication pain limited their exercise capacity were r and omized into a 24-week polestriding training program ( n = 25 , 65.8 ± 7.1 years of age ) or a nonexercise attention control group ( n = 24 , 68.0 ± 8.6 years of age ) . Those assigned to the polestriding group trained 3 times weekly . Control group subjects came to the laboratory biweekly for ankle blood pressure measurements . A symptom-limited ramp treadmill test , ratings of perceived leg pain , and QoL data ( using the Short Form-36 ) were obtained at baseline and upon completion of training . After 24 weeks of polestriding training , subjects increased their exercise endurance from 10.3 ± 4.1 minute to 15.1 ± 4.5 minute . This was significantly greater than control group subjects whose exercise endurance declined ( from 11.2 ± 4.7 to 10.3 ± 4.7 minute ; P ( P ( P = .04 ) , rate pressure product ( P = .05 ) , oxygen uptake ( P = .016 ) , and perceived leg pain ( P = .02 ) and exercise time improved from the baseline symptom-limited treadmill test to the 6-month symptom-limited treadmill test in the polestriding group compared to the control group . The improvement in the physical component summary score of the Short Form-36 was also greater in the polestriding group ( P = .031 ) . Polestriding training significantly improved the clinical indicators of cardiovascular fitness and QoL , and decreased symptoms of claudication pain during exertion",
"Arm cranking is a useful alternative exercise modality for improving walking performance in patients with intermittent claudication ; however , the mechanisms of such an improvement are poorly understood . The main aim of the present study was to investigate the effects of arm-crank exercise training on lower-limb O2 delivery in patients with intermittent claudication . A total of 57 patients with intermittent claudication ( age , 70+/-8 years ; mean+/-S.D. ) were r and omized to an arm-crank exercise group or a non-exercise control group . The exercise group trained twice weekly for 12 weeks . At baseline and 12 weeks , patients completed incremental tests to maximum exercise tolerance on both an arm-crank ergometer and a treadmill . Respiratory variables were measured breath-by-breath to determine peak VO2 ( O2 uptake ) and ventilatory threshold . Near-IR spectroscopy was used in the treadmill test to determine changes in calf muscle StO2 ( tissue O2 saturation ) . Patients also completed a square-wave treadmill-walking protocol to determine VO2 kinetics . A total of 51 patients completed the study . In the exercise group , higher maximum walking distances ( from 496+/-250 to 661+/-324 m ) and peak VO2 values ( from 17.2+/-2.7 to 18.2+/-3.4 ml.kg-1 of body mass.min-1 ) were recorded in the incremental treadmill test ( P time to minimum StO2 ( from 268+/-305 s to 410+/-366 s ) , a speeding of VO2 kinetics ( from 44.7+/-10.4 to 41.3+/-14.4 s ) and an increase in submaximal StO2 during treadmill walking ( P walking performance after arm-crank exercise training in patients with intermittent claudication is attributable , at least in part , to improved lower-limb O2 delivery",
"OBJECTIVE To determine the effects of a 6-month exercise program on ambulatory function , free-living daily physical activity , peripheral circulation , and health-related quality of life ( QOL ) in disabled older patients with intermittent claudication . DESIGN Prospect i ve , r and omized controlled trial . SETTING University Medical ( Center and Veterans Affairs Medical Center , Baltimore , Maryl and . PARTICIPANTS Thirty-one of 61 patients with Fontaine stage II peripheral arterial occlusive disease ( PAOD ) were r and omized to exercise rehabilitation and 30 to usual-care control . Three patients from the exercise group and six patients from the control group dropped out , leaving 28 and 24 patients , respectively , completing the study in each group . INTERVENTION Six months of exercise rehabilitation . MEASUREMENTS Treadmill distance walked to onset of claudication and to maximal claudication , ambulatory function , peripheral circulation , perceived QOL , and daily physical activity . RESULTS Compliance with the exercise program was 73 % of the possible sessions . Exercise rehabilitation increased treadmill distance walked to onset of claudication by 134 % ( P maximal claudication by 77 % ( P walking economy by 12 % ( P = .003 ) , 6-minute walk distance by 12 % ( P maximal calf blood flow by 30 % ( P Changes in distance walked to maximal pain correlated with changes in walking economy ( r = -.50 , P = .013 ) and changes in maximal calf blood flow ( r = .38 , P = .047 ) . Exercise rehabilitation increased accelerometer-derived daily physical activity by 38 % ( P distance walked to maximal pain ( r = .45 , P = .020 ) . These improvements were significantly better than the changes in the control group ( P exercise rehabilitation in older PAOD patients are dependent on improvements in peripheral circulation and walking economy . Improvement in treadmill claudication distances in these patients translated into increased accelerometer-derived physical activity in the community , which enabled the patients to become more functionally independent",
"BACKGROUND Exercise training is recommended as the first-line therapy for intermittent claudication patients . However , the effects of exercise therapy on cardiovascular function of these patients have been poorly studied . The aim of this study is to compare the effects of walking and strength training on cardiovascular responses assessed at rest and during exercise in patients with intermittent claudication . PATIENTS AND METHODS Thirty-four patients with stable symptoms of intermittent claudication were r and omized into two groups : strength training ( ST ) consisting of eight exercises , three sets of 10 repetitions , intensity of 11 - 13 on 15- grade Borg scale , 2-min interval between sets ; and walking training ( WT ) consisting of walking on a treadmill , 15 bouts of 2-min , intensity of 11 - 13 on 15- grade Borg scale , with a 2-min interval between bouts . Before and after 12 weeks , blood pressure , heart rate and rate pressure product were measured at rest and during a progressive treadmill test until maximal claudication pain . RESULTS Fifteen patients in each group completed the training program . After the training programs , resting systolic blood pressure ( ST:-6 ± 13 mmHg and WT:-3 ± 18 mmHg , P = .04 ) , heart rate ( ST : -6 ± 10 bpm and WT:-2 ± 9 bpm , P = .03 ) , and rate pressure product ( ST:-1485 ± 1442 mmHg*bpm and WT:- 605 ± 2145 mmHg*bpm , P = .01 ) decreased significantly and similarly in both groups . Submaximal systolic blood pressure ( ST : -14 ± 23 mmHg and WT:-6 ± 23 mmHg , P = .02 ) , and rate pressure product ( ST:-1579 ± 3444 mmHg*bpm and WT : -1264 ± 3005 mmHg*bpm , P = .04 ) decreased significantly and similarly in both groups . There were no changes in submaximal heart rate after ST and WT . Maximal systolic blood pressure , heart rate , and rate pressure product did not change in either group , although maximal exercise time increased similarly in the ST and WT groups ( + 31 ± 19 % , and + 31 ± 32 % , respectively , P . CONCLUSIONS Strength and walking trainings promoted similar increases in walking capacity and decreases in resting and submaximal exercise cardiovascular load",
"OBJECTIVES To investigate the effects of a 24-week program of upper- and lower-limb aerobic exercise training on walking performance in patients with symptomatic peripheral arterial disease ( PAD ) and to study the mechanisms that could influence symptomatic improvement . METHODS After approval from the North Sheffield Local Research Ethics Committee , 104 patients ( median age , 69 years ; range , 50 to 85 years ) with stable PAD were r and omized into an upper- or lower-limb aerobic exercise training group ( UL-Ex or LL-Ex ) , or to a nonexercise training control group . Training was performed twice weekly for 24 weeks at equivalent relative exercise intensities . An incremental arm- and leg-crank test ( ACT and LCT ) to maximum exercise tolerance was performed before and at 6 , 12 , 18 , and 24 weeks of the intervention to determine peak oxygen consumption ( VO(2 ) ) . Walking performance , defined as the claudicating distance ( CD ) and maximum walking distance ( MWD ) achieved before intolerable claudication pain , was assessed at the same time points by using a shuttle-walk protocol . Peak blood lactate concentration , Borg ratings of perceived exertion ( RPE ) and pain category ratio ( CR-10 ) were recorded during all assessment s. RESULTS CD and MWD increased over time ( P CD had improved by 51 % and 57 % , and MWD had improved by 29 % and 31 % ( all P peak heart rate at MWD in the UL-Ex group ( 109 + /- 4 vs 115 + /- 4 beats/min ; P amount of pain experienced in both groups ( P cardiovascular stress and an increased intensity of claudication pain before test termination after training . Patients assigned to exercise training also showed an increase in LCT peak VO2 at the 24-week time point in relation to baseline ( P ACT peak VO2 was only improved in the UL-Ex group ( P upper-limb aerobic exercise training in patients with PAD . Furthermore , that both arm- and leg-crank training could be useful exercise training modalities for improving cardiovascular function , walking performance , and exercise pain tolerance in patients with symptomatic PAD",
"BACKGROUND Treatment for claudication that is due to aortoiliac peripheral artery disease ( PAD ) often relies on stent revascularization ( ST ) . However , supervised exercise ( SE ) is known to provide comparable short-term ( 6-month ) improvements in functional status and quality of life . Longer-term outcomes are not known . OBJECTIVES The goal of this study was to report the longer-term ( 18-month ) efficacy of SE compared with ST and optimal medical care ( OMC ) . METHODS Of 111 patients with aortoiliac PAD r and omly assigned to receive OMC , OMC plus SE , or OMC plus ST , 79 completed the 18-month clinical and treadmill follow-up assessment . SE consisted of 6 months of SE and an additional year of telephone-based exercise counseling . Primary clinical outcomes included objective treadmill-based walking performance and subjective quality of life . RESULTS Peak walking time improved from baseline to 18 months for both SE ( 5.0 ± 5.4 min ) and ST ( 3.2 ± 4.7 min ) significantly more than for OMC ( 0.2 ± 2.1 min ; p significant ( p = 0.16 ) . Improvement in claudication onset time was greater for SE compared with OMC , but not for ST compared with OMC . Many disease-specific quality -of-life scales demonstrated durable improvements that were greater for ST compared with SE or OMC . CONCLUSIONS Both SE and ST had better 18-month outcomes than OMC . SE and ST provided comparable durable improvement in functional status and in quality of life up to 18 months . The durability of claudication exercise interventions merits its consideration as a primary PAD claudication treatment",
"BACKGROUND Disease severity in patients with intermittent claudication ( IC ) is often assessed using walking distances and treadmill tests . The aim of this study was to determine the agreement between walking distance as estimated by the patient , as measured during outside walking , and as determined using a non grade d treadmill protocol ( NGTP ) , and an incremental grade d ( Gardner-Skinner ) treadmill protocol ( GSP ) . METHODS In this prospect i ve observational study , 30 patients with IC estimated their maximal walking distance ( MWD ) and completed a \" Walking Impairment Question naire \" ( WIQ ) . Outside walking was determined using a measuring wheel and a GSP controlled device . Primary outcomes were differences in MWD and variability ( coefficient of variation , COV ) . Secondary outcomes were results of WIQ and differences in walking speed . RESULTS Estimated walking distance was significantly higher than MWD as objective ly measured during outside walking ( 400 m vs. 309 m , respectively , P = 0.02 ) . A substantial variability ( COV = 55 % ) was found between both parameters . A small 35-m MWD difference between outside walking and GSP was found with a substantial scatter ( COV = 42 % ) . In contrast , a much larger 122-m MWD difference was present between outside walking and NGTP ( COV = 89 % ) . Patients walked significantly faster in the open air than on treadmills ( median outside walking speed = 3.8 km/hr , GSP = 3.2 km/hr , NGTP = 2.8 km/hr ; P incremental grade d ( Gardner-Skinner ) treadmill protocol demonstrated the best agreement to outside walking . Discrepancies between treadmill tests and outside walking may be explained by a difference in walking speed . A single determination of a walking distance is a poor reflection of true walking capacity",
"Objectives To assess the effect of pain-free treadmill training on red blood cell deformability and walking distance in patients with claudication . Design R and omized-controlled trial of exercise training . Setting Patients were recruited from the primary care , vascular outpatient clinic . Patients A total of 60 patients with peripheral arterial occlusive disease ( stage II according to Leriche-Fontaine ) were r and omized into the treadmill program or a control group . Fifty-five patients completed the study ( 27 in the exercising group and 28 in the control group ) . Interventions Patients in the exercising group were walking on the treadmill 3 times a week for 3 months . Each session consisted of 1 hour repetitive walking [ performed to 85 % of the pain-free walking time ( PFWT ) ] was supervised by a qualified physiotherapist . Main Outcome Measurements Changes in erythrocyte deformability and treadmill walking performance ( PFWT , maximal walking time ) were assessed in both groups before the study and after 3 months . Results After 3 months of treadmill training , red blood cell deformability in the exercising group significantly increased ( P the erythrocyte deformability in the control group . PFWT was prolonged by 102 % from 191±34 to 386±60 seconds ( P ) , and maximal walking time increased by 49 % from 438±62 to 656±79 seconds ( P 3 months of pain-free treadmill training is associated with a significant increase in red cell deformability in patients with claudication",
"Twenty-three patients with intermittent claudication were su bmi tted to physical training during 4 - 6 months . Eleven other patients with intermittent claudication served as a control group and were given placebo tablets during the same period . The aim of the investigation was to study the influence of physical training on the blood flow conditions in the calf . The effect of treatment on walking tolerance , on calf blood flow , blood flow resistance , and systolic blood pressure graident between the systemic circulation and the vascular bed in the calf was studied . Half a year after the end of the treatment period the patients were reexamined . The walking tolerance increased in both groups but more in the trained group . The increase in walking tolerance even in the control group was caused by the fact that the control group began to train to some extent . In neither group the maximal calf blood flow changed significantly compared with the pretreatment values . The maximal blood flow showed an increasing trend in the training group after a period fo 4 months compared with the control goupr ( 2p greater than 0.10 ) . The blood flow resistance at maximal dilatation did not change significantly as compared with the initial values in any of the groups , but there was a significant difference ( 2p greater than 0.05 ) between the two groups with a decrease in the training group after 4 months . The changes in maximal calf blood flow and the changes in blood flow resistance at maximal dilatation were not related to the changes in walking tolerance . Half a year after the treatment period the walking tolerance had not decreased and there was no difference between the two groups . The maximal calf blood flow , the blood flow resistance , and the systolic pressure gradient were unchanged in comparison with the pretreatment values and there were no statistically significant differences between the two groups . The small changes in blood flow conditions observed after physical training can not be the only factor explaining the well known improvement in walking tolerance . However , training may cause a redistribution of the blood flow in the working muscle",
"PURPOSE We have previously shown that a program of upper limb exercise training can induce significant improvements in walking distance in patients with claudication . This study assessed whether upper limb exercise avoids the systemic inflammatory responses associated with lower limb exercise and also whether the inflammatory response to acute lower limb exertion is modified by a program of supervised exercise training . METHODS Fifty-two patients with stable intermittent claudication were r and omized into two groups who underwent 6 weeks of supervised upper ( n = 26 ) or lower ( n = 26 ) limb cardiorespiratory exercise training . A parallel control group ( n = 15 ) was provided with lifestyle advice only . Neutrophil activation markers ( CD11b and CD66b ) and plasma levels of von Willebr and factor ( marker of endothelial damage ) in response to an acute bout of sustained upper and lower limb exercise were assessed before and after the period of training . Plasma levels of soluble E-selectin ( marker of endothelial activation ) were also determined before and after the training period . RESULTS An acute bout of sustained lower limb exercise significantly increased the intensity of CD11b and CD66b expression by peripheral blood neutrophils in all groups , whereas upper limb exercise had no effect . Resting neutrophil expression of CD11b and CD66b and circulating von Willebr and factor levels were unaffected by the training program , as were the inflammatory responses to an acute bout of sustained upper and lower limb muscular work , despite the fact that both training programs significantly increased walking distances . CONCLUSIONS These findings indicate that upper limb exercise training programs may offer certain advantages over currently prescribed lower limb programs . Our results show that exercising nonischemic muscles in a way that promotes improved cardiorespiratory function and walking capacity can avoid the potentially deleterious systemic inflammatory responses associated with lower limb exertion in patients with stable intermittent claudication",
"Abstract The efficacy of treadmill walking training to improve pain-free ( PFWD ) and maximal ( MWD ) walking distance in patients with claudication is well documented . The effects of aerobic arm-ergometry to improve PFWD and MWD compared to treadmill walking or usual care are not known . Forty-one participants ( 29 male , 12 female , mean age 67.7 years , 92.7 % smoking history , 36.6 % with diabetes ) with lifestyle-limiting claudication were r and omized to 12 weeks of 3 hours/week of supervised exercise training using either arm-ergometry , treadmill walking , or a combination , versus control . PFWD and MWD were assessed before and after training , and after 12 weeks of follow-up . The 12-week MWD increased significantly in the arm-ergometry ( + 53 % ) , treadmill ( + 69 % ) , and combination ( + 68 % ) groups ( p 24-week MWD was maintained in the arm-ergometry ( p = 0.009 ) and treadmill ( p = 0.019 ) groups , whereas the combination group declined ( p = 0.751 ) versus control . The 12-week PFWD increased significantly in the arm-ergometry group ( + 82 % ; p = 0.025 versus control ) . Change in PFWD in treadmill ( + 54 % ; p = 0.196 versus control ) and combination ( + 60 % ; p = 0.107 versus control ) groups did not reach statistical significance . PFWD improvement was maintained in the arm-ergometry group after a 12-week follow-up ( + 123 % ; p = 0.011 versus control ) . In conclusion , these pilot data demonstrate for the first time that dynamic arm exercise training can improve walking capability in people with peripheral arterial disease (PAD)-induced claudication compared to participants receiving usual care and that improvement was not different from that seen with treadmill walking exercise training . Dynamic arm exercise may be a therapeutic exercise option for patients with PAD",
"Summary Background The classic symptom of peripheral arterial disease is the intermittent claudication ( IC ) . Generally , endurance training is recommended to improve patients ’ walking performance . A potential benefit of the combination with strength training and the optimal duration of such an exercise program remain unclear . Methods and results We evaluated the effects of a supervised exercise program combining endurance and strength training lasting 6 or 12 months in patients with IC . A total of 94 patients joined this study ; 42 completed the 6-month training program ( group A ) , whereas 52 patients completed the 12-month protocol ( group B ) . Both groups exhibited a significant increase in all parameters evaluated , but greater benefit was found in the 12-month training group . The absolute claudication distance increased similarly by 27.5 and 29.5 % , respectively , in both groups ( not significant ) ; however , group B exhibited a greater increase in walking speed ( 12.1 vs. 5.3 % , p strength parameters increased significantly in both the groups showing an increase for “ pushing ” by 90.0 % ( group A ) and 90.2 % ( group B ) , for “ pulling ” by 64.2 % ( group A ) and 75.3 % ( group B ) , and for “ tiptoe st and ing ” by 70.5 % ( group A ) and 113.7 % ( group B ; p combined exercise program significantly increases walking speed , absolute claudication distance , and muscle strength parameters . A greater benefit seems to result from a 12-month training program . ZusammenfassungHintergrundDas klassische Symptom der peripheren arteriellen Verschlusskrankheit ist die Claudicatio intermittens ( CI ) . I m Allgemeinen wird ein Ausdauertraining empfohlen , um die Gehleistung der Patienten zu verbessern . Ein möglicher Nutzen einer Kombination mit Krafttraining und die optimale Dauer solcher Trainingsprogramme sind aber unklar . Method en und ErgebnisseWir evaluierten den Effekt eines sechs beziehungsweise 12 Monate dauernden überwachten Trainingsprogrammes , in dem Kraft- und Ausdauertraining kombiniert waren , auf Patienten mit CI . 94 Patienten nahmen an dieser Studie teil , 42 absolvierten das 6-Monate-Trainingsprogramm ( Gruppe A ) , 52 das 12-Monate-Trainingsprogramm ( Gruppe B ) . In beiden Gruppen zeigte sich ein signifikanter Anstieg in den evaluierten Parametern , wobei ein größerer Nutzen in der 12-Monats-Gruppe gefunden wurde . Die absolute Claudicatio-Strecke stieg gleichermaßen um 27,5 % beziehungsweisen 29,5 % in beiden Gruppen ( n.s . ) , wobei Gruppe B einen größeren Anstieg in der Gehgeschwindigkeit aufwies ( 12,1 % vs. 5,3 % , p Alle Kraftparameter stiegen signifikant in beiden Gruppen an und zeigten einen Anstieg beim „ Drücken “ um 90,0 % ( Gruppe A ) beziehungsweise 90,2 % ( Gruppe B ) , für „ Ziehen “ 64,2 % beziehungsweise 75,3 % und bei den „ Zehenspitzenständen “ um 70,5 % beziehungsweise 113,7 % ( A vs. B , p die Kombination von Kraft- und Ausdauertraining signifikant die Gehgeschwindigkeit , die absolute Claudicatio-Strecke und die Kraft-Parameter erhöhen . Das 12-Monate-Trainingsprogramm scheint dabei einen größeren Nutzen zu erzielen",
"OBJECTIVES To assess the efficacy of whole-body progressive resistance training ( PRT ) as a treatment for the symptoms of peripheral arterial disease ( PAD ) in older adults . DESIGN R and omized controlled pilot trial . SETTING University clinical weight training facility in Sydney , Australia . PARTICIPANTS Twenty-two older adults with symptomatic PAD . INTERVENTIONS The efficacy of supervised whole-body high-intensity PRT ( H-PRT ) with low-intensity nonprogressive resistance training ( L-RT ) and a usual care control group that performed unsupervised walking for 6 months was compared . MEASUREMENTS Pilot outcome measures included 6-minute walk ( 6 MW ) outcomes , body composition , dynamic muscle strength and endurance , and performance-based tests of function . RESULTS Mean age was 71.1 ± 7.2 . Mean ankle brachial index was 0.55 ± 0.13 . Exercise adherence was similar in all groups ( P = .29 ) . H-PRT ( n = 8) improved total 6MW distance ( mean difference ( MD ) 62.6 ± 58.0 m , P = .02 ) significantly more than L-RT ( n = 7 ; MD=-48.2 ± 67.6 m ) and controls ( n = 7 ; MD=-9.9 ± 52.9 m ) . Change in 6MW onset of claudication was significantly and independently related to change in bilateral calf endurance ( correlation coefficient ( r ) = 0.65 , P = .03 ) , and change in 6MW distance was significantly and independently related to change in bilateral hip extensor endurance ( r = 0.71 , P = .02 ) in all groups . CONCLUSION H-PRT significantly improved 6MW ability in older adults with intermittent claudication from PAD , whereas L-RT and unsupervised walking did not . Improvement in walking ability was significantly related to improvements in bilateral calf and hip extensor endurance , supporting further investigations targeted at musculoskeletal impairment in this cohort",
" PURPOSE To determine whether a percutaneous vascular intervention ( PVI ) combined with supplemental supervised exercise therapy ( SET ) is more effective than a PVI alone in improving walking ability in patients with symptomatic peripheral arterial disease ( PAD ) . MATERIAL S AND METHODS In this prospect i ve r and omized trial , patients with PAD treated with a PVI were eligible . Exclusion criteria were major amputation or tissue loss , comorbidity preventing physical activity , insufficient knowledge of the Dutch language , no insurance for SET , and prior participation in a SET program . All patients received a PVI and subsequently were r and omly assigned to either the PVI alone group ( n = 35 ) or the PVI + SET group ( n = 35 ) . The primary outcome parameter was the absolute claudication distance ( ACD ) . This trial was registered at Clinical trials.gov , NCT00497445 . RESULTS The study included 70 patients , most of whom were treated for an aortoiliac lesion . The mean difference in ACD at 6 months of follow-up was 271.3 m ( 95 % confidence interval [ CI ] 64.0 - 478.6 , P = .011 ) in favor of additional SET . In the PVI alone group , 1 ( 3.7 % ) patient finished the complete treadmill test compared with 11 ( 32.4 % ) patients in the PVI + SET group ( P = .005 ) . Physical health-related quality -of-life score was 44.1 ± 7.8 in the PVI alone group compared with 41.9 ± 9.5 in the PVI + SET group , which was a nonsignificant difference ( P = .34 ) . CONCLUSIONS SET following a PVI is more effective in increasing walking distance compared with a PVI alone . These data indicate that SET is a useful adjunct to a PVI for the treatment of PAD",
"OBJECTIVE To determine the effects of 12-week exercise programme on ambulatory function , free-living daily physical activity and health-related quality of life in disabled older patients with intermittent claudication . DESIGN Prospect i ve , r and omized controlled trial . SETTING University Medical Center and Veterans Affairs Medical Center , Taipei , Taiwan . SUBJECTS Thirty-two of 64 patients with Fontaine stage II peripheral arterial occlusive disease ( PAOD ) were r and omized to exercise training and 32 to usual care control . Five patients from the exercise group and six patients from the control group dropped out , leaving 27 and 26 patients , respectively , completing the study in each group . INTERVENTIONS Twelve weeks of treadmill exercise training . MAIN OUTCOME MEASURES Treadmill walking time to onset of claudication pain and to maximal claudication pain , 6-min walk distance , self-reported ambulatory ability and perceived health-related quality of life ( QOL ) . RESULTS Compliance of exercise programme was 83 % of the possible sessions . Exercise training increased treadmill walking time to onset of claudication pain by 88 % ( P time to maximal pain by 70 % ( P 6-min walk distance by 21 % ( P Perception of health-related QOL improved from 12 % to 178 % in the exercise group . These improvements were significantly better than the changes in the control group ( P claudication following 12-week exercise training in elderly PAOD patients were observed . Increase in treadmill walking time to maximal claudication pain in these patients translated into the improvement of perceived physical health , which enabled the patients to become more functionally independent",
"OBJECTIVE to compare the effectiveness of invasive therapy , supervised physical training and no treatment in terms of health-related quality of life ( HRQL ) in patients with intermittent claudication ( IC ) . DESIGN a prospect i ve , r and omised , controlled study . MATERIAL S a total of 253 unselected patients with stable IC were sequentially r and omised into 3 balanced treatment groups . At 1 year follow-up data from a battery of generic and disease specific HRQL question naires , and global indices of quality of life and physical condition were available in 171 patients . RESULTS compared with a non-diseased reference group , claudicants were substantially limited in daily physical functioning , but little affected regarding emotional , cognitive and social functioning , or well-being . Invasive therapy yielded significantly greater improvements in some aspects of physical functioning and walk-related symptoms than training . Training was not superior to invasive therapy on any HRQL dimension and superior to no treatment on only one dimension . Treatment effects , however , were generally small-to-moderate and levels of physical dysfunction in all groups remained higher than reference values . CONCLUSIONS invasive therapy is more effective than supervised training in alleviating illness-specific symptoms and improving certain aspects of physical functioning - the primary HRQL domains impacted on by IC and the principal goals of its treatment . However , since treatment effect sizes were at most moderate and given that untreated claudicants reported at most small deterioration in HRQL , the level of evidence supporting invasive therapy is modest",
"OBJECTIVE Prevalence of peripheral arterial disease is equal in men and women . However , women seem to suffer more from the burden of disease . Current studies on gender-related outcomes following supervised exercise therapy ( SET ) for intermittent claudication ( IC ) yield conflicting results . METHODS A follow-up analysis was performed on data from the 2010 Exercise Therapy in Peripheral Arterial Disease ( EXITPAD ) study , a multicenter r and omized controlled trial including IC patients receiving SET or a walking advice . The SET program was supervised by physiotherapists and included interval-based treadmill walking approximating maximal pain combined with activities such as cycling and rowing . Patients usually started with three 30-minute sessions a week . Training frequency was adapted during the following year on the basis of individual needs . The primary outcome was gender differences regarding the change in absolute claudication distance ( ACD ) after SET . ACD was defined as the number of meters that a patient had covered just before he or she was forced to stop walking because of intolerable pain . Secondary outcomes were gender differences in change of functional walking distance , quality of life , and walking (dis)ability after SET . Walking distances were obtained by st and ardized treadmill testing according to the Gardner-Skinner protocol . Quality of life was measured by the 36-Item Short Form Health Survey , and walking (dis)ability was determined by the Walking Impairment Question naire ( WIQ ) . Measurements were performed at baseline and after 3 , 6 , 9 , and 12 months . Only patients who met the 12-month follow-up measure were included in the analysis . RESULTS A total of 113 men and 56 women were available for analysis . At baseline , groups were similar in terms of clinical characteristics and ACD walking distances ( men , 250 meters ; women , 270 meters ; P = .45 ) . ACD improved for both sexes . However , ACD increase was significantly lower for women than for men during the first 3 months of SET ( Δ 280 meters for men vs Δ 220 meters for women ; P = .04 ) . Moreover , absolute walking distance was significantly shorter for women compared with men after 1 year ( 565 meters vs 660 meters ; P = .032 ) . Women also reported less on several WIQ subdomains , although total WIQ score was similar ( 0.69 for men vs 0.61 for women ; P = .592 ) . No differences in quality of life after SET were observed . CONCLUSIONS Women with IC benefit less during the first 3 months of SET and have lower absolute walking distances after 12 months of follow-up compared with men . More research is needed to determine whether gender-based IC treatment strategies are required",
"OBJECTIVE / BACKGROUND Intermittent claudication ( IC ) is associated with a reduction in physical activity ( PA ) and a more rapid functional decline leading to a higher mortality rate compared with healthy individuals . Supervised exercise therapy ( SET ) is known to increase the walking capacity of patients with IC . However , it is unclear whether SET increases PA . The aim of this study was to investigate the effect of SET on PA levels and ambulatory activities in patients with IC . METHODS Patients newly diagnosed with IC were requested to wear an activity monitor 1 week prior to and 1 week immediately after 3 months of SET . The primary outcome was the percentage of patients meeting the minimum recommendations of PA ( American College of Sports Medicine [ACSM]/American Heart Association [ AHA ] recommendation for public health of ≥ 67 metabolic equivalents [METs]/min/day , in bouts of ≥ 10 min ) at baseline and after 3 months of SET . Additionally , daily PA level ( METs/min ) , duration of ambulatory activities , daily number of steps , pain free walking distance ( PFWD ) , maximal walking distance ( MWD ) , and Short Form Health Survey ( SF-36 ) health surveys were compared before and after SET . RESULTS Data from 41 participants were available for analysis . A higher number of participants met the ACSM minimum recommendation for PA at the 3 month follow up ( baseline : 43 % ; 3 months : 63 % ; p = .003 ) . Despite significant increases in PFWD ( baseline : 210 m ; 3 months : 390 m ; p = .001 ) , MWD ( baseline : 373 m ; 3 months : 555 m ; p = .002 ) and physical functioning score ( SF-36 ) following SET , no increase in the mean daily PA level was found ( 395 ± 220 vs. 411 ± 228 METs/min ; p = .43 ) . Furthermore , the total number of steps and time spent in ambulatory activities did not change following SET . CONCLUSION Three months of SET for IC leads to more patients meeting the ACSM/AHA public health minimum recommendations for PA . Assessment of PA could be incorporated as an outcome parameter in future research comparing different treatment modalities for peripheral arterial disease",
"BACKGROUND Uncertainty exists on whether there is adjuvant benefit of percutaneous transluminal angioplasty ( PTA ) over supervised exercise and best medical therapy in the treatment of intermittent claudication . METHODS Patients with symptoms of stable mild to moderate intermittent claudication ( MIMIC ) were r and omised in two multi-centre trials , for femoropopliteal and aortoiliac arterial disease , to receive either PTA or no PTA against a background of supervised exercise and best medical therapy and followed up for 24 months . Initial claudication distance ( ICD ) and absolute walking distance ( AWD ) on treadmill were compared between r and omised groups adjusting for the corresponding measure at baseline . Secondary outcomes included ankle-brachial pressure index ( ABPI ) and quality of life . FINDINGS A total of 93 patients were r and omised into the femoropopliteal trial ( 48 into PTA ) and 34 into the aortoiliac trial ( 19 to PTA ) . The mean ( st and ard deviation , SD ) age was 66(9 ) years for the femoropopliteal trial ( 63 % male ) and 63(9 ) for the aortoiliac trial ( 65 % male ) . At 24 months , there were significant improvements in both AWD and ICD in the PTA groups for both trials . The adjusted AWD was 38 % greater in the PTA group for the femoropopliteal trial ( 95 % ; CI 1 - 90 ) ( p=0.04 ) and 78 % greater in the PTA group for the aortoiliac trial ( 95 % ; CI 0 - 216 ) ( p=0.05 ) . Further benefits were demonstrated for ABPI but not for quality of life . INTERPRETATION PTA confers adjuvant benefit over supervised exercise and best medical therapy in terms of walking distances and ABPI 24 months after PTA in patients with stable mild to moderate intermittent claudication",
"Supervised walking exercise is an effective treatment to improve walking ability of patients with peripheral artery disease ( PAD ) , but few exercise programs in community setting s have been effective . The aim of this study was to determine the efficacy of a community-based walking exercise program with training , monitoring and coaching ( TMC ) components to improve exercise performance and patient-reported outcomes in PAD patients . This was a r and omized , controlled trial including PAD patients ( n=25 ) who previously received peripheral endovascular therapy or presented with stable claudication . Patients r and omized to the intervention group received a comprehensive community-based walking exercise program with elements of TMC over 14 weeks . Patients in the control group did not receive treatment beyond st and ard advice to walk . The primary outcome in the intent-to-treat ( ITT ) analyses was peak walking time ( PWT ) on a grade d treadmill . Secondary outcomes included claudication onset time ( COT ) and patient-reported outcomes assessed via the Walking Impairment Question naire ( WIQ ) . Intervention group patients ( n=10 ) did not significantly improve PWT when compared with the control group patients ( n=10 ) ( mean±st and ard error : + 2.1±0.7 versus 0.0±0.7 min , p=0.052 ) . Changes in COT and WIQ scores were greater for intervention patients compared with control patients ( COT : + 1.6±0.8 versus −0.6±0.7 min , p=0.045 ; WIQ : + 18.3±4.2 versus −4.6±4.2 % , p=0.001 ) . This pilot using a walking program with TMC and an ITT analysis did not improve the primary outcome in PAD patients . Other walking performance and patient self-reported outcomes were improved following exercise in community setting s. Further study is needed to determine whether this intervention improves outcomes in a trial employing a larger sample size",
"The mechanisms by which exercise training improves intermittent claudication remain unclear . In this article , the effects of local and systemic physiological factors on improved exercise tolerance after a supervised exercise program in claudicants are investigated . A total of 60 patients were r and omized to 3 months of supervised exercise followed by 3 months of unsupervised exercise , or to exercise advice alone ( control ) . Supervised exercise increased both pain-free and maximal walking distances . Heart rate during submaximal exercise and resting mean arterial pressure were lower after supervised exercise at 6 months . Serum lactate at maximum claudication increased significantly after 3 months in the supervised exercise group but this change had resolved by 6 months . Symptomatic improvement was accompanied by modest reductions in mean arterial pressure and submaximal heart rate on exercise . Increased serum lactate at maximum claudication subsequently declined despite continued improvement in walking distance , suggesting local adaptations to improve efficiency of muscle oxygen delivery and /or utilization",
"OBJECTIVE The initial treatment for intermittent claudication is supervised exercise therapy ( SET ) . Owing to limited capacity and patient transports costs of clinic-based SET , a concept of SET provided by local physiotherapists was developed . We hypothesized that provision of daily feedback with an accelerometer in addition to SET would further increase walking distance . METHODS This multicenter r and omized trial was set in vascular surgery outpatient clinics and included 304 patients with intermittent claudication . Patients were r and omized to exercise therapy in the form of \" go home and walk \" advice ( WA ) , SET , or SET with feedback . Local physiotherapists provided SET . The primary outcome measure was the change in absolute claudication distance . Secondary outcomes were the change in functional claudication distance and results on the Walking Impairment Question naire ( WIQ ) and Short-Form 36 ( SF-36 ) Health Survey after 12 months . RESULTS In 11 centers , 102 , 109 , and 93 patients were included , respectively , in the WA , SET , and SET with feedback groups , and data for 83 , 93 , and 76 , respectively , could be analyzed . The median ( interquartile range ) change in walking distance between 12 months and baseline in meters was 110 ( 0 - 300 ) in the WA group , 310 ( 145 - 995 ) in the SET group , and 360 ( 173 - 697 ) in the SET with feedback group ( P WIQ scores and relevant domains of the SF-36 improved statistically significantly in the SET groups . CONCLUSIONS SET is more effective than WA in improving walking distance , WIQ scores , and quality of life for patients with intermittent claudication . Additional feedback with an accelerometer did not result in further improvement . SET programs should be made available for all patients with intermittent claudication",
"The purpose of this study was to determine the impact of increased physical activity and cessation of smoking on the natural history of early peripheral arterial disease . We conducted a r and omised controlled trial in Perth , Western Australia , involving 882 men with early peripheral arterial disease identified via population -based screening using the Edinburgh Claudication Question naire and the ankle : brachial index . Members of the control group ( n = 441 ) received \" usual care \" from their general practitioner while members of the intervention group ( n = 441 ) were allocated to a \" stop smoking and keep walking \" regime - a combined community-based intervention of cessation of smoking ( where applicable ) and increased physical activity . Postal follow-up occurred at two and 12 months post-entry into the trial . The main outcome of interest was maximum walking distance . There were no statistically significant differences in the characteristics of the \" intervention \" and \" usual care \" groups at recruitment . Follow-up information at two and 12 months was available for 85 % and 84 % of participants , respectively . At 12 months , more men allocated to the intervention group had improved their maximum walking distance ( 23 % vs 15 % ; chi2 = 9.74 , df = 2 , p = 0.008 ) . In addition , more men in the intervention group reported walking more than three times per week for recreation ( 34 % vs 25 % , p = 0.01 ) . Although not statistically significant , more men in the intervention group who were smokers when enrolled in the trial had stopped smoking ( 12 % vs 8 % , p = 0.43 ) . It is concluded that referral of older patients with intermittent claudication to established physiotherapy programs in the community can increase levels of physical activity and reduce disability related to peripheral arterial disease . A combination of simple and safe interventions that are readily available in the community through physiotherapists and general practitioners has the potential to improve early peripheral arterial disease",
"The purpose of the study was to determine whether patients who participated in an intervention program would improve exercise and foot-care habits , reduce smoking , and would , in turn , have fewer PVD-related illnesses than patients not exposed to the intervention . Eighty-six patients with ankle/ brachial pressure indices of less than 1.0 on one or both legs were r and omly assigned to a study ( N=42 ) or control ( N=44 ) group . All patients were assessed on a variety of health-related and activity behaviors prior to and again 26 weeks after enrollment in the study . Study patients who participated in the intervention worked with professionals on selecting programs design ed to modify and improve their smoking , exercise , and / or foot-care habits . At the end of 26 weeks , chi-square analysis showed no significant differences between study and control groups on change in smoking and foot care , although the results were in the anticipated direction . Study patients who chose to increase their exercise showed greater increase than control patients in frequency ( p = .001 ) , distance ( p = .007 ) , and length ( p = .002 ) of walks . Although behaviors were modified , especially in the area of exercise , it was felt that longer interventions on a larger sample size are needed",
"BACKGROUND The most common indication for treating patients with peripheral arterial disease is to improve their health status : their symptoms , function , and quality of life . Quantifying health status requires a valid , reproducible , and sensitive disease-specific measure . The Peripheral Artery Question naire ( PAQ ) is a 20-item question naire developed to meet this need by quantifying patients ' physical limitations , symptoms , social function , treatment satisfaction , and quality of life . METHODS Psychometric and clinical properties of the PAQ were evaluated in a prospect i ve cohort study of 44 patients undergoing elective percutaneous peripheral revascularization . To establish reproducibility , 2 assessment s were performed 2 weeks apart and before revascularization . The change in scores before and 6 weeks after revascularization were used to determine the instruments ' responsiveness and were compared with the Short Form-36 and the Walking Impairment Question naire . A series of cross-sectional analyses were performed to establish the construct validity of the PAQ . RESULTS The 7 domains of the PAQ were internally reliable , with Cronbach alpha = 0.80 to 0.94 . The test-retest reliability analyses revealed insignificant mean changes of 0.6 to 2.3 points ( P = not significant for all ) . Conversely , the change after revascularization ranged from 13.7 to 41.9 points ( P PAQ to clinical improvement . The PAQ Summary Scale was the most sensitive of all scales tested . Construct validity was established by demonstrating correlations with other measures of patient health status . CONCLUSIONS The PAQ is a valid , reliable , and responsive disease-specific measure for patients with peripheral arterial disease . It may prove to be a useful end point in clinical trials and a potential aid in disease management",
"BACKGROUND Peripheral arterial occlusive disease ( PAOD ) at II stage results in a moderate to severe impairment in walking ability . Aim of this study , controlled and r and omized , was to evaluate the efficacy of an intensive 4 weeks exercise training in PAOD followed by a six-month period and to analyse the risk factors for atherosclerosis and the site of the lesion for possible predictors of result outcome . METHODS Patients with PAOD were included in the study ( ankle/arm ratio claudication distance ( ICD ) absolute claudication distance ( ACD ) a supervised walking exercise ( mean ICD 121.8 m , ACD 289.7 m ) and 20 to a non exercising control group ( ICD 111.6 m , ACD 230.1 m ) . Both groups were tested at 4 weeks ( T1 ) and 6 months ( T2 ) . Training group was enrolled in a 4-week supervised training program . RESULTS In the training group 10 % of patients became asymptomatic ( > 1000 m ) . At T1 ICD increased 141 % ( p ACD was with low-pain-claudication > 1000 m in 50 % , at T2 ICD was 200 % ( p ICD and ACD . Control group has a no significant increase of ICD and ACD at T1 and T2 . Only arterial hypertension and intermittent claudication severity emerged as negative predictive factors for the results of training . CONCLUSIONS Vascular training produces a significant and lasting improvement in walking distance in PAOD",
"Previous studies have demonstrated that supervised strength training ( ST ) or walking training ( WT ) improve walking capacity in patients with claudication . However , it remains unknown whether these improvements would be sustained over a subsequent unsupervised period . This article reports the findings of a study to analyze whether the improvements in walking capacity , achieved with a supervised ST or WT , would be sustained over a subsequent unsupervised therapy period in patients with claudication . Patients were initially r and omized to supervised exercise consisting of ST ( n = 15 ) or WT ( n = 15 ) for 12 weeks . After this period , 12 patients in each group consented to be followed for an additional 12 weeks of unsupervised therapy . Initial claudication distance ( ICD ) and total walking distance ( TWD ) were measured at baseline , after the supervised period ( Week 12 ) and after the unsupervised period ( Week 24 ) . In comparison with baseline values , both groups similarly increased ICD and TWD at Week 12 . From Week 12 to Week 24 , both groups similarly decreased ICD ( ST : -55 ± 110 m and WT : -82 ± 142 m , P = .04 ) and TWD ( ST : -68 ± 186 m and WT : -128 ± 112 m , P groups , ICD ( ST : + 126 ± 149 m and WT : + 50 ± 167 m , P = .01 ) and TWD ( ST : + 104 ± 162 m and WT : + 45 ± 139 m , P = .01 ) at Week 24 remained greater than baseline values . The conclusion is that supervised ST or WT followed by an unsupervised therapy period similarly decreased walking capacity in patients with claudication . However , after the unsupervised period , walking capacity remained at a higher level than before the onset of the supervised exercise-training period",
"OBJECTIVE This study describes the results and functioning of community-based supervised exercise therapy ( SET ) at one year of follow-up . METHODS We conducted a prospect i ve cohort study of community-based SET in regional physiotherapeutic practice s. Consecutive patients with intermittent claudication referred for community-based SET were included . Exclusion criteria for SET were pain at rest or tissue loss . All patients received a diagnostic workup consisting of an ankle-brachial index at rest and after exercise . Interventions were exercise therapy according to the guidelines of the Royal Dutch Society for Physiotherapy . The primary outcome measurement was the increase in absolute claudication distance ( ACD ) , assessed using a st and ardized treadmill protocol by a physiotherapist at baseline and at four , 12 , 26 , and 52 weeks of SET . RESULTS From January 2005 through September 2006 , 349 patients were referred by vascular surgeons for community-based SET . A total of 272 patients with intermittent claudication began the program . Of the 349 initially referred patients , 52 could not perform a st and ard treadmill test but did start community-based SET at a lower level , and 25 patients never started the program . At one year , 129 of the original 272 patients who began community-based SET ( 47.4 % ) were available for analysis of walking distance . In the interim , 143 patients discontinued the program for the following reasons : satisfaction with the acquired walking distance ( n = 19 ) ; unsatisfying results ( n = 26 ) ; not motivated ( n = 22 ) ; (non)vascular intercurrent disease ( n = 48 ) ; and other reasons ( n = 28 ) . ACD increased significantly from a median of 400 m at baseline to 1100 m after 12 months of follow-up ( P Community-based SET seems as effective as SET in a hospital-based approach in improving walking distance , however , it has a high dropout rate",
"BACKGROUND It is not clear whether subgroups of patients with peripheral artery disease ( PAD ) and claudication respond more favorably to exercise rehabilitation than others . We determined whether sex and diabetes were factors associated with the response to exercise rehabilitation in patients with claudication . METHODS Eighty patients were r and omized to home-based and supervised exercise programs , and 60 finished with complete exercise intervention data . Exercise consisted of intermittent walking to near maximal claudication pain for 3 months . Primary outcome measures included claudication onset time ( COT ) and peak walking time . Patients were partitioned into diabetic and nondiabetic groups and then further partitioned by sex to form four groups . RESULTS Overall , exercise adherence was high ( 84 % ) , and there was no significant difference ( P > .05 ) in the amount of exercise completed among the four groups . All groups had significant improvements ( P COT and peak walking time after exercise rehabilitation , except for diabetic women ( P > .05 ) . Only 37 % of women with diabetes had an increase in COT compared with 100 % of men with diabetes ( P Women with PAD and claudication , particularly those with diabetes , represent a vulnerable subgroup of patients who respond poorly to a program of exercise rehabilitation . Diabetic women with PAD and claudication may need a greater dose of exercise or another intervention separate from or in combination with exercise to elicit improvements in claudication measures that are similar to nondiabetic women and to diabetic and nondiabetic men",
"OBJECTIVES The Exercise Therapy in Peripheral Arterial Disease ( EXITPAD ) study has shown supervised exercise therapy ( SET ) to be more effective regarding walking distance and quality of life than a ' go home and walk ' advice ( WA ) for patients with intermittent claudication . The present study aims to assess the cost-effectiveness of SET versus WA . PATIENTS AND METHODS Data from the EXITPAD study , a 12-month r and omised controlled trial in 304 patients with claudication , was used to study the proportion of costs to walking distance and quality of life . Two different incremental cost-effectiveness ratios ( ICERs ) were calculated for SET versus WA : costs per extra metre on the treadmill test , and costs per quality -adjusted life year ( QALY ) . QALYs were based on utilities derived from the EuroQoL-5 dimensions ( EQ-5D ) . RESULTS Mean total costs were higher for SET than for WA ( 3407 versus 2304 Euros ) , mainly caused by the costs of exercise therapy . The median walking distance was 620 m for SET and 400 m for WA . QALYs were 0.71 for SET and 0.67 for WA . All differences were statistically significant . The ICER for cost per extra metre on the 12-month treadmill test was € 4.08 . For cost per QALY , the ICER was € 28,693 . CONCLUSION At a willingness-to-pay threshold of € 40,000 per QALY , SET likely is a cost-effective therapeutic option for patients with claudication"
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BACKGROUND The dominance of lactobacilli in healthy vaginal microbiota and its depletion in bacterial vaginosis ( BV ) has given rise to the concept of oral or vaginal instillation of probiotic Lactobacillus strains for the management of this condition . OBJECTIVES To ascertain the efficacy of probiotics in the treatment of BV . SEARCH STRATEGY We search ed electronic data bases irrespective of publication status or language . These included : Cochrane Central Register of Controlled Trials ( CENTRAL ) , the HIV/AIDS and STD Cochrane Review Groups ' specialized registers , the Cochrane Complementary Medicine Field 's Register of Controlled Trials , MEDLINE ( 1966 to 2008 ) , EMBASE ( 1980 to 2007 ) , ISI science citation index ( 1955 to 2007 ) , CINAHL ( Cumulative Index to Nursing & Allied Health Literature ( 1982 to 2007).We h and search ed of specialty journals , conference proceedings and publications list on the website of the International Scientific Association of Probiotics and Prebiotics (http://www.isapp.net/default.asp).For unpublished studies or ongoing trials , we contacted authors from relevant publications , nutraceutical companies and probiotic-related scientific associations . We search ed electronic data bases on ongoing clinical trials . SELECTION CRITERIA R and omized controlled trials using probiotics for the treatment of women of any age diagnosed with bacterial vaginosis , regardless of diagnostic method used . The probiotic preparation could be single or " cocktail " of strains , any preparation type/dosage/route of administration . Studies comparing probiotics with placebo , probiotics used in conjunction with conventional antibiotics compared with placebo or probiotics alone compared with conventional antibiotics were eligible for inclusion . DATA COLLECTION AND ANALYSIS We screened titles and abstract s , obtained full reports of relevant trials and independently appraised them for eligibility . A data extraction form was used to extract data from the four included studies . For dichotomous outcomes , odds ratios ( OR ) and 95 % confidence intervals ( CI ) were derived for each study using RevMan ( versions 4.2 and 5 ) . We did not perform meta- analysis due to significant differences in the probiotic preparations and trial method ologies . MAIN RESULTS Analysis suggests beneficial outcome of microbiological cure with the oral metronidazole/probiotic regimen ( OR 0.09 ( 95 % CI 0.03 to 0.26 ) ) and the probiotic/estriol preparation ( OR 0.02 , ( 95 % CI 0.00 to 0.47 ) ) . For the probiotic/estriol preparation , the OR and 95 % CI for physician-reported resolution of symptoms was OR 0.04 ( 95 % CI 0.00 to 0.56 ) . AUTHORS ' CONCLUSIONS The results do not provide sufficient evidence for or against recommending probiotics for the treatment of BV . The metronidazole/probiotic regimen and probiotic/estriol perparation appear promising but well- design ed r and omized controlled trials with st and ardized method ologies and larger patient size are needed
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"Bacterial vaginosis ( BV ) is a common condition in women that represents an imbalance of the vaginal microflora , lactobacilli depletion , and excess growth of mainly anaerobic Gram-negative pathogens . Diagnosis is made using a series of tests or a Gram stain of a vaginal smear . Treatment with antibiotics is quite effective , but recurrences are common . A study of 55 vaginal sample s from 11 postmenopausal women showed the presence of BV by the Gram stain-based Nugent scoring system , and polymerase chain reaction-denaturing gradient gel electrophoresis showed that Bacteroides or Prevotella species were the most common isolates recovered ( 24 of 25 ) , with Escherichia coli , Staphylococcus aureus , and Streptococcus agalactiae also found in some sample s. In one case , only Gardnerella vaginalis was found . These findings illustrate that BV remains common even among otherwise healthy women , but it is not caused solely by either Gardnerella or Mobiluncus . Use of a FemExam system ( Cooper Surgical , Shelton , CT ) , based upon elevated pH and trimethylamine levels , to screen vaginal smears from 59 healthy women showed poor correlation with the Gram stain method . A r and omized , placebo-controlled trial of these subjects showed that the lactobacilli-dominant microbiota was restored in subjects with BV but not in controls , following 2 months of daily oral intake of Lactobacillus rhamnosus GR-1 and Lactobacillus fermentum RC-14 . These studies show that nucleic acid-based methods are effective at identifying bacteria responsible for BV . If such methods could be used to develop a commercially available , self-use kit , women would be much better placed to take control of their own health , for example , using medicinal food or dietary supplement products such as the clinical ly proven probiotic strains L. rhamnosus GR-1 and L. fermentum RC-14",
"This prospect i ve cohort study examined the health-seeking behaviour of patients diagnosed with genital warts and vulvodynia who presented to Manly Sexual Health Service from March to June 2000 . A self-administered question naire was used to assess patients ' perceptions of their condition and their use of complementary therapies . Thirty-seven patients with genital warts and 26 patients with vulvodynia participated in the study . The use of at least one complementary health product or method was reported by 59 % of patients with genital warts and 96 % of vulvodynia patients ( P conflicting information and being worried about the condition was significantly associated with visits to complementary health providers . Acknowledgement of this search for complementary therapies and open discussion can help patients make informed decisions and to avoid drug interactions , and should ultimately lead to better patient care",
"60 women with bacterial vaginosis were entered into a double blind , placebo-controlled treatment trial with lyophilized Lactobacillus acidophilus . The lactobacilli used were producing H2O2 . Immediately after completion of treatment , 16 out of 28 women who were treated with lactobacilli had normal vaginal wet smear results , in comparison to none of the 29 women treated with placebo . All women harboured Bacteroides at inclusion . Bacteroides was eliminated from the vagina of 12 out of 16 healthy women after treatment . Only three of the women who received the Lactobacillus suppository were free of bacterial vaginosis after the subsequent menstruation",
"This study enrolled 125 premenopausal women diagnosed with bacterial vaginosis ( BV ) by presence of vaginal irritation , discharge and ' fishy ' odor , and Nugent criteria and detection of sialidase enzyme . The subjects were treated with oral metronidazole ( 500 mg ) twice daily from days 1 to 7 , and r and omized to receive oral Lactobacillus rhamnosus GR-1 ( 1 x 10(9 ) ) and Lactobacillus reuteri RC-14 ( 1 x 10(9 ) ) or placebo twice daily from days 1 to 30 . Primary outcome was cure of BV as determined by normal Nugent score , negative sialidase test and no symptoms or signs of BV at day 30 . A total of 106 subjects returned for 30-day follow-up , of which 88 % were cured in the antibiotic/probiotic group compared to 40 % in the antibiotic/placebo group ( p had BV , while 30 % in the placebo and 12 % in the probiotic group fell into the intermediate category based upon Nugent score , sialidase result and clinical findings . High counts of Lactobacillus sp. ( > 10(5 ) CFU/ml ) were recovered from the vagina of 96 % probiotic-treated subjects compared to 53 % controls at day 30 . In summary , this study showed efficacious use of lactobacilli and antibiotic in the eradication of BV in black African women",
"To compare and assess ingestion of yogurt that contained live Lactobacillus acidophilus with pasteurized yogurt as prophylaxis for recurrent bacterial vaginosis ( BV ) and c and idal vaginitis , we design ed a crossover trial during which patients were examined monthly for c and idal infection and BV while they were receiving either a pasteurized yogurt or a yogurt that contained live L acidophilus . Forty-six patients in 2 groups of 23 were r and omly assigned to each of the study groups . At least 28 ( 61 % ) participated during the first 4 months of the study . Seven patients completed the entire study protocol . We concluded that daily ingestion of 150 mL of yogurt , enriched with live L acidophilus , was associated with an increased prevalence of colonization of the rectum and vagina by the bacteria , and this ingestion of yogurt may have reduced episodes of BV",
"Objective : The aim of this study was investigate the impact of vaginal flora and vaginal inflammation on conception and early pregnancy loss following in-vitro fertilization ( IVF ) . Methods : We enrolled 91 women who were undergoing IVF . At embryo transfer ( ET ) , all of the women had quantitative vaginal culture , ET catheter-tip culture , and vaginal Gram stain scored for bacterial vaginosis and quantitated for polymorphonuclear leukocytes ( PMNs ) . Conception and early pregnancy loss were compared with culture and Gram stain results . Statistical analyses included the Chi-square test , Fisher 's exact test and the Mann – Whitney U-test . Results : The overall live birth rate ( LBR ) was 30 % ( 27/91 ) , and the rate of early pregnancy loss was 34 % ( 14/41 ) . In women with bacterial vaginosis , intermediate flora and normal flora , the conception rates were 30 % ( 3/10 ) , 39 % ( 12/31 ) and 52 % ( 26/50 ) , respectively ( p = 0.06 for trend ) . Early pregnancy loss occurred in 33 % ( 1/3 ) , 42 % ( 5/12 ) and 31 % ( 8/26 ) of women , respectively ( p = 0.06 , comparing intermediate and normal flora ) . The vaginal log concentration of hydrogen peroxide-producing lactobacilli was 7.3 ± 1.7 in women with a live birth ( n = 27 ) and 4.9 ± 2.5 in those with early pregnancy loss ( n = 14 ) ( p = 0.1 ) . Conclusions : IVF patients with bacterial vaginosis and with a decreased vaginal log concentration of hydrogen peroxide-producing lactobacilli may have decreased conception rates and increased rates of early pregnancy loss . A larger prospect i ve treatment trial design ed to evaluate the impact on IVF outcomes of optimizing the vaginal flora prior to IVF may be warranted",
" Forty-two healthy women were r and omized to receive one of three encapsulated Lactobacillus rhamnosus GR-1 plus Lactobacillus fermentum RC-14 probiotic dosage regimens or L. rhamnosus GG by mouth each day for 28 days . However , the vaginal flora , assessed by Nugent scoring , was only normal in 40 % of the cases , and 14 patients had asymptomatic bacterial vaginosis . Treatment with L. rhamnosus GR-1/L. fermentum RC-14 once and twice daily correlated with a healthy vaginal flora in up to 90 % of patients , and 7/11 patients with bacterial vaginosis converted to normal or intermediate scores within 1 month . Ingestion of L. rhamnosus GG failed to have an effect . This study confirms the potential efficacy of orally administered lactobacilli as a non-chemotherapeutic means to restore and maintain a normal urogenital flora , and shows that over 10(8 ) viable organisms per day is the required dose",
"Objective To assess whether the rate of bacterial vaginosis ( BV ) is higher in women with tubal factor infertility compared with those with other causes of infertility",
"Bacterial vaginosis ( BV ) is particularly common in black women , and in Nigeria it is often caused by Mycoplasma , as well as Atopobium , Prevotella and Gardnerella sp. Antimicrobial metronidazole oral therapy is poorly effective in eradicating the condition and restoring the Lactobacillus microbiota in the vagina . In this study , 40 women diagnosed with BV by discharge , fishy odor , sialidase positive test and Nugent Gram stain scoring , were r and omized to receive either two dried capsules containing Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 each night for 5 days , or 0.75 % metronidazole gel , applied vaginally twice a day ( in the morning and evening ) . Follow-up at day 6 , 15 and 30 showed cure of BV in significantly more probiotic treated subjects ( 16 , 17 and 18/20 , respectively ) compared to metronidazole treatment ( 9 , 9 and 11/20 : P=0.016 at day 6 , P=0.002 at day 15 and P=0.056 at day 30 ) . This is the first report of an effective ( 90 % ) cure of BV using probiotic lactobacilli . Given the correlation between BV and HIV , and the high risk of the latter in Nigeria , intravaginal use of lactobacilli could provide women with a self-use therapy , similar to over-the-counter anti-yeast medication , for treatment of urogenital infections",
"BACKGROUND The relationship between lactobacilli and other microbes and the association with vaginal pH in the female genital tract were examined . The study also included evaluation of the possibility of supplying probiotics to the genital tract by using panty liners impregnated with the probiotic strain Lactobacillus plantarum LB931 . METHODS This was a r and omized , placebo-controlled , double-blind , multicenter study involving 191 healthy fertile women . Specified microbes were counted and vaginal pH was measured once a month for five consecutive months . RESULTS Major individual variations in the genital microflora composition and the vaginal pH were found among the women . The number of lactobacilli was significantly related to vaginal pH ( p streptococci than women with low numbers ( p=0.036 ) , and these women had a lower mean vaginal pH. The number of lactobacilli also correlated with the prevalence of yeast . LB931 could be found in 86 % of the labial sample s and 54 % of the vaginal sample s. CONCLUSIONS High numbers of lactobacilli may contribute to a low vaginal pH and seem to have a negative influence on Group B streptococci . LB931 could be transferred from the panty liners to both the vagina and the labial fold",
"The efficacy of vaginal tablets ( Gynoflor ) containing 50 mg of a lyophilisate of viable , H2O2-producing Lactobacillus acidophilus ( at least 10(7 ) colony forming units/tablet ) and 0.03 mg estriol ( CAS 50 - 27 - 1 ) for the treatment of bacterial vaginosis ( BV ) was tested in a multicentric , r and omised , placebo-controlled clinical trial with parallel-group design . 32 non-menopausal women with positive diagnoses for BV , including intermediate cases , participated in the trial . Patients were diagnosed using the classical clinical parameters of BV according to Amsel and using microscopic analysis of the Gram-stained vaginal smear . A positive clinical diagnosis of BV required at least 2 of the following 4 clinical criteria to be positive ; greyish-white , homogeneous leukorrhea ; vaginal pH > 4.5 ; KOH test for volatile amines ; presence of clue cells . Microscopic diagnosis of BV , on the other h and , was obtained if examination of the Gram-stained vaginal smear showed less than 6 lactobacilli per field of view ( 1000 x magnification ) . This corresponds to another definition of BV as \" lactobacilli deficiency syndrome \" . The efficacy of the 6-day therapy with 1 - 2 vaginal tablets daily was evaluated using both clinical and microscopic analysis . Using Amsel 's classical clinical parameters of BV , the cure rate ( defined as cure rate was 88 % in the verum group and 22 % in the placebo group . At both control examinations , the cure rate for the test group was significantly higher than that for the placebo group ( p lactobacilli were capable of recolonising the vagina . A significant increase in the number of lactobacilli was observed in the Gram-stained vaginal smear for the patient group treated with the test preparation compared to the placebo patient group ( p < 0.05 , Fisher 's exact test , 2-sided , significance level 0.05 ) , two and four weeks after the start of the 6-day treatment",
"The expected 4-week cure rate after conventional treatment of bacterial vaginosis are only 65 - 70 % . In an attempt to improve the cure rate by adding probiotic lactobacilli we performed a double-blind placebo-controlled study of adjuvant lactobacilli treatment after an open treatment with vaginal clindamycin ovules . Women with bacterial vaginosis as defined by Amsel 's criteria were treated with clindamycin ovules . Vaginal smears were collected and analysed according to Nugent 's criteria . During the following menstruation period the women used , as an adjuvant treatment , either lactobacilli-prepared tampons or placebo tampons . The lactobacilli tampons were loaded with a mixture of freeze-dried L. fermentum , L. casei var . rhamnosus and L. gasseri . The cure rate was recorded after the second menstruation period . There was no improvement in the cure rate after treatment with lactobacilli-containing tampons compared to placebo tampons ; the cure rates as defined by Amsel 's criteria were 56 % and 62 % , respectively , and 55 % and 63 % , as defined by Nugent 's criteria . This is the first study to report cure rates for women with ' intermediate ' wet smear ratings according to Nugent 's classification and this group had an overall cure rate of 44 % . The cure rate of treatment of bacterial vaginosis was not improved by using lactobacilli-prepared tampons for one menstruation",
"Urogenital infections afflict an estimated one billion people each year . The size of this problem and the increased prevalence of multi-drug resistant pathogens make it imperative that alternative remedies be found . A r and omized , placebo-controlled trial of 64 healthy women given daily oral capsules of Lactobacillus rhamnosus GR-1 and Lactobacillus fermentum RC-14 for 60 days showed no adverse effects . Microscopy analysis showed restoration from asymptomatic bacterial vaginosis microflora to a normal lactobacilli colonized microflora in 37 % women during lactobacilli treatment compared to 13 % on placebo ( P=0.02 ) . Lactobacilli were detected in more women in the lactobacilli-treated group than in the placebo group at 28 day ( P=0.08 ) and 60 day ( P=0.05 ) test points . Culture findings confirmed a significant increase in vaginal lactobacilli at day 28 and 60 , a significant depletion in yeast at day 28 and a significant reduction in coliforms at day 28 , 60 and 90 for lactobacilli-treated subjects versus controls . The combination of probiotic L. rhamnosus GR-1 and L. fermentum RC-14 is not only safe for daily use in healthy women , but it can reduce colonization of the vagina by potential pathogenic bacteria and yeast",
"AIM The aim of this paper was to estimate the effectiveness of the contemporary oral administration of Lactobacilllus paracasei subsp paracasei F19 in association with vaginal suppositories containing Lactobacilllus acidofilus in the treatment of bacterial vaginosis and in the prevention of recurrent vaginitis . METHODS We have recruited 60 women in good health , aged between 18 and 40 years with suspect or confirmed diagnosis of bacterial vaginosis . The women were r and omized in 2 groups : Group A treated with vaginal suppositories containing Lactobacillus acidofilus ( Calagin , SIFFRA , Florence ) ; Group B treated with the same vaginal suppositories + probiotic containing Lactobacilllus paracasei subsp paracasei F 19 for oral administration ( Gene-filus F19 , SIFFRA , Florence ) . The patients were examined at the end of therapy ( 3 months ) and then after 3 months from the end of treatment . RESULTS In both groups at end of therapy there was a significant reduction of vaginal pH , an improvement of sniff test and of the subjective symptomatology after 3 months of treatment which still decreased during follow-up ( 3 months ) . In Group B there was a meaningful reduction of vaginal pH and of sniff test at the end of therapy and a maintenance of positive effect also after 3 months . CONCLUSIONS The results obtained in this study show that the therapy with vaginal Lactobacillus in the treatment of bacterial vaginosis is successful . The association of oral administration is useful to balance the vaginal environment with the intestinal microflora with improvement of long-term results . The use of probiotics was determinant in the treatment of a pathology like bacterial vaginosis and as an alternative to the conventional local antibiotic therapies",
"As various drugs might have an effect on the fetus during pregnancy , the use of drugs should be minimized in the pregnant woman . Since bacterial vaginosis ( BV ) can be associated with prematurity and postpartum complications , we search ed for alternative therapy for its cure during pregnancy . Commercial yoghurt incorporates both factors necessary for maintaining the protective mechanism of the vagina , vaginal pH and lactobacilhis . A total of 32 women with BV in the first trimester of pregnancy were treated with intravaginal application of yoghurt . The result was favorable indicating that the continuous correction of vaginal pH and lactobaccillus flora is crucial for normal vaginal ecology . During pregnancy , a local treatment restoring the normal acidity and vaginal flora , without systemic effect , may be preferable to any other treatment",
"Objective To evaluate the effectiveness of live lactobacilli in combination with low dose oestriol for restoration of the vaginal flora after anti‐infective treatment",
"Objective : To assess the association between vaginal douching and sexually transmitted infections ( STI ) among a group of female sex workers ( FSWs ) in Nairobi , Kenya . Methods : This study was part of a r and omised , placebo controlled trial of monthly prophylaxis with 1 g of azithromycin to prevent STIs and HIV infection in a cohort of Nairobi FSWs . Consenting women were administered a question naire and screened for STIs . Results : The seroprevalence of HIV-1 among 543 FSWs screened was 30 % . HIV infection was significantly associated with bacterial vaginosis ( BV ) , trichomoniasis , gonorrhoea , and the presence of a genital ulcer . Regular douching was reported by 72 % of the women , of whom the majority inserted fluids in the vagina , generally after each sexual intercourse . Water with soap was the fluid most often used ( 81 % ) , followed by salty water ( 18 % ) , water alone ( 9 % ) , and a commercial antiseptic ( 5 % ) . Douching in general and douching with soap and water were significantly associated with bacterial vaginosis ( p = 0.05 and p = 0.04 respectively ) . There was a significant trend for increased frequency of douching and higher prevalence of BV . There was no direct relation observed between douching and risk for HIV infection or other STIs . Conclusion : The widespread habit of douching among African female sex workers was confirmed . The association between vaginal douching and BV is of concern , given the increased risk of HIV infection with BV , which has now been shown in several studies . It is unclear why we could not demonstrate a direct association between douching and HIV infection . Further research is required to better underst and the complex relation between douching , risk for bacterial vaginosis , and risk for HIV and other STIs",
" Among 640 r and omly selected women who were attending a sexually transmitted disease clinic and did not have trichomoniasis , 33 % had bacterial vaginosis as defined by a composite of four clinical criteria : ( 1 ) Vaginal discharge was homogeneous ; ( 2 ) vaginal discharge had a pH greater than or equal to 4.7 ; ( 3 ) vaginal discharge had an amine-like odor when mixed with 10 % potassium hydroxide ; ( 4 ) vaginal discharge contained clue cells representing greater than or equal to 20 % of vaginal epithelial cells . Previously published Gram stain criteria for bacterial vaginosis correlated better than results of semiquantitative cultures for Gardnerella vaginalis with presence or absence of clue cells and with composite clinical criteria . Of 293 women with bacterial vaginosis by Gram stain criteria , 65 % had symptoms of increased vaginal discharge and /or vaginal malodor , while 74 % had signs of characteristic homogeneous vaginal discharge or amine-like odor . Elevated vaginal pH was the least specific and amine-like odor the least sensitive sign of bacterial vaginosis . Gram stain criteria for bacterial vaginosis were not associated with the concentrations of endocervical or vaginal inflammatory cells but were significantly associated with a clinical diagnosis of pelvic inflammatory disease . After adjusting for coinfection , sexual behavior , and other variables , bacterial vaginosis remained associated with adnexal tenderness ( odds ratio = 9.2 , p = 0.04 ) . Bacterial vaginosis , previously implicated as a risk factor for obstetric infections , may be a risk factor for pelvic inflammatory disease",
"OBJECTIVE To assess women 's satisfaction with a vaginal capsule containing human-derived , H(2)O(2)-producing Lactobacillus crispatus at completion of a r and omized , placebo-controlled study for treatment of bacterial vaginosis ( BV ) . METHODS Women aged 14 - 35 years with BV were r and omized to Lactobacillus or placebo intravaginal capsule twice daily for 3 days monthly for 3 months . Attitudes were assessed with a st and ardized scale at the final follow-up visit , and associations of satisfaction with clinical and gram stain cure of BV were determined . RESULTS Four hundred twenty-four women were r and omized at enrollment , and 232 ( 55 % ) provided data on satisfaction at the final visit . Overall , satisfaction with the capsule was high and was independent of subjects ' race , age , and prior history of BV . Report of satisfaction with the capsule , belief that it contained healthy bacteria , and belief that its use improved vaginal health were directly related to clinical cure and to improved Nugent score . Except for women who had BV at the final follow-up visit , most subjects believed that the capsule contained healthy bacteria independent of any outcome reflecting cure . Willingness to use the capsule again was not significantly related to whether subjects experienced clinical cure or normalization of Nugent score at either visit . Adverse effects were rare and were largely related to a perceived difference in vaginal discharge . CONCLUSIONS Satisfaction with an intravaginal capsule and positive beliefs about its use for BV treatment were prevalent , especially among women with a clinical and microbiological response to BV therapy . However , most women expressed willingness to use the product again regardless of clinical response . Acceptability of and interest in alternative BV treatments , such as L. crispatus intravaginal applications , are high",
"A prospect i ve , r and omized clinical trial was performed to study the efficacy of povidone iodine ( Betadine ® ) suppositories for the treatment of bacterial vaginosis ( BV ) in comparison to capsules containing lactobacilli ( Döderlein Med ® ) . Seventy patients with BV included in the study were r and omly assigned to be either treated with povidone iodine suppositories or lactobacilli . Patients were treated once a day for 5 days . Initial examinations took place on the first day of the study with follow-up examinations on days 8 and 15 . The examinations included clinical parameters , patient evaluation , secretion screens , and quantitative and qualitative microbiological tests of vaginal flora . Both treatment groups showed improvement of clinical parameters , condition of secretions and subjective state of health . At day 15 there was a trend towards a better efficacy of the treatment with povidone iodine but this was not significant . However , patients with acute BV treated with povidone iodine had significantly better scores after 15 days . Both treatments were well tolerated . The microbiological examinations showed an increase of the mean number of lactobacilli in the vagina on day 8 after initiation of treatment with lactobacilli , but a decrease on day 15 . Contrary to that the lactobacilli counts from patients treated with povidone iodine suppositories decreased after the first week but increased in the second one . Potentially pathogenic germs , e.g. Gardnerella , Bacteroides and Enterobacteria were reduced in a higher extent and with a longer lasting effect after treatment with povidone iodine suppositories than with capsules containing lactobacilli . The results of this study show that native lactobacilli rapidly re-colonize after the antiseptic treatment with povidone iodine . Therefore , there is no need to use lactobacilli in addition"
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4116ec64-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND The aim of this study was to systematic ally investigate the effectiveness of hatha yoga in treating acute , chronic and /or treatment-resistant mood and anxiety disorders . METHODS Medline , Cochrane Library , Current Controlled Trials , Clinical Trials.gov , NHR Centre for Review s and Dissemination , PsycINFO and CINAHL were search ed through June 2018 . R and omized controlled trials with patients with mood and anxiety disorders were included . Main outcomes were continuous measures of severity of mood and anxiety symptoms . Cohen 's d was calculated as a measure of effect size . Meta-analyses using a r and om effects model was applied to estimate direct comparisons between yoga and control conditions for depression and anxiety outcomes . Publication bias was visually inspected using funnel plots . RESULTS Eighteen studies were found , fourteen in acute patients and four in chronic patients . Most studies were of low quality . For depression outcomes , hatha yoga did not show a significant effect when compared to treatment as usual , an overall effect size of Cohen 's d -0.64 ( 95 % CI = -1.41 , 0.13 ) or to all active control groups , Cohen 's d -0.13 ( 95 % CI = -0.49 , 0.22 ) . A sub- analysis showed that yoga had a significant effect on the reduction of depression compared to psychoeducation control groups , Cohen 's d -0.52 ( 95 % CI = -0.96 , -0.08 ) but not to other active control groups , Cohen 's d 0.28 ( 95 % CI = -0.07 , 0.63 ) For studies using a follow-up of six months or more , hatha yoga had no effect on the reduction of depression compared to active control groups , Cohen 's d -0.14 ( 95 % CI = -0.60 , 0.33 ) . Regarding anxiety , hatha yoga had no significant effect when compared to active control groups , Cohen 's d -0.09 ( 95 % CI = -0.47 , 0.30 ) . The I2 and Q-statistic revealed heterogeneity amongst comparisons . Qualitative analyses suggest some promise of hatha yoga for chronic population s. CONCLUSIONS The ability to draw firm conclusions is limited by the notable heterogeneity and low quality of most of the included studies . With this caveat in mind , the results of the current meta- analysis suggest that hatha yoga does not have effects on acute , chronic and /or treatment-resistant mood and anxiety disorders compared to treatment as usual or active control groups . However , when compared to psychoeducation , hatha yoga showed more reductions in depression . It is clear that more high- quality studies are needed to advance the field
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"BACKGROUND The objective of this study was to determine whether hatha yoga is an efficacious adjunctive intervention for individuals with continued depressive symptoms despite antidepressant treatment . METHOD We conducted a r and omized controlled trial of weekly yoga classes ( n = 63 ) v. health education classes ( Healthy Living Workshop ; HLW ; n = 59 ) in individuals with elevated depression symptoms and antidepressant medication use . HLW served as an attention-control group . The intervention period was 10 weeks , with follow-up assessment s 3 and 6 months afterwards . The primary outcome was depression symptom severity assessed by blind rater at 10 weeks . Secondary outcomes included depression symptoms over the entire intervention and follow-up periods , social and role functioning , general health perceptions , pain , and physical functioning . RESULTS At 10 weeks , we did not find a statistically significant difference between groups in depression symptoms ( b = -0.82 , s.e . = 0.88 , p = 0.36 ) . However , over the entire intervention and follow-up period , when controlling for baseline , yoga participants showed lower levels of depression than HLW participants ( b = -1.38 , s.e . = 0.57 , p = 0.02 ) . At 6-month follow-up , 51 % of yoga participants demonstrated a response ( ⩾50 % reduction in depression symptoms ) compared with 31 % of HLW participants ( odds ratio = 2.31 ; p = 0.04 ) . Yoga participants showed significantly better social and role functioning and general health perceptions over time . CONCLUSIONS Although we did not see a difference in depression symptoms at the end of the intervention period , yoga participants showed fewer depression symptoms over the entire follow-up period . Benefits of yoga may accumulate over time",
"We conducted a pilot r and omized controlled trial ( RCT ) comparing a prenatal yoga intervention to perinatal-focused health education in pregnant women with depression . Findings document acceptability and feasibility of the yoga intervention : no yoga-related injuries were observed , instructors showed fidelity to the yoga manual , and women rated interventions as acceptable . Although improvements in depression were not statistically different between groups , they favored yoga . This study provides support for a larger scale RCT examining prenatal yoga to improve mood during pregnancy",
"BACKGROUND Current interventions for major depressive disorder ( MDD ) are suboptimal , and only one third respond to them on initial treatment . Neuroplasticity theories are the basis for several emerging treatments . Evidence on the impact of yoga , a well-known mind-body intervention , on neuroplasticity in MDD is limited . OBJECTIVES To determine the effects of 12-week yoga- and meditation-based lifestyle intervention ( YMLI ) on depression severity and systemic biomarkers of neuroplasticity in adult MDD patients on routine drug treatment . METHODS A total of 58 MDD patients were r and omized into yoga or control group . The severity of depression was assessed with Beck Depression Inventory-II scale ( BDI-II ) . Blood sample s were collected before and after intervention for the measurement of the biomarkers that characterize neuroplasticity , including mind-body communicative and cellular health biomarkers . RESULTS There was a significant decrease [ difference between means , ( 95 % CI ) ] in BDI-II score [ -5.83 ( -7.27 , -4.39 ) , p BDNF ( ng/ml ) [ 5.48 ( 3.50 , 7.46 ) , p DHEAS , sirtuin 1 , and telomerase activity levels , and decreased cortisol , and IL-6 levels , in addition to decreasing DNA damage and balancing oxidative stress . Multiple regression analyses were used to associate neuroplasticity biomarkers with depression severity . A ' post-intervention change in BDNF ' x ' group ' interaction indicated that yoga group had more BDNF in association with less BDI-II scores relative to controls . Increased sirtuin 1 and telomerase activity and decreased cortisol significantly predicted this association ( all p YMLI in MDD is associated with improved systemic biomarkers of neuroplasticity . Thus YMLI can be considered as a therapeutic intervention in MDD management",
"Background : Exercise training may be especially helpful for patients with generalized anxiety disorder ( GAD ) . We conducted a r and omized controlled trial to quantify the effects of 6 weeks of resistance ( RET ) or aerobic exercise training ( AET ) on remission and worry symptoms among sedentary patients with GAD . Methods : Thirty sedentary women aged 18–37 years , diagnosed by clinicians blinded to treatment allocation with a primary DSM-IV diagnosis of GAD and not engaged in any treatment other than pharmacotherapy , were r and omly allocated to RET , AET , or a wait list ( WL ) . RET involved 2 weekly sessions of lower-body weightlifting . AET involved 2 weekly sessions of leg cycling matched with RET for body region , positive work , time actively engaged in exercise , and load progression . Remission was measured by the number needed to treat ( NNT ) . Worry symptoms were measured by the Penn State Worry Question naire . Results : There were no adverse events . Remission rates were 60 % , 40 % , and 30 % for RET , AET , and WL , respectively . The NNT was 3 ( 95 % CI 2 to 56 ) for RET and 10 ( 95 % CI –7 to 3 ) for AET . A significant condition-by-time interaction was found for worry symptoms . A follow-up contrast showed significant reductions in worry symptoms for combined exercise conditions versus the WL . Conclusions : Exercise training , including RET , is a feasible , low-risk treatment that can potentially reduce worry symptoms among GAD patients and may be an effective adjuvant , short-term treatment or augmentation for GAD . Preliminary findings warrant further investigation",
"OBJECTIVES The impact of Hatha yoga as add-on treatment to quetiapine fumarate extended release ( QXR ) or escitalopram ( ESC ) in depressed patients on hypothalamic-pituitary-adrenal ( HPA ) axis activity was assessed . METHODS 60 in patients suffering from major depressive disorder ( MDD ) according to DSM-IV were r and omized for a 5 week treatment with Yoga or not ( control group ) and with either QXR ( 300 mg/day ) or ESC ( 10 mg/day ) . Serial dexamethasone/corticotropin releasing hormone ( DEX/CRH ) tests were performed to assess HPA axis function . The Hamilton Depression Rating Scale ( 21-HAMD ) was used weekly . RESULTS A more pronounced down regulation of the HPA axis activity due to yoga could not be detected . The stepwise long term cortisol reduction was seen in both medication groups , irrespectively of yoga add-on treatment . In addition , cortisol improvers in week 1 of therapy ( reduction in cortisol peak value within the DEX/CRH test ) reached significant greater amelioration of depressive symptoms after 5 weeks . CONCLUSIONS Our results suggest that antidepressant agents down regulate HPA axis function to a greater extent than additional Hatha yoga treatment . Moreover , an early reduction of HPA system hyperactivity after one week of pharmacological treatment seems to raise the possibility of a favorable treatment response",
"Exercise can be used to treat depression but there is a lack of evidence regarding the optimal intensity and mode . Our aim was to compare the effects of different exercise intensities on post-treatment depression severity . People aged 18 - 67years with mild to moderate depression ( Patient Health Question naire-9 score of ≥10 ) participated in a single-blind , parallel r and omized control trial lasting 12-weeks ( Sweden 2011 - 2013 ) . Four treatment arms were included : treatment as usual ( TAU ) ( n=310 ) , light exercise ( yoga or similar n=106 ) , moderate exercise ( aerobic conditioning , n=105 ) and vigorous exercise ( aerobic conditioning , n=99 ) . Depression severity was measured at baseline and post-treatment using the Montgomery-Åsberg Depression Rating Scale ( MADRS ) . Differences between the groups in depression severity at post-treatment were analysed using linear regression . Differences in exercise intensity were confirmed by heart rate monitoring . At post-treatment , the light ( -4.05 Confidence Interval (CI)=-5.94 , -2.17 ) , moderate ( -2.08 CI=-3.98 , -0.18 ) and vigorous exercise groups ( -3.13 CI=-5.07 , -1.19 ) had reduced their MADRS scores significantly more than TAU . No significant differences were found between the exercise groups , and no significant interaction effect was observed between group and gender . In conclusion , exercise , whether performed at a low ( yoga or similar ) , moderate or vigorous intensity ( aerobic training ) is effective in treating mild to moderate depression and is at least as effective as treatment as usual by a physician",
"Background : The dem and for clinical ly efficacious , safe , patient acceptable , and cost-effective forms of treatment for mental illness is growing . Several studies have demonstrated benefit from yoga in specific psychiatric symptoms and a general sense of well-being . Objective : To systematic ally examine the evidence for efficacy of yoga in the treatment of selected major psychiatric disorders . Methods : Electronic search es of The Cochrane Central Register of Controlled Trials and the st and ard bibliographic data bases , MEDLINE , EMBASE , and PsycINFO , were performed through April 2011 and an up date d in June 2011 using the keywords yoga AND psychiatry OR depression OR anxiety OR schizophrenia OR cognition OR memory OR attention AND r and omized controlled trial ( RCT ) . Studies with yoga as the independent variable and one of the above mentioned terms as the dependent variable were included and exclusion criteria were applied . Results : The search yielded a total of 124 trials , of which 16 met rigorous criteria for the final review . Grade B evidence supporting a potential acute benefit for yoga exists in depression ( four RCTs ) , as an adjunct to pharmacotherapy in schizophrenia ( three RCTs ) , in children with ADHD ( two RCTs ) , and Grade C evidence in sleep complaints ( three RCTs ) . RCTs in cognitive disorders and eating disorders yielded conflicting results . No studies looked at primary prevention , relapse prevention , or comparative effectiveness versus pharmacotherapy . Conclusion : There is emerging evidence from r and omized trials to support popular beliefs about yoga for depression , sleep disorders , and as an augmentation therapy . Limitations of literature include inability to do double-blind studies , multiplicity of comparisons within small studies , and lack of replication . Biomarker and neuroimaging studies , those comparing yoga with st and ard pharmaco- and psychotherapies , and studies of long-term efficacy are needed to fully translate the promise of yoga for enhancing mental health",
"Background Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates . Yoga may offer an alternative treatment option , but rigorous studies are few . This r and omized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression . Methods Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity , per structured psychiatric interview and scores of 14–28 on Beck Depression Inventory-II ( BDI ) . At screening , individuals engaged in psychotherapy , antidepressant pharmacotherapy , herbal or nutraceutical mood therapies , or mind-body practice s were excluded . Participants were 68 % female , with mean age 43.4 years ( SD = 14.8 , range = 22–72 ) , and mean BDI score 22.4 ( SD = 4.5 ) . Twenty participants were r and omized to 90-minute hatha yoga practice groups twice weekly for 8 weeks . Eighteen participants were r and omized to 90-minute attention control education groups twice weekly for 8 weeks . Certified yoga instructors delivered both interventions at a university clinic . Primary outcome was depression severity , measured by BDI scores every 2 weeks from baseline to 8 weeks . Secondary outcomes were self-efficacy and self-esteem , measured by scores on the General Self-Efficacy Scale ( GSES ) and Rosenberg Self-Esteem Scale ( RSES ) at baseline and at 8 weeks . Results In intent-to-treat analysis , yoga participants exhibited significantly greater 8-week decline in BDI scores than controls ( p-value = 0.034 ) . In sub-analyses of participants completing final 8-week measures , yoga participants were more likely to achieve remission , defined per final BDI score ≤ 9 ( p-value = 0.018 ) . Effect size of yoga in reducing BDI scores was large , per Cohen ’s d = -0.96 [ 95%CI , -1.81 to -0.12 ] . Intervention groups did not differ significantly in 8-week change scores for either the GSES or RSES . Conclusion In adults with mild-to-moderate major depression , an 8-week hatha yoga intervention result ed in statistically and clinical ly significant reductions in depression severity . Trial registration Clinical Trials.gov",
"The purpose of this study was to compare the effects of yoga ( physical activity ) versus social support ( verbal activity ) on prenatal and postpartum depression . Ninety-two prenatally depressed women were r and omly assigned to a yoga or a social support control group at 22 weeks gestation . The yoga group participated in a 20-min group session ( only physical poses ) once per week for 12 weeks . The social support group ( a leaderless discussion group ) met on the same schedule . At the end of the first and last sessions the yoga group reported less depression , anxiety , anger , back and leg pain as compared to the social support group . At the end of the last session the yoga group and the support group did not differ . They both had lower depression ( CES-D ) , anxiety ( STAI ) , and anger ( STAXI ) scores and improved relationship scores . In addition , cortisol levels decreased for both groups following each session . Estriol and progesterone levels decreased after the last session . At the postpartum follow-up assessment depression and anxiety levels were lower for both groups",
"& NA ; A mounting body of literature recommends that treatment for fibromyalgia ( FM ) encompass medications , exercise and improvement of coping skills . However , there is a significant gap in determining an effective counterpart to pharmacotherapy that incorporates both exercise and coping . The aim of this r and omized controlled trial was to evaluate the effects of a comprehensive yoga intervention on FM symptoms and coping . A sample of 53 female FM patients were r and omized to the 8‐week Yoga of Awareness program ( gentle poses , meditation , breathing exercises , yoga‐based coping instructions , group discussion s ) or to wait‐listed st and ard care . Data were analyzed by intention to treat . At post‐treatment , women assigned to the yoga program showed significantly greater improvements on st and ardized measures of FM symptoms and functioning , including pain , fatigue , and mood , and in pain catastrophizing , acceptance , and other coping strategies . This pilot study provides promising support for the potential benefits of a yoga program for women with FM",
"Previous research has shown positive effects of exercise on depression but studies have mainly focused on the short-term effects ; few have examined the long-term effect , especially with regard to differences in intensity . The aim of this study was to examine the long-term effects of prescribed exercise on depression , performed at three intensity levels . People aged 18 - 67years with mild to moderate depression ( Patient Health Question naire-9 score of ≥10 ) participated in a single-blind , parallel r and omized control trial lasting 12weeks ( Sweden 2011 - 2013 ) . Four arms were included : Treatment as usual ( TAU , n=310 ) , light ( n=106 ) , moderate ( n=105 ) and vigorous exercise ( n=99 ) . Severity of depression was measured at baseline , post-treatment and 12-month follow-up using the Montgomery-Åsberg Depression Rating Scale ( MADRS ) . Coefficients ( β ) and odds ratios were estimated using linear mixed models with time × group interactions . The results showed that at the 12month follow-up the light exercise group had significantly lower depression severity scores than the TAU ( -1.9 , 95 % CI : -3.7 , -0.04 ) and the moderate exercise group ( -2.94 95 % CI : -5.2 , -0.7 ) . The vigorous exercise group had significantly lower scores than the moderate exercise group only ( -2.7 , 95 % CI : -4.9 , -0.4 ) . In conclusion , compared to usual care for depression , only light exercise result ed in significantly lower depression severity at 12-month follow-up . Both light and vigorous exercise was more effective than moderate exercise . TRIAL REGISTRATION The study was registered with the German Clinical Trial Register ( DRKS study ID : DRKS00008745 )",
"BACKGROUND : Over the last two decades very few advances have been made in the development of new treatments for obsessive-compulsive disorder ( OCD ) . While patients with OCD improve with available treatments ( pharmacotherapy and /or cognitive-behavioral therapy ) , moderate levels of OCD symptoms often persist even with adequate doses and duration s of these treatments . Building on the growing body of evidence for the efficacy of exercise in the treatment of other psychiatric disorders , interventions to increase aerobic exercise in patients with OCD represent a potentially useful yet relatively unexplored strategy in OCD . METHODS / DESIGN : One hundred and two ( 102 ) patients with clinical ly significant OCD symptoms despite current engagement in recommended treatments ( pharmacotherapy and /or CBT ) will be r and omly assigned to receive either a 12-week moderate intensity aerobic exercise ( AE ) intervention or a health education control ( HEC ) intervention . Follow-up interviews will be conducted at the end of treatment and at 3- , 6- and 12-months post-intervention . They will assess OCD severity , nonspecific anxiety , depression , quality of life , cardiorespiratory fitness and cognition ( executive function ) . DISCUSSION : If efficacy is established , patients with OCD who have clinical ly significant residual symptoms despite current pharmacotherapy or CBT would gain a valuable and practical treatment augmentation option",
"Background : Although effective treatment of depressed patients requires regular follow-up contacts and symptom monitoring , an efficient method for assessing treatment outcome is lacking . We investigated responsiveness to treatment , reproducibility , and minimal clinical ly important difference of the Patient Health Question naire-9 ( PHQ-9 ) , a st and ard instrument for diagnosing depression in primary care . Methods : This study included 434 intervention subjects from the IMPACT study , a multisite treatment trial of late-life depression ( 63 % female , mean age 71 years ) . Changes in PHQ-9 scores over the course of time were evaluated with respect to change scores of the SCL-20 depression scale as well as 2 independent structured diagnostic interviews for depression during a 6-month period . Test-retest reliability and minimal clinical ly important difference were assessed in 2 subgroups of patients who completed the PHQ-9 twice exactly 7 days apart . Results : The PHQ-9 responsiveness as measured by effect size was significantly greater than the SCL-20 at 3 months ( −1.3 versus −0.9 ) and equivalent at 6 months ( −1.3 versus −1.2 ) . With respect to structured diagnostic interviews , both the PHQ-9 and the SCL-20 change scores accurately discriminated patients with persistent major depression , partial remission , and full remission . Test-retest reliability of the PHQ-9 was excellent , and its minimal clinical ly important difference for individual change , estimated as 2 st and ard errors of measurement , was 5 points on the 0 to 27 point PHQ-9 scale . Conclusions : Well-vali date d as a diagnostic measure , the PHQ-9 has now proven to be a responsive and reliable measure of depression treatment outcomes . Its responsiveness to treatment coupled with its brevity makes the PHQ-9 an attractive tool for gauging response to treatment in individual patient care as well as in clinical research",
"Goal of workBreast cancer survivors have limited options for the treatment of hot flashes and related symptoms . Further , therapies widely used to prevent recurrence in survivors , such as tamoxifen , tend to induce or exacerbate menopausal symptoms . The aim of this preliminary , r and omized controlled trial was to evaluate the effects of a yoga intervention on menopausal symptoms in a sample of survivors of early-stage breast cancer ( stages IA – IIB ) . Material s and methods Thirty-seven disease-free women experiencing hot flashes were r and omized to the 8-week Yoga of Awareness program ( gentle yoga poses , meditation , and breathing exercises ) or to wait-list control . The primary outcome was daily reports of hot flashes collected at baseline , posttreatment , and 3 months after treatment via an interactive telephone system . Data were analyzed by intention to treat . Main results At posttreatment , women who received the yoga program showed significantly greater improvements relative to the control condition in hot-flash frequency , severity , and total scores and in levels of joint pain , fatigue , sleep disturbance , symptom-related bother , and vigor . At 3 months follow-up , patients maintained their treatment gains in hot flashes , joint pain , fatigue , symptom-related bother , and vigor and showed additional significant gains in negative mood , relaxation , and acceptance . Conclusions This pilot study provides promising support for the beneficial effects of a comprehensive yoga program for hot flashes and other menopausal symptoms in early-stage breast cancer survivors",
"OBJECTIVES The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga intervention on depressive symptoms and rumination among depressed women . DESIGN Prospect i ve , r and omized , controlled 12 week intervention pilot study . Depressive symptoms were assessed at baseline , post-intervention ( 12 weeks ) , and one-month follow-up . SETTING Women with a history of diagnosed depression and currently depressed were r and omized to a mindfulness-based yoga condition or a walking control . INTERVENTIONS The mindfulness-based yoga intervention consisted of a home-based yoga asana , pranayama and meditation practice with mindfulness education sessions delivered over the telephone . The walking control condition consisted of home-based walking sessions and health education sessions delivered over the phone . MAIN OUTCOME MEASURES The Beck Depression Inventory ( BDI ) and Ruminative Responses Scale ( RRS ) . RESULTS Both groups reported decreases in depressive symptoms from baseline to post-intervention , f(1,33)=34.83 , p depression scores at post-intervention and the one-month follow-up assessment . The mindfulness-based yoga condition reported significantly lower levels of rumination than the control condition at post-intervention , after controlling for baseline levels of rumination , f(1,31)=6.23 , p mindfulness-based yoga may provide tools to manage ruminative thoughts among women with elevated depressive symptoms . Future studies , with larger sample s are needed to address the effect of yoga on depression and further explore the impact on rumination",
"Comorbidity among affective disorders is high . Rumination has been found to mediate cross-sectional and prospect i ve relations between anxiety and depressive symptoms in adolescents and adults . We examined whether rumination and worry , both forms of repetitive negative thinking , also explain the associations between affective disorders . This was studied using a prospect i ve cohort study . In a mixed sample of 2981 adults ( persons with a prior history of or a current affective disorder and healthy individuals ) we assessed DSM-IV affective disorders ( CIDI ) , rumination ( LEIDS-R ) and worry ( PSWQ ) . All measures were repeated 2 years and 4 years later . Using structural equation models , we found that baseline rumination and worry partly mediated the association of baseline fear disorders ( social anxiety disorder , panic disorder , agoraphobia ) with distress disorders ( dysthymia , major depressive disorder , generalized anxiety disorder ) . Moreover , baseline fear disorders predicted changes in distress disorders and changes in worry and rumination mediated these associations . The association between baseline distress disorders and changes in fear disorders was mediated by changes in rumination but not by changes in worry . From these results it can be concluded that repetitive negative thinking is an important transdiagnostic factor . Rumination and worry are partly responsible for the cross-sectional and prospect i ve co-occurrence of affective disorders and may be suitable targets for treatment",
"Major depressive disorder ( MDD ) is a common , debilitating chronic condition in the United States and worldwide . Particularly in women , depressive symptoms are often accompanied by high levels of stress and ruminations , or repetitive self-critical negative thinking . There is a research and clinical imperative to evaluate complementary therapies that are acceptable and feasible for women with depression and that target specific aspects of depression in women , such as ruminations . To begin to address this need , we conducted a r and omized , controlled , mixed- methods community-based study comparing an 8-week yoga intervention with an attention-control activity in 27 women with MDD . After controlling for baseline stress , there was a decrease in depression over time in both the yoga group and the attention-control group , with the yoga group having a unique trend in decreased ruminations . Participants in the yoga group reported experiencing increased connectedness and gaining a coping strategy through yoga . The findings provide support for future large scale research to explore the effects of yoga for depressed women and the unique role of yoga in decreasing rumination",
"Eighty-four prenatally depressed women were r and omly assigned to yoga , massage therapy or st and ard prenatal care control groups to determine the relative effects of yoga and massage therapy on prenatal depression and neonatal outcomes . Following 12 weeks of twice weekly yoga or massage therapy sessions ( 20 min each ) both therapy groups versus the control group had a greater decrease on depression , anxiety and back and leg pain scales and a greater increase on a relationship scale . In addition , the yoga and massage therapy groups did not differ on neonatal outcomes including gestational age and birthweight , and those groups , in turn , had greater gestational age and birthweight than the control group",
"The implementation of yogic practice s has proven benefits in both organic and psychological diseases . Forty-five women with anxiety selected by a r and om sampling method were divided into three groups . Experimental group I was subjected to asanas , relaxation and pranayama while Experimental group II was subjected to an integrated yoga module . The control group did not receive any intervention . Anxiety was measured by Taylor 's Manifest Anxiety Scale before and after treatment . Frustration was measured through Reaction to Frustration Scale . All data were spread in an Excel sheet to be analysed with SPSS 16 software using analysis of covariance ( ANCOVA ) . Selected yoga and asanas decreased anxiety and frustration scores but treatment with an integrated yoga module result ed in significant reduction of anxiety and frustration . To conclude , the practice of asanas and yoga decreased anxiety in women , and yoga as an integrated module significantly improved anxiety scores in young women with proven anxiety without any ill effects"
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4116eca0-06ff-11f0-808a-c43d1ab1c353
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ABSTRACT Objective : The aim of this systematic review and meta- analysis was to determine and clarify the impact of curcuminoids on serum lipid levels . Methods : R and omized controlled trials ( RCTs ) investigating the effects of curcuminoids on plasma lipids were search ed in PubMed - Medline , Scopus , Web of Science data bases ( from inception to April 3rd , 2017 ) . A r and om-effects model and generic inverse variance method were used for quantitative data synthesis . Sensitivity analysis was conducted using the leave-one-out method . A weighted r and om-effects meta-regression was performed to evaluate the impact of potential confounders on lipid concentrations . Results : A meta- analysis of 20 RCTs with 1427 participants suggested a significant decrease in plasma concentrations of triglycerides ( WMD : −21.36 mg/dL , 95 % CI : −32.18 , −10.53 , p an elevation in plasma HDL-C levels ( WMD : 1.42 mg/dL , 95 % CI : 0.03 , 2.81 , p = 0.046 ) , while plasma levels of LDL-C ( WMD : −5.82 mg/dL , 95 % CI : −15.80 , 4.16 , p = 0.253 ) and total cholesterol ( WMD : −9.57 mg/dL , 95 % CI : −20.89 , 1.75 , p = 0.098 ) were not altered . The effects of curcuminoids on lipids were not found to be dependent on the duration of supplementation . Conclusion : This meta- analysis has shown that curcuminoid therapy significantly reduces plasma triglycerides and increases HDL-C levels
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[
"Dyslipidemia is a leading risk factor for cardiovascular disease and is also a common feature of obesity . Curcumin is a bioactive phytochemical with well-known antioxidant , anti-inflammatory , and cardioprotective properties . The present study investigated the hypolipidemic activity of curcumin in obese individuals . Participants ( n = 30 ) were treated with curcuminoids ( 1 g/day ) , or placebo in a r and omized , double-blind , placebo-controlled , crossover trial . Serum concentrations of total cholesterol , triglycerides , low-density lipoprotein cholesterol and high-density lipoprotein cholesterol , together with anthropometric parameters and high-sensitivity C-reactive protein were measured before and after each treatment period . Anthropometric parameters including weight , BMI , waist circumference , hip circumference , arm circumference , and body fat remained statistically unchanged by the end of trial ( p > 0.05 ) . As for the lipid profile parameters , serum triglycerides were significantly reduced following curcumin supplementation ( p = 0.009 ) . However , curcuminoids were not found to affect serum levels of total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , and high-sensitivity C-reactive protein ( p > 0.05 ) . In summary , the findings of the present study indicated that curcuminoid supplementation ( 1 g/day for 30 days ) leads to a significant reduction in serum triglycerides concentrations but do not have a significant influence on other lipid profile parameters as well as body mass index and body fat",
"Background and Purpose — Treatment with statins reduces the rate of cardiovascular events in high-risk patients , but residual risk persists . At least part of that risk may be attributable to atherogenic dyslipidemia characterized by low high-density lipoprotein cholesterol ( ⩽40 mg/dL ) and high triglycerides ( triglycerides ≥150 mg/dL ) . Methods — We studied subjects with stroke or transient ischemic attack in the Prevention of Cerebrovascular and Cardiovascular Events of Ischemic Origin With Terutroban in Patients With a History of Ischemic Stroke or Transient Ischemic Attack ( PERFORM ; n=19 100 ) and Stroke Prevention by Aggressive Reduction in Cholesterol Levels ( SPARCL ; n=4731 ) trials who were treated with a statin and who had high-density lipoprotein cholesterol and triglycerides measurements 3 months after r and omization ( n=10 498 and 2900 , respectively ) . The primary outcome measure for this exploratory analysis was the occurrence of major cardiovascular events ( nonfatal myocardial infa rct ion , nonfatal stroke , or cardiovascular death ) . We also performed a time-varying analysis to account for all available high-density lipoprotein cholesterol and triglyceride measurements . Results — A total of 10 % of subjects in PERFORM and 9 % in SPARCL had atherogenic dyslipidemia after ≥3 months on start statin therapy . After a follow-up of 2.3 years ( PERFORM ) and 4.9 years ( SPARCL ) , a major cardiovascular event occurred in 1123 and 485 patients in the 2 trials , respectively . The risk of major cardiovascular events was higher in subjects with versus those without atherogenic dyslipidemia in both PERFORM ( hazard ratio , 1.36 ; 95 % confidence interval , 1.14–1.63 ) and SPARCL ( hazard ratio , 1.40 ; 95 % confidence interval , 1.06–1.85 ) . The association was attenuated after multivariable adjustment ( hazard ratio , 1.23 ; 95 % confidence interval , 1.03–1.48 in PERFORM and hazard ratio , 1.24 ; 95 % confidence interval , 0.93–1.65 in SPARCL ) . Time-varying analysis confirmed these findings . Conclusions — The presence of atherogenic dyslipidemia was associated with higher residual cardiovascular risk in PERFORM and SPARCL subjects with stroke or transient ischemic attack receiving statin therapy . Specific therapeutic interventions should now be trialed to address this residual risk",
"SCOPE Curcuminoids are poorly bioavailable , but potentially lipid- and inflammation-lowering phytochemicals . We hypothesized that curcuminoids , when administered as a micellar formulation with hundredfold enhanced bioavailability , decrease blood lipids and inflammation in subjects with moderately elevated cholesterol and C-reactive protein concentrations . METHODS AND RESULTS We carried out a r and omized , double-blind , crossover study ( 4-wk washout phase ) with 42 subjects consuming 294 mg curcuminoids per day ( as micelles ) or placebo for 6 wk . At the beginning , after 3 wk and at the end ( 6 wk ) of each intervention , we collected fasting blood sample s to determine curcuminoids , blood lipids , and markers of inflammation , glucose and iron homeostasis , and liver toxicity . Daily ingestion of 98 mg micellar curcuminoids with each principal meal for as little as 3 wk result ed in fasting curcuminoid plasma concentrations of 49 nmol/L. Neither blood lipids , nor markers of inflammation , glucose and iron homeostasis , or liver enzymes differed between curcuminoid and placebo interventions . CONCLUSION Consumption of 98 mg of highly bioavailable curcuminoids with each principal meal sufficed to achieve curcuminoid accumulation in the blood , was safe , and did not alter blood lipids , inflammation , glucose , or iron homeostasis in healthy subjects with slightly elevated blood cholesterol and C-reactive protein",
"Skin is among the first and most heavily damaged organs upon sulphur mustard ( SM ) exposure . Pruritus is the most common chronic skin complication of SM , which adversely affects the quality of life ( QoL ) . However , current therapies for the management of SM-induced pruritus are very limited and associated with side effects . The present trial investigated the efficacy of curcumin in the alleviation of SM-induced chronic pruritic symptoms . A total of ninety-six male Iranian veterans ( age 37 - 59 years ) were r and omised to receive either curcumin ( 1 g/d , n 46 ) or placebo ( n 50 ) for 4 weeks . Serum concentrations of substance P and activities of antioxidant enzymes were measured at baseline and at the end of the trial . Assessment of pruritus severity was performed using the pruritus score , visual analogue scale ( VAS ) and scoring atopic dermatitis ( SCORAD ) index . QoL was evaluated using the Dermatology Life Quality Index ( DLQI ) question naire . Serum concentrations of substance P ( P activities of superoxide dismutase ( P=0·02 ) , glutathione peroxidase ( P=0·006 ) and catalase ( P . Curcumin supplementation was also associated with significant reductions in measures of pruritus severity including the pruritus score ( P , VAS score ( P and objective SCORAD ( P=0·009 ) , and DLQI 's first question ( P the placebo group . As for the QoL , although DLQI scores decreased in both groups ( P the curcumin and placebo groups , respectively ) , the magnitude of reduction was significantly greater in the curcumin group ( P<0·001 ) . In conclusion , curcumin may be regarded as a natural , safe , widely available and inexpensive treatment for the management of SM-induced chronic pruritus",
"Curcumin is a phytocompound found in the root of turmeric , a common herbal ingredient in many Asian cuisines . The compound contains anti-inflammatory activity , which is mediated through an up-regulation of adiponectin and reduction of leptin . Consumption of curcumin was shown to prevent some deteriorative conditions caused by inflammation , such as ulcerative colitis , rheumatoid arthritis and esophagitis , and so on . Inflammation-associated cardiovascular conditions such as atherosclerosis are common in diabetes patients . The anti-inflammation effect of curcumin might be beneficial to prevent such condition in these patients . We aim to evaluate an antiatherosclerosis effect of curcumin in diabetes patients . Effects of curcumin on risk factors for atherosclerosis were investigated in a 6-month r and omized , double-blinded and placebo-controlled clinical trial that included subjects diagnosed with type 2 diabetes . An atherosclerosis parameter , the pulse wave velocity , and other metabolic parameters in patients treated with placebo and curcumin were compared . Our results showed that curcumin intervention significantly reduced pulse wave velocity , increased level of serum adiponectin and decreased level of leptin . These results are associated with reduced levels of homeostasis model assessment -insulin resistance , triglyceride , uric acid , visceral fat and total body fat . In summary , a 6-month curcumin intervention in type 2 diabetic population lowered the atherogenic risks . In addition , the extract helped to improve relevant metabolic profiles in this high-risk population",
"SCOPE We previously found that curcuminoids decreased blood glucose and improved insulin resistance by reducing serum free fatty acids ( FFAs ) and increasing fatty acid oxidation in skeletal muscle of diabetic rats . This study was to investigate whether curcuminoids have beneficial effects on type 2 diabetic patients , and its possible mechanisms . METHODS AND RESULTS Overweight/obese type 2 diabetic patients ( BMI ≥ 24.0 ; fasting blood glucose ≥ 7.0 mmol/L or postpr and ial blood glucose ≥11.1 mmol/L ) were r and omly assigned to curcuminoids ( 300 mg/day ) or placebo for 3 months . Bodyweight , glycosylated hemoglobin A1c ( HbA1c , % ) , serum fasting glucose , FFAs , lipids , and lipoprotein lipase ( LPL ) were determined . A total of 100 patients ( curcuminoids , n = 50 ; placebo , n = 50 ) completed the trial . Curcuminoids supplementation significantly decreased fasting blood glucose ( p ) , HbA1c ( p = 0.031 ) , and insulin resistance index ( HOMA-IR ) ( p type 2 diabetic patients . Curcuminoids also led to a significant decrease in serum total FFAs ( p ( P = 0.018 ) , an increase in LPL activity ( p of curcuminoids in type 2 diabetes , which is partially due to decrease in serum FFAs , which may result from promoting fatty acid oxidation and utilization",
"Numerous interventional studies in clinical and pre clinical setting stated that intake of curcumin may provide protection against cardiovascular disease . The aim of this trial was investigation of curcumin efficiency on some cardiovascular risk factors in patients with coronary artery disease ( CAD ) . A total of 33 patients with CAD who fulfilled inclusion and exclusion criteria were entered the study . Patients were r and omly assigned to receive curcumin or placebo , 500 mg capsules , four times daily for 8 weeks . Lipid profile , blood glucose and high sensitive C-reactive protein ( hs-CRP ) levels were analyzed at baseline and two months after treatment . Serum levels of triglycerides ( P=0.01 ) , LDL-cholesterol ( P=0.03 ) and VLDL-cholesterol ( P=0.04 ) significantly decreased in the curcumin group compared to baseline , without significant changes in total cholesterol , HDL-cholesterol , blood glucose and hs-CRP levels . In all mentioned laboratory parameters , significant difference was not detected between curcumin and placebo . Although curcumin improved some of lipid profile components , it did not show appreciable effect on inflammatory markers in patients with CAD . Therefore , more detailed assessment of metabolic effects or anti-inflammatory activities of curcumin need to perform by extensive human study",
"Background . Obesity is a disorder often accompanied by a heightened state of systemic inflammation and immunoactivation . The present r and omized crossover trial aim ed to investigate the efficacy of curcumin , a bioactive polyphenol with established anti-inflammatory and immunomodulatory effects , on the serum levels of a panel of cytokines and mediators in obese individuals . Methods . Thirty obese individuals were r and omized to receive curcumin at a daily dose of 1 g or a matched placebo for 4 weeks . Following a 2-week wash-out period , each group was assigned to the alternate treatment regimen for another 4 weeks . Serum sample s were collected at the start and end of each study period . Serum levels of IL-1α , IL-1β , IL-2 , IL-4 , IL-6 , IL-8 , IL-10 , VEGF , IFNγ , EGF , MCP-1 , and TNFα were measured using a multiplex Biochip Array Technology based method . Results . Mean serum IL-1β ( P = 0.042 ) , IL-4 ( P = 0.008 ) , and VEGF ( P = 0.01 ) were found to be significantly reduced by curcumin therapy . In contrast , no significant difference was observed in the concentrations of IL-2 , IL-6 , IL-8 , IL-10 , IFNγ , EGF , and MCP-1 . Conclusions . The findings of the present trial suggested that curcumin may exert immunomodulatory effects via altering the circulating concentrations of IL-1β , IL-4 , and VEGF",
"Background Patients with prior vascular disease remain at high risk for cardiovascular events despite intensive statin – based treatment . Inhibition of cholesteryl ester transfer protein by anacetrapib reduces low‐density lipoprotein ( LDL ) cholesterol by around 25 % to 40 % and more than doubles high‐density lipoprotein ( HDL ) cholesterol . However , it is not known if these apparently favorable lipid changes translate into reductions in cardiovascular events . Methods The REVEAL study is a r and omized , double‐blind , placebo‐controlled clinical trial that is assessing the efficacy and safety of adding anacetrapib to effective LDL‐lowering treatment with atorvastatin for an average of at least 4 years among patients with preexisting atherosclerotic vascular disease . The primary assessment is an intention‐to‐treat comparison among all r and omized participants of the effects of allocation to anacetrapib on major coronary events ( defined as the occurrence of coronary death , myocardial infa rct ion , or coronary revascularization ) . Results Between August 2011 and October 2013 , 30,449 individuals in Europe , North America , and China were r and omized to receive anacetrapib 100 mg daily or matching placebo . Mean ( SD ) age was 67 ( 8) years , 84 % were male , 88 % had a history of coronary heart disease , 22 % had cerebrovascular disease , and 37 % had diabetes mellitus . At the r and omization visit ( after at least 8 weeks on a protocol ‐defined atorvastatin regimen ) , mean plasma LDL cholesterol was 61 ( 15 ) mg/dL and HDL cholesterol was 40 ( 10 ) mg/dL. Interpretation The REVEAL trial will provide a robust evaluation of the clinical efficacy and safety of adding anacetrapib to an effective statin regimen . Results are anticipated in 2017",
"Objective : Diabetes mellitus is defined as a group of metabolic diseases characterized by hyperglycemia result ing from defects in insulin secretion , insulin action , or both or insulin resistance . Curcumin inhibits NF-κB signaling pathway . The aim of this study is evaluation of the effect of Nano-curcumin on HbA1C , fast blood glucose and lipid profile in diabetic patients . Material s and Methods : Seventy type-2 diabetic patients ( fasting blood glucose ( FBG ) ≥ 126 mg/dL or 2-hr postpr and ial blood glucose ≥200 mg/dl ) r and omly receivedeither Curcumin ( as nano-micelle 80 mg/day ) or placebo for 3 months in a double blind r and omized clinical trial . Fasting blood glucose , HbA1C , and lipids profile were checked before and after the intervention . Data analyses , including parametric and nonparametric tests were done using the SPSS 11.5 software . A p value Results : Mean age , BMI , FBG , total cholesterol ( TC ) , triglyceride ( TG ) , LDL , HDL , HbA1c , and sex and had no significant difference at the baseline between the groups . In Nano-curcumin group , a significant decrease was found in HbA1C , FBG , TG , and BMI comparing results of each subject before and after the treatment ( p groups , HbA1c , eAG , LDL-C , and BMI variables showed significant differences ( p HbA1c lowering effect for Nano-curcumin in type-2 diabetes ; also , it is partially decrease in serum LDL-C and BMI ",
"Background Curcumin extracts of turmeric are proposed to produce health benefits . To date , human intervention studies have focused mainly on people with existing health problems given high doses of poorly absorbed curcumin . The purpose of the current study was to check whether in healthy people , a low dose of a lipi date d curcumin extract could alter wellness-related measures . Methods The present study was conducted in healthy middle aged people ( 40–60 years old ) with a low dose of curcumin ( 80 mg/day ) in a lipi date d form expected to have good absorption . Subjects were given either curcumin ( N = 19 ) or placebo ( N = 19 ) for 4 wk . Blood and saliva sample s were taken before and after the 4 weeks and analyzed for a variety of blood and saliva measures relevant to health promotion . Results Curcumin , but not placebo , produced the following statistically significant changes : lowering of plasma triglyceride values , lowering of salivary amylase levels , raising of salivary radical scavenging capacities , raising of plasma catalase activities , lowering of plasma beta amyloid protein concentrations , lowering of plasma sICAM readings , increased plasma myeloperoxidase without increased c-reactive protein levels , increased plasma nitric oxide , and decreased plasma alanine amino transferase activities . Conclusion Collectively , these results demonstrate that a low dose of a curcumin-lipid preparation can produce a variety of potentially health promoting effects in healthy middle aged people",
"Purpose COPD is mainly caused by tobacco smoking and is associated with a high frequency of coronary artery disease . There is growing recognition that the inflammation in COPD is not only confined to the lungs but also involves the systemic circulation and can impact nonpulmonary organs , including blood vessels . α1-antitrypsin – low-density lipoprotein ( AT-LDL ) complex is an oxidatively modified LDL that accelerates atherosclerosis . Curcumin , one of the best-investigated natural products , is a powerful antioxidant . However , the effects of curcumin on AT-LDL remain unknown . We hypothesized that Theracurmin ® , a highly absorptive curcumin with improved bioavailability using a drug delivery system , ameliorates the inflammatory status in subjects with mild COPD . Patients and methods This is a r and omized , double-blind , parallel-group study . Subjects with stages I – II COPD according to the Japanese Respiratory Society criteria were r and omly assigned to receive 90 mg Theracurmin ® or placebo twice a day for 24 weeks , and changes in inflammatory parameters were evaluated . Results There were no differences between the Theracurmin ® and placebo groups in terms of age , male/female ratio , or body mass index in 39 evaluable subjects . The percent changes in blood pressure and hemoglobin A1c and LDL-cholesterol , triglyceride , or high-density lipoprotein-cholesterol levels after treatment were similar for the two groups . However , the percent change in the AT-LDL level was significantly ( P=0.020 ) lower in the Theracurmin ® group compared with the placebo group . Conclusion Theracurmin ® reduced levels of atherosclerotic AT-LDL , which may lead to the prevention of future cardiovascular events in mild COPD subjects",
"ABSTRACT Oxidative stress is implicated in the pathogenesis of osteoarthritis . Curcuminoids are natural polyphenols with strong antioxidant capacity and may thus be helpful in the treatment of osteoarthritis . The present r and omized double-blind placebo-controlled trial investigated the efficacy of curcuminoids in reducing systemic oxidative burden in patients suffering from knee osteoarthritis . Forty patients with mild-to-moderate primary knee osteoarthritis were given curcuminoid capsules ( 1500 mg/day in 3 divided doses ; n = 19 ) or matched placebo capsules ( n = 21 ) for a period of 6 weeks . Curcuminoids were co-administered with piperine ( 15 mg/day ) in order to improve the bioavailability . Serum activities of superoxide dismutase ( SOD ) and concentrations of reduced glutathione ( GSH ) and malonedialdehyde ( MDA ) were determined spectrophotometrically at baseline and at the end of the treatment period in both groups . Serum activities of SOD as well as GSH and MDA concentrations were comparable between the study groups at baseline ( p > 0.05 ) . There was a significant elevation in serum SOD activities ( mean change : 2.94 ± 3.73 vs. −0.38 ± 1.33 ; p borderline significant elevation in GSH concentrations ( mean change : 1.39 ± 2.78 vs. −0.02 ± 1.62 ; p = 0.064 ) and a significant reduction in MDA concentrations ( mean change : −5.26 ± 4.46 vs. −2.49 ± 3.81 ; p = 0.044 ) in the curcuminoids compared with the placebo group . Changes in serum activities of SOD and concentrations of GSH and MDA during the course of trial were significantly correlated . Short-term supplementation with curcuminoids attenuates systemic oxidative stress in patients with osteoarthritis . These antioxidant effects may account for the reported therapeutic effects of curcuminoids in relieving osteoarthritis symptoms",
"Background : Nonalcoholic fatty liver disease ( NAFLD ) is one of the most common hepatic diseases in the general adult population . Dyslipidemia , hyperuricemia , and insulin resistance are common risk factors and accompanying features of NAFLD . Curcumin is a dietary natural product with beneficial metabolic effects relevant to the treatment of NAFLD . Aim : To assess the effects of curcumin on metabolic profile in subjects with NAFLD . Methods : Patients diagnosed with NAFLD ( grade s 1–3 ; according to liver sonography ) were r and omly assigned to curcumin ( 1000 mg/d in 2 divided doses ) ( n = 50 ) or control ( n = 52 ) group for a period of 8 weeks . All patients received dietary and lifestyle advises before the start of trial . Anthropometric measurements , lipid profile , glucose , insulin , glycated hemoglobin , and uric acid concentrations were measured at baseline and after 8 weeks of follow-up . Results : Eighty-seven subjects ( n = 44 and 43 in the curcumin and control group , respectively ) completed the trial . Supplementation with curcumin was associated with a reduction in serum levels of total cholesterol ( P , low-density lipoprotein cholesterol ( P ) , triglycerides ( P , non – high-density lipoprotein cholesterol ( P and uric acid ( P whereas serum levels of high-density lipoprotein cholesterol and glucose control parameters remained unaltered . Curcumin was safe and well tolerated during this study . Conclusion : Results of the present trial suggest that curcumin supplementation reduces serum lipids and uric acid concentrations in patients with NAFLD",
"Abstract Background and objective : Hyperglycaemia leads to increased oxidative stress result ing in endothelial dysfunction . ACE inhibitors , antioxidants and HMG-CoA reductase inhibitors ( statins ) have been shown to improve endothelial function . The aim of this study was to compare the effects of NCB-02 ( a st and ardized preparation of curcuminoids ) , atorvastatin and placebo on endothelial function and its biomarkers in patients with type 2 diabetes mellitus . Methods : A total of 72 patients with type 2 diabetes were r and omized to receive NCB-02 ( two capsules containing curcumin 150 mg twice daily ) , atorvastatin 10 mg once daily or placebo for 8 weeks . Endothelial function assessment was performed at baseline and post-treatment using digital volume plethysmography ( salbutamol [ albuterol ] challenge test ) to measure change in reflective index , an indicator of arterial vascular tone . Blood sample s were similarly collected at baseline and post-treatment for estimations of malondialdehyde , endothelin-1 ( ET-1 ) , interleukin-6 ( IL-6 ) and tumour necrosis factor-α ( TNFα ) . Pre- and posttreatment safety assessment s were also conducted . ANOVA and paired t-test evaluations were used for comparison . Results : A total of 67 patients completed the study . At baseline , there was no significant difference in the various parameters tested . In all three groups , the change in reflective index at baseline was improvement in endothelial function after treatment with atorvastatin ( mean ± SD : −3.63 ± 3.17 % vs −8.95 ± 6.80 % , respectively ) and NCB-02 ( −2.69 ± 3.02 % vs −8.19 ± 5.73 % , respectively ) . Similarly , patients receiving atorvastatin or NCB-02 showed significant reductions in the levels of malondialdehyde , ET-1 , IL-6 and TNFα . No significant improvements were obtained in patients administered placebo . Conclusion : NCB-02 had a favourable effect , comparable to that of atorvastatin , on endothelial dysfunction in association with reductions in inflammatory cytokines and markers of oxidative stress . Further studies are needed to evaluate the potential long-term effects of NCB-02 and its combination with other herbal antioxidants ",
"Curcuminoids have potentially important functional qualities including anti-inflammatory and antioxidant properties . In this r and omized double-blind placebo-controlled cross-over trial , the effects of a curcuminoid supplement on serum pro-oxidant-antioxidant balance ( PAB ) and antibody titres to Hsp27 ( anti-Hsp27 ) and oxLDL ( anti-oxLDL ) were investigated . Thirty obese individuals were r and omized to receive either curcuminoids ( 1 g/day ) or placebo for a period of 30 days . After a wash-out period of 2 weeks , subjects were crossed over to the alternate regimen for another 30 days . Serum PAB along with anti-Hsp27 and anti-oxLDL titres was measured at the beginning and at the end of each study period . There was no significant carry-over effect for any of the assessed parameters . Curcuminoid supplementation was associated with a significant decrease in PAB ( p = 0.044 ) . However , no significant change was observed in serum concentrations of anti-Hsp27 or anti-oxLDL ( p > 0.05 ) . These findings suggest that oral curcuminoids supplementation ( 1g/day ) is effective in reducing oxidative stress burden , though this needs to be vali date d in larger study population",
"AIM to evaluate the effects of curcumin on total cholesterol , LDL cholesterol , HDL cholesterol , and triglyceride in acute coronary syndrome patients . METHODS this study were conducted at Dr. Cipto Mangunkusumo General Hospital ( RSUPN-CM ) , Persahabatan Hospital , MMC Hospital and Medistra Hospital , Jakarta . The study started from 1 May 2005 to 5 May 2006 . Study Design was an interventional study which was a r and omized double blind controlled trial to evaluate the effects of curcumin administration at escalating doses ( low dose 3 times 15 mg/day , moderate dose 3 times 30 mg/day , and high dose 3 times 60 mg/day ) on total cholesterol level , LDL cholesterol level , HDL cholesterol level , and triglyceride level in ACS patients . RESULTS a 75 ACS patients undergoing r and omization participated in r and omized controlled trial ( RCT ) . Of the 75 ACS patients participating in that RCT , 67 received care at RSCM , 6 at Persahabatan Hospital , and 2 at MMC Hospital . As many as 63 patients were able to participate in the RCT up to its conclusion . There was no significant difference in age , sex , risk factor of dyslipidemia , DM , smoking , hypertension , CHD history in family , height , body weight and body mass index , waist circumference , systolic blood pressure , diastolic blood pressure in the four groups of patients . This showed that the r and omization performed was reasonably good . There was no significant difference in laboratory parameters , such as total cholesterol , LDL cholesterol , HDL cholesterol , and triglyceride , fasting blood glucose , blood glucose 2 hours PP , glyco Hb , triglyceride , Hb , Ht , leukocyte , thrombocyte , ureum , creatinine , SGOT , SGPT , in the four groups . There was no significant difference in types of ACS and locations of ACS in the four groups as well . There was no significant difference in statin medicatios ( simvastatin ) , aspirin ACE inhibitor , and DM medications in the four groups . No patient used tiazolidindion . No significant difference was found in the percentage of compliance in the four groups of patients . The effects of curcumin on total cholesterol level and LDL cholesterol level , there was a trend that the lower the dose of curcumin , the higher the effect of reduction . For HDL cholesterol level , there was also a trend that the lower the dose of curcumin , the higher the effect of increase in HDL cholesterol level . However , for triglyceride the pattern was not the same , and the group of moderate-dose curcumin shoed the minimal effect of increase , followed by the low-dose curcumin and finally the high-dose curcumin that showed the highest effect of increase . CONCLUSION the administration of low-dose curcumin showed a trend of reduction in total cholesterol level and LDL cholesterol level in ACS patients",
"Curcumin possesses many properties which may prevent or ameliorate pathological processes underlying age-related cognitive decline , dementia or mood disorders . These benefits in pre clinical studies have not been established in humans . This r and omized , double-blind , placebo-controlled trial examined the acute ( 1 and 3 h after a single dose ) , chronic ( 4 weeks ) and acute-on-chronic ( 1 and 3 h after single dose following chronic treatment ) effects of solid lipid curcumin formulation ( 400 mg as Longvida ® ) on cognitive function , mood and blood biomarkers in 60 healthy adults aged 60–85 . One hour after administration curcumin significantly improved performance on sustained attention and working memory tasks , compared with placebo . Working memory and mood ( general fatigue and change in state calmness , contentedness and fatigue induced by psychological stress ) were significantly better following chronic treatment . A significant acute-on-chronic treatment effect on alertness and contentedness was also observed . Curcumin was associated with significantly reduced total and LDL cholesterol and had no effect on hematological safety measures . To our knowledge this is the first study to examine the effects of curcumin on cognition and mood in a healthy older population or to examine any acute behavioral effects in humans . Results highlight the need for further investigation of the potential psychological and cognitive benefits of curcumin in an older population",
"The identification of factors contributing to residual cardiovascular risk is important to improve the management of patients with established coronary artery disease ( CAD ) . This study was conducted to assess the predictive value of atherogenic dyslipidemia ( defined as high triglycerides and low high-density lipoprotein [ HDL ] cholesterol ) for long-term outcomes in patients with CAD . In 284 patients ( 238 men , 46 women ; mean age at baseline 59.2 + /- 8.9 years ) with coronary stenosis ( > 50 % in > or = 1 vessel ) , the presence of atherogenic dyslipidemia was prospect ively associated with the incidence of major adverse cardiovascular events ( MACEs ) during a median follow-up of 7.8 years . MACEs were defined as cardiovascular death , nonfatal myocardial infa rct ion , nonfatal stroke , the recurrence of angina , and revascularization procedures . MACEs were observed in 111 ( 39.1 % ) patients with CAD . MACEs occurred more frequently in patients with atherogenic dyslipidemia ( 50.9 % ) than in those with isolated low HDL cholesterol or high triglycerides ( 33.0 % ) or with normal HDL cholesterol and triglyceride concentrations ( 29.2 % ) ( p Kaplan-Meier survival analysis showed a decrease in event-free survival in patients with compared with those without atherogenic dyslipidemia ( log-rank p = 0.006 ) . Patients with atherogenic dyslipidemia presented with increased plasma concentrations of remnants , denser low-density lipoprotein , more atherogenic HDL particles , and insulin-resistant status . After adjustment for potential confounding variables , the magnitude of increased risk associated with atherogenic dyslipidemia was 1.58 ( 95 % confidence interval 1.12 to 2.21 , p = 0.008 ) . In conclusion , these data provide evidence that atherogenic dyslipidemia is an independent predictor of cardiovascular risk in patients with CAD , even stronger than isolated high triglycerides or low HDL cholesterol",
"Curcuminoids are bioactive polyphenolics with potent antiinflammatory properties . Although several lines of in vitro and pre clinical evidence suggest potent anticancer effects of curcuminoids , clinical findings have not been conclusive . The present r and omized double-blind placebo-controlled trial aim ed to evaluate the efficacy of curcuminoids as adjuvant therapy in cancer patients . Eighty subjects with solid tumors who were under st and ard chemotherapy regimens were r and omly assigned to a bioavailability-boosted curcuminoids preparation ( 180 mg/day ; n = 40 ) or matched placebo ( n = 40 ) for a period of 8 weeks . Efficacy measures were changes in the health-related quality of life ( QoL ) score ( evaluated using the University of Washington index ) and serum levels of a panel of mediators implicated in systemic inflammation including interleukins 6 ( IL-6 ) and 8 ( IL-8 ) , TNF-α , transforming growth factor-β ( TGFβ ) , high-sensitivity C-reactive protein ( hs-CRP ) , calcitonin gene-related peptide ( CGRP ) , substance P and monocyte chemotactic protein-1 ( MCP-1 ) . Curcuminoid supplementation was associated with a significantly greater improvement in QoL compared with placebo ( p reductions in TNF-α ( p , TGFβ ( p 0.001 ) , IL-6 ( p = 0.061 ) , substance P ( p = 0.005 ) , hs-CRP ( p and MCP-1 ( p reduction in serum IL-8 was significantly greater with placebo versus curcuminoids ( p = 0.012 ) . Quality of life variations were associated with changes in serum TGFβ levels in both correlation and regression analyses . Adjuvant therapy with a bioavailable curcuminoid preparation can significantly improve QoL and suppress systemic inflammation in patients with solid tumors who are under treatment with st and ard chemotherapy protocol",
"BACKGROUND Type 2 diabetes ( T2D ) is an established risk factor for cardiovascular disease ( CVD ) and is associated with disturbed metabolism of lipids and lipoproteins . Curcuminoids are natural products with anti-diabetic and lipid-modifying actions but their efficacy in improving dyslipidemia in diabetic individuals has not been sufficiently studied . OBJECTIVE To investigate the efficacy of supplementation with curcuminoids , plus piperine as an absorption enhancer , in improving serum lipids in patients with T2D . METHODS In this 12-week r and omized double-blind placebo-controlled trial , subjects with T2D ( n=118 ) were assigned to curcuminoids ( 1000mg/day plus piperine 10mg/day ) or placebo plus st and ard of care for T2D . Serum concentrations of lipids including total cholesterol ( TC ) , low-density lipoprotein cholesterol ( LDL-C ) , high-density lipoprotein cholesterol ( HDL-C ) , triglycerides ( TG ) , lipoprotein(a ) [ Lp(a ) ] , and non-HDL-C were determined at baseline and at the end of trial . RESULTS Between-group comparison of change in the study parameters revealed significant reductions in serum levels of TC ( -21.86±25.78 versus -17.06±41.51 , respectively ; p=0.023 ) , non-HDL-C ( -23.42±25.13 versus -16.84±41.42 , respectively ; p=0.014 ) and Lp(a ) ( -1.50±1.61 versus -0.34±1.73 , respectively ; p=0.001 ) and elevations in serum HDL-C levels ( 1.56±4.25 versus -0.22±4.62 , respectively ; p=0.048 ) in the curcuminoids group as compared with the placebo group ( p changes did not show any significant difference between the study groups ( p>0.05 ) . CONCLUSION Curcuminoids supplementation can reduce serum levels of atherogenic lipid indices including non-HDL-C and Lp(a ) . Therefore , curcuminoids supplementation could contribute to a reduced risk of cardiovascular events in dyslipidemic patients with T2D",
"Non-alcoholic fatty liver disease ( NAFLD ) is a global health problem . Although many aspects of NAFLD pathogenesis have been understood , there is a paucity of effective treatments to be used as the second line when lifestyle modification is insufficient . Curcumin , a natural polyphenol from turmeric , has been shown to be effective against development of hepatic steatosis and its progression to steatohepatitis , yet these beneficial effects have not been explored in clinical practice . The aim of this study is to investigate the effects of curcumin on hepatic fat content as well as biochemical and anthropometric features of patients with NAFLD . In this r and omized double-blind placebo-controlled trial , patients with ultrasonographic evidence of NAFLD were r and omly assigned to receive an amorphous dispersion curcumin formulation ( 500 mg/day equivalent to 70-mg curcumin ) or matched placebo for a period of 8 weeks . Liver fat content ( assessed through ultrasonography ) , glycemic and lipid profile , transaminase levels , and anthropometric indices were evaluated at baseline and at the end of follow-up period . The clinical trial protocol was registered under the Iranian Registry of Clinical Trials ID : I RCT 2014110511763N18 . Compared with placebo , curcumin was associated with a significant reduction in liver fat content ( 78.9 % improvement in the curcumin vs 27.5 % improvement in the placebo group ) . There were also significant reductions in body mass index and serum levels of total cholesterol , low-density lipoprotein cholesterol , triglycerides , aspartate aminotransferase , alanine aminotransferase , glucose , and glycated hemoglobin compared with the placebo group . Curcumin was safe and well tolerated during the course of trial . Findings of the present proof-of-concept trial suggested improvement of different features of NAFLD after a short-term supplementation with curcumin . Copyright © 2016 John Wiley & Sons ,",
"Studies in animals and a short-term human study have suggested that curcumin , a polyphenolic compound concentrated in the curry spice turmeric , decreases serum cholesterol concentration . However , no controlled human trials have examined the effect of curcumin on cholesterol . This study investigated the effects of consuming curcumin on the serum lipid profile in men and women . Elderly subjects ( n=36 ) consumed 4 g/d curcumin , 1g/d curcumin , or placebo in a 6-month , r and omized , double-blind trial . Plasma curcumin and its metabolites were measured at 1 month , and the serum lipid profile was measured at baseline , 1 month , and 6 months . The plasma curcumin concentration reached a mean of 490 nmol/L. The curcumin concentration was greater after capsule than powder administration . Consumption of either dose of curcumin did not significantly affect triacylglycerols , or total , LDL , and HDL cholesterol over 1 month or 6 months . However , the concentrations of plasma curcumin and serum cholesterol were positively and significantly correlated . Curcumin consumption does not appear to have a significant effect on the serum lipid profile , unless the absorbed concentration of curcumin is considered , in which case curcumin may modestly increase cholesterol",
"Pulmonary problems are among the most frequent chronic complications of sulfur mustard ( SM ) intoxication and are often accompanied by deregulated production of pro-inflammatory cytokines . Curcuminoids , comprising curcumin , demethoxycurcumin and bisdemethoxycurcumin , are phytochemicals with remarkable anti-inflammatory properties that are derived from dried rhizomes of the plant Curcuma longa L. ( turmeric ) . The present pilot study aim ed to investigate the clinical effects of supplementation with curcuminoids on markers of pulmonary function and systemic inflammation in SM-intoxicated subjects . In a r and omized double-blind placebo-controlled trial , 89 male subjects who were suffering from chronic SM-induced pulmonary complications were recruited and assigned to either curcuminoids ( 500 mg TID per oral ; n=45 ) or placebo ( n=44 ) for a period of 4 weeks . Efficacy measures were changes in the spirometric parameters ( FVC , FEV1 , FEV1/FVC ) and serum levels of inflammatory mediators including interleukins 6 ( IL-6 ) and 8 ( IL-8 ) , tumor necrosis factor-α ( TNFα ) , transforming growth factor-β ( TGFβ ) , high-sensitivity C-reactive protein ( hs-CRP ) , calcitonin gene related peptide ( CGRP ) , substance P and monocyte chemotactic protein-1 ( MCP-1 ) . 78 subjects completed the trial . Although FEV1 and FVC remained comparable between the groups , there was a greater effect of curcuminoids vs. placebo in improving FEV1/FVC ( p=0.002 ) . Curcuminoids were also significantly more efficacious compared to placebo in modulating all assessed inflammatory mediators : IL-6 ( p , IL-8 ( p=0.035 ) , TNFα ( p ) , TGFβ ( p ) , substance P ( p=0.016 ) , hs-CRP ( p ) , CGRP ( p ) and MCP-1 ( p ) . Curcuminoids were safe and well-tolerated throughout the trial . Short-term adjunctive therapy with curcuminoids can suppress systemic inflammation in patients suffering from SM-induced chronic pulmonary complications "
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Preoperative physical exercise protocol s prior to cancer surgery increased in popularity over recent years ; however , the beneficial effect of such protocol s is not well established , with conflicting results reported . We conducted a systematic review and meta- analysis of r and omized controlled trials ( RCTs ) to assess the effects of different modalities or combinations of preoperative exercise interventions and /or prehabilitation multicomponent training in patients with non-small-cell lung cancer ( NSCLC ) after surgery on the outcomes related to functional capacity , mental wellness and medical care . We search ed in OVID Embase , Pubmed , Cochrane Library , CINAHL , Scopus , and Web of Science . Characteristics of studies and program results and outcome data were extracted . Changes between the intervention and control groups , from baseline to follow-up ( st and ardized mean difference ( SMD ) or relative risk ( RR ) with 95 % confidence interval ( CI ) for each intervention was pooled using weighted r and om-effects models ) . A total of 676 participants from 10 RCTs were included in the final analysis ( aerobic training + inspiratory muscle training , n = 5 ; aerobic training + strength training + inspiratory muscle training , n = 2 ; aerobic training + strength training , n = 1 ; multicomponent training , n = 1 ; aerobic training alone , n = 1 ) . The results showed intervention-induced improvement in walking endurance ( SMD = 0.27 ; 95 % CI , 0.11 to 0.44 ; I2 = 0.0 % ) , peak exercise capacity ( SMD = 0.78 ; 95 % CI , 0.35 to 1.21 ; I2 = 76.7 % ) , dyspnoea ( SMD = -0.30 ; 95 % CI , -0.51 to -0.10 ; I2 = 0.0 % ) , risk of hospitalization ( SMD = -0.58 ; 95 % CI , -0.97 to -0.20 ; I2 = 70.7 % ) , and postoperative pulmonary complications ( relative risk ( RR ) = 0.50 ; 95 % CI , 0.39 to 0.66 ; I2 = 0.0 % ) . For the functional capacity and medical care parameters , preoperative combined aerobic , resistance , and inspiratory muscle training was shown to be effective if comprising one to four weeks , performing 1 - 3 sessions per week , with moderate intensity ( 50 % for endurance capacity ) . Further studies with larger sample s and higher method ological quality are needed to clarify the potential benefits of preoperative exercise training for patients with NSCLC
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"Background Physical activity ( PA ) improves fatigue and quality of life ( QOL ) in cancer survivors . Our aim was to assess whether a 2-month PA intervention improves fatigue and QOL for people with advanced lung cancer . Methods Participants with advanced lung cancer , Eastern Cooperative Oncology Group performance status ( PS ) ≤2 , > 6 months life expectancy , and ability to complete six-min walk test , were stratified ( disease stage , PS 0 - 1 versus 2 , centre ) and r and omized ( 1:1 ) in an open-label study to usual care ( UC ) ( nutrition and PA education material s ) or experimental intervention ( EX ) : UC plus 2-month supervised weekly PA and behaviour change sessions . Assessment s occurred at baseline , 2 , 4 , and 6 months . The primary endpoint was fatigue [ Functional Assessment of Cancer Therapy-Fatigue ( FACT-F ) question naire ] at 2 months . The study was design ed to detect a difference in mean FACT-F subscale score of 6 . Analysis was intention-to-treat using linear mixed models . Results We recruited 112 patients : 56 ( 50.4 % ) were r and omized to EX , 55(49.5 % ) to UC ; 1 ineligible . Male 55 % ; median age 64 years ( 34 - 80 ) ; 106 ( 96 % ) non-small cell lung cancer ; 106 ( 95.5 % ) stage IV . At 2 , 4 and 6 months , 90 , 73 and 62 participants were assessed , respectively , with no difference in attrition between groups . There were no significant differences in fatigue between the groups at 2 , 4 or 6 months : mean scores at 2 months EX 37.5 , UC 36.4 ( difference 1.2 , 95 % CI - 3.5 , 5.8 , P = 0.62 ) . There were no significant differences in QOL , symptoms , physical or functional status , or survival . Conclusions Adherence to the intervention was good but the intervention group did not increase their PA enough compared to the control group , and no difference was seen in fatigue or QOL . Trial Registration Australian New Zeal and Clinical Trials Registry No. ACTRN12609000971235",
"OBJECTIVES The goal of this study was to assess the impact of a preoperative 1-week , systematic , high-intensity inpatient exercise regimen on patients with lung cancer who had risk factors for postoperative pulmonary complications ( PPCs ) . METHODS We conducted a r and omized controlled trial with 101 subjects of a preoperative , 7-day systematic , integrated , high-intensity pulmonary exercise regimen . The control group received st and ard preoperative care . We analysed the occurrence of PPCs in both groups as the primary outcome ; other outcomes included changes in blood gas , quality of life , peak expiratory flow rate , the 6-min walk distance and others . RESULTS The 6-min walk distance showed an increase of 22.9 ± 25.9 m in the intervention group compared with 4.2 ± 9.2 m in the control group , giving a between-group difference of 18.7 m ( 95 % confidence interval : 8.8 - 28.6 ; P increased by 25.2 ± 24.6 l/min , compared with 4.2 ± 7.7 l/min ( between-group difference : 21.0 m , 95 % confidence interval : 7.2 - 34.8 ; P = 0.003 ) . The intervention group had a shorter average total ( 15.6 ± 3.6 vs 17.7 ± 5.3 days , P = 0.023 ) and postoperative length of stay ( 6.1 ± 3.0 vs 8.7 ± 4.6 days , P = 0.001 ) than the control group ; the incidence of PPCs ( 9.8 % , 5/51 vs 28.0 % , 14/50 , P = 0.019 ) was significantly lower . A multivariable analysis of the risk of PPCs identified short-term rehabilitation intervention to be an independent risk factor ( odds ratio = 0.156 , 95 % confidence interval : 0.037 - 0.649 , P = 0.011 ) . CONCLUSIONS The study results suggested that a systematic , high-intensity pulmonary exercise programme was a practical strategy when performed preoperatively in patients with lung cancer with risk factors for PPCs . CLINICAL TRIAL REGISTRATION ChiCTR-IOR-16008109",
"OBJECTIVES Poor aerobic fitness is a potential modifiable risk factor for long-term survival and quality of life in patients with lung cancer . This r and omized trial evaluates the impact of adding rehabilitation ( Rehab ) with high-intensity interval training ( HIIT ) before lung cancer surgery to enhance cardiorespiratory fitness and improve long-term postoperative outcome . METHODS Patients with operable lung cancer were r and omly assigned to usual care ( UC , n = 77 ) or to intervention group ( Rehab , n = 74 ) that entailed HIIT that was implemented only preoperatively . Cardiopulmonary exercise testing ( CPET ) and pulmonary functional tests ( PFTs ) including forced vital capacity ( FVC ) , forced expiratory volume ( FEV 1 ) and carbon monoxide transfer factor ( KCO ) were performed before and 1 year after surgery . RESULTS During the preoperative waiting time ( median 25 days ) , Rehab patients participated to a median of 8 HIIT sessions ( interquartile [ IQ ] 25 - 75 % , 7 - 10 ) . At 1 year follow-up , 91 % UC patients and 93 % Rehab patients were still alive ( P = 0.506 ) . Pulmonary functional changes were non-significant and comparable in both groups ( FEV 1 mean -7.5 % , 95 % CI , -3.6 to -12.9 and in KCO mean 5.8 % 95 % CI 0.8 - 11.8 ) Compared with preoperative CPET results , both groups demonstrated similar reduction in peak oxygen uptake ( mean -12.2 % 95 % CI -4.8 to -18.2 ) and in peak work rate ( mean -11.1 % 95 % CI -4.2 to -17.4 ) . CONCLUSIONS Short-term preoperative rehabilitation with HIIT does not improve pulmonary function and aerobic capacity measured at 1 year after lung cancer resection . TRIAL REGISTRY Clinical Trials.gov ; No. NCT01258478 ; www . clinical trials.gov",
"BACKGROUND The impact of short-term preoperative pulmonary rehabilitation on exercise capacity of patients with chronic obstructive pulmonary disease undergoing lobectomy for non-small cell lung cancer is evaluated . METHODS A prospect i ve observational study was design ed . Inclusion criteria consisted of an indication to lung resection because of a clinical stage I or II non-small cell lung cancer and a chronic obstructive disease on preoperative pulmonary function test . In such conditions , maximal oxygen consumption by a cardio-pulmonary exercise test was evaluated ; when this result ed as being pulmonary rehabilitation programme lasting 4 weeks was considered . Twelve patients fulfilled inclusion criteria , completed the preoperative rehabilitation programme and underwent a new functional evaluation prior to surgery . The postoperative record of these patients was collected . RESULTS On completion of pulmonary rehabilitation , the resting pulmonary function test and diffuse lung capacity of patients was unchanged , whereas the exercise performance was found to have significantly improved ; the mean increase in maximal oxygen consumption proved to be at 2.8 ml/kg/min ( p Eleven patients underwent lobectomy ; no postoperative mortality was noted and mean hospital stay was 17 days . Postoperative pulmonary complication was recorded in 8 patients . CONCLUSIONS Short-term preoperative pulmonary rehabilitation could improve the exercise capacity of patients with chronic obstructive pulmonary disease who are c and i date s for lung resection for non-small cell lung cancer",
"Abstract Background . Patients with lung cancer are often burdened by dyspnoea , fatigue , decreased physical ability and loss of weight . Earlier studies of physical exercise of patients with COPD have shown promising results . The aim of this study was to investigate , if a well-documented COPD rehabilitation protocol can improve physical fitness and quality of life ( QoL ) in patients with lung cancer . Material and methods . Forty-five patients , with a minimum walking distance of 50 meters , absence of cognitive deficits or severe heart disease and motivated for physical training were invited to an exercise intervention . The intervention consisted of seven weeks of twice weekly training , focusing on walking training , circuit training , h and ling of dyspnoea and instructions in daily diary-based training at home . Prior to , and after the intervention , Incremental- and Endurance Shuttle Walk Test ( ISWT and ESWT ) were performed , and pulmonary function as well as self-reported QoL ( EORTC-QLQ-C30 and LC13 ) were measured . Results . Fourteen subjects dropped out before commencement of the intervention . Seven were excluded after physiotherapeutic evaluation . Of the remaining 24 , three were excluded because of insufficient attendance ( thus 21 patients completed the intervention . For 17 patients with complete pre- and post intervention data , ISWT increased 9 % ( −77 to 39 % ) ( median and range ) ( p = 0.021 ) , while ESWT increased 109 % ( −70 to 432 % ) ( p = 0.002 ) . Twelve of 17 improved in ISWT , while 15 improved in ESWT . No changes in pulmonary function and improvements in QoL were observed . Conclusion . Patients with pulmonary cancer can achieve significant improvements in physical fitness measured with ISWT and ESWT after completion of the intervention program . No changes in pulmonary function and QoL were observed . In addition , we found that a large number of patients dropped out before intervention and that the patients , who succeeded , often discontinued training at home",
"Background The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise . Methods Using a 2x2 factorial design with continuous effect endpoint ( Maximal Oxygen Uptake ( VO2peak ) ) , 380 patients with non-small cell lung cancer ( NSCLC ) stage I-IIIa referred for surgical resection will be r and omly assigned to one of four groups : ( 1 ) preoperative and early postoperative rehabilitation ( starting two weeks after surgery ) ; ( 2 ) preoperative and late postoperative rehabilitation ( starting six weeks after surgery ) ; ( 3 ) early postoperative rehabilitation alone ; ( 4 ) today ’s st and ard care which is postoperative rehabilitation initiated six weeks after surgery . The preoperative rehabilitation program consists of an individually design ed , 30-minute home-based exercise program performed daily . The postoperative rehabilitation program consists of a supervised group exercise program comprising cardiovascular and resistance training two-hour weekly for 12 weeks combined with individual counseling . The primary study endpoint is VO2peak and secondary endpoints include : Six-minute walk distance ( 6MWD ) , one-repetition-maximum ( 1RM ) , pulmonary function , patient-reported outcomes ( PROs ) on health-related quality of life ( HRQoL ) , symptoms and side effects of the cancer disease and the treatment of the disease , anxiety , depression , wellbeing , lifestyle , hospitalization time , sick leave , work status , postoperative complications ( up to 30 days after surgery ) and survival . Endpoints will be assessed at baseline , the day before surgery , pre-intervention , post-intervention , six months after surgery and one year after surgery . Discussion The results of the PROLUCA study may potentially contribute to the identification of the optimal perioperative rehabilitation for operable lung cancer patients focusing on exercise initiated immediately after diagnosis and rehabilitation shortly after surgery . Trial Registration",
"Purpose This r and omized controlled trial tested the effects of a specially design ed strength and endurance training on the independence and quality of life in lung cancer patients in stages IIIA/IIIB/IV during palliative chemotherapy . Methods Between August 2010 and December 2011 , 46 patients were r and omized into two groups receiving either conventional physiotherapy or special physiotherapeutic training . The Barthel Index served as primary endpoint . The secondary endpoints were the European Organization for Research and Treatment of Cancer Quality of Life Question naire Core-30 ( EORTC QLQ C-30/LC-13 ) question naire , the 6-Minute Walk Test ( 6MWT ) , stair walking , the Modified Borg Scale , and muscle strength . Nonparametrical data were analyzed with the Wilcoxon and Mann – Whitney U test . For parametric , data student t tests were used . A p value of ≤.05 was accepted . Results Twenty-nine patients completed the trial ( Intervention group ( IG ) , n = 18 ; control group ( CG ) , n = 11 ) . Significant differences were detectable in the Barthel Index ( IGmean = 92.08 ; CGmean = 81.67 ; p = .041 ) , in single scores of the EORTC QLQ C-30/LC-13 question naire ( physical functioning , p = .025 ; hemoptysis , p = .019 ; pain in arms or shoulder , p = .048 ; peripheral neuropathy , p = .050 ; cognitive functioning , p = .050 ) , in the 6MWT , stair walking , strength capacity , and in the patient ’s dyspnoea perception during submaximal walking activities ( IG > CG ) . Conclusion According to these findings , lung cancer patients should receive enhanced physical activity intervention during palliative chemotherapy",
"Background : Although exercise has been addressed as an adjuvant treatment for anxiety , depression and cancer-related symptoms , limited studies have evaluated the effectiveness of exercise in patients with lung cancer . Methods : We recruited 116 patients from a medical centre in northern Taiwan , and r and omly assigned them to either a walking-exercise group ( n=58 ) or a usual-care group ( n=58 ) . We conducted a 12-week exercise programme that comprised home-based , moderate-intensity walking for 40 min per day , 3 days per week , and weekly exercise counselling . The outcome measures included the Hospital Anxiety and Depression Scale and the Taiwanese version of the MD And erson Symptom Inventory . Results : We analysed the effects of the exercise programme on anxiety , depression and cancer-related symptoms by using a generalised estimating equation method . The exercise group patients exhibited significant improvements in their anxiety levels over time ( P=0.009 and 0.006 in the third and sixth months , respectively ) and depression ( P=0.00006 and 0.004 in the third and sixth months , respectively ) than did the usual-care group patients . Conclusions : The home-based walking exercise programme is a feasible and effective intervention method for managing anxiety and depression in lung cancer survivors and can be considered as an essential component of lung cancer rehabilitation",
"Fatigue is a frequent problem after surgical treatment of solid tumours . Aerobic exercise and psychosocial interventions have been shown to reduce the severity of this symptom in cancer patients . Therefore , we compared the effect of the two therapies on fatigue in a r and omised controlled study . Seventy-two patients who underwent surgery for lung ( n=27 ) or gastrointestinal tumours ( n=42 ) were assigned to an aerobic exercise group ( stationary biking 30 min five times weekly ) or a progressive relaxation training group ( 45 min three times per week ) . Both interventions were carried out for 3 weeks . At the beginning and the end of the study , we evaluated physical , cognitive and emotional status and somatic complaints with the European Organization for Research and Treatment of Cancer Quality of Life Question naire Core Module ( EORTC-QLQ-30 ) question naire , and maximal physical performance with an ergometric stress test . Physical performance of the training group improved significantly during the programme ( 9.4±20 watts , p=0.01 ) but remained unchanged in the relaxation group ( 1.5±14.8 watts , p=0.37 ) . Fatigue and global health scores improved in both groups during the intervention ( fatigue : training group 21 % , relaxation group 19 % ; global health of both groups 19 % , p for all ≤0.01 ) ; however , there was no significant difference between changes in the scores of both groups ( p=0.67 ) . We conclude that a structured aerobic training programme improves the physical performance of patients recovering from surgery for solid tumours . However , exercise is not better than progressive relaxation training for the treatment of fatigue in this setting",
"Purpose Peak oxygen consumption ( VO2peak ) is an important predictive factor for long-term prognosis in patients with non-small cell lung cancer ( NSCLC ) . The purpose of this study was to investigate whether 8 weeks of exercise training improves exercise capacity , as assessed by VO2peak , and other related factors in patients with NSCLC receiving targeted therapy . Methods A total of 24 participants with adenocarcinoma were r and omly assigned to either the control group ( n = 11 ) or the exercise group ( n = 13 ) . Subjects in the exercise group participated in individualized , high-intensity aerobic interval training of exercise . The outcome measures assessed at baseline and after 8 weeks were as follows : VO2peak and the percentage of predicted VO2peak ( % predVO2peak ) , muscle strength and endurance of the right quadriceps , muscle oxygenation during exercise , insulin resistance as calculated by the homeostasis model , high-sensitivity C-reactive protein , and quality of life ( QoL ) question naire inventory . Results No exercise-related adverse events were reported . After exercise training , VO2peak and % predVO2peak increased by 1.6 mL kg−1 min−1 and 5.3 % ( p improvements in circulatory , respiratory , and muscular functions at peak exercise ( all p = 0.001 ) . The exercise group also had less dyspnea ( p = 0.01 ) and favorably lower fatigue ( p = 0.05 ) than baseline . Conclusions Patients with NSCLC receiving targeted therapy have quite a low exercise capacity , even with a relatively high QoL. Exercise training appears to improve exercise capacity and alleviate some cancer-related symptoms",
"Purpose . Despite mounting evidence indicating that exercise training has a positive effect on cancer recovery , the influence of cancer type on the response to exercise training remains uncharacterized . Therefore , the adaptations to exercise training were compared between groups composed of 7 different forms of cancer . Methods . A total of 319 cancer survivors completed fatigue inventories and participated in assessment s of cardiorespiratory function , which encompassed aerobic capacity ( VO2peak ) , pulmonary function ( forced vital capacity [ FVC ] and forced expiratory volume in 1 second [ FEV1 ] ) , and resting blood pressure and heart rate . Participants were divided into 7 groups based on cancer type , including breast cancer ( BC , n = 170 ) , prostate cancer and other male urogenital neoplasia ( PC , n = 38 ) , hematological malignancies ( HM , n = 34 ) , colorectal cancer ( CC , n = 25 ) , gynecological cancers ( GC , n = 20 ) , gl and ular and epithelial neoplasms ( GEN , n = 20 ) , and lung cancer ( LC , n = 12 ) . All participants completed an individualized , multimodal exercise intervention consisting of cardiorespiratory , flexibility , balance , and muscular strength training 3 days per week for 3 months . Following the intervention , all subjects were reassessed . Generalized Estimating Equations with exchangeable working correlation structure was used to model each response ; the group by time interaction effect represented the effect of cancer type on exercise-associated improvements . Results . No significant ( P > .05 ) group by time interaction effects were observed between different types of cancer for any parameter . Pre- to postexercise contrasts revealed significant improvements in VO2peak in BC , PC , HM , and GEN at the Bonferroni adjusted significance level ( .00714 ) . Heart rate was significantly lowered in the BC and CC groups . Mean fatigue indices decreased by at least 17 % in all groups , but these changes were only significant in the BC , HM , CC , and GC groups . Systolic blood pressure decreased significantly in BC and GC , and diastolic blood pressure decreased significantly only in the BC group while pulmonary function remained unchanged in all cancer types . Conclusion . Although trends toward improved cardiorespiratory and fatigue parameters only reached significance in some groups , there were no significant differences between cancer types . This suggests that cardiorespiratory and fatigue improvements following rehabilitative exercise are not dependent on cancer type . Further research investigating alternative physiological parameters are needed to confirm the relationship between cancer type and exercise-mediated rehabilitation",
"Background Systemic inflammation plays an important role in the initiation , promotion , and progression of lung carcinogenesis . In patients with non-small cell lung cancer ( NSCLC ) , fibrinogen levels correlate with neoplasia . Here we compared the effects of pulmonary rehabilitation ( PR ) with chest physical therapy ( CPT ) on fibrinogen and albumin levels in patients with LC and previous inflammatory lung disease awaiting lung resection . Methods We conducted a r and omized clinical trial with 24 patients who were r and omly assigned to Pulmonary Rehabilitation ( PR ) and Chest Physical Therapy ( CPT ) groups . Each group underwent training 5 days weekly for 4 weeks . All patients were assessed before and after four weeks of training through clinical assessment , measurement of fibrinogen and albumin levels , spirometry , 6-minute Walk Test ( 6MWT ) , quality of life survey , and anxiety and depression scale . PR involved strength and endurance training , and CPT involved lung expansion techniques . Both groups attended educational classes . Results A mixed between-within subjects analysis of variance ( ANOVA ) revealed a significant interaction between time ( before and after intervention ) and group ( PR vs. CPT ) on fibrinogen levels ( F(1 , 22 ) = 0.57 , p effect of time ( F(1 , 22 ) = 0.68 , p = 0.004 ) . Changes in albumin levels were not statistically significant relative to the interaction effect between time and group ( F(1 , 22 ) = 0.96 , p = 0.37 ) nor the main effects of time ( F(1 , 22 ) = 1.00 , p = 1.00 ) and group ( F(1 , 22 ) = 0.59 , p = 0.45 ) . A mixed between-within subjects ANOVA revealed significant interaction effects between time and group for the peak work rate of the unsupported upper limb exercise ( F(1 , 22 ) = 0.77 , p = 0.02 ) , endurance time ( F(1 , 22 ) = 0.60 , p = 0.001 ) , levels of anxiety ( F(1 , 22 ) = 0.60 , p = 0.002 ) and depression ( F(1 , 22 ) = 0.74 , p = 0.02 ) , and the SF-36 physical component summary ( F(1 , 22 ) = 0.83 , p = 0.07 ) . Conclusion PR reduced serum fibrinogen levels , improved functional parameters , and quality of life of patients with LC and inflammatory lung disease awaiting lung resection . Trial registration Current Controlled Trials RBR-3nm5bv",
"OBJECTIVES The aim of the study was to develop a multistr and ed pragmatic rehabilitation programme for operable lung cancer patients , that looks into feasibility , process indicators , outcome measures , local adaptability , compliance and potential cost benefit . METHODS An outpatient-based complex intervention , rehabilitation for operated lung cancer ( ROC ) programme , was developed to optimize physical status , prepare for the inpatient journey and support through recovery after surgery . It includes exercise classes , smoking cessation , dietary advice and patient education and was tested in an enriched cohort study within a regional thoracic unit over 18 months . RESULTS A multistr and ed pragmatic rehabilitation programme pre- and post-surgery is feasible . Fifty-eight patients received the intervention and 305 received st and ard care . Both groups were matched for age , lung function comorbidity and type of surgery . Patients in the intervention group attended exercise classes twice a week until surgery , which was not delayed . Patients attended four sessions presurgery ( range 1 - 15 ) , result ing in an improvement of 20 m ( range -73 - 195 , P = 0.001 ) in a 6-min walk test and 0.66 l in forced expiratory volume in 1 s ( range -1.85 from 1.11 , P = 0.009 ) from baseline to presurgery . Fifty-four percentage of smokers in the intervention group stopped smoking . Sixteen percentage of patients were identified as being at risk of malnourishment and received nutritional intervention . There was a trend in patients in the intervention group towards experiencing fewer postoperative pulmonary complications than those in the non-intervention group ( 9 vs 16 % , respectively , P = 0.21 ) and fewer readmissions to hospital because of complications ( 5 vs 14 % respectively , P = 0.12 ) . CONCLUSION Chronic obstructive pulmonary disease-type pulmonary rehabilitation before and after lung cancer surgery is viable , and preliminary results suggest improvement in physical measures . A multicentre , r and omized controlled trial is warranted to confirm clinical efficacy . IS RCT N REGISTRATION NUMBER IS RCT N00061628",
"Background Patients with advanced stage non-small cell lung cancer ( NSCLC ) or small cell lung cancer ( SCLC ) often experience multidimensional impairments , affecting quality of life during their course of disease . In lung cancer patients with operable disease , several studies have shown that exercise has a positive impact on quality of life and physical functioning . There is limited evidence regarding efficacy for advanced lung cancer patients undergoing palliative treatment . Therefore , the POSITIVE study aims to evaluate the benefit of a 24-week exercise intervention during palliative treatment in a r and omized controlled setting . Methods / design The POSITIVE study is a r and omized , controlled trial investigating the effects of a 24-week exercise intervention during palliative treatment on quality of life , physical performance and immune function in advanced , non-operable lung cancer patients . 250 patients will be recruited in the Clinic for Thoracic Diseases in Heidelberg , enrolment begun in November 2013 . Main inclusion criterion is histologically confirmed NSCLC ( stage IIIa , IIIb , IV ) or SCLC ( Limited Disease-SCLC , Extensive Disease-SCLC ) not amenable to surgery . Patients are r and omized into two groups . Both groups receive weekly care management phone calls ( CMPCs ) with the goal to assess symptoms and side effects . Additionally , one group receives a combined resistance and endurance training ( 3x/week ) . Primary endpoints are quality of life assessed by the Functional Assessment of Cancer Therapy for patients with lung cancer ( FACT-L , subcategory Physical Well-Being ) and General Fatigue measured by the Multidimensional Fatigue Inventory ( MFI-20 ) . Secondary endpoints are physical performance ( maximal voluntary isometric contraction , 6-min walk distance ) , psychosocial ( depression and anxiety ) and immunological parameters and overall survival . Discussion The aim of the POSITIVE trial is the evaluation of effects of a 24-week structured and guided exercise intervention during palliative treatment stages . Analysis of various outcomes ( such as quality of life , physical performance , self-efficacy , psychosocial and immunological parameters ) will contribute to a better underst and ing of the potential of exercise in advanced lung cancer patients . In contrast to other studies with advanced oncological patients the POSITIVE trial provides weekly phone calls to support patients both in the intervention and control group and to segregate the impact of physical activity on quality of life . Trial registration Clinical Trials.gov NCT02055508 ( Date : December 12 , 2013",
"Deterioration in exercise tolerance and impairment in quality of life ( QoL ) are common consequences of lobectomy . This study evaluates additional exercise and strength training after lung resection on QoL , exercise tolerance and muscle strength . Fifty-three ( 28 male ) patients attending thoracotomy for lung cancer , mean age , range 64 ( 32 - 82 ) years ; mean pack years ( SD ) 31.9 ( 26.8 ) ; BMI 25.6 ( 4.2 ) ; FEV1 2.0 ( 0.7 ) l were r and omised to control ( usual care ) or intervention ( twice daily training plus usual care ) . After discharge the intervention group received monthly home visits and weekly telephone calls , the control group received monthly telephone calls up to 12 weeks . Assessment pre-operatively , 5 day and 12 weeks post-operatively consisted of quadriceps strength using magnetic stimulation , 6 Minute Walking Distance ( 6MWD ) and QoL-EORTC-QLQ-LC13 . QoL was unchanged over 12 weeks ; 6MWD showed significant deterioration at 5 days post-operatively compared with pre-operatively , mean difference (SD)-131.6 ( 101.8 ) m and -128.0 ( 90.7 ) m in active and control groups respectively ( p=0.89 between groups ) which returned to pre-operative levels by 12 weeks in both groups . Quadriceps strength over the 5 day in-patient period showed a decrease of -8.3 ( 11.3 ) kg in the control group compared to increase of 4.0 ( 21.2 ) kg in the intervention group ( p=0.04 between groups ) . Strength training after thoracotomy successfully prevented the fall in quadriceps strength seen in controls , however , there was no effect on 6MWD or QoL. 6MWD returned to pre-operative levels by 12 weeks regardless of additional support offered",
"Background Many patients with lung cancer are deconditioned with poor physical fitness . Lung resection reduces physical fitness further , impairing the patient 's ability to function in daily life . Methods We conducted a single-blind r and omised controlled trial of high-intensity endurance and strength training ( 60 min , three times a week , 20 weeks ) , starting 5–7 weeks after surgery . The control group received st and ard postoperative care . The primary outcome was the change in peak oxygen uptake measured directly during walking until exhaustion . Other outcomes included changes in pulmonary function , muscular strength by one-repetition maximum ( 1RM ) , total muscle mass measured by dual energy X-ray absorptiometry , daily physical functioning and quality of life ( QoL ) . Results The intention-to-treat analysis of the 61 r and omised patients showed that the exercise group had a greater increase in peak oxygen uptake ( 3.4 mL/kg/min between-group difference , p=0.002 ) , carbon monoxide transfer factor ( Tlco ) ( 5.2 % predicted , p=0.007 ) , 1RM leg press ( 29.5 kg , p chair st and ( 2.1 times p stair run ( 4.3 steps , p=0.002 ) and total muscle mass ( 1.36 kg , p=0.012 ) compared with the controls . The mean±SD QoL ( SF-36 ) physical component summary score was 51.8±5.5 and 43.3±11.3 ( p=0.006 ) , and the mental component summary score was 55.5±5.3 and 46.6±14.0 ( p=0.015 ) in the exercise and control groups , respectively . Conclusions In patients recently operated for lung cancer , high-intensity endurance and strength training was well tolerated and induced clinical ly significant improvements in peak oxygen uptake , Tlco , muscular strength , total muscle mass , functional fitness and QoL. This study may provide a basis for exercise therapy after lung cancer surgery . Trial registration number NCT01748981",
"OBJECTIVE To assess the outcomes of a 6-month comprehensive multidisciplinary outpatient pulmonary rehabilitation programme in patients with chronic obstructive pulmonary disease according to age . DESIGN Prospect i ve cohort study . PATIENTS A total of 140 patients with chronic obstructive pulmonary disease ( Global Initiative for Chronic Obstructive Lung Disease ( GOLD ) 3 - 4 ) admitted to our centre for pulmonary rehabilitation . METHODS Patients were divided into 3 groups : group A ( . All the patients received an education and individualized training programme . Pulmonary rehabilitation efficacy was evaluated at 6 months of treatment and 12 months post-treatment . RESULTS A total of 116 patients completed the pulmonary rehabilitation programme : 59 in group A ( 85.5 % ) , 40 in group B ( 80 % ) and 17 in group C ( 80.9 % ) . All the parameters studied ( number of sessions , 6-min walking distance , isometric quadriceps strength , health-related quality of life , maximal load , peak oxygen uptake , maximal inspiratory and expiratory pressures ) were significantly improved in each of the groups at 3 and 6 months compared with baseline . Moreover , percentage changes from baseline at 6 months for all of the parameters studied were not significantly different between age-groups . CONCLUSION Pulmonary rehabilitation is efficient in elderly patients with severe and very severe chronic obstructive pulmonary disease , and their compliance with pulmonary rehabilitation was similar to that seen in younger groups . Therefore , elderly patients with chronic obstructive pulmonary disease should not be denied pulmonary rehabilitation ",
"Introduction : A stepwise approach to the functional assessment of lung resection c and i date s is widely accepted , and this approach incorporates the measurement of exercise peak Vo2 when spirometry and radionuclear studies suggest medical inoperability . A new functional operability ( FO ) algorithm incorporates peak exercise Vo2 earlier in the preoperative assessment to determine which patients require preoperative radionuclear studies . This algorithm has not been studied in a multicenter study . Methods : The CALGB ( Cancer and Leukemia Group B ) performed a prospect i ve multi-institutional study to investigate the use of primary exercise Vo2 measurement for the prediction of surgical risk . Patients with known or suspected resectable non-small cell lung cancer ( NSCLC ) were eligible . Exercise testing including measurement of peak oxygen uptake ( Vo2 ) , spirometry , and single breath diffusion capacity ( DLCO ) was performed on each patient . Nuclear perfusion scans were obtained on selected high-risk patients . After surgery , morbidity and mortality data were collected and correlated with preoperative data . Mortality and morbidity were retrospectively compared by algorithm-based risk groups . Results : Three hundred forty-six patients with suspected lung cancer from nine institutions underwent thoracotomy with or without resection ; 57 study patients did not undergo thoracotomy . Patients who underwent surgery had a median survival time of 30.9 months , whereas patients who did not undergo surgery had a median survival time of 15.6 months . Among the 346 patients who underwent thoracotomy , 15 patients died postoperatively ( 4 % ) , and 138 patients ( 39 % ) exhibited at least one cardiorespiratory complication postoperatively . We found that patients who had a peak exercise Vo2 of complications ( p = 0.0001 ) and were also more likely to have a poor outcome ( respiratory failure or death ) if the peak Vo2 was 58 patients who did not meet FO algorithm criteria for operability , but who still tolerated lung resection with a 2 % mortality rate . Conclusions : Our data provide multicenter validation for the use of exercise Vo2 for preoperative assessment of lung cancer patients , and we encourage an aggressive approach when evaluating these patients for surgery",
"BACKGROUND The feasibility and practicality of preoperative rehabilitation ( PR ) programs remains quite controversial in the treatment of lung cancer ( LC ) . This study explored whether a short-term high-intensity rehabilitation program could improve postoperative outcomes compared to those achieved with conventional inspiratory muscle training ( IMT ) . METHODS A three-armed r and omized controlled trial comparing the two training modalities and routine care was conducted in surgical LC patients . Patient groups received one of three treatment regimens : ( I ) high-intensity pulmonary rehabilitation ( PR ) that combined IMT with conventional resistance training ( CRT ) ( combined PR group ) ; ( II ) conventional PR ( single IMT group ) ; or ( III ) routine preoperative preparation ( control group ) . The primary endpoint was a change in the occurrence of post-operative pulmonary complications ( PPCs ) that occurred within 30 days after surgery , while secondary endpoints included changes in length of hospital stay , quality of life ( QoL ) scores , 6-min walk distance ( 6-MWD ) and peak expiratory flow ( PEF ) . RESULTS A total of 90 enrolled patients were r and omized into three groups with a computer-based 1:1:1 ratio . The intention-to-treat analysis of the study revealed that , compared with the Control Group , the Combined PR Group had a significant increase in ∆6-MWD ( by 32.67 m , P=0.002 ) , ∆PEF ( by 14.3 L/min , P=0.001 ) , ∆global scores ( by 3.7 , P=0.035 ) ; and a reduced ∆average total hospital stay ( by 3.2 d , P=0.001 ) and ∆postoperative stay ( by 3.6 d , P=0.001 ) . With regard to PPC rate , the Combined PR Group had a somewhat lower PPC severity ( grade II-V ) compared to the Control Group . CONCLUSIONS This hospital-based short-term program of PR combining high-intensity IMT with CRT was significantly superior to the conventional IMT program , indicating that this approach would be a feasible strategy for treating LC patients , especially those waiting operations with surgery-related risk factors",
"Purpose To provide evidence -based recommendations to up date the American Society of Clinical Oncology guideline on systemic therapy for stage IV non – small-cell lung cancer ( NSCLC ) . Methods An Up date Committee of the American Society of Clinical Oncology NSCLC Expert Panel based recommendations on a systematic review of r and omized controlled trials from January 2007 to February 2014 . Results This guideline up date reflects changes in evidence since the previous guideline . Recommendations There is no cure for patients with stage IV NSCLC . For patients with performance status ( PS ) 0 to 1 ( and appropriate patient cases with PS 2 ) and without an EGFR-sensitizing mutation or ALK gene rearrangement , combination cytotoxic chemotherapy is recommended , guided by histology , with early concurrent palliative care . Recommendations for patients in the first-line setting include platinum-doublet therapy for those with PS 0 to 1 ( bevacizumab may be added to carboplatin plus paclitaxel if no contraindications ) ; combination or single-agent chemotherapy or palliative care alone for those with PS 2 ; afatinib , erlotinib , or gefitinib for those with sensitizing EGFR mutations ; crizotinib for those with ALK or ROS1 gene rearrangement ; and following first-line recommendations or using platinum plus etoposide for those with large-cell neuroendocrine carcinoma . Maintenance therapy includes pemetrexed continuation for patients with stable disease or response to first-line pemetrexed-containing regimens , alternative chemotherapy , or a chemotherapy break . In the second-line setting , recommendations include docetaxel , erlotinib , gefitinib , or pemetrexed for patients with nonsquamous cell carcinoma ; docetaxel , erlotinib , or gefitinib for those with squamous cell carcinoma ; and chemotherapy or ceritinib for those with ALK rearrangement who experience progression after crizotinib . In the third-line setting , for patients who have not received erlotinib or gefitinib , treatment with erlotinib is recommended . There are insufficient data to recommend routine third-line cytotoxic therapy . Decisions regarding systemic therapy should not be made based on age alone . Additional information can be found at http://www.asco.org/ guidelines /nsclc and http://www.asco.org/ guidelines wiki . J Clin Oncol 33:3488 - 3515 . © 2015 by American Society of Clinical",
"BACKGROUND Physical exercise can improve cancer patients ' functioning and reduce their symptom levels . A r and omized , controlled trial was launched to test the hypothesis that physical exercise reduces fatigue and improves physical performance in cancer patients with advanced and incurable disease . METHODS Cancer patients ( n = 231 ) with a life expectancy ≤2 years were r and omized to a physical exercise group ( PEG , n = 121 ) or a control usual care group ( UCG , n = 110 ) . The PEG exercised under supervision 60 minutes twice a week for 8 weeks . Assessment s were performed before and after the intervention . The primary outcome was physical fatigue ( PF ) measured by the Fatigue Question naire . Physical performance was a secondary outcome measured by the Shuttle Walk Test ( SWT ) and h and grip strength ( HGS ) test . Analyses were performed after multiple imputations for missing data . The trial is registered with Clinical Trials.gov ( identifier , NCT00397774 ) . FINDINGS Thirty-six percent of the PEG were lost to follow-up compared with 23 % of the UCG , primarily as a result of disease progression . Seventy-eight PEG and 85 UCG patients completed the intervention . Analyses showed no significant between-group effects in PF . However , clinical ly and statistically significant between-group effects were found for the SWT and HGS test . INTERPRETATION Fatigue was not reduced but physical performance ( SWT and HGS test ) was significantly improved after 8 weeks of physical exercise . Physical exercise might therefore be a suitable approach for maintaining physical capacity in cancer patients with incurable and advanced disease",
"INTRODUCTION The evidence on the effectiveness of rehabilitation in lung cancer patients is limited . Whole body vibration ( WBV ) has been proposed as an alternative to conventional resistance training ( CRT ) . METHODS We investigated the effect of radical treatment ( RT ) and of two rehabilitation programmes in lung cancer patients . The primary endpoint was a change in 6-min walking distance ( 6MWD ) after rehabilitation . Patients were r and omised after RT to either CRT , WBVT or st and ard follow-up ( CON ) . Patients were evaluated before , after RT and after 12 weeks of intervention . RESULTS Of 121 included patients , 70 were r and omised to either CON ( 24 ) , CRT ( 24 ) or WBVT ( 22 ) . After RT , 6MWD decreased with a mean of 38 m ( 95 % CI 22 - 54 ) and increased with a mean of 95 m ( 95 % CI 58 - 132 ) in CRT ( p 6MWD by RT and allocation to either CRT or WBVT were prognostic for reaching the minimally clinical ly important difference of 54 m increase in 6MWD after intervention . CONCLUSIONS RT of lung cancer significantly impairs patients ' exercise capacity . CRT significantly improves and restores functional exercise capacity , whereas WBVT does not fully substitute for CRT",
" BACKGROUND Neoadjuvant chemotherapy ( NAC ) followed by surgery for resectable oesophageal or gastric cancer improves outcome when compared with surgery alone . However NAC has adverse effects . We assess here whether NAC adversely affects physical fitness and whether such an effect is associated with impaired survival following surgery . METHODS We prospect ively studied 116 patients with oesophageal or gastric cancer to assess the effect of NAC on physical fitness , of whom 89 underwent cardiopulmonary exercise testing ( CPET ) before NAC and proceeded to surgery . 39 patients were tested after all cycles of NAC but prior to surgery . Physical fitness was assessed by measuring oxygen uptake ( VO₂ in ml kg(-1 ) min(-1 ) ) at the estimated lactate threshold ( θL ) and at peak exercise ( VO₂ peak in ml kg(-1 ) min(-1 ) ) . RESULTS VO₂ at θL and at peak were significantly lower after NAC compared to pre-NAC values : VO₂ at θL 14.5 ± 3.8 ( baseline ) vs. 12.3 ± 3.0 ( post-NAC ) ml kg(-1 ) min(-1 ) ; p ≤ 0.001 ; VO₂ peak 20.8 ± 6.0 vs. 18.3 ± 5.1 ml kg(-1 ) min(-1 ) ; p ≤ 0.001 ; absolute VO₂ ( ml min(-1 ) ) at θL and peak were also lower post-NAC ; p ≤ 0.001 . Decreased baseline VO₂ at θL and peak were associated with increased one year mortality in patients who completed a full course of NAC and had surgery ; p = 0.014 . CONCLUSION NAC before cancer surgery significantly reduced physical fitness in the overall cohort . Lower baseline fitness was associated with reduced one-year-survival in patients completing NAC and surgery , but not in patients who did not complete NAC . It is possible that in some patients the harms of NAC may outweigh the benefits . Trials Registry Number : NCT01335555",
"Objectives : To investigate the effects of a preoperative pulmonary rehabilitation programme in patients with lung cancer undergoing video-assisted thoracic surgery . Design : R and omized , single-blind controlled trial . Setting : Teaching hospital . Subjects : Patients with suspected or confirmed lung cancer undergoing video-assisted thoracic surgery . Intervention : Participants were r and omized to either a prehabilitation group or a control group . Participants in the prehabilitation group underwent a combination of moderate endurance and resistance training plus breathing exercises three to five times per week . Main measures : The primary outcome of the study was exercise capacity . Secondary outcomes were muscle strength ( Senior Fitness Test ) , health-related quality of life ( Short-Form 36 ) and the postoperative outcomes . Patients were evaluated at baseline ( before r and omization ) , presurgery ( only the prehabilitation group ) , after surgery and three months post-operatively . Results : A total of 40 patients were r and omized and 22 finished the study ( 10 in the prehabilitation group and 12 in the control group ) . Three patients were lost to follow-up at three months . After the training , there was a statistically significant improvement in exercise tolerance ( + 397 seconds , p = 0.0001 ) , the physical summary component of the SF-36 ( + 4.4 points , p = 0.008 ) and muscle strength ( p the mean change of exercise capacity ( p = 0.005 ) , physical summary component ( p = 0.001 ) and upper and lower body strength ( p = 0.045 and p = 0.002 ) . Conclusions : A pulmonary rehabilitation programme before video-assisted thoracic surgery seems to improve patients ’ preoperative condition and may prevent functional decline after surgery . Clinical Registration Number : NCT01963923 ( Registration date 10/10/2013",
"BACKGROUND We planned to investigate the effect of preoperative short period intensive physical therapy on lung functions , gas-exchange , and capacity of diffusion , and ventilation-perfusion distribution of patients with non-small cell lung cancer . METHODS Sixty patients with lung cancer , who were deemed operable , were r and omly allocated into two groups . Intensive physical therapy was performed in patients in the study group before operation . Both groups received routine physical therapy after operation . RESULTS There was no difference in pulmonary function tests between the two groups . Intensive physical therapy statistically significantly increased peripheral blood oxygen saturation . At least one complication was noted in 5 patients ( 16.7 % ) in the control group , and 2 ( 6.7 % ) , in the study group . However , there was no statistically significant difference ( p = 0,4 ) . The hospital stay has been found to be statistically significantly shortened by intensive physical therapy ( p Ventilation-perfusion distribution was found to be significantly effected by intensive physical therapy . The change was prominent in the the contralateral lung ( p Intensive physical therapy appeared to increase oxygen saturation , reduce hospital stay , and change the ventilation/perfusion distribution . It had a significant , positive effect on the exercise capacity of patients",
"PURPOSE To create a maximum tolerated 45-minute aerobic training program for patients with chronic obstructive pulmonary disease ( COPD ) and to compare its outcomes with those of commonly prescribed moderate exercise . DESIGN Prospect i ve , r and omized trial . SETTING A work physiology laboratory . PATIENTS AND METHODS The maximum exercise intensities that 7 COPD patients could sustain for 45 minutes were determined on a bilevel exercise ergometer . The patients then exercised 45 minutes daily , 5 days a week for 6 weeks , working 2.03+/-0.4 kJ/kg per session . They were matched with 6 COPD patients who pushed an O2 cart for 45 minutes daily , 5 days a week for 6 weeks , working 1.44+/-.35 kJ/kg per session . RESULTS A 45 minute maximal regimen was established by alternating 1-minute peak exercise at peak VO2-levels with 4 minutes at the ventilatory anaerobic threshold or at 40 % of peak VO2 . Maximal bilevel training significantly decreased dyspnea at rest ( p blood lactate level during submaximal exercise ( p peak VO2 and total physical work ( p maximum inspiratory and expiratory pressures ( p grip and forearm strength and endurance ( p maximum voluntary ventilation while decreasing the ventilatory equivalent during exercise ( p 12-minute walk ( p COPD patients that can significantly improve both skeletal and respiratory muscle strength and endurance as well as dyspnea and physiologic parameters",
"Using Rogers ’ science of unitary human beings , changes in hope and power among 104 lung cancer patients were examined in relation to participation in a preoperative exercise program . Participants were r and omly assigned to exercise or no-exercise and a repeated measures ANOVA was employed . The exercise group ’s power increased while the no-exercise group ’s power decreased . No differences in hope emerged . Positive correlations between hope and power were observed . Findings suggest that exercise is a form of knowing participation in change and illustrate a relation between one ’s ability to envision a better future and one ’s potential to actualize options through choice",
"Background : When choosing a specific inhalation device for a chronic obstructive pulmonary disease ( COPD ) patient , the internal airflow resistance and the ability of the patient to overcome it and to create an optimal inspiratory flow are essential . Objectives : The purpose of the present study was to investigate : ( 1 ) the peak inspiratory flow ( PIF ) that a patient with COPD can generate while breathing through two dry powder inhalers and ( 2 ) whether in patients with low PIF specific inspiratory muscle training ( SIMT ) will increase the PIF and exceed the minimal PIF that is considered necessary to guarantee optimal lung deposition of the drug . Methods : Inspiratory muscle strength and PIFs were measured in 60 patients with COPD . Then 28 patients with severe COPD and low PIF were r and omized to receive SIMT or to a control group . Results : With the Turbuhaler , 12 patients ( 20 % ) could not generate the optimal flow of 60 l/min . PIF correlated very well with maximal inspiratory mouth pressure ( PImax ) for the Diskus and the Turbuhaler , as well as for both males and females ( p PImax in the training group . This increase was associated with a significant increase in the PIF . All patients overcame the minimal threshold PIF following the training . Conclusions : Some patients with severe COPD are not able to generate adequate flow to secure optimal lung deposition of the inhalation with the Turbuhaler . SIMT improves inspiratory muscle strength as well as PIF . Following 8 weeks of training , the optimal PIF enabling adequate lung deposition of the drug was attained in all the trained patients",
"BACKGROUND Pulmonary rehabilitation ( PR ) is proposed as an effective strategy to decrease surgical morbidity . However , appropriate rehabilitation plan , initiation time , and optimal duration of PR remain unclear . Lung cancer patients with chronic obstructive pulmonary disease ( COPD ) are considered high-risk population for postoperative pulmonary complications ( PPCs ) because of poor lung fitness and cardiopulmonary endurance . This study aims to assess the impact of a one-week , systematic and highly-intensive rehabilitation on surgical lung cancer patients with mild to moderate COPD . METHODS A r and omized controlled trial with 48 subjects was conducted ( 24 patients each for the intervention and groups ) . The intervention group received seven days of systematic , integrated and highly-intensive PR before surgical treatment , including : pharmacotherapy with atomizing terbutaline , pulmicort and infusion of ambroxol ; and physical rehabilitation with respiratory training and endurance training . The control group underwent st and ard preoperative care . RESULTS For the intervention group , the postoperative length of stay was shorter [ ( 6.17±2.91 ) d vs ( 8.08±2.21 ) d ; P=0.013 ] ; likewise for the duration of antibiotics use [ ( 3.61±2.53 ) d vs ( 5.36±3.12 ) d ; P=0.032 ] . No significant difference was found between the groups in total in-hospital cost [ ( 46,455.6±5,080.9 ) ¥ vs ( 45,536.0±4,195.8 ) ¥ , P=0.498 ] , medicine cost [ ( 7,760.3±2,366.0 ) vs ( 6,993.0±2,022.5 ) , P=0.223 ] , and material cost [ ( 21,155.5±10,512.1 ) ¥ vs ( 21,488.8±3,470.6 ) ¥ , P=0.883 ] . In the intervention group , peak expiratory flow [ ( 268.40±123.94 ) L/min vs ( 343.71±123.92 ) L/min ; P ] , 6-min walk distance ( 6-MWD ) [ ( 595.42±106.74 ) m vs ( 620.90±99.27 ) m ; P=0.004 ] , and energy consumption [ ( 59.93±10.61 ) kcal vs ( 61.03±10.47 ) kcal ; P=0.004 ] were statistically different after the seven-day exercise , compared with those on the first day . Finally , for the intervention group the incidence of PPCs ( 8.3 % , 2/24 vs 20.8 % , 5/24 , 20.8 % ; P=0.416 ) were lower . CONCLUSIONS The systematic and highly-intensive pulmonary rehabilitation combining abdominal respiration training , respiratory exercise with incentive spirometry , and aerobic exercise could improve the cardiorespiratory endurance of lung cancer patients with mild to moderate COPD . The proposed program may be a practicable preoperative strategy .",
"Background : Sleep disturbances and poor rest-activity rhythms , which can reduce the quality of life , are highly prevalent among patients with lung cancer . Methods : This trial investigated the effects of a 12-week exercise intervention including home-based walking exercise training and weekly exercise counseling on 111 lung cancer patients . Participants were r and omly allocated to receive the intervention or usual-care . Outcomes included objective sleep ( total sleep time , TST ; sleep efficiency , SE ; sleep onset latency , SOL ; and wake after sleep onset , WASO ) , subjective sleep ( Pittsburgh Sleep Quality Index , PSQI ) , and rest-activity rhythms ( r24 and I and TST ( Wald χ2=7.59 , P=0.023 ) of the patients in the exercise group significantly improved 3 and 6 months after intervention . The moderating effect of I The walking program is an effective intervention for improving the subjective and objective sleep quality of lung cancer patients and can be considered an optional component of lung cancer rehabilitation",
"Complete surgical resection is the most effective curative treatment for lung cancer . However , many patients with lung cancer also have severe COPD which increases their risk of postoperative complications and their likelihood of being considered \" inoperable . \" Preoperative pulmonary rehabilitation ( PR ) has been proposed as an intervention to decrease surgical morbidity but there is no established protocol and no r and omized study has been published to date . We tested two preoperative PR interventions in patients undergoing lung cancer resection and with moderate-severe COPD in a r and omized single blinded design . Outcomes were length of hospital stay and postoperative complications . The first study tested 4 weeks of guideline -based PR vs. usual care : that study proved to be very difficult to recruit as patients and providers were reluctant to delay surgery . Nine patients were r and omized and no differences were found between arms . The second study tested ten preoperative PR sessions using a customized protocol with nonst and ard components ( exercise prescription based on self efficacy , inspiratory muscle training , and the practice of slow breathing ) ( n=10 ) vs. usual care ( n=9 ) . The PR arm had shorter length of hospital stay by 3 days ( p=0.058 ) , fewer prolonged chest tubes ( 11 % vs. 63 % , p=0.03 ) and fewer days needing a chest tube ( 8.8 vs. 4.3 days p=0.04 ) compared to the controlled arm . A ten-session preoperative PR intervention may improve post operative lung reexpansion evidence d by shorter chest tube times and decrease the length of hospital stay , a crude estimator of post operative morbidity and costs . Our results suggest the potential for short term preoperative pulmonary rehabilitation interventions in patients with moderate-severe COPD undergoing curative lung resection . 4 weeks of conventional preoperative PR seems non feasible",
"OBJECTIVE To evaluate the effect of a combined hospital plus home exercise programme following curative surgery for non-small cell lung cancer ( NSCLC ) . DESIGN R and omised controlled trial . SETTING Teaching hospital . PARTICIPANTS One hundred and thirty-one subjects with NSCLC admitted for curative surgery . INTERVENTIONS Participants were r and omised to usual care or a hospital plus home exercise programme . OUTCOMES The primary outcome was the between-group difference in physical activity 4 weeks after surgery . Secondary outcomes were the difference in quadriceps strength , exercise tolerance and quality of life [ Short Form-36 ( SF-36 ) and European Organisation for Research and Treatment of Cancer ( EORTC ) QLQ-LC13 ] from pre-operatively ( baseline ) to 4 weeks after surgery . RESULTS The participants ( n=131 ) had a mean age of 68 [ st and ard deviation ( SD ) 11 ] years and mean forced expiratory volume in 1 second of 2.4 ( SD 1.1)l . There were no significant differences in physical activity between the groups 4 weeks after surgery [ mean difference adjusted for baseline 12minutes/day , 95 % confidence interval ( CI ) -20.2 to 44.1 ] . In addition , there were no significant differences in total SF-36 or EORTC QLQ-LC13 scores from baseline to 4 weeks after surgery . Both groups had recovered their pre-operative walking distance 4 weeks after surgery , and there were no differences between the groups ( mean difference in Incremental Shuttle Walk Test from baseline to 4 weeks after surgery ( -26 m , 95 % CI -94.2 to 42.3 ) . CONCLUSIONS A hospital plus home exercise programme showed little benefit in unselected patients with NSCLC following surgery . Regardless of group allocation , the patients had recovered their pre-operative exercise tolerance levels by 4 weeks after surgery",
"OBJECTIVES Peak VO2 , as measure of physical performance is central to a correct preoperative evaluation in patients with both non-small-cell lung cancer ( NSCLC ) and chronic obstructive pulmonary disease ( COPD ) because it is closely related both to operability criteria and the rate of postoperative complications . Strategies to improve peak VO2 , as a preoperative pulmonary rehabilitation programme ( PRP ) , should be considered favourably in these patients . In order to clarify the role of pulmonary rehabilitation , we have evaluated the effects of 3-week preoperative high-intensity training on physical performance and respiratory function in a group of patients with both NSCLC and COPD who underwent lobectomy . METHODS We studied 40 patients with both NSCLC and COPD , age Patients were r and omly divided into two groups ( R and S ) : Group R underwent an intensive preoperative PRP , while Group S underwent only lobectomy . We evaluated peak VO2 in all patients at Time 0 ( T0 ) , after PRP/before surgery in Group R/S ( T1 ) and 60 days after surgery , respectively , in both groups ( T2 ) . RESULTS There was no difference between groups in peak VO2 at T0 , while a significant difference was observed both at T1 and T2 . In Group R , peak VO2 improves significantly from T0 to T1 : 14.9 ± 2.3 - 17.8 ± 2.1 ml/kg/min ± st and ard deviation ( SD ) , P S peak VO2 did not change from T0 to T1 and significantly deteriorates from T1 to T2 : 14.5 ± 1.2 - 11.4 ± 1.2 ml/kg/min ± SD , P CONCLUSIONS PRP was a valid preoperative strategy to improve physical performance in patients with both NSCLC and COPD and this advantage was also maintained after surgery",
"This paper describes PEDro , the Physiotherapy Evidence Data base . PEDro is a web-based data base of r and omized controlled trials and systematic review s in physiotherapy . It can be accessed free of charge at http://ptwww.cchs.usyd.edu.au/pedro . The data base contains bibliographic details and abstract s of most English- language r and omized trials and systematic review s in physiotherapy , and of many trials and review s in other language s. Trials on the data base are rated on the basis of their method ological quality so that users of the data base can quickly identify trials of high quality . Trials and systematic review s are extensively indexed to facilitate search ing . PEDro provides an important information re source to support evidence -based clinical practice",
"Introduction : Little is known about the effects of rehabilitation for patients with lung cancer after thoracotomy . The primary objective of this study was to evaluate the effect of a multidisciplinary rehabilitation program on quality of life ( QOL ) and secondary objectives were to determine its effects on pain and exercise capacity and the feasibility of combining rehabilitation with adjuvant chemotherapy . Methods : Patients who had undergone a thoracotomy for lung cancer were r and omized between rehabilitation and usual care . Rehabilitation consisted of twice-weekly training for 12 weeks starting 1 month after hospital discharge , scheduled visits to pain specialists , and medical social work . QOL and pain were measured with vali date d question naires at baseline and after 1 , 3 , 6 , and 12 months . Exercise tolerance was assessed at baseline and after 3 months with a 6-minute walking distance test . Results : The study closed prematurely because of the introduction of video-assisted thoracoscopic surgery . Of 57 r and omized patients , 49 patients ( 23 active and 26 control ) were analyzed . QOL was not significantly different between groups , although , the active group reported more pain after 3 and 6 months and more limitations because of physical problems after 3 months . In the active group , 6-minute walking distance improved by 35 m from preoperative baseline , as opposed to the control group that showed a decline by 59 m ( p = 0.024 for difference ) . Patients treated with adjuvant chemotherapy showed decreased attendance at training sessions . Conclusion : Rehabilitation did not result in a better QOL . Exercise tolerance improved at the cost of more pain and more limitations because of physical problems . We suggest that rehabilitation is better postponed for 3 to 4 months after hospital discharge",
"Introduction . Patients with advanced-stage lung cancer face poor survival and experience co-occurring chronic physical and psychosocial symptoms . Despite several years of research in exercise oncology , few exercise studies have targeted advanced lung cancer patients undergoing chemotherapy . The aim of the present study was to investigate the benefits of a 6-week supervised group exercise intervention and to outline the effect on aerobic capacity , strength , health-related quality of life ( HRQoL ) , anxiety , and depression . Methods . VO2peak was assessed using an incremental exercise test . Muscle strength was measured with one repetition maximum test ( 1RM ) . HRQoL , anxiety , and depression were assessed using Functional Assessment of Cancer Therapy – Lung ( FACT-L ) scale and the Hospital Anxiety and Depression Scale ( HADS ) . Results . One hundred and forthteen patients with advanced stage lung cancer were recruited . Forty-three patients dropped out . No serious adverse events were reported . Exercise adherence in the group training was 68 % . Improvements in VO2peak ( P and 6-minute walk distance ( P and muscle strength measurements ( P reduction in anxiety level ( P = .0007 ) and improvement in the emotional well-being parameter ( FACT-L ) but no statistically significant changes in HRQoL were observed . Conclusion . The results of the present study show that during a 6-week hospital-based supervised , structured , and group-based exercise program , patients with advanced-stage lung cancer ( NSCLC IIIb-IV , ED-SCLC ) improve their physical capacity ( VO2peak , 1RM ) , functional capacity , anxiety level , and emotional well-being , but not their overall HRQoL. A r and omized controlled trial testing the intervention including 216 patients is currently being carried out",
"PURPOSE This study aim ed to evaluate the safety , feasibility , and effects of an 8-wk combined resistance and endurance exercise program in patients with advanced non-small cell lung cancer ( NSCLC ) during in- and outpatient care . METHODS In this intervention study , 40 patients with predominantly advanced NSCLC receiving simultaneous or sequential radiochemotherapy or chemotherapy alone were enrolled . For a period of 8 wk , patients were instructed to exercise at least five times per week during the inpatient setting and at least three times per week in the outpatient setting . Physical performance status ( endurance capacity : 6-min walk test ; strength capacity : h and held dynamometry ) , quality -of-life ( Functional Assessment of Cancer Therapy-Lung ) , fatigue ( Multidimensional Fatigue Inventory ) , and depression ( Patient Health Question naire ) were assessed at baseline ( T0 ) , after the exercise intervention ( T1 ) , and at a follow-up time point 8 wk later ( T2 ) . The primary end point was adequate adherence ( feasibility ) defined as completing at least two training sessions per week during a minimum of 6 wk . RESULTS Of 40 patients , 31 ( 77.5 % ) completed the postexercise assessment ( T1 ) and 22 ( 55 % ) completed follow-up ( T2 ) . The stages were IIA ( 5 % ) , IIIA ( 8 % ) , IIIB ( 20 % ) , and IV ( 67 % ) , and the median age was 63 yr ( range = 22 - 75 yr ) . Overall , adherence was 82 % for those patients who completed T1 , and 55 % of the 40 participating patients fulfilled the adequate adherence criterion . Those who completed the intervention showed a significant improvement in the 6-min walk distance and in knee , elbow , and hip muscle strength after the intervention ( T1 ) . Quality of life , fatigue , and depression scores remained stable or declined slightly . Significant improvements in knee-muscle strength were also observed at T2 . CONCLUSIONS Exercise training is feasible in advanced and metastatic NSCLC patients during anticancer treatment . In this pilot study , endurance and strength capacity improved over time , indicating the rehabilitative importance of the applied intervention . To investigate the potential impact of exercise training in this patient group , a larger r and omized trial is warranted",
"Background / Aims : Patients with postoperative pulmonary complications after esophagectomy often have increased mortality . The purpose of the study was to examine the efficacy of preventing postoperative pulmonary complications by an intensive preoperative respiratory rehabilitation ( PR ) program for esophageal cancer patients . Methods : This study was a prospect i ve r and omized controlled study . Thirty patients in the PR group and 30 patients in the no preoperative respiratory rehabilitation ( NPR ) group were included . The PR group received preoperative rehabilitation for more than 7 days , while the NPR group did not receive any preoperative rehabilitation . All patients underwent postoperative rehabilitation from the first postoperative day . The postoperative pulmonary complications were evaluated using the Clavien-Dindo classification ( CDC ) and the Utrecht Pneumonia Scoring System ( UPSS ) . Results : The CDC grade in the PR group was significantly lower than that in the NPR group ( p = 0.014 ) . The UPSS score in the PR group was significantly lower than that in the NPR group at postoperative day 1 ( p = 0.031 ) . In the multivariate analysis , NPR was an independent risk factor for postoperative pulmonary complications greater than CDC grade II ( OR : 3.99 , 95 % CI : 1.28 - 12.4 , p = 0.017 ) . Conclusions : This study showed that the intensive PR program was capable of reducing the postoperative pulmonary complications in esophageal cancer patients",
"Background : Two prevalent unmet supportive care needs reported by the non – small cell lung cancer ( NSCLC ) population include the need to manage fatigue and attain adequate exercise to meet the physical dem and s of daily living . Yet , there are no guidelines for routine rehabilitative support to address fatigue and exercise for persons with NSCLC during the critical transition from hospital to home after thoracotomy . Objective : The objective of this study was to evaluate the feasibility , acceptability , safety , and changes in study end points of a home-based exercise intervention to enhance perceived self-efficacy for cancer-related fatigue ( CRF ) self-management for persons after thoracotomy for NSCLC transitioning from hospital to home . Interventions / Methods : Guided by the principles of the Transitional Care Model and the Theory of Symptom Self-management , a single-arm design composed of 7 participants with early-stage NSCLC performed light-intensity walking and balance exercises in a virtual reality environment with the Nintendo Wii Fit Plus . Exercise started the first week after hospitalization for thoracotomy and continued for 6 weeks . Results : The intervention positively impacted end points such as CRF severity ; perceived self-efficacy for fatigue self-management , walking , and balance ; CRF self-management behaviors ( walking and balance exercises ) ; and functional performance ( number of steps taken per day ) . Conclusions : A home-based , light-intensity exercise intervention for patients after thoracotomy for NSCLC is feasible , safe , well tolerated , and highly acceptable showing positive changes in CRF self-management . Implication s for Practice : Beginning evidence suggests that a light-intensity in-home walking and balance intervention after hospitalization for thoracotomy for NSCLC is a potentially effective rehabilitative CRF self-management intervention . Next steps include testing of this health-promoting self-management intervention in a larger-scale r and omized controlled trial",
"Introduction : Impairment in aerobic fitness is a potential modifiable risk factor for postoperative complications . In this r and omized controlled trial , we hypothesized that a high‐intensity interval training ( HIIT ) program enhances cardiorespiratory fitness before lung cancer surgery and therefore reduces the risk of postoperative complications . Methods : Patients with operable lung cancer were r and omly assigned to usual care ( UC ) ( n = 77 ) or preoperative rehabilitation based on HIIT ( Rehab ) ( n = 74 ) . Maximal cardiopulmonary exercise testing and the 6‐minute walk test were performed twice before surgery . The primary outcome measure was a composite of death and in‐hospital postoperative complications . Results : The groups were well balanced in terms of patient characteristics . During the preoperative waiting period ( median 25 days ) , the peak oxygen consumption and the 6‐minute walking distance increased ( median + 15 % , interquartile range , 25th to 75 percentile [ IQR25%–75 % , % ] = + 9 % to + 22 % , p = 0.003 and + 15 % , IQR25%–75 % = + 8 % to + 28 % , p whereas peak oxygen consumption declined in the UC group ( median –8 % , IQR25%–75 % = –16 % to 0 % ] , p = 0.005 ) . The primary end point did not differ significantly between the two groups : at least one postoperative complication developed in 27 of the 74 patients ( 35.5 % ) in the Rehab group and 39 of 77 patients ( 50.6 % ) in the UC group ( p = 0.080 ) . Notably , the incidence of pulmonary complications was lower in the Rehab compared with in the UC group ( 23 % versus 44 % , p = 0.018 ) , owing to a significant reduction in atelectasis ( 12.2 % versus 36.4 % , p a shorter length of stay in the postanesthesia care unit ( median –7 hours , IQR25%–75 % = –4 to –10 ) . Conclusions : In this r and omized controlled trial , preoperative HIIT result ed in significant improvement in aerobic performances but failed to reduce early complications after lung cancer resection",
"BACKGROUND Lung resection surgery further decreases exercise capacity and negatively affects respiratory muscle function in patients with non-small cell lung cancer ( NSCLC ) . The best design for exercise interventions in these patients has not been determined yet . AIM To assess the impact of aerobic exercise and high-intensity respiratory muscle training on patient outcomes following lung cancer resection surgery . DESIGN Prospect i ve , single-blind , pilot r and omized controlled trial . SETTING Outpatient cardiopulmonary rehabilitation unit of two university hospitals . POPULATION Thirty-seven patients with NSCLC after tumor resection . METHODS Patients were r and omly assigned to exercise training or usual post-operative care . The training program consisted of aerobic exercises and high-intensity respiratory muscle training ( 24 supervised sessions , 3 per week , 8 weeks ) . Primary outcome was exercise capacity assessed with peak oxygen uptake ( VO2peak ) during cardiopulmonary exercise test . Secondary outcomes included changes in respiratory muscle strength , levels of serum insulin growth factor I ( IGF-I ) and IGF binding protein 3 ( IGFBP-3 ) , and quality of life assessed with the European Organization for Research and Treatment of Cancer ( EORTC QLQ-C30 ) question naire . RESULTS The 8-week training program was associated with significant improvement in VO2peak ( 2.13 mL/Kg/min [ 95%CI 0.06 to 4.20 ] ) , maximal inspiratory and expiratory pressures ( 18.96 cmH2O [ 95 % CI 2.7 to 24.1 ] and 18.58 cmH2O [ 95 % CI 4.0 to 33.1 ] , respectively ) and IGFBP-3 ( 0.61 µg/mL [ % 95 CI 0.1 to 1.12 ] ) . No significant differences were observed in the EORTC QLQ-C30 . CONCLUSIONS An 8-week exercise program consisting of aerobic exercise and high-intensity respiratory muscle training improved exercise capacity , respiratory muscle strength , and serum IGFBP-3 levels in NSCLC patients after lung resection . There was no impact on the other outcomes assessed . CLINICAL REHABILITATION IMPACT A combination of aerobic exercise and respiratory muscle training could be included in the rehabilitation program of deconditioned patients with NSCLC after lung resection surgery ",
"BACKGROUND As a newly developed treatment , preoperative pulmonary rehabilitation ( PR ) has been studied in depth . However , few studies have assessed the relationship between advanced age and a shorter term intensive pattern of preoperative PR in patients with lung cancer ( LC ) and especially those patients waiting for therapeutic LC surgeries . This study investigated short-term preoperative PR combined with inspiratory muscle training ( IMT ) and aerobic endurance training in elderly patients scheduled to undergo LC lobectomy . METHODS A prospect i ve r and omized controlled trial with a total of 60 subjects aged ≥70 y was conducted . The intervention group ( PR group ) was treated for 1 wk with systematic and highly intensive preoperative PR training before lobectomy , and the control group ( NPR group ) was treated with conventional preoperative respiratory management . We analyzed the 6-min walking distance ( 6-MWD ) , the peak expiratory flow ( PEF ) , and quality -of-life scores before and after the rehabilitation regimen as well as the incidence of postoperative pulmonary complications ( PPCs ) . RESULTS In total , 30 patients ( PR group ) completely executed the 7-d intensive preoperative PR , and 30 patients ( NPR group ) served as the control group . The two groups were comparable at baseline . During the preoperative PR , a significantly longer 6-MWD ( increase : 28.6 ± 18.2 versus 9.4 ± 27.0 m ; between-groups difference : 19.2 m , P = 0.029 ) and an increased PEF ( increase : 26.2 ± 22.5 versus 8.2 ± 10.3 L/min ; between-groups difference : 18.0 L/min , P the mean postoperative length of stay ( 6.9 ± 4.4 versus 10.7 ± 6.4 d , P = 0.010 ) and total hospital stay ( 16.0 ± 4.5 versus 19.7 ± 6.5 d , P = 0.012 ) were significantly reduced in the PR group . Thirty-day PPCs were noted in four ( 13.3 % ) patients in the PR group and 11 ( 36.7 % ) patients in the NPR group , with a significant difference between the two groups ( P = 0.037 ) . CONCLUSIONS For elderly LC patients scheduled to undergo surgery in China , a 7-d intensive pattern of preoperative PR combined with IMT and aerobic endurance training may be a feasible rehabilitation strategy with positive physical and psychological effects"
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OBJECTIVE To amass all available evidence regarding the safety of intravenous ( IV ) iron preparations to provide a true balance of efficacy and safety . METHODS Systematic review and meta- analysis of all r and omized clinical trials comparing IV iron to another comparator . All electronic data bases until January 1 , 2014 , were review ed . Primary outcome was occurrence of severe adverse events ( SAEs ) . Secondary outcomes included all-cause mortality and other adverse events ( AEs ) . Subgroup analysis was performed on the basis of type of IV iron , comparator , treated condition , and system involved . RESULTS A total of 103 trials published between 1965 through 2013 were included . A total of 10,390 patients were treated with IV iron compared with 4044 patients treated with oral iron , 1329 with no iron , 3335 with placebo , and 155 with intramuscular iron . There was no increased risk of SAEs with IV iron ( relative risk [ RR ] , 1.04 ; 95 % CI , 0.93 - 1.17 ; I(2)=9 % ) . Subgroup analysis revealed a decreased rate of SAEs when IV iron was used to treat heart failure ( RR , 0.45 ; 95 % CI , 0.29 - 0.70 ; I(2)=0 % ) . Severe infusion reactions were more common with IV iron ( RR , 2.47 ; 95 % CI , 1.43 - 4.28 ; I(2)=0 % ) . There was no increased risk of infections with IV iron . Gastrointestinal AEs were reduced with IV iron . CONCLUSION Intravenous iron therapy is not associated with an increased risk of SAEs or infections . Infusion reactions are more pronounced with IV iron
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"We conducted a r and omized study analyzing the impact of darbepoetin alfa ( DA ) administration with or without intravenous ( i.v . ) iron on erythroid recovery after autologous hematopoietic cell transplantation ( HCT ) . Patients were r and omized between no DA ( Arm 1 ) , DA 300 μg every 2 weeks starting on Day 28 after HCT ( Arm 2 ) , or DA plus i.v . iron 200 mg on Days 28 , 42 , and 56 ( Arm 3 ) . The proportion achieving complete hemoglobin ( Hb ) response within 18 weeks ( primary end point ) was 21 % in Arm 1 ( n = 24 ) , 79 % in Arm 2 ( n = 25 ) , and 100 % in Arm 3 ( n = 23 ; P was shown to be significantly higher in Arm 3 ( n = 46 ) than in Arm 2 ( n = 50 ; P = 0.008 ) , result ing in lower DA use , reduced drug costs , and improved quality of life scores , but the effect on transfusions was not significant . In multivariate analysis , DA administration ( P i.v . iron administration ( P = 0.0010 ) , high baseline Hb ( P achievement of complete Hb response . In conclusion , DA is highly effective to ensure full erythroid reconstitution after autologous HCT when started on Day 28 post‐transplant . I.v . iron sucrose further improves erythroid recovery . Am . J. Hematol . 88:990–996 , 2013 . © 2013 Wiley Periodicals ,",
"Abstract Objective : To compare oral iron to intravenous iron administration to women in late pregnancy and /or after labor to correct iron deficiency . Methods : 271 anemic women ( 148 pregnant women and 123 women post lower segment caesarean section ) with hemoglobin ( Hb ) levels below 110 g/L were enrolled over a two-year period and r and omized to receive either two tablets FGF ( ferrous sulfate with folic acid ) or 400 mg of intravenous iron sucrose plus folic acid 600 µg . Treatment effectiveness was assessed by measuring Hb and ferritin postpartum on day 1 , day 14 and day 42 . Transfusions of red blood cells and adverse drug reactions were recorded . Results : Data of 214 women were available for analysis . Both forms of iron replacement therapy led to increased hemoglobin and ferritin levels over the testing period . Ferritin was significantly higher in the i.v . iron treatment group compared to the oral iron treatment group ( p = 0.004 ) two weeks after delivery , while Hb values did not differ between the groups . No serious adverse drug reactions were observed . Red blood cell transfusion rate was low ( 1.9 % ) , with equal rates observed in both treatment groups . Conclusion : Intravenous and oral irons were both effective in correcting peripartum anemia , although intravenous iron restored stores faster than oral iron",
"PURPOSE To evaluate the safety and efficacy of intravenous ( IV ) sodium ferric gluconate complex ( FG ) , oral ferrous sulfate , or no iron to increase hemoglobin ( Hb ) in anemic cancer patients receiving chemotherapy and epoetin alfa . PATIENTS AND METHODS In this open-label , multicenter trial , 187 patients with chemotherapy-related anemia ( Hb or = 100 ng/ml or transferrin saturation > or = 15 % ) scheduled to receive chemotherapy and epoetin alfa ( 40,000 U subcutaneously weekly ) were r and omized to 8 weeks of 125 mg of IV FG weekly , 325 mg of oral ferrous sulfate three times daily , or no iron . The primary outcome was a change in Hb from baseline to endpoint , first whole-blood or red blood cell transfusion , or study withdrawal . RESULTS One hundred twenty-nine patients were evaluable for efficacy ( FG , n = 41 ; oral iron , n = 44 ; no iron , n = 44 ) . Mean increase in Hb was 2.4 g/dl ( 95 % confidence interval [ CI ] , 2.1 - 2.7 ) for FG ( p = .0092 vs. oral iron ; p = .0044 vs. no iron ) , 1.6 g/dl ( 95 % CI , 1.1 - 2.1 ) for oral iron ( p = .7695 vs. no iron ) , and 1.5 g/dl ( 95 % CI , 1.1 - 1.9 ) for no iron . Hb response ( increase > or = 2 g/dl ) was 73 % for FG ( p = .0099 vs. oral iron ; p = .0029 vs. no iron ) , 46 % for oral iron ( p = .6687 vs. no iron ) , and 41 % for no iron . FG was well tolerated . CONCLUSION For cancer patients with chemotherapy-related anemia receiving epoetin alfa , FG produces a significantly greater increase in Hb and Hb response compared with oral iron or no iron , supporting more aggressive treatment with IV iron supplementation for these patients",
"Objective To explore the safety and efficacy of intravenous ( IV ) iron sucrose in maintenance peritoneal dialysis ( PD ) . Design R and omized , controlled , parallel-group single-center trial . Setting Blood Purification Center of Chaoyang , Beijing Capital University of Medical Science , China . Methods 46 patients on PD were involved in this trial . 26 patients received IV iron sucrose ( 200 mg iron ) once per week for 4 weeks then once every other week for a further 4 weeks . The other 20 patients received oral ferrous succinate , 200 mg three times per day , for 8 weeks . Hemoglobin , hematocrit , serum ferritin ( SF ) level , and transferrin saturation ( TSAT ) were assessed at baseline and then again after 2 , 4 , and 8 weeks of treatment . Results There were no differences between the IV and oral groups in terms of sex , age , duration of PD , mean dialysate dosage per day , erythropoietin dosage per week , or hematological parameters at baseline . After 4 and 8 weeks of treatment , mean Hb and Hct were significantly increased in the IV group and were also significantly higher than those in the oral group . Levels of SF and TSAT were also significantly increased in the IV group , and significantly higher than in the oral group . After 8 weeks , the response rate in the IV group was 94.8 % , which was significantly higher than that in the oral group . The mean erythropoietin dose was significantly lower in the IV group than in the oral group . Hb , Hct , SF , and TSAT levels were maintained between 4 and 8 weeks in the IV group despite the decrease in dose frequency . There were no adverse events with IV iron . Eight patients in the oral group had adverse gastrointestinal effects . Conclusion IV iron sucrose is safe in PD patients . It increases Hb levels and serum iron parameters more effectively than oral iron ; it is well tolerated and can permit reductions in the required dose of erythropoietin",
"BACKGROUND Iron deficiency may impair aerobic performance . This study aim ed to determine whether treatment with intravenous iron ( ferric carboxymaltose ) would improve symptoms in patients who had heart failure , reduced left ventricular ejection fraction , and iron deficiency , either with or without anemia . METHODS We enrolled 459 patients with chronic heart failure of New York Heart Association ( NYHA ) functional class II or III , a left ventricular ejection fraction of 40 % or less ( for patients with NYHA class II ) or 45 % or less ( for NYHA class III ) , iron deficiency ( ferritin level were r and omly assigned , in a 2:1 ratio , to receive 200 mg of intravenous iron ( ferric carboxymaltose ) or saline ( placebo ) . The primary end points were the self-reported Patient Global Assessment and NYHA functional class , both at week 24 . Secondary end points included the distance walked in 6 minutes and the health-related quality of life . RESULTS Among the patients receiving ferric carboxymaltose , 50 % reported being much or moderately improved , as compared with 28 % of patients receiving placebo , according to the Patient Global Assessment ( odds ratio for improvement , 2.51 ; 95 % confidence interval [ CI ] , 1.75 to 3.61 ) . Among the patients assigned to ferric carboxymaltose , 47 % had an NYHA functional class I or II at week 24 , as compared with 30 % of patients assigned to placebo ( odds ratio for improvement by one class , 2.40 ; 95 % CI , 1.55 to 3.71 ) . Results were similar in patients with anemia and those without anemia . Significant improvements were seen with ferric carboxymaltose in the distance on the 6-minute walk test and quality -of-life assessment s. The rates of death , adverse events , and serious adverse events were similar in the two study groups . CONCLUSIONS Treatment with intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency , with or without anemia , improves symptoms , functional capacity , and quality of life ; the side-effect profile is acceptable . ( Clinical Trials.gov number , NCT00520780 )",
"OBJECTIVE : The aim of this study was to compare the efficacy of intravenous iron to oral iron in the treatment of anemia in pregnancy . METHODS : In this r and omized open-label study , 90 women with hemoglobin levels between 8 and 10.5 g/dL and ferritin values less than 13 & mgr;g/L received either oral iron polymaltose complex ( 300 mg elemental iron per day ) or intravenous iron sucrose . The iron sucrose dose was calculated from the following formula : weight before pregnancy ( kg ) × ( 110 g/L – actual hemoglobin [ g/L ] ) × 0.24 + 500 mg . Treatment efficacy was assessed by measuring hemoglobin and ferritin on the 14th and 28th days and at delivery , and the hemoglobin on the first postpartum day . Adverse drug reactions , fetal weight , hospitalization time , and blood transfusions were also recorded . RESULTS : Hemoglobin values varied significantly with time between groups ( interaction effect , P change in hemoglobin from baseline was significantly higher in the intravenous group than the oral group at each measurement ; the changes with respect to subsequent hemoglobin were significantly higher on the 14th ( P = .004 ) and 28th ( P = .031 ) days . Ferritin values were higher in patients receiving intravenous iron throughout pregnancy . No serious adverse drug reactions were observed . Fetal weight and hospitalization time were similar in the 2 groups . Blood transfusion was required for only one patient in the oral group . CONCLUSION : Intravenous iron treated iron-deficiency anemia of pregnancy and restored iron stores faster and more effectively than oral iron , with no serious adverse reactions . LEVEL OF EVIDENCE :",
"Acute mountain sickness ( AMS ) is a common and disabling condition that occurs in healthy individuals ascending to high altitude . Based on the ability of iron to influence cellular oxygen sensing pathways , we hypothesized that iron supplementation would protect against AMS . To examine this hypothesis , 24 healthy sea-level residents were r and omized to receive either intravenous iron(III)-hydroxide sucrose ( 200 mg ) or saline placebo , before ascending rapidly to Cerro de Pasco , Peru ( 4340 m ) . The Lake Louise scoring system was used to assess incidence and severity of AMS at sea level and on the first full day at altitude . No significant difference in absolute AMS score was detected between the two groups either at baseline or at high altitude . However , the mean increase in AMS score was 65 % smaller in the iron group than in the saline group ( p change in AMS score correlated negatively with the change in ferritin ( R=-0.43 ; p Hematocrit and arterial oxygen saturation were unaffected by iron . In conclusion , this preliminary r and omized , double-blinded , placebo-controlled trial suggests that intravenous iron supplementation may protect against the symptoms of AMS in healthy volunteers",
"OBJECTIVE ( 1 ) To determine an alternative iron supplementation with better efficacy , compliance & safety in treatment of iron deficiency anemia during pregnancy , ( 2 ) to reduce blood transfusion during pregnancy , labor and puerperium . MATERIAL AND METHOD A prospect i ve comparative study . A total number of 60 pregnant women with the gestational age of 12 - 34 weeks were included in the study who were suffering from iron deficiency anemia . They were divided in 3 groups ( A , B and C ) . Group A ( n = 15 ) received intravenous iron sucrose according to recommended dose containing 500 mg of iron sucrose for storage , in group B ( n = 20 ) iron sucrose was administered according to deficit calculated as per formula but 200 mg of iron was given for storage instead of 500 mg , to reduce cost . While group C received intra muscular iron Sorbitol in the dose used as practice . RESULTS Mean hemoglobin in group A and B was 8.0 + /- 1.1 g/dl and 8.9 + /- 0.7 respectively , in group C , it was 8.8 + /- 0.9 g/dl . In group A & B initial hemoglobin was assessed 3 weeks post therapy which showed an average rise of 2.8 g/dl ( group A ) and 1.9 g/dl ( group B ) and second assessment of Hemoglobin was done prior to delivery ( ave : 6.6 weeks ) showed a total rise of 3.8 g/dl ( group A ) and 2.4 g/dl ( group B ) . Pre delivery mean Hemoglobin in group A and B was 11.8 g/dl and 11.3 g/dl respectively . In group C , the Hemoglobin was assessed only prior to delivery ( average : 8.4 weeks from the start of therapy ) , and a rise of 1.4 g/dl was observed with pre delivery mean Hemoglobin of 10.2 g/dl . Target hemoglobin levels i.e. 11 g/dl was achieved by 80 % in Group A , 70 % in Group B and 28 % in Group C by the time of delivery . Blood transfusion was not required in any group . In group A and B one patient had moderate abdominal pain , 2 had weakness and shivering and 3 had phlebitis at the site where intravenous canula was retained . None of patient discontinued the therapy due to any adverse effect . In group C majority complained of pain at injection site while 5 patients dropped out from the study due to intolerance . CONCLUSION Intravenous iron therapy is safe , convenient and more effective then intramuscular iron therapy in treatment of iron deficiency anemia during pregnancy . The intravenous iron therapy can replace blood transfusion in antenatal period",
"OBJECTIVES Anaemia is a frequent complication after cardiopulmonary bypass surgery . Iron therapy has been variably employed by medical centres over the years . In our study we test the clinical effectiveness of intravenous and oral iron supplementation in correcting anaemia , and its impact on blood transfusion requirements , in patients undergoing cardiopulmonary bypass surgery . METHODS A double-blind , r and omized , placebo-controlled clinical trial with three parallel groups of patients . Group I ( n = 54 ) : intravenous iron(III)-hydroxide sucrose complex , three doses of 100 mg/24 h during pre- and postoperative hospitalization and 1 pill/24 h of oral placebo in the same period and during 1 month after discharge . Group II ( n = 53 ) : oral ferrous fumarate iron 1 pill/24 h pre- and postoperatively and during 1 month after discharge , and intravenous placebo while hospitalized . Group III ( n = 52 ) : oral and intravenous placebo pre- and postoperatively , following the same protocol . Data were collected preoperatively , at theatre , at intensive care unit admission , before hospital discharge and 1 month later . RESULTS ( 1 ) Baseline clinical and demographic characteristics and surgical procedures were similar in the three groups ; ( 2 ) no inter-group differences were found in haemoglobin and haematocrit during the postoperative period ; ( 3 ) the intravenous iron group showed higher serum ferritin levels at hospital discharge ( 1321 ± 495 ng/ml ; P in blood transfusion requirements between the three groups . CONCLUSIONS The use of intravenous or oral iron supplementation proved ineffective in correcting anaemia after cardiopulmonary bypass and did not reduce blood transfusion requirements . [ Current Controlled Trials number : NCT01078818 ( oral and intravenous iron in patients postoperative cardiovascular surgery under EC ) ]",
"Background : The aim of this study was to compare the efficacy , safety and achievement of the target hemoglobin level ( Hb ≥10 g/dl ) in patients with preoperative anemia due to menorrhagia who received intravenous iron sucrose compared with oral iron protein succinylate for anemia management . Methods : Seventy-six patients with Hb levels to receive either intravenous iron sucrose ( based on the calculated total iron deficit divided into 2 ampoule infusions intravenously 3 times a week , beginning 3 weeks before surgery ) or oral iron ( 80 mg/day of oral iron protein succinylate daily ) . Results : The intravenous iron group had higher increases in Hb ( 3.0 vs. 0.8 g/dl ; p ) and ferritin levels ( 170.1 vs. 4.1 μg/l ; p Achieving the target Hb was also higher in the intravenous iron group than in the oral iron group ( 76.7 vs. 11.5 % ; p There were tolerable adverse events in both groups . Conclusion : Preoperative intravenous iron sucrose administration is more effective than oral iron and is as safe as oral iron therapy in the correction of preoperative anemia due to menorrhagia",
"Although iron therapy is essential to optimize use of erythropoiesis-stimulating agents ( ESA ) , r and omized , controlled trials have heretofore been unavailable to evaluate reliably the efficacy of intravenous iron as an adjuvant to ESA treatment in peritoneal dialysis ( PD ) patients . In a multicenter trial , patients who had anemia , PD-dependent chronic kidney disease , stable ESA therapy , and a broad range of iron status ( ferritin were r and omly assigned to receive either 1 g of iron sucrose intravenously in three divided doses ( 300 mg over 1.5 h on days 1 and 15 , 400 mg over 2.5 h on day 29 ) or no supplemental iron . No serious adverse drug events occurred after intravenous iron administration . The primary end point , peak hemoglobin increase , was higher ( 1.3 + /- 1.1 versus 0.7 + /- 1.1 , mean + /- SD ; P = 0.0028 ) , and anemia intervention ( transfusion , increase in ESA dose , or intravenous iron therapy not called for in protocol ) occurred later ( P = 0.0137 ) and less often in intravenous iron-treated patients compared with untreated control subjects ( one of 66 [ 1.3 % ] versus five of 30 [ 16.7 % ] ) . Among patients who did not require intervention , iron-treated patients showed a calculated net ESA dose decrease compared with untreated control subjects . Baseline iron status did not predict responsiveness to intravenous iron therapy . Intravenous iron sucrose is an effective adjunct to ESA therapy in anemic patients with PD-dependent chronic kidney disease and is administered safely as 300 mg over 1.5 h or 400 mg over 2.5 h. Evidence of iron deficiency at baseline is not required to demonstrate intravenous iron efficacy",
"Background . Iron deficiency is a common cause of anaemia and hyporesponsiveness to erythropoiesis-stimulating agents ( ESAs ) in non-dialysis-dependent chronic kidney disease ( ND-CKD ) patients . Current intravenous iron agents can not be administered in a single high dose because of adverse effects . Ferric carboxymaltose , a non-dextran parenteral iron preparation , can be rapidly administered in high doses . Methods . This open-label trial r and omized 255 subjects with glomerular filtration rates ≤ 45 mL/min/1.73 m2 , haemoglobin ≤ 11 g/dL , transferrin saturation ≤ 25 % , ferritin ≤ 300 ng/mL , and stable ESA dose to either intravenous ferric carboxymaltose 1000 mg over 15 min ( with up to two additional doses of 500 mg at 2-week intervals ) or oral ferrous sulphate 325 mg thrice daily for a total of 195 mg elemental iron daily for 56 days . Results . In the modified intent-to-treat population , the proportion of subjects achieving a haemoglobin increase ≥ 1 g/dL at any time was 60.4 % with ferric carboxymaltose and 34.7 % with oral iron ( P 42 , mean increase in haemoglobin was 0.95 ± 1.12 vs 0.50 ± 1.23 g/dL ( P = 0.005 ) , mean increase in ferritin was 432 ± 189 ng/mL vs 18 ± 45 ng/mL ( P ) and mean increase in transferrin saturation was 13.6 ± 11.9 % vs 6.1 ± 8.1 % ( P events were significantly fewer with ferric carboxymaltose than with oral iron ( 2.7 % and 26.2 % , respectively ; P 1000 mg ferric carboxymaltose can be rapidly administered , is more effective and is better tolerated than oral iron for treatment of iron deficiency in ND-CKD patients",
"Patients undergoing maintenance hemodialysis have elevated markers of oxidative stress , but the reasons for this are not fully understood . Intravenous administration of iron , which many of these patients receive , may provoke the generation of bioactive iron , which enhances oxidative stress and lipid peroxidation . In this study , 110 hemodialysis patients were r and omly assigned to five groups that were administered single intravenous doses of iron sucrose , ranging from 20 to 500 mg . A time- and dosage-dependent rise in lymphocyte 8-hydroxy-2'-deoxyguanosine ( 8-OHdG ) levels in lymphocyte DNA , a marker of oxidative DNA damage , with a significant increase at 2 h after intravenous iron of > or = 200 mg ( P iron sucrose ( 100 mg of elemental iron ) or saline for 12 wk , and 89 patients completed the study . Mean lymphocyte 8-OHdG content was significantly higher in patients receiving intravenous iron compared with control subjects ( P 500 microg/L. In addition , flow cytometric techniques revealed increased production of reactive oxygen species in lymphocytes among those treated with intravenous iron . Treatment with intravenous iron but not saline was also associated with decreased plasma ascorbate and alpha-tocopherol levels and increased oxidized glutathione/reduced glutathione ratio ( P intravenous iron sucrose provokes oxidative damage to peripheral blood lymphocyte DNA in hemodialysis patients , especially among those with high levels of ferritin",
"This is the first study to investigate the efficacy of intravenous iron in treating fatigue in nonanemic patients with low serum ferritin concentration . In a r and omized , double-blinded , placebo-controlled study , 90 premenopausal women presenting with fatigue , serum ferritin ≤ 50 ng/mL , and hemoglobin ≥ 120 g/L were r and omized to receive either 800 mg of intravenous iron (III)-hydroxide sucrose or intravenous placebo . Fatigue and serum iron status were assessed at baseline and after 6 and 12 weeks . Median fatigue at baseline was 4.5 ( on a 0 - 10 scale ) . Fatigue decreased during the initial 6 weeks by 1.1 in the iron group compared with 0.7 in the placebo group ( P = .07 ) . Efficacy of iron was bound to depleted iron stores : In patients with baseline serum ferritin ≤ 15 ng/mL , fatigue decreased by 1.8 in the iron group compared with 0.4 in the placebo group ( P = .005 ) , and 82 % of iron-treated compared with 47 % of placebo-treated patients reported improved fatigue ( P = .03 ) . Drug-associated adverse events were observed in 21 % of iron-treated patients and in 7 % of placebo-treated patients ( P = .05 ) ; none of these events was serious . Intravenous administration of iron improved fatigue in iron-deficient , nonanemic women with a good safety and tolerability profile . The efficacy of intravenous iron was bound to a serum ferritin concentration ≤ 15 ng/mL. This study was registered at the International St and ard R and omized Controlled Trial Number Register ( www.is rct n.org ) as IS RCT N78430425",
"BACKGROUND This study was performed to evaluate the capacity of oral and intravenous ( i.v . ) iron administration during autologous blood donation ( ABD ) to improve the efficacy of ABD and to prevent the need for allogeneic blood transfusion in patients without iron deficiency who are undergoing major elective surgery for which a minimum of 3 autologous units have been ordered . STUDY DESIGN AND METHODS One hundred twenty-three patients were enrolled in an open-labeled , r and omized , controlled trial and assigned to three treatment groups : patients in Group 1 received 3 x 100 mg of Fe2 + per day given orally for 5 weeks before operation ; patients in Group 2 received 200 mg of Fe3 + given intravenously after each donation combined with initial i.v . iron supplementation in patients with hemoglobin under 15 g per dL ; and patients in Group 3 were in the control group that received no iron medication . A modest ABD program involving weekly phlebotomy and threshold hemoglobin values for donation of 11.5 g per dL in women and 12.0 g per dL in men was performed . RESULTS Ninety patients , 15 women and 15 men in each of the three groups , completed the study . The mean net red cell production during ABD was no higher ( p>0.2 ) in the iron-treated groups ( Group 1 : 473 + /- 178 mL ; Group 2 : 436 + /- 170 mL ; Group 3 ( controls ) : 397 + /- 174 mL ) . The mean number of autologous units donated per patient did not differ ( p>0.7 ) among the groups ( Group 1 : 3.1 + /- 0.6 ; Group 2 : 2.9 + /- 0.7 ; Group 3 : 3.0 + /- 0.7 ) . The proportion of patients who needed allogeneic blood transfusion showed no significant ( p>0.4 ) advantage for iron treatment , ( Group 1 : 7 % ; Group 2 : 20 % ; Group 3 : 10 % ) . CONCLUSION In non-iron-deficient patients undergoing modest ABD without erythropoietin therapy , neither oral nor i.v . application of iron during the preoperative period enhances the success of preoperative ABD",
"PURPOSE Functional iron deficiency may impair response to erythropoiesis-stimulating agents ( ESAs ) in iron-replete patients with chemotherapy-associated anemia ( CAA ) . This study evaluated whether coadministration of parenteral iron improves ESA efficacy in patients with CAA . PATIENTS AND METHODS This prospect i ve , multicenter , r and omized trial enrolled 502 patients with hemoglobin ( Hb ) less than 11 g/dL who were undergoing chemotherapy for nonmyeloid malignancies . All patients received darbepoetin alfa once every 3 weeks and were r and omly assigned to receive either ferric gluconate 187.5 mg intravenously ( IV ) every 3 weeks , oral daily ferrous sulfate 325 mg , or oral placebo for 16 weeks . RESULTS There was no difference in the erythropoietic response rate ( ie , proportion of patients achieving Hb ≥ 12 g/dL or Hb increase ≥ 2 g/dL from baseline ) : 69.5 % ( 95 % CI , 61.9 % to 76.5 % ) of IV iron-treated patients achieved an erythropoietic response compared with 66.9 % ( 95 % CI , 59.1 % to 74.0 % ) who received oral iron and 65.0 % ( 95 % CI , 57.2 % to 72.3 % ) who received oral placebo ( P = .75 ) . There were also no differences in the proportion of patients requiring red cell transfusions , changes in quality of life , or the dose of darbepoetin administered . Adverse events ( AEs ) tended to be more common in the IV iron arm : grade 3 or higher AEs occurred in 54 % ( 95 % CI , 46 % to 61 % ) of patients receiving IV iron compared with 44 % ( 95 % CI , 36 % to 52 % ) who received oral iron and 46 % ( 95 % CI , 38 % to 54 % ) who received oral placebo ( P = .16 ) . CONCLUSION In patients with CAA , addition of IV ferric gluconate to darbepoetin failed to provide additional benefit compared with oral iron or oral placebo",
"Background : Secondary thrombocytosis is a common clinical feature . In patients with cancer , it is a risk factor for venous thromboembolic events . In inflammatory bowel disease ( IBD ) , thrombocytosis is so far considered a marker of active disease and may contribute to the increased thromboembolic risk in this population . Observed effects of iron therapy on normalization of platelet counts led us to hypothesize that iron itself may regulate megakaryopoiesis . Here , we want to test the effect of iron replacement on platelet count and activity in IBD-associated thrombocytosis . Methods : We performed a r and omized , single-blinded placebo-controlled trial testing the effect of ferric carboxymaltose ( FCM ) in patients with IBD with secondary thrombocytosis ( platelets > 450 G/L ) . Changes in platelet counts , hemoglobin , iron parameters , disease activity , megakaryopoietic growth factors , erythropoietin , and platelet activity were assessed . Patients received placebo or up to 1500 mg iron as FCM . Endpoints were evaluated at week 6 . Results : A total of 26 patients were included in the study , 15 patients were available for the per protocol analysis . A drop in platelets > 25 % ( primary endpoint ) was observed in 4 of 8 ( 50 % , iron group ) and 1 of 7 patients ( 14 % , placebo group , P = 0.143 ) . Mean platelet counts dropped on FCM but not on placebo ( 536 G/L to 411 G/L versus 580 G/L to 559 G/L ; P = 0.002 ) . Disease activity and megakaryopoietic growth factors remained unchanged and hemoglobin and iron parameters increased on FCM . The normalization of platelet counts was associated with a decrease in platelet aggregation and P-selectin expression . Conclusion : FCM lowers platelet counts and platelet activation in patients with IBD-associated secondary thrombocytosis",
"OBJECTIVES : Anemia is a frequent complication in patients with inflammatory bowel disease ( IBD ) . The optimal route for iron supplementation to replenish iron stores has not been determined so far . We therefore evaluated the efficacy and safety of intravenous iron sucrose as compared with oral iron sulfate for the treatment of iron deficiency anemia ( IDA ) in patients with IBD . METHODS : A r and omized , prospect i ve , open-label , multicenter study was performed in 46 patients with anemia and transferrin saturation ≤20 % and /or serum ferritin concentrations ≤20 μg/L. The intravenous group received a single dose of iron sucrose of 7 mg iron/kg body weight , followed by five 200 mg infusions for the following 5 wks . The oral group received iron sulfate 100–200 mg per day for 6 wks . RESULTS : While a comparable increase in hemoglobin was observed for both administration routes ( median increase 0.25 g/L in the intravenous group vs 0.21 g/L in the oral group ) , only iron sucrose led to a rise in serum ferritin concentrations . Intractable gastrointestinal adverse events caused permanent study drug discontinuation in five patients ( 20.8 % ) receiving iron sulfate , whereas only one patient ( 4.5 % ) had to be withdrawn because of side effects due to iron sucrose . CONCLUSIONS : Although being equal in short-term efficacy and overall tolerability our results suggest a better gastrointestinal tolerability for iron sucrose . Larger trials are m and atory to prove a possible advantage of iron sucrose in short- and long-term efficacy as well as in tolerability over iron sulfate in the management of IDA in IBD",
"OBJECTIVES : In the largest head-to-head comparison between an oral and an intravenous ( IV ) iron compound in patients with inflammatory bowel disease ( IBD ) so far , we strived to determine whether IV iron isomaltoside 1,000 is non-inferior to oral iron sulfate in the treatment of iron deficiency anemia ( IDA ) . METHODS : This prospect i ve , r and omized , comparative , open-label , non-inferiority study was conducted at 36 sites in Europe and India . Patients with known intolerance to oral iron were excluded . A total of 338 IBD patients in clinical remission or with mild disease , a hemoglobin ( Hb ) receive either IV iron isomaltoside 1,000 according to the Ganzoni formula ( 225 patients ) or oral iron sulfate 200 mg daily ( equivalent to 200 mg elemental iron ; 113 patients ) . An interactive web response system method was used to r and omize the eligible patient to the treatment groups . The primary end point was change in Hb from baseline to week 8 . Iron isomaltoside 1,000 and iron sulfate was compared by a non-inferiority assessment with a margin of −0.5 g/dl . The secondary end points , which tested for superiority , included change in Hb from baseline to weeks 2 and 4 , change in s-ferritin , and TSAT to week 8 , number of patients who discontinued study because of lack of response or intolerance of investigational drugs , change in total quality of life ( QoL ) score to weeks 4 and 8 , and safety . Exploratory analyses included a responder analysis ( proportion of patients with an increase in Hb ≥2 g/dl after 8 weeks ) , the effect of regional differences and total iron dose level , and other potential predictors of the treatment response . RESULTS : Non-inferiority in change of Hb to week 8 could not be demonstrated . There was a trend for oral iron sulfate being more effective in increasing Hb than iron isomaltoside 1,000 . The estimated treatment effect was −0.37 ( 95 % confidence interval ( CI ) : −0.80 , 0.06 ) with P=0.09 in the full analysis set ( N=327 ) and −0.45 ( 95 % CI : −0.88 , −0.03 ) with P=0.04 in the per protocol analysis set ( N=299 ) . In patients treated with IV iron isomaltoside 1,000 , the mean change in s-ferritin concentration was higher with an estimated treatment effect of 48.7 ( 95 % CI : 18.6 , 78.8 ) with P=0.002 , whereas the mean change in TSAT was lower with an estimated treatment effect of −4.4 ( 95 % CI : −7.4 , −1.4 ) with P=0.005 , compared with patients treated with oral iron . No differences in changes of QoL were observed . The safety profile was similar between the groups . The proportion of responders with Hb ≥2 g/dl ( IV group : 67 % ; oral group : 61 % ) were comparable between the groups ( P=0.32 ) . Iron isomaltoside 1,000 was more efficacious with higher cumulative doses of > 1,000 mg IV . Significant predictors of Hb response to IV iron treatment were baseline Hb and C-reactive protein ( CRP ) . CONCLUSIONS : We could not demonstrate non-inferiority of IV iron isomaltoside 1,000 compared with oral iron in this study . Based on the dose – response relationship observed with the IV iron compound , we suggest that the true iron dem and of IV iron was underestimated by the Ganzoni formula in our study . Alternative calculations including Hb and CRP should be explored to gauge iron stores in patients with IBD",
"BACKGROUND AND OBJECTIVES Iron depletion is common in regular blood donors . The objective of the study was to investigate the frequency and severity of iron depletion in regular blood donors and whether IV iron is more effective than oral to avoid iron depletion and symptoms thereof , especially restless legs syndrome ( RLS ) . METHOD One hundred and twenty blood donors with at least five previous whole blood donations were r and omized to receive either IV iron sucrose ( Venofer ( ® ) , RenaPharma/Vifor , Uppsala , Sweden ) , 200 mg , or to 20 × 100 mg of oral iron sulphate ( Duroferon ( ® ) , GlaxoSmithKline , Stockholm , Sweden ) , after each blood donation during 1 year . Iron status and RLS incidence and severity were investigated . RESULTS Iron status was generally poor among regular blood donors , especially in women , with a high incidence of iron depletion ( > 20 % ) and RLS ( 18 % ) . The IV iron group increased storage iron to a greater extent than the oral iron group after 12 months ( P=0·0043 ) . Female donors were more responsive to IV iron sucrose compared to oral iron sulphate , particularly female donors below 50 years of age . RLS severity scores were significantly lower in the IV iron group . The two treatments were safe . CONCLUSION Iron status is poor in regular blood donors , restless legs syndrome is common , and the routine iron supplementation is insufficient . IV iron sucrose substitutes iron loss in blood donors more efficiently compared with oral iron sulphate , especially in women . Iron substitution to blood donors should be individualized and based on P-ferritin monitoring",
"Sensitivity to iron dextran is a potent obstacle to maintaining optimum iron status in patients with dialysis-associated anemia . As part of the North American clinical trials for iron sucrose injection , we examined the effect of intravenous ( IV ) iron sucrose in 23 hemodialysis patients with documented sensitivity to iron dextran , ongoing epoetin alfa therapy , and below-target-range hemoglobin ( Hgb ) levels ( We assigned patients to treatment groups according to whether reactions they had experienced to iron dextran were judged to be mild ( n = 16 ; group A ) or severe ( n = 7 ; group B ) . We prospect ively examined adverse events and vital signs after administering 100 mg of IV iron sucrose in each of 10 consecutive dialysis treatment sessions and compared results with those recorded in each of three consecutive dialysis sessions without iron treatment . We administered iron sucrose by IV push over 5 minutes to group A patients and by IV push over 5 minutes or IV infusion over 15 to 30 minutes to group B patients . We did not administer a test dose . Results showed no serious adverse drug reactions after a total of 223 doses of iron sucrose ( 184 doses by IV push , 39 doses by IV infusion ) . Intradialytic blood pressure changes after IV iron sucrose injection did not differ from those recorded during dialysis sessions without treatment . An increase in values for Hgb , hematocrit , transferrin saturation , and ferritin , coupled with no significant change in epoetin dose and a decrease in total iron-binding capacity , confirmed the efficacy of iron sucrose injection in managing anemia . We conclude that iron sucrose injection is safe and effective in the management of anemia in patients sensitive to iron dextran and can be administered without a test dose by IV push or infusion",
"BACKGROUND Correction of iron deficiency is critical in chronic hemodialysis patients , and intravenous administration is superior to the oral route in this goal . Recently , concern was raised that intravenous iron administration might promote infection in dialysis patients . METHODS We review ed the data from a recent prospect i ve study of 985 patients in which no link between iron therapy and bacteremia had been found . We tested the potential role of the administration route of the iron ( intravenous vs. oral ) , the weekly amount of iron administered and the administration rate on the risk for bacteremia in these patients . RESULTS were 4-fold : in multivariate analysis , neither intravenous iron administration in the whole population nor the weekly amount of iron in the subgroup of i.v . iron-treated patients were significant risk factors for bacteremia ; iron was not given more frequently intravenously in bacteremic than in non-bacteremic patients ; among patients treated with intravenous iron , the frequency and the amount of iron administered were significantly higher in those who developed bacteremia than in those who did not ; and in patients receiving i.v . iron , there was an increased risk of bacteremia associated with concurrent administration of erythropoietin , which was not observed in patients receiving iron orally . CONCLUSION This study failed to demonstrate a significant association between intravenous iron administration and the risk of bacteremia in dialysis patients . However , there might be a slightly increased risk of bacteremia in patients given high-frequency , high-dose intravenous iron",
"OBJECTIVE The aim of this study was to ascertain whether high-dose intravenous ( IV ) iron sucrose could improve symptoms and change brain iron concentrations in idiopathic RLS . METHODS The study was a r and omized , parallel-group double-blind study of 1000 mg iron sucrose given IV versus placebo . Primary measures of the clinical status were global rating scale ( GRS ) and periodic leg movements of sleep ( PLMS ) . Primary measures of brain iron status were CSF ferritin and MRI-determined iron in the substantia nigra . RESULTS At the time of the interim analysis there were 7 placebo and 11 iron-treated subjects . At 2-weeks post-treatment , iron treatment result ed in a small but significant increase in CSF ferritin and a decrease in RLS severity ( GRS ) but did not change PLMS or MRI iron index . None of the secondary outcomes changed with treatment . There was no single case of clear treatment benefit in any of the patients . This interim analysis revealed an effect size that was too small to allow for adequate power to find significant differences with the planed 36-subject enrollment for either the primary objective outcome of PLMS or any of the secondary outcomes . The study was stopped at this planned break-point given the lack of both adequate power and any indication for clinical ly significant benefit . CONCLUSIONS High-dose IV iron failed to demonstrate the robust changes reported in three prior open-label studies . Differences in iron formulation , dosing regiment , and peripheral iron status may explain some of the discrepancies between this and previous IV iron treatment studies",
"Although oral iron is the initial treatment approach for iron deficiency anemia ( IDA ) , some patients fail to respond to or can not tolerate oral iron . This double‐blind safety and efficacy study of the intravenous ( IV ) iron , ferumoxytol , r and omized patients with a history of unsatisfactory oral iron therapy , or in whom oral iron could not be used , to ferumoxytol ( n = 609 ) or placebo ( n = 203 ) . The proportion of patients achieving the primary endpoint ( hemoglobin increase ≥2.0 g/dL at Week 5 ) was 81.1 % with ferumoxytol versus 5.5 % with placebo ( P ) . The mean increase in hemoglobin from Baseline to Week 5 , a secondary endpoint ( also the alternative preplanned primary efficacy endpoint for other health authorities ) , was 2.7 versus 0.1 g/dL ( P of a hemoglobin ≥12 g/dL , time to a hemoglobin increase ≥2.0 g/dL , and improvement in the Functional Assessment of Chronic Illness Therapy Fatigue score also significantly favored ferumoxytol over placebo at Week 5 ( P 0.0001 ) . Ferumoxytol treatment‐emergent adverse events were mainly mild to moderate . Ferumoxytol was effective and well tolerated in patients with IDA of any underlying cause in whom oral iron was ineffective or could not be used . This trial was registered at www . clinical trials.gov as # NCT01114139 . Am . J. Hematol . 89:7–12 , 2014 . © 2013 Wiley Periodicals ,",
"Iron deficiency anemia is common among hospitalized patients , and blood losses from diagnostic phlebotomy increase the likelihood of a negative iron balance . The role for iron supplementation of total parenteral nutrition ( TPN ) in these patients is unclear . Twenty-three patients with iron deficiency anemia were identified . Twelve patients were r and omized to receive TPN without iron ( group 1 ) and 11 received TPN supplemented with 10 mg of iron as iron dextran daily ( group 2 ) . Both groups were matched for age , serum iron studies , red cell indices , and hemogram . After a 7-d period , the mean serum iron in group 2 increased from 10 to 26 micrograms/dL , with an increased transferrin saturation from 7.3 to 15.3 % ( each , p total iron binding capacity , ferritin , reticulocyte count , hemoglobin , hematocrit , or mean corpuscular volume were observed in the two groups . The incidence of infectious complications was not different between both groups . We conclude that iron supplementation of TPN appears safe and is effective in increasing serum iron levels . The use of iron-supplemented short-term TPN needs to be further studied given no change in red cell indices , hemoglobin , hematocrit , or transfusion requirement",
"There is limited safety information about ferric carboxymaltose ( FCM ) , a new intravenous iron preparation . This r and omized , crossover study compared the safety and tolerability of double‐blinded intravenous doses of FCM or placebo in patients with iron deficiency anemia . Subjects ( 559 ) with iron deficiency anemia received a dose of either FCM ( 15 mg/kg , maximum 1000 mg ) over 15 minutes or placebo on day 0 . On day 7 , subjects received the other agent . Safety evaluations were performed on days 7 and 14 . The primary endpoint was the incidence of treatment‐emergent adverse events during each 7‐day study period . During the first 24 hours and during the 7‐day treatment period , at least one treatment‐emergent adverse event was experienced by 15.0 % and 29.3 % of subjects after FCM and 11.4 % and 19.7 % after placebo , respectively . Most were classified as Grade 1 or 2 . Six subjects had Grade 3 treatment‐emergent adverse events after FCM and 9 subjects after placebo . One subject had a Grade 4 , and 1 subject had a Grade 5 treatment‐emergent adverse event , but neither was considered study drug‐related . During the first 24 hours of the treatment period , drug‐related adverse events were reported in 9.3 % of subjects receiving FCM and 4.8 % receiving placebo . Of drug‐related Grade 3 events , 4 subjects received FCM and 5 subjects received placebo . Administration of FCM ( 15 mg/kg , maximum of 1000 mg ) over 15 minutes was well tolerated and associated with minimal risk of adverse reactions in patients with iron deficiency anemia",
"Oral and intravenous iron were compared in patients treated with renal dialysis by a cross-over trial . Intravenous iron was given over 2 weeks as an iron dextran ( equivalent to 100 mg elemental iron ) . Oral iron was given daily as ferrous sulphate ( equivalent to 100 mg elemental iron ) in a wax matrix tablet . Each treatment period lasted 26 weeks . There was no significant difference in therapeutic or unwanted effects between the treatments",
"Background . Anemia after kidney transplantation has been associated with poor transplant outcomes . We hypothesized that intravenous ( IV ) iron may more rapidly correct anemia than oral ( PO ) iron . Methods . One hundred four kidney transplant recipients were prospect ively r and omized to IV iron polymaltose ( 500 mg single dose ) or PO ferrous sulfate ( 210 mg elemental iron daily , continuously ) . The primary outcome was time to resolution of anemia , defined as hemoglobin more than or equal to 11 g/dL. Secondary outcomes included infections , blood transfusions , gastrointestinal side-effects , and acute rejection . Results . There was no significant difference in the primary outcome comparing IV with PO iron ( hazards ratio 1.22 ; 95 % confidence interval 0.82–1.83 ; P=0.32 ) . The median time to resolution of anemia was 12 days in the IV group versus 21 days in the PO group . There were no differences in infections ( 20 % vs. 24 % , P=0.62 ) , acute rejection ( 8 % vs. 6 % , P=0.68 ) , blood transfusions ( 10 % vs. 18 % , P=0.24 ) , and severe gastrointestinal side-effects ( 6 % vs. 12 % , P=0.29 ) between the IV iron and the PO iron groups . Conclusions . We conclude that a single dose of IV iron did not result in more rapid resolution of anemia compared with PO iron . Both IV and PO iron are safe and effective in the management of posttransplant anemia",
"To compare two modalities of iron supplementation for the preoperative stimulation of erythropoiesis using recombinant human erythropoietin ( rhEPO ) , 12 adults in normal hemoglobin and iron status due for elective surgery were r and omized to rhEPO 200 U/kg body weight subcutaneously twice weekly combined with either iron sucrose 200 mg intravenously twice weekly or iron sulfate 160 mg/day orally , for 3 weeks preoperatively . Efficacy was measured by the increases over baseline in hemoglobin , reticulocyte count , and ferritin determined 3 days before surgery ; preoperative reticulocyte count and ferritin were significantly higher with intravenous iron , whereas the only significant intragroup increases in hemoglobin between time points also occurred in this group . Intravenous iron significantly boosts the hematopoietic response to rhEPO and prevents iatrogenic iron depletion in otherwise healthy c and i date s for elective surgery",
"OBJECTIVE To compare the incidence of repeated red blood cell ( RBC ) transfusion in anemic gynecologic cancer patients receiving platinum-based chemotherapy comparing intravenous and oral iron . MATERIAL S AND METHODS Forty-four anemic gynecologic cancer patients ( hemoglobin level below 10 mg/dl ) who required RBC transfusion were stratified and r and omized according to baseline hemoglobin levels and chemotherapy regimen . Study group received 200 mg of intravenous iron sucrose and control group received oral ferrous sulphate 600 mg/day . RBC transfusion requirement in the consecutive cycle of chemotherapy was the primary outcome . Quality of life was evaluated by vali date d Thai version of the Functional Assessment of Cancer Therapy-Anemia ( FACT-An ) . RESULTS In a total of the 44 patients , there were 22 patients in each group . Five patients ( 22.7 % ) in the study group and 14 patients ( 63.6 % ) in the control group required RBC transfusion in consecutive cycle of chemotherapy ( p=0.01 ) . No significant difference in baseline hemoglobin and hematocrit levels was demonstrated in both groups . Significantly higher mean hemoglobin and hematocrit levels after treatment were reported in the study group ( 10.0+/-0.8 g/dl and 30.5+/-2.4 % ) than the control group ( 9.5+/-0.9 g/dl and 28.4+/-2.7 % ) . No significant change of total FACT-An scores was noted between before and after treatment in both groups . No serious adverse events were reported and there was no significant difference among adverse events between both groups . CONCLUSION Intravenous iron is an alternative treatment for anemic gynecologic cancer patients receiving platinum-based chemotherapy and reduces the incidence of RBC transfusion without serious adverse events",
"Objective . Iron therapy may reinforce intestinal inflammation by catalysing production of reactive oxygen species . The effects of oral ferrous fumarate and intravenous iron sucrose on clinical disease activity and plasma redox status were investigated in patients with inflammatory bowel disease ( IBD ) . Material and methods . Nineteen patients with iron deficiency anaemia and Crohn 's disease ( 11 ) or ulcerative colitis ( 8) were included in a crossover study . The patients were r and omly assigned to start treatment with ferrous fumarate ( Neo-fer ® ) 120 mg orally once daily or iron sucrose ( Venofer ® ) 200 mg intravenously 3 times during a period of 14 days . Clinical disease activity assessment and blood and faecal analysis were performed on days 1 and 15 . Results . Following oral ferrous fumarate clinical disease activity ( p=0.037 ) , general well-being score ( i.e. patients felt worse ) ( p=0.027 ) and abdominal pain score ( p=0.027 ) increased , while no changes were seen following iron sucrose treatment . C-reactive protein ( CRP ) and faecal calprotectin were unchanged after both treatments . As compared with iron sucrose , ferrous fumarate increased Crohn 's disease activity index ( CDAI ) scores of general well-being ( p=0.049 ) , whereas alterations in clinical disease activity ( p=0.14 ) and abdominal pain score ( p=0.20 ) did not differ . Ferrous fumarate did not significantly alter plasma malondialdehyde ( MDA ) or plasma antioxidants . Iron sucrose increased plasma MDA ( p=0.004 ) and decreased plasma vitamin C ( p=0.017 ) and betacarotene ( p=0.008 ) . Conclusions . Oral ferrous fumarate , but not intravenous iron sucrose , increased clinical disease activity in IBD patients . Intravenous iron sucrose increased intravascular oxidative stress",
"BACKGROUND An optimal haemoglobin ( Hb ) response to erythropoietin requires elevated iron indices in dialysis patients ; however , it is unknown if the same applies in chronic kidney disease ( CKD ) . METHODS One hundred patients [ CKD Stages 3 - 5 , Hb > or= 110 g/L , iron replete , erythropoietin-stimulating agent (ESA)-naive , 47 % diabetic , median age 69.5 years ] were block-r and omized in an open-label study to receive up to 200 mg intravenous iron sucrose ( Group A , n = 52 ) bimonthly or oral iron sulphate ( Group B ) to maintain raised and normal iron indices ( respectively ) over 12 months . The primary endpoint was the change in Hb concentration at 12 months or at termination after at least 6 months of treatment . RESULTS Eighty-five patients reached the primary endpoint ( 43 , Group A ; 42 , Group B ) . Initial Hb was 119 + /- 7 vs 116 + /- 12 g/L ( mean + /- st and ard deviation ) ; ferritin 122 ( 71 - 176 ) , median ( inter-quartile range ) , vs 90 microg/L ( 58 - 150 ) ; transferrin saturation ( TSat ) 22 ( 18 - 26 ) vs 21 % ( 15 - 24 ) ; and creatinine 240 ( 195 - 313 ) vs 230 micromol/L ( 184 - 352 ) . Ferritin and TSat differed by month 2 [ 157 ( 103 - 220 ) vs 96 microg/L ( 73 - 162 ) , P = 0.003 ] and month 6 [ 25 ( 20 - 31 ) vs 21 % ( 17 - 27 ) , P = 0.02 ] , respectively . At study end , Hb did not differ between groups ( 121 + /- 10 vs 117 + /- 13 g/L ) . Ferritin was 362 ( 310 - 458 ) vs 125 microg/L ( 84 - 190 ) , P TSat 30 ( 23 - 34 ) vs 21 % ( 18 - 24 ) , P creatinine 229 ( 188 - 326 ) vs 272 micromol/L ( 195 - 413 ) , P = NS . For patients ( Groups A and B , n = 27 in each group ) whose creatinine regression slope increased ( indicating worsening function ) , the fall in Hb over 12 months also did not differ between groups despite adequate separation in iron indices . Serious adverse events overall did not differ between groups . CONCLUSIONS Elevated iron indices did not increase Hb synthesis in ESA-naive , iron replete , pre-dialysis patients with Hb > 110",
"Background Anemia secondary to iron deficiency is common in patients with non-dialysis dependent chronic kidney disease ( ND-CKD ) but it is unclear if oral supplementation is as effective as intravenous ( IV ) supplementation in re-establishing iron stores . The purpose of this study was to determine if oral Heme Iron Polypeptide ( HIP ) is as effective as IV iron sucrose in the treatment of iron-deficiency anemia for patients with ND-CKD . Methods Forty ND-CKD patients were r and omized ; 18 to HIP 11 mg orally 3 times per day and 22 to IV iron sucrose 200 mg monthly for 6 months . Baseline clinical and laboratory data were collected for all patients . The primary and secondary outcomes for the study were hemoglobin ( Hgb ) concentration and iron indices [ ferritin and percentage transferrin saturation ( TSAT ) ] at the end of 6 months respectively . Adverse events were also compared . Results The baseline demographic characteristics and laboratory values were similar for the two groups . After 6 months of treatment , Hb in the HIP group was 117 g/L and 113 g/L in the IV sucrose group ( p = 0.37 ) . The TSAT at 6 months was not different between the two groups { p = 0.82}but the serum ferritin was significantly higher in the IV iron sucrose group { 85.5 ug/L in HIP and 244 ug/L ; p = 0.004}. Overall adverse events were not different between the groups . Conclusion HIP is similar in efficacy to IV iron sucrose in maintaining hemoglobin in ND-CKD patients with no differences in adverse events over 6 months . It is unclear if the greater ferritin values in the IV iron sucrose group are clinical ly significant . Trial registration Clinical Trials.gov :",
"OBJECTIVES To compare the safety and efficacy of iron carboxymaltose with ferrous sulfate to treat iron deficiency anemia in the post partum . METHODS Patients were r and omized ( 2:1 ratio ) to receive iron carboxymaltose ( up to 3 weekly doses of 1000 mg maximum , applied in 15 min ; n=227 ) or ferrous sulfate ( 100 mg twice daily , 12 weeks ; n=117 ) . Changes in hemoglobin and iron stores up to week 12 were analyzed . RESULTS Iron carboxymaltose was as effective as oral iron sulfate in changing hemoglobin , despite the much shorter treatment period ( 2 weeks vs 12 weeks ) . Ferritin levels were significantly higher . Except for injection site burning , iron carboxymaltose was better tolerated than ferrous sulfate , mainly concerning gastrointestinal side effects . There were no safety concerns identified in breast-fed infants . CONCLUSION Parenteral iron carboxymaltose is a safe and effective treatment option for postpartum anemia , with advantages of a shorter treatment period , better compliance , rapid normalization of iron storages , and lower incidence of gastrointestinal side effects",
"Reporting harms may cause more trouble and discredit than the fame and glory associated with successful reporting of benefits ( 1 ) . The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement , a checklist ( Table 1 ) flow diagram first published in 1996 and revised 5 years later ( 2 , 3 ) , is an effort to st and ardize , and thereby improve , published reports of r and omized , controlled trials ( RCTs ) . One of the additions to the 2001 revision was an item about reporting adverse events . This single item did not do full justice to the importance of harms-related issues . The CONSORT Group met in September 2001 to discuss how to correct this deficiency . We aim ed to provide evidence -based guidance on the reporting of harms in RCTs . First , we search ed MEDLINE , EMBASE , Web of Science , and the Cochrane Library using a wide array of terms related to harms and identified pertinent evidence . We also communicated with experts and review ed bibliographies of identified articles to find additional studies . At a meeting in Montebello , Quebec , Canada , in May 2003 , CONSORT Group members , including several journal editors and additional experts in related fields , held a structured discussion of recommendations about reporting of harms-related issues in RCTs . The discussion s led to a written document that we circulated among the team members for comment . The present manuscript describes our recommendations on the appropriate reporting of harms in RCTs . Table 1 . Original CONSORT Checklist The terminology of harms-related issues in RCTs is confusing and often misleading or misused ( see Glossary ) ( 4 , 5 ) . Safety is a reassuring term that may obscure the real and potentially major harms that drugs and other interventions may cause . We encourage authors to use the term harms instead of safety . In addition to misused terminology , reporting of harms in RCTs has received less attention than reporting of efficacy and effectiveness and is often inadequate ( 6 - 14 ) . In short , both scientific evidence and ethical necessity call for action to improve the quality of reporting of harms in RCTs ( 15 , 16 ) . Here , we present a set of recommendations and accompanying explanations for the proper reporting of harms in RCTs . These recommendations should complement the existing CONSORT statement ( Table 2 ) . Examples are presented on the Annals and CONSORT ( www.consort-statement.org ) Web sites . Table 2 . Checklist of Items To Include When Reporting Harms in R and omized , Controlled Trials Recommendations Title and Abstract Recommendation 1 . If the study collected data on harms and benefits , the title or abstract should so state . The title should mention harms if the study of harms was a key trial objective . Many phase I and phase II trials , some phase II/III trials , and most phase IV trials ( 17 , 18 ) target harms as primary outcomes . Yet , the title and abstract seldom contain the word harm . Among 375143 entries in the Cochrane Central Register of Controlled Trials ( Cochrane Library , issue 3 , 2003 ) , search ing titles with the search terms harm or harms yielded 337 references ( compared with 55374 for efficacy and 23415 for safety ) . Of the 337 , excluding several irrelevant articles on self-harm or harm reduction , only 3 trial reports and 2 abstract s contained the word harm in their titles . Authors should present information on harms in the abstract . If no important harms occurred , authors should so state . Explicit reference to the reporting of adverse events in the title or abstract is also important for appropriate data base indexing and information retrieval ( 19 ) . Introduction Background Recommendation 2 . If the trial addresses both harms and benefits , the introduction should so state . The introduction states the scientific background and rationale of an RCT . This requires a balanced presentation whereby the possible benefits of the intervention under investigation are outlined along with the possible harms associated with the treatment . R and omized , controlled trials that focus primarily on harms should clearly state this interest when describing the study objectives in the Introduction and in defining these objectives in the Methods . Methods Outcomes Recommendation 3 . List addressed adverse events with definitions for each ( with attention , when relevant , to grading , expected vs. unexpected events , reference to st and ardized and vali date d definitions , and description of new definitions ) . The Methods section should succinctly define the recorded adverse events ( clinical and laboratory ) . Authors should clarify whether the reported adverse events encompass all the recorded adverse events or a selected sample . They should explain how , why , and who selected adverse events for reporting . In trials that do not mention harms-related data , the Methods section should briefly explain the reason for the omission ( for example , the design did not include the collection of any information on harms ) . Authors should also be explicit about separately reporting anticipated and unexpected adverse events . Expectation may influence the incidence of reported or ascertained adverse events . Making participants aware in the consent form of the possibility of a specific adverse event ( priming ) may increase the reporting rate of the event ( 20 ) . Another example of priming is the finding that the rates of withdrawals due to adverse events and the rates of specific adverse events were significantly higher in trials of aspirin , diclofenac , or indomethacin with comparator drugs compared with placebo-controlled trials ( 21 ) . Presumably , participants were more eager to come forth and report an adverse event or to withdraw from treatment when they knew they could not be receiving inactive placebo . Authors should report whether they used st and ardized and vali date d measurement instruments for adverse events . Several medical fields have developed st and ardized scales ( 22 - 32 ) . Use of nonvali date d scales is common . The source document for well-established definitions and scales should be referenced . New definitions for adverse events should be explicit and clear . Authors should describe how they developed and vali date d new scales . For interventions that target healthy individuals ( for example , many preventive interventions ) , any harm , however minor , may be important to capture and report because the balance of harms and benefits may easily lean toward harms in a low-risk population . For other population s and for interventions that improve major outcomes ( for example , survival ) , severe and life-threatening adverse events may be the only ones that are important in the balance of benefits and harms . Recommendation 4 . Clarify how harms-related information was collected ( mode of data collection , timing , attribution methods , intensity of ascertainment , and harms-related monitoring and stopping rules , if pertinent ) . It is important to describe the question naires , interviews , and tests used to collect information on harms , as well as their timing during follow-up . Passive surveillance of harms leads to fewer recorded adverse events than active surveillance ( 4 ) . Open-ended questions may yield different information , both quantitatively and qualitatively , than structured question naires ( 33 ) . Studies of nonsteroidal , anti-inflammatory drugs ( NSAIDs ) exemplify how data collection methods can affect the detection and reporting of harms . When selective NSAIDs with fewer gastrointestinal adverse events became available , trials reported more than 10 times as many ulcers when comparing these drugs with older NSAIDs as when older NSAIDs were compared with placebo . In the newer trials , more ulcers were detected because participants had regular endoscopy , and the case definition of ulcers was more sensitive ( 34 ) . Authors should specify the time frame of surveillance for adverse events . Some investigators stop recording adverse events at the end of the intervention period or a certain number of days afterward ( for example , 30 days after discontinuation of drug therapy ) and miss events with long latency ( 35 ) . Surgical trials often capture only the adverse events that occur intraoperatively . Several important surgical complications are likely to occur later . Finally , in crossover trials , delayed events might occur while the patient is taking a subsequent assigned treatment . Attribution is the process of deciding whether an adverse event is related to the intervention . Whenever authors filter events through an attribution process , they should state who makes the attribution ( investigators , participants , sponsors , or combinations ) , whether the process is blinded to assigned treatment , and what definitions of adverse events they use ( 4 ) . Discontinuations and withdrawals due to adverse events are especially important because they reflect the ultimate decision of the participant and /or physician to discontinue treatment . Although treatment may occasionally be discontinued for mild or moderate adverse events , attributing discontinuation to a specific reason ( to toxicity , lack of efficacy , other reasons , or combinations of reasons ) may be difficult . For example , in psychopharmacology , dropouts may reflect treatment ineffectiveness as much as toxicity-related intolerance ( 36 ) . Trial reports should specify who gave the reasons for discontinuation ( participants or physicians ) and whether attribution was blinded to the assigned treatment . For example , even in blinded trials , participants and their clinicians are often unblinded before they decide whether to discontinue the intervention . It is important to report participants who are nonadherent or lost to follow-up because their actions may reflect their inability to tolerate the intervention . Moreover , authors should specify how they h and led withdrawals in the analyses of the data . R and omized , controlled trials should report any plan for monitoring for harms and rules for stopping the trial because of harms ( 37 ) . They should clarify whether stopping guidelines examine benefits and harms",
"BACKGROUND Although iron deficiency frequently complicates anemia in patients with nondialysis-dependent CKD ( ND-CKD ) , the comparative treatment value of IV iron infusion and oral iron supplementation has not been established . METHODS In a r and omized , controlled multicenter trial , we compared the efficacy of iron sucrose , given as 1 g in divided IV doses over 14 days , with that of ferrous sulfate , given 325 mg orally thrice daily for 56 days in patients with ND-CKD stages 3 to 5 , Hb Epoetin/darbepoetin therapy , if any , was not changed for eight weeks prior to or during the study . RESULTS The proportion of patients achieving the primary outcome ( Hb increase > or = 1 g/dL ) was greater in the IV iron treatment group than in the oral iron treatment group ( 44.3 % vs. 28.0 % , P= 0.0344 ) , as was the mean increase in Hb by day 42 ( 0.7 vs. 0.4 g/dL , P= 0.0298 ) . Compared to those in the IV iron group , patients in the oral iron treatment group showed a greater decline in GFR during the study ( -4.40 vs. -1.45 mL/min/1.73m2 , P= 0.0100 ) . No serious adverse drug events ( ADE ) were seen in patients administered IV iron sucrose as 200 mg IV over two to five minutes , but drug-related hypotension , including one event considered serious , occurred in two females weighing less than 65 kg after 500 mg doses were given over four hours . CONCLUSION IV iron administration using 1000 mg iron sucrose in divided doses is superior to oral iron therapy in the management of ND-CKD patients with anemia and low iron indices",
"Iron deficiency is an important cause of anemia in patients with chronic kidney disease ( CKD ) , but intravenous iron is infrequently used among patients who are not on dialysis . Ferumoxytol is a novel intravenous iron product that can be administered as a rapid injection . This Phase III trial r and omly assigned 304 patients with CKD in a 3:1 ratio to two 510-mg doses of intravenous ferumoxytol within 5 + /- 3 d or 200 mg of elemental oral iron daily for 21 d. The increase in hemoglobin at day 35 , the primary efficacy end point , was 0.82 + /- 1.24 g/dl with ferumoxytol and 0.16 + /- 1.02 g/dl with oral iron ( P hemoglobin increased 0.62 + /- 1.02 g/dl with ferumoxytol and 0.13 + /- 0.93 g/dl with oral iron . Among patients who were receiving erythropoiesis-stimulating agents , hemoglobin increased 1.16 + /- 1.49 g/dl with ferumoxytol and 0.19 + /- 1.14 g/dl with oral iron . Treatment-related adverse events occurred in 10.6 % of patients who were treated with ferumoxytol and 24.0 % of those who were treated with oral iron ; none was serious . In summary , a regimen of two doses of 510 mg of intravenous ferumoxytol administered rapidly within 5 + /- 3 d was well tolerated and had the intended therapeutic effect . This regimen may offer a new , efficient option to treat iron deficiency anemia in patients with CKD",
"BACKGROUND Parenteral iron is often required by hemodialysis patients to maintain adequate iron stores . Until recently , the only available form of intravenous iron was iron dextran , which is associated with significant adverse reactions , including anaphylaxis and death . Sodium ferric gluconate complex ( SFGC ) was recently approved for use in the U.S. under FDA 's priority drug review . This Phase IV study was design ed to evaluate the safety of a single dose of intravenous SFGC as compared to placebo and a historical iron dextran control . METHODS This multicenter , crossover , r and omized , double blind , placebo-controlled prospect i ve comparative study was performed in hemodialysis patients requiring at least 125 mg of elemental iron . The historical control was obtained from a meta- analysis of four publications examining outcomes in patients exposed to iron dextran . SFGC naïve patients were administered SFGC without a test dose , undiluted , at a rate of 125 mg over 10 minutes , and compared to placebo comprising bacteriostatic saline . RESULTS A total of 2534 patients were enrolled . The incidence of drug intolerance ( an adverse event precluding re-exposure ) was significantly less [ 0.44 % , confidence interval ( CI ) 0.21 to 0.71 % ] after SFGC as compared to the iron dextran control ( 2.47 % , CI 1.87 to 3.07 % , P placebo ( 0.1 % , P = 0.02 ) . There was no difference found between SFGC and placebo in serious adverse events . A single life-threatening event occurred after SFGC ( 0.04 % , CI 0.00 to 0.22 % ) , which was significantly less than following iron dextran ( 0.61 % , CI 0.36 to 0.86 % ) , P = 0.0001 . CONCLUSION SFGC is well tolerated when given by intravenous push without a test dose . SFGC has a significantly lower incidence of drug intolerance and life-threatening events as compared to previous studies using iron dextran . The routine use of iron dextran in hemodialysis patients should be discontinued",
"BACKGROUND AIMS : Anemia is a common complication of inflammatory bowel diseases ( IBD ) This multicenter study tested the noninferiority and safety of a new intravenous iron preparation , ferric carboxymaltose ( FeCarb ) , in comparison with oral ferrous sulfate ( FeSulf ) in reducing iron deficiency anemia ( IDA ) in IBD . METHODS : Two hundred patients were r and omized in a 2:1 ratio ( 137 FeCarb:63 FeSulf ) to receive FeCarb ( maximum 1,000 mg iron per infusion ) at 1-wk intervals until the patients ' calculated total iron deficit was reached or FeSulf ( 100 mg b.i.d . ) for 12 wk . The primary end point was change in hemoglobin ( Hb ) from baseline to week 12 . RESULTS : The median Hb improved from 8.7 to 12.3 g/dL in the FeCarb group and from 9.1 to 12.1 g/dL in the FeSulf group , demonstrating noninferiority ( P = 0.6967 ) . Response ( defined as Hb increase of > 2.0 g/dL ) was higher for FeCarb at week 2 ( P = 0.0051 ) and week 4 ( P = 0.0346 ) . Median ferritin increased from 5.0 to 323.5 μg/L at week 2 , followed by a continuous decrease in the FeCarb group ( 43.5 μg/L at week 12 ) . In the FeSulf group , a moderate increase from 6.5 to 28.5 μg/L at week 12 was observed . Treatment-related adverse events ( AEs ) occurred in 28.5 % of the FeCarb and 22.2 % of the FeSulf groups , with discontinuation of study medication due to AEs in 1.5 % and 7.9 % , respectively . CONCLUSIONS : FeCarb is effective and safe in IBD-associated anemia . It is noninferior to FeSulf in terms of Hb change over 12 wk , and provides a fast Hb increase and a sufficient refill of iron stores",
"INTRODUCTION Anemia is the most common finding in chronic kidney disease patients . Iron supplements are commonly prescribed for these patients with or without erythropoietin therapy by means of oral and intravenous iron . Both oral and intravenous irons have their own advantage and disadvantage , and the efficacy is also different . The objective of the study is to analyze the efficacy of oral and intravenous iron in chronic kidney disease patients on erythropoietin therapy , an erythropoiesis stimulating agents for increment of haemoglobin . METHODS This is a prospect i ve study comparing intravenous iron to oral iron in chronic kidney disease patients who underwent maintenance hemodialysis at different centers and visited Kathm and u Medical College Teaching Hospital from April 2010 to April 2011 . Patients having a haemoglobin level of were allocated alternately into two groups to receive oral iron ( iron fumarate ) or IV iron ( iv sucrose ) . Haemoglobin was measured after 30 days of therapy . RESULTS A significant increase in haemoglobin levels was observed in both groups . But the mean haemoglobin increment was more in the IV iron group than in the oral iron group . Sixty percent 60 % of patients in the IV iron group had an increase in the haemoglobin level of more than 1gm/dl while only 20 % of the oral iron group had this increase . CONCLUSIONS Intravenous iron therapy is more effective in raising the hemoglobin level in hemodialysis dependent chronic kidney disease patients",
"OBJECTIVE Postpartum iron deficiency anaemia ( IDA ) is common in women . Most women are treated with either oral iron supplementation or blood transfusion . Hence , the aim of our study was to compare the effect of treatment with either oral ferrous sulphate or intravenous ferrous sucrose on postpartum IDA . DESIGN A single centre , prospect i ve r and omised controlled trial . SETTING Women 's Centre , John Radcliffe Hospital , Oxford , UK . POPULATION Forty-four women with haemoglobin ( Hb ) of METHODS Women were r and omised to receive either oral ferrous sulphate 200 mg twice daily for 6 weeks ( group O ) or intravenous ferrous sucrose 200 mg ( Venofer ; Vifor International Ltd , St Gallen , Switzerl and ) , two doses given on days 2 and 4 following recruitment ( group I ) . RESULTS were analysed by the Students t-test , chi-square test and analysis of variance . MAIN OUTCOME MEASURES Hb , haematocrit , red cell indices , ferritin and serum iron levels were measured on days 0 , 5 , 14 and 40 . Results By day 5 , the Hb level in women treated with intravenous iron had risen from 7.3 + /- 0.9 to 9.9 + /- 0.7 g/dl , while there was no change in those treated with oral iron . Women treated with intravenous iron had significantly higher Hb levels on days 5 and 14 ( P iron ; although by day 40 , there was no significant difference between the two groups . Throughout the study , ferritin levels rose rapidly in those treated with intravenous iron and remained significantly higher than in those treated with oral iron ( P Intravenous iron sucrose increases the Hb level more rapidly than oral ferrous sulphate in women with postpartum IDA . It also appears to replenish iron stores more rapidly . However , this study was not large enough to address the safety of this strategy",
"Background : Iron deficiency anemia ( IDA ) is the most common medical problem in pregnancy . Parenteral iron is a useful treatment , although iron dextran use decreased due to anaphylaxis . Iron sucrose is a newer agent that has overcome the shortcomings of iron dextran . Objective : The aim of this study was to compare the efficacy and tolerance of intravenous iron sucrose ( IVIS ) therapy with oral iron ( OI ) therapy in pregnant women with IDA and to study the factors influencing treatment . Material s and Methods : This prospect i ve , r and omized clinical trial included pregnant women between 14 and 36 weeks with established IDA who were treated with IVIS or OI ( ferrous fumarate ) . All patients were monitored for laboratory response and adverse effects . Independent sample -t test , Chi square test and ANOVA were used for statistical analysis . P hemoglobin increased in both the groups , increase in the reticulocyte count and percentage increase in hemoglobin was significantly higher in the IVIS group than in the OI group ( 23.62 % vs. 14.11 % ) . Serum ferritin was significantly higher in the IVIS group than in the OI group ( P = 0.000 ) . The IVIS group had no major side-effects . Compliance was good with OI , although 23 % had gastrointestinal side-effects . Patient weight , gestation at diagnosis , initial hemoglobin and ferritin levels did not influence the response to treatment . Conclusion : IVIS is safe and effective in the treatment of IDA during pregnancy . Iron stores increased better with IVIS compared with OI",
"BACKGROUND There are concerns about adverse vascular effects of intravenous iron by inducing oxidative stress . We therefore examined the effect of a single high dose of intravenous iron on endothelial function and biochemical markers of iron homeostasis . METHODS In a r and omized , placebo-controlled , double-blind , parallel-group study , forearm blood flow ( FBF ) was assessed by strain-gauge plethysmography in 38 peritoneal dialysis patients before and after a single intravenous infusion of 300 mg iron sucrose . RESULTS Iron infusion increased total ( Delta 601 microg/100 mL , CI 507 , 696 ) and non-transferrin-bound iron ( Delta 237.2 micromol/L , CI 173.6 , 300.8 ) approximately 10-fold , as well as redox-active iron nearly five-fold ( Delta 0.76 micromol/L , CI 0.54 , 0.98 ) . After iron infusion basal FBF was 59 % higher than after placebo . FBF response to acetylcholine before and after iron infusion was 263 + /- 32 % and 310 + /- 33 % , corresponding to 304 + /- 43 % and 373 + /- 29 % in the placebo group , respectively . Before and after iron or placebo infusion , glyceryl-trinitrate increased resting FBF to 232 + /- 22 % and 258 + /- 21 % in the iron group , and to 234 + /- 18 % and 270 + /- 30 % in the placebo group . L-N-monomethyl-arginine decreased FBF to 70 + /- 4 % and 72 + /- 3 % before and after iron , and to 74 + /- 4 % and 73 + /- 4 % before and after placebo infusions , respectively . Despite higher basal FBF after iron infusion , absolute and relative FBF changes in response to vasoactive substances were not significantly different between iron and placebo groups . CONCLUSION Our data suggest that 300 mg intravenous iron sucrose has a vasodilatory effect , but does not impair vascular reactivity in dialysis patients , despite a significant increase in non-transferrin-bound and redox-active iron",
"OBJECTIVE The aim of this study was to compare intravenous iron sucrose versus oral iron sulfate in anemia at 6 months of pregnancy . STUDY DESIGN A r and om , prospect i ve , open study with individual benefit was performed involving 50 patients with hemoglobin levels between 8 and 10 g/dL and a ferritin value of In the intravenous group ( IV group ) , the iron dose was calculated from the following formula : Weight before pregnancy ( kg ) x ( 120 g/L - Actual hemoglobin [ g/L ] ) x 0.24 + 500 mg . The oral group ( PO group ) received 240 mg of iron sulfate per day for 4 weeks . Treatment efficacy was assessed by measurement of hemoglobin and reticulocytes on days 8 , 15 , 21 , and 30 and at delivery and of ferritin on day 30 and at delivery . The baby 's birth weight and iron stores were noted . Results were expressed as median + /- interquartile range . Mann-Whitney and Wilcoxon tests were used for the analysis , with P hemoglobin was observed , rising from 9.6 + /- 0.79 g/dL to 11.11 + /- 1.3 g/dL on day 30 in the IV group and from 9.7 + /- 0.5 g/dL to 11 + /- 1.25 g/dL on day 30 in the PO group ( not significant ) . On day 30 ( P ferritin was higher in the IV group . A mean higher birth weight of 250 g was noted in the IV group ( not significant ) . CONCLUSION Iron sucrose appears to be a treatment without serious side effects indicated in correction of pregnancy anemia or iron stores depletion",
"BACKGROUND Iron deficiency anemia is a common complication in patients with chronic kidney disease ( CKD ) . Currently available intravenous ( IV ) iron replacement therapies have either inconvenient regimens of administration or adverse event profiles that limit their utility in the outpatient setting . Ferumoxytol is a novel , semisynthetic , carbohydrate-coated , superparamagnetic iron oxide nanoparticle that is administered IV as an injection . The main objective of this study was to assess the safety of ferumoxytol for the treatment of patients with CKD stages 1 to 5 and 5D . STUDY DESIGN Phase 3 , r and omized , double-blind , placebo-controlled , crossover , multicenter study of a single 510-mg dose of ferumoxytol versus saline as placebo . SETTING & PARTICIPANTS 750 patients with CKD stages 1 to 5 and 5D . INTERVENTION An IV injection of either 17 mL of ferumoxytol or saline placebo over 17 seconds on day 0 and the alternate agent on day 7 . OUTCOMES & MEASUREMENTS Descriptive comparison of adverse events , laboratory tests , and vital signs . RESULTS Of 750 r and omly assigned patients with CKD , 60 % were not on dialysis therapy . 713 patients received ferumoxytol , and 711 received placebo . There were 420 adverse events reported ; 242 in 152 patients ( 21.3 % ) with ferumoxytol and 178 in 119 patients ( 16.7 % ) with placebo . The incidence of related adverse events was 5.2 % with ferumoxytol and 4.5 % with placebo . The most common related adverse events after each treatment included symptoms related to the injection/infusion site , dizziness , pruritus , headache , fatigue , and nausea . Serious adverse events occurred in 21 patients ( 2.9 % ) after ferumoxytol and 13 patients ( 1.8 % ) after placebo . Serious related adverse events were observed in 1 patient ( 0.1 % ) after each treatment . There was no meaningful decrease in blood pressure after administration of ferumoxytol or placebo . LIMITATIONS Follow-up was 7 days after each study treatment . CONCLUSIONS Ferumoxytol is well tolerated and has a safety profile similar to placebo in anemic patients with CKD stages 1 to 5 and 5D",
"OBJECTIVE To assess and compare the efficacy and safety of two and three doses of intravenous iron sucrose with daily oral ferrous sulphate in the prophylaxis of iron deficiency anaemia in pregnant women . STUDY DESIGN 260 women with singleton pregnancy who met inclusion criteria and who gave informed consent were r and omised between the 21st and 24th week into either the intravenous iron group or the oral iron group . Of 130 women in the intravenous iron group , 75 women received two doses of 200 mg iron sucrose and 55 three doses of 200 mg iron sucrose . The first dose was administered between the 21st and 24th gestational weeks , the second between the 28th and 32nd and the third between the 35th and 37th . The women of the oral group were given oral tablets of 80 mg ferrous sulphate daily , beginning on the day of study enrolment and stopping on the day of delivery . RESULTS There was a non-significant trend to a higher frequency of responders ( haemoglobin > or = 11 g/dl ) in the intravenous iron group ( 75 vs. 80 % ) . There was a significant difference of repleted iron stores before delivery ( ferritin>50 microg/l ) in the group with three intravenous iron doses in comparison to the oral iron group ( 49 vs. 14 % ; p maternal and perinatal outcomes . CONCLUSIONS There was no clinical ly significant difference in the haematological , maternal and foetal outcomes in the parenteral route of iron prophylaxis in pregnant women",
"BACKGROUND & AIMS Iron-deficiency anemia is the most common systemic complication of inflammatory bowel diseases ( IBD ) . Iron-deficiency anemia recurs frequently and rapidly after iron-replacement therapy in patients with IBD . We performed a r and omized , placebo-controlled trial to determine if administration of ferric carboxymaltose ( FCM ) prevents anemia in patients with IBD and low levels of serum ferritin . METHODS We performed a single-blind , multicenter study of nonanemic patients who had completed the FERGIcor study . Serum levels of ferritin were assessed every second month , and patients were given FCM ( total iron dose , 1181 ± 662 mg ; n = 105 ) or placebo ( n = 99 ) when levels decreased to less than 100 μg/L. The primary end point was time to recurrence of anemia within 8 months . Secondary end points included changes of quality of life , disease activity , results from laboratory tests , and adverse events . RESULTS Anemia recurred in 26.7 % of subjects given FCM and in 39.4 % given placebo . The time to anemia recurrence was longer in the FCM group ( hazard ratio , 0.62 ; 95 % confidence interval , 0.38 - 1.00 ; P = .049 ) . Markers of body levels of iron increased or remained at normal levels in subjects given FCM ( ferritin increased by 30.3 μg/L , transferrin saturation increased by 0.6 % ) but decreased in the group given placebo ( ferritin decreased by 36.1 μg/L , transferrin saturation decreased by 4.0 % ) . Changes in quality of life and disease activity were comparable between groups . Adverse events were reported in 59.0 % of the FCM group and 50.5 % of the placebo group , and serious adverse events were reported in 6.7 % and 8.1 % , respectively . CONCLUSIONS FCM prevents recurrence of anemia in patients with IBD , compared with placebo . Nevertheless , the high rate of anemia recurrence warrants optimization of the frequency and requirements for FCM treatment",
"PURPOSE Recombinant human erythropoietin ( rHuEPO ) is the st and ard of care for patients with chemotherapy-related anemia . Intravenous ( IV ) iron improves hemoglobin ( Hb ) response and decreases dosage requirements in patients with anemia of kidney disease , but its effect has not been studied in r and omized trials in cancer patients . METHODS This prospect i ve , multicenter , open-label , r and omized trial enrolled 157 patients with chemotherapy-related anemia ( Hb subcutaneously rHuEPO 40000 U once weekly to : ( 1 ) . no-iron ; ( 2 ) . oral iron 325 mg twice daily ; ( 3 ) iron dextran repeated 100 mg IV bolus ; or ( 4 ) iron dextran total dose infusion ( TDI ) . Hb and quality of life ( QOL ) were measured at baseline and throughout . RESULTS All groups showed Hb ( P Mean Hb increases for both IV iron groups were greater ( P no-iron and oral iron groups . The percentage of patients with hematopoietic responses was higher ( P IV iron groups ( each case 68 % ) compared with no-iron ( 25 % ) and oral iron ( 36 % ) groups . IV iron groups showed increases in energy , activity , and overall QOL from baseline , compared with a decrease in energy and activity for no-iron group and no change in activity or overall QOL for oral iron group . CONCLUSION rHuEPO increases Hb levels and improves QOL in patients with chemotherapy-related anemia . Magnitude of Hb increase and QOL improvement is significantly greater if IV iron is added",
"BACKGROUND Preoperative treatment with rHuEPO ( epoetin alfa : EPREX , Janssen-Cilag ; or PROCRIT , Ortho Biotech ) in conjunction with iron supplementation increases the erythropoietic response in elective orthopedic surgery patients , but it is not known whether the magnitude of this response is dependent on the route of iron administration . STUDY DESIGN AND METHODS Non-iron-deficient patients undergoing elective orthopedic surgery ( N = 110 ) with baseline Hb > or = 10 to were r and omly assigned to receive either epoetin alfa ( 600 IU/kg ) plus IV iron ( n = 29 ) or oral iron ( n = 29 ) or placebo plus IV iron ( n = 25 ) or oral iron ( n = 27 ) in this 14-day study . RBC production , Hb , Hct , reticulocytes , iron status , and adverse events were monitored throughout the study . RESULTS Epoetin alfa treatment plus either oral or IV iron supplementation significantly increased total RBC production , Hb , Hct , and reticulocytes over the values seen with the respective placebo treatments ( p = 0.0001 ) . There were no differences between the epoetin alfa treatment groups . Placebo treatment plus oral or IV iron supplementation was not associated with increases in hematologic values . There were no differences in the incidence of adverse events among the treatment groups . CONCLUSION There was a comparable erythropoietic response to epoetin alfa , irrespective of the route of iron administration . The route of iron administration , therefore , does not modulate the erythropoietic response to epoetin alfa in patients who are not iron deficient . Safety and convenience benefits may be gained by adopting oral iron supplementation in this patient subset",
"Objective : To compare the efficacy and safety with a fixed dose of two parenteral iron preparations , iron sucrose complex and iron sorbitol citric acid as per the current practice . Material s and Methods : A prospect i ve r and omized open label study was conducted . In this study , 60 pregnant women with hemoglobin less than 8.5 g/dl received a fixed dose of either IV iron sucrose or IM iron sorbitol citric acid therapy . The efficacy of the therapy was assessed by laboratory parameters such as hemoglobin , hematocrit , MCV , MCH , and serum ferritin level after 14 and 28 days . To assess the safety , adverse drug reactions with both the therapies were recorded . Results : Hemoglobin concentration increased significantly ( P the hemoglobin level in third and fourth weeks was significantly higher in iron sucrose ( 0.92 g/dl ) than iron sorbitol citric acid therapy ( 0.56 g/dl ) . There was no significant change in the rise of the serum ferritin level after both the therapies . Adverse events were common with iron sorbitol citric acid therapy . However , no serious adverse drug reactions were observed . Conclusions : No significant difference in the efficacy of both of the therapy . However , adverse events and dropout rates were much more common in the group of pregnant women who received iron sorbitol citric acid",
"OBJECTIVE : To estimate efficacy of rapid , large-dose intravenous ( IV ) administration of ferric carboxymaltose compared with oral iron therapy in anemic postpartum women . METHODS : In a r and omized , controlled trial , we assigned anemic women ( hemoglobin [ Hb ] less than or equal to 10 g/dL ) within 10 days postpartum to receive either IV ferric carboxymaltose ( less than or equal to1,000 mg over 15 minutes , repeated weekly to achieve a total calculated replacement dose ) or ferrous sulfate ( FeSO4 ) 325 mg orally thrice daily for 6 weeks . RESULTS : One hundred seventy-four patients received 350 IV doses of ferric carboxymaltose ( mean total dose 1,403.1 mg ) in 3 , 2 , or 1 injection ( 10.9 % , 79.3 % , or 9.8 % of patients , respectively ) ; 178 received FeSO4 . Patients assigned to IV ferric carboxymaltose compared with those assigned to oral iron achieved a Hb rise greater than or equal to 2.0 g/dL earlier ( 7.0 compared with 14.0 days , P Hb rise greater than or equal to 3.0 g/dL at any time ( 86.3 % compared with 60.4 % , P Hb greater than 12.0 g/dL ( 90.5 % compared with 68.6 % , P Hb rise greater than or equal to 2.0 g/dL ( 96.4 % compared with 94.1 % , IV compared with oral , P=.443 ) . There were no serious adverse drug reactions . CONCLUSION : Large-dose IV ferric carboxymaltose administration is a new iron agent that is effective for the treatment of postpartum anemia . When compared with oral ferrous sulfate , IV ferric carboxymaltose is better tolerated , prompts a more rapid Hb response , and corrects anemia more reliably . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00396292 LEVEL OF EVIDENCE :",
"The development of secondary anaemia is a constant associated phenomenon of chronic renal failure . During its treatment by recombinant human erythropoietin ( rHuEPO ) erythropoiesis is accelerated and this increases dem and s on the supply of dietary erythropoietic precursors ( Fe , pyridoxine , folic acid , vitamin B12 ) . In particular as regards iron , frequently the dietary amount is not sufficient and supplementation is necessary . The objective of the present work is to compare oral and intravenous iron supplementation in the treatment of secondary anaemia by rHuEPO in patients with chronic renal failure treated by haemodialysis . A group of haemodialyzed patients ( n = 61 ) treated with erythropoietin , where the serum ferritin concentration had dropped beneath 300 ng/ml , or the transferrin concentration below 0.20 was divided at r and om into two sub-groups . To group \" A \" Actiferrin was administered 3 x 1 cps/d ( Ferrosi sulfas heptahydricus , corresponding to 34.5 mg elemental Fe and serine 129 mg per capsule , i.e. a total of 724.5 mg elemental Fe per week ) . To group \" A \" Ferrum-Lek was administered 1 vial per week by the i.v . route ( Ferri oxidum saccharatum , corresponding to 100 mg elemental iron per week ) . The two groups were comparable as to the mean erythropoietin dose ( 50 U/kg per week ) and the patients ' mean age ( 61 years ) , the male/female ratio and the spectrum of basic diseases . After six weeks of treatment a comparable increase of the haematocrit and serum iron concentration was observed in both groups . As to transferrin saturation , there was a more marked increment in the intravenously supplemented group . The serum ferritin values in group \" A \" declined , while in group \" F \" they increased . After both types of iron supplementation a comparable increase of the haematocrit and serum iron concentration occurred , the iron reserves represented by serum ferritin differed however and from the long-term aspect they are in favour of intravenous iron supplementation in haemodialyzed patients treated with erythropoietin",
"OBJECTIVE To explore the safety and efficacy of intravenous iron sucrose in maintenance dialysis and to establish the optimal administration frequency and dose . METHODS One hundred and ninety-four patients on maintenance dialysis with the hemoglobin ( Hb ) level of 60 - 100 g/L and hematocrit ( Hct ) of 18 % - 30 % were r and omly divided into 2 sex , age , duration of dialysis , weekly erythropoietin dosage , and hematological parameters-matched groups : intravenous iron sucrose group ( n = 102 ) and oral medication group ( n = 92 ) . The intravenous iron sucrose group were sub-divided into 2 subgroups : ( 1 ) hemodialysis ( HD ) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 100 mg once a week for a further 8 weeks , and ( 2 ) peritoneal dialysis ( PD ) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 200 mg once every other week for a further 8 weeks . The oral medication group received ferrous succinate 200 mg tid for 12 weeks . The levels of serum ferritin ( SF ) , transferrin saturation ( TSAT ) , Hb , and Hct were examined before treatment and 4 , 8 , and 12 weeks after treatment . RESULTS ( 1 ) Compared with baseline levels , the levels of Hb , Hct , SF , and TSAT significantly increased 2 weeks after treatment in the intravenous iron sucrose group , and 4 weeks after treatment in the oral medication group ( all P Hb , Hct , SF , and TSAT levels 4 , 6 , 8 , and 12 weeks after treatment of the 2 intravenous iron sucrose subgroups were all significantly higher than those of the oral medication group ( all P Hb , Hct , SF , and TSAT levels 12 weeks after treatment 6 , 8 , and 12 weeks after treatment were not significantly different from those 4 weeks after treatment in the intravenous iron sucrose group ( all P > 0.05 ) . ( 4 ) The response rate of the intravenous iron sucrose group was 95.09 % , significantly higher than that of the oral medication group ( 55.44 % , P mean EPO doses 6 , 8 and 12 weeks after treatment of the intravenous iron sucrose group were significantly lower than that before treatment and those of the oral medication group ( all P Hb , Hct , SF , and TSAT levels maintained stable during the period 6 , 8 , and 12 weeks after treatment in the intravenous iron sucrose group despite the decrease in dose and frequency . ( 7 ) The Hb , Hct , SF , and TSAT levels were significantly higher in the intravenous PD subgroup than in the intravenous HD subgroup . ( 8) No adverse event was found in the intravenous iron sucrose group , and adverse gastrointestinal effects occurred in 12 patients of the oral medication group . ( 9 ) After 12 weeks , the cost of EPO + intravenous iron sucrose was significantly higher than that of EPO + ferrous succinate . CONCLUSION Intravenous iron sucrose effectively increases the serum iron parameters and hemoglobin levels during maintenance peritoneal dialysis and is well tolerated . Infusing intravenous iron sucrose 200 mg every two weeks can maintain the serum iron parameters and hemoglobin level in maintenance peritoneal dialysis patients and n permits reduction of the required dose of EPO . However , the total cost of intravenous iron treatment is relatively high",
"Purpose To determine if early recovery from severe postoperative anemia is accelerated byiv iron therapy alone or in combination with recombinant erythropoietin ( EPO ) . Methods In this double-blinded , placebo-controlled r and omized study , consenting adult patients without preoperative anemia whose hemoglobin concentration ( Hb ) was 70 to 90 g·L-1 on the first day after cardiac or orthopedic surgery ( POD 1 ) were assigned to one of three groups : control , iv iron alone ( 200 mg of iron sucrose on POD 1 , 2 , and 3 ) or in combination with EPO ( 600 U·kg-1 on POD 1 and 3 ) . The primary outcome was increase in Hb ( adjusted for red blood cell transfusions ) from POD 1 to 7 . Analysis was by intention-to-treat in patients for whom the primary outcome was available . Group effect was analyzed by the ANOVA test , and between-group differences were specified with a Duncan multiple-range test . Results The primary outcome was available in 31 of 38 r and omized patients . The average POD 1 Hb was 84 ± 4 g·L-1 . There were no between-group differences in outcomes except for higher reticulocyte counts on POD-7 in the combination group . The average adjusted one-week increases in Hb were 7 ± 8 g·L-1 in the control group ( n = 10 ) , 9 ± 9 g·L-1 in theiv iron group ( n = 11 ) , and 10 ± 14 g·L-1 in the combination group ( n = 10 ) . The average adjusted six-week increases in Hb were 37 ± 14 g·L-1 in the control group , 40 ± 7 g·L-1 in theiv iron group , and 45 ± 12 g·L-1 in the combination group . Conclusion Early postoperative treatment withiv iron alone or in combination with EPO does not appear to accelerate early recovery from postoperative anemia . RésuméObjectifVérifier si la récupération précoce ďune sévère anémie postopératoire est accélérée par le fer iv seul ou en combinaison avec de ľérythropoÏétine recombinante (EPO).MéthodePour ľétude à double insu , r and omisée et contrôlée contre placebo , des adultes sans anémie préopératoire , chez qui la concentration ďhémoglobine ( Hb ) était de 70 à 90 g·L-1 au premier jour post-opération cardiaque ou orthopédique ( JPO 1 ) , ont été assignés à ľun des trois groupes : témoin , fer iv seul ( 200 mg de sucrose ferreux aux JPO 1 , 2 et 3 ) ou en combinaison avec de ľEPO ( 600 U·kg-1 aux JPO POD 1 et 3 ) . Le résultat principal était une hausse de ľHb ( ajustée pour les transfusions de culots globulaires ) des JPO 1 à 7 . Ľévaluation , pour les patients ayant atteint ce résultat , utilisait ľanalyse par intention de traiter . Ľeffet de groupe a été analysé par le test ANOVA test et les différences intergroupes ont été précisées avec le test à gamme multiple de Duncan . RésultatsLe résultat principal était atteint chez 31 des 38 patients r and omisés . La moyenne de ľHb au JPO 1 a été de 84 ± 4 g·L-1 . Il n’y a pas eu de différence de résultat intergroupe sauf pour une numération plus élevée des réticulocytes au JPO 7 dans le groupe ďEPO . Les hausses moyennes ďHb ajustées sur une semaine ont été de 7 ± 8 g·L-1dans le groupe témoin ( n = 10 ) , 9 ± 9 g·L-1 avec le fer iv ( n = 11 ) et 10 ± 14 g·L-1 avec ľEPO ( n = 10 ) . Les hausses moyennes ďHb ajustées sur six semaines ont été de 37 ± 14 g·L-1 chez les témoins , 40 ± 7 g·L-1 avec le fer iv et 45 ± 12 g·L-1 avec ľEPO . Conclusion Le traitement postopératoire précoce avec du fer iv seul ou en combinaison avec ľEPO ne semble pas hâter la récupération de ľanémie postopératoire ",
"Background : It is unknown whether intravenous iron or oral iron repletion alone can correct anemia associated with chronic kidney disease ( CKD ) . We conducted a r and omized multicenter controlled trial in adult anemic , iron-deficient non-dialysis CKD ( ND-CKD ) patients ( ≧stage 3 ) not receiving erythropoiesis-stimulating agents ( ESAs ) . Methods : The participants were r and omized to receive either a sodium ferric gluconate complex ( intravenous iron ) 250 mg i.v . weekly × 4 or ferrous sulfate ( oral iron ) 325 mg t.i.d . × 42 days . Hemoglobin ( Hgb ) , ferritin and transferrin saturation ( TSAT ) were measured serially , and the Kidney Disease Quality of Life ( KDQoL ) question naire was administered on days 1 and 43 . The primary outcome variable was change from baseline ( CFB ) to endpoint in Hgb values . Results : Seventy-five patients were analyzed ( intravenous iron n = 36 , oral iron n = 39 ) . CFB in Hgb was similar in the two groups ( intravenous iron 0.4 g/dl vs. oral iron 0.2 g/dl , p = n.s . ) . However , the increase in Hgb was only significant with intravenous iron ( p greater improvements in ferritin ( 232.0 ± 160.8 vs. 55.9 ± 236.2 ng/ml , p ) and TSAT ( 8.3 ± 7.5 vs. 2.9 ± 8.8 % , p = 0.007 ) . Intravenous iron caused greater improvements in KDQoL scores than oral iron ( p with intravenous iron was hypotension , while constipation was more common with oral iron . Conclusions : Oral and intravenous iron similarly increase Hgb in anemic iron-depleted ND-CKD patients not receiving ESAs . Although in comparison to oral iron , intravenous iron may result in a more rapid repletion of iron stores and greater improvement in quality of life , it exposes the patients to a greater risk of adverse effects and increases inconvenience and cost ",
"OBJECTIVE Intravenous ( IV ) iron has been used as a treatment to reduce Restless Legs Syndrome ( RLS ) symptoms , but two double-blinded trials of a frequently prescribed IV iron formulation , iron sucrose , failed to show lasting efficacy . This study evaluates efficacy and safety of a new IV iron formulation ( ferric carboxymaltose , FCM ) with molecular properties that may make iron more available for uptake to the brain than iron sucrose does . METHODS In this 28-day , multi-centre , r and omised , placebo-controlled trial 46 RLS patients were discontinued from all RLS treatment . Twenty-four received 500 mg FCM in two doses 5 days apart and 22 received a matching placebo . At day 28 , those on placebo were given a single 1000 mg IV FCM and those not responding to initial treatment were given a third dose of 500 mg FCM . Patients were followed up for 24 weeks or until needing added RLS treatment . RESULTS FCM significantly improved primary and secondary outcomes compared to placebo : International Restless Legs Syndrome study group severity scale ( IRLS ) average ( SD ) decrease of 8.9 ( 8.52 ) versus 4.0 ( 6.11 ) , p=0.040 ; Clinical Global Inventory of Change ( CGI-1 ) very much or much improved 48.3 % versus 14.3 % , p=0.004 . Quality of life was also significantly improved . Of the 24 with initial iron treatment 45 % responded and 29 % remitted ( IRLS ≤ 10 ) at day 28 , and 25 % continued free of other RLS medications at 24 weeks after treatment . The single 1000 mg dose on day 28 produced the same degree of treatment response as the divided dose , but the added 500 mg dose for those not responding to the initial treatment showed little benefit . There were no significant adverse events . CONCLUSIONS IV FCM provided a safe and effective treatment for RLS that lasted for at least 24 weeks for some patients . Larger studies are needed to confirm these results",
"BACKGROUND AND OBJECTIVES Intravenous iron is a key component of anemia management for chronic kidney disease ( CKD ) . Ferumoxytol is a unique intravenous iron product that can be administered as a rapid injection in doses up to 510 mg . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS This was a r and omized , open-label , controlled , multicenter Phase 3 trial to evaluate the safety and efficacy of intravenous ferumoxytol compared with oral iron . Anemic patients with CKD stage 5D on hemodialysis and on a stable erythropoiesis-stimulating agent regimen received either two injections of 510 mg of ferumoxytol within 7 d ( n = 114 ) or 200 mg elemental oral iron daily for 21 d ( n = 116 ) . The primary efficacy endpoint was the change in hemoglobin from baseline to day 35 . Safety was closely monitored . RESULTS Ferumoxytol result ed in a mean increase in hemoglobin of 1.02 + /- 1.13 g/dl at day 35 compared with 0.46 + /- 1.06 g/dl with oral iron ( P = 0.0002 ) . Twice as many ferumoxytol-treated patients than oral iron-treated patients achieved a > or = 1 g/dl hemoglobin increase at day 35 ( P = 0.0002 ) . There was a greater mean increase in transferrin saturation ( TSAT ) with ferumoxytol compared with oral iron at day 35 ( P hemoglobin increase after ferumoxytol compared with oral iron at day 35 persisted after adjustment for baseline hemoglobin , TSAT , and serum ferritin . Overall adverse event rates were comparable between groups . CONCLUSIONS In patients on hemodialysis , rapid intravenous injection of 510 mg of ferumoxytol led to significantly greater hemoglobin increases compared with oral iron , with comparable tolerability",
"OBJECTIVES To compare oral versus intravenous iron in pre-dialysis patients of chronic renal failure ( CRF ) receiving recombinant human erythropoietin ( rHuEPO ) . METHODS The study was undertaken in 40 adult patients of chronic renal failure . The patients were r and omly divided into two groups A and B of 20 patients each . Group A patients were given oral iron and group B patients were given intravenous iron . All patients in both groups were given recombinant human erythropoietin 2000 IU twice weekly subcutaneously . The study was carried for up to three months . Patients were monitored every month for renal parameters and haematological parameters which included haemoglobin , reticulocyte count and packed cell volume . Ferrokinetic studies were done at baseline and at three months . RESULTS It was observed that haematological parameters showed significant statistical improvement in the intravenous iron group as compared to group A ( oral iron group ) . The ferrokinetic studies revealed that serum iron , serum ferritin and transferrin saturation , decreased significantly in oral iron group , whereas significant increase was seen in group B ( intravenous iron group ) . None of the patients developed any adverse effects because of erythropoietin or iron therapy . CONCLUSIONS Concomitant use of intravenous iron is better than oral iron in CRF patients treated with rHuEPO . The intravenous route of iron administration may be a preferred route along with rHuEPO therapy , more so in the Indian context where prevalence of iron deficiency anaemia is fairly high",
"BACKGROUND The main objective of this study was to determine the efficacy of intravenous ( IV ) iron sucrose therapy reducing transfusion requirements in elderly patients undergoing hip fracture surgery . STUDY DESIGN AND METHODS This study was a prospect i ve r and omized controlled trial involving 200 patients undergoing hip fracture surgery . Group A ( 100 patients ) received st and ard treatment , while Group B ( 100 patients ) received iron sucrose ( 600 mg IV ) . The primary endpoint was the number of patients that were transfused postoperatively . The secondary endpoints were the rate of red blood cell units used , hematimetric variables of blood tests , mortality , infection rates , length of hospital stay , and appearance of side effects . RESULTS Differences in the percentage of patients requiring transfusion ( Group A 41.3 % vs. Group B 33.3 % ) and in the number of concentrates transfused ( 0.87±1.21 for Group A vs. 0.76±1.16 for Group B ) were not significant for the patient group as a whole , but were significant for patients with intracapsular fractures ( 45.7 % required transfusion in Group A vs. 14.3 % in Group B ; p patients with a baseline hemoglobin ( Hb ) level of 12 g/dL or more ( 35.2 % required transfusions in Group A vs. 19 % in Group B ; p CONCLUSIONS Transfusion requirements in patients with intracapsular fracture or baseline Hb level of 12 g/dL or more appear to be reduced by IV iron sucrose therapy , but there was no difference in morbidity , mortality , or length of hospital stay . The treatment is safe and hastens recovery from blood loss",
"BACKGROUND Anemia in heart failure patients and has been associated with increased morbi-mortality . Previous studies have treated anemia in heart failure patients with either erythropoietin alone or combination of erythropoietin and intravenous ( i.v . ) iron . However , the effect of i.v . or oral ( p.o . ) iron supplementation alone in heart failure patients with anemia was virtually unknown . AIM To compare , in a double-blind design , the effects of i.v . iron versus p.o . iron in anemic heart failure patients . METHODS IRON-HF study was a multicenter , investigator initiated , r and omized , double-blind , placebo controlled trial that enrolled anemic heart failure patients with preserved renal function , low transferrin saturation ( TSat ) and low-to-moderately elevated ferritin levels . Interventions were Iron Sucrose i.v . 200 mg , once a week , for 5 weeks , ferrous sulfate 200 mg p.o . TID , for 8 weeks , or placebo . Primary endpoint was variation of peak oxygen consumption ( peak VO2 ) assessed by ergospirometry over 3 month follow-up . RESULTS Eighteen patients had full follow-up data . There was an increment of 3.5 ml/kg/min in peak VO2 in the i.v . iron group . There was no increment in peak VO2 in the p.o . iron group . Patients ' ferritin and TSat increased significantly in both treated groups . Hemoglobin increased similarly in all groups . CONCLUSION I.v . iron seems to be superior in improving functional capacity of heart failure patients . However , correction of anemia seems to be at least similar between p.o . iron and i.v . iron supplementation",
"OBJECTIVE The objective of the study was to evaluate the efficacy , safety , and tolerability of intravenous ferric carboxymaltose , compared with oral ferrous sulfate in women with postpartum anemia . STUDY DESIGN In a multicenter , r and omized , controlled study , 291 women less than 10 days after delivery with hemoglobin 10 g/dL or less were r and omized to receive ferric carboxymaltose ( n = 143 ) 1000 mg or less intravenously over 15 minutes or less , repeated weekly to a calculated replacement dose ( maximum 2500 mg ) or ferrous sulfate ( n = 148 ) 325 mg orally thrice daily for 6 weeks . RESULTS Ferric carboxymaltose-treated subjects were significantly more likely to : ( 1 ) achieve a hemoglobin greater than 12 g/dL in a shorter time period with a sustained hemoglobin greater than 12 g/dL at day 42 , ( 2 ) achieve hemoglobin rise 3 g/dL or greater more quickly , and ( 3 ) attain higher serum transferrin saturation and ferritin levels . Drug-related adverse events occurred less frequently with ferric carboxymaltose . CONCLUSION Intravenous ferric carboxymaltose was safe and well tolerated with an efficacy superior to oral ferrous sulfate in the treatment of postpartum iron deficiency anemia",
"BACKGROUND Iron deficiency anaemia is the most common deficiency disorder in the world , affecting more than one billion people , with pregnant women at particular risk . OBJECTIVES AND DESIGN We conducted a single site , prospect i ve , nonblinded r and omized-controlled trial to compare the efficacy , safety , tolerability and compliance of st and ard oral daily iron versus intravenous iron . SUBJECTS We prospect ively screened 2654 pregnant women between March 2007 and January 2009 with a full blood count and iron studies , of which 461 ( 18 % ) had moderate IDA . Two hundred women matched for haemoglobin concentration and serum ferritin level were recruited . INTERVENTIONS Patients were r and omized to daily oral ferrous sulphate 250 mg ( elemental iron 80 mg ) with or without a single intravenous iron polymaltose infusion . RESULTS Prior to delivery , the intravenous plus oral iron arm was superior to the oral iron only arm as measured by the increase in haemoglobin level ( mean of 19.5 g/L vs. 12 g/L ; P increase in mean serum ferritin level ( 222 microg/L vs. 18 ug/L ; P percentage of mothers with ferritin levels below 30 microg/L ( 4.5 % vs. 79 % ; P intravenous iron polymaltose was well tolerated without significant side effects . CONCLUSIONS Our data indicate that intravenous iron polymaltose is safe and leads to improved efficacy and iron stores compared to oral iron alone in pregnancy-related IDA",
"BACKGROUND Correction of anaemia as a result of renal failure improves cardiovascular function and also provides significant cognitive and emotional benefits . The most appropriate route for iron supplementation has not been determined for patients with chronic renal failure who are not yet on dialysis . METHODS Forty-five anaemic patients with progressive renal insufficiency ( PRI ) were prospect ively r and omized to receive oral ( ferrous sulphate 200 mg tds ) or intravenous ( 300 mg iron sucrose monthly ) iron treatment . Erythropoietin ( rHuEpo ) was simultaneously commenced and the dose adjusted according to a pre-established protocol . RESULTS There were no significant differences in baseline patient characteristics between the two groups . The average follow-up was 5.2 months . Three patients suffered possible allergic reactions to iron sucrose . Haemoglobin response and changes in red cell hypochromasia were similar in the two groups , but serum ferritin was significantly higher in the intravenous group . The starting dose of rHuEpo could be temporarily discontinued in 43 % of patients on oral iron and 33 % of patients receiving iron sucrose ( NS ) . rHuEpo was increased after 3 months in 9 % of patients on oral iron and 19 % of patients receiving iron sucrose ( NS ) . Final doses of rHuEpo were 33.5 ( 0 - 66 ) and 41.6 ( 0 - 124 ) U/kg/week respectively in the oral and intravenous groups ( NS ) . Although gastro-intestinal symptoms were more commonly reported in patients taking oral iron , these were mild according to scores on visual analogue scales . Dietary protein and energy intake were not significantly different in the two groups at 0 , 3 and 6 months . CONCLUSIONS In pre-dialysis patients , the efficacy of monthly 300 mg iron sucrose given intravenously is not superior with regard to haemoglobin response and rHuEpo dose as compared with a daily oral dose of 600 mg of ferrous sulphate or equivalent . Where intravenous iron is preferred , lower doses may help to reduce the incidence of allergic or \" free iron \" reactions , especially in patients with low body mass",
"BACKGROUND The objective was to evaluate efficacy and safety of rapid , large-dose intravenous ( IV ) administration of ferric carboxymaltose compared to oral iron in correcting iron deficiency anemia due to heavy uterine bleeding . STUDY DESIGN AND METHODS In a r and omized , controlled trial , 477 women with anemia , iron deficiency , and heavy uterine bleeding were assigned to receive either IV ferric carboxymaltose ( of ferrous sulfate ( 65 mg elemental iron ) prescribed orally thrice daily for 6 weeks . RESULTS Compared to those assigned to ferrous sulfate , more patients assigned to ferric carboxymaltose responded with a hemoglobin ( Hb ) increase of 2.0 g/dL or more ( 82 % vs. 62 % , 95 % confidence interval for treatment difference 12.2 - 28.3 , p 3.0 g/dL or more increase ( 53 % vs. 36 % , p or= 12 g/dL ) of anemia ( 73 % vs. 50 % , p ferric carboxymaltose compared to those prescribed ferrous sulfate reported greater gains in vitality and physical function and experienced greater improvement in symptoms of fatigue ( p serious adverse drug events . CONCLUSIONS In patients with iron deficiency anemia due to heavy uterine bleeding , rapid IV administration of large doses of a new iron agent , ferric carboxymaltose , is more effective than oral iron therapy in correcting anemia , replenishing iron stores , and improving quality of life",
"Iron deficiency may exacerbate symptoms in the Restless Legs Syndrome ( RLS ) . We investigated the effect of intravenous iron sucrose or placebo on symptoms in patients with RLS and mild to moderate iron deficit . Sixty patients with primary RLS ( seven males , age 46 ( 9 ) years , S-ferritin r and omly assigned in a 12-months double-blind , multi-centre study of iron sucrose 1000 mg ( n = 29 ) or saline ( n = 31 ) . The primary efficacy variable was the RLS severity scale ( IRLS ) score at week 11 . Median IRLS score decreased from 24 to 7 ( week 11 ) after iron sucrose and from 26 to 17 after placebo ( P = 0.123 , N.S. for between treatment comparison ) . The corresponding scores at week 7 were 12 and 20 in the two groups ( P = 0.017 ) . Drop out rate because of lack of efficacy at 12 months was 19/31 after placebo and 5/29 patients after iron sucrose ( Kaplan-Meier estimate , log rank test P = 0.0006 ) suggesting an iron induced superior long term RLS symptom control . Iron sucrose was well tolerated . This study showed a lack of superiority of iron sucrose at 11 weeks but found evidence that iron sucrose reduced RLS symptoms both in the acute phase ( 7 weeks ) and during long-term follow up in patients with variable degree of iron deficiency . Further studies on target patient groups , dosing and dosing intervals are warranted before iron sucrose could be considered for treatment of iron deficient patients with RLS",
"Abstract : Anaemia is the most common medical disorder in pregnancy with iron deficiency anaemia accounting for the majority of cases . Over 90 % of the iron deficiency anaemia is due to red cell iron deficiency associated with depleted iron stores and deficient intake . The two main modalities of treating iron deficiency anaemia are oral or parenteral iron . Ferrous Hausmann ® ( iron dextrin ) is the latest iron preparation which can be used for intravenous parenteral administration as a total dose infusion . This study compares the efficacy of Ferrum Hausmann ® with oral ferrous fumarate therapy in the treatment of iron deficiency anaemia in pregnancy . Our study shows that treatment with intravenous Ferrum Hausmann ® ( iron dextrin ) result ed in a significantly better level and rate of increase of haemoglobin ( p ) . Serum ferritin , which is the best indicator of iron stores , was significantly higher ( p of iron status such as serum iron , serum transferrin and zinc protoporphyrin also showed a significant improvement in the intravenous group compared to those given oral iron . The results suggest that intravenous iron as a total dose infusion is able to replenish iron stores more efficiently , completely and at a faster rate than oral iron therapy , thus providing the fuel for stimulation of full erythopoiesis compared to oral iron . There were also no reports of any adverse reactions with intravenous iron dextrin , whereas there were a considerable proportion of women on oral iron therapy who reported side effects . In conclusion , intravenous iron therapy with Ferrous Hausmann ® ( iron dextrin ) is a suitable , effective and safe alternative to oral iron therapy in the treatment of iron deficiency anaemia in pregnancy",
"OBJECTIVE The incidence of anemia in the cervical cancer patients treated with concurrent chemoradiotherapy is estimated to be more than 50 % . Transfusion has been the mainstay of hematologic support with its inherent hazards including infection and transfusion reaction . The aim of this study was to examine the impact of intravenously administered iron sucrose on the prevention of anemia in the cervical cancer patients undergoing concurrent chemoradiotherapy . METHODS From Oct. 2003 to Dec. 2005 , 75 patients were treated with platinum-based concurrent chemoradiotherapy . Thirty patients received 200 mg of iron sucrose intravenously ( study group ) and 45 patients did not receive it ( control group ) . RESULTS In the study group , only 12 ( 40.0 % ) patients required blood transfusions , whereas 29 ( 64.0 % ) patients in the control group needed blood transfusions ( P=0.04 ) . Mean transfusion units were 1.87 units in the study group and 3.58 units in the control group ( P=0.04 ) . CONCLUSION This study showed that intravenous supply of iron sucrose could decrease transfusion requirement and increase serum hemoglobin level in patients with cervical carcinoma undergoing concurrent chemoradiotherapy . Therefore , intravenously administered iron sucrose would be effective in the prevention of anemia of cervical cancer patients receiving concurrent chemoradiotherapy",
"Few data exist to guide treatment of anemic hemodialysis patients with high ferritin and low transferrin saturation ( TSAT ) . The Dialysis Patients ' Response to IV Iron with Elevated Ferritin ( DRIVE ) trial was design ed to evaluate the efficacy of intravenous ferric gluconate in such patients . Inclusion criteria were hemoglobin epoetin dosage > or=225 IU/kg per wk or > or=22,500 IU/wk . Patients with known infections or recent significant blood loss were excluded . Participants ( n=134 ) were r and omly assigned to no iron ( control ) or to ferric gluconate 125 mg intravenously with eight consecutive hemodialysis sessions ( intravenous iron ) . At r and omization , epoetin was increased 25 % in both groups ; further dosage changes were prohibited . At 6 wk , hemoglobin increased significantly more ( P=0.028 ) in the intravenous iron group ( 1.6 + /- 1.3 g/dl ) than in the control group ( 1.1 + /- 1.4 g/dl ) . Hemoglobin response occurred faster ( P=0.035 ) and more patients responded after intravenous iron than in the control group ( P=0.041 ) . Ferritin or > 800 ng/ml had no relationship to the magnitude or likelihood of responsiveness to intravenous iron relative to the control group . Similarly , the superiority of intravenous iron compared with no iron was similar whether baseline TSAT was above or below the study median of 19 % . Ferritin decreased in control subjects ( -174 + /- 225 ng/ml ) and increased after intravenous iron ( 173 + /- 272 ng/ml ; P iron result ed in a greater increase in TSAT than in control subjects ( 7.5 + /- 7.4 versus 1.8 + /- 5.2 % ; P Reticulocyte hemoglobin content fell only in control subjects , suggesting worsening iron deficiency . Administration of ferric gluconate ( 125 mg for eight treatments ) is superior to no iron therapy in anemic dialysis patients receiving adequate epoetin dosages and have a ferritin 500 to 1200 ng/ml and TSAT < or=25 %",
"Background / Aims : Renal anemia is one of the commonest complications of chronic renal failure . Iron deficiency is the most common factor which affects the efficacy of recombinant human erythropoietin ( EPO ) therapy . Intravenous ( i.v . ) iron preparations are commonly used in Western countries , but iron sucrose is seldom used in Chinese patients on maintenance hemodialysis . The aim of the present study was to explore the safety and efficacy of i.v . iron sucrose in Chinese patients on maintenance hemodialysis and to explore the optimal administration frequency . Methods : One hundred and thirty-six patients on maintenance hemodialysis were involved in this r and omized , controlled , parallel-group , single-center trial . Seventy patients received i.v . iron sucrose ( Venofer ® , delivering 100 mg iron ) twice a week for 8 weeks , then once a week for another 4 weeks . The other 66 patients received oral ( p.o . ) ferrous succinate 200 mg t.i.d . for 12 weeks . Levels of serum ferritin ( SF ) , transferrin saturation ( TSAT ) , hemoglobin ( Hb ) and hematocrit ( Hct ) were assessed at baseline and then again after 4 , 8 and 12 weeks of treatment . Results : There were no differences between i.v . and p.o . groups in terms of sex , age , duration of hemodialysis , dialysis frequency per week , EPO dosage per week , the level of intact parathyroid hormone , serum creatinine , blood urea nitrogen , or hematological parameters at baseline . After 8 and 12 weeks of treatment , mean Hb concentration and Hct were significantly increased in the i.v . group , and were also significantly higher than those in the p.o . group . Levels of SF and TSAT were also significantly increased in the i.v . group , and significantly higher than in the p.o . group . After 8 weeks , the response rate in the i.v . group was 88.6 % , which was significantly higher than that in the p.o . group . The mean EPO dose was significantly lower in the i.v . group than the p.o . group . Hb , Hct , SF and TSAT levels were maintained between 8 and 12 weeks in the i.v . group despite the decrease in dose frequency . There were no adverse events related to i.v . iron administration . Twenty-two patients in the p.o . group had adverse gastrointestinal effects . After 12 weeks , the cost of EPO + i.v . iron was significantly higher than the cost of EPO + p.o . iron . Conclusion : Intravenous iron sucrose can effectively increase serum iron parameters and Hb levels in Chinese patients on maintenance hemodialysis and is well tolerated . Infusion of i.v . iron sucrose 100 mg per week can maintain serum iron parameters and Hb levels in Chinese patients on maintenance hemodialysis and can permit reductions in the required dose of EPO . However , the total cost of i.v . iron is relatively high",
"Background : Few studies compare oral to intravenous ( IV ) iron for managing anemia in patients with chronic kidney disease ( CKD ) not on dialysis . Methods : We enrolled 96 CKD anemic patients on erythropoietin in a r and omized , open-label , multicenter , controlled study . Patients received 29 days of oral FeSO4 ( 325 mg t.i.d . ) or intravenous ( IV ) iron sucrose ( 5 doses of 200 mg weekly ) . Assessment s were made up to 14 days after the last dose . Primary endpoints were changes in hemoglobin and ferritin , and clinical success was evaluated from the percent of patients with combined endpoints of rises in hemoglobin/ferritin , hemoglobin/ferritin/TSAT , and hemoglobin/TSAT . Results : There was no significant difference in hemoglobin values between IV and oral therapy . IV iron patients had greater increases in mean serum ferritin ( 288 ng/ml , p oral iron patients ( –5.1 ng/ml , p = NS ) . IV iron patients with baseline ferritin in hemoglobin ( 1.4 g/dl ) compared to oral iron patients ( 0.9 g/dl ) ( p More IV iron patients ( 54.2 % ) attained hemoglobin values > 11.0 g/dl compared to oral iron patients ( 31.3 % , p = 0.028 ) , and met hemoglobin/ferritin ( 62.5 % ) , hemoglobin/TSAT ( 47.9 % ) , hemoglobin/ferritin/TSAT ( 43.8 % ) , and ferritin/TSAT criteria ( 54.2 % ) than oral iron patients ( 0 , 22.9 , 0 , and 0 % , respectively ) . There were no serious side effects . Conclusions : These CKD patients had increases in both hemoglobin and ferritin following IV iron therapy , whereas those treated with oral iron had increases in hemoglobin without increases in iron stores . Iron sucrose , given weekly as 200 mg IV push over 5 min is an effective and safe anemia treatment in this population",
"Objective . To analyze the effect of intravenous ferrous sucrose compared with oral ferrous sulphate on hematological parameters and quality of life in women with postpartum anemia . Design . Open r and omised controlled trial . Setting . Multicentre study comprising five obstetrical departments in Norway . Population . Hundred and twenty‐eight postpartum women with hemorrhagic anemia ( Hb between 6.5 g/100 ml and 8.5 g/100 ml ) . The intervention group ( 59 women ) received 600 mg iron sucrose intravenously followed by 200 mg iron sulphate daily from week 5 . The control group ( 70 women ) were given 200 mg iron sulphate daily . Methods . R and omisation and start of treatment occurred within 48 hours of the delivery . Participants were followed up at 4 , 8 and 12 weeks . Main outcome measures . Hemoglobin , ferritin and quality of life assessed with the Medical Outcomes Study Short Form 36 ( SF‐36 ) and the Fatigue Scale . Results . After 4 weeks the mean hemoglobin values in both groups were similar ( 11.9g/100ml vs. 12.3g/100ml , p = 0.89 ) . The mean serum ferritin value after 4 weeks was significantly higher in the intervention group with 13.7μg/L vs. 4.2μg/L in the control group ( p the hematological parameters were similar . The total fatigue score was significantly improved in the intervention group at week 4 , 8 and 12 , whereas SF‐36 scores did not differ . Conclusion . Women who received 600 mg intravenous iron sucrose followed by st and ard oral iron after four weeks , replenished their iron stores more rapidly and had a more favorable development of the fatigue score indicating improved quality of life ",
"Bacteremic infections are a major cause of mortality and morbidity in chronic hemodialysis patients . New developments in managing these patients ( erythropoietin therapy , nasal mupirocin , long-term implanted catheters , and synthetic membranes ) may have altered the epidemiologic patterns of bacteremia in dialysis patients . This multicenter prospect i ve cross-sectional study was carried out to determine the current incidence of and risk factors for bacteremia in chronic hemodialysis patients in France . A total of 988 adults on chronic hemodialysis for 1 mo or longer was followed up prospect ively for 6 mo in 19 French dialysis units . The factors associated with the development of at least one bacteremic episode over 6 mo were determined using the multivariate Cox proportional hazards model . Staphylococcus aureus ( n=20 ) and coagulase-negative staphylococci ( n=15 ) were responsible for most of the 51 bacteremic episodes recorded . The incidence of bacteremia was 0.93 episode per 100 patient-months . Four risk factors for bacteremia were identified : ( 1 ) vascular access ( catheter versus fistula : RR=7.6 ; 95 % CI , 3.7 to 15.6 ) ; ( 2 ) history of bacteremia ( > or = 2 versus no previous episode : RR=7.3 ; 95 % CI , 3.2 to 16.4 ) ; ( 3 ) immunosuppressive therapy ( current versus no : RR=3.0 ; 95 % CI , 1.0 to 6.1 ) ; and ( 4 ) corpuscular hemoglobin ( per 1 g/dl increment : RR=0.7 ; 95 % CI , 0.6 to 0.9 ) . Catheters , especially long-term implanted catheters , were found to be the leading risk factor of bacteremia in chronic hemodialysis patients . There was a trend toward recurrence of bacteremia that was not associated with chronic staphylococcal nasal carriage . Synthetic membranes were not associated with a lower risk of bacteremia in this population of well dialyzed patients , but anemia linked to resistance to erythropoietin appeared to be a possible risk factor for bacteremia",
"Objective . Patients with inflammatory bowel disease ( IBD ) often have low iron stores or anaemia . There is controversy about whether iron should be supplemented orally or intravenously ( i.v . ) . The purpose of this study was to investigate whether treatment with intravenous iron is superior to treatment with oral iron . The primary end-points were response and remaining anaemia at the end of treatment ( EOT ) . Material and methods . Ninety-one patients with IBD and anaemia ( B-Hb were r and omized to oral iron sulphate ( n=46 ) or intravenous iron sucrose ( n=45 ) treatment for 20 weeks . Results . Forty-three patients in the intravenous iron group completed the study compared to 35 patients in the oral iron group ( p=0.0009 ) . Only 22 patients ( 48 % ) tolerated the prescribed oral dose , and 52 % reduced the dose or withdrew from treatment because of poor tolerance . At EOT , 47 % patients in the oral iron group increased their B-Hb by ≥20 g/L , compared with 66 % in the intravenous iron group ( p=0.07 ) . In the oral iron group , 41 % still had anaemia versus 16 % of the patients in the intravenous iron group ( p=0.007 ) , and 22 % versus 42 % reached their reference B-Hb level ( p=0.04 ) . Treatment with intravenous iron sucrose improved iron stores faster and more effectively than oral iron ( p=0.002 ) . Under treatment with intravenous iron , 74 % of the patients had no anaemia and normal S-ferritin levels ( > 25 µg/L ) at EOT compared with 48 % of patients receiving oral iron ( p=0.013 ) . Conclusions . Treatment with intravenous iron sucrose is effective , safe , well tolerated and superior to oral iron in correcting haemoglobin and iron stores in patients with IBD",
"OBJECTIVE To evaluate the safety and efficacy of intravenous iron sucrose complex ( ISC ) as compared with oral ferrous sulfate in the treatment of iron deficiency anemia during pregnancy . STUDY DESIGN prospect i ve , open , controlled study in which pregnant women with iron deficiency anemia were sequentially selected from the antenatal clinic and assigned either to ISC ( study group ) or to ferrous sulfate ( control group ) . METHODS Each study patient was given the total calculated amount of ICS ( Hb deficit ( g/l ) x body weight ( kg ) x 0.3 ) in divided doses ( 200 mg ( elemental iron ) in 100 ml normal saline intravenously over 1 h daily ) followed by 10 mg/kg to replenish iron stores . Each patient of the control group was given ferrous sulfate 300 mg ( 60 mg elemental iron ) orally three times a day . All patients were monitored for adverse effects , clinical and laboratory response . RESULTS There were 52 patients and 59 controls . ISC group achieved a significantly higher Hb level ( 128.5 + /- 6.6 g/l vs. 111.4 + /- 12.4 g/l in the control group P major side effects while 4 ( 6 % ) of the control group could not tolerate ferrous sulfate , 18 ( 30 % ) complained of disturbing gastrointestinal symptoms and 18 ( 30 % ) had poor compliance . CONCLUSION We conclude that ISC is safe and effective in the treatment of iron deficiency anemia during pregnancy",
"OBJECTIVES Our objective was to evaluate in a double-blind , r and omized , placebo-controlled study possible modifications in NT-pro-brain natriuretic peptide ( NT-proBNP ) and C-reactive protein ( CRP ) levels together with clinical and functional parameters , in a group of anemic patients with chronic heart failure ( CHF ) and chronic renal failure ( CRF ) receiving intravenous iron therapy , without recombinant human erythropoietin ( rhEPO ) , versus placebo . BACKGROUND Chronic heart failure and CRF associated with absolute or relative iron deficiency anemia is a common problem . This situation is linked with a variable inflammatory status . Both NT-proBNP and CRP are recognized markers for left ventricular dysfunction and inflammatory status , respectively . In this double-blind , r and omized , placebo-controlled study , modifications in NT-proBNP and CRP level and clinical and functional parameters , in anemic patients with CHF and CRF receiving intravenous iron therapy , without rhEPO , versus placebo were evaluated . METHODS Forty patients with hemoglobin ( Hb ) into 2 groups ( n = 20 for each ) . For 5 weeks , group A received isotonic saline solution and group B received iron sucrose complex , 200 mg weekly . Minnesota Living with Heart Failure Question naire ( MLHFQ ) and 6-min walk ( 6MW ) test were performed . NT-pro brain natriuretic peptide and CRP were evaluated throughout the study . No patients received erythroprotein any time . RESULTS After 6 months follow-up , group B showed better hematology values and CrCl ( p NT-proBNP ( 117.5 + /- 87.4 pg/ml vs. 450.9 + /- 248.8 pg/ml , p CRP ( 2.3 + /- 0.8 mg/l vs. 6.5 + /- 3.7 mg/l , p Hb and NT-proBNP ( group A : r = -0.94 and group B : r = -0.81 ) and after 6 months only in group A : r = -0.80 . Similar correlations were observed with Hb and CRP . Left ventricular ejection fraction percentage ( 35.7 + /- 4.7 vs. 28.8 + /- 2.4 ) , MLHFQ score , and 6MW test were all improved in group B ( p hospitalizations : 0 of 20 versus group A , 5 of 20 ( p Intravenous iron therapy without rhEPO substantially reduced NT-proBNP and inflammatory status in anemic patients with CHF and moderate CRF . This situation was associated with an improvement in LVEF , NYHA functional class , exercise capacity , renal function , and better quality of life",
"BACKGROUND To compare the efficacy of oral and intravenous administration of iron supplements for treating postpartum anemia . METHODS One hundred and four anemic postpartum women were studied prospect ively . The criteria for the diagnosis of anemia were Hb . They were r and omised into two groups . Group A consisted of 78 women who received i.v . a total amount of 300 mg iron sucrose in three days . Group B consisted of 26 women , who received orally 800 mg iron proteinsuccinylate daily for four weeks . RESULTS At the end of the study , in group A the increase of Hb mean level was 4.6 gr/dl and of ferritin mean level was 105 mg/L. In group B the increase in hemoglobin mean level was 2.3 gr/dl and ferritin mean level was 68 mg/L. There was significant difference in the increase of hemoglobin level ( p=0.0001 ) and also in the increase in ferritin level ( p=0.0004 ) between the two groups . CONCLUSION Intravenous administration of iron sucrose seems to be safe and it helps postpartum women to recover early from anemia",
"OBJECTIVE Is intravenous iron therapy as efficient as oral iron supplementation in patients undergoing autologous blood donation ? DESIGN Prospect i ve , r and omized study . PATIENTS AND SETTING 30 male and 30 female patients , separated into two groups were examined prior to total hip replacement . INTERVENTIONS Patients of group O were given 6 x 50 mg Fe2 + aspartate/day orally , and patients of group P were given 0.75 mg/kg BW complex-bound Fe3 + once a week by infusion . In both groups therapy was started two weeks prior to the first donation . The substitution was continued the following six weeks until surgery . Hemoglobin , ferritin plasma concentrations and reticulocytes were monitored . The appearance of unwanted side effects was studied by question naire . RESULTS Hb decreased significantly in both groups . A difference was seen in the reticulocyte count and in the ferritin levels . Here we found a significant increase in group P compared with group O. 40 % of the patients who took the iron orally complained about unwanted side effects such as obstipation and diarrhoea , whereas none of the patients of the parenteral group had any complaints . CONCLUSIONS Stimulation of the erythropoiesis appeared to be more efficient with intravenous iron therapy than with oral iron supplementation . The oral dose has in about 40 % unwanted side effects . For this reason a parenteral iron therapy can be considered , but one must be aware that in some cases dangerous anaphylactic reactions could appear",
"OBJECTIVES The aim of this study was to examine whether intravenous iron III-hydroxide sucrose complex ( IHSC ) used alone was sufficient to provide rapid correction of anemia after cardiac surgery and whether additional stimulation of erythropoiesis is possible by means of a single low dose of recombinant-human erythropoietin ( r-HuEPO ) administration . DESIGN Prospect i ve , r and omized , double-blind study . SETTING The study was conducted in a university hospital . PARTICIPANTS One hundred twenty American Society of Anesthesiologists II or III patients , who underwent elective cardiac surgery using cardiopulmonary bypass and in whom postpump hemoglobin ranged between 7 and 10 g/dL. INTERVENTIONS Patients were divided into 3 groups : group I = control ; group II received postoperative intravenous iron supplementation with an iron III-hydroxide sucrose complex ( IHSC ) ; and group III received IV iron and a single dose of r-HuEPO ( 300 U/kg ) . MEASUREMENTS AND RESULTS No significant difference in transfusion needs was observed among the 3 groups ( 22 % , 25 % , and 17 % of patients transfused in groups I , II , and III , respectively ) . Hemoglobin levels , reticulocyte counts , and serum ferritin levels were evaluated at different time intervals ( until day 30 postoperatively ) . No side effects because of iron administration were noted in the study . Reticulocyte counts increased rapidly at day 5 ( 2.24 % + /- 1.11 % , 1.99 % + /- 1.44 % , and 3.84 % + /- 2.02 % in groups I , II , and III , respectively ) and decreased after day 15 in the 3 groups . Ferritin levels increased significantly at day 5 in the 2 treated groups ( 899.33 + /- 321.55 ng/mL in group II , 845.75 + /- 289.96 ng/mL in group III v 463.15 + /- 227.74 ng/mL in group I ) . In group I , ferritin levels , after a slight elevation on day 5 , decreased at day 15 to lower than baseline levels . No significant difference in hemoglobin increase was noted among the 3 groups . CONCLUSION Postoperative intravenous iron supplementation alone or in combination with a single dose of r-HuEPO ( 300 U/kg ) is not effective in correcting anemia after cardiac surgery",
"Sixty pregnant patients with a haemoglobin ( Hb ) less than 8 g/dl and proven iron-deficiency anaemia were r and omly allocated to two treatment groups . Group A received the usual recommended dose of iron dextran ( Imferon ; Fisons ) and group B received two-thirds of the recommended dose . A further 30 patients received oral iron ( group C ) . There was no difference in Hb value between the three groups 4 weeks after treatment or 3 months after delivery . At 6 months after delivery , a higher mean Hb value was found in the patients in group A than those in groups B and C. Significantly higher serum ferritin levels were found in group A and this difference was still present 6 months postnatally . There was no significant difference in the incidence of delayed reactions between the two groups who received iron dextran",
"BACKGROUND Restless legs syndrome ( RLS ) is a common disorder in patients with end-stage renal disease ( ESRD ) that causes motor agitation and insomnia . Because RLS has been associated with iron deficiency , we sought to investigate the effects of intravenous ( IV ) iron dextran on symptoms of RLS in a double-blind placebo-controlled trial . METHODS Patients determined to have RLS by International RLS Study Group criteria were administered either iron dextran , 1,000 mg , or normal saline IV in a blinded fashion . Patient demographic data were collected , and blood chemistry tests , liver function studies , serum iron levels , ferritin levels , and total iron-binding capacity were obtained at baseline and 1 , 2 , and 4 weeks postinfusion . Side effects or adverse events to interventions were monitored , and RLS symptoms were assessed by a rating scale at the same intervals . RESULTS Eleven patients were r and omly assigned to the administration of iron dextran , and 14 patients to the administration of saline . RLS severity scores were slightly higher in the placebo group at baseline , but hemoglobin levels , iron stores , and other biochemical parameters did not differ . Although no change in symptoms were seen in the placebo-treated group , significant improvement in RLS symptom scores in response to iron dextran was seen 1 week after infusion ( -2 ; interquartile range [ IQR ] , -6 to -1 ; P = 0.03 , Wilcoxon 's rank sums ) , but was greatest at 2 weeks ( -3 ; IQR , -5 to -2 compared with -1 to 0 ; P = 0.01 ) . Salutary effects of iron persisted at 4 weeks , but were no longer statistically significant . The significant increase in serum ferritin levels and iron saturation observed in the iron dextran-treated group was not seen in the placebo-treated group . No differences in adverse events were noted between groups . CONCLUSION High-dose iron dextran infusion is associated with a significant , but transient , reduction in symptoms of RLS in patients with ESRD",
"For nearly half a century , parenteral iron has been considered dangerous and for use only in extreme situations and when oral iron was not tolerated . This proscription was based largely on poorly characterised and infrequent anaphylactoid reactions to the high-molecular-weight dextran preparation ( Imferon ) that for most of this time was the only product available . Moreover , when parenteral iron was necessary , the recommended approach was small intramuscular doses ( ≤100 mg ) , even after intravenous administration of the total iron defi cit as a single dose or as repetitive boluses was shown to be as safe and eff ective as the intramuscular route . This mindset persists despite the subsequent introduction of low-molecular-weight iron dextran and two iron salt preparations , ferric gluconate and iron saccharate ( the latter is also known as iron sucrose ) , all of which are associated with fewer serious adverse events than the high-molecular-weight dextran . The introduction of recombinant erythropoietin for dialysis patients was associated with the development , in some individuals , of functional iron defi ciency that limited effi cacy . Intravenous iron , unlike oral iron , improves erythropoietic response in dialysis patients , and is now routinely used . The discovery of the iron regulatory peptide , hepcidin , has improved our underst and ing of the anaemia of chronic infl ammatory states , including cancer . Hepcidin is upregulated in these conditions , result ing in increased synthesis by the liver . Hepcidin inhibits iron transport across cell membranes , which decreases the accessibility of storage iron and gastrointestinal absorption of dietary iron , leading to an increased frequency of iron-restricted erythropoiesis , especially during therapy with recombinant erythropoietin . The most frequent laboratory fi ndings during the anaemia of chronic infl ammation are hypoferraemia and a low percent transferrin saturation , although these fi ndings are not always present . The increasing use of recombinant erythropoietin to treat anaemia in patients with chronic diseases has exp and ed the population of patients with functional iron defi ciency and increased interest in safe rational approaches to parenteral iron therapy . There is mounting evidence that anaemic patients with cancer undergoing chemotherapy and receiving recombinant erythropoietin respond better when parenteral iron is administered . This benefi t is independent of baseline iron variables , such as ferritin , low percentage transferrin saturation , and stainable marrow haemosiderin , leaving the clinician in need of laboratory variables to reliably detect iron-restricted erythropoiesis in patients with infl ammatory illnesses and to predict improvement of erythropoietic response to parenteral iron in the setting of infl ammatory illness . Two new laboratory measures look promising : percent hypochromic red blood cells and reticulocyte haemoglobin content . These tests are reliable and accurate correlates of functional iron defi ciency . Although these investigations are not yet widely available , their use will probably exp and and guide identifi cation of functional iron defi ciency and rational intervention with parenteral iron . Currently , four parenteral iron preparations are available ( table ) . No r and omised trials have compared the safety and effi cacy of any of these agents . The largest retrospective review of dialysis experience suggests that most serious adverse events have been associated with the high-molecular-weight iron dextrans ( Imferon , which is no longer available and the current preparation , Dexferrum ) and are rare ( iron dextran or the two iron salts ( fi gure ) . Adverse event rates might be somewhat higher in patients with infl ammatory diseases in which immune-mediated drug reactions may be observed more commonly than in dialysis patients . Some of the adverse clinical experience with parenteral iron is due to inappropriate supportive care . Myalgias , when they include chest and back discomfort , are mistakenly described as anaphylaxis , prompting Low – molecular – weight iron dextran Iron saccharate Ferric gluconate High – molecular – weight iron",
"In view of current uncertainty regarding the optimum route for iron supplementation in patients receiving recombinant human erythropoietin ( EPO ) , a prospect i ve r and omized controlled study was design ed to investigate this issue . All iron-replete renal failure patients commencing EPO who had a hemoglobin concentration were r and omized into three groups with different iron supplementation : Group 1 , i.v . iron dextran 5 ml every 2 weeks ; Group 2 , oral ferrous sulphate 200 mg tds ; Group 3 , no iron . All patients were treated with 25 U/kg of EPO thrice weekly subcutaneously . The hemoglobin concentration , reticulocyte count , serum ferritin , transferrin saturation , and EPO dose were monitored every two weeks for the first four months . Thirty-seven patients entered the study ( 12 i.v . , 13 oral , 12 no iron ) . The three groups were equivalent with regard to age , sex , and other demographic details . Even allowing for dosage adjustments , the hemoglobin response in the group receiving i.v . iron ( 7.3 + /- 0.8 to 11.9 + /- 1.2 g/dl ) was significantly greater than that for the other two groups ( 7.2 + /- 1.1 to 10.2 + /- 1.4 g/dl and 7.3 + /- 0.8 to 9.9 + /- 1.6 g/dl for Groups 2 and 3 , respectively ; P iron and no iron . Serum ferritin levels remained constant in those receiving i.v . iron ( 345 + /- 273 to 359 + /- 140 micrograms/liter ) , in contrast to the other two groups in which ferritin levels fell significantly ( 309 + /- 218 to 116 + /- 87 micrograms/liter and 458 + /- 206 to 131 + /- 121 micrograms/liter for Groups 2 and 3 , respectively ; P Dosage requirements of EPO were less in Group 1 ( 1202 + /- 229 U/kg/16 weeks ) than in Group 2 ( 1294 + /- 314 U/kg/16 weeks ) or Group 3 ( 1475 + /- 311 U/kg/16 weeks ; P iron-replete patients , those supplemented with i.v . iron have an enhanced hemoglobin response to EPO with better maintenance of iron stores and lower dosage requirements of EPO , compared with those patients receiving oral iron and no iron supplementation",
"OBJECTIVES To compare the efficacy of intravenous iron and oral iron for prevention of blood transfusions in gynecologic cancer patients receiving platinum-based chemotherapy . MATERIAL S AND METHODS Sixty-four non anemic gynecologic cancer patients receiving adjuvant platinum-based chemotherapy were stratified and r and omized according to baseline hemoglobin levels and chemotherapy regimen . The study group received 200 mg of intravenous iron sucrose immediately after each chemotherapy infusion . The control group received oral ferrous fumarate at a dose of 200 mg three times a day . Complete blood count was monitored before each chemotherapy infusion . Blood transfusions were given if hemoglobin level was below 10mg/dl . RESULTS There were 32 patients in each group . No significant differences in baseline hemoglobin levels and baseline characteristics were demonstrated between both groups . Nine patients ( 28.1 % ) in the study group and 18 patients ( 56.3 % ) in the control group required blood transfusion through 6 cycles of chemotherapy ( p=0.02 ) . Fewer median number of total packed red cell units were required in the study group compared to the control group ( 0 and 0.5 unit , respectively , p=0.04 ) . Serious adverse events and hypersensitivity reactions were not reported . However , constipation was significantly higher in the control group ( 3.1 % and 40.6 % , p= Intravenous iron is an effective , well-tolerated treatment for primary prevention of blood transfusions in gynecologic cancer patients receiving platinum-based chemotherapy , associated with less constipation than the oral formulation",
"BACKGROUND Currently available intravenous ( IV ) iron agents vary in indication , dosing regimens and safety profiles . Ferric carboxymaltose ( FCM ) is a stable , non-dextran-containing iron formulation developed for rapid IV administration in high doses with controlled delivery of iron into target tissues . The objective of the present study was to evaluate the safety of FCM compared with st and ard medical care ( SMC ) in dialysis ( HD ) and non-dialysis-dependent ( NDD ) chronic kidney disease ( CKD ) patients . METHODS Adults 18 - 85 years of age with CKD were enrolled . NDD-CKD ( n = 204 ) patients received an undiluted IV dose of FCM ( 15 mg/kg to a maximum of 1000 mg IV ) and HD-CKD ( n = 50 ) patients received an undiluted IV push of 200 mg ~30 - 60 min into the dialysis session . Subjects r and omized to the SMC group ( n = 259 ) received treatment determined by the investigator that could include oral iron , IV iron or no iron . RESULTS Single doses of FCM of 200 mg in HD-CKD patients and up to 1000 mg in NDD-CKD patients were well tolerated . Incidences of treatment-emergent adverse events were similar between the groups : 30.3 % ( 77 of 254 ) in the FCM group and 32.8 % ( 85 of 259 ) in the SMC group . Incidences of serious adverse events were higher in the SMC group overall and in patients receiving iron sucrose or sodium ferric gluconate . There were no clinical ly significant differences in laboratory or clinical chemistry values or vital signs between the groups . There were no statistically significant differences between the FCM and SMC groups in indices of hemoglobin ( Hb ) improvement , including proportions of patients achieving a ≥ 1 g/dL increase in Hb and proportions of patients achieving Hb level of > 12 g/dL. CONCLUSION FCM in doses of 200 mg for HD-CKD patients and up to 1000 mg in NDD-CKD patients were well tolerated and displayed comparable efficacy to other IV iron formulations",
"AIM 135 puerperal women with iron deficiency anemia participated in our prospect i ve r and omized controlled trial in order to investigate alternative treatments to blood transfusion for anemia . MATERIAL S AND METHODS The criteria for the diagnosis of anemia were Hb Women were r and omly separated in two groups , A and B. Women of group A ( n = 109 women ) received a total amount of 1000 mg low molecular weight ( LMW ) iron-dextran intravenously in two doses . Group B ( n = 26 ) was the control group . They received orally 800 mg daily for 30 days of iron protein-succinylate . Three weeks later women of both groups underwent a full blood count analysis . RESULTS Hemoglobin and ferritin levels increased significantly in group A compared to group B ( p adverse side-effects due to the treatment were noted in either group . CONCLUSION It seems that total iron-dextran infusion is a safe and rapid therapy of iron-deficiency postpartum anemia increases the Hb level more rapidly than oral ferrous sulfate , and it also appears to replenish iron stores more rapidly",
"This study evaluated efficacy and safety of darbepoetin alfa administered every 3 weeks ( Q3W ) at fixed doses of 300 or 500 μg with or without intravenous ( IV ) iron in treating anemia in patients receiving multicycle chemotherapy . This Phase 2 , double‐blind , 2 × 2 factorial study r and omized patients to one of four treatment arms ; darbepoetin alfa 300 μg ( n = 62 ) , darbepoetin alfa 300 μg plus IV iron ( n = 60 ) , darbepoetin alfa 500 μg ( n = 60 ) , or darbepoetin alfa 500 μg plus IV iron ( n = 60 ) . Patients had nonmyeloid malignancies , hemoglobin levels ≤10 g dL−1 , and no iron deficiency . Primary endpoint was achievement of target hemoglobin ( ≥11 g dL−1 ) . Secondary endpoints included incidence of transfusions and change in Functional Assessment of Cancer Therapy Fatigue ( FACT‐F ) score from baseline to end of study . Safety was evaluated by incidence of adverse events . No evidence of a statistically significant interaction between darbepoetin alfa dose received and IV iron usage was observed , therefore , results are provided separately comparing darbepoetin alfa doses and comparing IV iron usage groups . Similar proportions of patients receiving darbepoetin alfa 300 or 500 μg achieved target hemoglobin ( 75 and 78 % , respectively ) ; Kaplan – Meier median time to target hemoglobin was 10 and 8 weeks , respectively . More patients receiving IV iron ( 82 % ) than not receiving IV iron ( 72 % ) achieved hemoglobin target . Adverse events profiles were similar for darbepoetin alfa treatment groups . Transient anaphylactoid reactions were reported in two patients receiving IV iron . Darbepoetin alfa at 300 μg Q3W and 500 μg Q3W showed similar benefit , while added IV iron improved treatment response in these patients . Am . J. Hematol . , 2010 . © 2010 Wiley‐Liss ,",
"AIM Iron deficiency is a leading cause of anemia in pregnancy . The present study aim ed to compare the efficacy of oral and intravenous iron therapy in improving iron deficiency anemia in pregnancy and restoring iron stores , compare the obstetric outcome in the two groups and evaluate the safety of intravenous iron sucrose . MATERIAL AND METHODS This was a prospect i ve study , where 100 anemic antenatal women with hemoglobin 7 - 9 g/dL , mean corpuscular volume were r and omized into two groups . In group A ( n=50 ) , the women received 200 mg tablets of ferrous sulphate , each containing 60 mg elemental iron , three times a day for 4 weeks . In group B ( n=50 ) , iron sucrose was given in divided doses of 200 mg each on alternate days by slow intravenous infusion . Primary outcome measure was treatment efficacy , assessed by measurement of hemoglobin , red blood cell indices and reticulocytes on days 7 , 14 , 21 , and 30 and at delivery , and of ferritin on day 30 and at delivery . Any side-effects of treatment and the neonatal outcome were studied as secondary outcome measures . RESULTS There was a statistically significant difference in increase of hemoglobin levels ( 3.1g/dL in group A vs 5.1 g/dL in group B ; P=0.002 ) and ferritin levels between the two groups on day 30 ( P=0.005 ) . The adverse effects from iron treatment were mild but more prominent in group A. Neonatal outcome was comparable in the two groups . CONCLUSION Intravenous administration of iron sucrose is a safe treatment for correction of anemia in pregnancy , without serious side-effects",
"OBJECTIVES We tested the hypothesis that intravenous iron improves exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure ( CHF ) and iron deficiency . BACKGROUND Anemia is common in heart failure . Iron metabolism is disturbed , and administration of iron might improve both symptoms and exercise tolerance . METHODS We r and omized 35 patients with CHF ( age 64 + /- 13 years , peak oxygen consumption [ pVO2 ] 14.0 + /- 2.7 ml/kg/min ) to 16 weeks of intravenous iron ( 200 mg weekly until ferritin > 500 ng/ml , 200 mg monthly thereafter ) or no treatment in a 2:1 ratio . Ferritin was required to be change in absolute pVO2 . RESULTS The difference ( 95 % confidence interval [ CI ] ) in the mean changes from baseline to end of study between the iron and control groups was 273 ( 151 to 396 ) ng/ml for ferritin ( p hemoglobin ( p = 0.9 ) , 96 ( -12 to 205 ) ml/min for absolute pVO2 ( p = 0.08 ) , 2.2 ( 0.5 to 4.0 ) ml/kg/min for pVO2/kg ( p = 0.01 ) , 60 ( -6 to 126 ) s for treadmill exercise duration ( p = 0.08 ) , -0.6 ( -0.9 to -0.2 ) for New York Heart Association ( NYHA ) functional class ( p = 0.007 ) , and 1.7 ( 0.7 to 2.6 ) for patient global assessment ( p = 0.002 ) . In anemic patients ( n = 18 ) , the difference ( 95 % CI ) was 204 ( 31 to 378 ) ml/min for absolute pVO2 ( p = 0.02 ) , and 3.9 ( 1.1 to 6.8 ) ml/kg/min for pVO2/kg ( p = 0.01 ) . In nonanemic patients , NYHA functional class improved ( p = 0.06 ) . Adverse events were similar . CONCLUSIONS Intravenous iron loading improved exercise capacity and symptoms in patients with CHF and evidence of abnormal iron metabolism . Benefits were more evident in anemic patients . ( Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure ; http://www . clinical trials.gov/ct/show/NCT00125996 ; NCT00125996 )",
"PURPOSE The concomitant use of intravenous ( IV ) iron as a supplement to erythropoiesis-stimulating agents in patients with chemotherapy-induced anemia is controversial . This study was design ed to evaluate the efficacy and safety of darbepoetin alpha given with IV iron versus with local st and ard practice ( oral iron or no iron ) . PATIENTS AND METHODS In this multicenter , r and omized , open-label , phase III study , 396 patients with nonmyeloid malignancies and hemoglobin ( Hb ) less than 11 g/dL received darbepoetin alpha 500 microg with ( n = 200 ) or without ( n = 196 ) IV iron once every 3 weeks ( Q3W ) for 16 weeks . RESULTS The hematopoietic response rate ( proportion of patients achieving Hb > or= 12 g/dL or Hb increase of > or= 2 g/dL from baseline ) was significantly higher in the IV iron group : 86 % versus 73 % in the st and ard practice group ( difference of 13 % [ 95 % CI , 3 % to 23 % ] ; P = .011 ) . Fewer RBC transfusions ( week 5 to the end of the treatment period ) occurred in the IV iron group : 9 % versus 20 % in the st and ard practice group ( difference of -11 % [ 95 % CI , -18 % to -3 % ] ; P = .005 ) . Both treatments were well tolerated with no notable differences in adverse events . Serious adverse events related to iron occurred in 3 % of patients in the IV iron group and were mostly gastrointestinal in nature . CONCLUSION Addition of IV iron to darbepoetin alpha Q3W in patients with chemotherapy-induced anemia was well tolerated , result ing in an improved hematopoietic response rate and lower incidence of transfusions compared with darbepoetin alpha alone",
"PURPOSE Unresponsiveness to erythropoiesis-stimulating agents , occurring in 30 % to 50 % of patients , is a major limitation to the treatment of chemotherapy-related anemia . We have prospect ively evaluated whether intravenous iron can increase the proportion of patients with chemotherapy-related anemia who respond to darbepoetin . PATIENTS AND METHODS Between December 2004 and February 2006 , 149 patients with lung , gynecologic , breast , and colorectal cancers and > or= 12 weeks of planned chemotherapy were enrolled from 33 institutions . Patients were required to have hemoglobin All patients received darbepoetin 150 microg subcutaneously once weekly for 12 weeks and were r and omly assigned to sodium ferric gluconate 125 mg intravenously ( IV ) weekly for the first 6 weeks ( n = 73 ) or no iron ( n = 76 ) . Primary end point of the study was the percentage of patients achieving hematopoietic response ( hemoglobin > or= 12 g/dL or > or= 2 g/dL increase ) . RESULTS Hematopoietic response by intention-to-treat analysis was 76.7 % ( 95%CI , 65.4 % to 85.8 % ) in the darbepoetin/iron group and 61.8 % ( 95%CI , 50.0 % to 72.7 % ) in the darbepoetin group ( P = .0495 ) . Among patients fulfilling eligibility criteria and having received at least four darbepoetin administrations , hematopoietic responses in the darbepoetin/iron group ( n = 53 ) and in the darbepoetin-only group ( n = 50 ) were 92.5 % ( 95 % CI , 81.8 % to 97.9 % ) and 70 % ( 95 % CI , 55.4 % to 82.1 % ) , respectively ( P = .0033 ) . Increase of hemoglobin during treatment period showed a time profile favoring darbepoetin/iron with statistically significant effect from week 5 on . The safety profile was comparable in the two arms . CONCLUSION In patients with chemotherapy-related anemia and no iron deficiency , IV iron supplementation significantly reduces treatment failures to darbepoetin without additional toxicity"
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The overall objective is to assess the effects of dem and -side financing ( DSF ) interventions on maternal health service utilisation and on maternal health outcomes in low and middleincome countries . Broader effects on perinatal and infant health , the situation of underprivileged women and the health care system will also be assessed . For example , we will examine evidence on the appropriateness and meaningfulness of DSF for meeting the needs of rural , poor or socially excluded women , and evidence on the feasibility and appropriateness of DSF in terms of quality of care , sustainability and institutional capacity to run such schemes
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"OBJECTIVES To evaluate the impact of Oportunidades , a large-scale , conditional cash transfer programme in Mexico , on birthweight . The programme provides cash transfers to low-income , rural households in Mexico , conditional on accepting nutritional supplements health education , and health care . METHODS The primary analyses used retrospective reports from 840 women in poor rural communities participating in an effectiveness study and r and omly assigned to incorporation into the programme in 1998 or 1999 across seven Mexican states . Pregnant women in participating households received nutrition supplements and health care , and accepted cash transfers . Using multivariate and instrumental variable analyses , we estimated the impact of the programme on birthweight in grams and low birthweight ( 2500 g ) , receipt of any pre-natal care , and number of pre-natal visits . RESULTS Oportunidades beneficiary status was associated with 127.3 g higher birthweight among participating women and a 4.6 percentage point reduction in low birthweight . CONCLUSION The Oportunidades conditional cash transfer programme improved birthweight outcomes . This finding is relevant to countries implementing conditional cash transfer programmes ",
"OBJECTIVES To evaluate the impact of Mexico 's conditional cash transfer programme on the quality of health care received by poor women . Quality is measured by maternal reports of prenatal care procedures received that correspond with clinical guidelines . METHODS The data describe retrospective reports of care received from 892 women in poor rural communities in seven Mexican states . The women were participating in an effectiveness study and r and omly assigned to incorporation into the programme in 1998 or 1999 . Eligible women accepted cash transfers conditional on obtaining health care and nutritional supplements , and participated in health education sessions . RESULTS Oportunidades beneficiaries received 12.2 % more prenatal procedures compared with non-beneficiaries ( adjusted mean 78.9 , 95 % Confidence Interval ( CI ) : 77.5 - 80.3 ; P Oportunidades conditional cash transfer programme is associated with better quality of prenatal care for low-income , rural women in Mexico . This result is probably a manifestation of the programme 's empowerment goal , by encouraging beneficiaries to be informed and active health consumers",
"Since 1997 , discount vouchers for insecticide-treated nets ( ITNs ) have been used in two rural districts of southern Tanzania as a way to target subsidies to children under 5 years and pregnant women . We assessed appropriate use and misuse of discount vouchers through a follow-up study of 104 r and omly selected vouchers . We traced these vouchers from their original issue in mother- and -child health ( MCH ) clinics through to being redeemed at a sales agent . We found that all vouchers that reached the target population ( 100 % , 56/56 ) were used to buy an ITN . Moreover , 94 % of the ITNs bought with vouchers were used by those intended , women and children under 5 years . However , up to 48 % ( 50/104 ) of the vouchers had been misused at the clinics that issued them . Nevertheless , large-scale misuse occurred only at three of 21 clinics . Although most women slept under a net while pregnant , the use of voucher-subsidized ITNs during pregnancy was low despite widespread knowledge of the scheme . Parents had apparently decided to buy the subsidized ITNs once the child was born and not during pregnancy . Importantly , in 20 % of households the only existing net had been bought with a voucher . Our findings suggest that vouchers are properly used by the target population , and that to minimize voucher leakage , control measures are needed at MCH clinics and to a certain extent for commercial sales agents . Increased awareness among the whole community on the right to receive a discount voucher may also help to control misuse at health facilities",
"Objective To measure whether there was an association between the introduction of an output-based voucher programme and the odds of a facility-based delivery in two Nairobi informal settlements . Data sources Nairobi Urban Health and Demographic Surveillance System ( NUHDSS ) and two cross-sectional household surveys in Korogocho and Viw and ani informal settlements in 2004–05 and 2006–08 . Methods Odds of facility-based delivery were estimated before and after introduction of an output-based voucher . Supporting NUHDSS data were used to determine whether any trend in maternal health care was coincident with immunizations , a non-voucher outpatient service . As part of NUHDSS , households in Korogocho and Viw and ani reported place of delivery and the presence of a skilled birth attendant ( 2003–10 ) and vaccination coverage ( 2003–09 ) . A detailed maternal and child health ( MCH ) tool was added to NUHDSS ( September 2006–10 ) . Prospect i ve enrolment in NUHDSS-MCH was conditional on having a newborn after September 2006 . In addition to recording mother ’s place of delivery , NUHDSS-MCH recorded the use of the voucher . Findings There were significantly greater odds of a facility-based delivery among respondents during the voucher programme compared with similar respondents prior to voucher launch . Testing whether unrelated outpatient care also increased , a falsification exercise found no significant increase in immunizations for children 12–23 months of age in the same period . Although the proportion completing any antenatal care ( ANC ) visit remained above 95 % of all reported pregnancies and there was a significant increase in facility-based deliveries , the proportion of women completing 4 + ANC visits was significantly lower during the voucher programme . Conclusions A positive association was observed between vouchers and facility-based deliveries in Nairobi . Although there is a need for higher quality evidence and validation in future studies , this statistically significant and policy relevant finding suggests that increases in facility-based deliveries can be achieved through output-based finance models that target subsidies to underserved population",
"Background Only 39 % of deliveries in Pakistan are attended by skilled birth attendants , while Pakistan 's target for skilled birth attendance by 2015 is > 90 % . Methods A 12-month maternal health voucher intervention was implemented in Dera Ghazi Khan City , located in Southern Punjab , Pakistan in 2009 . A pre-test/post-test non-experimental study was conducted to assess the impact of the intervention . Household interviews were conducted with r and omly selected women who delivered in 2008 ( the year prior to the voucher intervention ) , and with r and omly selected women who delivered in 2009 . A strong outreach model was used and voucher booklets valued at $ 50 , containing redeemable coupons for three antenatal care ( ANC ) visits , a postnatal care ( PNC ) visit and institutional delivery , were sold for $ 1.25 to low-income women targeted by project workers . Regression analysis was conducted to determine the impact of the voucher scheme on ANC , PNC , and institutional delivery . Marginal effects estimated from logistic regression analyses were used to assess the magnitude of the impact of the intervention . Results The women targeted by voucher outreach workers were poorer , less educated , and at higher parity . After adjusting for these differences , women who delivered in 2009 and were sold voucher booklets were significantly more likely than women who delivered in 2008 to make at least three ANC visits , deliver in a health facility , and make a postnatal visit . Purchase of a voucher booklet was associated with a 22 percentage point increase in ANC use , a 22 percentage point increase in institutional delivery , and a 35 percentage point increase in PNC use . Conclusions A voucher intervention implemented for 12 months was associated with a substantial increase in institutional delivery . A substantial scale-up of maternal health vouchers that focus on institutional delivery is likely to bring Pakistan closer to achieving its 2015 target for institutional delivery",
"Background Dem and -side financing projects are now being implemented in many developing countries , yet evidence showing that they reach the poor is scanty . Methods A maternal health voucher scheme provided voucher-paid services in Jhang , a predominantly rural district of Pakistan , during 2010 . A pre-test/post-test quasi-experimental design was used to assess the changes in the proportion of facility-based deliveries and related maternal health services among the poor . Household interviews were conducted with r and omly selected women in the intervention and control union councils , before and after the intervention . A strong outreach model was used . Voucher promoters were given basic training in identification of poor women using the Poverty Scorecard for Pakistan , in the types of problems women could face during delivery , and in the promotion of antenatal care ( ANC ) , institutional delivery and postnatal care ( PNC ) . Voucher booklets valued at Rs . 4,000 ( $ 48 ) , including three ANC visits , a PNC visit , an institutional delivery , and a postnatal family planning visit , were sold for Rs . 100 ( $ 1.2 ) to low-income women targeted by project outreach workers . Women suffering from complications were referred to emergency obstetric care services . Analysis was conducted at the bivariate and the multivariate levels . At the multivariate level , logistic regression analysis was conducted to determine whether the increase in institutional delivery was greater among poor women ( defined for this study as women in the fourth or fifth quintiles ) relative to non-poor women ( defined for this study as women in the first quintile ) in the intervention union councils compared to the control union councils . Results Bivariate analysis showed significant increases in the institutional delivery rate among women in the fourth or fifth wealth quintiles in the intervention union councils but no significant changes in this indicator among women in the same wealth quintiles in the control union councils . Multivariate analysis showed that the increase in institutional delivery among poor women relative to non-poor women was significantly greater in the intervention compared to the control union councils . Conclusions Dem and -side financing projects using vouchers can be an effective way of reducing inequities in institutional delivery",
"BACKGROUND Scaling-up of effective preventive interventions in child and maternal health is constrained in many developing countries by lack of dem and . In Latin America , some governments have been trying to increase dem and for health interventions by making direct payments to poor households contingent on them keeping up-to- date with preventive health services . We undertook a public health programme effectiveness trial in Honduras to assess this approach , contrasting it with a direct transfer of re sources to local health teams . METHODS 70 municipalities were selected because they had the country 's highest prevalence of malnutrition . They were allocated at r and om to four groups : money to households ; re sources to local health teams combined with a community-based nutrition intervention ; both packages ; and neither . Evaluation surveys of about 5600 households were undertaken at baseline and roughly 2 years later . Pregnant women and mothers of children younger than 3 years old were asked about use of health services ( primary outcome ) and coverage of interventions such as immunisation and growth monitoring ( secondary outcome ) . Reports were supplemented with data from children 's health cards and government service utilisation data . Analysis was by mixed effects regression , accounting for the municipality-level r and omisation . FINDINGS The household-level intervention had a large impact ( 15 - 20 percentage points ; p coverage of antenatal care and well-child check-ups . Childhood immunisation series could thus be started more opportunely , and the coverage of growth monitoring was markedly increased ( 15 - 21 percentage points ; p Measles and tetanus toxoid immunisation were not affected . The transfer of re sources to local health teams could not be implemented properly because of legal complications . INTERPRETATION Conditional payments to households increase the use and coverage of preventive health care interventions",
"BACKGROUND Caesarean section rates are increasing in Mexico and Latin America . This study evaluates the impact of a large-scale , conditional cash transfer programme in Mexico on caesarean section rates . The programme provides cash transfers to participating low income , rural households in Mexico conditional on accepting health care and nutrition supplements . METHODS The primary analyses uses retrospective reports from 979 women in poor rural communities participating in an effectiveness study and r and omly assigned to incorporation into the programme in 1998 or 1999 across seven Mexican states . Using multivariate and instrumental variable analyses , we estimate the impact of the programme on caesarean sections and predict the adjusted mean rates by clinical setting . Programme participation is measured by beneficiary status , programme months and cash transfers . RESULTS More than two-thirds of poor rural women delivered in a health facility . Beneficiary status is associated with a 5.1 percentage point increase in caesarean rates ; this impact increases to 7.5 percentage points for beneficiaries enrolled in the programme for > or=6 months before delivery . Beneficiaries had significantly higher caesarean delivery rates in social security facilities ( 24.0 compared with 5.6 % among non-beneficiaries ) and in other government facilities ( 19.3 compared with 9.5 % ) . CONCLUSION The Oportunidades conditional cash transfer programme is associated with higher caesarean section rates in social security and government health facilities . This effect appears to be driven by the increases in disposable income from the cash transfer . These findings are relevant to other countries implementing conditional cash transfer programmes and health care requirements",
"BACKGROUND Conditional Cash Transfer ( CCT ) schemes have shown largely favorable changes in the health seeking behavior . This evaluation study assesses the process and performance of an Additional Cash Incentive ( ACI ) scheme within an ongoing CCT scheme in India , and document lessons . MATERIAL AND METHODS A controlled before and during design study was conducted in Madhya Pradesh state of India , from August 2007 to March 2008 , with increased in institutional deliveries as a primary outcome . In depth interviews , focus group discussion s and household surveys were done for data collection . RESULTS Lack of awareness about ACI scheme amongst general population and beneficiaries , cumbersome cash disbursement procedure , intricate eligibility criteria , extensive paper work , and insufficient focus on community involvement were the major implementation challenges . There were anecdotal reports of political interference and possible scope for corruption . At the end of implementation period , overall rate of institutional deliveries had increased in both target and control population s ; however , the differences were not statistically significant . No cause and effect association could be proven by this study . CONCLUSIONS Poor planning and coordination , and lack of public awareness about the scheme result ed in low utilization . Thus , proper IEC and training , detailed implementation plan , orientation training for implementer , sufficient budgetary allocation , and community participation should be an integral part for successful implementation of any such scheme . The lesson learned this evaluation study may be useful in any developing country setting and may be utilized for planning and implementation of any ACI scheme in future",
"Substantial healthcare expenses can impoverish households or push them further into poverty . In this paper , we examine the cost of obstetric care and the social and economic consequences associated with exposure to economic shocks up to a year following the end of pregnancy in Burkina Faso . Burkina Faso is a low-income country with poor health outcomes and a poorly functioning health system . We present an inter-disciplinary analysis of an ethnographic study of 82 women nested in a prospect i ve cohort study of 1013 women . We compare the experiences of women who survived life-threatening obstetric complications ( ' near-miss ' events ) with women who delivered without complications in hospitals . The cost of emergency obstetric care was significantly higher than the cost of care for uncomplicated delivery . Compared with women who had uncomplicated deliveries , women who survived near-miss events experienced substantial difficulties meeting the costs of care , reflecting the high cost of emergency obstetric care and the low socioeconomic status of their households . They reported more frequent sale of assets , borrowing and slower repayment of debt in the year following the expenditure . Healthcare costs consumed a large part of households ' re sources and women who survived near-miss events continued to spend significantly more on healthcare in the year following the event , while at the same time experiencing continued cost barriers to accessing healthcare . In-depth interviews confirm that the economic burden of emergency obstetric care contributed to severe and long-lasting consequences for women and their households . The necessity of meeting unexpectedly high costs challenged social expectations and patterns of reciprocity between husb and s , wives and wider social networks , placed enormous strain on everyday survival and shaped physical , social and economic well-being in the year that followed the event . In conclusion , we consider the implication s of our findings for financing mechanisms for maternity care in low-income setting"
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Background Potential cardiovascular ( CV ) risks of testosterone replacement therapy ( TRT ) are currently a topic of intense interest . However , no studies have addressed CV risk as a function of the route of administration of TRT . Methods Two meta-analyses were conducted , one of CV adverse events ( AEs ) in 35 r and omized controlled trials ( RCTs ) of TRT lasting 12 weeks or more , and one of 32 studies reporting the effect of TRT on serum testosterone and dihydrotestosterone ( DHT ) . Results CV risks of TRT : Of 2,313 studies identified , 35 were eligible and included 3,703 mostly older men who experienced 218 CV-related AEs . No significant risk for CV AEs was present when all TRT administration routes were grouped ( relative risk ( RR ) = 1.28 , 95 % confidence interval ( CI ) : 0.76 to 2.13 , P = 0.34 ) . When analyzed separately , oral TRT produced significant CV risk ( RR = 2.20 , 95 % CI : 1.45 to 3.55 , P = 0.015 ) , while neither intramuscular ( RR = 0.66 , 95 % CI : 0.28 to 1.56 , P = 0.32 ) nor transdermal ( gel or patch ) TRT ( RR = 1.27 , 95 % CI : 0.62 to 2.62 , P = 0.48 ) significantly altered CV risk . Serum testosterone/DHT following TRT : Of 419 studies identified , 32 were eligible which included 1,152 men receiving TRT . No significant difference in the elevation of serum testosterone was present between intramuscular or transdermal TRT . However , transdermal TRT elevated serum DHT ( 5.46-fold , 95 % CI : 4.51 to 6.60 ) to a greater magnitude than intramuscular TRT ( 2.20-fold , 95 % CI : 1.74 to 2.77 ) . Conclusions Oral TRT produces significant CV risk . While no significant effects on CV risk were observed with either injected or transdermal TRT , the point estimates suggest that further research is needed to establish whether administration by these routes is protective or detrimental , respectively . Differences in the degree to which serum DHT is elevated may underlie the varying CV risk by TRT administration route , as elevated serum dihydrotestosterone has been shown to be associated with CV risk in observational studies
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"CONTEXT Steroid 5α-reductase inhibitors are used to treat benign prostatic hyperplasia and and rogenic alopecia , but the role of 5α-dihydrotestosterone ( DHT ) in mediating testosterone 's effects on muscle , sexual function , erythropoiesis , and other and rogen-dependent processes remains poorly understood . OBJECTIVE To determine whether testosterone 's effects on muscle mass , strength , sexual function , hematocrit level , prostate volume , sebum production , and lipid levels are attenuated when its conversion to DHT is blocked by dutasteride ( an inhibitor of 5α-reductase type 1 and 2 ) . DESIGN , SETTING , AND PATIENTS The 5α-Reductase Trial was a r and omized controlled trial of healthy men aged 18 to 50 years comparing placebo plus testosterone enthanate with dutasteride plus testosterone enanthate from May 2005 through June 2010 . INTERVENTIONS Eight treatment groups received 50 , 125 , 300 , or 600 mg/wk of testosterone enanthate for 20 weeks plus placebo ( 4 groups ) or 2.5 mg/d of dutasteride ( 4 groups ) . MAIN OUTCOME MEASURES The primary outcome was change in fat-free mass ; secondary outcomes : changes in fat mass , muscle strength , sexual function , prostate volume , sebum production , and hematocrit and lipid levels . RESULTS A total of 139 men were r and omized ; 102 completed the 20-week intervention . Men assigned to dutasteride were similar at baseline to those assigned to placebo . The mean fat-free mass gained by the dutasteride groups was 0.6 kg ( 95 % CI , -0.1 to 1.2 kg ) when receiving 50 mg/wk of testosterone enanthate , 2.6 kg ( 95 % CI , 0.9 to 4.3 kg ) for 125 mg/wk , 5.8 kg ( 95 % CI , 4.8 to 6.9 kg ) for 300 mg/wk , and 7.1 kg ( 95 % CI , 6.0 to 8.2 kg ) for 600 mg/wk . The mean fat-free mass gained by the placebo groups was 0.8 kg ( 95 % CI , -0.1 to 1.7 kg ) when receiving 50 mg/wk of testosterone enanthate , 3.5 kg ( 95 % CI , 2.1 to 4.8 kg ) for 125 mg/wk , 5.7 kg ( 95 % CI , 4.8 to 6.5 kg ) for 300 mg/wk , and 8.1 kg ( 95 % CI , 6.7 to 9.5 kg ) for 600 mg/wk . The dose-adjusted differences between the dutasteride and placebo groups for fat-free mass were not significant ( P = .18 ) . Changes in fat mass , muscle strength , sexual function , prostate volume , sebum production , and hematocrit and lipid levels did not differ between groups . CONCLUSION Changes in fat-free mass in response to grade d testosterone doses did not differ in men in whom DHT was suppressed by dutasteride from those treated with placebo , indicating that conversion of testosterone to DHT is not essential for mediating its anabolic effects on muscle . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00493987",
"Current testosterone substitution therapy either by injectable or oral testosterone esters suffers from markedly fluctuating serum testosterone levels often far above or below the physiological range . Recently , a transdermal therapeutic system ( TTS ) for the delivery of testosterone was developed which , when applied to the scrotum , provides smooth serum testosterone levels . Here we report results from seven hypogonadal men treated with the TTS for 14 months by applying a new patch every day . In all patients serum testosterone and dihydrotestosterone ( DHT ) determined 3 - 5 h after applying a new patch increased significantly and remained within the physiological range during the entire treatment period . The DHT/testosterone ratio remained constant . In 4 of these patients and 2 others under TTS treatment serum testosterone and DHT were also determined over a 24-h period at regular intervals . In these patients serum testosterone levels in the physiological range were seen during the entire observation period , whereas an increase in the DHT/testosterone ratio occurred towards the end of the one-day treatment phase . All patients in the 14-month treatment study were clinical ly well substituted and responded with good compliance . Clinical chemistry showed no abnormalities during treatment . Thus , the TTS appears to be an effective and safe new modality for the treatment of male hypogonadism ",
"Older men , particularly those with low serum testosterone ( T ) levels , might benefit from T therapy to improve bone mineral density ( BMD ) and reduce fracture risk . Concerns exist , however , about the impact of T therapy on the prostate in older men . We hypothesized that the combination of T and finasteride ( F ) , a 5 alpha-reductase inhibitor , might increase BMD in older men without adverse effects on the prostate . Seventy men aged 65 yr or older , with a serum T less than 12.1 nmol/liter on two occasions , were r and omly assigned to receive one of three regimens for 36 months : T enanthate , 200 mg i m every 2 wk with placebo pills daily ( T-only ) ; T enanthate , 200 mg every 2 wk with 5 mg F daily ( T+F ) ; or placebo injections and pills ( placebo ) . Low BMD was not an inclusion criterion . We obtained serial measurements of BMD of the lumbar spine and hip by dual x-ray absorptiometry . Prostate-specific antigen ( PSA ) and prostate size were measured at baseline and during treatment to assess the impact of therapy on the prostate . Fifty men completed the 36-month protocol . By an intent-to-treat analysis including all men for as long as they contributed data , T therapy for 36 months increased BMD in these men at the lumbar spine [ 10.2 + /- 1.4 % ( mean percentage increase from baseline + /- SEM ; T-only ) and 9.3 + /- 1.4 % ( T+F ) vs. 1.3 + /- 1.4 % for placebo ( P hip [ 2.7 + /- 0.7 % ( T-only ) and 2.2 + /- 0.7 % ( T+F ) vs. -0.2 + /- 0.7 % for placebo , ( P increases in BMD were seen also in the intertrochanteric and trochanteric regions of the hip . After 6 months of therapy , urinary deoxypyridinoline ( a bone-resorption marker ) decreased significantly compared with baseline in both the T-only and T+F groups ( P PSA increased significantly from baseline in the T-only group ( P Prostate volume increased in all groups during the 36-month treatment period , but this increase was significantly less in the T+F group compared with both the T-only and placebo groups ( P = 0.02 ) . These results demonstrate that T therapy in older men with low serum T increases vertebral and hip BMD over 36 months , both when administered alone and when combined with F. This finding suggests that dihydrotestosterone is not essential for the beneficial effects of T on BMD in men . In addition , the concomitant administration of F with T appears to attenuate the impact of T therapy on prostate size and PSA and might reduce the chance of benign prostatic hypertrophy or other prostate-related complications in older men on T therapy . These findings have important implication s for the prevention and treatment of osteoporosis in older men with low T levels",
"BACKGROUND During testosterone ( T ) therapy , T is partly converted to 17beta-estradiol ( E2 ) and 5alpha-dihydrotestosterone ( DHT ) . Effects of age , testosterone dose , and body composition on total and free E2 and DHT levels are unknown . OBJECTIVE We evaluated age and dose-related differences in E2 and DHT levels in response to grade d doses of testosterone enanthate in young and older men . METHODS Fifty-one young ( aged 19 - 35 yr ) and 52 older ( aged 59 - 75 yr ) men completed treatment with monthly injections of a GnRH agonist plus r and omly assigned weekly doses of testosterone enanthate ( 25 , 50 , 125 , 300 , or 600 mg ) for 5 months . RESULTS During testosterone administration , total and free E2 levels increased dose-dependently ( dose effect , P older men . Total and free E2 levels and E2:T ratios during T administration were higher in older than young men , but age-related differences in free E2 and free E2:T ratios were not significant after adjusting for testosterone levels , percentage fat mass , and SHBG . DHT levels and DHT : T ratios were dose-related but did not differ between young and older men . Mechanistic modeling of free hormone data revealed that the conversions of T to E2 and DHT were both consistent with saturable Michaelis-Menten kinetics . The in vivo Km values were estimated to be 1.83 nm for aromatase and 3.35 nm for 5alpha-reductase , independent of age . The Vmax parameter for E2 was 40 % higher in older men than younger men , but Vmax for DHT was not significantly different between age groups . CONCLUSIONS During i m testosterone administration , E2 and DHT levels exhibit saturable increases with dose . The rate of whole body aromatization is higher in older men , partly related to their higher percentage fat mass , SHBG , and testosterone levels",
"Background : No r and omized study exists comparing the effects of different modes of and rogen substitution on bone mineral density ( BMD ) . Methods : We performed a prospect i ve , r and omized , trial assigning 53 hypogonadal men to the following treatment groups : mesterolone 100 mg p.o . daily , testosterone undecanoate 160 mg p.o . daily , testosterone enanthate 250 mg i.m . every 21 days , or a single subcutaneous implantation of 1,200 mg crystalline testosterone . The BMD was determined by peripheral quantitative computed tomography . Results : At baseline , men with secondary hypogonadism ( n = 33 ) had a lower BMD ( –1.52 ± 0.23 SDS ; Z-scores ) than men with primary hypogonadism ( n = 20 , –0.87 ± 0.23 SDS , p the BMD increased dose dependently ( crystalline testosterone + 7.0 ± 1.3 % , testosterone enanthate + 4.8 ± 0.2 % , testosterone undecanoate + 3.4 ± 2.5 % , mesterolone + 0.8 ± 1.6 % ) after 6 months of therapy . Only secondary hypogonadal men treated with testosterone enanthate experienced an increase of the BMD . Conclusions : In primary hypogonadal men the BMD responds dose dependently to testosterone substitution , whereas in secondary hypogonadism only testosterone enanthate treatment significantly increased the BMD ",
"Background . The beneficial effects of testosterone treatment ( TT ) are debated . Methods . Double-blinded , placebo-controlled study of six months TT ( gel ) in 54 men aged 60–78 with bioavailable testosterone ( BioT ) 94 cm r and omized to TT ( 50–100 mg/day , n = 20 ) , placebo ( n = 18 ) , or strength training ( ST ) ( n = 16 ) for 24 weeks . Moreover , the ST group was r and omized to TT ( n = 7 ) or placebo ( n = 9 ) after 12 weeks . Outcomes . Chemokines ( MIF , MCP-1 , and MIP-1α ) and lean body mass ( LBM ) , total , central , extremity , visceral , and subcutaneous ( SAT ) fat mass established by DXA and MRI . Results . From 0 to 24 weeks , MIF and SAT decreased during ST + placebo versus placebo , whereas BioT and LBM were unchanged . TT decreased fat mass ( total , central , extremity , and SAT ) and increased BioT and LBM versus placebo . MIF levels increased during TT versus ST + placebo . ST + TT decreased fat mass ( total , central , and extremity ) and increased BioT and LBM versus placebo . From 12 to 24 weeks , MCP-1 levels increased during TT versus placebo and MCP-1 levels decreased during ST + placebo versus placebo . Conclusion . ST + placebo was associated with decreased MIF levels suggesting decreased inflammatory activity . TT may be associated with increased inflammatory activity . This trial is registered with Clinical Trials.gov NCT00700024",
"CONTEXT Aging in men is associated with reduced testosterone ( T ) levels and physiological changes leading to frailty , but the benefits of T supplementation are inconclusive . OBJECTIVE We studied the effects of T supplementation with and without progressive resistance training ( PRT ) on functional performance , strength , and body composition . DESIGN , SETTING , AND PARTICIPANTS We recruited 167 generally healthy community-dwelling older men ( 66 ± 5 years ) with low-normal baseline total T levels ( 200 - 350 ng/dL ) . INTERVENTION Subjects were r and omized to placebo or transdermal T gel [ 2 doses targeting either a lower ( 400 - 550 ng/dL ) or higher ( 600 - 1000 ng/dL ) T range ] and to either PRT or no exercise for 12 months . MAIN OUTCOME MEASURE The primary outcome was functional performance , whereas secondary outcomes were strength and body composition . RESULTS A total of 143 men completed the study . At 12 months , total T was 528 ± 287 ng/dL in subjects receiving any T and 287 ± 65 ng/dL in the placebo group . In the PRT group , function and strength were not different between T- and placebo-treated subjects , despite greater improvements in fat mass ( P = .04 ) and fat-free mass ( P = .01 ) with T. In the non-PRT group , T did not improve function but improved fat mass ( P = .005 ) , fat-free mass ( P = .03 ) , and upper body strength ( P = .03 ) compared with placebo . There were fewer cardiovascular events in the T-treated groups compared with placebo . CONCLUSIONS T supplementation was well tolerated and improved body composition but had no effect on functional performance . T supplementation improved upper body strength only in nonexercisers compared with placebo",
"INTRODUCTION Male hypogonadism is a significant and growing problem that can be successfully treated with testosterone replacement therapy . A new formulation of testosterone gel ( 1.62 % ) was developed with increased viscosity , reduced volume of application , and increased skin permeation compared with other currently available testosterone gels . AIM To evaluate the efficacy and safety of titrated doses of 1.62 % testosterone gel after daily application to the skin of hypogonadal men for 182 days . METHODS This was a multicenter , r and omized , double-blind , placebo-controlled study in hypogonadal men ( 234 active ; 40 placebo ) , 18 to 80 years of age with average serum total testosterone concentrations Topical testosterone gel ( 1.62 % ) , 1.25 g , 2.5 g , 3.75 g , and 5.0 g , or placebo gel was applied once daily to either upper arms/shoulders or abdomen . Dose adjustments were made on days 14 , 28 , and 42 . Main Outcome Measures . The percentage of subjects with serum total testosterone average concentrations ( C(av ) ) within the normal range of 300 - 1,000 ng/dL on study days 14 , 56 , 112 , and 182 . RESULTS Following titration , significantly ( P testosterone C(av ) values ( range 81.6 % to 82.5 % ) within the eugonadal range compared with placebo ( range 28.6 % to 37.0 % ) on all study days . The 1.62 % gel was safe and well tolerated . CONCLUSIONS In this study , treatment with 1.62 % testosterone gel was safe and efficacious , result ing in an acceptable percentage of hypogonadal males achieving eugonadal serum testosterone levels",
"Background Experimental studies suggest that and rogens induce coronary vasodilatation . We performed this pilot project to examine the clinical effects of long-term low-dose and rogens in men with angina . Methods and Results Forty-six men with stable angina completed a 2-week , single-blind placebo run-in , followed by double-blind r and omization to 5 mg testosterone daily by transdermal patch or matching placebo for 12 weeks , in addition to their current medication . Time to 1-mm ST-segment depression on treadmill exercise testing and hormone levels were measured and quality of life was assessed by SF-36 at baseline and after 4 and 12 weeks of treatment . Active treatment result ed in a 2-fold increase in and rogen levels and an increase in time to 1-mm ST-segment depression from ( mean±SEM ) 309±27 seconds at baseline to 343±26 seconds after 4 weeks and to 361±22 seconds after 12 weeks . This change was statistically significant compared with that seen in the placebo group ( from 266±25 seconds at baseline to 284±23 seconds after 4 weeks and to 292±24 seconds after 12 weeks;P = 0.02 between the 2 groups by ANCOVA ) . The magnitude of the response was greater in those with lower baseline levels of bioavailable testosterone ( r = −0.455 , P changes in prostate specific antigen , hemoglobin , lipids , or coagulation profiles during the study . There were significant improvements in pain perception ( P = 0.026 ) and role limitation result ing from physical problems ( P = 0.024 ) in the testosterone-treated group . Conclusions Low-dose supplemental testosterone treatment in men with chronic stable angina reduces exercise-induced myocardial ischemia ",
"This study prospect ively examined changes in cognition in hypogonadal men given testosterone ( T ) or older hypogonadal men given dihydrotestosterone ( DHT ) gel . A battery of cognitive tests assessing verbal and spatial memory , language , and attention was administered at baseline ( prior to medication ) and again at days 90 and 180 of treatment for men receiving T gel and at baseline and days 30 and 90 of treatment for men receiving DHT gel . For men receiving T gel , circulating total T and estradiol ( E(2 ) ) were significantly raised compared with baseline , and a significant improvement in verbal memory was observed . For men receiving DHT gel , serum DHT levels increased and T levels decreased significantly compared with baseline , and a significant improvement in spatial memory was observed . The results suggest that beneficial changes in cognition can occur in hypogonadal men using T replacement levels and DHT treatment , and these changes in cognition can be reliably measured during a relative steady-state dose level . Further , our results suggest that aromatization of T to E(2 ) may regulate verbal memory in men , whereas nonaromatizable and rogens may regulate spatial memory",
"Thirty-five male patients , aged 34 - 79 yr , with definite rheumatoid arthritis ( RA ) were recruited from out-patient clinics and r and omized to receive monthly injections of testosterone enanthate 250 mg or placebo as an adjunct therapy for 9 months . Endpoints included disease activity parameters and bone mineral density ( BMD ) . At baseline , there were negative correlations between the ESR and serum testosterone ( r = -0.42 , P BMD ( hip , r = -0.65 , P vertebral fracture , most having multiple fractures . Back pain , however , was not more prevalent in fracture patients ( 55 % vs 50 % ) . Disease activity was significantly higher in the fracture group ( joint score P Thirty patients completed the trial , 15 receiving testosterone and 15 receiving placebo . There were significant rises in serum testosterone , dihydrotestosterone and oestradiol in the treatment group . There was no significant effect of treatment on disease activity overall , five patients receiving testosterone underwent a \" flare ' . Differences in mean BMD following testosterone or placebo were non-significant ( spine : + 1.2 % vs -1.1 % ; femur : -0.3 % vs + 0.3 % ) . There was no suggestion of a positive effect of testosterone on disease activity in men with RA",
"IMPORTANCE Rates of testosterone therapy are increasing and the effects of testosterone therapy on cardiovascular outcomes and mortality are unknown . A recent r and omized clinical trial of testosterone therapy in men with a high prevalence of cardiovascular diseases was stopped prematurely due to adverse cardiovascular events raising concerns about testosterone therapy safety . OBJECTIVES To assess the association between testosterone therapy and all-cause mortality , myocardial infa rct ion ( MI ) , or stroke among male veterans and to determine whether this association is modified by underlying coronary artery disease . DESIGN , SETTING , AND PATIENTS A retrospective national cohort study of men with low testosterone levels ( coronary angiography in the Veterans Affairs ( VA ) system between 2005 and 2011 . MAIN OUTCOMES AND MEASURES Primary outcome was a composite of all-cause mortality , MI , and ischemic stroke . RESULTS Of the 8709 men with a total testosterone level lower than 300 ng/dL , 1223 patients started testosterone therapy after a median of 531 days following coronary angiography . Of the 1710 outcome events , 748 men died , 443 had MIs , and 519 had strokes . Of 7486 patients not receiving testosterone therapy , 681 died , 420 had MIs , and 486 had strokes . Among 1223 patients receiving testosterone therapy , 67 died , 23 had MIs , and 33 had strokes . At 3 years after coronary angiography , the Kaplan-Meier estimated cumulative percentages with events were 19.9%in the no testosterone therapy group vs 25.7%in the testosterone therapy group , with an absolute risk difference of 5.8%(95%CI , -1.4%to 13.1 % ) [corrected].The Kaplan-Meier estimated cumulative percentages with events among the no testosterone therapy group vs testosterone therapy group at 1 year after coronary angiography were 10.1 % vs 11.3 % ; at 2 years , 15.4 % vs 18.5 % ; and at 3 years , 19.9 % vs 25.7 [corrected].There was no significant difference in the effect size of testosterone therapy among those with and without coronary artery disease ( test for interaction , P = .41 ) . CONCLUSIONS AND RELEVANCE Among a cohort of men in the VA health care system who underwent coronary angiography and had a low serum testosterone level , the use of testosterone therapy was associated with increased risk of adverse outcomes . These findings may inform the discussion about the potential risks of testosterone therapy",
"BACKGROUND Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men . The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied . METHODS Community-dwelling men , 65 years of age or older , with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter ( 3.5 to 12.1 nmol per liter ) or a free serum testosterone level of less than 50 pg per milliliter ( 173 pmol per liter ) were r and omly assigned to receive placebo gel or testosterone gel , to be applied daily for 6 months . Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification . The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group . RESULTS A total of 209 men ( mean age , 74 years ) were enrolled at the time the trial was terminated . At baseline , there was a high prevalence of hypertension , diabetes , hyperlipidemia , and obesity among the participants . During the course of the study , the testosterone group had higher rates of cardiac , respiratory , and dermatologic events than did the placebo group . A total of 23 subjects in the testosterone group , as compared with 5 in the placebo group , had cardiovascular-related adverse events . The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period . As compared with the placebo group , the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load . CONCLUSIONS In this population of older men with limitations in mobility and a high prevalence of chronic disease , the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events . The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy . ( Clinical Trials.gov number , NCT00240981 .",
"We investigated the effects of 6 mo of near-physiological testosterone administration to older men on skeletal muscle function and muscle protein metabolism . Twelve older men ( > or = 60 yr ) with serum total testosterone concentrations were r and omly assigned in double-blind manner to receive either placebo ( n = 5 ) or testosterone enanthate ( TE ; n = 7 ) injections . Weekly intramuscular injections were given for the 1st mo to establish increased blood testosterone concentrations at 1 mo and then changed to biweekly injections until the 6-mo time point . TE doses were adjusted to maintain nadir serum testosterone concentrations between 17 and 28 nmol/l . Lean body mass ( LBM ) , muscle volume , prostate size , and urinary flow were measured at baseline and at 6 mo . Protein expression of and rogen receptor ( AR ) and insulin-like growth factor I , along with muscle strength and muscle protein metabolism , were measured at baseline and at 1 and 6 mo of treatment . Hematological parameters were followed monthly throughout the study . Older men receiving testosterone increased total and leg LBM , muscle volume , and leg and arm muscle strength after 6 mo . LBM accretion result ed from an increase in muscle protein net balance , due to a decrease in muscle protein breakdown . TE treatment increased expression of AR protein at 1 mo , but expression returned to pre-TE treatment levels by 6 mo . IGF-I protein expression increased at 1 mo and remained increased throughout TE administration . We conclude that physiological and near-physiological increases of testosterone in older men will increase muscle protein anabolism and muscle strength",
"AIMS Chronic heart failure is associated with maladaptive and prolonged neurohormonal and pro-inflammatory cytokine activation causing a metabolic shift favouring catabolism , vasodilator incapacity , and loss of skeletal muscle bulk and function . In men , and rogens are important determinants of anabolic function and physical strength and also possess anti-inflammatory and vasodilatory properties . METHODS AND RESULTS We conducted a r and omized , double-blind , placebo-controlled parallel trial of testosterone replacement therapy ( 5 mg And roderm ) at physiological doses in 76 men ( mean+/-SD , age 64+/-9.9 ) with heart failure ( ejection fraction 32.5+/-11 % ) over a maximum follow-up period of 12 months . The primary endpoint was functional capacity as assessed by the incremental shuttle walk test ( ISWT ) . At baseline , 18 ( 24 % ) had serum testosterone below the normal range and bioavailable testosterone correlated with distance walked on the initial ISWT ( r=0.3 , P=0.01 ) . Exercise capacity significantly improved with testosterone therapy compared with placebo over the full study period ( mean change + 25+/-15 m ) corresponding to a 15+/-11 % improvement from baseline ( P=0.006 ANOVA ) . Symptoms improved by at least one functional class on testosterone in 13 ( 35 % ) vs. 3 ( 8 % ) on placebo ( P=0.01 ) . No significant changes were found in h and grip strength , skeletal muscle bulk by cross-sectional computed tomography , or in tumour necrosis factor levels . Testosterone therapy was safe with no excess of adverse events although the patch preparation was not well tolerated by the study patients . CONCLUSION Testosterone replacement therapy improves functional capacity and symptoms in men with moderately severe heart failure",
"Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists",
"Currently available testosterone ( T ) injections in the United States are administered at 2 - 3 weekly intervals . Less frequent injections with favorable serum T pharmacokinetics would benefit hypogonadal men . The objective of this study is to assess the pharmacokinetics of long-acting testosterone undecanoate ( TU ) intramuscular ( IM ) injection in hypogonadal men . An unblinded , multicenter phase 3 clinical trial was conducted in 31 academic centers and contract research organizations . Males ( 130 ) more than 18 years of age with serum total T and received 750-mg injections of TU at weeks 0 and 4 and every 10 weeks thereafter for 9 injections over 84 weeks . The main outcome variables were serum total T , free T , dihydrotestosterone ( DHT ) , estradiol ( E(2 ) ) levels , and safety parameters . After the first injection , patients maintained average trough T concentrations in the adult male range ( 300 - 1000 ng/dL or 10.4 - 34.7 nmol/L ) before each injection and at multiple time points measured after the third and fourth injections . Serum free T , DHT , and E(2 ) levels and their ratios to serum T remained relatively consistent once steady state was attained . TU injections were generally well tolerated , with safety profiles similar to other T replacement . We conclude that hypogonadal patients treated for 84 weeks with a 750-mg IM injection of TU every 10 weeks demonstrated average concentrations of T , its metabolites ( DHT and E(2 ) ) , and ratios -- DHT : T and E(2):T -- within the adult male reference range at all time points measured . TU injections would be an acceptable alternative to the currently available 2 - 3 weekly injectables",
"Objectives Testosterone replacement therapy in hypogonadal men relieves symptoms and restores serum testosterone levels to the physiological range . In this study , we assessed the safety , pharmacokinetics , and efficacy of the 2 % formulation of testosterone topical solution applied daily to the axillae",
"Clinical studies suggest there may be a threshold concentration of serum testosterone below which replacement will result in skeletal and psychological benefit . We evaluated the response to testosterone in men with borderline hypogonadism . A r and omized double-blind placebo-controlled trial in 39 men over age 40 years presenting with sexual dysfunction and a borderline low testosterone level ( total testosterone Patients were r and omized to Testoderm TTS body patch ( 5 mg/day , n = 20 ) or a placebo patch ( n = 19 ) for 6 months , followed by open-label testosterone replacement for a further 6 months in all patients . During the placebo-controlled phase of the study serum testosterone increased significantly on testosterone vs. placebo treatment ( p = 0.004 ) ; this was associated with a decrease in total body fat mass ( p = 0.019 ) and increase in haemoglobin level ( p = 0.036 ) . There were no significant changes in lean body mass , markers of bone turnover , and measures of bone mineral density ( BMD ) . There was evidence of difference in quality of life according to the Male Erectile Dysfunction Quality of Life question naire ( MEDQoL score , p = 0.017 ) , mainly accounted for by deterioration in the placebo arm . When the active treatment period was combined for placebo and testosterone groups , the within-patient analysis showed a significant effect of testosterone to decrease markers of bone resorption ( uNTX/Cr , p = 0.007 ; iFDPD/Cr , p = 0.0006 ) and to increase lean body mass ( p = 0.001 ) . There was little convincing evidence from this study that testosterone replacement is likely to have major benefit in men over age 40 years with borderline hypogonadism and sexual dysfunction . However , there was evidence of suppression in bone resorption and hence longer and larger studies are needed to examine its effect on BMD",
"BACKGROUND The role of sex hormones in the prevention of cognitive decline is uncertain . Animal studies suggest mechanisms for sex hormones including testosterone to maintain optimal cognitive function . But , there are studies to suggest that endogenous testosterone levels are associated with aggression in men with cognitive impairment . METHODS In this pilot study , 11 men ( mean age 80 + /- 5 years , range 73 - 87 years ) with early cognitive decline and bioavailable testosterone levels below 128 ng/dl ( lower limit for adult normal range ) were r and omized to receive intramuscular testosterone ( 200 mg every 3 weeks ) or placebo for 12 weeks . Outcome measures included sex hormones ( testosterone , bioavailable testosterone , sex hormone binding globulin , estradiol , and estrone ) , Behave AD Question naire , Katz Activities of Daily Living , Geriatric Depression Scale , Digit Span , Clock Face Drawing , Clock Face Perception , Verbal Fluency , Trail-Making B , and International Prostate Symptom Score at baseline , 4 weeks , and 10 weeks . RESULTS All men completed the study . Total and bioavailable testosterone , estrone , and estradiol levels increased in men receiving testosterone , but no changes were detected in men receiving placebo . No significant changes were found in behavior following testosterone supplementation , nor was there evidence of change in depression or activities of daily living . No discernable changes were found in any of the cognitive tests . Symptoms of prostate hyperplasia remained unchanged in the testosterone ( 6.6 + 5.8 to 5.2 + 3.6 ; p = .39 ) and placebo ( 8.8 + 6.4 to 6.4 + 3.8 ; p = .15 ) groups , and prostate-specific antigen levels did not change significantly . CONCLUSION No significant changes in behavior , function , depression , or cognitive performance occurred following 12 weeks of testosterone replacement in men with low testosterone levels and early-to-moderate cognitive impairment . This pilot work suggests that testosterone can be given to men with early cognitive impairment without significant concern about worsening aggressive or unwanted behaviors",
"Testosterone undecanoate ( TU ) or placebo was administered orally ( for 12 weeks ) in a double blind study , to 19 patients with chronic renal insufficiency on hemodialysis in a daily dose of 240 mg . Effect on plasma testosterone ( T ) , dihydrotestosterone ( DHT ) , and rostenedione ( A ) , 110H and rostenedione ( 110A ) , FSH , LH and PRL concentration and the pituitary responsiveness to LH-RH/TRH stimulation was studied . These hormone levels were determined before the study and after 6 and 12 weeks of treatment . There was a rise in plasma and rogen concentration in all treated patients . Mean plasma DHT , A and 110A increased at 12 weeks from 0.3 , 0.85 and 1.13 ng/ml to 1.13 ( p less than 0.05 ) , 1.4 ( p less than 0.05 ) and 1.44 ( p less than 0.05 ) respectively . There was no change in plasma T or free testosterone . However , basal LH , FSH fell progressively from 5.51 and 5.51 ng/ml to 2.13 and 1.84 ng/ml ( p less than 0.05 ) . The level of significance of these changes was confirmed when the response to LH-RH was considered . Basal plasma PRL also decreased from 376 microU/nl to 306 ( p less than 0.05 ) , but PRL response to TRH remained unchanged . In contrast , none of these modifications were observed in placebo-treated patients . We conclude that oral TU restored to normal the pituitary-testicular axis . This form of treatment should be preferentially chosen instead of intramuscular injections in these frequently heparinized patients on hemodialysis",
"BACKGROUND Hypogonadism and anemia are common comorbid conditions in dialysis patients . Testosterone replacement may improve such clinical parameters as anemia , sarcopenia , and low libido . Additionally , by increasing hemoglobin levels , testosterone replacement may allow for a dose reduction in recombinant human erythropoietin ( rHuEPO ) , thereby reducing cost . METHODS This phase IV , single-center , placebo-controlled , double-blind study assessed the effect of transdermal testosterone on serum testosterone levels , rHuEPO dose required to maintain hemoglobin level , bone mineral content , lean body mass and fat content , cholesterol level , sexual function , and mood . Forty hypogonadal male hemodialysis patients who were administered rHuEPO were r and omly assigned to 100 mg of topical 1 % testosterone gel ( Testim ; Auxilium Pharmaceuticals , Norristown , PA ) or placebo , applied daily for 6 months . RESULTS Forty men with a mean age of 56 years and baseline serum testosterone level less than 300 ng/dL ( In men assigned to administration of transdermal testosterone , there was an increase beyond that in the placebo group in mean serum testosterone ( 77.1 ng/dL [ 2.7 nmol/L ] ) , dihydrotestosterone ( DHT ; 0.8 nmol/L ) , and estradiol levels ( 6.3 pg/mL [ 23.0 pmol/L ] ) and a decrease in mean serum luteinizing hormone levels ( -3.1 IU/L ) . Compared with subjects administered placebo , participants on testosterone replacement therapy did not show an appreciable change in rHuEPO dose ( mean difference adjusted for baseline values , 12.6 U/kg/wk ; P = 0.73 ) , bone mineral density , lean body mass or fat content , cholesterol level , sexual function , or mood . CONCLUSION Daily administration of 100 mg of topical 1 % testosterone gel for 6 months failed to significantly increase serum testosterone or DHT levels in hypogonadal men with end-stage renal disease . Treatment with transdermal testosterone did not impact on rHuEPO requirement or clinical parameters in this small placebo-controlled study . Greater serum testosterone levels may be required to show clinical benefit in men with end-stage renal disease",
"A decline in testicular function is recognized as a common occurrence in older men . However data are sparse regarding the effects of hypogonadism on age-associated physical and cognitive declines . This study was undertaken to examine the year-long effects of testosterone administration in this patient population . Fifteen hypogonadal men ( mean age 68 + /- 6 yr ) were r and omly assigned to receive a placebo , and 17 hypogonadal men ( mean age 65 + /- 7 yr ) were r and omly assigned to receive testosterone . Hypogonadism was defined as a bioavailable testosterone placebo or 200 mg testosterone cypionate biweekly for 12 months . The main outcomes measured included grip strength , hemoglobin , prostate-specific antigen , leptin , and memory . Testosterone improved bilateral grip strength ( P hemoglobin ( P testosterone had greater decreases in leptin than those assigned to the control group ( mean + /- SEM : -2.0 + /- 0.9 ng/dL vs. 0.8 + /- 0.7 ng/dL ; P prostate-specific antigen or memory . Three subjects receiving placebo and seven subjects receiving testosterone withdrew from the study . Three of those seven withdrew because of an abnormal elevation in hematocrit . Testosterone supplementation improved strength , increased hemoglobin , and lowered leptin levels in older hypogonadal men . Testosterone may have a role in the treatment of frailty in males with hypogonadism ; however , older men receiving testosterone must be carefully monitored because of its potential risks",
"INTRODUCTION Testosterone ( T ) administration to men increases T , estradiol ( E2 ) , dihydrotestosterone ( DHT ) , and fat-free mass ( FFM ) , and decreases fat mass ( FM ) but does not consistently improve insulin sensitivity ( IS ) . AIM The aim of this study was to examine the effects of T administration in obese , nondiabetic men on body composition and IS , and to determine if inhibition ( i ) of metabolism of T to E2 with anastrazole or to DHT with dutasteride alters these effects . METHODS This was a 98-day r and omized , double-blind , parallel group , placebo-controlled trial of 57 men , 24 - 51 year , free T in the lower 25 % of normal range ( Subjects were r and omized to one of four groups : ( i ) placebo : gel , pills , and injection ; ( ii ) T/DHT/iE2 : T gel , anastrazole , and acyline ( gonadotropin releasing-hormone antagonist to suppress endogenous T ) ; ( iii ) T/iDHT/E2 : T gel , dutasteride , and acyline ; ( iv ) T/DHT/E2 : T gel , placebo pills , and acyline . MAIN OUTCOME MEASURES Main outcome measures are insulin sensitivity as percent change ( % Δ ) in glucose disposal rates ( GDR ) from a two-step euglycemic clamp ( GDR1 and 2 ) , and % FM and % FFM by dual X-ray absorptiometry scan . RESULTS Insulin Sensitivity : % Δ GDR1 differed across groups ( P = 0.02 , anova ) and was significantly higher in the dutasteride ( T/iDHT/E2 ) compared with the placebo and T gel ( T/DHT/E2 ) groups . % ΔGDR2 was higher in the dutasteride ( T/iDHT/E2 ) compared with the anastrazole ( T/DHT/iE2 ) group . Body Composition : T gel alone ( T/DHT/E2 ) or with dutasteride ( T/iDHT/E2 ) significantly increased % FFM ( P 0.05 ) and decreased % FM ( P in % FFM or % FM after placebo or anastrazole ( T/DHT/iE2 ) . CONCLUSIONS The combination of T plus dutasteride improved body composition and IS while T alone improved body composition but not IS , suggesting that when T is administered to men , reduction to DHT attenuates the beneficial effects of aromatization to E2 on IS but not body composition ",
"OBJECTIVES To study long-term efficacy and safety of a testosterone-in-adhesive matrix patch , delivering 4.8 mg of testosterone daily . METHODS R and omized , open label , multicenter 1-year study . 224 hypogonadal patients were included . 188 received 2 patches of 60 cm2 every 48 h and 36 patients had IM testosterone enanthate injection every 3 weeks . T , bioavailable T ( BT ) , DHT , E2 , LH , FSH and SHBG and clinical symptom scores ( AMS and MSF-4 ) were assessed at 3 , 6 and 12 months . RESULTS In the patch group , T serum levels were above 3 ng/mL in 85 % of patients and remained stable over time . BT , DHT and E2 levels were restored within physiological range . BT/T ratio varied from 20 to 70 % . In the IM group , the percentages of \" normalized \" patients appeared to be lower , although the two groups can not be adequately compared due to the kinetic profile of T following IM administration , result ing in greater variations of serum T levels , blood samplings occurring r and omly at time of peak , trough , or in between . A significant correlation was found between T , BT and the MSF-4 changes . BT levels were significantly related to total AMS score . PSA values showed a mean ( S.D. ) increase of 0.13 ( 0.38 ) , 0.23 ( 0.79 ) and 0.30 (1.47)ng/mL at weeks 14 , 27 and 53 , respectively . The patch was well tolerated with no negative impact either on lipid profile , or red blood cells . Administration site reactions occurred in 35 patients ( 18.8 % ) . Adhesiveness was good ( > or=75 % ) in > 90 % patients over the 1 year application period . CONCLUSION Two 60 cm2 patches , allowed constant physiological levels of sexual hormones over time . This new patch was well tolerated , easy to use , well accepted by the patients and displayed a very good adhesiveness . Clinical efficacy was more related to BT than to",
"The study was performed to measure the impact of testosterone ( T ) administration on circulating levels of 5α‐dihydrotestosterone ( DHT ) . Group 1 ( 32 men ; mean age 61 years ; mean T 6.9 ± 1.9 nmol l−1 ) were treated for 15 months with long‐acting T undecanoate . Group 2 ( 23 men , mean age 60 years , mean T 7.6 ± 2.0 nmol l−1 ) were treated for 9 months with T gel . Plasma T and DHT were measured before and after 9 months T administration . In the men treated with T undecanoate plasma T and DHT were also measured after 12 and 15 months . Before T administration , plasma DHT ranged from 0.39 to 1.76 nmol l−1 ( 0.30–1.90 nmol l−1 ) . Mean DHT declined upon T administration from 0.95 ± 0.50 to 0.55 ± 0.30 nmol l−1 ( P 21 values of DHT > 0.60 nmol l−1 had fallen from 1.29 ± 0.50 to 0.70 ± 0.60 nmol l−1 ( P cohort of elderly men with subnormal plasma T levels plasma DHT levels declined upon T administration when they were in the higher range of normal ( > 0.6 nmol l−1 ) , with a profound shift of DHT/T ratios presumed to be an indicator of a reduced 5α‐reductase activity . Below plasma DHT levels of 0.6 nmol l−1 , responses of plasma DHT to T administration varied",
"PURPOSE Benign prostatic hyperplasia and hypogonadism are common disorders in aging men . There is concern that and rogen replacement in older men may increase prostate size and symptoms of benign prostatic hyperplasia . We examined whether combining dutasteride , which inhibits testosterone to dihydrotestosterone conversion , with testosterone treatment in older hypogonadal men with benign prostatic hyperplasia reduces and rogenic stimulation of the prostate compared to testosterone alone . MATERIAL S AND METHODS We conducted a double-blind , placebo controlled trial of 53 men 51 to 82 years old with symptomatic benign prostatic hyperplasia , prostate volume 30 cc or greater and serum total testosterone less than 280 ng/dl ( less than 9.7 nmol/l ) . Subjects were r and omized to daily transdermal 1 % T gel plus oral placebo or dutasteride for 6 months . Testosterone dosing was adjusted to a serum testosterone of 500 to 1,000 ng/dl . The primary outcomes were prostate volume measured by magnetic resonance imaging , serum prostate specific antigen and and rogen levels . RESULTS A total of 46 subjects completed all procedures . Serum testosterone increased similarly into the mid-normal range in both groups . Serum dihydrotestosterone increased in the testosterone only but decreased in the testosterone plus dutasteride group . In the testosterone plus dutasteride group prostate volume and prostate specific antigen ( mean ± SEM ) decreased 12 % ± 2.5 % and 35 % ± 5 % , respectively , compared to the testosterone only group in which prostate volume and prostate specific antigen increased 7.5 % ± 3.3 % and 19 % ± 7 % ( p = 0.03 and p = 0.008 ) , respectively , after 6 months of treatment . Prostate symptom scores improved in both groups . CONCLUSIONS Combined treatment with testosterone plus dutasteride reduces prostate volume and prostate specific antigen compared to testosterone only . Coadministration of a 5α-reductase inhibitor with testosterone appears to spare the prostate from and rogenic stimulation during testosterone replacement in older , hypogonadal men with symptomatic benign prostatic hyperplasia",
"An important aim in treating male hypogonadism is restoration of physiological concentrations of testosterone and its metabolites . We have assessed hormone levels , pharmacokinetics and clinical response , including safety , of a permeation‐enhanced testosterone transdermal system ( TTD ) in the treatment of hypogonadal men for a 12‐month period",
"CONTEXT Low testosterone levels in men have been associated with increased mortality . However , the influence of testosterone treatment on mortality in men with low testosterone levels is not known . OBJECTIVE The objective of the study was to examine the association between testosterone treatment and mortality in men with low testosterone levels . DESIGN This was an observational study of mortality in testosterone-treated compared with untreated men , assessed with time-varying , adjusted Cox proportional hazards regression models . Effect modification by age , diabetes , and coronary heart disease was tested a priori . SETTING The study was conducted with a clinical data base that included seven Northwest Veterans Affairs medical centers . PATIENTS Patients included a cohort of 1031 male veterans , aged older than 40 yr , with low total testosterone [ ≤250 ng/dl ( 8.7 nmol/liter ) ] and no history of prostate cancer , assessed between January 2001 and December 2002 and followed up through the end of 2005 . MAIN OUTCOME MEASURE Total mortality in testosterone-treated compared with untreated men was measured . RESULTS Testosterone treatment was initiated in 398 men ( 39 % ) during routine clinical care . The mortality in testosterone-treated men was 10.3 % compared with 20.7 % in untreated men ( P a mortality rate of 3.4 deaths per 100 person-years for testosterone-treated men and 5.7 deaths per 100 person-years in men not treated with testosterone . After multivariable adjustment including age , body mass index , testosterone level , medical morbidity , diabetes , and coronary heart disease , testosterone treatment was associated with decreased risk of death ( hazard ratio 0.61 ; 95 % confidence interval 0.42 - 0.88 ; P = 0.008 ) . No significant effect modification was found by age , diabetes , or coronary heart disease . CONCLUSIONS In an observational cohort of men with low testosterone levels , testosterone treatment was associated with decreased mortality compared with no testosterone treatment . These results should be interpreted cautiously because residual confounding may still be a source of bias . Large , r and omized clinical trials are needed to better characterize the health effects of testosterone treatment in older men with low testosterone levels",
"CONTEXT Physical frailty is associated with reduced muscle strength , impaired physical function , and quality of life . Testosterone ( T ) increases muscle mass and strength in hypogonadal patients . It is unclear whether T has similar effects in intermediate-frail and frail elderly men with low to borderline-low T. OBJECTIVE Our objective was to determine the effects of 6 months T treatment in intermediate-frail and frail elderly men , on muscle mass and strength , physical function , and quality of life . DESIGN AND SETTING We conducted a r and omized , double-blind , placebo-controlled , parallel-group , single-center study . PARTICIPANTS PARTICIPANTS were community-dwelling intermediate-frail and frail elderly men at least 65 yr of age with a total T at or below 12 nmol/liter or free T at or below 250 pmol/liter . METHODS Two hundred seventy-four participants were r and omized to transdermal T ( 50 mg/d ) or placebo gel for 6 months . Outcome measures included muscle strength , lean and fat mass , physical function , and self-reported quality of life . RESULTS Isometric knee extension peak torque improved in the T group ( vs. placebo at 6 months ) , adjusted difference was 8.6 ( 95 % confidence interval , 1.3 - 16.0 ; P = 0.02 ) Newton-meters . Lean body mass increased and fat mass decreased significantly in the T group by 1.08 + /- 1.8 and 0.9 + /- 1.6 kg , respectively . Physical function improved among older and frailer men . Somatic and sexual symptom scores decreased with T treatment ; adjusted difference was -1.2 ( -2.4 to -0.04 ) and -1.3 ( -2.5 to -0.2 ) , respectively . CONCLUSIONS T treatment in intermediate-frail and frail elderly men with low to borderline-low T for 6 months may prevent age-associated loss of lower limb muscle strength and improve body composition , quality of life , and physical function . Further investigations are warranted to extend these results",
"Testosterone ( T ) in a hydroalcoholic gel has been developed as an effective and convenient open system for transdermal delivery of the hormone to men . Because the gel can be applied either to small or large areas of skin , it was important to assess whether the skin surface area on which the gel was applied was an important determinant of serum T levels . To answer this question , the pharmacokinetics of a transdermal 1 % hydroalcoholic gel preparation of T was studied in nine hypogonadal men . The subjects applied in r and om order a 25-mg metered dose of T gel either four times at one site ( left arm/shoulder ) or at four different sites ( left and right arms/shoulders and left and right abdomen ) once daily ( 6 - 8 min ) for 7 consecutive days . After 7 days of washout , each subject was then crossed over to the opposite regimen for another 7 days of treatment . Serum sample s were collected for measurements of T , 5alpha dihydrotestosterone ( DHT ) , and estradiol before , during ( days 1 , 2 , 3 , 5 , and 7 ) , and after ( days 8 , 9 , 11 , 13 , and 15 ) application of T gel . Multiple blood sample s were drawn on the 1st and 7th day after gel application ; single sample s were obtained just before the next T gel application on other days ( 24 h after the previous gel application ) . The T gel dried in less than 5 min , left no residue , and produced no skin irritation in any of the subjects . Mean serum T levels , irrespective of application at one site or four sites followed the same pattern : rising to 2- to 3- and 4- to 5-fold above baseline at 0.5 and 24 h after first application , respectively . Thereafter , serum T levels reached steady state and remained at 4- to 5-fold above baseline ( at the upper limit of the normal adult range ) for the duration of gel application and returned to baseline within 4 days after stopping application . The application of T gel at four sites ( application skin area approximately four times that of one site ) result ed in a mean area under the curve ( AUC0 - 24h ) for serum T levels on the 7th day ( 868 + /- 72 nmol*h/L , mean + /- SEM ) , which was 23 % higher but not significantly different ( P = 0.06 ) than repeated application at one site ( 706 + /- 59 nmol*h/L ) . This could be due to the limited number of subjects studied ( n = 9 ) . Mean serum DHT levels followed the same pattern as serum T , achieving steady-state levels by 2 days . The mean concentration of serum DHT on the 7th day was significantly higher after application at four sites ( 9.15 + /- 1.26 nmol/L , P serum DHT levels were at or above the normal adult male range . Serum DHT : T ratio was not significantly altered by T gel application . Serum estradiol levels followed the same pattern as serum T and showed no significant difference between the one- or four-site application . We conclude that transdermal daily application of 100 mg T gel result ed in similar steady levels of serum T. The surface area of the skin to which the gel was applied had only a modest impact on serum T and DHT levels . Mean serum levels of T and DHT was higher by 23 % and 33 % , respectively , despite application of the gel to four times the skin area in the four sites compared with the one site group . Because of the greater dosage flexibility provided , hydroalcoholic T gel application over multiple sites seems to be an effective and nonskin-irritating method of transdermal T delivery for hypogonadal men . Dose-ranging studies are required to determine dosage regimens for T gel application as a replacement therapy in hypogonadal men",
"PURPOSE Because the effects of and rogen replacement on lipoprotein levels are uncertain , we sought to determine the effect of transdermal testosterone treatment on serum lipid and apolipoprotein levels in elderly men . SUBJECTS AND METHODS One hundred and eight healthy men more than 65 years of age who had serum testosterone concentrations > 1 SD below the mean for young men were r and omly assigned to receive either testosterone ( 54 men ; 6 mg/day ) or placebo ( 54 men ) transdermally in a double-blind fashion for 36 months . Serum concentrations of lipids and apolipoproteins were measured , and cardiovascular events recorded . RESULTS Serum total cholesterol concentrations decreased in both the testosterone-treated men and placebo-treated men , but the 3-year mean ( + /- SD ) decreases in the two groups ( testosterone treated , -17 + /- 29 mg/dL ; placebo treated , -12 + /- 38 mg/dL ) were not significantly different from each other ( P = 0.4 ) . Similarly , serum low-density lipoprotein ( LDL ) cholesterol levels decreased in both treatment groups , but the decreases in the two groups ( testosterone treated , -16 + /- 24 mg/dL ; placebo treated , -16 + /- 33 mg/dL ) were similar ( P = 1.0 ) . Levels of high-density lipoprotein ( HDL ) cholesterol , triglycerides , and apolipoproteins A-I and B did not change . Lipoprotein(a ) levels increased in both groups by similar amounts ( testosterone treated , 3 + /- 9 mg/dL ; placebo treated , 4 + /- 6 mg/dL ; P = 1.0 ) . The number of cardiovascular events was small and did not differ significantly between the testosterone-treated men ( 9 events ) and the placebo-treated men ( 5 events ) during the 3-year study ( relative risk = 1.8 ; 95 % confidence interval : 0.7 to 5.0 ) . CONCLUSIONS As compared with placebo , transdermal testosterone treatment of healthy elderly men for 3 years did not affect any of the lipid or apolipoprotein parameters that we measured . The effect of testosterone treatment on cardiovascular events was unclear , because the number of events was small",
"A r and omized , double-blind , placebo-controlled trial was conducted to ( 1 ) evaluate efficacy and safety of transdermal testosterone gel ( And roGel ) for hypogonadal men in Taiwan , and ( 2 ) observe improvements in sexual function through international index of erectile function ( IIEF ) scores . Eligible hypogonadal men were r and omized to receive 50 mg/day transdermal testosterone gel ( TTG ) or placebo for 3 months . Primary end point was change from baseline in total testosterone ( TT ) and free testosterone ( FT ) . Secondary end points were change from baseline in serum hormone levels ( such as dihydrotestosterone ( DHT ) , estradiol ( E2 ) , luteinizing hormone ( LH ) , follicle-stimulating hormone ( FSH ) and sex-hormone-binding globulin ( SHBG ) ) and changes in IIEF scores . Safety evaluations included adverse events ( AEs ) and skin irritation assessment . Compared with baseline , the TTG group ( n=20 ) had statistically significant increases in mean TT levels at month 1 ( P=0.024 ) and month 2 ( P=0.025 ) , but no significant changes at month 3 . TT levels in the placebo group ( n=18 ) showed no statistically significant change at any visit . Changes in FT levels paralleled changes in TT levels in both groups . TTG group IIEF scores were significantly increased at month 3 ( P=0.01 ) , compared with a decline in placebo scores . No drug-related AEs occurred in the TTG group ; the placebo group had 2 AEs ( mild skin rash ) . In conclusion , TTG effectively restores serum TT and FT levels to a normal physiological range for hypogonadal men in Taiwan and improves sexual function ",
"A double-blind , placebo-controlled multicenter trial was conducted to determine the efficacy of oral testosterone treatment ( 200 mg three times daily ) in men with alcoholic cirrhosis . By skewed r and omization ( 3:2 ) , 134 patients received testosterone and 87 placebo . Patients were followed from 8 to 62 months ( median = 28 months ) . In the testosterone group , 33 patients died ( 25 % ; 95 % confidence limits = 18 to 33 % ) as compared to 18 ( 21 % ; 95 % confidence limits = 13 to 31 % ) in the placebo group . Taking age and significant prognostic variables into consideration , this corresponds with a relative mortality risk of 1.17 ( 95 % confidence limits = 0.65 to 2.15 ) in the testosterone group vs. the placebo group . Testosterone treatment did not significantly affect liver biochemistry , prevalence of complications to cirrhosis or causes of death . Patients treated with testosterone developed significantly ( p less than 0.05 ) higher serum testosterone and blood hemoglobin concentrations and significantly ( p less than 0.05 ) lower plasma IgM concentrations as compared to the placebo group . The prevalence of gynecomastia decreased significantly ( p less than 0.05 ) in the testosterone group as compared to the placebo group . We conclude that oral testosterone treatment has no beneficial effect on survival and liver biochemistry in men with alcoholic cirrhosis , and adverse effects can not be excluded",
"Transdermal delivery of testosterone ( T ) represents an effective alternative to injectable and rogens . Transdermal T patches normalize serum T levels and reverse the symptoms of and rogen deficiency in hypogonadal men . However , the acceptance of the closed system T patches has been limited by skin irritation and /or lack of adherence . T gels have been proposed as delivery modes that minimize these problems . In this study we examined the pharmacokinetic profiles after 1 , 30 , 90 , and 180 days of daily application of 2 doses of T gel ( 50 and 100 mg T in 5 and 10 g gel , delivering 5 and 10 mg T/day , respectively ) and a permeation-enhanced T patch ( 2 patches delivering 5 mg T/day ) in 227 hypogonadal men . This new 1 % hydroalcoholic T gel formulation when applied to the upper arms , shoulders , and abdomen dried within a few minutes , and about 9 - 14 % of the T applied was bioavailable . After 90 days of T gel treatment , the dose was titrated up ( 50 mg to 75 mg ) or down ( 100 mg to 75 mg ) if the preapplication serum T levels were outside the normal adult male range . Serum T rose rapidly into the normal adult male range on day 1 with the first T gel or patch application . Our previous study showed that steady state T levels were achieved 48 - 72 h after first application of the gel . The pharmacokinetic parameters for serum total and free T were very similar on days 30 , 90 , and 180 in all treatment groups . After repeated daily application of the T formulations for 180 days , the average serum T level over the 24-h sampling period ( C(avg ) ) was highest in the 100 mg T gel group ( 1.4- and 1.9-fold higher than the C(avg ) in the 50 mg T gel and T patch groups , respectively ) . Mean serum steady state T levels remained stable over the 180 days of T gel application . Upward dose adjustment from T gel 50 to 75 mg/day did not significantly increase the C(avg ) , whereas downward dose adjustment from 100 to 75 mg/day reduced serum T levels to the normal range for most patients . Serum free T levels paralleled those of serum total T , and the percent free T was not changed with transdermal T preparations . The serum dihydrotestosterone C(avg ) rose 1.3-fold above baseline after T patch application , but was more significantly increased by 3.6- and 4.6-fold with T gel 50 and 100 mg/day , respectively , result ing in a small , but significant , increase in the serum dihydrotestosterone/T ratios in the two T gel groups . Serum estradiol rose , and serum LH and FSH levels were suppressed proportionately with serum T in all study groups ; serum sex hormone-binding globulin showed small decreases that were significant only in the 100 mg T gel group . We conclude that transdermal T gel application can efficiently and rapidly increase serum T and free T levels in hypogonadal men to within the normal range . Transdermal T gel provided flexibility in dosing with little skin irritation and a low discontinuation rate",
"BACKGROUND Dehydroepi and rosterone ( DHEA ) and testosterone are widely promoted as antiaging supplements , but the long-term benefits , as compared with potential harm , are unknown . METHODS We performed a 2-year , placebo-controlled , r and omized , double-blind study involving 87 elderly men with low levels of the sulfated form of DHEA and bioavailable testosterone and 57 elderly women with low levels of sulfated DHEA . Among the men , 29 received DHEA , 27 received testosterone , and 31 received placebo . Among the women , 27 received DHEA and 30 received placebo . Outcome measures included physical performance , body composition , bone mineral density ( BMD ) , glucose tolerance , and quality of life . RESULTS As compared with the change from baseline to 24 months in the placebo group , subjects who received DHEA for 2 years had an increase in plasma levels of sulfated DHEA by a median of 3.4 microg per milliliter ( 9.2 micromol per liter ) in men and by 3.8 microg per milliliter ( 10.3 micromol per liter ) in women . Among men who received testosterone , the level of bioavailable testosterone increased by a median of 30.4 ng per deciliter ( 1.1 nmol per liter ) , as compared with the change in the placebo group . A separate analysis of men and women showed no significant effect of DHEA on body-composition measurements . Neither hormone altered the peak volume of oxygen consumed per minute , muscle strength , or insulin sensitivity . Men who received testosterone had a slight increase in fat-free mass , and men in both treatment groups had an increase in BMD at the femoral neck . Women who received DHEA had an increase in BMD at the ultradistal radius . Neither treatment improved the quality of life or had major adverse effects . CONCLUSIONS Neither DHEA nor low-dose testosterone replacement in elderly people has physiologically relevant beneficial effects on body composition , physical performance , insulin sensitivity , or quality of life . ( Clinical Trials.gov number , NCT00254371 [ Clinical Trials.gov ] . )",
"BACKGROUND This study assessed the feasibility of a 12-week program of exercise , with and without intramuscular testosterone supplementation , in male patients with chronic heart failure ( CHF ) and low testosterone status and collected preliminary data for key health outcomes . METHODS Male patients with CHF ( n = 41 , age 67.2 years , range 51 - 84 years ) with mean ± SD testosterone levels of 10.7 ± 2.6 nmol/L ( 309 ± 76 ng/dL ) were r and omly allocated to exercise with testosterone or placebo groups . Feasibility was assessed in terms of recruitment , intervention compliance , and attrition . Outcomes included an incremental shuttle walk test , peak oxygen uptake , muscular strength , echocardiographic measures , N-terminal pro-brain natriuretic peptide , inflammatory markers , depression ( Beck Depression Inventory ) , and health-related quality of life ( Minnesota Living with Heart Failure Question naire and Medical Outcomes Study Short-Form ) . RESULTS Attrition was 30 % but with 100 % compliance to exercise and injections in patients who completed the study . Similar improvements in shuttle walk test ( 18 % vs 19 % ) , body mass ( -1.3 kg vs -1.0 kg ) , and h and grip strength ( 2.1 kg vs 2.5 kg ) from baseline were observed in both groups . The exercise with testosterone group showed improvements from baseline in peak oxygen uptake ( P ( P ( P domains ( P the exercise with placebo group . Echocardiographic measures , N-terminal pro-brain natriuretic peptide , and inflammatory markers were mostly unchanged . CONCLUSIONS This study shows for the first time that testosterone supplementation during a program of exercise rehabilitation is feasible and can positively impact on a range of key health outcomes in elderly male patients with CHF who have a low testosterone status",
"Enzyme immunoassays ( EIA ) are commonly utilized for the evaluation of and rogens in biological fluids ; however , careful consideration must be given to cross-reactivity with other endogenous sex-steroid hormones . Our purpose was to determine the validity of a commonly-utilized commercially-available dihydrotestosterone ( DHT ) EIA . Serum sample s obtained from older hypogonadal men who participated in a 12-month r and omized controlled trial evaluating the effects of testosterone-enanthate ( 125 mg/week ) or vehicle in combination with finasteride ( 5mg/day ) or placebo were assayed for DHT via EIA and using a vali date d gold-st and ard LC-MS/MS approach . Additionally , commercially-available ( DHT-free ) buffer containing grade d testosterone doses was evaluated by DHT immunoassay . DHT concentrations measured via EIA were 79 % to > 1000 % higher than values obtained by LC-MS/MS ( p serum DHT to a similar magnitude . In contrast , finasteride-induced reductions in DHT were detected by LC-MS/MS , but not EIA ( p DHT concentrations between measurement techniques . Cross-reactivity of testosterone with the immunoassay ranged from 18 % to 99 % and DHT concentrations measured by EIA were highly associated with the spiked testosterone concentrations in DHT-free buffer ( r=0.885 , p DHT observed via EIA were not associated with a vali date d gold-st and ard measurement technique . The cross-reactivity of testosterone is particularly concerning because testsoterone is present in 100-fold greater concentrations than is DHT within the circulation",
"OBJECTIVES This study investigated the effect of a 12-week long-acting testosterone administration on maximal exercise capacity , ventilatory efficiency , muscle strength , insulin resistance , and baroreflex sensitivity ( BRS ) in elderly patients with chronic heart failure ( CHF ) . BACKGROUND CHF is characterized by a metabolic shift favoring catabolism and impairment in skeletal muscle bulk and function that could be involved in the pathophysiology of heart failure . METHODS Seventy elderly patients with stable CHF-median age 70 years , ejection fraction 31.8 + /- 7%-were r and omly assigned to receive testosterone ( n = 35 , intramuscular injection every 6 weeks ) or placebo ( n = 35 ) , both on top of optimal medical therapy . At baseline and at the end of the study , all patients underwent echocardiogram , cardiopulmonary exercise test , 6-min walk test ( 6MWT ) , quadriceps maximal voluntary contraction ( MVC ) , and isokinetic strength ( peak torque ) and BRS assessment ( sequences technique ) . RESULTS Baseline peak oxygen consumption ( VO(2 ) ) and quadriceps isometric strength showed a direct relation with serum testosterone concentration . Peak VO(2 ) significantly improved in testosterone but was unchanged in placebo . Insulin sensitivity was significantly improved in testosterone . The MVC and peak torque significantly increased in testosterone but not in placebo . The BRS significantly improved in testosterone but not in placebo . Increase in testosterone levels was significantly related to improvement in peak VO(2 ) and MVC . There were no significant changes in left ventricular function either in testosterone or placebo . CONCLUSIONS These results suggest that long-acting testosterone therapy improves exercise capacity , muscle strength , glucose metabolism , and BRS in men with moderately severe CHF . Testosterone benefits seem to be mediated by metabolic and peripheral effects",
"OBJECTIVES To investigate the effects of testosterone supplementation on bone , body composition , muscle , physical function , and safety in older men . DESIGN Double-blind , r and omized , placebo-controlled trial . SETTING A major medical institution . PARTICIPANTS One hundred thirty-one men ( mean age 77.1 + /- 7.6 ) with low testosterone , history of fracture , or bone mineral density ( BMD ) T-score less than -2.0 and frailty . INTERVENTION Participants received 5 mg/d of testosterone or placebo for 12 to 24 months ; all received calcium ( 1500 mg/d diet and supplement ) and cholecalciferol ( 1,000 IU/d ) . MEASUREMENTS BMD of hip , lumbar spine , and mid-radius ; body composition ; sex hormones , calcium-regulating hormones ; bone turnover markers ; strength ; physical performance ; and safety parameters . RESULTS Ninety-nine men ( 75.6 % ) completed 12 months , and 62 ( 47.3 % ) completed end therapy ( mean 23 months ; range 16 - 24 months for 62 who completed therapy ) . Study adherence was 54 % , with 40 % of subjects maintaining 70 % or greater adherence . Testosterone and bioavailable testosterone levels at 12 months were 583 ng/dL and 157 ng/dL , respectively , in the treatment group . BMD on testosterone increased 1.4 % at the femoral neck and 3.2 % at the lumbar spine ( P=.005 ) and decreased 1.3 % at the mid-radius ( P lean mass and a decrease in fat mass in the testosterone group but no differences in strength or physical performance . There were no differences in safety parameters . CONCLUSION Older , frail men receiving testosterone replacement increased testosterone levels and had favorable changes in body composition , modest changes in axial BMD , and no substantial changes in physical function",
"CONTEXT Cycling and rogens has been reported by athletes to improve physical performance by enhancing muscle mass and strength , a paradigm that has not been studied , and may have clinical value in older men being treated with testosterone . OBJECTIVE We investigated the efficacy of a monthly cycled testosterone regimen that uses half the testosterone dose as the current st and ard of care continuous therapy on body composition and muscle strength in older men . DESIGN , SETTING , AND PATIENTS Twenty-four community-dwelling older men 70 ± 2 yr of age with total testosterone levels below 500 ng/dl were r and omized at the Institute for Translational Sciences- Clinical Research Center into a 5-month double-blind placebo-controlled trial . INTERVENTION Subjects were dosed weekly for 5 months , receiving continuous testosterone ( TE , n = 8 ; 100 mg testosterone enanthate , i m injection ) , monthly cycled testosterone ( MO , n = 8 ; alternating months of testosterone and placebo ) , or placebo ( PL , n = 8) . MAIN OUTCOME MEASURES Main outcomes included body composition by dual-energy x-ray absorptiometry and upper and lower body muscle strength . Secondary outcomes included body weight , serum hormones , and mixed-muscle protein fractional synthesis rate ( FSR ) . RESULTS Total lean body mass was increased and percent fat was reduced after 5 months in TE and MO ( P increased in TE , and lower body muscle strength increased in TE and MO ( P ) . FSR increased in TE and MO ( P CONCLUSIONS Cycled testosterone improved body composition and increased muscle strength compared with placebo and increased FSR similarly to continuous testosterone",
"OBJECTIVE To investigate the effects of oral testosterone undecanoate ( TU ) on symptoms associated with late-onset hypogonadism ( LOH ) . Design Multicenter , r and omized , double-blind , placebo-controlled . METHODS The study was performed in 14 study centers in seven European countries . Men > or = 50 years ( n=322 ) with symptoms of hypogonadism and testosterone deficiency ( calculated free testosterone and treated for 12 months with placebo or oral TU 80 , 160 or 240 mg/day . Primary outcome was the total score on the Aging Males ' Symptoms ( AMS ) rating scale after six months of treatment . RESULTS Treatment of mild-to-moderate LOH symptoms in subjects with borderline hypogonadism with oral TU result ed in an improved total AMS score at month 6 , but differences between groups were not statistically significant . There was greater improvement in subjects when compared with subjects > or = 60 years ( P=0.001 ) , but baseline testosterone level had no influence on treatment response . The AMS sexual symptoms domain improved with oral TU 160 mg/day at months 6 ( P=0.008 ) and 12 ( P=0.012 ) compared with placebo , but not with 80 and 240 mg/day . Treatment was well-tolerated and there were no between-group differences in adverse events or drop-out rates . CONCLUSIONS In one of the largest placebo-controlled studies of testosterone therapy in LOH , oral TU did not improve total AMS score in subjects with mild-to-moderate symptoms compared with placebo , except the sexual symptom sub-domain where a modest improvement was reported with oral TU 160 mg/day",
"BACKGROUND Erectile dysfunction and low testosterone levels frequently occur together . OBJECTIVE To determine whether addition of testosterone to sildenafil therapy improves erectile response in men with erectile dysfunction and low testosterone levels . DESIGN R and omized , double-blind , parallel , placebo-controlled trial . ( Clinical Trials.gov registration number : NCT00512707 ) SETTING Outpatient academic research center . PARTICIPANTS Men aged 40 to 70 years with scores of 25 or less for the erectile function domain ( EFD ) of the International Index of Erectile Function , total testosterone levels less than 11.45 nmol/L ( free testosterone levels less than 173.35 pmol/L ( INTERVENTION Sildenafil dose was optimized , and 140 participants were then r and omly assigned to 14 weeks of daily transdermal gel that contained 10-g testosterone for 70 participants and placebo for the remaining 70 participants . All participants were included in the primary analysis , although 10 in the testosterone group and 12 in the placebo group did not complete the study . RESULTS At baseline , the 2 groups had similar EFD scores . Administration of sildenafil alone was associated with a substantial increase in EFD score ( mean , 7.7 [ 95 % CI , 6.5 to 8.8 ] ) , but change in EFD score after r and omization did not differ between the groups ( difference , 2.2 [ CI , -0.8 to 5.1 ] ; P = 0.150 ) . The findings were similar for other domains of sexual function in younger men , more obese men , and men with lower baseline testosterone levels or an inadequate response to sildenafil alone . Frequency of adverse events was similar for testosterone and placebo groups . LIMITATION Whether testosterone could improve erectile function without sildenafil was not studied . CONCLUSION Sildenafil plus testosterone was not superior to sildenafil plus placebo in improving erectile function in men with erectile dysfunction and low testosterone levels . PRIMARY FUNDING SOURCE National Institute of Child Health and Human Development"
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This systematic review aim ed to evaluate the efficacy of neurofeedback ( NF ) compared to stimulant medication in treating children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) . Included in this review are eight r and omized controlled trials that compared an NF condition , either alone or combined with medication , to a medication condition , which was mainly methylpheni date . Outcome measures included behavioral assessment s by parents and teachers , self-reports , neurocognitive measures , electroencephalogram power spectra and event-related potentials . When only trials are considered that include probably blinded ratings or those that are sham-NF or semi-active controlled or those that employed optimally titration procedures , the findings do not support theta/beta NF as a st and alone treatment for children or adolescents with ADHD . Nevertheless , an additive treatment effect of NF was observed on top of stimulants and theta/beta NF was able to decrease medication dosages , and both results were maintained at 6-month follow-up . This review concludes that the present role of NF in treating children diagnosed with ADHD should be considered as complementary in a multimodal treatment approach , individualized to the needs of the child , and may be considered a viable alternative to stimulants for a specific group of patients . Particularly patients with the following characteristics may benefit from NF treatment : low responders to medication , intolerable side effects due to medication , higher baseline theta power spectra and possibly having no comorbid psychiatric disorders . Future research should prioritize the identification of markers that differentiate responders from nonresponders to NF treatment , the potential of NF to decrease stimulant dosage , the st and ardization of NF treatment protocol s and the identification of the most favorable neurophysiological treatment targets
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"Background Many non-pharmacological treatments for children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) have been attempted , but reports indicate that most are ineffective . Although neurofeedback ( NF ) is a treatment approach for children with ADHD that remains promising , a variety of appropriate measures have been used in reporting and evaluating its effect . Objective To report the self-evaluations of NF treatment by children and adolescents with ADHD . Methods R and omized controlled trial in 91 children and adolescents with ADHD , aged less than 18 years ( mean , 11.2 years ) participated in a 30-session program of intensive NF treatment . Participants were r and omized and allocated by sequentially numbered sealed envelopes into three groups : methylpheni date ( MPH ) as an active control group , and two trial groups NF with MPH , and NF alone . ADHD core symptoms and school performance were given on a scale of 1 to 10 using a self-reporting question naire , and the changes in these scores after treatment were used as the self-reported evaluation . Basic statistical methods ( descriptive , analyses of variance , exact χ2 test , and paired t-test ) were used to investigate the baseline data . Changes in ADHD core symptoms and treatment effects were investigated using a general linear model for repeated measures . Results Eighty participants completed the treatment study and 73 ( 91 % ) responded sufficiently on the self-reporting question naires . The treatment groups were comparable in age , sex , and cognition as well as in the baseline levels of core ADHD symptoms . All treatments result ed in significant improvements regarding attention and hyperactivity ( P treatment effect in school performance was observed ( P=0.042 ) , in which only the NF group showed a significant improvement . Conclusion The self-reported improvements in ADHD core symptoms and school performance shortly after treatment indicate NF treatment being promising in comparison with medication , suggesting NF as an alternative treatment for children and adolescents who do not respond to MPH , or who suffer side effects . Further long-term follow-up is needed",
"Abstract Background : Different treatment approaches aim ed at reducing attention-deficit/hyperactivity disorder ( ADHD ) core symptoms are available . However , factors such as intolerance , side-effects , lack of efficacy , high new technology costs , and placebo effect have spurred on an increasing interest in alternative or complementary treatment . Aim : The aim of this study is to explore efficacy of multimodal treatment consisting of st and ard stimulant medication ( methylpheni date ) and neurofeedback ( NF ) in combination , and to compare it with the single treatment in 6-month follow-up in ADHD children and adolescents . Methods : This r and omized controlled trial with 6-month follow-up comprised three treatment arms : multimodal treatment ( NF + MED ) , MED alone , and NF alone . A total of 130 ADHD children/adolescents participated , and 62 % completed the study . ADHD core symptoms were recorded pre-/post-treatment , using parents ’ and teachers ’ forms taken from Barkley ’s Defiant Children : A Clinician ’s Manual for Assessment and Parent Training , and a self-report question naire . Results : Significant ADHD core symptom improvements were reported 6 months after treatment completion by parents , teachers , and participants in all three groups , with marked improvement in inattention in all groups . However , no significant improvements in hyperactivity or academic performance were reported by teachers or self-reported by children/adolescents , respectively , in the three groups . Changes obtained with multimodal treatment at 6-month follow-up were comparable to those with single medication treatment , as reported by all participants . Conclusions : Multimodal treatment using combined stimulant medication and NF showed 6-month efficacy in ADHD treatment . More research is needed to explore whether multimodal treatment is suitable for ADHD children and adolescents who showed a poor response to single medication treatment , and for those who want to reduce the use of stimulant medication",
"Abstract Attention Deficit Hyperactivity Disorder ( ADHD ) is associated with poor self‐control , underpinned by inferior fronto‐striatal deficits . Real‐time functional magnetic resonance neurofeedback ( rtfMRI‐NF ) allows participants to gain self‐control over dysregulated brain regions . Despite evidence for beneficial effects of electrophysiological‐NF on ADHD symptoms , no study has applied the spatially superior rtfMRI‐NF neurotherapy to ADHD . A r and omized controlled trial tested the efficacy of rtfMRI‐NF of right inferior prefrontal cortex ( rIFG ) , a key region that is compromised in ADHD and upregulated with psychostimulants , on improvement of ADHD symptoms , cognition , and inhibitory fMRI activation . To control for region‐specificity , an active control group received rtfMRI‐NF of the left parahippocampal gyrus ( lPHG ) . Thirty‐one ADHD boys were r and omly allocated and had to learn to upregulate their target brain region in an average of 11 rtfMRI‐NF runs over 2 weeks . Feedback was provided through a video‐clip of a rocket that had to be moved up into space . A transfer session without feedback tested learning retention as a proximal measure of transfer to everyday life . Both NF groups showed significant linear activation increases with increasing number of runs in their respective target regions and significant reduction in ADHD symptoms after neurotherapy and at 11‐month follow‐up . Only the group targeting rIFG , however , showed a transfer effect , which correlated with ADHD symptom reductions , improved at trend level in sustained attention , and showed increased IFG activation during an inhibitory fMRI task . This proof‐of‐concept study demonstrates for the first time feasibility , safety , and shorter‐ and longer‐term efficacy of rtfMRI‐NF of rIFG in adolescents with ADHD . Hum Brain Mapp 38:3190–3209 , 2017 . © 2017 The Authors Human Brain Mapping Published by Wiley Periodicals ,",
"OBJECTIVE The efficacy of neurofeedback as a treatment for attention-deficit/hyperactivity disorder ( ADHD ) , and whether neurofeedback is a viable alternative for stimulant medication , is still an intensely debated subject . The current r and omized controlled trial compared neurofeedback to ( 1 ) optimally titrated methylpheni date and ( 2 ) a semi-active control intervention , physical activity , to account for nonspecific effects . METHODS A multicenter 3-way parallel-group study with balanced r and omization was conducted . Children with a DSM-IV-TR diagnosis of ADHD , aged 7 - 13 years , were r and omly allocated to receive neurofeedback ( n = 39 ) , methylpheni date ( n = 36 ) , or physical activity ( n = 37 ) over a period of 10 - 12 weeks . Neurofeedback comprised theta/beta training on the vertex ( Cz ) . Physical activity consisted of moderate to vigorous intensity exercises . Neurofeedback and physical activity were balanced in terms of number ( ~30 ) and duration of sessions . A double-blind pseudor and omized placebo-controlled crossover titration procedure was used to determine an optimal dose in the methylpheni date intervention . Parent and teacher ratings on the Strengths and Difficulties Question naire ( SDQ ) and Strengths and Weaknesses of ADHD Symptoms and Normal Behavior ( SWAN ) were used to assess intervention outcomes . Data collection took place between September 2010 and March 2014 . RESULTS Intention-to-treat analyses revealed an improvement in parent-reported behavior on the SDQ and the SWAN Hyperactivity/Impulsivity scale , irrespective of received intervention ( ηp² = 0.21 - 0.22 , P ≤ .001 ) , whereas the SWAN Inattention scale revealed more improvement in children who received methylpheni date than neurofeedback and physical activity ( ηp² = 0.13 , P ≤ .001 ) . Teachers reported a decrease of ADHD symptoms on all measures for methylpheni date , but not for neurofeedback or physical activity ( range of ηp² = 0.14 - 0.29 , P superior to neurofeedback and physical activity in decreasing ADHD symptoms in children with ADHD . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01363544",
"BACKGROUND The clinical and neurophysiological effects of neurofeedback ( NF ) as treatment for children with ADHD are still unclear . This r and omized controlled trial ( RCT ) examined electroencephalogram ( EEG ) power spectra before and after NF compared to methylpheni date ( MPH ) treatment and physical activity ( PA ) - as semi-active control group - during resting and active ( effortful ) task conditions to determine whether NF can induce sustained alterations in brain function . METHODS Using a multicentre three-way parallel group RCT design , 112 children with a DSM-IV diagnosis of ADHD , aged between 7 and 13 years , were initially included . NF training consisted of 30 sessions of theta/beta training at Cz over a 10-week period . PA training was a semi-active control group , matched in frequency and duration . Methylpheni date was titrated using a double-blind placebo controlled procedure in 6 weeks , followed by a stable dose for 4 weeks . EEG power spectra measures during eyes open ( EO ) , eyes closed ( EC ) and task ( effortful ) conditions were available for 81 children at pre- and postintervention ( n = 29 NF , n = 25 MPH , n = 27 PA ) . CLINICAL TRIALS REGISTRATION Train Your Brain ? Exercise and Neurofeedback Intervention for ADHD , https:// clinical trials.gov/show/;NCT01363544 , Ref . No. NCT01363544 . RESULTS Both NF and MPH result ed in comparable reductions in theta power from pre- to postintervention during the EO condition compared to PA ( ηp ( 2 ) = .08 and .12 ) . For NF , greater reductions in theta were related to greater reductions in ADHD symptoms . During the task condition , only MPH showed reductions in theta and alpha power compared to PA ( ηp ( 2 ) = .10 and .12 ) . CONCLUSIONS This study provides evidence for specific neurophysiological effects after theta/beta NF and MPH treatment in children with ADHD . However , for NF these effects did not generalize to an active task condition , potentially explaining reduced behavioural effects of NF in the classroom",
"Background A r and omized and controlled clinical study was performed to evaluate the use of neurofeedback ( NF ) to treat attention-deficit/hyperactivity disorder ( ADHD ) in children and adolescents . Methods The ADHD population was selected from an outpatient clinic for Child and Adolescent Mental Health in Norway . Ninety-one of the 275 children and adolescents ranging in age from 6 to 18 years ( 10.5 years ) participated in 30 sessions of an intensive NF program . The reinforcement contingency was based on the subjects ’ production of cortical beta1 activity ( 15–18 Hz ) . The ADHD participants were r and omized into three groups , with 30 in the NF group , 31 controls in a group that was given methylpheni date , and 30 in a group that received NF and methylpheni date . ADHD core symptoms were reported by parents using the parent form of the Clinician ’s Manual for Assessment by Russell A. Barkley . Results Ninety-one children and adolescents were effectively r and omized by age , sex , intelligence and distribution of ADHD core symptoms . The parents reported significant effects of the treatments , but no significant differences between the treatment groups were observed . Conclusions NF was as effective as methylpheni date at treating the attentional and hyperactivity symptoms of ADHD , based on parental reports . Trial registration Current Controlled Trials",
"Neurofeedback ( NFB ) is a potential alternative treatment for children with ADHD that aims to optimize brain activity . Whereas most studies into NFB have investigated behavioral effects , less attention has been paid to the effects on neurocognitive functioning . The present r and omized controlled trial ( RCT ) compared neurocognitive effects of NFB to ( 1 ) optimally titrated methylpheni date ( MPH ) and ( 2 ) a semi-active control intervention , physical activity ( PA ) , to control for non-specific effects . Using a multicentre three-way parallel group RCT design , children with ADHD , aged 7–13 , were r and omly allocated to NFB ( n = 39 ) , MPH ( n = 36 ) or PA ( n = 37 ) over a period of 10–12 weeks . NFB comprised theta/beta training at CZ . The PA intervention was matched in frequency and duration to NFB . MPH was titrated using a double-blind placebo controlled procedure to determine the optimal dose . Neurocognitive functioning was assessed using parameters derived from the auditory oddball- , stop-signal- and visual spatial working memory task . Data collection took place between September 2010 and March 2014 . Intention-to-treat analyses showed improved attention for MPH compared to NFB and PA , as reflected by decreased response speed during the oddball task [ ηp2 = 0.21 , p as improved inhibition , impulsivity and attention , as reflected by faster stop signal reaction times , lower commission and omission error rates during the stop-signal task ( range ηp2 = 0.09–0.18 , p values improved over time , irrespective of received treatment ( ηp2 = 0.17 , p over NFB to improve neurocognitive functioning . Hence , the findings do not support theta/beta training applied as a st and -alone treatment in children with ADHD",
"OBJECTIVE The purpose of this pilot study was to compare the effects of 30 sessions of neurofeedback ( NF ) with stimulant medication on attention-deficit/hyperactivity disorder ( ADHD ) patients . METHODS Thirty-two medication-naïve ADHD patients , ages 7 - 16 , from a neuropsychiatric clinic , were r and omized to NF ( n=16 ) or drug treatment ( n=16 ) . Other actions , such as parent management training , information , or support in school were given as needed , with no differences between the groups . All participants were assessed before treatment on two rating scales , each with parent and teacher forms . In addition , quantitative electroencephalogram ( QEEG ) and event-related potentials ( ERPs ) , which included behavioral data from a go/no go test were administered . NF training took place in the clinic over a period of 7 - 11 months , and was followed by a repeat of the same assessment tools . The mean time interval between pre- and postassesment was not significantly different in the two groups . The 18 symptoms of ADHD ( American Psychiatric Association , Diagnostic and Statistical Manual of Mental Disorders , 4th ed . ( DSM-IV ) ) were used as the primary outcome measure . RESULTS Analysis of covariance revealed a significant difference between the groups at evaluation in favor of medication , with a large effect size . This picture was confirmed by other outcome measures . The QEEG spectral power in the theta and beta b and s did not change in either group . In ERP , the P3 no go component increased significantly in 8 of 12 patients who had a clinical ly relevant medication effect , but did not increase in the medication nonresponders or the NF group . CONCLUSIONS Our study supports effects for stimulants , but not for NF . Effects of NF may require thorough patient selection , frequent training sessions , a system for excluding nonresponders , and active transfer training . The P3 no go ERP component may be a marker for treatment response",
"Neurofeedback ( NF ) has been identified as a \" possibly efficacious \" treatment in current evidence -based review s ; therefore , more research is needed to determine its effects . The current study examined the potential additive effect of NF for children diagnosed with ADHD beginning a medication trial first . Thirty-six children ( 6 - 12 years ) with a DSM-IV-TR diagnosis of ADHD were r and omly assigned to an NF with medication ( NF condition ) or a medication only condition . Children in the NF group attended 20 twice-weekly sessions . Outcome measures included individual cognitive performance scores ( ADS , K-WISC-III ) , ADHD rating scores completed by their parents ( ARS , CRS ) and brainwave indices of left and right hemispheres before and after NF treatment . Significant additive treatment effect in any of the symptom variables was found and a reduction of theta waves in both the right and left hemispheres was recorded in NF condition participants . However our r and omized controlled study could not demonstrate superior effects of combined NF on intelligent functioning compared to the medication treatment only . This study suggested any possible evidence of positive and additive treatment effects of NF on brainwaves and ADHD symptomatology",
"OBJECTIVE Electroencephalographic ( EEG ) neurofeedback ( NF ) is considered a nonpharmacological alternative for medication in attention-deficit/hyperactivity disorder ( ADHD ) . Comparisons of the behavioral efficacy of NF and medication have produced inconsistent results . EEG measures can provide insight into treatment mechanisms , but have received little consideration . In this r and omized controlled trial ( RCT ) , effects of NF were compared with methylpheni date ( MPH ) , and physical activity ( PA ) in children with ADHD on event-related potential ( ERP ) indices of response inhibition , which are involved in ADHD psychopathology . METHODS Using a multicenter three way parallel group RCT design , 112 children with a Diagnostic and Statistical Manual of Mental Disorders , 4th ed . ( DSM-IV ) ( American Psychiatric Association 1994 ) diagnosis of ADHD , between 7 and 13 years of age , were initially included . NF training consisted of 30 sessions of theta/beta training at Cz over a 10 week period . PA training was a semiactive control group , matched in frequency and duration . MPH was titrated using a double-blind placebo controlled procedure in 6 weeks , followed by a stable dose for 4 weeks . ERP measures of response inhibition , N2 and P3 , were available for 81 children at pre- and postintervention ( n = 32 NF , n = 25 MPH , n = 24 PA ) . RESULTS Only the medication group showed a specific increase in P3 amplitude compared with NF ( partial eta-squared [ ηp(2 ) ] = 0.121 ) and PA ( ηp(2 ) = 0.283 ) , which was related to improved response inhibition . Source localization of medication effects on P3 amplitude indicated increased activation primarily in thalamic and striatal nuclei . CONCLUSIONS This is the first study that simultaneously compared NF with stimulant treatment and a semiactive control group . Only stimulant treatment demonstrated specific improvements in brain function related to response inhibition . These results are in line with recent doubts on the efficacy and specificity of NF as treatment for ADHD . CLINICAL TRIALS REGISTRATION Train Your Brain ? Exercise and Neurofeedback Intervention for ADHD , https:// clinical trials.gov/show/NCT01363544 , Ref . No. NCT01363544",
"The present study is a r and omized controlled trial that aims to evaluate the efficacy of Neurofeedback compared to st and ard pharmacological intervention in the treatment of attention deficit/hyperactivity disorder ( ADHD ) . The final sample consisted of 23 children with ADHD ( 11 boys and 12 girls , 7 - 14 years old ) . Participants carried out 40 theta/beta training sessions or received methylpheni date . Behavioral rating scales were completed by fathers , mothers , and teachers at pre- , post-treatment , two- , and six-month naturalistic follow-up . In both groups , similar significant reductions were reported in ADHD functional impairment by parents ; and in primary ADHD symptoms by parents and teachers . However , significant academic performance improvements were only detected in the Neurofeedback group . Our findings provide new evidence for the efficacy of Neurofeedback , and contribute to enlarge the range of non-pharmacological ADHD intervention choices . To our knowledge , this is the first r and omized controlled trial with a six-month follow-up that compares Neurofeedback and stimulant medication in ADHD",
"PURPOSE To evaluate the efficacy of combined methylpheni date and EEG feedback treatment for children with ADHD . METHODS Forty patients with ADHD were r and omly assigned to the combination group ( methylpheni date therapy and EEG feedback training ) or control group ( methylpheni date therapy and non-feedback attention training ) in a 1:1 ratio using the double-blind method . These patients , who met the DSM-IV diagnostic criteria and were aged between 7 and 16 years , had obtained optimal therapeutic effects by titrating the methylpheni date dose prior to the trial . The patients were assessed using multiple parameters at baseline , after 20 treatment sessions , after 40 treatment sessions , and in 6-month follow-up studies . RESULTS Compared to the control group , patients in the combination group had reduced ADHD symptoms and improved in related behavioural and brain functions . CONCLUSION The combination of EEG feedback and methylpheni date treatment is more effective than methylpheni date alone . The combined therapy is especially suitable for children and adolescents with ADHD who insufficiently respond to single drug treatment or experience drug side effects",
"OBJECTIVE Neurofeedback aims to reduce symptoms of attention-deficit/hyperactivity disorder ( ADHD ) , mainly attention problems . However , the additional influence of neurofeedback over treatment as usual ( TAU ) on neurocognitive functioning for adolescents with ADHD remains unclear . METHOD By using a multicenter parallel r and omized controlled trial ( RCT ) design , male adolescents with a DSM-IV-TR diagnosis of ADHD ( mean age = 16.1 years ; range , 12 - 24 ) were r and omized to receive either a combination of TAU and neurofeedback ( n = 45 ) or TAU ( n = 26 ) . R and omization was computer generated and stratified by age group ( ages 12 through 15 , 16 through 20 , and 21 through 24 years ) . The neurofeedback intervention consisted of approximately 37 sessions over a period of 25 weeks of theta/sensorimotor rhythm training on the vertex ( Cz ) . Primary neurocognitive outcomes included performance parameters derived from the D2 Test of Attention , the Digit Span backward , the Stroop Color-Word Test and the Tower of London , all assessed preintervention and postintervention . Data were collected between December 2009 and July 2012 . RESULTS At postintervention , outcomes of attention and /or motor speed were improved , with faster processing times for both intervention conditions and with medium to large effect sizes ( range , ηp2 = .08-.54 ; P values for higher executive functions were observed . Results might partly resemble practice effects . CONCLUSIONS Although neurocognitive outcomes improved in all adolescents receiving treatment for ADHD , no additional value for neurofeedback over TAU was observed . Hence , this study does not provide evidence for using theta/sensorimotor rhythm neurofeedback to enhance neurocognitive performance as additional intervention to TAU for adolescents with ADHD symptoms . TRIAL REGISTRATION Trialregister.nl identifier : 1759",
"BACKGROUND The Multimodal Treatment Study ( MTA ) began as a 14-month r and omized clinical trial of behavioral and pharmacological treatments of 579 children ( 7 - 10 years of age ) diagnosed with attention-deficit/hyperactivity disorder (ADHD)-combined type . It transitioned into an observational long-term follow-up of 515 cases consented for continuation and 289 classmates ( 258 without ADHD ) added as a local normative comparison group ( LNCG ) , with assessment s 2 - 16 years after baseline . METHODS Primary ( symptom severity ) and secondary ( adult height ) outcomes in adulthood were specified . Treatment was monitored to age 18 , and naturalistic subgroups were formed based on three patterns of long-term use of stimulant medication ( Consistent , Inconsistent , and Negligible ) . For the follow-up , hypothesis-generating analyses were performed on outcomes in early adulthood ( at 25 years of age ) . Planned comparisons were used to estimate ADHD-LNCG differences reflecting persistence of symptoms and naturalistic subgroup differences reflecting benefit ( symptom reduction ) and cost ( height suppression ) associated with extended use of medication . RESULTS For ratings of symptom severity , the ADHD-LNCG comparison was statistically significant for the parent/self-report average ( 0.51 ± 0.04 , p symptom persistence , and for the parent/self-report difference ( 0.21 ± 0.04 , p adult height , the ADHD group was 1.29 ± 0.55 cm shorter than the LNCG ( p symptom persistence compared to local norms from the LNCG . Within naturalistic subgroups of ADHD cases , extended use of medication was associated with suppression of adult height but not with reduction of symptom severity "
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4116ee26-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE To evaluate the association of probiotic supplementation during pregnancy or infancy with childhood asthma and wheeze . DESIGN Systematic review and meta- analysis of r and omised controlled trials . DATA SOURCES Medline , Embase , and Central ( Cochrane Library ) data bases from inception to August 2013 , plus the World Health Organization 's international clinical trials registry platform and relevant conference proceedings for the preceding five years . Included trials and relevant review s were forward search ed in Web of Science . REVIEW METHODS Two review ers independently identified r and omised controlled trials evaluating probiotics administered to mothers during pregnancy or to infants during the first year of life . The primary outcome was doctor diagnosed asthma ; secondary outcomes included wheeze and lower respiratory tract infection . RESULTS We identified 20 eligible trials including 4866 children . Trials were heterogeneous in the type and duration of probiotic supplementation , and duration of follow-up . Only five trials conducted follow-up beyond participants ' age of 6 years ( median 24 months ) , and none were powered to detect asthma as the primary outcome . The overall rate of doctor diagnosed asthma was 10.7 % ; overall rates of incident wheeze and lower respiratory tract infection were 33.3 % and 13.9 % , respectively . Among 3257 infants enrolled in nine trials contributing asthma data , the risk ratio of doctor diagnosed asthma in participants r and omised to receive probiotics was 0.99 ( 95 % confidence interval 0.81 to 1.21 , I(2)=0 % ) . The risk ratio of incident wheeze was 0.97 ( 0.87 to 1.09 , I(2)=0 % , 9 trials , 1949 infants ) . Among 1364 infants enrolled in six trials , the risk ratio of lower respiratory tract infection after probiotic supplementation was 1.26 ( 0.99 to 1.61 , I(2)=0 % ) . We adjudicated most trials to be of high ( ten trials ) or unclear ( nine trials ) risk of bias , mainly due to attrition . CONCLUSIONS We found no evidence to support a protective association between perinatal use of probiotics and doctor diagnosed asthma or childhood wheeze . R and omised controlled trials to date have not yielded sufficient evidence to recommend probiotics for the primary prevention of these disorders . Extended follow-up of existing trials , along with further clinical and basic research , are needed to accurately define the role of probiotics in the prevention of childhood asthma . SYSTEMATIC REVIEW REGISTRATION PROSPERO ( CRD42013004385 )
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"BACKGROUND Probiotics and prebiotics are considered to be beneficial to the gastrointestinal health of infants . OBJECTIVE The objective was to evaluate infant formulas containing probiotics and synbiotics ( combinations of probiotics and prebiotics ) for safety and tolerance . DESIGN In a prospect i ve , controlled , double-blind , r and omized trial , healthy full-term infants were exclusively fed a control formula or study formulas containing Bifidobacterium longum BL999 ( BL999 ) + Lactobacillus rhamnosus LPR ( LPR ) , BL999 + LPR + 4 g/L of 90 % galactooligosaccharide/10 % short-chain fructooligosaccharide ( GOS/SCFOS ) , or BL999 + Lactobacillus paracasei ST11 ( ST11 ) + 4 g/L GOS/SCFOS from . Safety and tolerance were assessed based on weight gain during the treatment period ( primary outcome ) as well as recumbent length , head circumference , digestive tolerance , and adverse events ( secondary outcomes ) , which were evaluated at 2 , 4 , 8 , 12 , 16 , and 52 wk of age . RESULTS Two hundred eighty-four infants were enrolled . During the treatment period , difference in mean weight gain between control and study formula groups in both the intention-to-treat and per- protocol population s were within the predefined equivalence boundaries of + /-3.9 g/d , indicating equivalent weight gain . Secondary outcomes did not show significant differences between groups during the treatment period . CONCLUSION Infants fed formulas containing probiotics or synbiotics show a similar rate in weight gain compared with those fed a control formula and tolerate these formulas well",
"BACKGROUND It is debated whether a low total diversity of the gut microbiota in early childhood is more important than an altered prevalence of particular bacterial species for the increasing incidence of allergic disease . The advent of powerful , cultivation-free molecular methods makes it possible to characterize the total microbiome down to the genus level in large cohorts . OBJECTIVE We sought to assess microbial diversity and characterize the dominant bacteria in stool during the first year of life in relation to atopic eczema development . METHODS Microbial diversity and composition were analyzed with barcoded 16S rDNA 454-pyrosequencing in stool sample s at 1 week , 1 month , and 12 months of age in 20 infants with IgE-associated eczema and 20 infants without any allergic manifestation until 2 years of age ( Clinical Trials.gov ID NCT01285830 ) . RESULTS Infants with IgE-associated eczema had a lower diversity of the total microbiota at 1 month ( P = .004 ) and a lower diversity of the bacterial phylum Bacteroidetes and the genus Bacteroides at 1 month ( P = .02 and P = .01 ) and the phylum Proteobacteria at 12 months of age ( P = .02 ) . The microbiota was less uniform at 1 month than at 12 months of age , with a high interindividual variability . At 12 months , when the microbiota had stabilized , Proteobacteria , comprising gram-negative organisms , were more abundant in infants without allergic manifestation ( Empirical Analysis of Digital Gene Expression in R [ edgeR ] test : P = .008 , q = 0.02 ) . CONCLUSION Low intestinal microbial diversity during the first month of life was associated with subsequent atopic eczema",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"A reduced microbial load early in life has been suggested to be linked to the increasing prevalence of allergic diseases in the industrialized world . Some studies have indicated that probiotics may be effective in the prevention of eczema . In vitro studies indicate that probiotics have immunomodulatory effects . In the present study , we evaluated the effects of feeding Lactobacillus F19 during weaning on the incidence of eczema and Th1/Th2 balance . In a double-blind , placebo-controlled r and omized intervention trial , infants were fed cereals with ( n = 89 ) or without Lactobacillus F19 ( n = 90 ) from 4 to 13 months of age . We assessed the cumulative incidence of eczema at 13 months of age . The ratio of interferon-gamma ( IFN-gamma ) to interleukin 4 ( IL4 ) mRNA expression levels in polyclonally stimulated peripheral blood T cells was used as a proxy for immune balance . Total and specific IgE serum levels were also assessed . The cumulative incidence of eczema at 13 months was 11 % ( 4 - 17 % , 95 % CI ) and 22 % ( 13 - 31 % , 95 % CI ) in the probiotic and placebo groups , respectively ( p IFN-gamma/IL4 mRNA ratio was higher in the probiotic compared with the placebo group ( p serum concentrations of IgE. In summary , feeding Lactobacillus F19 during weaning could be an effective tool in the prevention of early manifestation of allergy , e.g. , eczema . The higher Th1/Th2 ratio in the probiotic compared with the placebo group suggests enhancing effects of Lactobacillus F19 on the T cell-mediated immune response",
"Using a double blind r and omized placebo‐controlled trial ( Australian New Zeal and Clinical Trials Registry : ACTRN12607000518460 ) , we have shown that in a high risk birth cohort , maternal supplementation from 35 weeks gestation until 6 months if breastfeeding and infant supplementation until 2 years with Lactobacillus rhamnosus HN001 ( HN001 ) ( 6 × 109 cfu/day ) halved the cumulative prevalence of eczema by age 2 years . Bifidobacterium animalis subsp lactis HN019 ( HN019 ) ( 9 × 109 cfu/day ) had no effect",
"Background Analyses of circulating chemokines offer novel tools to investigate the T helper (Th)1/Th2 imbalance in allergic disease in vivo",
"Microbial exposure is necessary for the development of normal immune function , which has driven the idea of using probiotics for treatment and prevention of immune-mediated diseases in infancy and childhood . Mounting evidence indicates that probiotics have immunomodulatory effects . However , the mechanisms are still poorly understood . Specific antibody response is a valuable proxy for immune system maturation status in infancy . We aim ed at determining the impact of Lactobacillus F19 ( LF19 ) during weaning on infections and IgG antibody responses to routine vaccines . In a double-blind , placebo-controlled r and omized intervention trial , infants were fed cereals with ( n = 89 ) or without LF19 ( n = 90 ) from 4 to 13 months of age . Infants were immunized with DTaP ( diphtheria and tetanus toxoid and acellular pertussis ) , polio and Hib-conjugate vaccines at ( 3 ) , 5(1/2 ) and 12 months of age . We assessed the number of days with infections , antibiotic prescriptions and antibody concentrations to Hib capsular polysaccharide ( HibPS ) , diphtheria toxin ( D ) and tetanus toxoid ( T ) before and after the second and third doses . Days with infectious symptoms did not differ between the groups . Days with antibiotic prescriptions were fewer in the LF19 group ( p = 0.044 ) . LF19 enhanced anti-D concentrations when adjusting for breastfeeding duration and colonization with LF19 ( p = 0.024 ) . There was an interaction of the intervention and colonization with LF19 on anti-T concentrations during the course of vaccination ( p = 0.035 ) . The anti-HibPS concentrations were higher after the first and second dose of Hib vaccine in infants breastfed or = 6 months ( p infections , but increased the capacity to raise immune responses to protein antigens , with more pronounced effects in infants breastfed < 6 months",
"Objectives : Breast-feeding induces a gut microbiota rich in bifidobacteria , whereas formula-fed babies have a more diverse colonization . This ecosystem contributes to the development of the immune response and the lower incidence of diarrhea and allergy in breast-fed infants . This r and omized double-blind controlled trial aim ed to evaluate the bifidogenic effect of a mainly whey protein study formula low in phosphate and protein , allowing a composition closer to that of human milk . Patients and Methods : One hundred ninety healthy infants exclusively received study formula with or without Bifidobacterium longum ( BL999 ) , or a control formula for up to 4 months . Breast-fed infants served as a reference population . Stool sample s collected at 2 months of age were analyzed for bacterial counts ( log colony-forming unit [CFU]/g ) . Results : Bifidobacteria counts were significantly higher in infants receiving the study formula alone ( 10.0[0.8 ] , P breast-fed infants ( 10.1[0.4 ] , P > 0.05 ) . The difference between the 2 study groups was 0.16 log CFU/g ( 90 % confidence interval [ CI ] [ 0–0.4 ] ) , within the predefined equivalence margin . Microbiota profile , as a percentage of total bacteria counts , showed about 50 % Bifidobacteria , 8 % Enterobacteria , and growth measurements , digestive tolerance , and adverse events between groups . Conclusions : This study showed that infant formula closer resembling human milk was more bifidogenic than the control formula and led to a microbiota profile similar to that for breast-fed infants",
"BACKGROUND The role of probiotics in prevention of allergic disease is still not clearly established , although early reports suggested Lactobacillus GG halved the risk of eczema at 2 years . OBJECTIVE To determine whether probiotic supplementation in early life could prevent development of eczema and atopy at 2 years . METHODS Double-blind , r and omized placebo-controlled trial of infants at risk of allergic disease . Pregnant women were r and omized to take Lactobacillus rhamnosus HN001 ( L rhamnosus ) , Bifidobacterium animalis subsp lactis strain HN019 or placebo daily from 35 weeks gestation until 6 months if breast-feeding , and their infants were r and omized to receive the same treatment from birth to 2 years ( n = 474 ) . The infant 's cumulative prevalence of eczema and point prevalence of atopy , using skin prick tests to common allergens , was assessed at 2 years . RESULTS Infants receiving L rhamnosus had a significantly ( P = .01 ) reduced risk of eczema ( hazard ratio [ HR ] , 0.51 ; 95 % CI , 0.30 - 0.85 ) compared with placebo , but this was not the case for B animalis subsp lactis ( HR , 0.90 ; 95 % CI , 0.58 - 1.41 ) . There was no significant effect of L rhamnosus ( HR , 0.74 ; 95 % CI , 0.46 - 1.18 ) or B animalis subsp lactis ( HR , 0.82 ; 95 % CI , 0.52 - 1.28 ) on atopy . L rhamnosus ( 71.5 % ) was more likely than B animalis subsp lactis ( 22.6 % ) to be present in the feces at 3 months , although detection rates were similar by 24 months . CONCLUSION We found that supplementation with L rhamnosus , but not B animalis subsp lactis , substantially reduced the cumulative prevalence of eczema , but not atopy , by 2 years . Underst and ing how Lactobacilli act to prevent eczema requires further investigation",
"Lactic acid bacteria and bifidobacteria are increasingly being administered to pregnant women and infants with the intention of improving health . Although these organisms have a long record of safe use , it is important to identify any adverse effects in potentially vulnerable population s. In a r and omized , double-blinded , placebo-controlled trial , we evaluated the safety of a bacterial dietary supplement for the prevention of atopy in infants . Two strains of lactobacilli ( Lactobacillus salivarius CUL61 and Lactobacillus paracasei CUL08 ) and bifidobacteria ( Bifidobacterium animalis subsp . lactis CUL34 and Bifidobacterium bifidum CUL20 ) with a total of 1 x 10(10 ) colony-forming units were administered daily to women during the last month of pregnancy and to infants aged 0 - 6 mo . Adverse events ( AE ) were classified according to WHO International Statistical Classification of Diseases criteria . Common symptoms were recorded by regular question naires . Baseline characteristics of 220 mother-infant dyads in the treatment and 234 in the placebo group were similar . Compliance with the trial interventions , loss to follow-up , symptoms , drug usage , infant growth , method of feeding , visits to the doctor , and mothers ' assessment of infant health were similar in the 2 groups . Fifteen ( 6.8 % ) mothers and 73 ( 33.2 % ) infants in the treatment group and 21 ( 9.0 % ) mothers and 75 ( 32.1 % ) infants in the placebo group reported AE ( P = 0.49 and P = 0.84 , respectively ) . Severe AE occurred in 18 mothers and 63 infants with a similar frequency in each group . None of the AE were attributed to the intervention . Our findings support the safe use of this consortium of organisms during pregnancy and early infancy",
"Objectives : The aim of the study was to examine the effects of a follow-on formula containing Lactobacillus fermentum CECT5716 ( L fermentum ) on the incidence of infections in infants between the ages of 6 and 12 months . Patients and Methods : A r and omized double-blinded controlled study including infants at the age of 6 months was conducted . Infants were assigned r and omly to either follow-on formula supplemented with L fermentum plus galactooligosaccharide ( experimental group , EG ) , or the same formula supplemented with only galactooligosaccharide ( control group , CG ) . The main outcome was the incidence of infections for the 6-month duration of the study . Results : The EG showed a significant 46 % reduction in the incidence rate ( IR ) of gastrointestinal infections ( EG : 0.196 ± 0.51 , CG : 0.363 ± 0.53 , IR ratio 0.54 , 95 % confidence interval [ CI ] 0.307–0.950 , P = 0.032 ) , 27 % reduction in the incidence of upper respiratory tract infections ( EG : 0.969 ± 0.96 , CG : 1.330 ± 1.23 , IR ratio 0.729 , 95 % CI 0.46–1.38 , P = 0.026 ) , and 30 % reduction in the total number of infections ( EG : 1.464 ± 1.15 , CG : 2.077 ± 1.59 , IR ratio 0.70 , 95 % CI 0.46–1.38 , P = 0.003 ) , at the end of the study period compared with CG . Conclusions : Administration of a follow-on formula with L fermentum CECT5716 may be useful for the prevention of community-acquired gastrointestinal and upper respiratory infections ",
"OBJECTIVES The larger number of bifidobacteria in the intestine of breast-fed infants has been associated with their better health compared with formula-fed infants . We assessed the safety and tolerability of an experimental formula containing 2 x 10(7 ) colony-forming units of Bifidobacterium longum BL999 and 4 g/L of a prebiotic mixture containing 90 % galacto-oligosaccharides and 10 % fructo-oligosaccharides . METHODS A 7-mo prospect i ve , r and omized , reference-controlled , double-blinded trial was performed in infants who were not breast fed after the 14th day of birth . One hundred thirty-eight infants were enrolled and assigned to receive the control or experimental formula until they were 112 d old . Mean weight gain ( primary outcome ) and recumbent length , head circumference , tolerability ( gastrointestinal symptoms ) , and overall morbidity ( secondary outcomes ) were measured at 14 , 28 , 56 , 84 , and 112 d of age . RESULTS Equivalence in mean weight gain between the two groups was shown . The treatment difference in the intention-to-treat and per- protocol population s were within the predefined equivalence boundaries of + /-3.9 g/d . No statistically significant difference in recumbent length , head circumference , or incidence of adverse events was found between the two groups . Infants in the experimental group had fewer incidences of constipation and had stool characteristics that suggest that the experimental formula was tolerated well . Furthermore , these infants showed a trend toward fewer respiratory tract infections . CONCLUSIONS The starter formula containing BL999 and galacto-oligosaccharides/fructo-oligosaccharides is safe and well-tolerated",
"To cite this article : van der Aa LB , van Aalderen WMC , Heymans HSA , Henk Sillevis Smitt J , Nauta AJ , Knippels LMJ , Ben Amor K , Sprikkelman AB , the Synbad Study Group . Synbiotics prevent asthma‐like symptoms in infants with atopic dermatitis . Allergy 2011 ; 66 : 170–177",
"The role of probiotics in prevention of allergic disease is still not clear ; efficacy may depend on the timing , dose , duration , and specific probiotic used . Using a double‐blind r and omized placebo‐controlled trial ( Australian New Zeal and Clinical Trials Registry : ACTRN12607000518460 ) , we have shown that in a high‐risk birth cohort , maternal supplementation from 35 weeks gestation until 6 months if breastfeeding and infant supplementation from birth until 2 years with Lactobacillus rhamnosus HN001 ( HN001 ) ( 6 × 109 cfu/day ) halved the cumulative prevalence of eczema at 2 and 4 years . Bifidobacterium animalis subsp lactis HN019 ( HN019 ) ( 9 × 109 cfu/day ) had no significant effect ",
"Early treatment of new-born high-risk children with certain probiotic strains has reduced the risk of atopic eczema . Whether probiotics reduce risk for airway inflammation in long term is not known . We aim ed at study ing the effect of probiotic treatment during the six first months of life on airway inflammation at age 5 yr . In a r and omized double-blind allergy prevention trial between 2000 and 2007 in Helsinki , Finl and , we gave a probiotic combination , plus pre-biotics , or placebo , to 1018 children during 6 months from birth . At age 5 , we measured exhaled nitric oxide ( FE(NO ) ) in a r and omized sub- population of 160 children . Allergic diseases and IgE-sensitization were assessed in all infants . FE(NO ) did not differ between probiotic and placebo groups , median ( interquartile range , IQR ) 5.45 ( 4.3 - 7.3 ) vs. 5.70 ( 3.9 - 6.8 ) ppb , p = 0.22 . FE(NO ) was elevated among those suffering from asthma during the first 5 yr than in healthy non-sensitized children ( p = 0.009 ) . FE(NO ) correlated positively with serum total and allergen-specific IgE concentrations . Early intervention with probiotics and pre-biotics does not affect airway inflammation later in childhood",
"BACKGROUND The increase in allergic diseases is attributed to a relative lack of microbial stimulation of the infantile gut immune system . Probiotics , live health-promoting microbes , might offer such stimulation . OBJECTIVE We studied the effect of a mixture of 4 probiotic bacterial strains along with prebiotic galacto-oligosaccharides in preventing allergic diseases . METHODS We r and omized 1223 pregnant women carrying high-risk children to use a probiotic preparation or a placebo for 2 to 4 weeks before delivery . Their infants received the same probiotics plus galacto-oligosaccharides ( n = 461 ) or a placebo ( n = 464 ) for 6 months . At 2 years , we evaluated the cumulative incidence of allergic diseases ( food allergy , eczema , asthma , and allergic rhinitis ) and IgE sensitization ( positive skin prick test response or serum antigen-specific IgE level > 0.7 kU/L ) . Fecal bacteria were analyzed during treatment and at age 2 years . RESULTS Probiotic treatment compared with placebo showed no effect on the cumulative incidence of allergic diseases but tended to reduce IgE-associated ( atopic ) diseases ( odds ratio [ OR ] , 0.71 ; 95 % CI , 0.50 - 1.00 ; P = .052 ) . Probiotic treatment reduced eczema ( OR , 0.74 ; 95 % CI , 0.55 - 0.98 ; P = .035 ) and atopic eczema ( OR , 0.66 ; 95 % CI , 0.46 - 0.95 ; P = .025 ) . Lactobacilli and bifidobacteria more frequently ( P treatment showed no effect on the incidence of all allergic diseases by age 2 years but significantly prevented eczema and especially atopic eczema . The results suggest an inverse association between atopic diseases and colonization of the gut by probiotics . CLINICAL IMPLICATION S The prevention of atopic eczema in high-risk infants is possible by modulating the infant 's gut microbiota with probiotics and prebiotics",
"BACKGROUND Cow 's milk allergy ( CMA ) is the most frequently diagnosed food allergy in infancy . In general , patients have a good prognosis because the majority acquire tolerance within the first years . Interventions have been proposed to accelerate tolerance and reduce morbidity . Probiotic supplementation could be effective through modulation of the immune system . OBJECTIVE We sought to determine whether supplementation with a combination of probiotics ( Lactobacillus casei CRL431 and Bifidobacterium lactis Bb-12 ) accelerates tolerance to cow 's milk ( CM ) in infants with CMA . METHODS We performed a double-blind , r and omized , placebo-controlled trial in 119 infants with CMA . Infants received CRL431 and Bb-12 supplemented to their st and ard treatment of extensively hydrolyzed formula for 12 months . Primary outcome was clinical tolerance to CM at 6 and 12 months of treatment . Furthermore , we analyzed T- and B-lymphocyte subsets ( CD3(+ ) , CD3(+)CD4(+ ) , CD3(+)CD8(+ ) , and CD20(+ ) ) in peripheral blood at r and omization and at 12 months with flow cytometry and examined the presence of viable probiotic strains in fecal sample s. RESULTS The cumulative percentage of tolerance to CM at 6 and 12 months was similar in both groups : 56 ( 77 % ) in the probiotics group versus 54 ( 81 % ) in the placebo group . Infants in the placebo group had higher percentages of CD3(+ ) and CD3(+)CD4(+ ) lymphocytes compared with those seen in probiotic-treated infants . Probiotic intake was confirmed because probiotics were isolated from feces more often in treated infants than in the placebo group . CONCLUSION Supplementation of CRL431 and Bb-12 to extensively hydrolyzed formula does not accelerate CM tolerance in infants with CMA",
"BACKGROUND Less microbial exposure in early childhood is associated with more allergic disease later . Allergic children have a different fecal microflora , with less lactobacilli and bifidobacteria . Beneficial effects regarding the development of allergy have been suggested to come through probiotic supplementation . OBJECTIVE We sought to study the effect of probiotic and prebiotic supplementation in preventing allergies . METHODS In a double-blinded , placebo-controlled study we r and omized 1223 mothers with infants at high risk for allergy to receive a probiotic mixture ( 2 lactobacilli , bifidobacteria , and propionibacteria ) or placebo during the last month of pregnancy and their infants to receive it from birth until age 6 months . Infants also received a prebiotic galacto-oligosaccharide or placebo . At 5 years , we evaluated the cumulative incidence of allergic diseases ( eczema , food allergy , allergic rhinitis , and asthma ) and IgE sensitization . RESULTS Of the 1018 intent-to-treat infants , 891 ( 88 % ) attended the 5-year visit . Frequencies of allergic and IgE-associated allergic disease and sensitization in the probiotic and placebo groups were similar : 52.6 % versus 54.9 % and 29.5 % versus 26.6 % , respectively , and 41.3 % in both . No significant difference appeared in frequencies of eczema ( 39.3 % vs 43.3 % ) , atopic eczema ( 24.0 % vs 25.1 % ) , allergic rhinitis ( 20.7 % vs 19.1 % ) , or asthma ( 13.0 % vs 14.1 % ) between groups . However , less IgE-associated allergic disease occurred in cesarean-delivered children receiving probiotics ( 24.3 % vs 40.5 % ; odds ratio , 0.47 ; 95 % CI , 0.23 % to 0.96 % ; P = .035 ) . CONCLUSIONS No allergy-preventive effect that extended to age 5 years was achieved with perinatal supplementation of probiotic bacteria to high-risk mothers and children . It conferred protection only to cesarean-delivered children"
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4116ee62-06ff-11f0-808a-c43d1ab1c353
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Objective The aim of this study was to perform a systematic review on the effectiveness of dance-based programs in patients with fibromyalgia , as well as calculate the overall effect size of the improvements , through a meta- analysis . Methods The Cochrane Library , Physiotherapy Evidence Data base ( PEDro ) , PubMed , TRIP , and Web of Science ( WOS ) were selected to identify the articles included in this systematic review and meta- analysis . A total of seven articles fulfilled all inclusion and exclusion criteria . PRISMA guidelines were followed in the data extraction process . The level of evidence was established following guidelines from the Dutch Institute for Healthcare Improvement ( CBO ) . Results The studies were all r and omized controlled trials , but not double-blind . Duration of dance programs ranged from 12 to 24 weeks . Sessions lasted between 60 and 120 minutes and were performed 1 - 2 times per week . The overall effect size for pain was -1.64 with a 95 % CI from -2.69 to -0.59 which can be interpreted as large . In addition , significant improvements were observed in quality of life , depression , impact of the disease , anxiety , and physical function . Conclusion Dance-based intervention programs can be an effective intervention for people suffering from fibromyalgia , leading to a significant reduction of the level of pain with an effect size that can be considered as large . However , findings and conclusions from this meta- analysis must be taken with caution due to the small number of articles and the large heterogeneity
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"Objective : There is a growing body of literature supporting the use of creative arts therapies ; however , the efficacy of creative arts therapies in the treatment of posttraumatic stress disorder ( PTSD ) has not been systematic ally evaluated . The aim of this systematic review was to examine the efficacy of creative arts therapy including music therapy , art therapy , dance/movement therapy , and drama therapy , in the treatment of PTSD . Method : Ten data bases were search ed for peer- review ed literature published from inception to December 2016 . Studies were included in the review if they used a r and omized controlled trial ( RCT ) , a pseudo RCT , or a controlled study design ; tested the efficacy of one of the creative arts therapies described above ; and reported changes to PTSD diagnosis or symptomatology . Results : From an initial yield of 1,918 records , 1,653 records were screened on title and abstract and 125 were screened at full-text . Seven studies met the inclusion criteria for review , with four studies investigating art therapy , two studies investigating music therapy , and a final study investigating drama therapy . Individual studies were initially rated on a st and ardized quality and bias checklist , and then GRADE was used to rate the overall evidence for each intervention . The evidence for music therapy , art therapy , and drama therapy was ranked as low to very low , with no studies found for dance/movement therapy . Generally , the quality of the trials was very poor . Future directions for this field of research are to improve the scientific quality of the research trials in this area",
"Background The Beck Depression Inventory , 2nd edition ( BDI-II ) is widely used in research on depression . However , the minimal clinical ly important difference ( MCID ) is unknown . MCID can be estimated in several ways . Here we take a patient-centred approach , anchoring the change on the BDI-II to the patient 's global report of improvement . Method We used data collected ( n = 1039 ) from three r and omized controlled trials for the management of depression . Improvement on a ‘ global rating of change ’ question was compared with changes in BDI-II scores using general linear modelling to explore baseline dependency , assessing whether MCID is best measured in absolute terms ( i.e. difference ) or as percent reduction in scores from baseline ( i.e. ratio ) , and receiver operator characteristics ( ROC ) to estimate MCID according to the optimal threshold above which individuals report feeling ‘ better ’ . Results Improvement in BDI-II scores associated with reporting feeling ‘ better ’ depended on initial depression severity , and statistical modelling indicated that MCID is best measured on a ratio scale as a percentage reduction of score . We estimated a MCID of a 17.5 % reduction in scores from baseline from ROC analyses . The corresponding estimate for individuals with longer duration depression who had not responded to antidepressants was higher at 32 % . Conclusions MCID on the BDI-II is dependent on baseline severity , is best measured on a ratio scale , and the MCID for treatment-resistant depression is larger than that for more typical depression . This has important implication s for clinical trials and practice",
"OBJECTIVE To evaluate the feasibility of 8 months of supervised exercise therapy in warm water and its effects on the impact of fibromyalgia on physical and mental health and physical fitness in affected women . METHODS Thirty women with fibromyalgia were r and omly assigned to an exercise therapy group ( n = 15 ) or a control group ( inactive ) ( n = 15 ) . The impact of fibromyalgia on physical and mental health was assessed using the Fibromyalgia Impact Question naire and the anxiety state with State-Trait Anxiety Inventory . Physical fitness was measured using the following tests : Canadian Aerobic Fitness ; h and -grip dynamometry ; 10-metre walking ; 10-step stair-climbing and blind 1-leg stance . RESULTS After 8 months of training , the exercise therapy group improved compared with the control group in terms of physical function ( 20 % ) , pain ( 8 % ) , stiffness ( 53 % ) , anxiety ( 41 % ) , depression ( 27 % ) , Fibromyalgia Impact Question naire total scores ( 18 % ) , State-Trait Anxiety Inventory score ( 22 % ) , aerobic capacity ( 22 % ) , balance ( 30 % ) , functional capacity for walking ( 6 % ) , stair-climbing with no extra weight ( 14 % ) and stair-climbing 10 kg-weighted ( 25 % ) . CONCLUSION Eight months of supervised exercise in warm water was feasible and led to long-term improvements in physical and mental health in patients with fibromyalgia at a similar magnitude to those of shorter therapy programmes",
"Background Only a few workplace initiatives among cleaners have been reported , even though they constitute a job group in great need of health promotion . The purpose of this trial was to evaluate the effect of either physical coordination training or cognitive behavioural training on musculoskeletal pain , work ability and sickness absence among cleaners . Methods A cluster-r and omised controlled trial was conducted among 294 female cleaners allocated to either physical coordination training ( PCT ) , cognitive behavioural training ( CBTr ) or a reference group ( REF ) . Question naires about musculoskeletal pain and work ability were completed at baseline and after one year 's intervention . Sickness absence data were obtained from the managers ' records . Analyses were performed according to the intention-to-treat-principle ( ITT ) . Results No overall reduction in musculoskeletal pain , work ability or sickness absence from either PCT or CBTr compared with REF was found in conservative ITT analyses . However , explorative analyses revealed a treatment effect for musculoskeletal pain of the PCT . People with chronic neck/shoulder pain at baseline were more frequently non-chronic at follow-up after PCT compared with REF ( p = 0.05 ) . Conclusions The PCT intervention appeared effective for reducing chronic neck/shoulder pain among the female cleaners . It is recommended that future interventions among similar high-risk job groups focus on the implementation aspects of the interventions to maximise outcomes more distal from the intervention such as work ability and sickness absence . Trial registration IS RCT N : IS RCT",
"Fibromyalgia is characterized by chronic and extended musculoskeletal pain . The combination of exercise therapy with the warm water may be an appropriate treatment . However , studies focusing on the analysis of immediate pain during and after an exercise session are rare . This study aim ed to determine the immediate changes of a warm water pool-based exercise program ( 12 weeks ) on pain ( before vs. after session ) in female fibromyalgia patients . 33 Spanish women with fibromyalgia were selected to participate in a 12 weeks ( 2 sessions/week ) low-moderate intensity warm water pool-based program . We assessed pain by means of a Visual Analogue Scale before and after each single session ( i. e. , 24 sessions ) . We observed immediate benefits on pain with a mean decrease ~15 % in all sessions , except in the fourth one . There was an association of pain difference ( pre-post ) session with pain pre session ( p=0.005 ; β=0.097±0.034 ) and with age ( p on pain , pre session , post session , and pre-post changes ( all p>0.05 ) . Therefore this study showed that a warm water pool-based exercise program for 12 weeks ( 2 times/week ) led to a positive immediate decrease in level of pain in female patients with fibromyalgia . Improvements were higher in older women and in those with more intense pain",
"Background Exergames are a new form of rehabilitation that combine the characteristics of physical exercise and the benefits of non-immersive virtual reality ( VR ) . Effects of this novel therapy in women fibromyalgia are still unknown . The objective was to evaluate the effects of exergame-based intervention on mobility skills , balance and fear of falling in women with fibromyalgia . Methods This study was a r and omized controlled trial with concealed allocation . Seventy-six women with fibromyalgia were divided into two groups : the exercise group received an eight week intervention based on exergames , while the control group continued their usual activities . Mobility skills were evaluated using the timed up and go test , while balance was assessed using the functional reach test , and the CTSIB protocol . Fear of falling was evaluated on a scale of 0–100 ( 0 , no fear ; 100 , extreme fear ) . Measurements were performed before and after the intervention . A repeated- measures linear mixed model was used to compare the effects of the intervention between the two groups . Results The exercise group was significantly quicker than the control group in the timed up and go test ( MD , −0.71 ; 95 % CI [ −1.09–0.32 ] ; p improvements in functional reach and a reduced fear of falling ( MD , 4.34 ; 95 % CI [ 1.39–7.30 ] ; p = 0.005 and MD , −9.85 ; 95 % CI [ −0.19–−0.08 ] ; p = 0.048 , respectively ) . Discussion The improved TUG observed herein was better than the smallest real difference . Based on the results on mobility skills , balance and fear of falling , exergames may be an effective tool as a therapy for women with fibromyalgia",
"Introduction Physical therapy in warm water has been effective and highly recommended for persons with fibromyalgia , but its efficiency remains largely unknown . Should patients or health care managers invest in this therapy ? The aim of the current study was to assess the cost-utility of adding an aquatic exercise programme to the usual care of women with fibromyalgia . Methods Costs to the health care system and to society were considered in this study that included 33 participants , r and omly assigned to the experimental group ( n = 17 ) or a control group ( n = 16 ) . The intervention in the experimental group consisted of a 1-h , supervised , water-based exercise sessions , three times per week for 8 months . The main outcome measures were the health care costs and the number of quality -adjusted life-years ( QALYs ) using the time trade-off elicitation technique from the EuroQol EQ-5D instrument . Sensitivity analyses were performed for variations in staff salary , number of women attending sessions and time spent going to the pool . The cost effectiveness acceptability curves were created using a non-parametric bootstrap technique . Results The mean incremental treatment costs exceeded those for usual care per patient by € 517 for health care costs and € 1,032 for societal costs . The mean incremental QALY associated with the intervention was 0.131 ( 95 % CI : 0.011 to 0.290 ) . Each QALY gained in association with the exercise programme cost an additional € 3,947/QALY ( 95 % CI : 1,782 to 47,000 ) for a health care perspective and € 7,878/QALY ( 3,559 to 93,818 ) from a societal perspective . The curves showed a 95 % probability that the addition of the water-based programme is a cost-effective strategy if the ceiling of inversion is € 14,200/QALY from a health care perspective and € 28,300/QALY from a societal perspective . Conclusion The addition of an aquatic exercise programme to the usual care regime for fibromyalgia in women is cost effective in terms of both health care costs and societal costs . However , the characteristics of facilities ( distance from the patients ' homes and number of patients that can be accommo date d per session ) are major determinants to consider before investing in such a programme . Trial registration Current controlled trials IS RCT N53367487",
"OBJECTIVES To evaluate the effects of a 16-week exercise therapy in a chest-high pool of warm water through applicable tests in the clinical practice on the global symptomatology of women with fibromyalgia ( FM ) and to determine exercise adherence levels . DESIGN A r and omized controlled trial . SETTING Testing and training were completed at the university . PARTICIPANTS Middle-aged women with FM ( n=60 ) and healthy women ( n=25 ) . INTERVENTION A 16-week aquatic training program , including strength training , aerobic training , and relaxation exercises . MAIN OUTCOME MEASURES Tender point count ( syringe calibrated ) , health status ( Fibromyalgia Impact Question naire ) ; sleep quality ( Pittsburgh Sleep Quality Index ) ; physical ( endurance strength to low loads tests ) , psychologic ( State Anxiety Inventory ) , and cognitive function ( Paced Auditory Serial Addition Task ) ; and adherence 12 months after the completion of the study . RESULTS For all the measurements , the patients showed significant deficiencies compared with the healthy subjects . Efficacy analysis ( n=29 ) and intent-to-treat analysis ( n=34 ) of the exercise therapy was effective in decreasing the tender point count and improving sleep quality , cognitive function , and physical function . Anxiety remained unchanged during the follow-up . The exercise group had a significant improvement of health status , not associated exclusively with the exercise intervention . There were no changes in the control group . Twenty-three patients in the exercise group were exercising regularly 12 months after completing the program . CONCLUSIONS An exercise therapy 3 times a week for 16 weeks in a warm pool could improve most of the symptoms of FM and cause a high adherence to exercise in unfit women with heightened FM symptomatology . The therapeutic intervention 's effects can be assessed through applicable tests in the clinical practice",
"OBJECTIVE To evaluate the effects of an exergame-based intervention on a population sample of women with fibromyalgia . DESIGN Single-blinded , r and omized controlled trial with 8-week intervention . SETTING Fibromyalgia center . PARTICIPANTS Participants ( all women ) ( N=83 ) were divided into 2 groups : an exercise group ( n=42 ; mean age ± SD , 52.52±9.73y ) and a nonexercise group ( n=41 ; mean age ± SD , 52.47±8.75y ) . INTERVENTIONS Women in the exercise group completed an 8-week exergame-based training program , which was focused on postural control and coordination of the upper and lower limbs , aerobic conditioning , strength , and mobility . Women ( groups of 3 ) were encouraged to exercise for 120 minutes ( over 2 sessions ) per week . MAIN OUTCOME MEASURES Main outcome measures included pain and disease effect , which were assessed with the Fibromyalgia Impact Question naire ( FIQ ) , a specific measure for fibromyalgia . Secondary outcome measure included quality of life , which was assessed with the EuroQoL-5 Dimensions-5 Levels ( EQ-5D-5L ) generic instrument . RESULTS The results showed that 97.62 % of participants in the exercise group completed the 8-week intervention . The exercise group showed a significant improvement ( P the EQ-5D-5L utility index , and in 3 of 5 dimensions . For the FIQ , significant improvements were observed in the dimensions of pain , stiffness , anxiety , and feel good . The FIQ score was also reduced . The mean between-group improvement was 8.25 ( 95 % confidence interval , 2.85 - 13.65 ) . CONCLUSIONS The results and levels of compliance/adherence suggest this exergame-based training program is an effective intervention for reducing pain and increasing health-related quality of life in women with fibromyalgia",
"OBJECTIVES The aim of the present study was to assess the effectiveness of belly dance as a treatment option for patients with fibromyalgia . METHODS Eighty female patients with fibromyalgia between 18 to 65 years were r and omly allocated to a dance group ( n=40 ) and control group ( n=40 ) . Patients in the dance group underwent 16 weeks of belly dance twice a week , while the patients in the control group remained on a waiting list . The patients were evaluated with regard to pain ( VAS ) , function ( 6MWT ) , quality of life ( FIQ and SF-36 ) , depression ( Beck Inventory ) , anxiety ( STAI ) and self-image ( BDDE ) . Evaluations were carried out at baseline , 16 weeks and 32 weeks by a blinded assessor . RESULTS The dance group achieved significant improvements in VAS for pain ( p as well as the pain ( p ) , emotional aspects ( p ) and mental health ( p Belly dance can be used in the treatment of fibromyalgia to reduce pain and improve functional capacity , quality of life and self-image",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"OBJECTIVE To compare the clinical effectiveness of aerobic exercise in the water with walking/jogging for women with fibromyalgia ( FM ) . METHODS Sixty sedentary women with FM , ages 18 - 60 years , were r and omly assigned to either deep water running ( DWR ) or l and -based exercises ( LBE ) . Patients were trained for 15 weeks at their anaerobic threshold . Visual analog scale of pain , Fibromyalgia Impact Question naire ( FIQ ) , Beck Depression Inventory , Short Form 36 Health Survey ( SF-36 ) , and a patient 's global assessment of response to therapy ( PGART ) were measured at baseline , week 8 , and week 15 . Statistical analysis included all patients . RESULTS Four patients dropped out from each group . Both groups improved significantly at week 15 compared with baseline , with an average 36 % reduction in pain intensity . For PGART , 40 % of the DWR group and 30 % of the LBE group answered \" much better \" at posttreatment . FIQ total score and FIQ depression improvements in the DWR group were faster ( week 8) than the LBE group and kept improving ( week 15 ; P improvements in SF-36 role emotional ( P = 0.006 ) . No significant between-group differences were observed for peak oxygen uptake and other outcomes . CONCLUSION DWR is a safe exercise that has been shown to be as effective as LBE regarding pain . However , it has been shown to bring more advantages related to emotional aspects . Aerobic gain was similar for both groups , regardless of symptom improvement . Therefore , DWR could be studied as an exercise option for patients with FM who have problems adapting to LBE or lower limbs limitations",
"OBJECTIVE The objective of this study was to determine the effects of a 3-month Biodanza intervention in women with fibromyalgia ( FM ) . DESIGN This was a controlled trial . SETTING /LOCATION The study was conducted at a university research laboratory and social center . SUBJECTS The study comprised 59 women with FM recruited from a local association of patients with FM . Participants were allocated to the Biodanza intervention group ( n = 27 ) or usual-care group ( n = 32 ) . INTERVENTION The Biodanza intervention was carried out once a week for 3 months . OUTCOME MEASURES The outcome measures included the following : Pain threshold , body composition ( body-mass index and estimated body fat percentage ) , physical fitness ( 30-second chair st and , h and grip strength , chair sit and reach , back scratch , blind flamingo , 8 feet up and go , and 6-minute walk test ) and psychologic outcomes ( Fibromyalgia Impact Question naire [ FIQ ] , Short-Form Health Survey 36 , V and erbilt Pain Management Inventory , Hospital Anxiety and Depression Scale , General Self-Efficacy Scale , and Rosenberg Self-Esteem Scale ) . RESULTS We observed a significant interaction effect ( group*time ) for pain threshold of several tender points ( left [ L ] and right [ R ] side of the anterior cervical and supraspinatus , trapezius L and lateral epicondyle R , algometer score , tender points count ) , body fat percentage , and FIQ total score . In the intervention group , post hoc analysis revealed a significant improvement in pain threshold of the anterior cervical R and L and supraspinatus R and L tender points ( all p algometer score ( p = 0.008 ) , tender point count ( p = 0.002 ) , body fat percentage ( p = 0.001 ) , and FIQ total score ( p = 0.003 ) . CONCLUSIONS A 3-month ( one session per week ) Biodanza intervention shows improvements on pain , body composition , and FM impact in female patients",
"INTRODUCTION The importance of physical exercise for patients with fibromyalgia ( FM ) is very clear in the literature . Dancing is a type of aerobic exercise that has great acceptance . In addition to the beneficial effects of aerobic exercise , Zumba works on motor coordination and also has socializing as a part that should be included in patients with fibromyalgia . OBJECTIVES To evaluate the effectiveness of Zumba dancing in improving pain , functional capacity , quality of sleep and quality of life of women with fibromyalgia . DESIGN A pre-post treatment design . METHODS We evaluated 19 women with fibromyalgia , selected by convenience . Data were collected in the second half of 2016 . Zumba dancing was performed twice a week for 12 weeks . Patients were evaluated at week 0 ( T0 ) and at week 12 ( T12 ) , by the following instruments : VAS ( Visual Analogic Scale ) , Likert Scale , TUG ( Timed Up an Go Test ) , 6MWT ( Six-minute Walk Test ) , FIQ ( Fibromyalgia Impact Question naire ) , PSQI ( Pittsburgh Sleep Quality Index ) , ESS ( Epworth Sleepiness Scale ) and SF-36 quality of life . RESULTS We found differences in pain ( VAST0 = 6.21 and VAST12 = 4.53 ) with p = 0.001 and in the domain physical functioning of SF36 ( T0 = 42.37 and T12 = 52.11 ) with p = 0.04 . No differences were found for the other variables between the times . CONCLUSION Zumba dancing as a form of treatment for three months for patients with fibromyalgia was effective in improving pain and physical functioning . Future controlled and r and omized clinical trials should be performed to improve the evidence of Zumba dancing in women with fibromyalgia"
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INTRODUCTION Idiopathic mastalgia ( benign breast pain of unknown origin ) is often poorly managed because of its subjective nature and unclear aetiology . Mastalgia is a reason for up to 50 % of breast outpatient referrals . Existing systematic review s discuss date d treatment options that provide limited symptomatic relief . METHODS A systematic review was conducted for aetiology and treatment of idiopathic mastalgia in accordance with PRISMA ( Preferred Reporting Items for Systematic Review s and Meta-Analyses ) guidance . Data bases such as PubMed , MEDLINE , Cochrane Data base and the Clinical Trial Registry were search ed ( February 2016 ) . RESULTS Reassurance plus bra-fitting advice provides relief for most women . If symptoms persist , addition of topical non-steroidal anti-inflammatory drugs ( NSAIDs ) provides relief in 70 - 92 % of women . There is some benefit in reducing dietary coffee and fat intake . Medical treatments have serious side-effects ( often and rogenic or menopausal ) and should be considered only in cases resistant to simpler measures . Dopamine agonists are useful , but less effective than endocrine treatments such as Danazol or Tamoxifen . Of the Selective Oestrogen Receptor Modulator drugs , Ormeloxifene appears most effective , but is not licenced in the United Kingdom . Relaxation therapy , acupuncture and kinesiology may be useful but currently lack good evidence of effectiveness . DISCUSSION First-line management of breast pain should be explanation , reassurance and a bra-fitting advice . Subsequent drug therapy should be balanced against its side-effects ; topical NSAIDs and Ormeloxifene show greatest benefit with least side-effects . Newer agents ( Ormeloxifene ) currently being used for mastalgia in India could be considered in the developed world
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"OBJECTIVE To determine the therapeutic effect of lisuride maleate on premenstrual mastalgia in premenopausal women . DESIGN Double-blind r and omized prospect i ve study . SETTING Department of obstetrics and gynecology at a university hospital . PATIENT(S ) Sixty women with premenstrual mastalgia were included in the study . Study and control groups consisted of 30 women each . INTERVENTION(S ) Women enrolled in the study and control group were given one tablet daily ( 0.2 mg ) of lisuride maleate or placebo orally for 2 months . Severity of mastalgia was evaluated using the visual analog scale . MAIN OUTCOME MEASURE(S ) Severity of mastalgia and side effects of the drug administered . RESULT ( S ) Mastalgia subsided significantly in women receiving lisuride maleate compared with controls . There were no significant side effects from lisuride maleate . Prolactin levels decreased significantly in the group receiving lisuride , which correlated well with pain resolution . CONCLUSION ( S ) Lisuride maleate may be useful for the symptomatic treatment of premenstrual mastalgia",
"BACKGROUND The aim of the study was to investigate the effects of topical nonsteroidal antiinflammatory drugs ( NSAIDs ) on mastalgia . STUDY DESIGN A prospect i ve , r and omized , blinded , placebo-controlled study was performed to evaluate the effects of topical NSAIDs on cyclic and noncyclic mastalgia . A total of 108 patients , 60 with cyclic ( group I ) and 48 with noncyclic ( group II ) breast pain were enrolled . Patients within each group were r and omly assigned to receive either topical NSAIDs or placebo three times daily for at least 6 months . Severity of pain was measured before and after 6 months of treatment . RESULTS The pain score decreased significantly when the mean initial breast pain score was compared with the sixth-month breast pain score of the treatment or the placebo group of cyclic ( p = 0.0001 and p = 0.0001 , respectively ) or noncyclic mastalgia ( p = 0.0001 and p = 0.0001 , respectively ) . Significant differences were found when the mean within-person change in pain values in each treatment group were compared with the change in the respective placebo group for either cyclic or noncyclic mastalgia ( p = 0.0001 and p = 0.0001 , respectively ) . Changes in pain within treatment groups or placebo groups for cyclic versus noncyclic mastalgia were not found to be statistically different ( p = 0.53 and p = 0.96 , respectively ) . No side effect was seen in any group . CONCLUSIONS Topical application of NSAIDs was effective in both cyclic and noncyclic mastalgia with minimal side effects ",
"OBJECTIVE To describe an accurate and reproducible method to quantify a patient 's subjective experience of breast pain . DESIGN Prospect i ve diary study . SETTING Military tertiary care hospital . PATIENTS Thirty female military health care beneficiaries from the Walter Reed Army Medical Center , Washington , DC , gynecology and general surgery clinics . MAIN OUTCOME MEASURES Daily mastalgia was recorded using a visual analog scale and menstrual symptoms were measured using a daily question naire . These measures were correlated with results of a screening question naire completed prior to study entry . RESULTS Patients identified as having cyclical mastalgia based on the screening question naire ( n= 15 ) were found to have higher peak perimenstrual mastalgia according to their daily diaries than patients who did not meet diagnostic criteria ( n=15 ) ( 5.3+/-0.7 vs 3.5+/-0.5 , P question naire to the diary data , 17 of 30 patients met diagnostic criteria for cyclical mastalgia . The ability of the screening question naire to predict the results of the prospect i ve diary data was calculated , and positive and negative predictive values were 73 % and 60 % , respectively . Most patients with cyclical mastalgia also have other perimenstrual psychological and somatic complaints , although a subset of patients has high levels of mastalgia with minimal associated symptoms . CONCLUSIONS Accurate assessment of mastalgia can not be done with a retrospective question naire and requires prospect i ve diary evaluation , owing to the variable and subjective nature of symptoms and recall bias . A daily visual analog scale provides reproducible results and is easy for patients to use",
"Cyclical mastalgia is very common in Western population s and is believed to have an hormonal basis . Simple measures such as vitamins or evening primrose oil are not very effective , yet the disease rarely warrants anti-oestrogen therapies . Isoflavones are a subgroup of phytoestrogens which we hypothesized might be a simple and effective means of therapy as they act as a weak anti-oestrogen in pre-menopausal women and have no side-effects . A double-blind r and omized control trial of either placebo , 40 mg or 80 mg of isoflavones was undertaken after an initial 2 month single-blind ' Placebo Lead-in ' to exclude women with a significant placebo response . Eighteen women were r and omized to the treatment phase of the trial . Nine of the 12 women on treatment had a worthwhile improvement in their pain compared to only two of six on placebo . The reduction in pain was 13 % for placebo , 44 % for 40 mg of isoflavone per day and 31 % for 80 mg per day . There have been no previous clinical studies of isoflavones for the treatment of mastalgia and the benefit demonstrated in this study adds another valuable arm to therapy",
" We conducted a r and omized trial to evaluate effectiveness of Centchroman in control of mastalgia and compared it with Danazol . Research Question - Is proportion of pain relief achieved by Centchroman similar to or inferior to that achieved by Danazol ? In a r and omized controlled trial of Centchroman vs. Danazol in mastalgia , 81 patients with mastalgia were studied . Thirty-nine patients were r and omized to Danazol arm and 42 in Centchroman arm . The treatment was given for 12 weeks , followed by observation for 12 weeks . The pain was measured by visual analogue scale ( VAS ) of 0–10 . At 12 weeks 89.7 % women achieved reduction in pain score to ≤3 in Centchroman group ( pvalue 0.001 ) . In Danazol group 69.44 % women achieved reduction in pain score to ≤ 3 ( p = 0.001 ) . Three months after stopping therapy , Centchroman was more effective in pain score reduction at 24 weeks as compared to Danazol ( p = 0.019 ) . Centchroman is an effective , safe and inexpensive alternative to Danazol for treatment of mastalgia",
"Differences in breast tissue can be determined using breast-enhanced scintigraphy test ( BEST ) imaging . Minimal work in vivo has been done previously to determine the effects of soy protein on breast tissue . The authors ' earlier work demonstrated reduction in inflammatory changes in breast tissue . This work was conducted to examine the effect of daily soy protein consumption on a larger group of women over the course of 1 year . Sixty-four premenopausal women were studied after initial BEST imaging evaluation revealed fibrocystic changes of the breast . Women were asked to consume a medical- grade soy protein on a daily basis , making no other dietary or lifestyle changes during that time . Each woman underwent BEST imaging 1 year later with the results compared to the initial findings . Women and their physicians reported a subjective reduction in both breast tenderness and fibrocystic disease ( FCD ) . There was a nonstatistical reduction in both the average and maximal count breast activity following 1 year of daily soy consumption . There was a statistically significant reduction ( P variability of tissue activity following 1 year of soy protein treatment . This is the first in vivo study looking at the effect of soy protein on breast tissue health . The findings are promising and showed both objective and subjective findings consistent with a reduction in fibrocystic disease of the breast . Further research is needed to confirm these findings in a greater number of women and to determine if soy protein has the same beneficial effect in atypia and breast cancer",
"Background Many women experience symptoms of cyclical mastalgia , such as breast pain , tenderness , and nodularity . Tamoxifen and other drugs have been used to alleviate cyclical mastalgia symptoms ; however , their use is associated with potentially serious side effects . The current study compared the safety and efficacy of two doses of a topical gel containing 4-hydroxytamoxifen ( Afimoxifene , formerly known as 4-OHT ) with placebo gel for the treatment of moderate to severe cyclical mastalgia . Methods Premenopausal women aged at least 18 years experiencing moderate to severe symptoms were r and omized to receive placebo , 2 mg , or 4 mg of Afimoxifene daily delivered as a transdermal hydroalcoholic gel for 4 menstrual cycles . The primary efficacy parameter was change in mean pain intensity as measured by the Visual Analog Scale ( VAS ) for the seven worst pain score days within a cycle from baseline to the fourth cycle . Results After 4 cycles of treatment , statistically significant improvements relative to placebo were measured in mean VAS score in the 4-mg Afimoxifene group ( −12.71 mm [ 95 % confidence interval , −0.96 to −24.47 ; P = 0.034 ] ) . Patient global assessment of pain , physician ’s assessment of pain , tenderness on palpation , and nodularity following 4 cycles of treatment were significantly more likely to show improvements in the 4-mg group , compared with placebo ( P = 0.010 [ pain ] ; P = 0.012 [ tenderness ] ; P = 0.017 [ nodularity ] ) . Overall , Afimoxifene was well tolerated with few adverse events and no drug-related SAE occurred in any group . There were no changes in menstrual pattern or plasma hormone levels and no breakthrough vaginal bleeding in patients treated with Afimoxifene . Conclusion After 4 months of treatment , daily topical breast application of Afimoxifene result ed in statistically significant improvements in signs and symptoms of cyclical mastalgia across patient- and physician-rated scales with excellent tolerability and safety",
"Objectives Centchroman ( Ormeloxifene ) is a novel non-steroidal , selective antiestrogen . Because of its selective antiestrogen action , centchroman has been used for treatment of mastalgia and fibroadenoma . Material s and Methods Benign breast disease patients up to 35 years of age attending our surgery outpatient department from August 2003 to September 2004 and fulfilling the inclusion criterion were included in this study . They were started on centchroman 30 mg on alternate days for a period of 3 months and were followed up for 6 months . Results were recorded as per clinical examination , visual analog scale ( VAS ) for pain , and ultrasonography for breast lump size . Results A total of 60 patients were included in this pilot study , 42 ( 70 % ) of whom had mastalgia with or without nodularity , and 18 ( 30 % ) had fibroadenoma . Noncyclical pain was recorded in 38 patients ( 90 % ) , and cyclical pain was recorded in only 4 ( 10 % ) patients . A VAS score of 10 was recorded by 33 ( 80 % ) patients ( severe pain ) , and the remaining 9 patients ( 20 % ) had VAS scores from 7 to 10 . Fibroadenoma size ranged from 1.5 to 5 cm . , single or multiple in one or both breasts . There was a good response in the mastalgia group , with a decrease in the VAS scoring from 10 to 3 in 90 % of the patients in the first week . Almost all of the patients were painless at the end of one month , with complete disappearance of the nodularity . In the fibroadenoma group there was a mixed response , with complete disappearence in 40 % , partial regression in 20 % , and no response at all in the remaining 40 % . There were very few side effects . Conclusions Centchroman is a safe nonsteroidal drug for the treatment of mastalgia and fibroadenoma . It has shown good results in mastalgia and is a safe drug as compared to the drugs of choice used at present ( danazole and bromocriptine ) . Further r and omized studies are in progress and are needed to determine its definitive role in this patient group",
"BACKGROUND In most Western countries gamolenic acid is the first-line treatment for women with cyclical mastalgia . METHODS A prospect i ve study was carried out in the breast referral clinic of the Department of Surgery , University of Hong Kong to evaluate the treatment of cyclical mastalgia using gamolenic acid provided in evening primrose oil ( Efamast , Scotia Pharmaceuticals Ltd , Scotia House , Stirling , Scotl and ) as a pioneer experience in Asia . In addition , the features of cyclical mastalgia in Oriental women were studied by conducting a survey using anonymous question naires . RESULTS Sixty-six women with disturbing cyclical mastalgia seen by one breast surgeon were followed up with a breast pain diary . Thirty-four women had persistently disturbing mastalgia and were commenced on Efamast . Responses were measured at 3 and 6 months according to a st and ardized protocol . An overall useful response rate of 97 % was observed at 6 months . Side-effects were found in 12 % but all were insignificant . CONCLUSIONS Efamast may be recommended as a first-line specific treatment for Oriental women with disturbing cyclical mastalgia",
"Perimenstrual breast pain ( cyclical mastalgia ) is a common problem that can be sufficiently severe to interfere with usual activities , and has been associated with elevated mammography usage in young women . This study was undertaken to replicate clinic-based research on cyclical mastalgia , and to examine the association between this disorder and health-related behaviors and perceived stress . Using r and om digit dialing throughout Virginia , 874 women aged 18 - 44 were interviewed . Sixty-eight per cent of women experienced cyclical breast symptoms ; 22 % experienced moderate to extreme discomfort ( classified as cyclical mastalgia ) . Hormonal contraceptive usage was associated with significantly less mastalgia and premenstrual syndrome ( PMS ) . Smoking , caffeine consumption and perceived stress were associated with mastalgia ( odds ratios = 1.52 , 1.53 and 1.7 , respectively ) . Young women ( under 35 years ) with mastalgia were more likely to have had a mammogram ( 20.2 % ) than those without mastalgia ( 9.9 % ) . Most women with this disorder ( 77.5 % ) did not have PMS . The prevalence of cyclical mastalgia and its association with mammography replicate clinic-based findings . Associations with smoking and stress had not previously been reported . Prospect i ve research is needed to determine the biopsychosocial factors contributing to this disorder",
"Background Breast pain is a common symptom in patients attending breast clinics . Although most patients experience mastalgia of mild to moderate severity , approximately 15 % of patients suffer from severe pain that causes significant distress and some disturbance in their daily life that lead them to seek treatment . Despite a considerable number of drugs suggested for decreasing the severity of mastalgia , there is no st and ard treatment for the complaint . In this study , we investigated the effect of naproxen on reducing the complaint of breast pain compared with placebo . Methods Eighty-one women suffering from noncyclic breast pain were recruited to a r and omized , double-blind , clinical trial between January 2002 and September 2004 . All patients were suffering from this complaint for at least 3 months before the study . Patients were r and omly assigned to two groups . Patients in the case group received naproxen 250 mg BD . Patients in the placebo group took placebo in a similar manner . The intensity of mastalgia was assessed before and twice after intervention by using a Visual Analogue Scale . Results Forty-two of 81 patients were recruited r and omly as cases and the remaining 39 were assigned placebo . Of these 24 and 22 patients fulfilled the study protocol respectively . The mean age of patients was 35 ( SD = 7.5 ; range , 19–55 ) years . The mean pain severity at the beginning of the study was 5.8 and 6.1 in naproxen and placebo groups , respectively . The severity of pain was decreased significantly at the end of the study in both groups ( 3.9 in patients and 3.7 in controls ( P = 0.005 and 0.0001 ) ) . Although the decrease in pain severity in each individual group was statistically significant , it was not significant compared with one another ( P = 0.64 ) . Conclusions Breast pain is a complex symptom that can be relieved significantly with reassurance . According to the result of this study , naproxen has no superiority over placebo in reducing noncyclic breast pain",
"Thirty‐one of 62 consecutive premenopausal women with primary cancer of the breast completed a 1‐year investigation period , receiving either 30 mg tamoxifen daily ( 15 patients ) or placebo ( 16 patients ) . They were examined at the operation ( t0 ) and at 3‐month intervals ( t1 , t2 , t3 , and t4 ) . Bone mineral content ( BMC ) was measured at operation and after 12 months . Fifty‐six patients with benign tumors were included as healthy controls . All values of both cancer treatment groups and of the benign tumor group were comparable at the time of operation . BMC decreased significantly in both cancer patient groups when 12‐month values were compared to the initial level ( tamoxifen , −3.2 % , P placebo −2.5 % , P difference in BMC changes was noted between tamoxifen and placebo treatment . The serum phosphate was significantly decreased in the tamoxifen treatment group at each examination . In the placebo group , the alkaline phosphatase level increased significantly at each examination , whereas the serum magnesium fell at the 6‐ and 12‐month examinations . All other biochemical indices of calcium metabolism were basically unchanged . It is concluded that BMC is reduced in metastatic breast cancer through osteolytic metastatic bone foci . Tamoxifen also decreases the BMC . It is , however , unclear if this effect is due to a progression of the disease in spite of the treatment or if it is caused by a direct action of tamoxifen on bone",
"INTRODUCTION Several agents have been tried in the management of mastalgia . Centchroman ( Ormeloxifene ) , a novel non-steroidal selective estrogen receptor modulator ( SERM ) , has also been recently used in the management of mastalgia . METHODS Eligible patients , who had mastalgia for more than 3 months , were r and omized into two groups - Group A received centchroman 30 mg daily and Group B received tamoxifen 10 mg daily . Treatment was continued for a total of 12 weeks ; thereafter , patients were followed for another 12 weeks without medication to assess the continuum of relief . Pain severity was measured with VAS score . Patients were considered to have complete pain relief if their VAS score decreased to 3 or less . RESULTS Patients , in both the groups , showed gradual improvement in mastalgia with passage of time up to 12 weeks . Following cessation of treatment at 12 weeks , partial relapse of pain was observed at 24 weeks . There was no significant difference between Group A and Group B in terms of mean VAS Score and proportion of women reporting pain relief at 4 , 8 , 12 , and 24 weeks . Fifteen patients in Group A had side effects namely dizziness , menstrual irregularities and development of ovarian cysts . There was no side effect noted in group B. CONCLUSION Centchroman and tamoxifen were found to be of similar effectiveness in providing pain relief in mastalgia . High frequency of side effects , particularly development of ovarian cyst , in patients receiving centchroman is a matter of concern",
"Although the aetiology of cyclical mastalgia is poorly understood , the consistent finding of an increased prolactin stimulation response probably due to oestrogen dominance has led to the use of treatment with prolactin-lowering drugs and antioestrogens . The efficacy and safety in cyclical mastalgia of gestrinone , which has and rogenic , anti-oestrogenic , and antiprogestagenic properties , were investigated in a multicentre study . In a double-blind r and omisation procedure , 72 patients were allocated placebo and 73 treatment with gestrinone ( 2.5 mg twice a week ) for 3 months . The patients recorded the severity of breast pain on a visual analogue scale before and during treatment and scored other breast symptoms as not present ( 0 ) , mild ( 1 ) , moderate ( 2 ) , or severe ( 3 ) . The gestrinone group had significantly greater reductions than the placebo group in breast pain score at months 1 , 2 , and 3 of treatment ( mean reduction 59.5 [ SD 22.6 ] to 11.7 [ 17.0 ] vs 58.2 [ 17.6 ] to 36.7 [ 23.0 ] at month 3 ; p less than 0.0001 ) . All six breast symptoms had lower scores in the gestrinone than in the placebo group by the end of treatment . In a subset of 30 participants ( 15 from each group ) , serum concentrations of oestradiol , progesterone , and tri-iodothyronine were significantly lower than baseline after 3 months of gestrinone , but concentrations of luteinising hormone , follicle-stimulating hormone , prolactin , thyroid-stimulating hormone , and thyroxine did not change . 41 % of gestrinone-treated and 14 % of placebo-treated patients reported at least one side-effect ; most of these were and rogen-mediated . 11 placebo-treated patients and 4 on gestrinone discontinued treatment . Thus , gestrinone was very effective in the treatment of cyclical mastalgia and was well tolerated",
"Cyclic mastalgia is one of the most prevalent disorders among fertile women . To date , hormonal agents , despite their side effects , have been widely used for treatment of this ailment . This study was performed to clarify the therapeutic effects of Vitamin E ( Vit E ) as a safe treatment for cyclic mastalgia among fertile women . This study was conducted as a double blind clinical trial ; 150 women with cyclic mastalgia , referred by three public health centers in Qazvin City in Iran , were enrolled in the trial and r and omly divided into two distinct case and control groups ; each containing 75 patients . The severity and duration of breast pain were measured according to both the Cardiff Breast Pain Chart and the Visual Analog Scale . Simple , chewable tablets of either Vit E or a placebo were prescribed twice a day for 4 months for case and control participants , respectively . Follow-up was performed at the end of both the second and the fourth months and , at that time , the severity , duration and side effects of intervention were evaluated . The administration of Vit E had significant curative results as tested at both the 2- and 4-month benchmarks . Chi-square testing indicated that after both 2 and 4 months of therapy , the efficacy demonstrated by the Vit E recipient case group was superior to that of the group that received a placebo . Applying the Mc Nemar Test , it also was shown that there was no significant difference in the benefits received between treatment courses of 2 versus 4 months . A 2-month prescription of Vit E has positive therapeutic effects on cyclic mastalgia . Given its lack of significant side effects , Vit E , therefore , can be considered a safe alternative to hormonal therapies currently being used in the treatment of cyclic mastalgia",
"OBJECTIVE To compare oil of evening primrose ( OEP ) and topical nonsteroidal anti-inflammatory ( NSAIDs ) with respect to safety , effectiveness , rapidity of response , cost effectiveness and acceptability in the treatment of breast pain . STUDY DESIGN An open , non-r and omised , comparative study of topical ( NSAI ) gel versus OEP was carried out , over a period of one year . PATIENTS AND METHODS Fifty female patients attending the outpatient department with moderate to severe breast pain were given one of the two agents alternatively , after selection . RESULTS Results showed that out of 25 patients treated with OEP , 64 % had a clinical ly significant response after three months of treatment , compared with 92 % with topical NSAIDs . Only one patient ( 4 % ) had side effects with OEP , while no patient had side effects with topical NSAIDs . Twenty per cent and seventy per cent showed acceptability as far as costs were concerned and mode of administration respectively , with OEP . The acceptability rate was 68 % and 96 % respectively , with topical NSAIDs . CONCLUSION This study has shown topical NSAIDs to be safe , effective , rapid and acceptable mode of treatment for cyclical and non-cyclical mastalgia",
"HYPOTHESIS Toremifen is effective in reducing breast pain and does not increase the incidence of adverse events as a therapy for moderate to severe mastalgia . DESIGN AND PATIENTS In a double-blind r and omized controlled trial , patients with moderate to severe mastalgia received toremifen citrate , 30 mg daily , or a placebo tablet for 3 menstrual cycles and were followed up for breast pain score and adverse events . The serum levels of estradiol , progesterone , and prolactin were examined before treatment and correlated with the response rate to toremifen treatment . RESULTS Seventy-two ( 69.2 % ) of 104 patients receiving toremifen and 29 ( 31.9 % ) of 91 receiving placebo responded to the treatment , with reduction in breast pain score of more than 50 % ( P patients with cyclical mastalgia , the response rate for toremifen was 76.7 % ( 59/77 ) , whereas the response rate for placebo was 34.8 % ( 23/66 ; P response rate of patients with noncyclical mastalgia was 48.1 % ( 13/27 ) for toremifen and 24.0 % ( 6/25 ) for placebo ( P = .09 ) . Adverse events were observed in 44 ( 42.9 % ) of 104 patients receiving placebo and 46 ( 50.5 % ) of 91 patients receiving toremifen ( P = .45 ) . A positive correlation between baseline breast pain score and serum estradiol level was observed in patients with cyclical mastalgia ( r = 0.35 , P = .003 ) . CONCLUSIONS Toremifen effectively relieves moderate and severe cyclical mastalgia and tends to exert a positive therapeutic effect on noncyclical mastalgia . In addition , toremifen therapy does not increase the incidence of intolerable adverse event . Therefore , it is a feasible therapy for mastalgia , especially cyclical mastalgia",
"One of the successful treatments for cyclical mastalgia is bromocriptine evening primrose combination . A double blind study was applied on 80 patients with cyclical mastalgia . They were r and omly divided into two groups ( A and B ) . In group A , patients were treated by bromocriptine/evening primrose . To group B , LILT with specified dosimetry was applied , using a device that delivers He-Ne laser combined with 4 infra-red diode laser . Evaluation of treatment was both subjective ( using VAS ) and objective ( study ing the degree of drop in plasma cortisol level ) . The drop of plasma cortisol with treatment was studied using the student -t distribution . A good response was observed in the laser group in 82.5 % , compared to 63.9 % in the bromocriptine/evening primrose group . There was a significant deference before and after treatment in both groups ( P difference was more for the drug treated group than for the laser treated group , but in the latter , it acted on a wider sector of patients . In conclusion , LILT is recommended as a new treatment modality for cyclical mastalgia",
"BACKGROUND Breast pain and non-discrete breast nodularity are common in women . METHODS We did a r and omized , double-blind , placebocontrolled trial of oral ormeloxifene 30 mg , a selective oestrogen receptor modulator ( SERM ) or placebo twice a week for 3 months in 20 - 50-year-old women with breast pain with or without lumpiness . Women with a discrete benign lump or cancer were excluded from the study . Serial assessment s of pain on a visual analogue scale and nodularity grade on a 5-point ordinal Lucknow-Cardiff scale were done . A total of 151 patients were r and omly allocated to two interventions using a block size of 4 . RESULTS Of the 151 patients , 121 ( active 57 , placebo 64 ) were available for efficacy analysis . The mean pain level showed a systematic downward trend over five visits ( F=105.23 , p variation in pain over time for the individual groups differ from the overall mean pattern for the two groups and thus from one another ( F=44.43 , p Cumulative frequencies of breast nodularity grade s during successive visits showed significant improvement ( p=0.001 ) compared to placebo at the end of the third month . The effect of the active drug persisted till the completion ( 6 months ) of treatment ( p grade 2 or lower nodularity as compared to 71.1 % in the placebo group . Oligomenorrhoea alone was reported by 12 patients . CONCLUSION Ormeloxifene showed significant efficacy for treating breast pain and nodularity",
"Abstract Background : Mastalgia is a debilitating disorder , which has serious effects on one 's daily life and causes significant medical costs . Aim : Mastalgia patients determine the overall approach and improve the quality of life of patients . Methods : In this study , the outcomes of psychoeducation on anxiety and pain in a group of patients with mastalgia without an organic etiology have been investigated . 88 patients were included in this study . The socio-demographic data form , the Symptom Checklist 90 ( SCL-90 ) , the Toronto Alexithymia Scale-20 ( TAS-20 ) , the Hamilton Anxiety Scorer ( HAM-A ) , the State – Trait Anxiety Inventory ( STAI-I , STAI-2 ) and the Visual Analogue Scale ( VAS ) were all applied to the patients . 64 r and omly selected patients ( Group 1 ) were given psychoeducation while the remaining 24 ( Group 2 ) were not . All patients were called back after 1 month for repeats of the HAM-A , STAI-I , STAI-2 and VAS tests . Results : The results of this study demonstrated that psychoeducation has positive impacts on the perception of pain besides stationary , contemporary and total anxiety scores . Conclusions : It is concluded that the administration of psychoeducation is a good choice in the degradation of anxiety symptoms and pain",
"60 patients with severe mastalgia of more than 6 months ' duration were r and omly selected for treatment with either tamoxifen 20 mg daily or placebo for 3 months . As measured by linear analogue scoring , pain relief was achieved in 22/31 ( 71 % ) of those receiving tamoxifen and 11/29 ( 38 % ) of those taking placebo . Patients who did not respond to the first course of treatment were allocated to the alternative treatment for 3 months . Pain control was achieved in 8/12 ( 75 % ) of those receiving tamoxifen and 2/6 ( 33 % ) of those receiving placebo . The commonest side-effects were hot flushes ( 27 % of patients receiving tamoxifen and 11 % of those receiving placebo ) and vaginal discharge ( 17 % tamoxifen , 7 % placebo ) . Side-effects caused 6 patients in each group to discontinue treatment . Tamoxifen is of value in the management of severe cyclical and non-cyclical mastalgia , and relief can be achieved without undue side-effects in the majority of patients",
"A single-blind , r and omized clinical trial of 56 female subjects was conducted to determine whether decreased consumption of caffeine decreases breast pain/tenderness or nodularity in patients with suspected benign proliferative breast disease . The subjects were r and omly assigned to one of three groups -- a control group ( no dietary restrictions ) , a placebo group ( cholesterol-free diet ) , and an experimental group ( caffeine-free diet ) . At the initial examination , the subjects reported on the presence of breast pain , the degree to which pain affects daily activities , the frequency of pain , the degree of pain associated with breast examinations , and the degree of pain associated with close-fitting clothing . Subjects were then examined and the four quadrants of each breast were rated on a scale of 0 to 3 ( 0 = normal , fatty tissue , 1 = little seedy bumps or fine nodularity , 2 = discrete nodules or ropy tissue , 3 = confluent areas , hard or soft masses ) . Subjects in all three groups returned for 2- and 4-month follow-up examinations . Total nodularity scores , degree of pain/tenderness , and compliance with dietary restrictions were analyzed . The data showed that decreased caffeine consumption did not result in a significant reduction of palpable breast nodules or in a lessening of breast pain/tenderness",
"A double-blind crossover study giving 20 mg/day of medroxyprogesterone acetate during the luteal phase was carried out in 26 women with cyclical mastalgia . Symptomatic response to this progestogen supplementation or placebo was assessed objective ly by clinical examination and subjectively by linear analogue scales and breast pain charts . No significant relief of pain or tenderness was found on placebo or active treatment , irrespective of treatment order , and breast nodularity was similarly unaltered . No evidence of progesterone deficiency or prolactin abnormality was found . Side-effects were incurred in 11 patients ( five on placebo , five on active treatment and one while on both ) and were mostly vague premenstrual symptoms . We conclude that the therapeutic response of medroxyprogesterone acetate in cyclical mastalgia is no better than placebo and that progestogen supplementation can no longer be recommended for routine use in the management of breast pain",
"OBJECTIVE To evaluate the effectiveness of vitamin E , evening primrose oil ( EPO ) , and the combination of vitamin E and EPO for pain control in women with cyclical mastalgia . PROCEDURE A double-blind , r and omized , placebo-controlled trial was conducted at two U.S. academic medical centers . Eighty-five women with premenstrual cyclical breast discomfort were enrolled . Participants were r and omly assigned to one of four six-month oral treatments : vitamin E ( 1,200 IU per day ) , EPO ( 3,000 mg per day ) , vitamin E ( 1,200 IU per day ) plus EPO ( 3,000 mg per day ) , or double placebo . The primary outcome measure was change in breast pain , measured by the modified McGill Pain Question naire at enrollment and at six months . RESULTS Forty-one patients completed the study . Intent-to-treat analysis ( pretesting and post testing ) showed a difference in worst-pain improvement with the treatments EPO ( p=0.005 ) , vitamin E ( p=0.04 ) , and EPO plus vitamin E ( p=0.05 ) , but no difference with placebo ( p=0.93 ) . Results from two- sample t-test showed a nonsignificant decrease in cyclical mastalgia individually for the three treatment groups compared with the placebo group ( EPO , p=0.18 ; vitamin E , p=0.10 ; and EPO plus vitamin E , p=0.16 ) . The data were also analyzed with the separation test by Aickin , which showed a trend toward a reduction of cyclical mastalgia with vitamin E and EPO individually and in combination . CONCLUSION Daily doses of 1,200 IU vitamin E , 3,000 mg EPO , or vitamin E and EPO in combination at these same dosages taken for six months may decrease the severity of cyclical mastalgia",
"Severe mastalgia was the dominant feature in 10 women with diffuse fibrocystic disease of the breast as judged by palpation and mammography and verified histologically . One patient ( case 1 ) had galactorrhoea . None had prominent characteristics of the premenstrual syndrome . Mastalgia had been present for from six months to several years . In a double-blind crossover trial patients were allocated at r and om to receive either bromocriptine or identical placebo capsules , each for a period of two months , in a dose of one capsule ( bromocriptine 2 - 5 mg or placebo ) daily during the first week of each period and thereafter two capsules daily . For one month before the trial and throughout the period of medication the presence and intensity of pain were recorded daily by each patient . They were seen in the outpatient clinic every four weeks . The code was broken at the end of each trial . Serum prolactin concentration was measured before the trial , on the day of crossover , and on the final day of the trial ( normal range 3 - 0 - 13 - 5 jug/l ) . During treatment with bromocriptine pain was totally or almost totally relieved in eight patients and in two the pain was much reduced ( table ) . Placebo treatment failed to relieve mastalgia in any patient except one ( case 9 ) , in whom the relief during bromocriptine continued while taking placebo . Statistical analysis by Koch 's method ' showed that the relief obtained during bromocriptine therapy was significantly greater ( P placebo medication , while period effects as well as carry-over effects were absent ( P > 0 - 05 ) . Mastalgia reappeared as soon as active medication was stopped , with the exception of the patient in case 9 . The breasts became smaller , softer , and less tender during bromocriptine treatment . The pretrial serum prolactin concentration was slightly raised in three patients and normal in seven . During treatment with bromocriptine these concentrations were significantly lowered ( P side effects from placebo . While taking bromocriptine five patients had slight , transitory nausea and dizziness , which is a recognised side effect . Three others had persistent and more pronounced nausea , dizziness , and general malaise",
"In a placebo-controlled , r and omized , double-blind study the efficacy of a Vitex agnus castus extract-containing solution ( VACS ) was investigated in patients suffering from cyclical mastalgia . Patients had mastalgia on at least 5 days in the pre-treatment cycle . During this cycle and during treatment ( 3 cycles ; 2 x 30 drops/day ) , the intensity of mastalgia was recorded once per cycle using a visual analogue scale ( VAS ) . After one/two treatment cycles , the mean decrease in pain intensity ( mm , VAS ) was 21.4 mm /33.7 mm in women taking VACS ( n=48 ) and 10.6 mm/20.3 mm with placebo ( n=49 ) . The differences of the VAS-values for VACS were significantly greater than those with placebo ( p=0.018 ; p=0.006 ) . After three cycles , the mean VAS-score reduction for women taking VACS was 34.3 mm , a reduction of ' borderline significance ' ( p=0.064 ) on statistical testing compared with placebo ( 25.7 mm ) . There was no difference in the frequency of adverse events between both groups ( VACS : n=5 ; placebo : n=4 ) . VACS appears effective and was well tolerated and further evaluation of this agent in the treatment of cyclical mastalgia is warranted",
"Twenty patients with cyclical breast pain were enrolled in a double-blind cross-over trial in which either a soy protein drink or a flavoured cow 's milk was taken orally each day for 3 months before crossing over to the alternate drink for a further 3 months . Records of pain scores were taken throughout the study . Blood was also taken before and after 3 and 6 months for the measurement of phytoestrogents to assess compliance . Two women withdrew from the study at the outset leaving 18 evaluable patients who completed the study . Of these 10 ( 56 % ) felt that soy protein improved breast pain ( two of whom received soy as first treatment ) and two ( 11 % ) felt that cow 's milk alleviated symptoms ( one receiving this as first preparation ) and the remaining six ( 33 % ) experienced no relief of pain with either dietary preparation . Blood levels of diadzein and genistein were elevated after the ingestion of soy protein in only 13 patients ( seven of whom felt that soy improved their breast pain ) ; in the remaining five patients ( three of whom suggested that soy protein improved breast pain ) phytoestrogen levels were no higher than pretreatment values . Although the ingestion of soy protein may be associated with relief of breast pain , these results illustrate the problem of non-specific effects in studies of mastalgia in that 1 ) cow 's milk also relieved breast pain in some patients and 2 ) that the benefits of soy protein were not always associated with evidence of elevated circulating levels of phyto-estrogens , indicating the difficulty of compliance in dietary intervention studies using soy foods",
"In a r and omised parallel-block trial in thirteen European centres bromocriptine 2.5 mg twice a day was compared with placebo therapy for cyclical mastalgia . 272 patients were enrolled into the study . Linear analogue charts and diary pain cards were used for assessment of response . Reduction in breast pain , heaviness , tenderness , and serum prolactin after 3 and 6 months ' therapy were significantly greater with bromocriptine than with placebo . Improvement in symptoms with bromocriptine was maintained for at least 6 months after therapy . Overall 29 % of patients dropped out while on therapy , more from the bromocriptine than from the placebo group . Adverse effects , especially nausea and dizziness , were commoner among the bromocriptine-treated patients , but blood pressure was unaffected",
"In a double-blind , placebo-controlled , parallel group , multicenter study , 555 women with moderate to severe mastalgia were r and omized to one of the four treatment groups to receive ( a ) gamolenic acid ( GLA ) and antioxidants , ( b ) placebo fatty acids and antioxidants , ( c ) GLA and placebo antioxidants , or ( d ) placebo fatty acids and placebo antioxidants , for four menstrual cycles . This was followed by a further eight menstrual cycles of open treatment in which all patients received GLA , but continued to be r and omized to active or placebo antioxidants as in the preceding parallel phase . Diary pain cards and linear analog charts were used for assessment of response . A reduction in breast pain was seen in all four treatment groups during the blinded treatment phase . There was a substantial improvement in the placebo fatty acids groups ( response rate of 40 % ) , and there were no significant differences among the four treatment groups . During the open treatment phase , a further reduction in breast pain was seen in all groups , with no statistically significant differences between groups . This study showed that GLA ( Efamast ) efficacy did not differ from that of placebo fatty acids , regardless of whether or not antioxidant vitamins were present",
"OBJECTIVE Our goal was to evaluate the efficacy and side effects of danazol 200 mg daily given only in the luteal phase of the menstrual cycle to treat premenstrual syndrome and premenstrual mastalgia . STUDY DESIGN We conducted a r and omized , double-blind , placebo-controlled study of 3 menstrual cycles in a postgraduate medical school and National Health Service hospital . The subjects of the study were 100 women who had been referred to the premenstrual syndrome clinic at the North Staffordshire Hospital for the management of premenstrual syndrome and premenstrual breast pain . Outcome measures for the study included assessment of improvement in symptoms measured by specific daily visual analogue scales for 4 principal symptoms of premenstrual syndrome and for premenstrual mastalgia and assessment of side effects and adverse events . RESULTS Significant improvement in symptoms was seen in visual analog scores for mastalgia in months 1 ( P = .03 ) , 2 ( P = .004 ) , and 3 ( P = .01 ) of the study during active therapy compared with placebo . No improvement was seen for any other symptom or for the global premenstrual syndrome score . Side effects on danazol and on placebo were equal and minimal . CONCLUSIONS Luteal phase-only danazol is not effective for the treatment of the general symptoms of premenstrual syndrome but appears highly effective for the relief of premenstrual mastalgia . This approach to therapy is associated with few side effects . Studies of cyclic mastalgia using strict diagnostic criteria are required to see whether the freedom from symptomatic side effects is found in longer-term studies and to determine whether such a regimen avoids potentially detrimental effects on the lipid status",
"Breast pain is a very common complaint in women presenting to the outpatient department . It causes a certain degree of discomfort , anxiety leading to repeated investigations , and to some degree disturbs their lifestyle . This prospect i ve study was carried out at King Fahd Hospital of the University , Alkhobar . Two hundred women presenting to the outpatient surgical department with mastalgia were included ; 100 women received treatment with danazole , and the other 100 were asked to wear sports brassieres for 12 weeks . They were requested to answer a structured question naire during the specified period , and an extensive review of the literature was also performed . Patients were compliant with the instructions . The first group had 58 % relief of symptoms , but 42 % experienced drug side effects ; in the second group , all participants had some degree of initial discomfort followed by relief of symptoms in 85 % of cases . Most patients cl aim ed that their lifestyle had changed dramatically after using the sports brassieres . Mastalgia is a common disease that may run a chronic course . Many patients are unsatisfied with prescribed medications and tend to discontinue treatment when side effects develop . Active breast movement on its weak suspensory ligaments may contribute considerably to mastalgia . Good external support by sports brassieres can relieve most of the patient 's symptoms",
"A prospect i ve study of the effectiveness of the topical application of non-steroidal anti-inflammatory drugs ( NSAIDs ) as a gel preparation was carried out in 26 women with severe breast pain . The results showed a satisfactory relief of pain in 81 % of the women : 11 of 13 with cyclical pain , eight of 11 with non-cyclical pain , and in two women with severe scar pain after lumpectomy and radiotherapy . Topical NSAID gel was applied as required ; the relief of severe pain was rapid and no side effects were reported . These factors compare favourably with established recommended treatments which usually involve months of continuous treatment , tailoring of drug dosages and a significant incidence of intolerable side effects . This study has shown that topical NSAID application is an effective , safe , acceptable and easily administered treatment for severe cyclical and non-cyclical breast pain"
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Purpose To assess the effectiveness and safety of botulinum toxin A ( BTX-A ) at different dosages for overactive bladder ( OAB ) . Material s and Methods The MEDLINE , EMBASE , and Cochrane Controlled Trials Register data bases were search ed through November 3 , 2016 to identify relevant r and omized controlled trials ( RCTs ) . Results Eleven studies were identified in this meta- analysis . Compared with placebo , the urinary incontinence ( UI ) episodes per week as the primary outcomes , urodynamic parameters including maximum cystometric capacity ( MCC ) , and maximum detrusor pressure ( MDP ) for neurogenic detrusor overactivity ( NDO ) at 6 weeks , and for idiopathic detrusor overactivity ( IDO ) at 36 weeks were evaluated . These and other outcomes for effectiveness of BTX-A at different dosages in two observation periods indicate that a dose greater than 50 U is significantly more effective for certain symptoms of OAB compared with placebo . However , there were no significant differences between some dosages . Compared with placebo , the outcomes of total adverse events for NDO and for IDO show that doses of 300 U and 200 U for NDO are associated with more complications . Conclusions In consideration that the treatments of BTX-A were with minimal , local , and manageable adverse effects , this meta- analysis demonstrates that BTX-A 200 U is recommended for management of NDO for short-term treatment for there was no significant difference from the larger dose of 300U . The short-term efficacies of BTX-A for IDO remain to be investigated
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"BACKGROUND Overactive bladder ( OAB ) syndrome with urinary incontinence ( UI ) is prevalent in the population and impairs health-related quality of life ( HRQOL ) . OBJECTIVE To assess the impact on efficacy , safety , and HRQOL of onabotulinumtoxinA ( BOTOX ( ® ) , Allergan , Inc. ) treatment in patients with OAB with UI . DESIGN , SETTING , AND PARTICIPANTS This pivotal , multicentre , double-blind , r and omised , placebo-controlled , phase 3 study enrolled patients with idiopathic OAB with ≥ 3 urgency UI episodes over 3 d and ≥ 8 micturitions per day who were inadequately managed by anticholinergics . INTERVENTION OnabotulinumtoxinA at a 100U dose ( n=277 ) or placebo ( n=271 ) , administered as 20 intradetrusor injections of 0.5 ml . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Co- primary end points were change from baseline in the number of UI episodes per day and proportion of patients reporting positive treatment response on the treatment benefit scale ( TBS ) at week 12 . Additional end points included other OAB symptoms ( episodes of urinary urgency incontinence , micturition , urgency , and nocturia ) and HRQOL ( Incontinence Quality of Life [ I-QOL ] , King 's Health Question naire [ KHQ ] ) . Safety assessment s included adverse events ( AEs ) , postvoid residual ( PVR ) urine volume , and initiation of clean intermittent catheterisation ( CIC ) . RESULTS AND LIMITATIONS OnabotulinumtoxinA significantly decreased UI episodes per day at week 12 ( -2.95 for onabotulinumtoxinA versus -1.03 for placebo ; p ) . Reductions from baseline in all other OAB symptoms were also significantly greater following onabotulinumtoxinA compared with placebo ( p ≤ 0.01 ) . Patients perceived a significant improvement in their condition , as measured by patients with a positive treatment response on the TBS ( 62.8 % for onabotulinumtoxinA versus 26.8 % for placebo ; p baseline in all I-QOL and KHQ multi-item domains ( p indicated positive impact on HRQOL . AEs were mainly localised to the urinary tract . Mean PVR was higher in the onabotulinumtoxinA group ( 46.9 ml versus 10.1 ml at week 2 ; p OAB symptoms , patient-reported benefit , and HRQOL in patients inadequately managed by anticholinergics . TRIAL REGISTRATION Clinical Trials.gov : NCT00910520",
"PURPOSE We evaluated the use of botulinum toxin-A in treating patients with idiopathic detrusor overactivity refractory to anticholinergics . MATERIAL S AND METHODS This double-blind , placebo controlled trial r and omized participants to intradetrusor injections of 200 U botulinum toxin-A ( 16 patients ) or placebo ( 18 patients ) . The primary outcome measure was change in maximum cystometric capacity . Secondary outcome measures included changes in overactive bladder symptoms , post-void residual , maximum detrusor pressure during filling cystometry and reflex detrusor volume . Quality of life was assessed using the Incontinence Impact Question naire short form 7 and Urogenital Distress Inventory short form 6 . Followup occurred at 4 and 12 weeks after injection , at which point the study was unblinded . Further followup in the botulinum toxin-A group occurred at 24 weeks . RESULTS Significant increases in maximum cystometric capacity were observed at 4 weeks ( difference 144.69 ml , 95 % CI 100.95 to 215.75 , p botulinum toxin-A compared to placebo . Botulinum toxin-A reduced frequency ( p urgency urinary incontinence ( p = 0.03 , p = 0.008 ) episodes at 4 and 12 weeks , respectively . Urgency was reduced at 4 weeks ( p = 0.005 ) in the botulinum toxin-A group . In patients receiving botulinum toxin-A , post-void residual increased at 4 weeks ( p = 0.024 ) but became insignificant by 12 weeks ( p = 0.406 ) . Of these patients 6 required intermittent self-catheterization . Significant improvements in quality of life were observed following botulinum toxin-A. The extension study suggests that the beneficial effects of botulinum toxin-A are maintained for at least 24 weeks . CONCLUSIONS Botulinum toxin-A at 200 U is safe and effective for idiopathic detrusor overactivity and the beneficial effects persist for at least 24 weeks",
"Introduction A prespecified pooled analysis of two placebo-controlled , phase 3 trials evaluated whether the number of prior anticholinergics used or reason for their discontinuation affected the treatment response to onabotulinumtoxinA 100U in overactive bladder ( OAB ) patients with urinary incontinence ( UI ) . Methods Patients with symptoms of OAB received intradetrusor injections of onabotulinumtoxinA 100U or placebo , sparing the trigone . Change from baseline at week 12 in UI episodes/day , proportion of patients reporting a positive response ( ‘ greatly improved ’ or ‘ improved ’ ) on the treatment benefit scale ( TBS ) , micturition and urgency were evaluated by number of prior anticholinergics ( 1 , 2 or ≥ 3 ) and reason for their discontinuation ( insufficient efficacy or side effects ) . Adverse events ( AE ) were assessed . Results Patients had taken an average of 2.4 anticholinergics before study enrolment . OnabotulinumtoxinA reduced UI episodes/day from baseline vs. placebo , regardless of the number of prior anticholinergics ( −2.82 vs. −1.52 for one prior anticholinergic ; −2.58 vs. −0.58 for two prior anticholinergics ; and −2.92 vs. −0.73 for three or more prior anticholinergics ; all p The proportion of TBS responders was higher with onabotulinumtoxinA vs. placebo ( 69.0 % vs. 37.2 % for one prior anticholinergic ; 58.8 % vs. 24.8 % for two prior anticholinergics and 56.4 % vs. 22.5 % for three or more prior anticholinergics ; all p reduced the episodes of urgency and frequency of micturition vs. placebo in all groups . AEs were well tolerated , with a comparable incidence in all groups . Conclusion In patients with symptoms of OAB who were inadequately managed by one or more anticholinergics , onabotulinumtoxinA 100U provided significant and similar treatment benefit and safety profile regardless of the number of prior anticholinergics used or reason for inadequate management of OAB . Clinical Trials.gov : NCT00910845 , NCT00910520",
"OBJECTIVE To evaluate the long-term efficacy and safety of repeat onabotulinumtoxinA injections in patients inadequately managed by anticholinergics for urinary incontinence ( UI ) due to neurogenic detrusor overactivity . MATERIAL S AND METHODS Patients who completed either of 2 preceding phase III studies were offered entry into an extension study and received repeat onabotulinumtoxinA 200 U or 300 U. The data were integrated across the phase III and ongoing extension studies . The present interim analysis included all patients who received ≥ 1 onabotulinumtoxinA treatment . The data were analyzed by treatment cycle ( cycles 1 - 5 ) . The primary assessment was the change from baseline in UI episodes/wk at 6 weeks after each treatment . Additional assessment s included ≥ 50 % and 100 % reductions in UI episodes , volume/void , Incontinence Quality of Life responses , and adverse events . RESULTS A total of 387 , 336 , 241 , 113 , and 46 patients received 1 , 2 , 3 , 4 , and 5 onabotulinumtoxinA treatments , respectively . The UI episodes/wk were consistently reduced compared with baseline after repeated onabotulinumtoxinA treatment ( -22.7 , -23.3 , -23.1 , -25.3 , and -31.9 for the 200-U onabotulinumtoxinA group in cycles 1 - 5 ) . The proportion of patients reporting ≥ 50 % and 100 % ( \" dry \" ) reductions from baseline in UI episodes at week 6 ranged from 73%-94 % and 36%-55 % , respectively . Increases in the mean volume/void ( mean increase > 130 mL ) and improvements in quality of life were also observed after repeat treatment . The most common adverse events were urinary tract infections and urinary retention , with no change in the adverse event profile over time . CONCLUSION The results of our study have shown that repeated onabotulinumtoxinA treatments provide sustained reductions in UI episodes and increases in the volume/void and quality of life in patients with neurogenic detrusor overactivity and UI who were inadequately managed by anticholinergics , with no new safety signals",
"Introduction To evaluate the efficacy and safety of onabotulinumtoxinA for the treatment of neurogenic detrusor overactivity ( NDO ) in sub population s of etiology ( multiple sclerosis [ MS ] or spinal cord injury [ SCI ] ) and concomitant anticholinergics ( use/non-use ) . Methods Data were pooled from two double-blind , placebo-controlled , pivotal , phase 3 studies including a total of 691 patients with ≥14 urinary incontinence ( UI ) episodes/week due to MS ( n = 381 ) or SCI ( n = 310 ) . Patients received intradetrusor injections of onabotulinumtoxinA 200U ( n = 227 ) , 300U ( n = 223 ) , or placebo ( n = 241 ) . Change from baseline at week 6 in UI episodes/week ( primary endpoint ) , urodynamics , quality of life ( QOL ) , and adverse events ( AEs ) were assessed . Results Significant and similar reductions in UI episodes were observed regardless of etiology or anticholinergic use : at week 6 , mean weekly decreases of −22.6 and −19.6 were seen in MS and SCI patients , respectively , and −20.3 and −22.5 in anticholinergic users and non-users , respectively , treated with onabotulinumtoxinA 200U . The 300U dose did not add to the clinical efficacy in any sub population . Similar proportions of patients achieved ≥50 % or 100 % reductions in UI episodes in all subgroups . Improvements in maximum cystometric capacity , maximum detrusor pressure during first involuntary detrusor contraction , and QOL were significant in both etiologies and were independent of anticholinergic use . The most common AEs in all groups were urinary tract infection and urinary retention . Conclusion Regardless of concomitant anticholinergic use or etiology , onabotulinumtoxinA significantly improved UI symptoms , urodynamics , and QOL in patients with UI due to NDO . OnabotulinumtoxinA was well tolerated in all groups",
"PURPOSE We determined the safety and efficacy of each of 2 doses of botulinum toxin type A ( BTX-A ) ( 200 or 300 U BOTOX ) injected into the detrusor for urinary incontinence caused by neurogenic detrusor overactivity of predominantly spinal cord origin . MATERIAL S AND METHODS A total of 59 patients with urinary incontinence caused by neurogenic detrusor overactivity ( due to spinal cord injury in 53 and multiple sclerosis in 6 ) requiring clean intermittent self-catheterization were r and omized to receive a single dose into the detrusor of BTX-A ( 200 U or 300 U ) or placebo . Changes in daily frequency of urinary incontinence episodes were monitored via a patient bladder diary during 24 weeks . Key urodynamic assessment s ( maximum cystometric capacity , reflex detrusor volume and maximum detrusor pressure during bladder contraction ) were used to provide objective measures of the treatment effect on bladder function . The impact of treatment on quality of life was assessed using the Incontinence Quality of Life question naire . RESULTS There were significant posttreatment decreases in incontinence episodes from baseline in the 2 BTX-A groups ( p placebo group . In addition , more patients who received BTX-A reported no incontinence episodes during at least 1 posttreatment evaluation period . Positive treatment effects were also reflected by significant improvements in bladder function in the BTX-A groups , as assessed by urodynamics and in patient quality of life . Benefits were observed from the first evaluation at week 2 to the end of the 24-week study . No safety concerns were raised . CONCLUSIONS Intramuscular injections of BTX-A into the detrusor can provide rapid , well tolerated , clinical ly significant decreases in the signs and symptoms of urinary incontinence caused by neurogenic detrusor overactivity during a 24-week study period",
"BACKGROUND In the treatment of patients with idiopathic overactive bladder ( iOAB ) , high doses of botulinum toxin type A ( BoNTA ) were often associated with complications result ing from high postvoid residuals ( PVR ) , leading to clean intermittent catheterisation ( CIC ) and urinary tract infections ( UTI ) . OBJECTIVE Evaluate the efficacy and tolerability of low doses of onabotulinumtoxinA compared to placebo in patients with iOAB . DESIGN , SETTING , AND PARTICIPANTS Between 2005 and 2009 , adults with persistent iOAB were included in a prospect i ve , r and omised , double-blind , placebo-controlled comparative trial . INTERVENTION Patients were r and omised to undergo a single intradetrusor injection procedure of either placebo or onabotulinumtoxinA ( 50 U , 100 U or 150 U ) . MEASUREMENTS The initial evaluations ( ie , clinical and urodynamic variables as well as quality of life [ QoL ] ) were repeated at day 8 and months 1 , 3 , 5 , and 6 . RESULTS AND LIMITATIONS Ninety-nine patients were included in the efficacy analysis . Three months after the procedure , we observed>50 % improvement versus baseline in urgency and urge urinary incontinence ( UUI ) in 65 % and 56 % of patients who respectively received 100 U ( p=0.086 ) and 150 U ( p=0.261 ) BoNTA injections and > 75 % improvement in 40 % of patients of both groups ( 100 U [ p=0.058 ] and 150 U [ p=0.022 ] ) . Complete continence was observed in 55 % and 50 % patients after 100 U and 150 U BoNTA treatment , respectively , at month 3 . Frequency symptoms and QoL improved up to the 6-mo visit . We observed only three patients with a PVR>200 ml in the 150 U group and a few UTIs . CONCLUSIONS 100 U and 150 U BoNTA injections were well tolerated and have both shown to improve symptoms and QoL in patients with iOAB . Nevertheless , 100 U injections showed a reasonable efficacy , with a lower risk of high PVR . TRIAL REGISTRATION Clinical Trials.gov NCT00231491",
"PURPOSE We determined the effectiveness of cystoscopic administration of botulinum-A toxin compared to placebo for the treatment of urinary incontinence in subjects with idiopathic overactive bladder . MATERIAL S AND METHODS Subjects were recruited from the Division of Urogynecology at the University of Rochester . Inclusion criteria were overactive bladder refractory to anticholinergic medications , multiple daily incontinence episodes and a 24-hour pad weight of 100 gm or greater . Subjects with low leak point pressures , increased post-void residual volume or neurological etiologies were excluded from study . Subjects were r and omized to placebo or to 1 of 2 doses of botulinum-A toxin . The detrusor was injected at 8 to 10 sites above the trigone . Evaluations were performed at baseline , and at 3 and 6 weeks after injection , and included bladder diaries , pad weights , quality of life question naires and urodynamic studies . RESULTS A total of 22 subjects participated in stage 1 of this 2-stage study . We report on the outcomes of stage 1 of this study . Because stage 2 is still ongoing and investigators remain blind to the doses of botulinum-A toxin , the 2 botulinum-A toxin groups were combined for this report . There were no differences in mean baseline measurements between the 2 groups . Statistically significant improvements in daily incontinence episodes , pads changed per day and quality of life question naires were seen in the botulinum-A toxin group with no changes in the placebo group . No change in nocturia , daily voiding frequency , peak flow or detrusor pressure was seen in either group . Of 15 subjects 4 ( 26 % ) receiving botulinum-A toxin had a post-void residual volume of 200 cc or greater and 1 subject required intermittent catheterization . Four subjects experienced a urinary tract infection , 2 ( 13 % ) in the botulinum-A toxin group and 2 ( 28 % ) in the placebo group ( not significant ) . CONCLUSIONS Botulinum-A toxin can significantly reduce urge urinary incontinence due to overactive bladder at 6 weeks . However , there is a risk of urinary retention requiring self-catheterization",
"Objective : To evaluate the effects of onabotulinumtoxinA on patient-reported outcomes including health-related quality of life ( HRQOL ) , treatment satisfaction , and treatment goal attainment in patients with urinary incontinence ( UI ) due to neurogenic detrusor overactivity ( NDO ) . Methods : In this multicenter , double-blind , r and omized , placebo-controlled , phase III , 52-week study ( Clinical Trials.gov NCT00311376 ) , patients with UI due to NDO who were not adequately managed with anticholinergic therapy were treated with intradetrusor injections of onabotulinumtoxinA ( 200 or 300 U ) or placebo ( 0.9 % saline ) . HRQOL measures included the Incontinence Quality of Life ( I-QOL ) Question naire total score , and the 3 domain scores ( avoidance and limiting behavior , psychosocial , and social embarrassment ) , the modified Overactive Bladder Patient Satisfaction with Treatment Question naire ( OAB-PSTQ ) , and Patient Global Assessment . Assessment s were made at baseline , posttreatment week 6 ( primary time point ) , week 12 , and at 12-week intervals . Results : Patients ( mean age of 46 years with 30.5 weekly UI episodes at baseline ) were r and omized to receive placebo ( n = 149 ) or onabotulinumtoxinA ( 200 U [ n = 135 ] or 300 U [ n = 132 ] ) . At week 6 , improvements from baseline in I-QOL Question naire total score were greater ( p OAB-PSTQ also demonstrated greater mean improvements from baseline ( p Patient Global Assessment than those in the placebo group ( p ≤ 0.001 vs placebo ) . Conclusions : Patients with UI due to NDO reported greater improvement in HRQOL and treatment satisfaction with onabotulinumtoxinA than with placebo consistently across several patient-reported outcome instruments . Classification of evidence : This study provides Class I evidence that onabotulinumtoxinA intradetrusor injections ( 200 or 300 U ) can improve quality of life measures in patients with NDO not adequately managed with anticholinergic therapy",
"PURPOSE Overactive bladder affects 12 % to 17 % of the general population and almost a third experience urinary incontinence , which may severely impact health related quality of life . Oral anticholinergics are the mainstay of pharmacological treatment but they are limited by inadequate efficacy or side effects , leading to a high discontinuation rate . We report the results of the first large ( 557 patients ) , phase 3 , placebo controlled trial of onabotulinumtoxinA in patients with overactive bladder and urinary incontinence inadequately managed with anticholinergics . MATERIAL S AND METHODS Eligible patients with overactive bladder , 3 or more urgency urinary incontinence episodes in 3 days and 8 or more micturitions per day were r and omized 1:1 to receive intradetrusor injection of onabotulinumtoxinA 100 U or placebo . Co- primary end points were the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a positive response on the treatment benefit scale at posttreatment week 12 . Secondary end points included other overactive bladder symptoms and health related quality of life . Adverse events were assessed . RESULTS OnabotulinumtoxinA significantly decreased the daily frequency of urinary incontinence episodes vs placebo ( -2.65 vs -0.87 , p positive response on the treatment benefit scale ( 60.8 % vs 29.2 % , p overactive bladder symptoms improved vs placebo ( p ≤ 0.05 ) . OnabotulinumtoxinA improved patient health related quality of life across multiple measures ( p Uncomplicated urinary tract infection was the most common adverse event . A 5.4 % rate of urinary retention was observed . CONCLUSIONS OnabotulinumtoxinA 100 U showed significant , clinical ly relevant improvement in all overactive bladder symptoms and health related quality of life in patients inadequately treated with anticholinergics and was well tolerated",
"PURPOSE We determined the effect of 150 units of botulinum-A toxin ( Botox , Allergan , Irvine , California ) on subjects with severe urge urinary incontinence ( UUI ) . MATERIAL S AND METHODS This was an open label uncontrolled clinical trial . Subjects were recruited from the female urology and urogynecology clinics at Duke University . Inclusion criteria included evidence of UUI on 3-day bladder diary , a 24-hour pad weight of 100 gm or greater , absent or minimal stress leakage , absent detrusor dysfunction , and a history of failed anticholinergic and physical therapies . Exclusion criteria included evidence of a urinary tract infection , or other correctable or neurological etiology for UUI . The detrusor of each subject was injected with 150 units of botulinum-A toxin . Evaluations were performed at 2 weeks , 6 weeks , 3 months and 6 months after injection . Outcome measures included daily incontinence episodes , Urogenital Distress Inventory and the Incontinence Impact Question naire , 24-hour pad weights , daily pad usage and urinalysis at all visits . Urodynamic studies were performed at the 6-week and 3-month visits . RESULTS Three subjects had uncomplicated urinary tract infections during followup . No other adverse effects occurred . Statistically and clinical ly significant decreases greater than 50 % were seen in virtually all outcome measures at all visits up to 3 months . Most subjects showed signs of recurrent UUI by 6 months . All subjects reported remarkable subjective improvement in incontinence . No significant changes in maximal cystometric capacity , maximal detrusor pressure , peak flow or post-void residual volumes were seen . CONCLUSIONS Botulinum-A toxin can significantly decrease urge urinary incontinence and improve quality of life for 3 months after injection . Additional studies are needed to determine ideal doses , dosing intervals , safety and cost-effectiveness of this therapy",
"OBJECTIVES To investigate the clinical and urodynamic effects of suburothelial injection of botulinum A toxin on patients with nonneurogenic detrusor overactivity . Intradetrusor injection of botulinum A toxin has been used to treat patients with detrusor overactivity . Suburothelial injection of botulinum A toxin might effectively inhibit the occurrence of detrusor overactivity mediated by sensory nerves . METHODS Twenty patients with nonneurogenic detrusor overactivity refractory to anticholinergics were enrolled and treated with injection of 200 U botulinum A toxin into the suburothelial space . The clinical effects on the lower urinary tract symptoms and urodynamic parameters were assessed . RESULTS At 3 months after treatment , 9 patients had regained continence ( 45 % ) , 8 had improvement ( 40 % ) , and treatment had failed in 3 ( 15 % ) . At 6 months after treatment , 7 patients remained continent , but treatment had failed in 5 . Hematuria developed in 1 patient , urinary tract infection in 7 ( 35 % ) , and a large postvoid residual urine volume requiring catheterization in 6 ( 30 % ) . Hesitancy in initiation and difficult urination was also noted in 15 patients ( 75 % ) . The volume of the first sensation of bladder filling and bladder capacity increased about two times ; however , the voiding efficiency was reduced by 50 % at 2 weeks after treatment . The postvoid residual urine volume was increased by seven times the baseline value at 2 weeks and had decreased to three times greater at 3 and 6 months after treatment . CONCLUSIONS The results of this study have shown that suburothelial injection of 200 U botulinum A toxin impairs bladder sensation and voiding efficiency , but is effective in the treatment of nonneurogenic detrusor overactivity . Transient urinary retention and the development of urinary tract infection should be carefully monitored",
"PURPOSE Several studies have shown that intradetrusor injections of botulinum neurotoxin type A ( BoNT/A ) may effectively treat intractable spinal neurogenic detrusor overactivity ( NDO ) , but fewer reports exist on the use of BoNT/A in patients with idiopathic detrusor overactivity ( IDO ) . The purpose of this study was to investigate whether comparable efficacy could be displayed in the response of patients with IDO to those with NDO . MATERIAL S AND METHODS In a prospect i ve , open label study , patients with urgency , and /or urgency incontinence due to urodynamically proven intractable detrusor overactivity received 300 units ( NDO ) or 200 units ( IDO ) of Botox injected into the bladder with a minimally invasive outpatient technique . Urodynamic maximum cystometric capacity and maximum detrusor pressure during filling , frequency of voids ( frequency ) , number of incontinence episodes ( leak ) and number of voids associated with urgency per 24 hours ( urgency ) from 4-day voiding diaries were compared between the 2 groups at baseline and for changes at 4 and 16 weeks after treatment . RESULTS A total of 44 patients with spinal NDO and 31 with IDO were treated . At 16 weeks , mean + /- st and ard error maximum cystometric capacity increased from 229.1 + /- 24.8 to 427.0 + /- 26.9 ml , p Maximum detrusor pressure during filling decreased from 60.7 + /- 6.8 to 26.1 + /- 3.7 cm H2O , p Frequency decreased from 12.3 + /- 0.7 to 6.6 + /- 0.6 voids per 24 hours , p Leak decreased from 3.9 + /- 0.5 to 0.7 + /- 0.2 incontinence episodes per 24 hours , p urgency decreased from 7.5 + /- 0.6 to 1.44 + /- 0.3 episodes per 24 hours , p improvement in urgency was greater in patients with NDO at 4 weeks ( 78.2 % vs 56.3 % , p=0.019 ) and 16 weeks ( 78.3 % vs 50.7 % , p=0.013 ) . Of patients with NDO 69 % required self-catheterization de novo posttreatment compared with 19.3 % of those with IDO . CONCLUSIONS Patients with intractable IDO respond to intradetrusor BoNT/A with equally significant improvements in urodynamic and lower urinary tract symptom parameters as those with spinal NDO , despite the lower dose of toxin used",
"To assess , in a prospect i ve study , whether botulinum toxin A ( BTXA ) injected into the detrusor muscle is safe and well tolerated , produces significant changes in urodynamic variables , if the effect is durable , as measured by the Bristol Female Lower Urinary Tract Symptom Question naire ( BFLUTS ) , and to assess changes in quality of life , as measured by the Kings Health Question naire ( KHQ ) , when it is used to manage idiopathic detrusor overactivity",
"ABSTRACT Objective : To evaluate the efficacy and safety of a single intra detrusor injection of BoNTA comparing two different doses ( 100 U or 200 U ) in patients with idiopathic overactive bladder . Material s and Methods : A r and omized prospect i ve study evaluated the efficacy of BoNTA in management of refractory idiopathic overactive bladder and included 80 patients . All patients were assessed initially by taking a history , a physical examination , overactive bladder symptom score , urine analysis , routine laboratory investigations , KUB and pelviabdominal . OABSS was adjusted on all patients postoperative at 1,3,6,9 months also Urodynamic was done for all patients preoperative and postoperative at 3 , 6 , 9 months . Results : The mean age was 30.22±8.37 and 31.35±7.61 in group I and II respectively . There was no statistically difference between both groups in all parameters all over the study except at 9 months after treatment . Hematuria was observed 6 and 9 patients in group I and II respectively . Dysuria was observed in 6 and 15 patients in group I and II respectively . UTI was detected in 3 and 7 patients in group I and II respectively . Conclusion : A single-injection procedure of 100 U or 200 U BoNTA is an effective and safe treatment for patients with IOAB who failed anticholinergic regimens . OABSS and QoL were improved for 6 months ; 100 U injections seemed to have comparable results with 200 U. There was a significant difference at month 9 towards 200 U with more incidences of adverse events",
"Background Sacral neuromodulation is well established in the treatment of refractory , non-neurogenic lower urinary tract dysfunction , but its efficacy and safety in patients with lower urinary tract dysfunction of neurological origin is unclear . Only few case series have been reported for multiple sclerosis . We prospect ively evaluated the efficacy and safety of sacral neuromodulation in patients with multiple sclerosis . Methods Seventeen patients ( 13 women , 4 men ) treated with sacral neuromodulation for refractory neurogenic lower urinary tract dysfunction caused by multiple sclerosis were prospect ively enrolled ( 2007–2011 ) . Patients had to have stable disease and confirmed neurogenic lower urinary tract dysfunction . Voiding variables , adverse events , and subjective satisfaction were assessed . Results Sixteen ( 94 % ) patients had a positive test phase with a > 70 % improvement . After implantation of the pulse generator ( InterStim II ) , the improvement in voiding variables persisted . At 3 years , the median voided volume had improved significantly from 125 ( range 0 to 350 ) to 265 ml ( range 200 to 350 ) ( p post void residual from 170 ( range 0 to 730 ) to 25 ml ( range 0 to 300 ) ( p = 0.01 ) , micturition frequency from 12 ( range 6 to 20 ) to 7 ( range 4 to 12 ) ( p = 0.003 ) , and number of incontinence episodes from 3 ( range 0 to 10 ) to 0 ( range 0 to 1 ) ( p = 0.006 ) . The median subjective degree of satisfaction was 80 % . Only two patients developed lack of benefit . No major complications occurred . Conclusions Chronic sacral neuromodulation promises to be an effective and safe treatment of refractory neurogenic lower urinary tract dysfunction in selected patients with multiple sclerosis",
"BACKGROUND Neurogenic detrusor overactivity ( NDO ) frequently results in urinary incontinence ( UI ) which impairs quality of life ( QOL ) and puts the upper urinary tract at risk . OBJECTIVE To assess the effects of onabotulinumtoxinA ( BOTOX ( ® ) , Allergan , Inc. ) on UI , urodynamic variables , and QOL in incontinent patients with NDO . DESIGN , SETTING , AND PARTICIPANTS This multicentre , r and omised , double-blind , placebo-controlled study enrolled patients with multiple sclerosis ( MS ; n=154 ) or spinal cord injury ( SCI ; n=121 ) with UI due to NDO ( ≥14 UI episodes per week ) . INTERVENTION Patients received 30 intradetrusor injections of onabotulinumtoxinA 200 U ( n=92 ) , 300 U ( n=91 ) , or placebo ( n=92 ) , avoiding the trigone . MEASUREMENTS Primary end point was change from baseline in UI episodes per week ( week 6 ) . Secondary end points included urodynamics ( maximum cystometric capacity [ MCC ] , maximum detrusor pressure during first involuntary detrusor contraction [ P(detmaxIDC ) ] ) , and Incontinence Quality of Life ( I-QOL ) total score . Adverse events ( AEs ) were assessed . RESULTS AND LIMITATIONS At baseline , mean UI episodes per week ( 33.5 ) were similar across groups . At week 6 , onabotulinumtoxinA 200 U and 300 U significantly reduced UI episodes per week ( -21.8 and -19.4 , respectively ) compared with placebo ( -13.2 ; p Improvements in MCC , P(detmaxIDC ) , and I-QOL at week 6 were significantly greater with both onabotulinumtoxinA doses than with placebo ( p The median time to patient request for retreatment was the same for both onabotulinumtoxinA doses ( 42.1 wk ) and greater than placebo ( 13.1 wk ; p were localised urologic events ( urinary tract infections and urinary retention , which were dose related in patients not using clean intermittent catheterisation [ CIC ] at baseline ) . Significant increases in postvoid residual were observed in patients not using CIC prior to treatment , and 12 % , 30 % , and 42 % of patients in the placebo , 200-U , and 300-U groups , respectively , initiated CIC posttreatment . CONCLUSIONS OnabotulinumtoxinA significantly reduced UI and improved urodynamics and QOL in MS and SCI patients with NDO . Both doses were well tolerated with no clinical ly relevant differences in efficacy or duration of effect between the two doses ( http://www . clinical trials.gov ; NCT00461292 )",
"PURPOSE We assessed the efficacy , safety and effects on quality of life of onabotulinumtoxinA in patients with neurogenic detrusor overactivity . MATERIAL S AND METHODS In this 52-week , international , multicenter , double-blind , r and omized , placebo controlled trial 416 patients with neurogenic detrusor overactivity and urinary incontinence ( 14 or more episodes per week ) result ing from multiple sclerosis ( 227 ) and spinal cord injury ( 189 ) were treated with intradetrusor injections of onabotulinumtoxinA ( 200 or 300 U ) or placebo . The primary end point was the change from baseline in the mean number of urinary incontinence episodes per week at week 6 . Maximum cystometric capacity , maximum detrusor pressure during the first involuntary detrusor contraction and Incontinence Quality of Life total score were secondary end points . Adverse events were monitored . RESULTS OnabotulinumtoxinA at a dose of 200 U in 135 patients and 300 U in 132 decreased mean urinary incontinence at week 6 by 21 and 23 episodes per week , respectively , vs 9 episodes per week in 149 on placebo ( each dose p maximum cystometric capacity , maximum detrusor pressure during the first involuntary detrusor contraction and Incontinence Quality of Life score were significantly improved over values in the placebo group ( each dose p Median time to patient re-treatment request was greater for onabotulinumtoxinA 200 and 300 U than for placebo ( 256 and 254 days , respectively , vs 92 ) . The most common adverse events were urinary tract infection and urinary retention . Of patients who did not catheterize at baseline 10 % on placebo , 35 % on 200 U and 42 % on 300 U initiated catheterization due to urinary retention . CONCLUSIONS OnabotulinumtoxinA significantly improved neurogenic detrusor overactivity symptoms vs placebo . Clean intermittent catheterization initiation due to urinary retention appeared to increase in a dose dependent fashion . No clinical ly relevant benefit in efficacy or duration was identified for the 300 U dose over the 200 U dose",
"OBJECTIVE We investigated the effect of botulinum-a toxin injections into the detrusor and external sphincter muscle in patients with overactive bladder ( OAB ) symptoms . METHODS We included 44 patients - 41 women and three men with a mean age of 66.1 years - who were suffering from OAB symptoms that were refractory to anticholinergic treatment . We injected 200 - 300 U of BTX-A ( Botox ) into the detrusor muscle ; 22 patients also received external sphincter injections . For outcome analysis , we used a bladder diary , a urodynamic examination , and a question naire that consisted of 27 vali date d questions . RESULTS Changes in the bladder diary 4 weeks and 3 , 6 , and 9 months after BTX-A injection were as follows : Micturition frequency was reduced by 12 % , 16 % , 13 % and 9 % , respectively . Average pad use decreased from 4.2 pads per day to at most 2.4 pads per day after 6 months . Urodynamic changes were most distinct after 4 weeks : the volume when the first uninhibited detrusor contraction occurred increased from 149+/-18.2 mL to 263 + /- 24.2 mL , and maximum cystometric bladder capacity increased from 228 + /- 19.2 mL to 305 + /- 19.0 mL. Subjectively , 86 % of the patients would choose this procedure for their bladder condition again . Residua 4 weeks after additional injection into the sphincter muscle were distinctly smaller than in the \" only detrusor \" group . CONCLUSIONS BTX-A detrusor and sphincter injection is very effective in treating OAB symptoms . For patients who might be expected to have residual urine after injection only into the detrusor , additional injection of low doses of BTX-A into the external sphincter muscle could be one option to reduce that risk",
"Purpose Many trials do not measure quality -adjusted life years ( QALYs ) . Therefore , decision analysts often map condition-specific outcomes to preference scores . We estimated the relationship between changes in preference scores and commonly reported condition-specific outcomes in patients with urinary incontinence ( UI ) due to neurogenic detrusor overactivity . Methods In 59 patients recruited to a neurogenic UI trial , clinical outcomes ( UI episodes ) , condition-specific quality of life ( Incontinence Quality of Life Instrument ( I-QOL ) ) , and SF-6D preference scores were measured at enrollment and 24 weeks . We used multiple linear regression to estimate the impact on SF-6D scores of 50 ; 50–99 and 100 % reductions in UI episodes and a 10-point improvement in I-QOL . Results By 24 weeks , mean ( 95 % CI ) daily UI episodes fell by 0.85 ( 0.04 , 1.3 ) and mean I-QOL scores improved by 18 ( 12 , 24 ) . SF-6D scores increased by 0.03 ( 0.003 , 0.058 ) , due to improvements in role limitations . A ≥ 50 % reduction in UI episodes was achieved by 49 % of patients and corresponded to a 0.09 ( 0.02 , 0.16 ) SF-6D increase . A ≥ 10-point increase in I-QOL was attained by 65 % of patients and was associated with a 0.05 ( −0.02 , 0.12 ) SF-6D increase . Conclusions These estimates provide preliminary data for decision analysts wishing to map neurogenic UI outcomes to preference scores",
"PURPOSE Treatment options for patients with overactive bladder refractory to anticholinergics are limited . We assessed the dose response across a range of doses of onabotulinumtoxinA ( BOTOX ® ) in patients with idiopathic overactive bladder and urinary urgency incontinence whose symptoms were not adequately managed with anticholinergics . MATERIAL S AND METHODS In a phase 2 , multicenter , r and omized , double-blind study , 313 patients with idiopathic overactive bladder and urinary urgency incontinence experiencing 8 or more urinary urgency incontinence episodes a week and 8 or more micturitions daily at baseline received 50 , 100 , 150 , 200 or 300 U intradetrusor onabotulinumtoxinA , or placebo . Symptoms were recorded using a 7-day bladder diary . The primary efficacy variable was weekly urinary urgency incontinence episodes and the primary end point was week 12 . RESULTS Demographics and baseline characteristics were balanced across the treatment groups . Durable efficacy was observed for all onabotulinumtoxinA dose groups of 100 U or greater for primary and secondary efficacy measures , including the proportion of incontinence-free patients . When the dose response curves were analyzed , doses greater than 150 U contributed minimal additional or clinical ly relevant improvement in symptoms . This finding was also reflected in health related quality of life assessment s. Dose dependent changes in post-void residual urine volume were observed and the use of clean intermittent catheterization was also dose dependent . The only adverse events significantly greater with onabotulinumtoxinA than with placebo were urinary tract infection and urinary retention . CONCLUSIONS OnabotulinumtoxinA at doses of 100 U or greater demonstrated durable efficacy in the management of idiopathic overactive bladder and urinary urgency incontinence . A dose of 100 U may be the dose that appropriately balances the symptom benefits with the post-void residual urine volume related safety profile",
"AIMS To assess and compare the effect of botulinum A toxin ( BTX-A ) injections into the detrusor in idiopathic and neurogenic detrusor overactivity resistant to anticholinergic treatment . PATIENTS AND METHODS In a prospect i ve study , 11 patients with idiopathic and 11 with neurogenic detrusor overactivity resistant to anticholinergic treatment were injected with 300 U of BTX-A ( Botox ) into the detrusor . Clinical and urodynamic parameters were assessed before and after BTX-A injections . RESULTS In idiopathic as well as in neurogenic detrusor overactivity , median daytime frequency decreased significantly from 11 to 4 ( P = 0.004 ) and 12 to 5 ( P = 0.001 ) , median nocturia from 3 to 1 ( P = 0.004 ) and 3 to 1 ( P = 0.001 ) , and median number of used pads from 5 to 0 ( P = 0.001 ) and 5 to 0 ( P = 0.002 ) , respectively . There was a significant increase in median maximum cystometric capacity from 220 to 340 ml ( P = 0.001 ) and 190 to 410 ml ( to instead of ) ( P = 0.001 ) , median bladder compliance from 20 to 55 ml/cm H(2)O ( P = 0.001 ) and 23 to 60 ml/cm H(2)O ( P = 0.004 ) and median post void residual from 10 to 140 ml ( P = 0.002 ) and 30 to 240 ml ( P = 0.002 ) , respectively . Median maximum detrusor pressure decreased significantly from 45 to 29 cm H(2)O ( P = 0.002 ) and 40 to 24 cm H(2)O ( P = 0.002 ) , and median detrusor pressure at maximum flow rate from 30 to 14 ml/sec ( P = 0.001 ) and 38 to 21 ml/sec ( P = 0.016 ) , respectively . Due to post void residuals > 150 ml following BTX-A injections , de novo clean intermittent self-catheterization was necessary in nine patients ( four with idiopathic and five with neurogenic detrusor overactivity ) and in one patient ( with idiopathic detrusor overactivity ) a suprapubic catheter was placed . The effect of BTX-A injections lasted for a median time of 5 months in both idiopathic and neurogenic detrusor overactivity . There was no significant difference in idiopathic compared to neurogenic detrusor overactivity in regard to clinical and urodynamic parameters assessed before and after BTX-A injections . CONCLUSIONS BTX-A injections into the detrusor have a significant and comparable but temporally limited effect in idiopathic and neurogenic detrusor overactivity resistant to anticholinergic treatment",
"PURPOSE In this prospect i ve , nonr and omized , ongoing study we evaluated the efficacy and safety of botulinum-A toxin injections in the detrusor muscle to treat patients with idiopathic overactive bladder resistant to conventional treatment , such as anticholinergic drugs . MATERIAL S AND METHODS A total of 23 men and 77 women with a mean age of 63 years ( range 24 to 89 ) with nonneurogenic overactive bladder , including urgency-frequency syndrome , and incontinence despite the administration of maximal doses of anticholinergics were consecutively treated with injections of 100 U botulinum-A toxin in the detrusor muscle at 30 sites under cystoscopic guidance . Micturition diary , full urodynamics , neurological status and urine probes were performed in all participants before treatment . Bladder biopsies were done only in cases of suspected bladder fibrosis or unclear findings . Special attention was given to reflex volume , maximal bladder capacity , detrusor compliance , post-void residual urine , urgency and frequency/nocturia . Clinical , urodynamic and quality of life assessment s were performed at baseline , and 4 , 12 and 36 weeks after botulinum-A toxin treatment . RESULTS Overall after 4 and 12 weeks 88 % of our patients showed significant improvement in bladder function in regard to subjective symptoms , quality of life and urodynamic parameters ( p Urgency disappeared in 82 % of the patients and incontinence resolved in 86 % within 1 to 2 weeks after botulinum-A toxin injections . Mean frequency decreased from 14 to 7 micturitions daily ( -50 % ) and nocturia decreased from 4 to 1.5 micturitions . Mean maximal bladder capacity increased 56 % from 246 to 381 ml , mean detrusor compliance increased from 24 to 41 ml/cm H(2)O and pretreatment detrusor instability ( mean reflex volume 169 ml ) resolved in 74 % of patients . Mean volume at first desire to void increased from 126 to 212 ml and mean urge volume increased from 214 to 309 ml . There were no severe side effects except temporary urine retention in 4 cases . Only in 8 patients was the clinical benefit poor and analysis revealed preoperative low detrusor compliance . Mean efficacy duration + /- SD was at least approximately 6 + /- 2 months and then symptoms began to increase . CONCLUSIONS Our results show that intradetrusor botulinum-A toxin injections may be an efficient and safe treatment option in patients with severe overactive bladder resistant to all conventional treatments",
"AIMS We assessed the effects of onabotulinumtoxinA ( BOTOX ® ) on clinical and urodynamic variables in patients with idiopathic overactive bladder ( OAB ) and urinary urgency incontinence ( UUI ) with or without detrusor overactivity ( DO ) , inadequately managed with anticholinergics . METHODS Three hundred thirteen patients with OAB were r and omized to double-blind intradetrusor injection with placebo ( n = 44 ) or 1 of 5 onabotulinumtoxinA doses ( 50 - 300 U ; n = 269 ) . Primary efficacy variable was change from baseline in UUI episodes/week at week 12 . Urodynamic assessment s at baseline and weeks 12 and 36 included maximum cystometric capacity ( MCC ) and volume at first involuntary detrusor contraction ( IDC ) . RESULTS 76.0 % of patients had baseline DO . Changes from baseline in MCC and volume at first IDC with onabotulinumtoxinA ≥100 U were superior to placebo at week 12 , generally decreasing by week 36 . Significant dose-dependent increases in MCC were observed for all onabotulinumtoxinA doses at week 12 , and for 150 , 200 , and 300 U at week 36 . Data suggested a dose-response relationship . At week 12 on diary , 15.9 % of placebo and 29.8 - 57.1 % of onabotulinumtoxinA 50 - 300 U recipients , respectively , did not demonstrate UUI . OnabotulinumtoxinA doses > 150 U were more commonly associated with post-void residual urine volumes > 200 ml . CONCLUSIONS Improvements in urodynamic parameters and clinical outcomes generally trended together following onabotulinumtoxinA treatment . This therapy improved key urodynamic parameters in patients with idiopathic OAB and UUI , with no differences in outcomes between those with and those without baseline DO . Therefore , successful idiopathic OAB treatment with onabotulinumtoxinA does not appear to be related to pretreatment finding of DO"
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BACKGROUND Because of the disability associated with surgery for anal fissure and the risk of incontinence , medical alternatives for surgery have been sought . Most recently , pharmacologic methods that relax the anal smooth muscle , to accomplish reversibly what occurs in surgery , have been used to obtain fissure healing . OBJECTIVES To assess the efficacy and morbidity of various medical therapies for anal fissure . SEARCH STRATEGY Search terms include " anal fissure r and omized " . Timing from 1966 to May 2006 . Further details of the search below . SELECTION CRITERIA Studies in which participants were r and omized to a non-surgical therapy for anal fissure . Comparison groups may include an operative procedure , an alternate medical therapy or placebo . Chronic fissure , acute fissure and fissure in children are included in the review . Atypical fissures associated with inflammatory bowel disease or cancer or anal infection are excluded . DATA COLLECTION AND ANALYSIS Data were abstract ed from published reports and meeting abstract s , assessing method of r and omization , blinding , " intention to treat " and drop-outs , therapies , supportive measures ( applied to both groups ) , dosing and frequency and cross-overs . Dichotomous outcome measures included Non-healing of the fissure ( a combination of persistence and recurrence ) , and Adverse events ( including incontinence , headache , infection , anaphylaxis ) . Continuous outcome measures included measures of pain relief and anorectal manometry . MAIN RESULTS 48 different comparisons of the ability of medical therapies to heal anal fissure have been reported in 53 RCTs . Eleven agents were used ( nitroglycerin ointment ( GTN ) , isosorbide dinitrate , Botulinum toxin ( Botox ) , diltiazem , nifedipine ( Calcium channel blockers or CCBs ) , hydrocortisone , lignocaine , bran , minoxidil , indoramin , and placebo ) as well as anal dilators and surgical sphincterotomy . GTN was found to be marginally but significantly better than placebo in healing anal fissure ( 48.6 % vs. 37 % , p late recurrence of fissure was common , in the range of 50 % of those initially cured . Botox and CCBs were equivalent to GTN in efficacy with fewer adverse events . No medical therapy came close to the efficacy of surgical sphincterotomy , though none in these RCTs was associated with the risk of incontinence . AUTHORS ' CONCLUSIONS Medical therapy for chronic anal fissure , acute fissure and fissure in children may be applied with a chance of cure that is marginally better than placebo , and , for chronic fissure in adults , far less effective than surgery
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"The conventional treatment of chronic anal fissure is lateral sphincterotomy ( LAS ) . The alternative options of tailored sphincterotomy ( TS ) and ‘ chemical sphincterotomy ’ using medication such as nifedipine have recently become available",
"BACKGROUND Anal fissure is a frequent proctologic disease . There are many and various treatments adopted to cure this disease . In this study we applied radiofrequencies to the subcutaneous lateral internal sphincterotomy and we compared the techniques in a r and omised trial . METHODS Patients have been r and omized in two groups : in group A 18 patients underwent subcutaneous lateral internal sphincterotomy using radiofrequency bistoury while in group B 17 patients underwent the conventional lateral internal sphincterotomy described by Parks . RESULTS The mean values for operative time were 6.6 min for group A and 9.1 min for group B. According to pain score , patients ' mean values were 1.8 for group A and 1.9 for group B. Healing of the wound was faster in group A than group B , while healing of the anal fissure was approximately the same . CONCLUSION Lateral subcutaneous sphincterotomy is the most advantageous operation for the treatment of the idiopathic anal fissure . The radiofrequency bistoury easies the procedure , lessens operating times and healing process of the surgical wounds",
"Purpose The objective of this study was to compare the efficacy of 0.25 percent glycerin trinitrate ointment in association with cryothermal anal dilators with 0.25 percent glycerin trinitrate ointment only and cryothermal anal dilators only . Methods A total of 48 patients suffering from chronic anal fissure were enrolled in this prospect i ve , r and omized study between January 2002 and December 2003 : Group A , 16 patients were treated with 0.25 percent glycerin trinitrate ointment and also used cryothermal anal dilators ; Group B , 16 patients were treated with 0.25 percent glycerin trinitrate ointment only ; Group C , 16 patients were treated with cryothermal anal dilator use only . All patients in each group followed the specified treatment protocol for six weeks . Results After seven weeks of treatment , the symptoms complained of were resolved in 15 patients ( 93.7 percent ) in Group A , 12 patients ( 75 percent ) in Group B , and 12 patients ( 78 percent ) in Group C. After two years of follow-up , 14 patients ( 87.5 percent ) in Group A , 9 patients ( 56.2 percent ) in Group B , and 10 patients ( 62.5 percent ) in Group C presented no recurrence of symptoms . No patient in any group reported serious side effects of the treatment proposed , and treatment did not have to be withdrawn in any of the r and omized patients . No episodes of anal incontinence of gas or feces were recorded in the patients who had used the anal dilators . Conclusions The combined treatment for chronic anal fissure proved to be efficacious , safe , and with statistically significant better results than the other treatments analyzed",
"Background There is common belief among some medical research ers that if a potential surrogate endpoint is highly correlated with a true endpoint , then a positive ( or negative ) difference in potential surrogate endpoints between r and omization groups would imply a positive ( or negative ) difference in unobserved true endpoints between r and omization groups . We investigate this belief when the potential surrogate and unobserved true endpoints are perfectly correlated within each r and omization group . Methods We use a graphical approach . The vertical axis is the unobserved true endpoint and the horizontal axis is the potential surrogate endpoint . Perfect correlation within each r and omization group implies that , for each r and omization group , potential surrogate and true endpoints are related by a straight line . In this scenario the investigator does not know the slopes or intercepts . We consider a plausible example where the slope of the line is higher for the experimental group than for the control group . Results In our example with unknown lines , a decrease in mean potential surrogate endpoints from control to experimental groups corresponds to an increase in mean true endpoint from control to experimental groups . Thus the potential surrogate endpoints give the wrong inference . Similar results hold for binary potential surrogate and true outcomes ( although the notion of correlation does not apply ) . The potential surrogate endpointwould give the correct inference if either ( i ) the unknown lines for the two group coincided , which means that the distribution of true endpoint conditional on potential surrogate endpoint does not depend on treatment group , which is called the Prentice Criterion or ( ii ) if one could accurately predict the lines based on data from prior studies . Conclusion Perfect correlation between potential surrogate and unobserved true outcomes within r and omized groups does not guarantee correct inference based on a potential surrogate endpoint . Even in early phase trials , investigators should not base conclusions on potential surrogate endpoints in which the only validation is high correlation with the true endpoint within a group",
"Abstract . Mean maximum anal resting pressure is directly related to the activity of the smooth muscles of the internal and external sphincters and has been found to be increased in the patients of anal fissure . It has been shown that blood flow at the posterior midline of anoderm is inversely related to the mean maximum anal resting pressure , and topical application of glyceryl trinitrate ( GTN ) ointments is a very successful treatment . This r and omized study was design ed to evaluate the relative value of a nitroglycerin patch applied at a distance from the fissure site in healing anal fissure compared to GTN ointment and compared to surgical treatment . Forty-two consecutive patients with chronic anal fissure of more than 4 months ' duration were r and omized into two equally sized groups : those in group A received 0.2 % GTN ointment while those in group B received a 10-mg nitroglycerin patch for 8 weeks . Patients were also asked to rate their pain intensity on a scale of 0–10 . Five patients were excluded for various reasons ; results were analyzed for the remaining 37 patients ( group A , n=18 ; group B , n=19 ) . A control group C consisted of 12 patients who underwent surgical treatment . Fissures healed completely in 12 of 18 ( 66.7 % ) patients in group A , 12 of 19 ( 63.2 % ) in group B and 11/12 ( 91.7 % ) in group C. The healing rates in groups A and B did not differ significantly ( P=0.7 ) , nor was there a difference between these and surgical group C ( P=0.13 ) . The local application of GTN ointment and the nitroglycerin patch are both effective , economical , and alternative treatment options for most patients with anal fissures",
"Aim The present study aims to evaluate and compare the efficacy of two nitrate gels , containing isosorbide-5-mononitrate ( ISMN ) or glyceryl trinitrate ( GTN ) , in the therapy of chronic anal fissure . Material s and methods The patients were r and omly assigned to three groups : 0.1 % ISMN gel ( 21 patients ) , 0.1 % GTN gel ( 21 patients ) and a placebo group ( ten patients ) . The ethic committee of our hospital approved the protocol and informed consent was obtained from all participants . All patients underwent clinical examination , visual inspection of the fissure and anal manometry prior to and after therapy . Results The chronic anal fissure was completely healed in 71 % of the patients treated with ISMN , 67 % with GTN and in 30 % from the placebo group . One patient in the ISMN group reported mild headache . Three patients in the GTN group had anal burning . Conclusion Both topical nitrate treatments ( ISMN and GTN ) were effective for chronic anal fissures . The reduction of the anal pressure was slightly higher after ISMN treatment ( 28 % ) than the treatment with GTN ( 23 % ) . However , the statistical difference was not significant ( p > 0.05 )",
"Abstract . Background The surgical approach in chronic anal fissures ( CAF ) may , occasionally result in anal incontinence . The aim of this investigation was to study feasibility , effectiveness , and safety of hydropneumatic anal dilation ( HAD ) in conservative treatment of CAF and to compare it with local nitroglycerin ( GTN ) treatment . Methods Efficacy of HAD was evaluated in 109 patients ( 65 male , 44 female ; mean age , 53.3 years ) , following anal dilation using Microvasive Rigiflex instrument ( Otw 40 mm ) . Thereafter , 36 patients were r and omly divided into two groups to undergo treatment with 0.25 % GTN or HAD . Results Recovery rate with HAD was 79.8 % after 10 days and 94.5 % after 30 days . An immediate ( within 24 hours ) drop was observed in the level of pain ; no significant complications or recurrence were reported within 2 years . Healing rate was 94.5 % following HAD vs. 38.9 % after GTN . Conclusion HAD should be considered a new safe option in CAF treatment",
"Objective The aim of this study was to compare prospect ively diltiazem with GTN ointment in the treatment of anal fissure",
"One hundred and three patients with an acute first episode of posterior anal fissure were r and omised to receive a three week trial of lignocaine ointment ( n = 33 ) versus hydrocortisone ointment ( n = 35 ) or warm sitz baths combined with an intake of unprocessed bran ( n = 35 ) . Seven patients were withdrawn owing to failure to adhere to the trial protocol . After one and two weeks of treatment symptomatic relief was significantly better among patients treated with sitz baths and bran than among patients treated with lignocaine ointment or hydrocortisone ointment . After three weeks there was no difference in symptomatic relief among the three groups . Patients treated with lignocaine , however , had significantly fewer healed fissures ( 60 % ) than patients treated with hydrocortisone ( 82.4 % ) or warm sitz baths and bran ( 87 % ) . In this study warm sitz baths plus an intake of unprocessed bran came out as the treatment of choice for an acute first episode of posterior anal fissure . This treatment is cheap , has no potential serious side effects , and brings the best and quickest relief of symptoms",
"The effect of unprocessed bran in a dose of 5 g three times daily and a dose of 2.5 g three times daily for one year on the recurrence rate of anal fissures was studied in a double-blind , placebo-controlled trial in 90 patients with recently healed acute posterior anal fissures . Fifteen patients ( 16.6 % ) were withdrawn before the code was broken due to failure to follow the trial protocol for various reasons . Significantly fewer recurrences occurred in patients receiving bran 5 g throe times daily ( recurrence rate 16 % , 95 % confidence limits , 4.54 to 36.08 ) when compared with patients receiving bran 2.5 g three times daily ( 60 % ; 38.67 to 78.87 ) ( P placebo three times daily ( 68 % ; 46.50 to 85.05 ) ( P No significant difference in recurrences was found between patients on bran 2.5 g and those on placebo",
"BACKGROUND Anal fissure is most commonly treated surgically by internal anal sphincterotomy . However , there is some concern over the effects of this procedure on continence . Nitric oxide donors such as glyceryl trinitrate ( GTN ) have been shown to cause a reversible chemical sphincterotomy capable of healing fissures in a small series of cases . This study reports a prospect i ve , r and omised , double-blind , placebo-controlled trial to test the hypothesis that topical GTN is the best first-line treatment for chronic anal fissure . METHODS 80 consecutive patients were r and omised to receive treatments with topical 0.2 % GTN ointment or placebo . Maximum anal resting pressure ( MARP ) was measured with a constantly perfused side-hole catheter before and after the first application of trial ointment . Anodermal blood flow was measured during manometry by laser Doppler flowmetry . After initial treatments , patients were given a supply of ointment ( either GTN or placebo ) to be applied to the lower anal canal twice daily . Patients were review ed 2-weekly . At the initial and follow up visits patients were asked to record pain experienced on defaecation on a linear analogue pain score . Endpoints were healing of the fissure or condition after 8 weeks of treatment . FINDINGS After 8 weeks , healing was observed in 26/38 ( 68 % ) patients treated with GTN and in 3/39 ( 8 % ) patients treated with placebo ( p Linear analogue pain score fell significantly in both groups after 2 weeks of treatment . This fall was maintained in those treated with GTN but pain scores returned to pre-treatment values by 4 weeks on treatment with placebo . MARP fell significantly from a mean of 115.9 ( SD 31.6 ) to 75.9 ( 30.1 ) cm H2O ( p GTN but no change was seen in MARP after placebo . Anodermal blood flow measured by laser Doppler flowmetry significantly increased after application of GTN ointment but was unaffected by placebo . INTERPRETATION Topical GTN provides rapid , sustained relief of pain in patients with anal fissure . Over two-thirds of patients treated in this way avoided surgery which would otherwise have been required for healing . Long-term follow up is needed to assess the risk of recurrent fissure in patients with GTN",
"PURPOSE : This was a multicenter , r and omized , controlled trial to compare the effectiveness of topical nitroglycerin with internal sphincterotomy in the treatment of chronic anal fissure . METHODS : Patients with symptomatic chronic anal fissures were r and omly assigned to 0.25 percent nitroglycerintid or internal sphincterotomy . Both groups received stool softeners and fiber supplements and were assessed at six weeks and six months . RESULTS : Ninety patients were accrued , but 8 were excluded from the analysis because they refused internal sphincterotomy after r and omization ( 6 ) , the fissure healed before surgery ( 1 ) , or a fissure was not observed at surgery ( 1 ) . There were 38 patients in the internal sphincterotomy group ( 22 males ; mean age , 40.3 years ) and 44 patients in the nitroglycerin group ( 15 males ; mean age , 38.7 years ) . At six weeks 34 patients ( 89.5 percent ) in the internal sphincterotomy group compared with 13 patients ( 29.5 percent ) in the nitroglycerin group had complete healing of the fissure ( P=5 × 10−8 ) . Five of the 13 patients in the nitroglycerin group relapsed , whereas none in the internal sphincterotomy group did . At six months fissures in 35 ( 92.1 percent ) patients in the internal sphincterotomy group compared with 12 ( 27.2 percent ) patients in the nitroglycerin group had healed ( P=3 × 10−9 ) . One ( 2.6 percent ) patient in the internal sphincterotomy group required further surgery for a superficial fistula compared with 20 ( 45.4 percent ) patients in the nitroglycerin group who required an internal sphincterotomy ( P=9 × 10−6 ) . Eleven ( 28.9 percent ) patients in the internal sphincterotomy group developed side effects compared with 37 ( 84 percent ) patients in the nitroglycerin group ( P headaches ( 8) or a severe syncopal attack ( 1 ) . CONCLUSIONS : Internal sphincterotomy is superior to topical nitroglycerin 0.25 percent in the treatment of chronic anal fissure , with a high rate of healing , few side effects , and low risk of early incontinence . Thus , internal sphincterotomy remains the treatment of choice for chronic anal fissure",
"Purpose Anal fissure is a common problem affecting all age groups with an equal incidence in both sexes . Traditional surgical treatments , like manual anal dilatation or a sphincterotomy , effectively heal most fissures within a few weeks but such procedures may result in anal incontinence . In recent years , various medical therapies have been used for the treatment of chronic anal fissure without fear of incontinence . Methods Ninety patients with a symptomatic anal fissure were r and omly divided into three groups . Group I was treated with 2 % diltiazem ointment , Group II was treated with 0.2 % glyceryl trinitrate ( GTN ) ointment , and Group III was kept as the control group . The improvement in the signs and symptoms , the time taken for healing , and side effects were recorded in each group . The patients were followed up monthly and then every 3 months for any recurrence of fissure . Comparative evaluations of the three groups regarding an improvement in symptoms , progress in healing , appearance of side effects , and recurrence were made using the Tukey HSD test . Results Diltiazem ointment was found to be superior regarding pain relief , fewer side effects , and late recurrence as compared with GTN ointment . Conclusion Diltiazem ointment ( 2 % ) and GTN ointment ( 0.2 % ) are both effective treatment modalities for chronic anal fissure , with diltiazem giving better patient outcome",
"OBJECTIVES : To evaluate the efficacy and safety of botulinum toxin A injection compared with topical nitroglycerin ointment for the treatment of chronic anal fissure ( CAF ) . METHODS : Fifty out patients with CAF were r and omized to receive either a single botulinum toxin injection ( 30 IU Botox ® ) or topical nitroglycerin ointment 0.2 % b.i.d . for 2 wk . If the initial therapy failed , patients were assigned to the other treatment group for a further 2 wk . If CAF still showed no healing at wk 4 , patients received combination therapy of botulinum toxin and nitroglycerin for 4 additional wk . Persisting CAF at wk 8 was treated according to the investigator 's decision . Healing rates , symptoms , and side effects of the therapy were recorded at wk 2 , 4 , 8 , 12 , and 24 after r and omization . RESULTS : The group initially treated with nitroglycerin showed a higher healing rate of CAF ( 13 of 25 , 52 % ) as compared with the botulinum toxin group ( 6 of 25 , 24 % ) after the first 2 wk of therapy ( p , CAF healed in three additional patients , all receiving nitroglycerin after initial botulinum toxin injection . Mild side effects occurred in 13 of 50 ( 26 % ) patients , all except one were on nitroglycerin . CONCLUSIONS : Nitroglycerin ointment was superior to the more expensive and invasive botulinum toxin injection for initial healing of CAF , but was associated with more but mild side effects ",
"Abstract This study was design ed to compare the effect of topical glyceryl trinitrate ( GTN ) and oral nifedipine treatments on maximal anal resting pressure ( MarP ) and subsequently to assess their effectiveness in healing of chronic anal fissure ( CAF ) . Patients were allocated r and omly to receive either oral nifedipine retard ( 10 patients ) 20 mg twice daily or instructed to apply glyceryl trinitrate ( 0.2 percent ) ointment ( 10 patients ) into the lower half of the anal canal twice daily . They were review ed and assessed at the first visit and every fortnight for measurement of MARP , pain scores , blood pressure , pulse rate , healing of the fissure and adverse effects . Treatment were continued until healing had occurred or for up to 8 weeks . MARP values before and after application of the GTN ointment was 113.2 cm H2O and 72.5 cm H2O respectively ( P Nifedipine caused a reduction in mean MARP from 105.2 to 74.0 cm H2O ( P Linear analogue pain scores were significantly reduced after 2 weeks treatment with GTN and nifedipine ( P healed ( 5 ) or improved ( 2 ) , compared with 6 of the 10 patients in the nifedipine group ( 5 healed , 1 improved ) . Headaches occurred in 3 patients in the GTN group , compared with one patient in the nifedipine group . There was no significant difference between GTN and nifedipine in terms of reduction in MARP and pain score , healing of the fissure and incidence of early recurrence and side effects of treatments . We conclude that GTN ointment and oral nifedipine are equally effective in the treatment of chronic anal fissure",
"BACKGROUND Topical application of glyceryl trinitrate ( GTN ) ointment heals chronic anal fissures , providing an alternative to the traditional first line treatment of surgical sphincterotomy . AIMS To determine the most effective dose of topical GTN for treatment of chronic anal fissures and to assess long term results . METHODS Seventy consecutive patients with chronic anal fissure , were r and omly allocated to eight weeks treatment with placebo , 0.2 % GTN three times daily , or GTN starting at 0.2 % with weekly 0.1 % increments to a maximum of 0.6 % , in a double blind study . RESULTS After eight weeks fissure had healed in 67 % of patients treated with GTN compared with 32 % with placebo ( p=0.008 ) . No significant difference was seen between the two active treatments . Headaches were reported by 72 % of patients on GTN compared with 27 % on placebo ( p Maximum anal sphincter pressure reduced significantly from baseline by GTN treatment ( p=0.02 ) , but not placebo ( p=0.8 ) . Mean pain scores were lower after treatment with GTN compared with placebo ( NS ) . Of fissures healed with placebo 43 % recurred , compared with 33 % of those healed with 0.2 % GTN and 25 % healed with escalating dose GTN ( p=0.7 ) . CONCLUSIONS GTN is a good first line treatment for two thirds of patients with anal fissure . An escalating dose of GTN does not result in earlier healing . Significant recurrence of symptomatic fissures and a high incidence of headaches are limitations of the treatment",
"BACKGROUND Anal fissure is a chronic condition characterized by painful defecation and rectal bleeding . The aim of this study was to compare injection of botulinum toxin versus surgical sphincterotomy for treatment of chronic anal fissure . PATIENTS AND METHODS In a quasi-experimental trial in a university hospital in Kerman , 50 patients diagnosed with chronic anal fissure received 20 units botulinum toxin ( n=25 ) or underwent lateral internal sphincterotomy ( n=25 ) . All patients were evaluated for pain , bleeding and healing of the fissure from one to six months later by another surgeon . The data was analyzed by SPSS software with the Mann-Whitney and Fisher ’s exact tests . RESULTS One month after treatment , the rate of healing and bleeding in the operation group was better than in the toxin group ( P pain was equal . After two months , none of the patients in either group had complications . After six months follow-up , bleeding , pain and healing were better in the operation group . CONCLUSION In the clinical evaluation , botulinum toxin is an effective alternative nonsurgical modality for the treatment of chronic anal fissure . We recommend botulinum toxin as the first step in treatment because of the 60 % chance of cure with an easily performed treatment",
"AIMS To determine the effectiveness and safety of topical glyceryl trinitrate ( GTN ) in the management of acute anal fissure in children . METHODS Individual children were r and omised to receive GTN paste or placebo for six weeks in addition to oral senna and lactulose . Patients took laxatives alone for a further 10 weeks . Each week a research nurse telephoned families to assess pain scores and give advice . Main outcome measures were vali date d st and ardised pain scores and time to painless defaecation . RESULTS Forty subjects were recruited from 46 eligible children ; 31 children completed the trial ( 13 in the GTN group and 18 in the placebo group ) . No differences in the proportion of those achieving pain free defaecation with relation to time were seen between the two groups . Similarly , there were no significant differences in pain scores between the two groups over the 16 week study period . However , in both groups pain scores had decreased significantly . There were no differences in the incidence of rectal bleeding , faecal soiling , presence of visible fissure , skin tag , or faecal loading at outpatient review at the time of recruitment , or at 6 weeks and 16 weeks . No serious adverse effects were observed . CONCLUSIONS This study suggests that 0.2 % GTN paste is ineffective in the treatment of acute anal fissures in childhood . However the overall fissure healing rate is high ( 84 % ) with associated reduction in pain scores , suggesting that a nurse based treatment programme can achieve a high rate of fissure healing",
"Background : Anal fissure is a common painful condition affecting the anal canal . The majority of acute fissures heal spontaneously . However , some of these acute fissures do not resolve but become chronic . Chronic anal fissures were traditionally treated by anal dilation or by lateral sphincterotomy . However , both of these surgical treatments may cause a degree of incontinence in up to 30 % of patients . Several recent trials have shown that nitric oxide donors such as glyceryl trinitrate ( GTN ) can reduce sphincter pressure and heal up to 70 % of chronic fissures . Aim : This study addressed the dose-response to three different concentrations of GTN ointment compared with placebo in a double blind r and omised controlled trial . Method : A double blind , multicentre , r and omised controlled trial was set up to compare placebo ointment against three active treatment arms ( 0.1 % , 0.2 % , and 0.4 % GTN ointment applied at a dose of 220 mg twice daily ) in chronic anal fissures . The primary end point was complete healing of the fissure . Results : Two hundred patients were recruited over an eight month period from 18 centres . After eight weeks of treatment the healing rate in the placebo group was 37.5 % compared with 46.9 % for 0.1 % , 40.4 % for 0.2 % , and 54.1 % for 0.4 % GTN . None was significantly better than the placebo response . A secondary analysis excluded fissures without secondary criteria for chronicity . Healing rates were then found to be 24 % in the placebo group compared with 50 % in the 0.1 % GTN group , 36 % in the 0.2 % group , and 57 % in the 0.4 % GTN group . These values were statistically significantly different for the placebo group compared with 0.1 % GTN , 0.4 % GTN , and for the GTN treated group as a whole . Conclusions : The results of this study have demonstrated the significant benefit of topical GTN when applied to patients suffering from chronic anal fissures but acute fissures showed a tendency to resolve spontaneously . The high proportion of fissures which healed in the placebo group suggests that the definition of “ chronicity ” needs to be reassessed . Further studies are required to confirm the optimal therapeutic strategy",
"To assess the efficacy and patient compliance of topical mononitrate hydrogel for the treatment of anal fissure",
"Introduction : Topical nitroglycerin ( GTN ) is one of the medical treatments of choice in chronic anal fissure . The present prospect i ve , r and omized , clinical trial was conducted to study the symptomatic relief , healing , and changes in the maximum anal resting pressure ( MARP ) in patients with chronic anal fissure comparing topical GTN and lateral sphincterotomy",
"Purpose This study was design ed to compare the efficacy of two different “ chemical sphincterotomies ” for chronic anal fissure . Methods From January to December 2001 , 30 consecutive patients ( 17 males ; mean age , 41.8 years ) with chronic posterior anal fissure were enrolled . The patients were r and omly assigned to receive 0.2 percent glycerine trinitrate ointment applied three times daily at theanal margin for eight weeks ( Group A ) or 20 units Botulinum toxin A injection into the internal anal sphincter on each side of the anterior midline ( Group B ) . The patients were review ed at 15 days , 1 , 3 , 6 , 12 , and every other 12 months . Follow-up ranged between 36 and 46 months . Patients in either group who failed to improve were referred for surgical treatment . Results Twelve patients in Group A and 11 in Group B had improvement or relief from symptoms at the first visit . The fissure was healed in ten patients in Group A and in eight in Group B within three months ( 66.7 and 57.1 percent ) . Recurrence of the fissure occurred in five patients in each group during the follow-up . The healing rate at three years was 40 and 33.3 percent for Group A and B , respectively . No patients in either group reported serious adverse effects ; however , three patients in Group A ( 20 percent ) had transient headache . None had fecal incontinence . Conclusion Both treatments may be considered as first-line treatment even if less effective than surgery",
"A r and omized clinical trial assessed the value of regular anal dilatation in combination with a topical local anaesthetic in the treatment of 82 patients with a posterior fissure‐in‐ano . One month after treatment the fissure had healed in 43·6 per cent of patients using 2 per cent lignocaine gel alone and in 41·9 per cent of patients who also used a St Mark 's Hospital anal dilator . Thus the regular use of such a dilator did not contribute to the success of conservative therapy in patients with a posterior anal fissure . A review of patients who presented with anterior or lateral anal fissures during the trial period revealed that healing was achieved in 73·3 per cent of patients without operation within 1 month of diagnosis",
"INTRODUCTION : Glyceryl trinitrate has been shown to be an effective treatment for chronic anal fissure . It decreases anal tone and ultimately heals anal fissures . The aim of this trial was to compare glyceryl trinitrate with lateral sphincterotomy ( current st and ard treatment ) as definitive management for chronic anal fissure . METHODS : All patients with symptoms of chronic anal fissure were r and omly assigned to one of two treatment arms . The glyceryl trinitrate group applied 0.2 percent paste to the perianal area three times a day for eight weeks . Patients in the lateral sphincterotomy group underwent surgery on the next available operating list . Patients were review ed at two weekly intervals until the fissure healed . RESULTS : Sixty‐five patients were enrolled in the trial , with 31 in the lateral sphincterotomy group and 34 in the glyceryl trinitrate group . Five patients were excluded after r and omization . Twenty of 33 ( 60.6 percent ) glyceryl trinitrate patients had healed fissures in eight weeks compared with 26 of 27 ( 97 percent ) in the sphincterotomy group ( P = 0.001 ) . Twelve patients in the glyceryl trinitrate group had little improvement in their symptoms and underwent lateral sphincterotomy . Poor tolerance and poor compliance with treatment were important factors in patients whose fissures did not heal with glyceryl trinitrate . Fissures healed significantly faster after sphincterotomy compared with glyceryl trinitrate treatment ( P = 0.0001 ) . Nine of the 20 patients whose fissures healed with glyceryl trinitrate paste subsequently had a recurrence of their fissures . There were no long‐term complications from lateral sphincterotomy . CONCLUSION : Glyceryl trinitrate paste heals the majority of chronic anal fissures . However , a significant minority have little improvement or develop side effects and require conventional surgical treatment . Poor compliance with prescribed treatment often contributes to nonhealing . In addition , some fissures which initially heal with glyceryl trinitrate paste recur and require further treatment . Glyceryl trinitrate treatment is labor intensive for patients and physicians and has not been shown to be superior to lateral sphincterotomy ",
"Background The aim of this study was to compare the efficacy of the local application of 0.5 % nifedipine ointment vs. lateral internal sphincterotomy in the healing of chronic anal fissure . Patients and methods Sixty-four patients with symptomatic chronic anal fissures were r and omly assigned to 0.5 % nifedipine ointment ( n=32 ) every 8 h for 8 weeks or lateral internal sphincterotomy ( n=32 ) . Both groups received stool softeners and fiber supplements and were assessed at 2 , 4 , 6 , and 8 weeks . Long-term outcomes were determined after a median follow-up of 19 months ( nifedipine group ) and 20.5 months ( lateral internal sphincterotomy group ) . Results Complete healing at 8 weeks was achieved in 30 out of 31 patients ( 96.7 % ) in the nifedipine group and 32 out of 32 patients ( 100 % ) in the lateral internal sphincterotomy group ( p=0.49 ) . The overall healing rates at the end of follow-up were 28 out of 30 ( 93 % ) vs. 32 out of 32 ( 100 % ) in the nifedipine and sphincterotomy groups respectively ( p=0.48 ) . Two of the 30 patients in the nifedipine group relapsed whereas none in the sphincterotomy group did . Sixteen patients ( 50 % ) developed side effects in the nifedipine group , compared with six patients ( 18.7 % ) in the sphincterotomy group . Conclusions Topical application of 0.5 % nifedipine ointment represents a new , promising , easily h and led , effective alternative to lateral internal sphincterotomy ",
"Several treatments for anal fissure offer different responses and risks for complications . Reversible chemical sphincterotomy with topical nitroglycerin is an alternative to surgical sphincterotomy . The aim of this observational prospect i ve study was to compare the effectiveness of topical nitroglycerin with the conventional medical treatment . Forty-three patients with anal fissure were treated : 22 ( 16 chronic and 6 acute ) received 0.25 % nitroglycerin topically , and 21 ( 16 chronic and 5 acute ) received conventional treatment . Nitroglycerin or placebo was administered in two daily applications for two weeks . Median follow-up was 39 weeks . Healing rate with NTG was 75 % for chronic and 83 % for acute fissures , but recurrence rate for chronic fissures at 9 months was 67 % . Healing rate with placebo for chronic fissures was only anecdotical ( 1 out of 16 patients ) . Headache as side effects occurred in 17 cases ( 77 % ) . In conclusion , both treatments were effective for acute fissures , whereas for chronic ones NTG had a high healing rate but also a high recurrence rate",
"PURPOSE : Lateral internal sphincterotomy is an effective treatment for chronic anal fissures ; however , the risk of “ incontinence ” has generated interest in pharmacologic approaches that are far less effective and may be poorly tolerated . This study was design ed to objective ly define the risk of incontinence with sphincterotomy using the Fecal Incontinence Severity Index and assess the implication s for quality of life using the Fecal Incontinence Quality of Life Scale . METHODS : A prospect i ve study was undertaken on all patients undergoing lateral internal sphincterotomy for a chronic anal fissure by a single surgeon at a university teaching hospital from January 1 , 2000 to September 30 , 2002 . All patients had failed at least six weeks of nonoperative management . Patient demographics and use of nitroglycerin were noted . The Fecal Incontinence Severity Index was measured preoperatively and at a six-week postoperative visit when fissure healing and postoperative complications were assessed . The Fecal Incontinence Quality of Life Scale was administered to patients with an incontinence score > 0 . RESULTS : Thirty-five patients ( 15 males ) underwent sphincterotomy during the study period . Thirty-one of 35 had failed nitrates : 10 because of unacceptable side effects , and 21 because of lack of efficacy . Thirty-two patients returned for their six-week postoperative visits , and two completed their question naires by telephone . One patient was lost to follow-up . Mean age was 41.2 ( range , 21–67 ) years . Thirty of 32 ( 94 percent ) evaluable fissures had healed by six weeks , one healed by three months , and the other required V-Y anoplasty . There were two minor complications . Three patients had postoperative deterioration in their continence score . Quality of life deteriorated in only one patient . CONCLUSIONS : Lateral internal sphincterotomy is a safe and effective treatment for chronic anal fissures that only occasionally impairs continence and rarely diminishes quality of life",
"Background : Chronic anal fissure is a significant cause of morbidity . Internal sphincterotomy has long been the operative treatment of choice . Concerns remain , however , on its effects on continence . Botulinum toxin has been used as an agent for chemical sphincterotomy , causing temporary alleviation of sphincter spasm and allowing the fissure to heal . The aim of the present study was to compare the results of sphincterotomy to botulinum toxin",
"BACKGROUND Anal fissure is a common disease . Treatment includes conservative measures or surgery . One of the treatment options is topical Nitroglycerin ointment . MATERIAL S AND METHODS We present a prospect i ve , r and omized , double-blind study , encompassing 48 patients suffering from chronic anal fissure . The subjects were divided into three groups according to the dose of Nitroglycerin ointment received -- group I--0 % ( placebo ) , group II--0.2 % ( 0.75 mg ) and group III--0.4 % ( 1.5 mg ) . Demographic data , medical history and physical findings were recorded . Healing , pain relief and adverse events were evaluated during and after the treatment period . RESULTS No significant difference ( p amount of ointment used and adverse events . Thirty three of the 48 ( 69 % ) patients completed the study . No significant differences were found between the groups with respect to the reasons and rates of leaving the study ( p=0.494 ) . Fifteen patients failed to complete the study ; eight patients ( 17 % ) due to headaches , one patient was operated upon and six patients left the study because of cooperation problems . No significant difference was found between the groups regarding healing ( p=0.952 ) or pain relief ( p=0.458 - 0.8 according to the type of pain checked ) . CONCLUSIONS According to our study , there was no benefit regarding healing or pain relief , in treating patients suffering from an anal fissure with Nitroglycerin ointment in combination with stool softeners and sitz baths , compared to the same treatment without Nitroglycerin ointment",
"BACKGROUND The aim of this prospect i ve r and omized trial was to compare the effectiveness and morbidity of surgical versus chemical sphincterotomy in the treatment of chronic anal fissure after a 3-year follow-up . METHODS Eighty patients with chronic anal fissure were treated by whether open lateral internal sphincterotomy ( group 1 ) or chemical sphincterotomy with 25 U botulinum toxin injected into the internal sphincter ( group 2 ) . Clinical and manometric results were analyzed . RESULTS Overall healing was 92.5 % in the open sphincterotomy group and 45 % in the toxin botulinum group ( P clinical ( duration of disease > 12 months and presence of a sentinel pile before treatment ) and manometric factors ( persistently elevated mean resting pressure , % of time presence of slow waves , and number of patients or the time presence ultra slow waves after treatment ) associated with a higher recurrence of anal fissure . The final percentage of incontinence was 5 % in the open sphincterotomy group and 0 % in the botulinum toxin group ( P>.05 ) . CONCLUSION We recommend surgical sphincterotomy as the first therapeutic approach in patients with clinical and manometric factors of recurrence . We prefer the use of botulinum toxin in patients older than 50 years or with risk factors for incontinence , despite the higher rate of recurrence , since it avoids the greater risk of incontinence in the surgical group",
"The gold st and ard surgical treatment of chronic anal fissure is lateral internal sphincterotomy which lowers the resting anal pressure and effectively heals the majority of fissures . Local application of 0.2 % glyceryl trinitrate ointment has been used as an agent for chemical sphincterotomy , causing temporary alleviation of sphincter spasm and allowing the fissure to heal without compromising the anal continence . The aim of the present study was to compare the results of surgical sphincterotomy with that of local 0.2 % glyceryl trinitrate ointment in the treatment of chronic anal fissure . Seventy adult patients between the age of 18 and 50 years with chronic anal fissure were r and omized in a prospect i ve trial to receive either surgical sphincterotomy or 0.2 % glyceryl trinitrate ointment locally . Patients were followed up at 2 weeks ' interval for 10 weeks . Symptom relief , fissure healing and continence scores were the outcomes assessed . Six patients were excluded for protocol violations . Surgical sphincterotomy was significantly more effective in providing pain relief and was associated with significantly better fissure healing rates at 6 weeks and 10 weeks ( both p slow healing and longer time needed for symptomatic relief . Minor incontinence was 6 % in sphincterotomy group and none in ointment group ( p > 0.05 ) . Considering early symptomatic relief , rapid fissure healing and better patient compliance surgical sphincterotomy is the treatment of choice for chronic anal fissure ",
" Glyceryl trinitrate ( GTN ) ointment ( 0·2 per cent ) has an efficacy of up to 68 per cent in healing chronic anal fissure , but with headache as a major side‐effect . Diltiazem hydrochloride ( DTZ ) cream ( 2 per cent ) is expected to have fewer side‐effects ",
"BACKGROUND Chronic anal fissure is a frequent and troubling condition , that may need surgical sphincterotomy for relief of symptoms . However , this approach may yield minor incontinence in up to 30 % of cases . Interest has , therefore , recently increased in \" chemical sphincterotomy \" by using topical glyceryl trinitrate ointment . Unfortunately , there is , to date , no specific pharmaceutical preparation of such compound . AIMS To compare , according to a r and omized double-blind crossover study , the effects of a pharmaceutical preparation of a specific 0.2 % glyceryl trinitrate ointment ( PMF 303 ) and of the common preparation reported in the literature on the anal resting pressure in patients with anal fissure . PATIENTS AND METHODS Twelve patients with chronic anal fissure ( 6 males and 6 females , age range 23 - 60 years ] were recruited for the study . Two paired manometric studies were carried out at one-week intervals . After the basal anal pressure had been assessed , the patients were r and omized to receive either one of the two preparations , and manometric measurements were repeated at 20 , 40 and 60 minutes . RESULTS No differences were found between anal resting pressure in the basal study . Both preparations were able to significantly decrease ( p=0.001 ) anal pressure throughout the study period . No significant differences were found between the two preparations . CONCLUSIONS PMF 303 is able to decrease anal pressure in patients with anal fissure , to a similar extent to the widely tested ( galenic ) literature preparation . Availability of a specific formulation for the treatment of this condition may be clinical ly useful",
"Indoramin is an α1‐adrenoceptor antagonist and has been shown to reduce anal resting pressure . Its therapeutic potential has not been explored . The aim of this study was to determine the outcome of treatment with oral indoramin on patients with chronic anal fissure in the setting of a double‐blind r and omized placebo‐controlled trial",
"Botox ® injection of the anal sphincter muscle cures chronic uncomplicated anal fissures in up to 80 % of patients . This study examines the therapeutic efficacy and side effect profile of the British botulinum product Dysport ® . Fifty patients ( 29 women ) were recruited to participate in this r and omized dose‐finding study , their mean age being 32.9 years . The low dose group A was treated with a total dose of 20 U injected in two sites each lateral to the fissure , the high dose group B was treated with 40 U. Eighty‐two percent of patients were pain‐free within a week following the injections . The fissure was healed in 78 % of treated patients after 3 months . Three patients relapsed within 6 months . The most common adverse side effect was transient incontinence ( n = 4 ) . Clinical outcome was not significantly different between the two treatment groups . The low dose can therefore be regarded sufficient for the treatment of anal fissure . Therapeutic efficacy was equivalent to published data on Botox treatment . Both Dysport ® and Botox ® can therefore be used to treat chronic uncomplicated anal fissures . Both Dysport ® and Botox ® therapy are well tolerated , can be performed on an out‐patient basis and avoid the risk of permanent faecal incontinence which complicates surgical treatment of anal fissures",
"Abstract PURPOSE : Nifedipine ( administered orally or applied topically ) has been effective for nonsurgical treatment of anal fissure . We compared the efficacy of nifedipine vs. glyceryl trinitrate for chemical sphincterotomy of anal fissure . METHODS : In a prospect i ve , double-blind trial , 52 patients suffering from chronic anal fissure were r and omly and equally allocated to receive either glyceryl trinitrate or nifedipine , both applied topically to the perianal region . The end point of the study was healing within a predetermined period ( 6 months ) . Variables assessed included demographic data ( age , gender ) , symptoms associated with the fissure , duration of treatment , percentage of healing , untoward effects of treatment , pain scores , duration of follow-up , recurrence , and need for complementary means of treatment . Descriptive data are presented as mean ± st and ard deviation and quantal data as percentage . Inference analysis was performed using the Student ’s t-test for the descriptive data and the chi-squared or Fisher ’s exact test for nominal variables . RESULTS : No significant differences were recorded with regard to age , gender , symptoms associated with the fissure , or duration of treatment . Healing rate was higher ( P nifedipine ( 89 percent ) as compared with glyceryl trinitrate ( 58 percent ) . Treatment side effects ( headache , flushing ) were more frequent ( P glyceryl trinitrate ( 40 percent ) as compared with nifedipine ( 5 percent ) . Pain scores were significantly lower ( P nifedipine vs. 6.2 and 6.1 , respectively ) , but did not differ between the two groups . Recurrence occurred in 31 percent of patients treated with glyceryl trinitrate and 42 percent of those treated with nifedipine after a mean period of 18 ± 3 weeks and 12 ± 4 weeks , respectively . CONCLUSION : Topical application of nifedipine for management of chronic anal fissure was more effective and had fewer side effects than topical glyceryl trinitrate . Recurrence was frequent with both drugs",
"PURPOSE As lateral sphincterotomy and anal dilatation causes complications , a reversible chemical sphincterotomy method has been recently proposed as an alternative treatment in patients with anal fissure . In this study , the effect of botulinum toxin causing temporary paralysis in internal anal sphincter was compared with that of lidocaine in patients with chronic anal fissure . METHOD A total of 62 out patients were r and omly assigned to receive botulinum toxin or lidocaine pomade . The patients were evaluated before and after two months of treatment with physical examination and anal manometry . Pain and nocturnal pain were scored . RESULTS In an evaluation period of two months , in 24 of 34 patients of botulinum group ( 70.58 % ) , and in six of 28 patients of lidocaine group ( 21.42 % ) showed complete epithelization ( p = 0.006 ) . All patients who had previously reported nocturnal pain became symptom free in botulinum group and in four patients of lidocaine group . Pain following defecation disappeared in 24 patients of botulinum group and in 20 patients of control group ( p = 0.959 ) . There was no adverse effect in both groups . While resting anal pressure and maximum voluntary pressure were significantly low in botulinum toxin group , both parameters did not change in lidocaine group . CONCLUSIONS Botulinum toxin is a reliable and effective method for patients with chronic anal fissure . It can be applied easily without any anesthesia and instrumentation . It is cheaper in comparison with surgical methods and it can be a good alternative treatment in patients with risk of incontinence",
"INTRODUCTION Topical glyceryl trinitrate ( GTN ) has gained popularity as a treatment for anal fissure in the West . In our country , lignocaine is still the current treatment for the entity . This study was done to compare the effect of GTN with lignocaine in terms of healing rate and recurrence in South Asian population . METHODS A prospect i ve , double blinded , r and omised controlled trial was conducted on 50 patients ( both treatment arms included ) of all ages and either gender with a clinical diagnosis of anal fissure . Group A was given 0.2 % GTN ointment and Group B was given lignocaine ointment . Both subjective and objective signs of healing were assessed and adverse effects of the treatment were sought . RESULTS Symptomatic relief was earlier with GTN as compared with lignocaine . Pain relief was steady and sustained in those treated with GTN but returned to pre-treatment status within 5 weeks in patients with lignocaine . After 8 weeks of treatment , 80 % of patients in Group A showed clinical signs of healing compared to 32 % in Group B ( p=0.001 ) . Headache was the main side effect of GTN . At 6-month follow-up , recurrence was seen in 3/8 patients in Group B compared to 8/20 in the GTN Group ( p=1 ) . CONCLUSION Topical GTN has earlier and a higher rate of clinical healing of anal fissure with acceptable side effects . The recurrence rate is high and comparable to lignocaine ointment . It is a safe and an effective treatment of anal fissure in a South Asian population",
"Abstract PURPOSE : Chronic anal fissure may be treated by chemical or surgical sphincterotomy . The aim of this study was to test the efficacy of local application of nifedipine and lidocaine ointment in healing chronic anal fissure . METHODS : The study was performed according to a prospect i ve , r and omized , double-blind design . One hundred ten patients who gave informed consent were recruited . They received a clinical examination , a question naire to evaluate symptoms and pain , anorectal manometry , and anoscopy . Healing of anal fissure at Day 42 of therapy was defined as the primary efficacy variable of the study . Patients treated with nifedipine ( n = 55 ) used topical 0.3 percent nifedipine and 1.5 percent lidocaine ointment every 12 hours for 6 weeks . The control group ( n = 55 ) received topical 1.5 percent lidocaine and 1 percent hydrocortisone acetate ointment during therapy . Anal pressures were measured by recording resting and maximal voluntary contraction pressures at baseline and at Day 21 . Long-term outcomes were determined after a median follow-up of 18 months . RESULTS : Healing of chronic anal fissure was achieved after 6 weeks of therapy in 94.5 percent of the nifedipine-treated patients ( P controls . Mean anal resting pressure decreased from a mean value ± st and ard deviation of 47.2 ± 14.6 to 42 ± 12.4 mmHg in the nifedipine group . This represents a mean reduction of 11 percent ( P = 0.002 ) . Changes of maximal voluntary contraction in nifedipine-treated patients were not significant . No changes in mean anal resting pressure and maximal voluntary contraction were observed in the control group . We did not observe any systemic side effect in patients treated with nifedipine . After the blinding was removed , recurrence of the fissure was observed in 3 of 52 patients in the nifedipine group within 1 year of treatment , and 2 of these patients healed with an additional course of topical nifedipine and lidocaine ointment . CONCLUSIONS : Our study clearly demonstrates that the therapeutic use of topical nifedipine and lidocaine ointment should be extended to the conservative treatment of chronic anal fissure",
"Purpose Topical nitroglycerin has been widely used as a means for avoiding surgery in patients with anal fissure . However , nitroglycerin has not been universally accepted for this application because of inconsistency of efficacy and side effects . This study compares conventional digital application with precise intra-anal dosing of nitroglycerin using a specialized dose-delivery device and anal cannula . Methods Twenty-six consecutive patients ( 13 males ) with chronic anal fissure and no previous treatment were r and omly allocated to receive 0.75 ml of 0.3 percent nitroglycerin ointment ( 2.25 mg nitroglycerin ) t.i.d . intra-anal using the cannula ( Group A ) or perianally with the gloved finger ( Group B ) . Nitroglycerin dosage was controlled in Group A by the dose-delivery device connected to the cannula and by single-dose preloaded syringes in Group B. Results Anal manometry : pressure reduction after application of nitroglycerin was 47 ± 18.6 in Group A and 20.7 ± 13.4 percent in Group B ( P 0.01 ) . Headaches were reported by 1 of 10 patients in Group A and 10 of 12 patients in Group B ( P = 0.0027 ) . Seven patients of Group B had to be crossed to intra-anal treatment as a result of intensity of headaches . Pain relief was noted by 8 of 10 and 9 of 12 patients in Groups A and B , respectively ( P = 0.6 ) . Sphincterotomy was required in only 13.6 percent of all patients . Conclusions Controlled intra-anal dosing of topical nitroglycerin produces a significantly greater reduction in sphincteric pressure and lower incidence of headaches than with perianal administration of the same dose ofointment . These results suggest a new paradigm for increasing safety and efficacy of dose-dependent prescription anal topical medications",
"Objective R and omized controlled trials have reported fissure healing rates of 60–70 % using topical 0.2 % GTN ointment , but the effectiveness of this therapy in routine clinical practice , particularly in the long term , is uncertain . This study aim ed to evaluate the efficacy of topical GTN for anal fissures in an outpatient setting",
"Purpose : The aim of this trial was to compare lateral internal sphincterotomy with local 0.2 percent isosorbide dinitrate in the treatment of chronic anal fissure to minimize surgical complications such as minor fecal incontinence . Methods : Fifty-four patients with chronic anal fissure were r and omized in a prospect i ve trial to either sphincterotomy or local 0.2 percent isosorbide dinitrate . All patients had anal function tests before and 5 weeks after treatment . Results : In the ointment group , 18 patients ( 67 percent ) healed at 5 weeks and 24 ( 89 percent ) healed at 10 weeks of treatment . Maximum resting anal pressure was reduced 30 percent . Eight patients ( 30 percent ) had minor side effects . In the surgical group , 26 patients ( 96 percent ) healed at 5 weeks and 100 percent healed at 10 weeks after treatment , with 33 percent reduction in maximum resting anal pressure . Forty-four percent of patients had minor fecal incontinence , which remained in 15 percent after 24 months follow-up . No statistical difference in maximum resting anal pressure was found between groups ( P = 0.16 ) , but the percentage of healing at 5 weeks was greater in the surgical group ( P Isosorbide dinitrate ointment must be considered as the first choice of treatment in patients with chronic anal fissure . Surgery should be indicated if chemical sphincterotomy fails",
"INTRODUCTION The duration of physiologic action of topical glyceryl trinitrate in the management of anal fissure has been the source of some controversy . This study was design ed to assess the manometric effect of glyceryl trinitrate on internal sphincter resting tone with continuous monitoring . METHODS Twenty-seven patients with a chronic anal fissure were assessed with fissure , pain , bleeding , and continence scores . Twenty-two were r and omized to 1 cm of topical 0.2 percent glyceryl trinitrate paste , applied to the lower anal canal . Five patients were r and omized to 1 cm of water-soluble lubricating jelly to the lower anal canal . Continuous stationary six radial channel water perfusion anorectal manometry was performed for 5 minutes before treatment and then for a further 30 minutes . The 22 glyceryl trinitrate patients were then advised to apply topical 0.2 percent glyceryl trinitrate , three times daily , for eight weeks . Twenty-four hours after completing treatment , all baseline assessment s were repeated . The lubricant jelly cohort was discharged from the study after the initial assessment . RESULTS During the initial manometric assessment , 21 glyceryl trinitrate patients ( 95 percent ) had 20 percent or more reduction in mean and maximum anal resting pressure after treatment . However , there was no statistical difference at 20 minutes compared with 0 minutes ( P > 0.1 ) . After eight-week treatment , 16 patients ( 73 percent ) reported symptom resolution and 15 ( 67 percent ) were found to be healed on examination . Clinical healing and resolution of symptoms positively correlated with a higher pretreatment maximum anal resting pressure in the mid anal canal ( P maximum resting pressure after application of glyceryl trinitrate ( P mean and maximum anal resting pressure at Week 8 was not significantly different from the baseline values ( P > 0.05 ) . During continuous manometry , the anal resting pressure did not significantly change in the patients treated with lubricating jelly . CONCLUSIONS In those patients with a lower fissure score , a higher mid anal canal anal resting pressure , and a greater resting pressure reduction after glyceryl trinitrate application , a favorable clinical outcome can be expected with glyceryl trinitrate treatment . However , because the physiologic response has resolved in fewer than 20 minutes , the dosing regime should be reassessed",
"BACKGROUND AND METHODS Lateral internal sphincterotomy , the most common treatment for chronic anal fissure , may cause permanent injury to the anal sphincter , which can lead to fecal incontinence . We compared two nonsurgical treatments that avert the risk of fecal incontinence . We r and omly assigned 50 adults with symptomatic chronic posterior anal fissures to receive treatment with either a total of 20 U of botulinum toxin injected into the internal anal sphincter on each side of the anterior midline or 0.2 percent nitroglycerin ointment applied twice daily for six weeks . RESULTS After two months , the fissures were healed in 24 of the 25 patients ( 96 percent ) in the botulinum-toxin group and in 15 of the 25 ( 60 percent ) in the nitroglycerin group ( P=0.005 ) . No patient in either group had fecal incontinence . At some time during treatment , five patients in the nitroglycerin group had transient , moderate-to-severe headaches that were related to treatment . None of the patients in the botulinum-toxin group reported adverse effects . Ten patients who did not have a response to the assigned treatment - 1 in the botulinum-toxin group and 9 in the nitroglycerin group - crossed over to the other treatment ; the fissures subsequently healed in all 10 patients . There were no relapses during an average of about 15 months of follow-up . CONCLUSIONS Although treatment with either topical nitroglycerin or botulinum toxin is effective as an alternative to surgery for patients with chronic anal fissure , botulinum toxin is the more effective nonsurgical treatment",
"PURPOSE : Nitric oxide is an important neurotransmitter mediating internal anal sphincter relaxation . Patients suffering from fissure-in-ano were treated with topical nitroglycerine . The clinical evidence for therapeutic adequacy was examined in a prospect i ve , r and omized study . METHODS : The study included 35 patients with acute and chronic anal fissures . In Group A , including 20 patients with the clinical diagnosis of acute ( 12 patients ) and chronic ( 8 patients ) anal fissures , treatment consisted of topical nitroglycerine . Group B , consisting of 15 patients ( 10 acute and 5 chronic fissures ) , received topical anesthetic gel during therapy . Manometry was performed before and on days 14 and 28 in the course of topical application of either 0.2 percent glyceryl trinitrate ointment or anesthetic gel ( lignocaine ) . Anal pressures were documented by recording the maximum resting and squeeze pressures . RESULTS : In 60 percent of cases treated with topical nitroglycerine ( Group A , 11 acute ( 91.6 percent ) and 1 chronic ( 12.5 percent ) ) , anal fissure healed within 14 days , in contrast to Group B in which no healing was observed . The healing rate after one month was 80 percent ( 11 acute ( 91.6 percent ) ; 5 chronic ( 62.5 percent ) ) in Group A and was significantly superior to Group B ( healing rate , 40 percent : 5 acute ( 50 percent ) ; 1 chronic ( 20 percent ) ) . DISCUSSION : Previously increased maximum resting pressures decreased from a mean value of 110 to 87 cm H2O . This represents a mean reduction of 20 percent ( P=0.0022 ) . We also noted a significant decrease in squeeze pressures ( from 177.8 to 157.9 cm H2O ( 11 percent ) ) . However , anal pressures did not decrease significantly in the four chronic fissure patients from Group A , whose fissures only healed after 28 days . Similarly to these Group A chronic fissure patients , no significant anal pressure reduction was observed in any Group B patients . Except for mild headache ( 20 percent ) , no side effects of treatment were reported . CONCLUSIONS : Topical application of nitroglycerine represents a new , easily h and led , and effective alternative in the treatment of anal fissures . All of our patients reported a dramatic reduction in acute anal pain . However , it should be noted that a lack of sphincter tone reduction is a likely reason for the great tendency of chronic anal fissures to recur",
"PURPOSE : This study was performed according to a prospect i ve , r and omized , double-blind , multicenter design . The aim was to test the efficacy of local application of nifedipine gela in healing acute anal fissure by relaxing the internal anal sphincter . METHODS : Two hundred eighty-three patients who gave informed consent were recruited ; they received a clinical examination . A question naire to evaluate the symptoms and the pain was administered , and a proctoscopy and anorectal manometry were performed . Patients treated with nifedipine ( n=141 ) used topical 0.2 percent nifedipine gel every 12 hours for three weeks . The control group , consisting of 142 patients , received topical 1 percent lidocaine and 1 percent hydrocortisone acetate gel during therapy . Manometry was performed before and on Days 14 and 21 . Anal pressures were measured by recording resting and squeeze pressures . RESULTS : Results obtained were as follows : total remission from acute anal fissure was achieved after 21 days of therapy in 95 percent of the nifedipine-treated patients ( P elevated maximum resting anal pressures decreased from a mean value ± st and ard deviation of 72.5±10.07 mmHg to 50.5±10.03 mmHg in the nifedipine group . This represents a mean reduction of 30 percent ( P decrease in squeeze pressures in nifedipine-treated patients ( from a mean ± st and ard deviation of 130.5±19.25 mmHg to 108.5±18.55 mmHg , a mean reduction of 16.8 percent;P . No changes in anal pressures were observed in the control group . We did not observe any systemic side effect or significant anorectal bleeding in patients treated with nifedipine . CONCLUSIONS : Our study clearly demonstrates that the therapeutic use of nifedipine , which at present is used only in cardiovascular pathologies , should be extended with local use to the conservative treatment of anal fissures",
"PURPOSE : Internal anal sphincterotomy for treating chronic anal fissure can irreversibly damage anal continence . Reversible chemical sphincterotomy may be achieved by anal application of glyceryl trinitrate ointment ( nitric oxide donor ) , which has been reported to heal the majority of patients with anal fissure by inducing sphincter relaxation and improving anodermal blood flow . This trial aim ed to further clarify the role of glyceryl trinitrate in the treatment of chronic anal fissure . METHODS : A total of 132 consecutive patients from nine centers were r and omly assigned to receive 0.2 percent glyceryl trinitrate ointment or placebo twice daily for at least four weeks . The severity of pain and maximum anal resting pressure were measured before and after one week of treatment . Anodermal blood flow was measured before and after application of glyceryl trinitrate or placebo in ten patients . RESULTS : The study was completed by 119 patients ( 59 glyceryl trinitrate and 60 placebo ) , matched for gender , age , duration of symptoms , duration of treatment , site of fissure , previous attempts to treat , pain score , and maximum anal resting pressure . Twenty-nine patients ( 49.2 percent ) healed after glyceryl trinitrate and 31 patients ( 51.7 percent ) healed after placebo ( P= not significant ) . Pain score fell significantly in both groups , in addition to maximum anal resting pressure . Anodermal blood flow improved significantly in seven patients receiving glyceryl trinitrate , but not in the three receiving placebo . Twenty-three patients ( 33.8 percent ) experienced headache and 4 ( 5.9 percent ) , orthostatic hypotension after glyceryl trinitrate . CONCLUSION : This trial fails to demonstrate any superiority of topical 0.2 percent glyceryl trinitrate treatmentvs . a placebo , although the effects of glyceryl trinitrate on anodermal blood flow and sphincter pressure are confirmed . This finding , together with the high incidence of side-effects , should discourage the use of this treatment as a substitute for surgery in chronic anal fissure",
"BACKGROUND Botulinum toxin induces healing in patients with idiopathic anal fissures . METHODS One hundred-fifty patients with posterior anal fissures were treated with botulinum toxin injected in the internal anal sphincter on each side of the anterior midline . Subjects were r and omized into 2 treatment groups based on the number of units of botulinum toxin injected . Patients in group I were treated with 20 units of botulinum toxin and , if the fissure persisted , were retreated with 30 units . Patients in group II were treated with 30 units and retreated with 50 units , if the fissure persisted . RESULTS The 2 groups were comparable in age , gender distribution , duration of symptoms , resting pressure , and maximum voluntary pressure at anorectal manometry . One month after the injection , examinations revealed complete healing in 55 patients ( 73 % ) from group I and 65 patients ( 87 % ) from group II ( P = .04 ) . Five patients from group II reported a mild incontinence of flatus that lasted 2 weeks after the treatment and disappeared spontaneously . The values of the resting anal pressure ( P=.3 ) and the maximum voluntary pressure ( P = .2 ) did not differ between the 2 groups . At 2 months ' evaluation , a healing scar was found in 67 patients ( 89 % ) from group I and 72 patients ( 96 % ) from group II . A relapse of the fissure was observed in 6 patients ( 8 % ) from group I who had a healing scar at 1 month , and 2 other patients never healed . A persistent fissure was present in 3 patients from group II who had no other symptoms . CONCLUSIONS Botulinum toxin injected into the internal anal sphincter is effective in managing anal fissures and avoiding permanent complications . All patients were treated with the active drug and healed after 1 or 2 successive treatments . The results also confirm that higher doses account for a higher success rate , with little increase in complications or side effects , which is probably related to the diffusion of the toxin to the external sphincter",
"BACKGROUND 0.2 per cent topical glyceryl trinitrate ( GTN ) ointment heals up to two-thirds of chronic anal fissures in adults although many patients experience troublesome headaches . This double blind r and omised pilot study assessed the efficacy and side effects of 0.1 and 0.05 per cent GTN ointment in treatment of chronic anal fissures in children . MATERIAL / METHODS 15 consecutive children with chronic anal fissures were r and omised to receive either 0.05 or 0.1 per cent GTN ointment applied topically twice daily for eight weeks . Clinical review was undertaken at weeks 4 and 8 and questions relating to symptoms and the incidence of headache were asked . RESULTS The median age of the 15 ( 8 male ) patients was 6 years ( range 3 - 13 ) . There were 5 anterior and 10 posterior fissures . The median duration of symptoms was 9 ( 3 - 30 ) months . 13/15 ( 86.7 % ) patients were taking laxatives at the time of referral . Fissure healing was complete at 8 weeks in all seven patients who received 0.05 % and in 5/8 ( 62.5 % ) patients using the 0.1 % ointment ( Fisher 's exact test , not significant ) . One patient from each arm experienced headaches during the first week of the trial which resolved without treatment and did not affect compliance . There were no other side effects . CONCLUSIONS Topical glyceryl trinitrate ointment is effective in healing chronic anal fissures in children . Healing rates and side effect profile are comparable when either 0.05 or 0.1 per cent ointment is used",
"OBJECTIVE To compare symptomatic relief , healing , and changes in maximal anal resting pressure with the use of topical formulations in patients with chronic anal fissure . METHODS Sixty-four consecutive patients with chronic anal fissure were r and omized into 4 groups that received , in a double-blind manner , a topical ointment that contained 0.2 % nitroglycerine ( GTN ) , 5 % xylocaine , Proctosedyl ( hydrocortisone acetate , heparin , framycetin sulfate , esculoside , ethoform , butoform ) or petroleum jelly ( Vaseline ) , to be applied twice daily . Patients were review ed at 2-week intervals for 6 weeks . Anal manometry was done before , and 20 minutes after , the first application of the ointment . RESULTS There was significant ( p mean anal resting pressure after application of GTN , but not any other ointment . Of 16 patients receiving GTN , complete pain relief occurred in 6 and 15 patients after 2 and 4 weeks of treatment , respectively ; this was more frequent than in the other 3 groups . At 6 weeks also , complete pain relief occurred more often with GTN than with Vaseline or xylocaine . After 4 weeks of treatment , 3 patients on GTN had complete healing of fissure as compared to one each in the xylocaine and Proctosedyl groups and none in the Vaseline group . At 6 weeks , healing of fissure had occurred in 15 of 16 patients receiving GTN as compared to 4 receiving Vaseline , 11 receiving xylocaine , and 12 on Proctosedyl . CONCLUSIONS Topical nitroglycerine produces ' chemical sphincterotomy ' with reduction in mean anal resting pressure . Pain relief and healing of fissure occurred earlier with GTN than with other treatments . GTN should be considered as the treatment of choice for the non-surgical management of patients with chronic anal fissure",
"OBJECTIVE To compare outcomes 24 months after treatment of chronic anal fissure with 0.2 % glyceryl trinitrate ointment ( GTN ) or lateral internal sphincterotomy . DESIGN Prospect i ve , r and omised trial . SETTING One teaching , one private , and 3 district hospitals , U.K. SUBJECTS Seventy patients were r and omised into two groups of 35 each to use 0.2 % GTN ointment or have a lateral internal sphincterotomy . MAIN OUTCOME MEASURES Resolution of symptoms and healing of fissures assessed after 24 months . RESULTS All those operated on were initially cured but one fissure recurred after 8 months . Nineteen of 35 fissures treated with GTN healed . The remaining 16 patients r and omised to use GTN ointment whose fissures did not heal were then treated by sphincterotomy . Three patients whose fissures healed successfully with GTN developed recurrences within 6 months of completing treatment . The remaining 16 of 19 patients treated with GTN whose fissures healed were free of symptoms with no clinical evidence of recurrence after 24 months follow-up . CONCLUSIONS Many anal fissures heal with topical treatment with GTN . Lateral internal sphincterotomy remains effective but should be reserved for patients who fail to respond to initial chemical sphincterotomy",
"BACKGROUND Topical glyceryl trinitrate ( GTN ) may produce healing of anal fissure by decreasing the high resting anal sphincter pressure in these patients . The present study assessed the efficacy of GTN in chronic anal fissure in a double-blind placebo-controlled trial . METHOD Patients with chronic anal fissure ( for more than 8 weeks ) underwent measurement of maximum anal resting pressure ( MARP ) before and 12 minutes after application of either 0.2 % GTN or placebo ointment in a r and omized manner . They then received twice-daily local application of their respective ointment for 6 weeks . Symptoms and healing of fissure were assessed ; patients were evaluated at 3 months for evidence of relapse . RESULTS 19 adult patients ( 12 men ) were studied ; 10 received GTN and 9 placebo . Mean ( SD ) MARP decreased from 131.0 ( 32.3 ) cm H2O to 93.5 ( 28.4 ) cm H2O ( p GTN and from 150.5 ( 36.9 ) cm H2O to 142.8 ( 35.0 ) cm H2O ( p = ns ) with placebo . Fissure healed in 7 of 10 patients treated with GTN and 2 of 9 patients treated with placebo ( p relapse of fissure in either group . CONCLUSION Local application of GTN was effective in healing chronic anal fissure",
"BACKGROUND Anal fissure in children usually is treated by sitz baths , stool softeners , and analgesic ointments . However , some cases are intractable to the treatment . In recent years , it has been reported that nitric oxide donors such as local glyceryl-trinitrate ( GTN ) ointment causes a reversible chemical sphincterotomy . Although the GTN ointment can be an alternative therapy for adult cases , it has not yet been studied in the children who suffer from anal fissure . METHODS Sixty-five children with anal fissure were divided r and omly into 3 groups . Each group received double-blinded a topical ointment that contained either 0.2 % GTN , 10 % lidocaine , or placebo . These ointments were applied to the lowest part of the anal canal twice daily . Patients were periodically review ed , and the study was ended after 8 weeks . RESULTS Complete healing of the fissure occurred in 26 of 31 ( 83.9 % ) patients treated with GTN , 7 of 14 ( 50 % ) patients treated with lidocaine , and 6 of 17 ( 35.2 % ) treated with placebo . In 29 of 31 ( 93.5 % ) GTN-treated patients , a total relief of symptoms was observed , whereas this occurred in 7 of 14 ( 50 % ) treated with lidocaine and 6 of 11 ( 35.3 % ) in the placebo group . The differences between the study group and control groups were highly statistically significant ( P children suffering from anal fissure will be cured and have relief of symptoms after topical application of GTN ointment to the anal canal",
"Background and aim : Hypertonicity of internal anal sphincter plays a major role in the persistence of chronic anal fissure . Botulinum toxin could induce internal anal sphincter relaxation without the adverse effects of surgery ( long‐term faecal incontinence ) or topical nitrates ( anal burning , headaches , hypotension ) ",
"AIM Anal fissures are associated with hypertonia of the internal anal sphincter and pain . We evaluated the efficacy of local application of a combination of minoxidil and lignocaine in healing anal fissures . METHODS In this prospect i ve , r and omized , double-blind study , 90 patients with anal fissure were recruited . Patients received local applications of ointments containing 5 % lignocaine ( n=28 ) , 0.5 % minoxidil ( n=36 ) , or both ( n=26 ) . Healing of anal fissure at 6 weeks was used as the primary end-point . RESULTS Rates of complete healing of fissure were similar in the three groups ( lignocaine alone 8/27 , minoxidil alone 10/34 , combination 7/22 ; p = ns ) . Mean ( SD ) time taken for complete healing with combination treatment [ 1.9 ( 0.6 ) weeks ] was significantly shorter than that with minoxidil alone ( 3.1 [ 1.7 ] weeks ; p=0.001 ) or with lignocaine alone ( 3.3 [ 0.8 ] weeks ; p=0.002 ) . Rates of pain relief were similar in the three groups . Stoppage of bleeding occurred more often with combination treatment than with lignocaine alone . No patient had systemic or local side effects . CONCLUSION Combination treatment with minoxidil and lignocaine helps in faster healing of anal fissures and provides better symptomatic relief than either drug alone",
"Patients presenting with acute anal fissure were r and omized into two treatment groups in a prospect i ve clinical trial . Both groups received treatment for 3 weeks with a stool softener and lignocaine jelly . Those entered in group 1 ( 35 patients ) were asked in addition to insert an anal dilator ( no. 2 ) twice daily while those in group 2 ( 31 patients ) applied the anaesthetic jelly without a dilator . At 6 weeks 11 ( 31·4 per cent ) patients in group 1 and 12 ( 38·7 per cent ) patients in group 2 had been referred for sphincterotomy owing to failure of the treatment . At 6 months this figure had risen to 14 ( 40 per cent ) in group 1 and 15 ( 48·4 per cent ) in group 2 . This difference was not statistically significant , suggesting that the addition of a dilator to the conservative treatment regimen did not diminish the likelihood of surgery ",
"PURPOSE : A r and omized , double-blind , placebo-controlled trial was performed to test the effect of intra-anal glyceryl trinitrate ointment in patients with chronic anal fissures that would normally have been treated by sphincterotomy . Long-term follow-up was then performed to assess fissure healing . METHODS : Patients with chronic anal fissures were r and omly assigned to 0.2 percent topical glyceryl trinitrate ointment or placebo . Anal manometry was performed before treatment , one week later , and 48 hours after treatment ceased at four weeks . Fissure healing was assessed by an observer blinded to the treatment arm . Pain was recorded on a linear analog scale . At the completion of the trial , treatment was continued with glyceryl trinitrate until fissure healing was obtained or lateral sphincterotomy was performed if required for ongoing pain . A long-term follow-up assessment was made at a mean of 29 ( range , 25–33 ) months . RESULTS : There was a significant reduction in anal resting pressure at Week 1 with glyceryl trinitrate ( P=0.001 ) but not placebo , and at Week 4 there was a significant reduction in pain score with glyceryl trinitrate ( P=0.001 ) and placebo ( P=0.01 ) and a significant reduction in fissure grade with glyceryl trinitrate ( P=0.0001 ) and placebo ( P=0.02 ) . Forty-six percent of fissures healed with glyceryl trinitrate and 16 percent healed with placebo ( P=0.001 ) . At long-term follow-up in 40 of 43 patients , 14 patients ( 35 percent ) had undergone lateral sphincterotomy , and in the remainder who were treated with glyceryl trinitrate there was a significant reduction in pain score ( P=0.0002 ) . Seventeen patients attended for repeat manometry and fissures were healed with glyceryl trinitrate in ten ( 59 percent ) cases . High internal sphincter pressures persisted at long-term follow-up in patients successfully treated with glyceryl trinitrate , indicating that the sphincter is the cause rather than effect of anal fissure . CONCLUSION : Topical glyceryl trinitrate produces a successful internal sphincterotomy , which result ed in long-term healing of 59 percent of chronic anal fissures and significant improvement in pain . Internal sphincter spasm is the cause of chronic anal fissure",
"Purpose This study was design ed to assess the safety and efficacy of 0.2 percent glyceryl trinitrate suppository form in the healing of chronic anal fissure . Methods Thirty-four patients with symptomatic chronic anal fissures were assigned to 0.2 percent glyceryl trinitrate suppository ( n = 21 ) or placebo ( n = 13 ) in a double blind design . Patient 's symptom scores were registered at first visit . A vali date d daily chart was given to assess their symptoms on a daily basis . Both groups received psyllium from the beginning of the study . They were assessed at two-week intervals for six weeks . Then , they started a washout period of one month and after that were crossed over for another six weeks . Chi-squared , t-tests , and analysis of variance were used for statistical analysis . Results Complete healing at six weeks was achieved in 12 of 21 patients ( 57 percent ) in the glyceryl trinitrate group and 5 of 13 patients ( 38 percent ) in the placebo ( P overall healing rates at the end of study were 15 of 21 ( 71 percent ) vs. 11 of 13 ( 84 percent ) in the glyceryl trinitrate and placebo groups , respectively ( P > 0.05 ) . Conclusions Application of 0.2 percent glyceryl trinitrate suppository form represents a new , promising , and effective treatment for chronic anal fissure",
"Procedures involving the use of anal dilators or topical nitroderivatives for the treatment of anal fissure are efficacious , economic and safe . The aim of our study was to compare the efficacy of two conservative treatments - passive dilation with anal dilators or topical nitroderivatives - in reducing anal pressure and resolving anal fissures . A total of 40 patients with a clinical diagnosis of acute anal fissure in the absence of hypotonic anal sphincter , abscess or perianal fistula , haemorrhoidal thrombosis , chronic inflammatory bowel disease or lower gastrointestinal neoplasia were r and omly assigned to treatment with dilators ( 20 patients ) or topical nitroderivatives ( 20 patients ) . After 4 weeks of treatment , 90 % of patients treated with dilators and only 45 % treated with topical nitroderivatives showed complete resolution of their anal fissures and a reduction of sphincter hypertone . After 12 weeks , 2/18 patients successfully treated with dilators and 1/9 patients successfully treated with topical derivatives presented recurrence of the anal fissure . The use of anal dilators would appear to induce better resolution of acute anal fissures than topical nitroderivates , as confirmed by the low relapse rate at 12 weeks",
"Background : Botulinum neurotoxin induces healing in patients with idiopathic fissure . The optimal dosage is not well established",
"Abstract PURPOSE : Botulinum toxin injection into the internal anal sphincter has been shown to be an effective treatment for chronic anal fissure . A r and omized , prospect i ve trial was conducted to compare botulinum toxin with lateral internal anal sphincterotomy as definitive management for chronic anal fissure . METHODS : Patients diagnosed as having chronic anal fissure were r and omly assigned to one of the two treatment arms . In the botulinum toxin group ( n = 61 ) , 20 to 30 U ( approximately 0.3 U/kg ) of type A botulinum toxin ( Botox ® ) was injected into the internal anal sphincter . The injection was repeated two months later if complete healing was not accomplished . Patients in the sphincterotomy group ( n = 50 ) underwent lateral internal anal sphincterotomy . The same investigators evaluated the patients on postoperative/postinjection days 7 and 28 , and then in a blinded manner at 2 , 6 , and 12 months . RESULTS : In the botulinum group , single injection result ed in complete healing in 45 of the 61 patients ( 73.8 percent ) at the second month . Of the 16 failures , 6 patients refused further treatment , and 10 were treated with a second injection , which result ed in an overall healing rate of 86.9 percent ( 53/61 ) at 6 months . In the sphincterotomy group , the success rate was 82 percent ( 41/50 ) at day 28 and 98 percent ( 49/50 ) at the second month ( P = 0.023 and P developed recurrences , and the healing rate was similar to that of the botulinum group ( 86.9 vs. 96.4 percent ; P = 0.212 ) . At 12 months , the success rate of the Botox ® group fell to 75.4 percent ( 46/61 ) with 7 recurrences , whereas it remained stable in the sphincterotomy group ( 94 percent , P = 0.008 ) . Sphincterotomy was associated with a significantly higher complication rate ( 8 cases of anal incontinence vs. none in the botulinum toxin group ; P 0.001 ) . Full return to daily activities took significantly less time in the botulinum group ( 1 vs. 14.8 ± 5.7 days ; P the healing rate of chronic anal fissure is considerably high with botulinum toxin injection with earlier recovery and less complications compared with sphincterotomy , it occasionally requires a repeat injection , and the healing is slower . The early ( two months ) and late ( one year ) healing rates are significantly higher in the sphincterotomy group , the two groups reaching similar healing rates only at six months",
"INTRODUCTION : Chemical sphincterotomy has proved effective in treating chronic anal fissure . Glyceryl trinitrate is the most widely used agent , and topical 0.2 percent glyceryl trinitrate ointment heals up to two thirds of chronic anal fissures . Unfortunately , however , many patients experience troublesome headaches as a side effect of this treatment . This study assessed the effectiveness of oral and topical diltiazem in healing chronic fissures . METHODS : Fifty consecutive patients with chronic anal fissures were r and omly assigned to receive oral ( 60 mg ) or topical ( 2 percent gel ) diltiazem twice daily for up to eight weeks . Anal manometry was performed before and after the first dose , and blood pressure was recorded at 15-minute intervals . Patients were review ed fortnightly , pain was expressed with a visual linear analog scale , blood pressure was recorded , fissure healing was assessed , and side effects were noted . RESULTS : Twenty-four patients received oral diltiazem , and 26 received topical diltiazem . Mean ( ± st and ard error of the mean ) maximum resting anal pressures fell by 15 and 23 percent from 95±4 to 81±4 and from 102±5 to 79±5 cm H2O in the two groups , respectively . There was no significant reduction in blood pressure during the study or at follow-up in either group . Fissure healing was complete in 9 patients ( 38 percent ) receiving oral diltiazem and 15 ( 65 percent ) on topical treatment by eight weeks . Oral diltiazem caused side effects in eight patients ( rash , two ; headaches , two ; nausea or vomiting , three ; reduced smell and taste , one ) , whereas no side effects were seen in those receiving topical therapy ( P=0.001 ) . CONCLUSION : Oral and topical diltiazem heal chronic anal fissures . Topical diltiazem is more effective , achieving healing rates comparable to those reported with topical nitrates , with significantly fewer side effects",
"BACKGROUND / PURPOSE Anal fissures would result in constipation in children , worsening the clinical picture , thus , justifying a fast response therapy . In this r and omized , prospect i ve , placebo-controlled study , it was aim ed to determine the response rates to fissure treatment by lidocaine , EMLA and GTN on the 10th day and after 8 weeks of therapy . Related childhood literature is scarce , and EMLA is tried for the first time in fissure treatment . METHODS One hundred two children with anal fissures were allocated r and omly into 4 groups . Placebo group ( P ; n = 20 ) received vaseline ; group L ( n = 24 ) , 10 % lidocaine ; group EMLA ( n = 25 ) , eutectic mixture of 5 % prilocaine-5 % lidocaine ; and group GTN ( n = 22 ) , 0.2 % glyceryl trinitrate ointment twice daily to the distal anal canal . Symptoms and physical findings were separately scored as 0 , 1 , and 2 . On the 10th day , the number of patients with scores of 0 ( unresponsive ) and in the 8th week with scores of 2 ( healed and symptom free ) were analyzed statistically . RESULTS Ninety-one patients completed the study . On the 10th day children with 0 symptomatic and fissure healing scores were , respectively , 90 % to 95 % in group P , 75 % to 80 % in group L , 20 % to 40 % in group EMLA , and 5 % to 10 % in group GTN . These results were statistically significant . In the eighth week , children with symptomatic and healing scores of 2 were , respectively , 10 % to 5 % in group P , 42 % to 29 % in group L , 76 % to 64 % in group EMLA , and 91 % to 82 % in group GTN . Results in groups GTN and EMLA were statistically similar ( P > .05 ) and better than the other 2 groups ( P GTN application , and similar and high success rates could be gained by GTN or EMLA by 8 weeks of treatment",
"BACKGROUND Chronic anal fissure is a lineal ulcer of the lower part of the anal canal . It is a painful condition characterized by postdefecational pain and bleeding . It is associated with internal anal sphincter spasm . The relief of internal anal sphincter spasm is the key for providing fissure healing . Gold st and ard in the treatment of chronic anal fissure is partial lateral internal anal sphincterotomy . METHODS Sixty patients with chronic anal fissure were r and omly assigned into two groups treated either by surgical sphincterotomy or injections of botulinum toxin into internal anal sphincter . Manometric measurements were performed before and three months after treatment . Follow up period was six months . The aim of the study was to compare results between these two groups . RESULTS Both methods efficiently reduced resting anal pressure and successfully healed chronic anal fissure . CONCLUSION Surgical and biologic sphincterotomy are almost equally effective in the treatment of chronic anal fissure . Injecting botulinum toxin into internal anal sphincter is a safe , easy to apply and effective method in the management of anal fissure",
"Lateral internal sphincterotomy has been the st and ard treatment for chronic anal fissure , but fissure healing rates of up to 80 % with topical glyceryl trinitrate ( GTN ) treatment have suggested that this operation may become redundant . We evaluated the results of topical treatment of chronic anal fissures with 0.2 % GTN for 6 weeks in the outpatient clinical setting , outside the confines of a r and omized clinical trial . The role of lateral internal sphincterotomy in the GTN era was also assessed . GTN induced fissure healing in 21 of 49 consecutive patients . Fissures healed spontaneously in 2 patients who discontinued GTN because of headache . Lateral internal sphincterotomy was performed in 26 patients who had persistent symptoms after 6 weeks of GTN therapy . At the 6-week post-sphincterotomy review , all fissures had healed and there were no complications . In this study topical GTN for treatment of chronic anal fissure in the outpatient setting was not as effective as demonstrated in controlled clinical trials . Lateral internal sphincterotomy is still a good therapeutic option , especially in patients not responding to GTN",
"PURPOSE : This study was undertaken to compare local application of a glyceryl trinitrate ointment with lateral internal sphincterotomy for the treatment of chronic fissure-in-ano . PATIENTS AND METHODS : A sample of 24 consecutive patients with chronic anal fissure was r and omly allocated to treatment with sphincterotomy or local glyceryl trinitrate . Patients were followed-up for a median of 22 months . RESULTS : All 12 patients healed following sphincterotomy ; 10 of 12 healed with local glyceryl trinitrate ( P=0.239 ) . There were no recurrences or side-effects in either group . CONCLUSIONS : Local application of glyceryl trinitrate can avoid surgery in more than 80 percent of patients with chronic anal fissure",
"OBJECTIVE To assess the efficacy of isosorbide dinitrate in healing anal fissures . DESIGN R and omised , prospect i ve , double blind , placebo controlled trial . SETTING Teaching hospital , The Netherl and s. SUBJECTS 37 consecutive subjects with anal fissure diagnosed in the surgical outpatient department . INTERVENTIONS After r and omisation , 20 patients were given isosorbide dinitrate , and 17 patients placebo . MAIN OUTCOME MEASURES Healing of anal fissure , recurrence , and tolerance . RESULTS Both groups were treated for a median ( range ) of 5 weeks ( range 1 - 10 ) . After this period , 17 in the isosorbide group had healed compared with 6 controls ( p fissure recurred in 2 patients who had had an initial good response to isosorbide , and in 2 in the control group . Side effects ( particularly headache ) were more common after isosorbide dinitrate , but not significantly so ( 9/20 compared with 3/17 ) . CONCLUSIONS Isosorbide dinitrate is an effective treatment for anal fissure , and is significantly better than placebo",
"BACKGROUND Botulinum toxin induces healing in patients with idiopathic anal fissure . METHODS Fifty patients affected by posterior anal fissure were treated with 20 units of botulinum toxin , injection in the internal anal sphincter on each side of the posterior midline ( group I ) or on each side of the anterior midline ( group II ) . RESULTS At 2 months evaluation , a healing scar was observed in 15 patients of group I and in 22 patients of group II(P = 0.025 ) . Resting anal pressure was significantly different from the baseline values at 1-month as well as at 2-month check-ups in both groups , but the values were significantly lower in patients of group II . CONCLUSIONS The intersite comparison revealed that anterior injection of the internal anal sphincter result ed in improved lowering of resting anal pressure and produced an earlier healing scar",
"Purpose This study was design ed to assess whether addition of glyceryl trinitrate to botulinum toxin improves the healing rate of glyceryl trinitrate-resistant fissures over that achieved with botulinum toxin alone . Methods Patients were r and omized between botulinum toxin plus glyceryl trinitrate ( Group A ) and botulinum toxin plus placebo paste ( Group B ) . Patients were seen at baseline , four and eight weeks , and six months . The primary end point was fissure healing at eight weeks . Secondary end points were symptomatic relief , need for surgery , side effects , and reduction in maximum resting and squeeze pressures . Results Thirty patients were r and omized . Two-thirds of patients had maximum anal resting pressures below or within the normal range at entry to the study . Healing rates in both treatment groups were disappointing . There was a nonsignificant trend to better outcomes in Group A compared with Group B in terms of fissure healing ( 47 vs. 27 percent ) , symptomatic improvement ( 87 vs. 67 percent ) , and resort to surgery ( 27 vs. 47 percent ) . Conclusions There is some evidence to suggest that combining glyceryl trinitrate with botulinum toxin is superior to the use of botulinum toxin alone for glyceryl trinitrate-resistant anal fissure . The poor healing rate may reflect the fact that many of the patients did not have significant anal spasm at trial entry"
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OVER the past decade , the percentage of surgical procedures being performed in outpatient centers has increased . In response , outpatient anesthetic practice and research have focused on providing anesthetics that minimize symptoms ( e.g. , nausea and vomiting ) in the postanesthesia care unit and hasten time to discharge . Much effort has been placed on development of newer agents with a more favorable recovery profile . Similarly , examination of the economic parameters ( e.g. , length of recovery room stay , cost-effectiveness of drugs ) after ambulatory surgery has focused on the immediate predischarge , postoperative period . A significant portion of research in this area has concentrated on minimizing immediate postoperative symptoms to facilitate patient discharge from the hospital . On the other h and , relatively few studies have evaluated the impact of patient-reported symptoms after discharge from the postanesthesia care unit . Postdischarge symptoms ( those occurring after discharge from the ambulatory surgical unit ) may have an important impact on patient recovery after ambulatory surgery and the economic burden on patients and their caregivers ; however , there has not been a systematic examination of postdischarge symptoms . It is important to know the frequency with which patients experience postdischarge symptoms so that providers can better inform patients and research ers can better estimate the burden of these symptoms and potential for the incidence of postdischarge symptoms to serve as a measure of quality of care . Quantification of the incidence of postdischarge symptoms would be the first step in the process in determining the extent of the problem and if perioperative interventions ( e.g. , intraoperative anesthetic technique , multimodal analgesia , or pharmacologic agents ) would be effective in diminishing the impact of these patient-related symptoms on functional recovery and health-related quality of life . Therefore , we conducted a systematic review and analysis to evaluate the incidence of patient-reported symptoms after outpatient surgery
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"UNLABELLED Reconstruction of the anterior cruciate ligament ( ACL ) of the knee is associated with a considerable degree of postoperative pain . Although immediate-release oral opioids are usually effective in relieving moderate to severe pain , they must be given every 4 - 6 h. A controlled-release ( CR ) formulation of oxycodone maintains therapeutic opioid concentrations for a more prolonged period , thus providing sustained pain relief . We design ed this study to determine whether CR oxycodone is more effective and clinical ly acceptable than immediate-release oxycodone for managing pain after ambulatory ACL repair surgery . All patients received a st and ard general anesthetic and postoperative analgesic regimen with one of three oxycodone dosing regimens : oxycodone 10 mg every 4 h as needed , oxycodone 10 mg every 4 h , and CR oxycodone 20 mg every 12 h. Rescue analgesic consisted of oxycodone 5 mg every 6 h as needed . At 24 , 36 , 48 , 60 , and 72 h , there was a difference in pain scores among the groups ( P pain in the CR oxycodone group . At most times , the fixed-dose group had lower pain scores than the as-needed group . The sedation scores were significantly different at 12 h ( P alert in the CR oxycodone group . The 72-h consumption of oxycodone was less in the CR oxycodone group ( P less sleep disturbance ( P satisfied ( P less vomiting ( P CR oxycodone in the immediate 72 h after ambulatory ACL surgery provides more effective analgesia with less sedation , sleep disturbance , and postoperative vomiting compared with oxycodone prescribed on either a fixed dose or as-needed schedule . IMPLICATION S A controlled-release formulation of oxycodone in patients undergoing anterior cruciate ligament repair on an ambulatory basis provides significant analgesic benefit and a lowering of side effects compared with either fixed-dose or as-needed oxycodone regimens",
"STUDY OBJECTIVE To estimate the financial costs incurred by outpatient surgical centers in managing postoperative nausea and vomiting ( PONV ) . DESIGN Prospect i ve , observational study . SETTING 6 hospital-based outpatient surgery centers . PATIENTS 211 adult patients undergoing outpatient surgery for laparoscopy , dilatation and curettage , knee arthroscopy , or hernia repair . MEASUREMENTS AND MAIN RESULTS Of the 211 patients studied , 34 experienced PONV in the recovery room . For those patients experiencing PONV , personnel , supply , and drug costs for management of this condition averaged $ 14.94 per patient . In addition , PONV increased the centers ' operating costs by delaying patient discharge by an average of 24 minutes . A minimum estimate of this cost , based on nurses ' wage rates , was $ 7.12 . This estimate is appropriate only for short-run considerations in outpatient surgery centers that operate at low capacity . An appropriate valuation for long-run considerations and for centers operating near capacity is based on the revenue that centers lose as a result of extended stays . Lost revenue was estimated to be $ 415 per patient experiencing PONV . CONCLUSIONS PONV substantially increases the costs incurred by outpatient surgical centers",
"To underst and better the factors important to the safety of anaesthesia provided for day surgical procedures , we analyzed the intraoperative and immediate postoperative course of patients at four Canadian teaching hospitals ’ day treatment centres . After excluding those who received only monitored anaesthesia care , there were 6,914 adult ( non-obstetrical ) patients seen over a twelve-month period in 1988–89 . The rate of adverse outcome consequent to their care was identified by a comprehensive surveillance system which included review of anaesthetic records ( four hospitals ) and follow-up telephone calls ( two hospitals ) . The relationship between adverse events and preoperative factors was determined by using a multiple logistic regression analysis that included age , sex , duration of the procedure and the hospital care . There were no deaths during the study period and major morbid events were infrequent . Patient preoperative disease was predictive of some intraoperative events relating to the same organ system , but not to events in the PACU . Some unexpected relationships emerged including preoperative hypertension being related to a greater risk of difficult intubation , and neurological disease to perioperative cardiac abnormalities . Patients judged obese , or inadequately fasted , were found to experience a greater rate of recovery problems as well as discomfort . While the low response rate ( 36 % ) to the telephone interviews created a sampling bias , the high rate of patient dissatisfaction among those reached is disconcerting . We conclude that day surgical patients with preoperative medical conditions , even when optimally managed , are at higher risk for adverse events in the perioperative period . RésuméAfin de mieux comprendre les facteurs importants pour la sécurité de l’anesthésie prodiguée en chirurgie ambulatoire , nous avons analysé le décours intra-opératoire en post-opératoire immédiat chez les patients des centres de chirurgie ambulatoire de quatre hopitaux d’enseignement canadiens . Après exclusion des cas n ’ ayant nécessité qu ’ une surveillance anesthésique , il y avait 6914 patients adultes ( non obstétricaux ) pour une période de douze mois en 1988–89 . Le taux d’issues défavorables secondaires aux soins a été identifié par un systeme de surveillance d’ensemble qui incluait la révision des dossiers anesthésiques ( quatre hôpitaux ) et des appels téléphoniques pour assurer le suivi ( deux hôpitaux ) . La relation entre les événements défavorables et les facteurs pré-opératoires était déterminée par une analyse de régression logistique multiple qui incluait l’age , le sexe , la durée de l’intervention et l’hôpital ayant fourni les soins . Il n’y a pas eu de décès durant la periode de l’étude et les événements morbides majeurs ont été peu fréquents . La maladie du patient en préopératoire était un facteur de prédiction de quelques événements intra-opératoires reliés au même système d’organes , mais ne l’était pas pour les événements survenus en salle de réveil . Quelques relations imprévues ont émergées do nt la relation entre l’hypertension artérielle pré-opératoire et un plus gr and risque a’intubation difficile , et la relation entre une maladie neurologique et les anomalies cardiaques en péri-opératoire . Les patients considérés obèses , ou sans jeûne adéquat , ont présentés un plus haut taux de problèmes au réveil et un plus gr and inconfort . Bien que le faible taux de réponse ( 36 % ) aux entrevues téléphoniques a créé un biais d’échantillonnage , le haut taux d’insatisfaction des patients parmi ceux qui furent rejoints est déconcertant . En conclusion , les patients de chirurgie ambulatoire qui présentent des problèmes médicaux pré-opératoires , même lorsque traités de façon optimale , sont à plus haut risque de présenter des événements défavorables en période péri-opératoire",
"CONTEXT The North American Symptomatic Carotid Endarterectomy Trial ( NASCET ) and the Asymptomatic Carotid Atherosclerosis Study ( ACAS ) demonstrated the efficacy of carotid endarterectomy ( CEA ) in reducing the risk of stroke and death in selected patients when surgery was performed in institutions whose participation depended on demonstrated excellence . Thirty-day mortality rates in the trials were very low : 0.6 % in NASCET and 0.1 % in ACAS . OBJECTIVE To assess perioperative mortality among Medicare patients undergoing CEA in all nonfederal institutional setting s. DESIGN Retrospective national cohort study . SETTING AND PATIENTS All 113300 Medicare patients undergoing CEA during 1992 and 1993 in \" trial hospitals \" ( those participating in NASCET and ACAS , n=86 ) and \" nontrial hospitals \" ( all other nonfederal institutions performing CEAs , n=2613 ) . Nontrial hospitals were stratified into terciles based on volume of CEAs performed . MAIN OUTCOME MEASURES Crude and adjusted perioperative ( 30 day ) mortality rates . RESULTS The perioperative mortality rate was 1.4 % ( 95 % confidence interval [ CI ] , 1.2%-1.7 % ) at trial hospitals ; mortality in nontrial hospitals was higher : 1.7 % ( 95 % CI , 1.6%-1.8 % ) ( high volume ) ; 1.9 % ( 95 % CI , 1.7%-2.1 % ) ( average volume ) ; 2.5 % ( 95 % CI , 2.0%-2.9 % ) ( low volume ) ; ( P for trend , mortality risk reduction of 15 % ( 95 % CI , 0%-31 % ) compared with high-volume nontrial hospitals , 25 % ( 95 % CI , 7%-40 % ) compared with average-volume hospitals , and 43 % ( 95 % CI , 25%-56 % ) compared with low-volume hospitals ( P for trend , Medicare patients ' perioperative mortality following CEA is substantially higher than that reported in the trials , even in those institutions that participated in the r and omized studies . Caution is advised in translating the efficacy of carefully controlled studies of CEA to effectiveness in everyday practice",
"Background : In an era of growing economic constraints on healthcare delivery , anesthesiologists are increasingly expected to underst and cost analysis and evaluate clinical practice s. Postoperative nausea and vomiting ( PONV ) are distressing for patients and may increase costs in an ambulatory surgical unit . The authors compared the cost-effectiveness of four prophylactic intravenous regimens for PONV:—4 mg ondansetron , 0.625 mg droperidol , 1.25 mg droperidol , and placebo . Methods : Adult surgical out patients at high risk for PONV were studied . Study drugs were administered intravenously within 20 min of induction of nitrous oxide – isoflurane or enflurane anesthesia . A decision-tree analysis was used to group patients into 12 mutually exclusive subgroups based on treatment and outcome . Costs were calculated for the prevention and treatment of PONV . Cost-effectiveness analysis was performed for each group . Results : Two thous and sixty-one patients were enrolled . Efficacy data for study drugs have been previously reported , and the data base from that study was used for pharmacoeconomic analysis . The mean – median total cost per patient who received prophylactic treatment with 4 mg ondansetron , 0.625 mg droperidol , 1.25 mg droperidol , and placebo were $ 112 or $ 16.44 , $ 109 or $ 0.63 , $ 104 or $ 0.51 , and $ 164 or $ 51.20 , respectively ( P = 0.001 , active treatment groups vs. placebo ) . The use of a prophylactic antiemetic agent significantly increased patient satisfaction ( P Personnel costs in managing PONV and unexpected hospital admission constitute major cost components in our analysis . Exclusion of nursing labor costs from the calculation did not alter the overall conclusions regarding the relative costs of antiemetic therapy . Conclusion : The use of prophylactic antiemetic therapy in high-risk ambulatory surgical patients was more effective in preventing PONV and achieved greater patient satisfaction at a lower cost compared with placebo . The use of 1.25 mg droperidol intravenously was associated with greater effectiveness , lower costs , and similar patient satisfaction compared with 0.625 mg droperidol intravenously and 4 mg ondansetron intravenously",
"Postoperative pain is a common reason for the delayed discharge and unanticipated hospital admission of out patients .In this study , we examined the pattern of pain in ambulatory surgical patients and determined those factors that predict postoperative pain . Ten thous and eight consecutive ambulatory surgical patients were prospect ively studied . Preoperative patient characteristics , intraoperative variables , and pain in the postanesthesia care unit ( PACU ) and the ambulatory surgical unit ( ASU ) and 24 h postoperatively were documented . The incidence of severe pain was 5.3 % in the PACU , 1.7 % in the ASU , and 5.3 % 24 h postoperatively . In the PACU , younger male adults ( 36 + /- 13 vs 47 + /- 22 yr ) , ASA physical status I patients , and patients with a higher body mass index ( 26 + /- 5 vs 25 + /- 5 kg ) had a higher incidence of severe pain . In the group with severe pain , the duration of anesthesia , the duration of stay in the PACU and the ASU , and the time to discharge was longer than in the group without severe pain . In the PACU , orthopedic patients had the highest incidence of pain ( 16.1 % ) , followed by urologic ( 13.4 % ) , general surgery ( 11.5 % ) , and plastic surgery ( 10.0 % ) patients . In patients who had general anesthesia , the intraoperative dose of fentanyl was significantly smaller in the group with severe pain than in the group without severe pain when body mass index and duration of anesthesia were taken into consideration . Body mass index , duration of anesthesia , and certain types of surgery were significant predictors of severe pain in the PACU . This knowledge will allow us to identify those patients at risk of severe postoperative pain and manage them prophylactically . Implication s : The pattern of pain was examined in 10,008 consecutive ambulatory surgical patients . The incidence of severe pain was 5.3 % in the postanesthesia care unit , 1.7 % in the ambulatory surgical unit , and 5.3 % 24 h postoperatively . Body mass , duration of anesthesia , and certain types of surgery were significant predictors of pain in the postanesthesia care unit . These data will allow us to better predict those patients who need intense prophylactic analgesic therapy . ( Anesth Analg 1997;85:808 - 16",
"BACKGROUND Iletrospective studies fail to identify predictors of postoperative nausea and vomiting ( PONV ) . The authors prospect ively studied 17,638 consecutive out patients who had surgery to identify predictors . METHODS Data on medical conditions , anesthesia , surgery , and PONV were collected in the post-anesthesia care unit , in the ambulatory surgical unit , and in telephone interviews conducted 24 h after surgery . Multiple logistic regression with backward stepwise elimination was used to develop a predictive model An independent set of patients was used to vali date the model RESULTS Age ( younger or older ) , sex ( female or male ) , smoking status ( nonsmokers or smokers ) , previous PONV , type of anesthesia ( general or other ) , duration of anesthesia ( longer or shorter ) , and type of surgery ( plastic , orthopedic shoulder , or other ) were independent predictors of PONV . A 10-yr increase in age decreased the likelihood of PONV by 13 % . The risk for men was one third that for women . A 30-min increase in the duration of anesthesia increased the likelihood of PONV by 59 % . General anesthesia increased the likelihood of PONV 11 times compared with other types of anesthesia . Patients with plastic and orthopedic shoulder surgery had a sixfold increase in the risk for PONV . The model predicted PONV accurately and yielded an area under the receiver operating characteristic curve of 0.785+/-0.011 using an independent validation set . CONCLUSIONS A vali date d mathematical model is provided to calculate the risk of PONV in out patients having surgery . Knowing the factors that predict PONV will help anesthesiologists determine which patients will need antiemetic therapy",
"BACKGROUND Previous research suggests that people respond differently to health status measures when data are collected by interview or self completion of a question naire . The objective of this study was to determine whether SF-36 health status scores differ systematic ally by method of administration . METHOD A r and omized cross-over study was carried out on 210 new attenders at general medicine , endocrinology , gastroenterology and urological out-patient departments . The outcome was the difference in SF-36 profiles comparing clinic based interviews with self completion at home by the same subjects . RESULTS For seven of the eight variables of the SF-36 scores were lower in the self assessment , the differences being statistically significant in four of the eight comparisons . The largest differences were in role limitations due to emotional problems ( difference 14.74 , 95 per cent confidence interval ( CI ) 7.76 - 21.7 ) and social function ( difference 7.21 , 95 per cent CI 3.19 - 11.23 ) . CONCLUSIONS Clinic based interviews systematic ally exaggerate health status compared with self assessment . The difference is sufficiently large to underestimate the effectiveness of health service interventions when a clinic based pre-intervention and postal self completed follow-up design is used , unless adjustment is made for this systematic bias",
"OBJECTIVE Open cholecystectomy ( OC ) has been superseded by laparoscopic cholecystectomy ( LC ) for the treatment of cholelithiasis , although this fashion has not been vali date d by prospect i ve studies . Our aim was to compare the two techniques . DESIGN Prospect i ve , r and omised , open study . SETTING University hospital , Finl and . PATIENTS 49 patients who required cholecystectomy for cholelithiasis confirmed by ultrasound . INTERVENTIONS 49 patients were r and omly allocated to LC ( n = 27 ) or OC ( n = 22 ) : 25 and 22 , respectively , eventually had the operation . LC was done using a four-trocar technique , and OC through a transverse right subcostal incision , as short as possible . MAIN OUTCOME MEASURES Length of hospital stay and the duration of the sick leave were the primary outcome measures . Secondary outcome measures were : postoperative pain evaluated by visual analogue scale ( VAS ) and the need for opioids ; pulmonary function measured by forced vital capacity ( FVC ) , forced expiratory volume in one second ( FEV1 ) , peak flow velocity ( PEFV ) , and arterial oxygen tension ( PaO2 ) , and endocrine stress measured by plasma catecholamines , cortisol and glucose concentrations . RESULTS The median ( range ) hospital stay was significantly shorter after LC than OC , being 2.0 ( 1 - 15 ) compared with 4.5 ( 2 - 19 ) days p duration of sick leave was also significantly shorter after LC than OC , being 14 ( 7 - 17 ) compared with 29 ( 4 - 34 ) , p postoperative pain after LC than OC as reflected by the need for opioids . Pulmonary function and arterial oxygen tension deteriorated significantly less after LC than OC . The stress response was equal . There were three documented complications , one pneumonia after LC and two wound infections after OC . CONCLUSIONS LC gives significantly better results in terms of less postoperative pain , better pulmonary function , better arterial oxygenation , and shorter hospital stay and duration of sick leave",
"Many health status surveys have been design ed for mail , telephone , or inperson administration . However , with rare exception , investigators have not studied the effect the survey mode of administration has on the way respondents assess their health and other important parameters ( such as response rates , nonresponse bias , and data quality ) , which can affect the generalizability of results . Using a national sampling frame of noninstitutionalized adults from the General Social Survey , we r and omly assigned adults to a mail survey ( 80 % ) or a computer-assisted telephone survey ( 20 % ) . The surveys were design ed to provide national norms for the SF-36 Health Survey . Total data collection costs per case for the telephone survey ( $ 47.86 ) were 77 % higher than that for the mail survey ( $ 27.07 ) . A significantly higher response rate was achieved among respondents r and omly assigned to the mail ( 79.2 % ) than telephone survey ( 68.9 % ) . Nonresponse bias was evident in both modes but , with the exception of age , was not differential between modes . The rate of missing responses was higher for mail than telephone respondents ( 1.59 vs. 0.49 missing items ) . Health ratings based on the SF-36 scales were less favorable , and reports of chronic conditions were more frequent , for mail than telephone respondents . Results are discussed in light of the trade-offs involved in choosing a survey methodology for health status assessment applications . Norms for mail and telephone versions of the SF-36 survey are provided for use in interpreting individual and group scores",
"Purpose To test the hypothesis that the type of surgical procedure influences the incidence of postoperative symptoms . Also the effect of demographic and clinical risk variables : age , sex , ASA status , duration of anaesthesia on the postoperative symptoms were evaluated for each type of surgery . Methods Demographic , medical , anaesthetic and surgical data on 1,017 patients were prospect ively collected by a research assistant who telephoned each patient 24 hr after discharge to administer a question naire to determine postoperative symptoms . Postoperative symptoms included incisional pain , nausea/vomiting , drowsiness , dizziness , headache and fever . In addition , 270 patients were asked the % ( 0–100 ) of their return to daily living function at 24 hr . Results Incisionat pain ( 26.9 % ) , headache ( 11.6 % ) , and drowsiness ( 11.5 % ) were the most frequently reported symptoms . Dizziness was reported by 9.7 % and nausea/vomiting by 7.1 % . Approximately 50 % of patients undergoing laparoscopy , orthopaedic and general surgery reported 24-hr postoperative incisionat pain . The incidence of 24-hr postoperative nausea/vomiting was highest after general 17.4 % , orthopaedic , 11.2 % , and laparoscopic surgery , 9.4 % . Drowsiness was highest after laparoscopy 36.1 % , followed by general surgery , 21.4 % . Dizziness was most frequent after laparoscopy , 24.1 % , followed by general surgery , 16.1 % . After laparoscopy , postoperative drowsiness or dizziness was related to anaesthesia duration . After general surgery , postoperative dizziness or drowsiness were related to age ; the younger the patient , the more likely the symptoms . Conclusions Postoperative pain , nausea/vomiting , drowsiness , dizziness , and headache were the more frequent postoperative symptoms 24 hr after ambulatory surgery and they were influenced by the type of surgical procedure . In addition , the type of surgery and the 24-hr postoperative symptoms determined the degree of return to daily living function . RésuméObjectifVérifier l’hypothèse selon laquelle le type d’intervention influence la symptomatologie postopératoire . De plus , l’influence sur les symptômes postopératoires des facteurs de risque démographiques et cliniques comme l’âge , le sexe , la classe ASA , la durée de l’anesthésie a été évaluée en tenant compte du type de chirurgie . MéthodesUn assistant de recherche a recueilli propectivement les données démographiques , médicales , anesthésiques et chirurgicales de 1 017 opérés qui ont été contactés par téléphone 24 h après leur congé de l’hôpital pour connaître leurs symptômes postopératoires . Ces symptômes comprenaient la douleur au site de l’incision , les nausées et vomissements , la somnolence , les étourdissements , la céphalée et la fièvre . En outre , on a dem and é à 270 patients d’estimer en pourcentage ( 0–100 % ) la reprise de leurs activités quotidiennes usuelles après 24 h . RésultatsLa douleur de l’incision ( 26,90 % ) , la céphalée ( 11,6 % ) et la somnolence ( 11.5 % ) représentaient les symptômes les plus fréquents . Les patients se sont aussi plaints d’étourdissements ( 9,7 % ) et de nausées et vomissements ( 7,1 % ) . Environ 50 % des patients soumis à une laparoscopie , à des interventions orthopédiques et chirurgicales générales ont rapporté une douleur au site de l’incision à la 24 ’ heure . À la suite d’une chirurgie générale , l’incidence après 24 h de nausées et vomissements était plus élevée ( 17,4 % ) qu’après une chirurgie orthopédique ( 11,2 % ) ou laparoscopique ( 9,4 % ) . L’incidence de la somnolence était la plus élevée après une laparoscopie ( 26,1 % ) ; suivait la chirurgie générale ( 21,4 % ) . Les étourdissements étaient les plus fréquents après la laparoscopie ( 24,1 % ) ; suivait la chirurgie générale ( 16,1 % ) . Après une laparoscopie , la somnolence et les étourdissements étaient proportionnels à la durée de l’anesthésie . Après une chirurgie générale , la somnolence et tes étourdissements postopératoires dépendaient de l’âge , la susceptibilité étant plus gr and e chez le patient jeune . Conclusion La douleur postopératoire , les nausées , les vomissements , la somnolence , les étourdissements et la céphalée constituaient les symptômes postopératoires les plus fréquents 24 h après une chirurgie ambulatoire . Ces symptômes étaient influencés par le type d’intervention . En outre , le type d’intervention et les symptômes déterminaient 24 h après l’intervention le degré de retour à la vie quotidienne fonctionnelle",
"BACKGROUND Chickenpox , the primary infection caused by the varicella-zoster virus , affects more than 3 million children a year in the United States . Although usually self-limited , chickenpox can cause prolonged discomfort and is associated with infrequent but serious complications . METHODS To evaluate the effectiveness of acyclovir for the treatment of chickenpox , we conducted a multicenter , double-blind , placebo-controlled study involving 815 healthy children 2 to 12 years old who contracted chickenpox . Treatment with acyclovir was begun within the first 24 hours of rash and was administered by the oral route in a dose of 20 mg per kilogram of body weight four times daily for five days . RESULTS The children treated with acyclovir had fewer varicella lesions than those given placebo ( mean number , 294 vs 347 ; P less than 0.001 ) , and a smaller proportion of them had more than 500 lesions ( 21 percent , as compared with 38 percent with placebo ; P less than 0.001 ) . In over 95 percent of the recipients of acyclovir no new lesions formed after day 3 , whereas new lesions were forming in 20 percent of the placebo recipients on day 6 or later . The recipients of acyclovir also had accelerated progression to the crusted and healed stages , less itching , and fewer residual lesions after 28 days . In the children treated with acyclovir the duration of fever and constitutional symptoms was limited to three to four days , whereas in 20 percent of the children given placebo illness lasted more than four days . There was no significant difference between groups in the distribution of 11 disease complications ( 10 bacterial skin infections and 1 case of transient cerebellar ataxia ) . Acyclovir was well tolerated , and there was no significant difference between groups in the titers of antibodies against varicella-zoster virus . CONCLUSIONS Acyclovir is a safe treatment that reduces the duration and severity of chickenpox in normal children when therapy is initiated during the first 24 hours of rash . Whether treatment with acyclovir can reduce the rare , serious complications of chickenpox remains uncertain",
"Despite careful technique , a proportion of patients undergoing rubber b and ligation ( RBL ) of haemorrhoids will experience pain or discomfort . To investigate this , a group of 52 unselected patients presenting to the surgical outpatient clinic of Bristol Royal Infirmary were entered into a prospect i ve study using question naires , of which 50 ( 96 % ) replied . Pain and discomfort were scored on a 10 cm visual analogue scale . Of these patients , 42 ( 84 % ) reported pain in the first 24 h ; this was moderate to severe in 9 ( 18 % ) ; 30 ( 60 % ) had pain in the second 24 h , with 7 ( 14 % ) patients suffering moderate to severe pain . In all , 14 ( 28 % ) patients were unable to perform their normal activities on the day of treatment and a further 14 ( 28 % ) patients felt faint immediately after RBL . The results of this study indicate that pain after RBL occurs more often than previously recognised . It is suggested that informed consent be obtained before RBL and that patients should be given the opportunity to delay treatment if they so wish",
"This study investigated the impact of perioperative fluid status on adverse clinical outcomes in ambulatory surgery . Two hundred ASA grade I-III ambulatory surgical patients were prospect ively r and omized into two groups to receive high ( 20 mL/kg ) or low ( 2 mL/kg ) infusions of isotonic electrolyte solution over 30 min preoperatively . A st and ardized balanced anesthetic was used . A minimal amount of fluid was given during the intraoperative and postoperative periods . Adverse outcomes were assessed by an investigator blinded to the fluid treatment group at 30 and 60 min after surgery , at discharge , and the first postoperative day . The incidence of thirst , drowsiness , and dizziness was significantly lower in the high-infusion group at all intervals . We recommend perioperative hydration of 20 mL/kg for patients undergoing general anesthesia for short ambulatory surgery . ( Anesth Analg 1995;80:682 - 6",
"UNLABELLED A variety of methods have been used to quantify aspects of recovery after anesthesia . Most are narrowly focused , are not patient-rated , and have not been vali date d. We therefore set out to develop a patient-rated quality of recovery score . We constructed a 61-item question naire that asked individuals ( patients and relatives , medical and nursing staff ; total n = 136 ) to rate various postoperative items describing features a patient may experience postoperatively . The most highly ranked items were included in a final nine-point index score , which we called the \" QoR Score . \" We then studied two cohorts of surgical patients ( n = 449 ) . There was good convergent validity between the QoR Score and the visual analog scale score ( rho = 0.55 , P QoR Scores in patients undergoing day-stay , minor , and major surgery ( P = 0.008 ) , as well as a negative correlation with duration of hospital stay ( rho = -0.20 , P QoR Score and female gender ( P = 0.048 ) and older age ( P = 0.041 ) . There was also good interrater agreement ( rho = 0.55 , P test-retest reliability ( median rho = 0.61 , P internal consistency ( alpha = 0.57 and 0.90 , P QoR Score has good validity , reliability , and clinical acceptability in patients undergoing many types of surgery . IMPLICATION S We set out to develop a patient-rated quality of recovery score ( QoR ) that could be used both as a measure of outcome in perioperative trials and for clinical audit . We first surveyed patients and staff to identify important aspects of recovery , then developed a nine-point QoR Score . This was then compared with other measures of postoperative outcome . We found that the QoR Score is a useful measure of recovery after anesthesia and surgery",
"The substitution of ambulatory for inpatient care has become a common cost-containment proposal ; it assumes that an equivalent or better clinical outcome at lower cost will result . However , when criteria for measuring cost and efficacy are appropriately defined , there is little published information available that support this assumption . Only four of 134 relevant papers that we analyzed provided enough data on both cost and efficacy to allow statistically valid conclusions . Two of these four demonstrated that potential savings would be accompanied by a slightly poorer clinical outcome ; two showed ambulatory care to be as effective as inpatient care and less costly . Future study should include both appropriate calculations of costs and properly controlled measurements of clinical outcome . Indirect costs can not be ignored in such calculations if the total costs of illness , not simply payments to the health industry , are to be reduced",
"A prospect i ve r and omized multicentre study was performed to compare the outcome of laparoscopic and open appendicectomy in patients with suspected acute appendicitis",
"PURPOSE Two large studies reported a very low rate ( 0.5 - 1.8 % ) of postdural puncture headache ( PDPH ) with the use of 27-G spinal needles . We suspected that it might be higher in young ambulatory patients . The purpose of this study was to establish the rate prospect ively in such a patient population using two types of needles . METHODS Two hundred male and female , out patients , 18 - 45 yr , undergoing knee arthroscopy under spinal anaesthesia were r and omly assigned to receive spinal anaesthesia with hyperbaric lidocaine 5 % using either a Quincke or a Whitacre 27-G needle . Twenty patients choosing general anaesthesia formed a comparative group . Using a previously vali date d question naire , the incidence and nature of PDPH were evaluated by telephone three to five days after surgery by an anaesthetist unaware of the anaesthetic technique used . Once all data were collected , an anaesthetist not involved in the study determined in a blinded fashion which headaches were likely to be PDPH . Grading and classification of headaches were based on several criteria : postural nature , duration , intensity and confinement to bed . RESULTS The overall incidence of PDPH in both spinal groups was 9.3 % . The incidence in women , 20.4 % , was higher than in men , 5.5 % , ( P blood patch . Both types of needle were comparable with respect to the incidence , severity and duration of PDPH , number of dural punctures and failed spinal blocks . CONCLUSION The rate of PDPH was higher than in large published studies with 27-G Quincke and Whitacre needles and greater in women than in men",
"The impact of administration mode on health-related quality of life measurement instruments has received little attention , especially for the SF-36 . General community members were r and omly selected to complete the Australian version of the SF-36 Health Survey using either telephone or mail modes . Modes were compared across a number of indices : data collection costs ; consent rates and non-consent bias ; data quality ( completeness of data and internal consistency reliability ) ; and response effects . Data collection costs were lower for the telephone mode . A significantly higher consent rate was achieved with the telephone mode . Those who were younger were more likely to refuse to participate when the mail mode was adopted , while older people were more likely not to consent to the telephone mode . The rate of missing responses was higher for the mail mode , while significant differences were found between modes in internal consistency reliability estimates . Health ratings were more favorable for the telephone administration . The results are discussed in light of the advantages and disadvantages of each administration mode"
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4116ef98-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND This system review and meta- analysis was conducted to systematic ally review and analyze the clinical benefits of different antihypertensive agents in improving arterial stiffness in hypertensive patients . METHODS PubMed data base was search ed for r and omized controlled trials ( RCTs ) evaluating the effects of angiotensin receptor blockers ( ARB ) or other types of antihypertensive agents on pulse wave velocity ( PWV ) . The main indicators were the improvements of PWV and augmentation index ( AI ) before and after r and omized treatments with antihypertensive agents . For the studies that only provided the mean and st and ard deviation of the indicators before and after r and omization , the st and ardized mean difference ( SMD ) method was directly applied to combine the mean and st and ard deviation of various indicators after the treatment . For the studies provided the mean and st and ard deviation of the changes of the indicators , the weighted mean difference ( MD ) method was applied to combine the mean and st and ard deviation of the therapeutic effect . RESULTS Ten RCT studies were included and the sample sizes range from 40 to 201 ( total : 938 ) . Four studies provided the changes of PWV before and after r and omization , the pooled analysis showed that the changes of PWV in ARB group were not significantly higher than other antihypertensive agents [ MD : 125.76 , 95 % confidence interval ( CI ) : -78.70 to 330.23 , P=0.23 ] ; 4 studies provided the PWV values before and after r and omization , the PWV values in ARB group were not significantly superior ( SMD : 0.04 , 95 % CI : -0.16 to 0.24 , P=0.71 ) . Three studies provided the changes of AI before and after r and omization , the ability of ARB to lower the level of the AI was superior to other antihypertensive agents ( MD : 8.94 , 95 % CI : 2.18 - 5.71 , P=0.01 ) ; 2 studies provided the AI value after r and omization , the abilities of ARB and other anti-hypertensive agents to improve the AI were similar ( SMD : 0.03 , 95 % CI : -1.20 to 1.26 , P=0.06 ) . CONCLUSIONS The effect of ARB on the improvement of the PWV level is not superior to other types of antihypertensive agents , but ARB is superior to other types of antihypertensive agents for improving the AI level . Overall , to improve of arterial stiffness , ARB maybe is superior to other antihypertensive agents
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"Increased arterial stiffness , as estimated from aortic pulse wave velocity ( Ao-PWV ) , and albuminuria are independent predictors for cardiovascular disease in type 2 diabetes mellitus ( T2DM ) . Whether angiotensin receptor blockers ( ARBs ) , drugs with cardio-renal protective effects , improve Ao-PWV to a greater extent than other equipotent antihypertensive medications remains unclear . After a 4-week washout phase , we compared the effects of valsartan ( n=66 ) , an ARB , with that of amlodipine ( n=65 ) , a calcium channel blocker on Ao-PWV in 131 T2DM patients with pulse pressure ( PP ) ≥60 mm Hg and raised albumin excretion rate ( AER ) in a 24-week r and omized , double-blind , parallel group study . Hydrochlorothiazide ( HCTZ ) 25 mg/d was added to valsartan 160 mg and amlodipine 5 mg/od uptitrated to 10 mg/od after 4 weeks to ensure equivalent BP control . After 24 weeks brachial and central aortic PP had fallen to a similar extent with attained mean ( SD ) brachial and central PP of 61.6 ( 13.6 ) and 47.3 ( 14.1 ) mm Hg in the valsartan/HCTZ group and 61.5 ( 12.2 ) and 47.3 ( 9.9 ) mm Hg in the amlodipine group , respectively . Ao-PWV showed a significantly greater reduction , mean ( 95 % CI ) , −0.9 m/s ( −1.4 to −0.3 ) for valsartan/HCTZ compared to amlodipine ( P=0.002 ) . AER fell significantly only with Val/HCTZ from 30.8(20.4 , 46.5 ) to 18.2(12.5 , 26.3 ) mcg/min , ( P=0.01 ) with between treatment difference in favor of Val/HCTZ of −15.3mcg/min ( P were not correlated . Valsartan/HCTZ improves arterial stiffness and AER to a significantly greater extent than amlodipine despite similar central and brachial BP control . These 2 effects , which appear independent of each other , may explain the specific cardio-renal protective properties of ARBs",
"The renin-angiotensin system ( RAS ) may play a role in vascular aging . The authors hypothesized that blockade of the angiotensin II type 1 receptor with an angiotensin receptor blocker in healthy elderly subjects improves vascular compliance and endothelial function . Thirty-five healthy elderly subjects were r and omized to valsartan or placebo in a double-blind crossover study after baseline testing for pulse wave velocity , aortic augmentation index , and brachial artery flow-mediated dilation . Angiotensin II type 1 receptor blockade with valsartan improved vascular compliance but not flow-mediated dilation . Changes in pulse wave velocity with valsartan were correlated with change in central systolic blood pressure and pulse pressure and remained associated on multivariate analysis . Change in pulse wave velocity after adjusting for degree of blood pressure change , age , and sex remained correlated with assignment to the angiotensin receptor blocker but not placebo . These data suggest that angiotensin II type 1 receptor blockade improves aging-related vascular compliance without alterations in flow-mediated dilation . Mechanisms regulating compliance and endothelial function are complex and may not necessarily converge in aging",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"Renin – angiotensin system ( RAS ) blockers have shown clinical outcomes superior to those of the beta (β)-blocker atenolol , despite similar reductions in the peripheral blood pressure ( BP ) , perhaps because of different impacts on central hemodynamics . However , few comparative studies of RAS blockers and newer vasodilating β-blockers have been performed . We compared the central hemodynamic effects of losartan and carvedilol in a prospect i ve , r and omized , open , blinded end point study . Of the 201 hypertensive patients enrolled , 182 ( 49.6±9.9 years , losartan group=88 and carvedilol group=94 ) were analyzed . Carotid-femoral pulse wave velocity ( cfPWV ) , aortic augmentation index ( AIx ) , AIx corrected for a heart rate ( HR ) of 75 beats per minute ( AIx@HR75 ) and central BP were measured noninvasively at baseline and after a 24-week treatment regimen with losartan or carvedilol . After 24 weeks , there were no between-group differences in the brachial BP , cfPWV , AIx@HR75 or central BP changes , except for a more favorable AIx effect with losartan . The changes in all measured metabolic and inflammatory parameters were also not significantly different between the two groups , except for uric acid . Losartan and carvedilol showed generally comparable effects on central hemodynamic indices , metabolic profile , inflammatory parameters and peripheral arterial pressure with a 24-week treatment",
"Objective . Angiotensin-converting enzyme ( ACE ) inhibitors have been shown to lower central augmentation index ( cAI ) , an index of arterial wave reflection , more than β-blockers . We tested whether this is also true for long-term treatment with an angiotensin receptor blocker ( ARB ) . Methods . One-hundred and fifty-six subjects with essential hypertension were r and omised to treatment with either irbesartan or atenolol . cAI and central blood pressure ( BP ) were determined by pulse wave analysis from the radial and the carotid artery after six and after 18 months treatment . Results . Peripheral and central systolic and diastolic BP were reduced to a similar extent A in the two groups . cAI was reduced with irbesartan , but increased with atenolol ( derived from the carotid artery : -6±10 vs. -4±12 % after six months , p . Furthermore , central to peripheral pulse pressure ( PP ) amplification was unaffected by treatment with irbesartan , but decreased with atenolol . Conclusions . Although treatment with irbesartan and atenolol similarly decreased peripheral and central BP , only treatment with irbesartan had beneficial effects on arterial wave reflection and preserved PP amplification . These haemodynamic effects may at least partly explain the reported differential effects of ARB versus β-blocker treatment on cardiovascular mortality in patients with essential hypertension",
"When observed in elderly hypertensive patients , increased pulse pressure ( PP ) and arterial stiffness are known to be independent risk factors for cardiovascular diseases . Increased systolic blood pressure ( SBP ) leads to left ventricular hypertrophy , while decreased diastolic blood pressure ( DBP ) results in decreased coronary circulation . It is known that increased arterial stiffness is the major cause of increased PP . Thus basic morbid states of cardiac failure or ischemic heart diseases are more likely to develop in elderly hypertensive patients with increased PP and arterial stiffness , and there is need of antihypertensive drugs that decrease these effects in elderly hypertensives . In this study , we compared the effects of an angiotensin-receptor blocker ( ARB : valsartan ) , an angiotensin-converting enzyme inhibitor ( ACE-I : temocapril ) , and long-acting Ca antagonists ( L- and N-type Ca channel blocker : cilnidipine ; and L-type Ca channel blocker : nifedipine CR ) on PP and arterial stiffness measured by pulse wave velocity in elderly hypertensive patients for 3 months . The ARB yielded the largest reductions in PP and brachial-ankle pulse wave velocity ( baPWV ) , followed by the ACE-I and L- and N-type Ca channel blocker , while the L-type Ca channel blocker yielded no improvement . The effects on arterial stiffness and PP thus varied among the drug characteristics . Although ARB achieved the largest reduction in baPWV , this decrease was not associated with any reductions in PP , SBP , DBP , or mean blood pressure , as were the baPWV-decreases achieved by the other drugs , suggesting that ARB may further reduce the risk of arteriosclerosis in elderly hypertensive patients by decreasing arterial stiffness in addition to its antihypertensive effect",
"Background Cardiovascular disease ( CVD ) is highly prevalent in patients with chronic kidney disease ( CKD ) . Inhibition of the renin-angiotensinsystem ( RAS ) in hypertension causes differential effects on central and brachial blood pressure ( BP ) , which has been translated into improved outcome . The objective was to examine if a more complete inhibition of RAS by combining an angiotensin converting enzyme inhibitor ( ACEI ) and an angiotensin receptor antagonist ( ARB ) compared to monotherapy has an additive effect on central BP and pulse-wave velocity ( PWV ) , which are known markers of CVD . Methods Sixty-seven CKD patients ( mean GFR 30 , range 13–59 ml/min/1.73 m2 ) participated in an open r and omized study of 16 weeks of monotherapy with either enalapril or c and esartan followed by 8 weeks of dual blockade aim ing at a total dose of 16 mg c and esartan and 20 mg enalapril o.d . Pulse-wave measurements were performed at week 0 , 8 , 16 and 24 by the SphygmoCor device . Results Significant additive BP independent reductions were found after dual blockade in aortic PWV ( −0.3 m/s , P in augmentation index ( −2 % , P Furthermore pulse pressure amplification was improved ( P ) and central systolic BP reduced ( −6 mmHg , P CKD patients . Trial Registration Clinical trial.gov",
"In spontaneously hypertensive rats resistance artery structure , endothelial dysfunction and geometry-independent wall stiffness were reduced by an angiotensin AT1-receptor antagonist . In previous studies of human hypertension , interruption of the renin-angiotensin system corrected small artery structure and endothelial dysfunction , whereas the β-blocker atenolol did not . We hypothesized that the AT1R antagonist losartan , but not the β-blocker atenolol , would reduce stiffness of gluteal subcutaneous small arteries in essential hypertensive patients . Seventeen untreated mild essential hypertensive patients ( 47±2years ; 75 % male ) were r and omly assigned in double-blind fashion to losartan or atenolol treatment for one year . Small , resistance size arteries were studied on pressurized myographs . Blood pressure ( mmHg ) was reduced ( p losartan and atenolol , respectively . The media/lumen ratio of small arteries was unaffected by atenolol ( 8.3±0.3 % before and 8.8±0.5 % after treatment ) . In contrast , losartan reduced media/lumen ratio from 8.4±0.4 % to 6.7±0.3 % ( p Whereas isobaric elastic modulus was unaffected by either treatment , geometry-independent stiffness ( slope of elastic modulus vs. stress ) was reduced from 9.7±1.2 to 6.1±0.9 ( P under losartan treatment , but was unchanged by atenolol ( 8.2±1.3 to 7.8±0.6 ) . In conclusion , treatment with losartan reduced stiffness and structural alterations of subcutaneous resistance arteries of previously untreated essential hypertensive patients , whereas atenolol failed to do so",
"Background Antihypertensive drugs are used to control blood pressure ( BP ) and reduce macro- and microvascular complications in hypertensive patients with diabetes . Objectives The present study aim ed to compare the functional vascular changes in hypertensive patients with type 2 diabetes mellitus after 6 weeks of treatment with amlodipine or losartan . Methods Patients with a previous diagnosis of hypertension and type 2 diabetes mellitus were r and omly divided into 2 groups and evaluated after 6 weeks of treatment with amlodipine ( 5 mg/day ) or losartan ( 100 mg/day ) . Patient evaluation included BP measurement , ambulatory BP monitoring , and assessment of vascular parameters using applanation tonometry , pulse wave velocity ( PWV ) , and flow-mediated dilation ( FMD ) of the brachial artery . Results A total of 42 patients were evaluated ( 21 in each group ) , with a predominance of women ( 71 % ) in both groups . The mean age of the patients in both groups was similar ( amlodipine group : 54.9 ± 4.5 years ; losartan group : 54.0 ± 6.9 years ) , with no significant difference in the mean BP [ amlodipine group : 145 ± 14 mmHg ( systolic ) and 84 ± 8 mmHg ( diastolic ) ; losartan group : 153 ± 19 mmHg ( systolic ) and 90 ± 9 mmHg ( diastolic ) ] . The augmentation index ( 30 % ± 9 % and 36 % ± 8 % , p = 0.025 ) and augmentation pressure ( 16 ± 6 mmHg and 20 ± 8 mmHg , p = 0.045 ) were lower in the amlodipine group when compared with the losartan group . PWV and FMD were similar in both groups . Conclusions Hypertensive patients with type 2 diabetes mellitus treated with amlodipine exhibited an improved pattern of pulse wave reflection in comparison with those treated with losartan . However , the use of losartan may be associated with independent vascular reactivity to the pressor effect",
"Introduction : Blockade of the renin-angiotensin system ( RAS ) is a critical approach to the management of hypertension , especially in proteinuric patients . It is well proven that the direct renin inhibitor aliskiren shows comparable clinical efficacy to the angiotensin II receptor blocker valsartan on blood pressure control and albuminuria . However , there is only limited data on the h and -to-h and effectiveness of these two RAS blockers in improving arterial stiffness . We tested whether aliskiren or valsartan would improve arterial stiffness in hypertensive patients with albuminuria who are already on antihypertensive therapy . Material and methods : Thirty-four patients with hypertension and albuminuria , after a wash-out period of three weeks , were r and omized to aliskiren or valsartan in a 24-week r and omized parallel-group study . Results : A nonsignificant difference in blood pressure was seen between the two treatment groups . Albuminuria was significantly reduced in both groups ( 56 % for the aliskiren group , p the valsartan group , p Only valsartan but not aliskiren significantly reduced carotid-femoral pulse wave velocity ( –1.1 ± 0.8 m/s ( p = 0.02 ) for valsartan and + 0.1 ± 0.7 m/s ( ns ) for aliskiren ) . Conclusion : The results of our study showed that valsartan improves arterial stiffness to a significantly greater extent than aliskiren , despite a similar antihypertensive and antiproteinuric effect ",
"BACKGROUND High pulse wave velocity ( PWV ) is related to cardiovascular risk in essential hypertension ( EHT ) . It is reported that short-term treatment with an angiotensin II receptor blocker ( ARB ) decreases PWV , as well as blood pressure ( BP ) , and increases the serum adiponectin , known as an adipocytokine , which has an anti-atherosclerotic effect . However , it is not known whether long-term treatment with ARB prevents the increase in PWV independently of the reduction of BP , and whether adiponectin is related to the chronic effect of ARB on PWV . METHODS AND RESULTS In order to examine the short-term effect of ARB on PWV , 9 subjects with EHT had PWV measured before and after treatment with an ARB for 1 month . The treatment significantly reduced PWV and BP . For evaluation of the long-term effect of ARB therapy , 56 consecutive subjects with EHT who were already taking anti-hypertensive drugs other than an angiotensin-converting enzyme inhibitor had their PWV measured . We divided the EHT subjects into 2 groups : ( 1 ) the ARB group ( EHT treated with an ARB for at least 6 months ) and ( 2 ) the control group ( EHT treated with anti-hypertensive drugs other than an ARB ) . Although there was no significant difference between the 2 groups in BP , age or body mass index , the PWV value in the ARB group was significantly lower than that in the control group . Moreover , the serum adiponectin concentration in the ARB group was significantly higher than that in the control group . CONCLUSIONS Long-term treatment with ARB inhibits the progression of arterial stiffness independent of BP reduction . One of the mechanisms may be related to the increased serum adiponectin concentration after treatment with an ARB",
"Agents blocking the renin-angiotensin-aldosterone system are frequently used in patients with end-stage renal disease , but whether they exert beneficial cardiovascular effects is unclear . Here the long-term effects of the angiotensin II receptor blocker , irbesartan , were studied in hemodialysis patients in a double-blind r and omized placebo-controlled 1-year intervention trial using a predefined systolic blood pressure target of 140 mm Hg ( SAFIR study ) . Each group of 41 patients did not differ in terms of age , blood pressure , comorbidity , antihypertensive treatment , dialysis parameters , and residual renal function . Brachial blood pressure decreased significantly in both groups , but there was no significant difference between placebo and irbesartan . Use of additional antihypertensive medication , ultrafiltration volume , and dialysis dosage were not different . Intermediate cardiovascular end points such as central aortic blood pressure , carotid-femoral pulse wave velocity , left ventricular mass index , N-terminal brain natriuretic prohormone , heart rate variability , and plasma catecholamines were not significantly affected by irbesartan treatment . Changes in systolic blood pressure during the study period significantly correlated with changes in both left ventricular mass and arterial stiffness . Thus , significant effects of irbesartan on intermediate cardiovascular end points beyond blood pressure reduction were absent in hemodialysis patients",
"Postmenopausal women are at greater risk for hypertension-related cardiovascular disease . Antihypertensive therapy may help alleviate arterial stiffness that represents a potential modifiable risk factor of hypertension . This r and omized controlled study investigated the difference between an angiotensin receptor blocker and a calcium channel blocker in reducing arterial stiffness . Overall , 125 postmenopausal hypertensive women ( age , 61.4 ± 6 years ; systolic blood pressure/diastolic blood pressure [ SBP/DBP ] , 158 ± 11/92 ± 9 mm Hg ) were r and omized to valsartan 320 mg ± hydrochlorothiazide ( HCTZ ) ( n = 63 ) or amlodipine 10 mg ± HCTZ ( n = 62 ) . The primary outcome was carotid-to-femoral pulse wave velocity ( PWV ) changes after 38 weeks of treatment . Both treatments lowered peripheral blood pressure ( BP ) ( -22.9/-10.9 mm Hg for valsartan and -25.2/-11.7 mm Hg for amlodipine , P = not significant ) and central BP ( -15.7/-7.6 mm Hg for valsartan and -19.2/-10.3 mm Hg for amlodipine , P reduced the carotid-femoral PWV ( -1.9 vs -1.7 m/s ; P = not significant ) . Amlodipine was associated with a higher incidence of peripheral edema compared with the valsartan group ( 77 % vs 14 % , P postmenopausal women led to a reduction in arterial stiffness as assessed by PWV measurement . Both regimens reduced PWV to a similar degree after 38 weeks of treatment despite differences in central BP lowering , suggesting that the effect of valsartan on PWV is mediated through nonhemodynamic effects",
"The objective of this study was to examine the effect of angiotensin II ( Ang II ) and angiotensin II type 1 ( AT(1 ) ) receptor blockade on pulse wave velocity ( PWV ) in healthy humans . We studied nine young male volunteers in a double-blind r and omised crossover design . Carotid-femoral PWV ( an index of arterial stiffness ) was measured by using a Complior machine . Subjects were previously treated for 3 days with once-daily dose of either a placebo or valsartan 80 mg . On the third day , they were infused with either placebo or 5 ng/kg/min of Ang II over 30 min . Subjects thus received placebo capsule + placebo infusion ( P ) , valsartan + placebo infusion ( V ) , placebo + Ang II infusion ( A ) , and valsartan + Ang II infusion ( VA ) combinations . Heart rate ( HR ) , blood pressure and PWV were recorded at baseline and then every 10 min during infusion and once after the end of infusion . There were significant increases in systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) and mean arterial pressure ( MAP ) with A compared with P ( P = 0.002 , P = 0.002 , P = 0.001 respectively ) . These rises in blood pressure were completely blocked by valsartan . A significant rise in PWV by A was seen compared with P ( 8.38 + /- 0.24 vs 7.48 + /- 0.24 m/sec , P = 0.013 ) and was completely blocked by valsartan ; VA compared with P ( 7.27 + /- 0.24 vs 7.48 + /- 0.24 m/sec , P = NS ) . Multiple linear regression analysis showed that blockade of Ang II induced increase in blood pressure by valsartan contributed to only 30 % of the total reduction in Ang II induced rise in PWV ( R(2 ) = 0.306 ) . The conclusions were that valsartan completely blocks the effect of Ang II on PWV . The effect of Ang II on PWV is mediated through AT(1)receptors . Reduction in PWV by Ang II antagonist is not fully explained by its pressure lowering effect of Ang II and may be partially independent of its effect on blood pressure",
"It is known that the angiotensin receptor blockers ( ARBs ) have organ protective effects in patients with heart failure or renal impairment . Several studies have revealed that the ARB telmisartan has an organ protective effect , but there have been few studies directly comparing the effects of telmisartan and calcium antagonists , since most clinical studies on telmisartan have been conducted in treated patients or patients on combination therapy . The present study was conducted to compare the renal and vascular protective effects of telmisartan monotherapy and calcium antagonist monotherapy in untreated hypertensive patients . Forty-three patients with untreated essential hypertension were r and omized to receive amlodipine ( n=22 ) or telmisartan ( n=21 ) , which were respectively administered at doses of 5 mg and 40 mg once daily in the morning for 24 weeks . The patients were examined before and after treatment to assess changes of renal function , flow-mediated dilation ( a parameter of vascular endothelial function ) , and brachial-ankle pulse wave velocity ( baPWV ; a parameter of arteriosclerosis ) . Before treatment , there were no significant differences in these parameters between groups . The decreases of urinary albumin excretion and baPWV , and the increase of flow-mediated dilation were significantly greater in the telmisartan group than the amlodipine group , while the antihypertensive effects were not significantly different between the two groups . In conclusion , these results suggest that telmisartan is more effective at protecting renal function and vascular endothelial function , and at improving arteriosclerosis than the calcium channel blocker in patients with essential hypertension",
"Aims : In this study , we examined whether addition of an angiotensin II type 1 receptor blocker ( ARB ) , c and esartan or valsartan , to conventional antihypertensive treatment could improve blood pressure ( BP ) variability in hypertensive patients on peritoneal dialysis . Methods : 45 hypertensive patients on chronic peritoneal dialysis therapy were r and omly assigned to the ARB treatment groups either by c and esartan ( n = 15 ) or valsartan ( n = 15 ) , or the control group ( n = 15 ) . At baseline and 6 months after the treatment , 24-hour ambulatory BP monitoring , echocardiography , and measurement of brachial-ankle pulse wave velocity ( baPWV ) were performed . Results : After the 6 months of treatment , 24-hour ambulatory BP values were similarly decreased in both the control group and ARB groups . However , short-term BP variability assessed on the basis of the st and ard deviation of 24-hour ambulatory BP was significantly decreased in the ARB groups , but remained unchanged in the control group . Furthermore , parameters of cardiovascular remodeling assessed by natriuretic peptides , echocardiography , and baPWV were significantly improved in the ARB groups but not in the control group . Conclusion : ARB treatment and control antihypertensive treatment similarly controlled 24-hour ambulatory BP values in hypertensive patients on peritoneal dialysis . However , ARB treatment is beneficial for the suppression of pathological cardiovascular remodeling with a decrease in BP variability",
"Background and Objectives Obesity exacerbates hypertension and stimulates the renin – angiotensin – aldosterone system ( RAAS ) . Full-dose RAAS inhibition could be a therapeutic option in overweight or obese patients with hypertension . This study compared four RAAS inhibitors at full therapeutic doses to determine their effect on blood pressure ( BP ) and cardiovascular risk factors in these patients . Methods We conducted a 24-week , single-blind , r and omized , parallel-group study in 120 overweight or obese patients ( body mass index ≥27 kg/m2 ) with hypertension , aged 18–60 years . The primary endpoint was the change in mean 24-h systolic BP and diastolic BP from baseline to study end . Central BP , arterial stiffness , and metabolic and cardiac indices were also investigated . Patients were r and omly allocated to perindopril 10 mg/day , enalapril 20 mg/day , losartan 100 mg/day or telmisartan 80 mg/day . Nonpharmacological interventions were also recommended . Results Reductions in mean 24-h systolic BP ( and diastolic BP ) were all significant ( p for perindopril , enalapril , losartan and telmisartan : systolic BP −22 , −11 , −12 and −15 mmHg , respectively ; ( and diastolic BP −13 , −6 , −13 and −12 mmHg , respectively ) . Aortic elasticity improved with perindopril and telmisartan . Perindopril was associated with the greatest reductions in central aortic BP and leptin levels [ 30 % versus 2 % , 7 % and 14 % with enalapril , losartan and telmisartan , respectively ( all p ] . Reductions in other BP , echocardiographic , metabolic and anthropometric parameters occurred with all treatments . Conclusion Full-dose RAAS inhibition , particularly with perindopril , effectively reduces BP , improves arterial structure and regulates cardiovascular risk factors in overweight or obese patients with hypertension",
"AIM Recently , a novel device for measuring the cardio-ankle vascular index ( CAVI ) as an arterial stiffness parameter has been developed . In this study , we evaluated the effect of angiotensin II receptor blocker ( ARB ) and calcium channel ( Ca ) blocker on CAVI in type 2 diabetic patients with hypertension . METHODS Seventy type 2 diabetes mellitus patients with hypertension were enrolled and r and omly divided into two groups . One group was administered olmesartan medoxomil 20 mg/day [ DOSAGE ERROR CORRECTED ] for 12 months ( ARB group ) , and the other group was administered amlodipine besilate 5 mg/day for 12 months ( Ca blocker group ) . RESULTS In the ARB group , a significant decrease in CAVI was observed after 12 months ; however , no significant change in CAVI was observed in the Ca blocker group although changes in blood pressure were almost the same . By simple regression analyses , CAVI changes correlated positively with 8-OHdG changes . CONCLUSIONS Olmesartan , an ARB , improved arterial stiffness more than amlodipine , and this effect might be due to not only the blood pressure-lowering effect but also to reducing the potential of oxidative stress recognized in olmesartan",
"BACKGROUND The aim of this study was to compare the effects of long-term antihypertensive treatment on brachial-ankle pulse wave velocity ( PWV ) , a marker of systemic arterial stiffness , between angiotensin II receptor blocker valsartan and long-acting calcium channel blocker nifedipine coat-core . METHODS Forty-one patients ( 54 + /- 3 years of age , 20 men and 21 women ) with essential hypertension ( 155 + /- 3/95 + /- 3 mm Hg ) were r and omly allocated to the treatment with valsartan ( 80 mg once daily ) or nifedipine coat-core ( 20 mg once daily ) . Brachial-ankle PWV and 24-h ambulatory blood pressures ( BP ) were measured before and 3 months after treatment . RESULTS Baseline data did not differ between the valsartan and nifedipine groups . The PWV also was similar between the groups ( 1669 + /- 65 v 1622 + /- 64 cm/sec ) . Three months of treatment similarly reduced resting systolic and diastolic BP ( nifedipine , -18.4 + /- 4.2/-11.9 + /- 2.7 mm Hg ; valsartan , - 17.4 + /- 3.3/-9.8 + /- 2.1 mm Hg , all P PWV was significantly reduced compared with baseline values in the valsartan group ( -195 + /- 42 cm/sec , P nifedipine group ( -69 + /- 40 cm/sec , NS ) . The 24-h mean heart rate increased in the nifedipine group but remained unchanged in the valsartan group , although BP were similarly lowered for 24 h. A tachycardic response was associated with an increase or lesser reduction in PWV in a group treated with nifedipine ( r = 0.584 , P valsartan could reduce arterial stiffness better than nifedipine-coat core . The favorable vascular effect of valsartan was due in part to its nonhypotensive effect . The expected decrease in arterial stiffness may be offset by reflex sympathetic activation in some patients treated with nifedipine",
"Abstract : We assessed the contribution of blood pressure ( BP ) , inflammation , and endothelial activation to the development of structural vascular and cardiac changes in hypertension . Furthermore , the effects of antihypertensive therapy were studied . We studied 114 patients with hypertension and left ventricular hypertrophy and 38 matched hypertensive subjects without cardiac hypertrophy and 38 normotensive subjects . The group with hypertension and cardiac hypertrophy were r and omized to treatment with an angiotensin receptor blocker ( irbesartan ) or a beta-adrenergic receptor blocker ( atenolol ) for 48 weeks . Markers of inflammation ( high-sensitive C-reactive protein , interleukin-6 , leukocyte counts ) , vascular function ( ambulatory aortic stiffness index , arterial compliance , and pulse pressure ) , and endothelial activation ( E-selectin , intracellular adhesion molecule-1 , vascular adhesion molecule-1 ) were assessed . Markers of inflammation and arterial stiffness were lowest in the normotensive group and highest in patients with hypertensive heart disease ; endothelial markers were similar between groups . Inflammation was independently related to BP . Markers of arterial stiffness were independently related to BP and to a lesser extent to left ventricular mass . Antihypertensive treatment improved arterial compliance ; inflammatory and endothelial markers remained unchanged . In conclusion , markers of inflammation and arterial stiffness are independently related to BP . Antihypertensive therapy seems to improve arterial stiffness , but effects on markers of inflammation and endothelial activation are small",
"OBJECTIVE Previous studies have shown increases in ambulatory short-term blood pressure ( BP ) variability to be related to cardiovascular disease . In this study , we examined whether an angiotensin II type 1 receptor blocker losartan would improve ambulatory short-term BP variability in hypertensive patients on hemodialysis . METHODS Forty hypertensive patients on hemodialysis therapy were r and omly assigned to the losartan treatment group ( n=20 ) or the control treatment group ( n=20 ) . At baseline and 6 and 12 months after the treatment , 24-h ambulatory BP monitoring was performed . Echocardiography and measurements of brachial-ankle pulse wave velocity ( baPWV ) and biochemical parameters were also performed before and after therapy . RESULTS After 6- and 12-months of treatment , nighttime short-term BP variability , assessed on the basis of the coefficient of variation of ambulatory BP , was significantly decreased in the losartan group , but remained unchanged in the control group . Compared with the control group , losartan significantly decreased left ventricular mass index ( LVMI ) , baPWV , and the plasma levels of brain natriuretic peptide and advanced glycation end products ( AGE ) . Furthermore , multiple regression analysis showed significant correlations between changes in LVMI and changes in nighttime short-term BP variability , as well as between changes in LVMI and changes in the plasma levels of AGE . CONCLUSION These results suggest that losartan is beneficial for the suppression of pathological cardiovascular remodeling though its inhibitory effect on ambulatory short-term BP variability during nighttime",
"BACKGROUND Antihypertensive drugs may have differential , pressure-independent effects on hypertension-associated alterations of arterial function . We compared the effects of a 12-week therapy with the AT(1)-receptor antagonist valsartan ( Val ) versus the beta-blocker metoprolol ( Met ) on arterial stiffness and endothelial function in mildly hypertensive patients at rest and during generalized sympathetic stimulation . METHODS Sixty-eight patients ( 37 male , 31 female , 46 + /- 6 years ) were r and omized to Val ( 80 - 160 mg/d ) or Met ( 50 - 100 mg/d ) . Effects of therapy on endothelial function , brachial and carotid artery distensibility coefficients , pulse wave velocity , carotid intima-media thickness and elastic modulus were assessed at rest and during the cold pressor test . RESULTS Fifty-two patients were available for per protocol analysis . Blood pressure was comparably reduced in both treatment groups . Effects on endothelial function and large artery elastic wall properties did not differ significantly between the two antihypertensive treatment regimens . Trends did not differ significantly between groups for any parameter including carotid intima-media thickness and elastic modulus . CONCLUSION Short-term treatment with Val and Met had similar effects on large artery functional vessel wall properties in a population of mildly hypertensive patients"
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Background Debate over the role of fructose in mediating cardiovascular risk remains active . To up date the evidence on the effect of fructose on established therapeutic lipid targets for cardiovascular disease ( low-density lipoprotein cholesterol [LDL]-C , apolipoprotein B , non-high-density lipoprotein cholesterol [ HDL-C ] ) , and metabolic syndrome ( triglycerides and HDL-C ) , we conducted a systematic review and meta- analysis of controlled feeding trials . Methods and Results MEDLINE , EMBASE , CINHAL , and the Cochrane Library were search ed through July 7 , 2015 for controlled feeding trials with follow-up ≥7 days , which investigated the effect of oral fructose compared to a control carbohydrate on lipids ( LDL-C , apolipoprotein B , non-HDL-C , triglycerides , and HDL-C ) in participants of all health background s. Two independent review ers extracted relevant data . Data were pooled using r and om effects models and expressed as mean difference with 95 % CI . Inter study heterogeneity was assessed ( Cochran Q statistic ) and quantified ( I2 statistic ) . Eligibility criteria were met by 51 isocaloric trials ( n=943 ) , in which fructose was provided in isocaloric exchange for other carbohydrates , and 8 hypercaloric trials ( n=125 ) , in which fructose supplemented control diets with excess calories compared to the control diets alone without the excess calories . Fructose had no effect on LDL-C , non-HDL-C , apolipoprotein B , triglycerides , or HDL-C in isocaloric trials . However , in hypercaloric trials , fructose increased apolipoprotein B ( n=2 trials ; mean difference = 0.18 mmol/L ; 95 % CI : 0.05 , 0.30 ; P=0.005 ) and triglycerides ( n=8 trials ; mean difference = 0.26 mmol/L ; 95 % CI : 0.11 , 0.41 ; P that fructose only had an adverse effect on established lipid targets when added to existing diets so as to provide excess calories ( + 21 % to 35 % energy ) . When isocalorically exchanged for other carbohydrates , fructose had no adverse effects on blood lipids . More trials that are larger , longer , and higher quality are required . Clinical Trials Registration URL : https://www . clinical trials.gov/. Unique Identifier : NCT01363791
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"BACKGROUND & AIMS Diets high in fructose have been proposed to contribute to nonalcoholic fatty liver disease . We compared the effects of high-fructose and matched glucose intake on hepatic triacylglycerol ( TAG ) concentration and other liver parameters . DESIGN In a double-blind study , we r and omly assigned 32 healthy but central ly overweight men to groups that received either a high-fructose or high-glucose diet ( 25 % energy ) . These diets were provided during an initial isocaloric period of 2 weeks , followed by a 6-week washout period , and then again during a hypercaloric 2-week period . The primary outcome measure was hepatic level of TAG , with additional assessment s of TAG levels in serum and soleus muscle , hepatic levels of adenosine triphosphate , and systemic and hepatic insulin resistance . RESULTS During the isocaloric period of the study , both groups had stable body weights and concentrations of TAG in liver , serum , and soleus muscle . The high-fructose diet produced an increase of 22 ± 52 μmol/L in the serum level of uric acid , whereas the high-glucose diet led to a reduction of 23 ± 25 μmol/L ( P high-fructose diet also produced an increase of 0.8 ± 0.9 in the homeostasis model assessment of insulin resistance , whereas the high-glucose diet produced an increase of only 0.1 ± 0.7 ( P = .03 ) . During the hypercaloric period , participants in the high-fructose and high-glucose groups had similar increases in weight ( 1.0 ± 1.4 vs 0.6 ± 1.0 kg ; P = .29 ) and absolute concentration of TAG in liver ( 1.70 % ± 2.6 % vs 2.05 % ± 2.9 % ; P = .73 ) and serum ( 0.36 ± 0.75 vs 0.33 ± 0.38 mmol/L ; P = .91 ) , and similar results in biochemical assays of liver function . Body weight changes were associated with changes in liver biochemistry and concentration of TAGs . CONCLUSIONS In the isocaloric period , overweight men who were on a high-fructose or a high-glucose diet did not develop any significant changes in hepatic concentration of TAGs or serum levels of liver enzymes . However , in the hypercaloric period , both high-fructose and high-glucose diets produced significant increases in these parameters without any significant difference between the 2 groups . This indicates an energy-mediated , rather than a specific macronutrient-mediated , effect . Clinical trials.gov no : NCT01050140",
"OBJECTIVE Adverse effects of hypercaloric , high-fructose diets on insulin sensitivity and lipids in human subjects have been shown repeatedly . The implication s of fructose in amounts close to usual daily consumption , however , have not been well studied . This study assessed the effect of moderate amounts of fructose and sucrose compared with glucose on glucose and lipid metabolism . RESEARCH DESIGN AND METHODS Nine healthy , normal-weight male volunteers ( aged 21–25 years ) were studied in this double-blind , r and omized , cross-over trial . All subjects consumed four different sweetened beverages ( 600 mL/day ) for 3 weeks each : medium fructose ( MF ) at 40 g/day , and high fructose ( HF ) , high glucose ( HG ) , and high sucrose ( HS ) each at 80 g/day . Euglycemic-hyperinsulinemic clamps with [6,6]-2H2 glucose labeling were used to measure endogenous glucose production . Lipid profile , glucose , and insulin were measured in fasting sample s. RESULTS Hepatic suppression of glucose production during the clamp was significantly lower after HF ( 59.4 ± 11.0 % ) than HG ( 70.3 ± 10.5 % , P whereas fasting glucose , insulin , and C-peptide did not differ between the interventions . Compared with HG , LDL cholesterol and total cholesterol were significantly higher after MF , HF , and HS , and free fatty acids were significantly increased after MF , but not after the two other interventions ( P 0.05 ) . Subjects ’ energy intake during the interventions did not differ significantly from baseline intake . CONCLUSIONS This study clearly shows that moderate amounts of fructose and sucrose significantly alter hepatic insulin sensitivity and lipid metabolism compared with similar amounts of glucose",
"Nonalcoholic fatty liver disease ( NAFLD ) is now thought to be the most common liver disease worldwide . Cardiovascular complications are a leading cause of mortality in NAFLD . Fructose , a common nutrient in the westernized diet , has been reported to be associated with increased cardiovascular risk , but its impact on adolescents with NAFLD is not well understood . We design ed a 4-week r and omized , controlled , double-blinded beverage intervention study . Twenty-four overweight Hispanic-American adolescents who had hepatic fat > 8 % on imaging and who were regular consumers of sweet beverages were enrolled and r and omized to calorie-matched study -provided fructose only or glucose only beverages . After 4 weeks , there was no significant change in hepatic fat or body weight in either group . In the glucose beverage group there was significantly improved adipose insulin sensitivity , high sensitivity C-reactive protein ( hs-CRP ) , and low-density lipoprotein ( LDL ) oxidation . These findings demonstrate that reduction of fructose improves several important factors related to cardiovascular disease despite a lack of measurable improvement in hepatic steatosis . Reducing dietary fructose may be an effective intervention to blunt atherosclerosis progression among NAFLD patients and should be evaluated in longer term clinical trials",
" Twelve carbohydrate-sensitive men selected due to their abnormally high insulin responses to a sucrose load and 12 men with normal insulin responses were fed diets containing 0 , 7.5 , and 15 % fructose for 5 wk each in a cross-over design . The diets contained 43 % total carbohydrate , 42 % fat , and 15 % protein . Initial fasting total cholesterol and low-density lipoprotein cholesterol were higher in the hyperinsulinemic men than in the controls . Diastolic blood pressure was not affected by diet , but systolic blood pressure was slightly higher after the men consumed the 0 % fructose diet . Free fatty acids were not different . Total plasma cholesterol and low-density lipoprotein cholesterol were higher after the men consumed 7.5 and 15 % fructose than when they consumed the 0 % fructose diet . Plasma triglyceride increased significantly as fructose in the diets of the hyperinsulinemics increased , but was not affected in the controls . These changes in blood lipids are associated with heart disease",
"BACKGROUND About 9 % of average dietary energy intake in the United States comes from fructose . Such a high consumption raises concern about the metabolic effects of this sugar . OBJECTIVE The objective of this study was to determine the effect of dietary fructose on plasma lipids . DESIGN The study was conducted in the General Clinical Research Center at Fairview-University of Minnesota Medical Center . The participants were 24 healthy adult volunteers ( 12 men and 12 women ; 6 of each sex were aged /=40 y ) . All subjects received 2 isoenergetic study diets assigned by using a r and omized , balanced crossover design . One diet provided 17 % of energy as fructose . The other diet was sweetened with glucose and was nearly devoid of fructose . Each diet was fed for 6 wk . Both diets were composed of common foods and contained nearly identical amounts of carbohydrate , protein , fat , fiber , cholesterol , and saturated , monounsaturated , and polyunsaturated fatty acids . All meals were prepared in the metabolic kitchen of the General Clinical Research Center . RESULTS The responses to the study diets differed by sex . In men , the fructose diet produced significantly higher fasting , postpr and ial , and daylong plasma triacylglycerol concentrations than did the glucose diet . The daylong plasma triacylglycerol concentration after 6 wk of the fructose diet was 32 % greater in men than the corresponding concentration during the glucose diet ( P : fructose diet had no significant effect on fasting or postpr and ial plasma triacylglycerol concentrations in women . The fructose diet also had no persistent effect on fasting plasma cholesterol , HDL cholesterol , or LDL cholesterol in either men or women . CONCLUSIONS Dietary fructose was associated with increased fasting and postpr and ial plasma triacylglycerol concentrations in men . Diets high in added fructose may be undesirable , particularly for men . Glucose may be a suitable replacement sugar",
"Ten hyperinsulinemic and 11 nonhyperinsulinemic men consumed for 5 wk each in a cross-over design a diet , similar to one currently consumed in the United States , with 20 % of the kilocalories from either fructose or high-amylose cornstarch to determine the effects of the two diets on various blood metabolites considered to be risk factors associated with heart disease . In the hyperinsulinemic men the intake of fructose as compared with cornstarch significantly increased total triglycerides and their lipoprotein distribution ; total and very-low-density lipoprotein cholesterol ; apoproteins B-100 , C-II , C-III ; and uric acid . In the nonhyperinsulinemic men total triglycerides , total and low-density lipoprotein cholesterol and uric acid were significantly greater after the consumption of fructose than after cornstarch . The results indicate that in a diet high in saturated fatty acids and cholesterol , fructose increases the levels of risk factors associated with heart disease , especially in hyperinsulinemic men",
"The effect of dietary fructose ( 20 % of carbohydrate calories , 45 - 65 g day-1 for 4 weeks ) on glycaemic control , serum lipid , lipoprotein and apoprotein A-I and A-II concentrations and on insulin sensitivity was studied in 10 type 2 diabetic patients . The study was done in a r and omized , double-blind fashion with crystalline fructose or placebo administered evenly during 4 meals or snacks per day . The patients were hospitalized throughout the study periods . The fasting plasma glucose concentration decreased during the fructose ( from 10.7 + /- 1.4 mmol l-1 to 8.0 + /- 0.8 mmol l-1 , P control diet ( from 10.1 + /- 0.9 mmol l-1 to 8.0 + /- 0.7 mmol l-1 , P mean diurnal blood glucose concentration also fell both during the fructose ( from 10.8 + /- 0.5 mmol l-1 to 8.4 + /- 0.3 mmol l-1 , P HbA1 concentration improved ( P Insulin sensitivity increased by 34 % ( P Serum insulin , triglyceride , apoprotein A-I and A-II concentrations , body weight , blood pressure and blood lactate remained unchanged during both diets . In conclusion , substitution of moderate amounts of fructose for complex carbohydrates can improve glycaemic control and insulin sensitivity in patients with type 2 diabetes",
"Consumption of simple carbohydrates has markedly increased over the past decades , and may be involved in the increased prevalence in metabolic diseases . Whether an increased intake of fructose is specifically related to a dysregulation of glucose and lipid metabolism remains controversial . We therefore compared the effects of hypercaloric diets enriched with fructose ( HFrD ) or glucose ( HGlcD ) in healthy men . Eleven subjects were studied in a r and omised order after 7 d of the following diets : ( 1 ) weight maintenance , control diet ; ( 2 ) HFrD ( 3.5 g fructose/kg fat-free mass ( ffm ) per d , + 35 % energy intake ) ; ( 3 ) HGlcD ( 3.5 g glucose/kg ffm per d , + 35 % energy intake ) . Fasting hepatic glucose output ( HGO ) was measured with 6,6 - 2H2-glucose . Intrahepatocellular lipids ( IHCL ) and intramyocellular lipids ( IMCL ) were measured by 1H magnetic resonance spectroscopy . Both fructose and glucose increased fasting VLDL-TAG ( HFrD : + 59 % , P IHCL ( HFrD : + 52 % , P HGO increased after both diets ( HFrD : + 5 % , P fasting glycaemia , insulin and alanine aminotransferase concentrations . IMCL increased significantly only after the HGlcD ( HFrD : + 24 % , NS ; HGlcD : + 59 % , P IHCL and VLDL-TAG were not different between hypercaloric HFrD and HGlcD , but were increased compared to values observed with a weight maintenance diet . However , glucose led to a higher increase in IMCL than fructose",
"CONTEXT Combining foods with recognized cholesterol-lowering properties ( dietary portfolio ) has proven highly effective in lowering serum cholesterol under metabolically controlled conditions . OBJECTIVE To assess the effect of a dietary portfolio administered at 2 levels of intensity on percentage change in low-density lipoprotein cholesterol ( LDL-C ) among participants following self-selected diets . DESIGN , SETTING , AND PARTICIPANTS A parallel- design study of 351 participants with hyperlipidemia from 4 participating academic centers across Canada ( Quebec City , Toronto , Winnipeg , and Vancouver ) r and omized between June 25 , 2007 , and February 19 , 2009 , to 1 of 3 treatments lasting 6 months . INTERVENTION Participants received dietary advice for 6 months on either a low-saturated fat therapeutic diet ( control ) or a dietary portfolio , for which counseling was delivered at different frequencies , that emphasized dietary incorporation of plant sterols , soy protein , viscous fibers , and nuts . Routine dietary portfolio involved 2 clinic visits over 6 months and intensive dietary portfolio involved 7 clinic visits over 6 months . MAIN OUTCOME MEASURES Percentage change in serum LDL-C. RESULTS In the modified intention-to-treat analysis of 345 participants , the overall attrition rate was not significantly different between treatments ( 18 % for intensive dietary portfolio , 23 % for routine dietary portfolio , and 26 % for control ; Fisher exact test , P = .33 ) . The LDL-C reductions from an overall mean of 171 mg/dL ( 95 % confidence interval [ CI ] , 168 - 174 mg/dL ) were -13.8 % ( 95 % CI , -17.2 % to -10.3 % ; P dietary portfolio ; -13.1 % ( 95 % CI , -16.7 % to -9.5 % ; P Percentage LDL-C reductions for each dietary portfolio were significantly more than the control diet ( P 2 dietary portfolio interventions did not differ significantly ( P = .66 ) . Among participants r and omized to one of the dietary portfolio interventions , percentage reduction in LDL-C on the dietary portfolio was associated with dietary adherence ( r = -0.34 , n = 157 , P dietary portfolio compared with the low-saturated fat dietary advice result ed in greater LDL-C lowering during 6 months of follow-up . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00438425",
"An increasing amount of fructose in the diet is suggested to play a causal role in the pathogenesis of the metabolic syndrome , type 2 diabetes and fatty liver . Our aim was to investigate and compare the effects of very high fructose and very high glucose in hyperenergetic diets on glucose and lipid metabolism and on fat depots in healthy humans . We conducted an exploratory , prospect i ve , r and omised , single-blinded , intervention trial . Participants in addition to a balanced weight-maintaining diet received 150 g of fructose or glucose/d for 4 weeks . Insulin sensitivity was estimated from oral glucose tolerance tests . Visceral and subcutaneous abdominal fat was determined with MRI . Liver fat and intramyocellular lipids of the tibialis anterior muscle were measured with (1)H magnetic resonance spectroscopy . A total of twenty healthy subjects ( fructose group n 10 and glucose group n 10 ; twelve males and eight females ) completed the study . They had a mean age of 30·5 ( SEM 2·0 ) years and a mean BMI of 25·9 ( SEM 0·5 ) kg/m(2 ) . Insulin sensitivity appeared to decrease both in the fructose and glucose groups . TAG markedly increased in the fructose group . No strong alterations or treatment effects were found for liver fat , visceral fat , subcutaneous abdominal fat and intramyocellular lipids of the tibialis anterior muscle . In conclusion , the effects of very high fructose and very high glucose in hyperenergetic diets on glucose metabolism and body fat composition were not different in the healthy participants of the present study . However , elevation of plasma TAG seemed to be fructose-specific",
"BACKGROUND Both nutritional and genetic factors are involved in the pathogenesis of nonalcoholic fatty liver disease and insulin resistance . OBJECTIVE The aim was to assess the effects of fructose , a potent stimulator of hepatic de novo lipogenesis , on intrahepatocellular lipids ( IHCLs ) and insulin sensitivity in healthy offspring of patients with type 2 diabetes (OffT2D)--a subgroup of individuals prone to metabolic disorders . DESIGN Sixteen male OffT2D and 8 control subjects were studied in a crossover design after either a 7-d isocaloric diet or a hypercaloric high-fructose diet ( 3.5 g x kg FFM(-1 ) x d(-1 ) , + 35 % energy intake ) . Hepatic and whole-body insulin sensitivity were assessed with a 2-step hyperinsulinemic euglycemic clamp ( 0.3 and 1.0 mU x kg(-1 ) x min(-1 ) ) , together with 6,6-[2H2]glucose . IHCLs and intramyocellular lipids ( IMCLs ) were measured by 1H-magnetic resonance spectroscopy . RESULTS The OffT2D group had significantly ( P IHCLs ( + 94 % ) , total triacylglycerols ( + 35 % ) , and lower whole-body insulin sensitivity ( -27 % ) than did the control group . The high-fructose diet significantly increased IHCLs ( control : + 76 % ; OffT2D : + 79 % ) , IMCLs ( control : + 47 % ; OffT2D : + 24 % ) , VLDL-triacylglycerols ( control : + 51 % ; OffT2D : + 110 % ) , and fasting hepatic glucose output ( control : + 4 % ; OffT2D : + 5 % ) . Furthermore , the effects of fructose on VLDL-triacylglycerols were higher in the OffT2D group ( group x diet interaction : P 7-d high-fructose diet increased ectopic lipid deposition in liver and muscle and fasting VLDL-triacylglycerols and decreased hepatic insulin sensitivity . Fructose-induced alterations in VLDL-triacylglycerols appeared to be of greater magnitude in the OffT2D group , which suggests that these individuals may be more prone to developing dyslipidemia when challenged by high fructose intakes . This trial was registered at clinical trials.gov as NCT00523562",
"The published literature contains numerous reports of clinical studies . A problem in their interpretation is that studies in which the observed efficacy of the treatment is high are much more likely to be reported than those in which the observed efficacy is average or poor . This phenomenon has had the consequence of generally discrediting the reliability of the literature , especially that of non-r and omized studies . In this paper a model is developed which permits estimation of the potential magnitude by which the reported efficacy of a treatment might be inflated . This quantity is termed the publication bias . The magnitude of the bias depends on the sample size of the study and the number of similar studies conducted concurrently . Tabulated values of the bias are presented , permitting easy computation . The new measure may have potential use for physicians in clinical decision making in that it characterizes the reliability of results from a specific published study , especially when there are no definitive r and omized studies . However , correction of publication bias in this manner is not a substitute for a well controlled or a r and omized study . The technique merely assists in the interpretation of available evidence from the literature . Moreover , it must be used with due caution in recognition of the assumptions and approximations involved in the calculation",
" Using a crossover design , eight healthy volunteers r and omly received physiologic amounts ( ⅓ of each subject 's total carbohydrate intake ) of either fructose or sucrose as the primary source of simple sugar , incorporated into isocaloric diets comprised of typical American foods . After 7 and 14 days of consuming either of the two sugars , no change occurred in fasting glucose or insulin levels . In addition , total triglyceride , totalcholesterol , low-density-lipoprotein ( LDL ) cholesterol , and high-density-lipoprotein ( HDL ) cholesterol concentrations were unaltered . Since our study used conventional foods in normal eating patterns rather than contrived formulas or excessive amounts of simple sugar , our data indicate that there is no difference between sucrose or fructose on various lipid components or glucose and fasting insulin levels in the “ real world ” innormal subjects"
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4116f01a-06ff-11f0-808a-c43d1ab1c353
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Background Health technology assessment s ( HTAs ) by the National Institute for Health and Clinical Excellence ( NICE ) enjoy high levels of international attention . The present analysis addresses NICE 's appraisal of methylpheni date , atomoxetine and dexamphetamine for attention-deficit/hyperactivity disorder ( ADHD ) in children and adolescents , published in March 2006 . Methods A qualitative study of NICE Technology Appraisal No. 98 was done focusing on the > 600-page technology assessment report , which aim ed at evaluating ADHD treatment strategies by a clinical effectiveness review and an economic analysis using meta-analytical techniques and a cost-effectiveness model . Results The technology assessment was unable to differentiate between the various drugs in terms of efficacy , and its economic model was ultimately driven by cost differences . While the assessment concluded that the economic model " clearly identified an optimal treatment strategy " with first-line dexamphetamine , the NICE appraisal committee subsequently found it impossible to distinguish between the different strategies on grounds of cost-effectiveness . Analyzing the assessment reveals gaps and inconsistencies concerning data selection ( ultimately relying on a small number of short-term studies only ) , data synthesis ( pooling of heterogeneous study design s and clinical endpoints ) , and economic model structure ( identifying double-counting of nonresponders as a likely source of bias , alongside further method ological anomalies ) . Conclusion Many conclusions of the NICE technology assessment rest on shaky grounds . There remains a need for a new , state-of-the-art systematic review of ADHD treatment strategies including economic evaluation , which ideally should address outcomes beyond children 's health-related quality of life , such as long-term sequelae of the disorder and caregiver burden
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[
"OBJECTIVE To test the hypotheses that in children with attention-deficit/hyperactivity disorder ( ADHD ) ( 1 ) symptoms of ADHD , oppositional defiant disorder , and overall functioning are significantly improved by methylpheni date combined with intensive multimodal psychosocial treatment compared with methylpheni date alone and with methylpheni date plus attention control and ( 2 ) more children receiving combined treatment can be taken off methylpheni date . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to short-term methylpheni date were r and omized for 2 years to ( 1 ) methylpheni date alone ; ( 2 ) methylpheni date plus psychosocial treatment that included parent training and counseling , social skills training , psychotherapy , and academic assistance , or ( 3 ) methylpheni date plus attention psychosocial control treatment . Assessment s included parent , teacher , and psychiatrist ratings , and observations in academic and gym classes . RESULTS Combination treatment did not lead to superior functioning and did not facilitate methylpheni date discontinuation . Significant improvement occurred across all treatments and continued over 2 years . CONCLUSIONS In stimulant-responsive children with ADHD , there is no support for adding ambitious long-term psychosocial intervention to improve ADHD and oppositional defiant disorder symptoms . Significant benefits from methylpheni date were stable over 2 years",
"OBJECTIVE Atomoxetine is an investigational , nonstimulant pharmacotherapy being studied as potential treatment for attention-deficit/hyperactivity disorder ( ADHD ) . It is thought to act via blockade of the presynaptic norepinephrine transporter in the brain . We assessed the efficacy of 3 doses of atomoxetine compared with placebo in children and adolescents with ADHD . METHODS A total of 297 children and adolescents who were 8 to 18 years of age and had ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders , 4th edition , were r and omized to placebo or atomoxetine dosed on a weight-adjusted basis at 0.5 mg/kg/day , 1.2 mg/kg/day , or 1.8 mg/kg/day for an 8-week period . ADHD symptoms , affective symptoms , and social and family functioning were assessed using parent and investigator rating scales . RESULTS Approximately 71 % of children enrolled were male , approximately 67 % met criteria for mixed subtype ( both inattentive and hyperactive/impulsive symptoms ) , and the only common psychiatric comorbidity was oppositional defiant disorder ( approximately 38 % of the sample ) . At baseline , symptom severity was rated as moderate to severe for most children . At endpoint , atomoxetine 1.2 mg/kg/day and 1.8 mg/kg/day were consistently associated with superior outcomes in ADHD symptoms compared with placebo and were not different from each other . The dose of 0.5 mg/kg/day was associated with intermediate efficacy between placebo and the 2 higher doses , suggesting a grade d dose-response . Social and family functioning also were improved in the atomoxetine groups compared with placebo with statistically significant improvements in measures of children 's ability to meet psychosocial role expectations and parental impact . Discontinuations as a result of adverse events were children and adolescents aged 8 to 18 , atomoxetine was superior to placebo in reducing ADHD symptoms and in improving social and family functioning symptoms . Atomoxetine was associated with a grade d dose-response , and 1.2 mg/kg/day seems to be as effective as 1.8 mg/kg/day and is likely to be the appropriate initial target dose for most patients . Treatment with atomoxetine was safe and well tolerated",
"BACKGROUND Previous studies have demonstrated the short-term efficacy of pharmacotherapy and behavior therapy for attention-deficit/hyperactivity disorder ( ADHD ) , but no longer-term ( i.e. , > 4 months ) investigations have compared these 2 treatments or their combination . METHODS A group of 579 children with ADHD Combined Type , aged 7 to 9.9 years , were assigned to 14 months of medication management ( titration followed by monthly visits ) ; intensive behavioral treatment ( parent , school , and child components , with therapist involvement gradually reduced over time ) ; the two combined ; or st and ard community care ( treatments by community providers ) . Outcomes were assessed in multiple domains before and during treatment and at treatment end point ( with the combined treatment and medication management groups continuing medication at all assessment points ) . Data were analyzed through intent-to-treat r and om-effects regression procedures . RESULTS All 4 groups showed sizable reductions in symptoms over time , with significant differences among them in degrees of change . For most ADHD symptoms , children in the combined treatment and medication management groups showed significantly greater improvement than those given intensive behavioral treatment and community care . Combined and medication management treatments did not differ significantly on any direct comparisons , but in several instances ( oppositional/aggressive symptoms , internalizing symptoms , teacher-rated social skills , parent-child relations , and reading achievement ) combined treatment proved superior to intensive behavioral treatment and /or community care while medication management did not . Study medication strategies were superior to community care treatments , despite the fact that two thirds of community-treated subjects received medication during the study period . CONCLUSIONS For ADHD symptoms , our carefully crafted medication management was superior to behavioral treatment and to routine community care that included medication . Our combined treatment did not yield significantly greater benefits than medication management for core ADHD symptoms , but may have provided modest advantages for non-ADHD symptom and positive functioning outcomes",
"OBJECTIVES Mathematical modeling is used widely in economic evaluations of pharmaceuticals and other health-care technologies . Users of models in government and the private sector need to be able to evaluate the quality of models according to scientific criteria of good practice . This report describes the consensus of a task force convened to provide modelers with guidelines for conducting and reporting modeling studies . METHODS The task force was appointed with the advice and consent of the Board of Directors of ISPOR . Members were experienced developers or users of models , worked in academia and industry , and came from several countries in North America and Europe . The task force met on three occasions , conducted frequent correspondence and exchanges of drafts by electronic mail , and solicited comments on three drafts from a core group of external review ers and more broadly from the membership of ISPOR . RESULTS Criteria for assessing the quality of models fell into three areas : model structure , data used as inputs to models , and model validation . Several major themes cut across these areas . Models and their results should be represented as aids to decision making , not as statements of scientific fact ; therefore , it is inappropriate to dem and that models be vali date d prospect ively before use . However , model assumptions regarding causal structure and parameter estimates should be continually assessed against data , and models should be revised accordingly . Structural assumptions and parameter estimates should be reported clearly and explicitly , and opportunities for users to appreciate the conditional relationship between inputs and outputs should be provided through sensitivity analyses . CONCLUSIONS Model-based evaluations are a valuable re source for health-care decision makers . It is the responsibility of model developers to conduct modeling studies according to the best practicable st and ards of quality and to communicate results with adequate disclosure of assumptions and with the caveat that conclusions are conditional upon the assumptions and data on which the model is built",
"OBJECTIVE Clinical trials in psychiatry frequently fail to maximize clinical utility for practicing clinicians , or , stated differently , available evidence is not perceived by clinicians ( and other decision makers ) as sufficiently relevant to clinical practice , thereby diluting its impact . To attain maximum clinical relevance and acceptability , research ers must conduct clinical trials design ed to meet the needs of clinicians and others who are making decisions about patients ' care . The authors present the case for psychiatry 's adoption of the practical clinical trials model , which is widely used in research in other areas of medicine . METHOD The authors outline the characteristics and scope of practical clinical trials , give examples of practical clinical trials , and discuss the challenges of using the practical clinical trials model in psychiatry , including issues of funding . RESULTS Practical clinical trials , which are intended to provide generalizable answers to important clinical questions without bias , are characterized by eight key features : a straightforward clinical ly relevant question , a representative sample of patients and practice setting s , sufficient power to identify modest clinical ly relevant effects , r and omization to protect against bias , clinical uncertainty regarding the outcome of treatment at the patient level , assessment and treatment protocol s that enact best clinical practice s , simple and clinical ly relevant outcomes , and limited subject and investigator burden . CONCLUSIONS To implement the practical clinical trials model in psychiatry will require stable funding for network construction and maintenance plus method ological innovation in governance and trial selection , assessment , treatment , data management , site management , and data analytic procedures",
"BACKGROUND The thrice daily dosing regimen of immediate release methylpheni date ( IR-MPH ) for Attention Deficit/Hyperactivity Disorder ( ADHD ) requires in-school dosing , leading to issues surrounding dispensing and storage of controlled substances by school personnel and concerns over children?s privacy and the embarrassment associated with taking medication in public at school . OROS-methylpheni date ( OROS-MPH ) is a once-daily controlled-release formulation of methylpheni date ( MPH ) developed to overcome some of the limitations associated with IR-MPH and first-generation sustained-release formulations . R and omized , controlled trials ( RCTs ) that focus on treatment efficacy provide the best evidence for demonstrating whether an intervention works , but under ideal conditions one can not discount the importance of efficacy study results . However , the most useful information to clinicians comes from an effectiveness study design . OBJECTIVES To evaluate the effectiveness and tolerability of OROS-MPH versus usual care with IR-MPH in children aged 6 to 12 years with ADHD . METHODS This 8 week , multicentre , open-label study r and omized 147 subjects to either once-daily OROS-MPH or usual care with IR-MPH . Subjects were titrated to a clinical ly effective dose of either study medication over 4 weeks and maintained on that dose for an additional 4 weeks . The SNAP-IV parent-rating scale was used to assess effectiveness . RESULTS OROS-MPH showed statistically significant superiority to IR-MPH in remission rate based on the 18 ADHD symptoms ( p=0.0002 , X2=13.8 , df=1 ) and severity of ADHD and ODD symptoms ( p=0.004 , F=8.4 , df=1,127 ) , as well as on the following secondary assessment s : IOWA Conners , Conners Parent Rating Scale ( short version ) , Parent Stress Index , ( short version ) ; Visual Analogue Scale for social play ; Clinical Global Impression-Severity , Clinical Global Impression-Improvement and Parent Satisfaction with treatment . OROS-MPH and IR-MPH were both well tolerated with a similar side effect profile . CONCLUSIONS Once-daily OROS-MPH is significantly more effective than usual care with IR-MPH based on multiple outcome measures including remission rate",
"This community-based study was design ed to evaluate treatment outcomes with OROS ® methylpheni date ( MPH ) and atomoxetine in children with attentiondeficit/hyperactivity disorder ( ADHD ) , as assessed by physicians and parents in a setting that resembles clinical practice . In a multicenter , prospect i ve , open-label study , children 6 to 12 years of age with ADHD were r and omized ( 2:1 , respectively ) to 3 weeks of treatment with once-daily OROS MPH or atomoxetine . Investigatorrated measures of symptoms included the ADHD Rating Scale ( ADHD-RS ) and the Clinical Global Impression-Improvement of Illness scale ( CGI-I ) . Assessment s were made at baseline and during a telephone interview in week 1 , a clinic visit in week 2 , and a final clinic visit in week 3 . In total , 1323 patients received OROS MPH ( n=850 ) or atomoxetine ( n=473 ) . Significant reductions from baseline in investigator-evaluated ADHD-RS scores were observed among patients receiving OROS MPH and those receiving atomoxetine . At the end of the study , mean decreases from baseline ADHD-RS scores were 20.24 for OROS MPH and 16 for atomoxetine ( P 3 , respectively ; P ( ie , 25 % reduction from baseline ADHD-RS scores ) was significantly greater at each evaluation for patients taking OROS MPH than for those taking atomoxetine ( P taking OROS MPH ( 4.8 % ) and atomoxetine ( 5.5 % ) withdrew because of adverse events . Although community-based studies often lack the control of r and omized , placebo-controlled trials , these results nevertheless suggest greater ADHD symptom improvement with OROS MPH compared with atomoxetine",
"This report introduces a method for obtaining behavioral time-response information for a short-acting psychotropic drug ( methylpheni date [ Ritalin ] ) that is widely used to treat behaviorally hyperactive children . We used a laboratory learning task to document that between one and two hours after the administration of a single dose of methylpheni date , the drug exerts its maximum effect on performance in a learning task in the laboratory . This effect on cognitive performance dissipates within the same day . This rapid and transient effect of methylpheni date makes it possible to classify patients in a single day into those who respond favorably and those who respond adversely to the drug in terms of its effect on cognitive behavior",
"OBJECTIVE In the Multimodal Treatment Study of ADHD ( MTA ) , the effects of medication management ( MedMgt ) and behavior modification therapy ( Beh ) and their combination ( Comb ) and usual community comparison ( CC ) in the treatment of attention-deficit/hyperactivity disorder ( ADHD ) differed at the 14-month assessment as a result of superiority of the MTA MedMgt strategy ( Comb or MedMgt ) over Beh and CC and modest additional benefits of Comb over MedMgt alone . Here we evaluate the persistence of these beneficial effects 10 months beyond the 14 months of intensive intervention . METHODS Of 579 children who entered the study , 540 ( 93 % ) participated in the first follow-up 10 months after the end of treatment . Mixed-effects regression models explored possible persisting effects of the MTA medication strategy , the incremental benefits of Comb over MedMgt alone , and the possible superiority of Beh over CC on 5 effectiveness and 4 service use domains . RESULTS The MTA medication strategy showed persisting significant superiority over Beh and CC for ADHD and oppositional-defiant symptoms at 24 months , although not as great as at 14 months . Significant additional benefits of Comb over MedMgt and of Beh over CC were not found . The groups differed significantly in mean dose ( methylpheni date equivalents 30.4 , 37.5 , 25.7 , and 24.0 mg/day , respectively ) . Continuing medication use partly mediated the persisting superiority of Comb and MedMgt . CONCLUSION The benefits of intensive MedMgt for ADHD extend 10 months beyond the intensive treatment phase only in symptom domains and diminish over time",
"OBJECTIVE To describe the rationale , methodology , and sample characteristics of a dual-site treatment study ( New York and Montreal ) of children with attention-deficit/hyperactivity disorder ( ADHD ) conducted between 1990 and 1995 . The hypotheses were that ( 1 ) methylpheni date combined with comprehensive multimodal psychosocial treatment was superior to methylpheni date alone in improving multiple functions and ( 2 ) the efficacy of the psychosocial intervention result ed from its specific components and not from nonspecific treatment effects . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to methylpheni date , were r and omized for 2 years to ( 1 ) methylpheni date treatment alone ; ( 2 ) methylpheni date combined with multimodal psychosocial treatment that included parent training and counseling , academic assistance , psychotherapy , and social skills training ; or ( 3 ) methylpheni date plus attention control treatment that excluded specific aspects of the psychosocial intervention . Children were switched to single-blind placebo after 12 months ; methylpheni date was reinstituted when clinical ly indicated . Assessment s included ratings by parents , teachers , children , and psychiatrists ; school observations in academic and gym classes ; and academic performance tests . Almost 80 % of families completed the 2-year study . Companion papers present treatment effects . CONCLUSIONS A comprehensive 2-year psychosocial treatment was delivered successfully to children with ADHD and their families",
"OBJECTIVE The investigation of attention-deficit/hyperactivity disorder ( ADHD ) in girls raises complex questions of referral bias and selection criteria . The authors sought to determine whether they could recruit a research sample of comparably affected girls using a combination of sex-independent diagnostic criteria and sex-normed cutoffs on teacher ratings . They also report on the largest placebo-controlled crossover comparison of methylpheni date and dextroamphetamine in girls with ADHD . METHOD Subjects were 42 girls with DSM-III-R/DSM-IV ADHD ( combined type ) contrasted to 56 previously studied boys with ADHD on comorbid diagnoses , behavioral ratings , psychological measures , psychiatric family history , and stimulant drug response . RESULTS Girls with ADHD were statistically indistinguishable from comparison boys on nearly all measures . Girls exhibited robust beneficial effects on both stimulants , with nearly all ( 95 % ) responding favorably to one or both drugs in this short-term trial . Dextroamphetamine produced significantly greater weight loss than methylpheni date . CONCLUSIONS This highly selected group of ADHD girls was strikingly comparable with comparison boys on a wide range of measures . The results confirm that girls with ADHD do not differ from boys in response to methylpheni date and dextroamphetamine and that both stimulants should be tried when response to the first is not optimal",
"IT IS the thesis of this paper that most therapeutic trials are inadequately formulated , and this from the earliest stages of their conception . Their inadequacy is basic , in that the trials may be aim ed at the solution of one or other of two radically different kinds of problem ; the result ing ambiguity affects the definition of the treatments , the assessment of the results , the choice of subjects and the way in which the treatments are compared . It often occurs that one type of approach is ethically less defensible than the other , or may even be ruled out altogether on ethical grounds . We postpone consideration of this aspect of the question until a later section",
"BACKGROUND Intent-to-treat analyses of the study revealed that medication management , alone or combined with intensive behavioral treatment , was superior to behavioral treatment and community care in reducing attention-deficit/hyperactivity disorder ( ADHD ) symptoms ; but only combined treatment showed consistently greater benefit than community care across other outcome domains ( disruptive and internalizing symptoms , achievement , parent-child relations , and social skills ) . We examine response patterns in subgroups defined by baseline variables ( moderators ) or variables related to treatment implementation ( mediators ) . METHODS We reconducted r and om-effects regression ( RR ) analyses , adding factors defined by moderators ( sex , prior medication use , comorbid disruptive or anxiety disorder , and public assistance ) and a mediator ( treatment acceptance/attendance ) . RESULTS Study outcomes ( N = 579 ) were upheld in most moderator subgroups ( boys and girls , children with and without prior medication , children with and without comorbid disruptive disorders ) . Comorbid anxiety disorder did moderate outcome ; in participants without anxiety , results paralleled intent-to-treat findings . For those with anxiety disorders , however , behavioral treatment yielded significantly better outcomes than community care ( and was no longer statistically different from medication management and combined treatment ) regarding ADHD-related and internalizing symptoms . In families receiving public assistance , medication management yielded decreased closeness in parent-child interactions , and combined treatment yielded relatively greater benefits for teacher-reported social skills . In families with high treatment acceptance/attendance , intent-to-treat results were upheld . Acceptance/attendance was particularly important for medication treatments . Finally , two thirds of children given community care received stimulants . Behavioral treatment did not significantly differ from , but medication management was superior to , this subgroup . CONCLUSIONS Exploratory analyses revealed that our study ( the Multimodal Treatment Study of Children With Attention-Deficit/Hyperactivity Disorder [ MTA ] ) results were confirmed across most baseline variables and treatment acceptance/attendance . In children with ADHD plus anxiety , behavioral treatment surpassed community care and approached medication-based treatments regarding parent-reported ADHD symptoms"
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4116f056-06ff-11f0-808a-c43d1ab1c353
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Objective This systematic review aims to summarize current evidence on which naturally present cannabinoids contribute to cannabis psychoactivity , considering their reported concentrations and pharmacodynamics in humans . Design Following PRISMA guidelines , papers published before March 2016 in Medline , Scopus -Elsevier , Scopus , ISI-Web of Knowledge and COCHRANE , and fulfilling established a-priori selection criteria have been included . Results In 40 original papers , three naturally present cannabinoids ( ∆-9-Tetrahydrocannabinol , ∆-8-Tetrahydrocannabinol and Cannabinol ) and one human metabolite ( 11-OH-THC ) had clinical relevance . Of these , the metabolite produces the greatest psychoactive effects . Cannabidiol ( CBD ) is not psychoactive but plays a modulating role on cannabis psychoactive effects . The proportion of 9-THC in plant material is higher ( up to 40 % ) than in other cannabinoids ( up to 9 % ) . Pharmacodynamic reports vary due to differences in method ological aspects ( doses , administration route and volunteers ' previous experience with cannabis ) . Conclusions Findings reveal that 9-THC contributes the most to cannabis psychoactivity . Due to lower psychoactive potency and smaller proportions in plant material , other psychoactive cannabinoids have a weak influence on cannabis final effects . Current lack of st and ard methodology hinders homogenized research on cannabis health effects . Working on a st and ard cannabis unit considering 9-THC is recommended
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"This study investigated the contribution of different cannabinoids to the subjective , behavioral and neurophysiological effects of smoked marijuana . Healthy marijuana users ( 12 men , 11 women ) participated in four sessions . They were r and omly assigned to a low or a high Δ9-tetrahydrocannabinol group ( THC ; 1.8 % versus 3.6 % ) . In the four sessions under blinded conditions subjects smoked marijuana cigarettes containing placebo ( no active cannabinoids ) , or cigarettes containing THC with low or high levels of cannabichromene ( CBC ; 0.1 % versus 0.5 % ) and low or high levels of cannabidiol ( CBD ; 0.2 % versus 1.0 % ) . Dependent measures included subjective reports , measures of cognitive task performance and neurophysiological measures [ electroencephalographic ( EEG ) and event-related potential ( ERP ) ] . Compared to placebo , active THC cigarettes produced expected effects on mood , behavior and brain activity . A decrease in performance , reduction in EEG power and attenuation of ERP components reflecting attentional processes were observed during tests of working memory and episodic memory . Most of these effects were not dose-dependent . Varying the concentrations of CBC and CBD did not change subjects ' responses on any of the outcome measures . These findings are consistent with previous studies indicating that THC and its metabolites are the primary active constituents of marijuana . They also suggest that neurophysiological EEG and ERP measures are useful biomarkers of the effects of THC",
"Abstract Rationale . Although some aspects of memory functions are known to be acutely impaired by Δ9-tetrahydrocannabinol ( Δ9-THC ; the main active constituent of marijuana ) , effects on other aspects of memory are not known and the time course of functional impairments is unclear . Objective . The present study aim ed to detail the acute and residual cognitive effects of Δ9-THC in infrequent cannabis users . Methods . A balanced , double-blind cross-over design was used to compare the effects of 7.5 mg and 15 mg Δ9-THC with matched placebo in 15 male volunteers . Participants were assessed pre and 1 , 2 , 4 , 6 , 8 , 24 and 48 h post-drug . Results . Δ9-THC 15 mg impaired performance on two explicit memory tasks at the time of peak plasma concentration ( 2 h post-drug ) . At the same time point , performance on an implicit memory task was preserved intact . The higher dose of Δ9-THC result ed in no learning whatsoever occurring over a three-trial selective reminding task at 2 h. Working memory was generally unaffected by Δ9-THC . In several tasks , Δ9-THC increased both speed and error rates , reflecting \" riskier \" speed-accuracy trade-offs . Subjective effects were also most marked at 2 h but often persisted longer , with participants rating themselves as \" stoned \" for 8 h. Participants experienced a strong drug effect , liked this effect and , until 4 h , wanted more oral Δ9-THC . No effects of Δ9-THC were found 24 or 48 h following ingestion indicating that the residual effects of oral Δ9-THC are minimal . Conclusions . These data demonstrate that oral Δ9-THC impairs episodic memory and learning in a dose-dependent manner whilst sparing perceptual priming and working memory",
"Rationale Δ9-Tetrahydrocannabinol ( THC ) is the main active constituent of cannabis . In recent years , the average THC content of some cannabis cigarettes has increased up to approximately 60 mg per cigarette ( 20 % THC cigarettes ) . Acute cognitive and psychomotor effects of THC among recreational users after smoking cannabis cigarettes containing such high doses are unknown . Objectives The objective of this study was to study the dose – effect relationship between the THC dose contained in cannabis cigarettes and cognitive and psychomotor effects for THC doses up to 69.4 mg ( 23 % ) . Material s and methods This double-blind , placebo-controlled , r and omised , four-way cross-over study included 24 non-daily male cannabis users ( two to nine cannabis cigarettes per month ) . Participants smoked four cannabis cigarettes containing 0 , 29.3 , 49.1 and 69.4 mg THC on four exposure days . Results The THC dose in smoked cannabis was linearly associated with a slower response time in all tasks ( simple reaction time , visuo-spatial selective attention , sustained attention , divided attention and short-term memory tasks ) and motor control impairment in the motor control task . The number of errors increased significantly with increasing doses in the short-term memory and the sustained attention tasks . Some participants showed no impairment in motor control even at THC serum concentrations higher than 40 ng/mL. High feeling and drowsiness differed significantly between treatments . Conclusions Response time slowed down and motor control worsened , both linearly , with increasing THC doses . Consequently , cannabis with high THC concentrations may be a concern for public health and safety if cannabis smokers are unable to titrate to a high feeling corresponding to a desired plasma THC level",
"The pharmacological activity of several doses of △ 8-THC and △ 9-TΗC was studied comparatively using rats ( climbing rope test ) , mice ( catatonia and spontaneous motor activity tests ) and rabbits ( Gayer test ) and also human volunteers ( pulse rate , time discrimination and subjective symptoms ) . △ 9-TΗC was twice as active as △ 8-THC in rats and mice ; both compounds were equiactive in rabbits . In man △ 9-THC revealed to be nearly twice as active as its isomer . There were no qualitative differences between both drugs neither in man nor in the laboratory animals",
"Community-based studies suggest that cannabis products that are high in Δ9-tetrahydrocannabinol ( THC ) but low in cannabidiol ( CBD ) are particularly hazardous for mental health . Laboratory-based studies are ideal for clarifying this issue because THC and CBD can be administered in pure form , under controlled conditions . In a between-subjects design , we tested the hypothesis that pre-treatment with CBD inhibited THC-elicited psychosis and cognitive impairment . Healthy participants were r and omised to receive oral CBD 600 mg ( n=22 ) or placebo ( n=26 ) , 210 min ahead of intravenous ( IV ) THC ( 1.5 mg ) . Post-THC , there were lower PANSS positive scores in the CBD group , but this did not reach statistical significance . However , clinical ly significant positive psychotic symptoms ( defined a priori as increases ≥3 points ) were less likely in the CBD group compared with the placebo group , odds ratio (OR)=0.22 ( χ2=4.74 , p , post-THC paranoia , as rated with the State Social Paranoia Scale ( SSPS ) , was less in the CBD group compared with the placebo group ( t=2.28 , p , indexed by scores on the Hopkins Verbal Learning Task-revised ( HVLT-R ) , was poorer , relative to baseline , in the placebo pre-treated group ( -10.6±18.9 % ) compared with the CBD group ( -0.4%±9.7 % ) ( t=2.39 , p high-THC/low-CBD cannabis products are associated with increased risks for mental health ",
"Oral doses of delta‐9‐tetrahydrocannabinol ( THC ) 20 mg , combined with placebo or with 40 mg doses of cannabinol ( CBN ) and cannabidiol ( CBD ) , were given to volunteers . The combination of THC with CBN produced no detectable changes in the quality , intensity , or duration of the effects of THC alone . The THC‐CBD combination tended to delay onset and prolong effects of THC , while making them somewhat more intense . Even this interactive effect was slight , providing no reason to ab and on the current practice of basing doses of marihuana for clinical studies solely on THC content",
"Rationale Δ9-Tetrahydrocannabinol ( THC ) is the main active constituent of cannabis . In recent years , the average THC content of some cannabis cigarettes has increased up to approximately 60 mg per cigarette ( 20 % THC cigarettes ) . The pharmacokinetics of THC after smoking cannabis cigarettes containing more than approximately 35 mg THC ( 3.55 % THC cigarettes ) is unknown . To be able to perform suitable exposure risk analysis , it is important to know if there is a linear relation at higher doses . Objectives The present study aim ed to characterise the pharmacokinetics of THC , the active metabolite 11-OH-THC and the inactive metabolite THC-COOH after smoking a combination of tobacco and cannabis containing high THC doses . Material s and methods This double-blind , placebo-controlled , four-way , cross-over study included 24 male non-daily cannabis users ( two to nine joints per month ) . Participants were r and omly assigned to smoke cannabis cigarettes containing 29.3 , 49.1 and 69.4 mg THC and a placebo . Serial serum sample s collected over a period of 0–8 h were analysed by liquid chromatography electrospray t and em mass spectrometry . Effects on heart rate , blood pressure and ‘ high ’ feeling were also measured . Results Mean maximal concentrations ( Cmax ) were 135.1 , 202.9 and 231.0 μg/L for THC and 9.2 , 16.4 and 15.8 μg/L for 11-OH-THC after smoking a 29.3- , 49.1- and 69.4-mg THC cigarette , respectively . A large inter-individual variability in Cmax was observed . Heart rate and ‘ high ’ feeling significantly increased with increasing THC dose . Conclusions This study demonstrates that the known linear association between THC dose and THC serum concentration also applies for high THC doses",
"Cannabidiol ( CBD ) , a major phytocannabinoid constituent of cannabis , is attracting growing attention in medicine for its anxiolytic , antipsychotic , antiemetic and anti-inflammatory properties . However , up to this point , a comprehensive literature review of the effects of CBD in humans is lacking . The aim of the present systematic review is to examine the r and omized and crossover studies that administered CBD to healthy controls and to clinical patients . A systematic search was performed in the electronic data bases PubMed and EMBASE using the key word “ cannabidiol ” . Both monotherapy and combination studies ( e.g. , CBD + ∆9-THC ) were included . A total of 34 studies were identified : 16 of these were experimental studies , conducted in healthy subjects , and 18 were conducted in clinical population s , including multiple sclerosis ( six studies ) , schizophrenia and bipolar mania ( four studies ) , social anxiety disorder ( two studies ) , neuropathic and cancer pain ( two studies ) , cancer anorexia ( one study ) , Huntington ’s disease ( one study ) , insomnia ( one study ) , and epilepsy ( one study ) . Experimental studies indicate that a high-dose of inhaled/intravenous CBD is required to inhibit the effects of a lower dose of ∆9-THC . Moreover , some experimental and clinical studies suggest that oral/oromucosal CBD may prolong and /or intensify ∆9-THC-induced effects , whereas others suggest that it may inhibit ∆9-THC-induced effects . Finally , preliminary clinical trials suggest that high-dose oral CBD ( 150–600 mg/d ) may exert a therapeutic effect for social anxiety disorder , insomnia and epilepsy , but also that it may cause mental sedation . Potential pharmacokinetic and pharmacodynamic explanations for these results are discussed",
"Cannabis is one of the most widely used illicit substances and there is growing interest in the association between cannabis use and psychosis . Delta-9-Tetrahydrocannabinol ( Δ-9-THC ) the principal active ingredient of cannabis has been shown to induce psychotomimetic and amnestic effects in healthy individuals . Whether people who frequently use cannabis are either protected from or are tolerant to these effects of Δ-9-THC has not been established . In a 3-day , double-blind , r and omized , placebo-controlled study , the dose-related effects of 0 , 2.5 , and 5 mg intravenous Δ-9-THC were studied in 30 frequent users of cannabis and compared to 22 healthy controls . Δ-9-THC ( 1 ) produced transient psychotomimetic effects and perceptual alterations ; ( 2 ) impaired memory and attention ; ( 3 ) increased subjective effects of ‘ high ’ ; ( 4 ) produced tachycardia ; and ( 5 ) increased serum cortisol in both groups . However , relative to controls , frequent users showed blunted responses to the psychotomimetic , perceptual altering , cognitive impairing , anxiogenic , and cortisol increasing effects of Δ-9-THC but not to its euphoric effects . Frequent users also had lower prolactin levels . These data suggest that frequent users of cannabis are either inherently blunted in their response to , and /or develop tolerance to the psychotomimetic , perceptual altering , amnestic , endocrine , and other effects of cannabinoids",
"The purpose of this study was to determine whether marijuana produced dose-dependent antinociception in humans and , if so , whether endogenous opiates modulate this effect . A total of five male regular marijuana users participated in three test sessions during which they smoked cigarettes containing 0 % ( placebo ) and 3 . 55 % Delta(9)-tetrahydrocannabinol ( Delta(9)-THC ) ( active ) . Each of four controlled smoking bouts per session , spaced at 40-min intervals , consisted of nine puffs from active and placebo cigarettes ( three cigarettes , three puffs per cigarette , one puff per min ) . During successive bouts , participants smoked 0 , 3 , 6 and 9 ( 0 , 3 , 9 and 18 cumulative ) puffs from active marijuana cigarettes , with the remainder of puffs from placebo cigarettes . Test sessions were identical , except for naltrexone 0 , 50 or 200 mg p.o . ( r and omized , double-blind ) administration 1 h before the first smoking bout on the different days . Before smoking , between smoking bouts and postsmoking , participants completed an assessment battery that included antinociceptive ( finger withdrawal from radiant heat stimulation ) , biological , subjective , observer-rated signs and performance measures . Marijuana produced significant dose-dependent antinociception ( increased finger withdrawal latency ) and biobehavioral effects . Naltrexone did not significantly influence marijuana dose-effect curves , suggesting no role of endogenous opiates in marijuana-induced antinociception under these conditions",
"Cannabidiol ( CBD ) , a constituent of cannabis with few psychoactive effects , has been reported in some studies to attenuate certain aspects of Δ9-tetrahydrocannabinol ( THC ) intoxication . However , most studies have tested only one dose of CBD in combination with one dose of oral THC , making it difficult to assess the nature of this interaction . Further , the effect of oral CBD on smoked cannabis administration is unknown . The objective of this multi-site , r and omized , double-blind , within-subject laboratory study was to assess the influence of CBD ( 0 , 200 , 400 , 800 mg , p.o . ) pretreatment on the reinforcing , subjective , cognitive , and physiological effects of smoked cannabis ( 0.01 ( inactive ) , 5.30–5.80 % THC ) . Non-treatment-seeking , healthy cannabis smokers ( n=31 ; 17 M , 14 F ) completed eight outpatient sessions . CBD was administered 90 min prior to cannabis administration . The behavioral and cardiovascular effects of cannabis were measured at baseline and repeatedly throughout the session . A subset of participants ( n=8 ) completed an additional session to measure plasma CBD concentrations after administration of the highest CBD dose ( 800 mg ) . Under placebo CBD conditions , active cannabis ( 1 ) was self-administered by significantly more participants than placebo cannabis and ( 2 ) produced significant , time-dependent increases in ratings of ‘ High ’ , ‘ Good Effect ’ , ratings of the cannabis cigarette ( eg , strength , liking ) , and heart rate relative to inactive cannabis . CBD , which alone produced no significant psychoactive or cardiovascular effects , did not significantly alter any of these outcomes . Cannabis self-administration , subjective effects , and cannabis ratings did not vary as a function of CBD dose relative to placebo capsules . These findings suggest that oral CBD does not reduce the reinforcing , physiological , or positive subjective effects of smoked cannabis",
"BACKGROUND AND AIMS Between 2000 and 2005 the average percentage of Δ(9 ) -tetrahydrocannabinol ( THC ) in marijuana as sold in Dutch coffeeshops has increased substantially ; the potency of domestic products ( Nederwiet and Nederhasj ) has particularly increased . In contrast with imported marijuana , Nederwiet hardly contained any cannabidiol ( CBD ) , a cannabinoid that is thought to offset some of the adverse effects of THC . In 2005 , the THC content in Nederwiet was significantly lower than in 2004 . This study investigates the further decrease or increase of cannabinoids in these cannabis products . METHODS From 2005 to 2015 five different cannabis products were bought anonymously in 50 coffeeshops that were selected r and omly each year from all coffeeshops in the Netherl and s. A total of 2126 cannabis sample s were bought , consisting of 664 Nederwiet sample s ( most popular ) , 537 Nederwiet sample s ( supposed strongest varieties ) , 183 imported herbal cannabis sample s , 140 sample s of cannabis resin made of Nederwiet and 602 sample s of imported cannabis resin . All sample s were analysed chemically for their THC , CBD and cannabinol ( CBN ) content . RESULTS Between 2005 and 2015 , the mean potencies of the most popular and the strongest Nederwiet and of imported cannabis resin were 16.0±4.0 % , 17.0±3,9 % and 16.5±6.3 % , respectively . Imported herbal cannabis ( 6.5±3.5 % ) and cannabis resin made from Nederwiet ( 30.2±16.4 % ) contained , respectively , less ( β=-10.0 , P ) THC than imported cannabis resin . Linear regression models were used to study the trends in THC of the different cannabis products over time . A marginal , but significant ( P decline of THC per year of 0.22 % was found in all cannabis products . However , no significant difference was found between the five products in the THC linear trajectories across time . Of all the cannabis products , only imported cannabis resin contained a relatively high CBD/THC ratio ( median 0.42 ) . CONCLUSION The average tetrahydrocannabinol ( THC ) content of the most popular herbal cannabis products in the Netherl and s has decreased slightly since 2005 . The popular Nederwiet type still has a relatively high THC to cannabidiol ratio",
"The total concentration of THC has been monitored in cannabis preparations sold in Dutch coffee shops since 1999 . This annual monitoring was issued by the Ministry of Health after reports of increased potency . The level of the main psychoactive compound , Δ 9 ‐tetrahydrocannabinol ( THC ) , is measured in marijuana and hashish . A comparison is made between imported and Dutch preparations , and between seasons . Sample s of cannabis preparations from r and omly selected coffee shops were analyzed using gas chromatography ( GC‐FID ) for THC , CBD and CBN . In 2004 , the average THC level of Dutch home‐grown marijuana ( Nederwiet ) ( 20.4 % THC ) was significantly higher than that of imported marijuana ( 7.0 % THC ) . Hashish derived from Dutch marijuana ( Nederhasj ) contained 39.3 % THC in 2004 , compared with 18.2 % THC in imported hashish . The average THC percentage of Dutch marijuana , Dutch hashish and imported hashish was significantly higher than in previous years . It nearly doubled over 5 years . During this period , the THC percentage in imported marijuana remained unchanged . A higher price had to be paid for cannabis with higher levels of THC . Whether the increase in THC levels causes increased health risks for users can only be concluded when more data are available on adjusted patterns of use , abuse liability , bioavailability and levels of THC in the brain",
"Experiments investigating the possible interaction of tetrahydrocannabinol ( THC ) and cannabidiol ( CBD ) , two major components of marihuana , were conducted under controlled laboratory conditions in a double‐blind manner . In one study , 15 male volunteers were given placebo or 25 µg/kg of THC together with either placebo or 150 µg/kg of CBD by inhalation of the smoke of a single cigarette . All four treatments were assigned to each subject according to a series of Latin‐square design s. CBD significantly attenuated the subjective euphoria of THC . Psychomotor impairment due to THC was not significantly altered by the simultaneous administration of CBD , but a trend indicating a decrease in THC‐like effects was observed after the combination . When administered alone CBD was inactive for all the parameters measured . In a second study , 8 male subjects were given CBD ( 0 or 150 µg/kg ) by smoke inhalation 30 min before THC ( 0 or 25 µg/kg ) in a second cigarette . In contrast to the simultaneous administration of both drugs , CBD pretreatment did not alter the effects of THC on the parameters observed"
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Background : Currently , there is a widespread reliance on self‐reported question naires to assess low back pain patients . However , it has been suggested that objective measures of low back pain patients ' functional status should be used to aid clinical assessment . The aim of this study is to systematic ally review which kinematic /kinetic parameters have been used to assess low back pain patients against healthy controls and to propose clinical kinematic/kinetic measures . Methods : PubMed , Embase and Scopus data bases were search ed for relevant studies . Reference lists of selected studies and h and search es were performed . Studies had to compare people with and without non‐specific low back pain while performing functional tasks and report body segment/joint kinematic and /or kinetic data . Two review ers independently identified relevant papers . Findings : Sixty‐two studies were included . Common biases identified were lack of assessor blinding and sample size calculation , use of sample s of convenience , and poor experimental protocol st and ardization . Studies had small sample sizes . Range of motion maneuvers were the main task performed ( 33/62 ) . Kinematic/kinetic data of different individual or combination of body segments/joints were reported among the studies , commonest was to assess the hip joint and lumbar segment motion ( 13/62 ) . Only one study described full body movement . The most commonly reported outcome was range of motion . Statistically significant differences between controls and low back pain groups were reported for different outcomes among the studies . Moreover , when the same outcome was reported disagreements were noted . Interpretation : The literature to date offers limited and inconsistent evidence of kinematic/kinetic measures in low back pain patients that could be used clinical ly . HighlightsCurrent low back pain assessment relies on subjective measures .Use of objective measures ( kinematics/kinetics ) is encouraged in low back pain assessment .This review highlights the heterogeneity of studies with low back pain and healthy subjects . There is poor evidence for kinematic/kinetic parameters as low back pain objective measures .Functional tasks , whole body and not only range of motion should be considered
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"The effect of low back pain , with or without nerve root signs , on the joint coordination and kinematics of the lumbar spine and hips during everyday activities , such as picking up an object from the floor , are largely unknown . An experimental study was design ed to compare lumbar spine and hip joint kinematics and coordination in subjects with and without sub-acute low back pain , while picking up an object in a sitting position . A three-dimensional real-time electromagnetic tracking device was used to measure movements of the lumbar spine and hips . Sixty participants with subacute low back pain , with or without straight leg raise signs , and twenty healthy asymptomatic participants were recruited . The ranges of motions of lumbar spine and hips were determined . Movement coordination between the two regions was examined by cross-correlation . Results showed that mobility was significantly reduced in subjects with back pain , who compensated for limited motion through various strategies . The contribution of the lumbar spine relative to that of the hip was , however , found to be similar in all groups . The lumbar spine – hip joint coordination was substantially altered in subjects with back pain , in particular , those with a positive straight leg raise sign . We conclude that changes in the lumbar and hip kinematics were related to back pain and limitation in straight leg raise . Lumbar – hip coordination was mainly affected by the presence of positive straight leg raise sign when picking up an object in a sitting position",
"This study investigated whether people with low back pain ( LBP ) reduce variability of movement between the pelvis and thorax ( trunk ) in the transverse plane during gait at different speeds compared to healthy controls . Thirteen people with chronic LBP and twelve healthy controls walked on a treadmill at speeds from 0.5 to 1.72 m/s , with increments of 0.11 m/s . Step-to-step variability of the trunk , pelvis , and thorax rotations were calculated . Step-to-step deviations of pelvis and thorax rotations from the average pattern ( residual rotations ) were correlated to each other , and the linear regression coefficients between these deviations calculated . Spectral analysis was used to determine the frequencies of the residual rotations , to infer the relation of reduced trunk variability to trunk stiffness and /or damping . Variability of trunk motion ( thorax relative to pelvis ) was lower ( P=0.02 ) , covariance between the residual rotations of pelvis and thorax motions was higher ( P=0.03 ) , and the linear regression coefficients were closer to 1 ( P=0.05 ) in the LBP group . Most power of segmental residual rotations was below stride frequency ( ~1 Hz ) . In this frequency range , trunk residual rotations had less power than pelvis or thorax residual rotations . These data show that people with LBP had lower variability of trunk rotations , as a result of the coupling of deviations of residual rotations in one segment to deviations of a similar shape ( correlation ) and amplitude ( regression coefficient ) in the other segment . These results support the argument that people with LBP adopt a protective movement strategy , possibly by increased trunk stiffness",
"The reported association of low-back pain and musculoskeletal disorders contributed to the examination of the lumbar spine and hip extensor activation patterns in back pain sufferers during walking . Seventeen idiopathic low-back pain male subjects and 16 healthy volunteers participated in the study . Hip joint ROMs in the sagittal plane and neuromuscular activities of erector spinae [ L3 , T12 ] , gluteus maximus and biceps femoris were recorded on one r and omly selected body side in each group . Analysis using the Student 's t-test revealed significant differences for hip joint range of motion , stride time and significantly earlier onsets of the lumbar spine and hip extensors of the back pain sufferers compared with the healthy controls . It is assumed , that low-back disorders are related to changes of the lumbar spine and hip extensor recruitment pattern",
"Study Design . A prospect i ve study was conducted on a group of patients with unilateral nonspecific low back pain ( LBP ) and healthy controls . Objectives . To answer 3 questions : ( 1 ) Does pelvic asymmetry measured in st and ing affect the dynamics of motion performed in sitting ? ( 2 ) Do patients with LBP perform trunk motions differently from non-LBP participants in sitting position ? and ( 3 ) Do the kinematics of lateral flexion and axial rotation differ between sitting and st and ing positions ? Summary of Background Data . The effect of pelvic asymmetry on trunk motion while sitting remains unclear . LBP has been associated with altered trunk kinematics in st and ing ; however , there is limited information available describing trunk kinematics in sitting position in comparison to st and ing . Methods . Pelvic asymmetry was measured in 54 patients with unilateral nonspecific LBP and 59 control subjects . A motion- analysis system was used to test the range and symmetry of lateral flexion and axial rotation in sitting and st and ing positions . Bivariate correlations , regression , multivariate analysis of variance , and paired sample t tests were used to test for associations between variables and differences between groups . Results . We found significant : ( 1 ) correlations between pelvic asymmetry and asymmetric trunk motion performed in sitting , ( 2 ) differences between the LBP and control groups in patterns of trunk motion performed in a sitting posture , and ( 3 ) differences between kinematics of motions performed in sitting versus st and ing postures . Conclusions . This study shows a link between pelvic asymmetry and altered trunk motion in sitting position . We suggest that people with LBP may have a distinct compensatory mechanism , secondary to pelvic asymmetry , which puts the lumbar spine under higher stress . Movement asymmetry , rather than range of motion , may be a better indicator of disturbed function for people with LBP . Structural and functional asymmetries are factors that may be considered in the seating design and work environment",
"Study Design . Classification and functional assessment model for nonspecific low back pain ( LBP ) patients and controls on the basis of kinematic analysis parameters . Objective . Develop a logistic regression model using kinematic analysis variables to ( 1 ) discriminate between LBP patients and controls and ( 2 ) obtain objective parameters for LBP functional assessment . Summary of Background Data . Functional assessment of spinal disorders has been carried out traditionally by means of subjective scales . Objective functional techniques have been developed , which usually involve the application of external loads or the analysis of highly st and ardized trunk flexion-extension maneuvers . Few studies have used everyday activities such as sit-to-st and or lifting an object from the ground . They have shown that the motion patterns of LBP patients differ from those of healthy subjects . Nevertheless , very few studies have tried to correlate objective findings to the results of subjective scales , and no previous study has developed a LBP classification and functional assessment model on the basis of kinematic analysis of everyday activities . Methods . Sixteen controls and 39 LBP patients performed a sit-to-st and task , and lifted three different weights from a st and ing position . The vertical forces exerted and the relative positions of the lower limb and the cervical , thoracic , lumbar , and sacroiliac regions were recorded . Reliability was determined from repetitions of the tests performed by the control group . Binary logistic regression analyses were computed . The results of the selected regression equation were correlated to the Oswestry Disability Index scale results , to check the validity of the procedure for the measurement of functional disability . Results . Reliability of the parameters was good . The selected regression model used two variables , and correctly classified 97.3 % of the patients . High correlations were found between the results of this regression equation and the Oswestry Disability Index scale . Conclusion . It is possible to distinguish LBP patients from healthy subjects by means of the biomechanical analysis of everyday tasks . This kind of analysis can produce objective and reliable indexes about the patients ' degree of functional impairment",
"Background obesity is nowadays a p and emic condition . Obese subjects are commonly characterized by musculoskeletal disorders and particularly by non-specific chronic low back pain ( cLBP ) . However , the relationship between obesity and cLBP remains to date unsupported by an objective measurement of the mechanical behaviour of the spine and its morphology in obese subjects . Such analysis may provide a deeper underst and ing of the relationships between function and the onset of clinical symptoms . Purpose to objective ly assess the posture and function of the spine during st and ing , flexion and lateral bending in obese subjects with and without cLBP and to investigate the role of obesity in cLBP . Study design Cross-sectional study Patient sample thirteen obese subjects , thirteen obese subjects with cLBP , and eleven healthy subjects were enrolled in this study . Outcome measures we evaluated the outcome in terms of angles at the initial st and ing position ( START ) and at maximum forward flexion ( MAX ) . The range of motion ( ROM ) between START and MAX was also computed . Methods we studied forward flexion and lateral bending of the spine using an optoelectronic system and passive retroreflective markers applied on the trunk . A biomechanical model was developed in order to analyse kinematics and define angles of clinical interest . Results obesity was characterized by a generally reduced ROM of the spine , due to a reduced mobility at both pelvic and thoracic level ; a static postural adaptation with an increased anterior pelvic tilt . Obesity with cLBP is associated with an increased lumbar lordosis . In lateral bending , obesity with cLBP is associated with a reduced ROM of the lumbar and thoracic spine , whereas obesity on its own appears to affect only the thoracic curve . Conclusions obese individuals with cLBP showed higher degree of spinal impairment when compared to those without cLBP . The observed obesity-related thoracic stiffness may characterize this sub-group of patients , even if prospect i ve studies should be carried out to verify this hypothesis",
"OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity",
"BACKGROUND AND PURPOSE Little is known about how acute low back pain affects pelvic and lumbar movements during walking . The aim of the present study was to determine if measurement of the amplitude of the angular movements of the pelvis and lumbar spine during walking is useful in the evaluation of people with acute low back pain . METHOD The study used a repeated- measures and correlational design ; 11 individuals with low back pain ( tested in the acute phase and six weeks later when symptoms had resolved ) and matched control subjects were tested during treadmill walking . A video- analysis system was used to measure the amplitudes of movements of the pelvis and lumbar spine during walking . Pain level was measured with a visual analogue scale ( VAS ) . RESULTS During walking , movements of the pelvis ( axial rotation ) and lumbar spine ( lateral flexion ) were reduced in people with acute back pain compared with the resolved condition , but were not different from a group without a history of back pain . The amplitudes of the frontal plane movements of the pelvis and lumbar spine were negatively correlated with the intensity of pain ( r(s ) = -0.74 ) . CONCLUSIONS Measurement of pelvic and lumbar movements during walking is unlikely to have useful clinical applications for individuals , or when discriminating between impaired and unimpaired people , but may be applied to groups for hypothesis testing in evaluating change in back pain over time . An hypothesized model to explain the observed movements has been proposed",
"BACKGROUND Although the effect of symptomatic back pain on functional movement has been investigated , changes to spinal movement patterns in essentially pain-free people with a history of recurrent back pain are largely unreported . Reaching activities , important for everyday and occupational function , often present problems to such people , but have not been considered in this population . The purpose of this study was to compare the amplitude and timing of spinal and hip motions during two , seated reaching activities in people with and without a history of recurrent low back pain ( RLBP ) . METHODS Spinal and hip motions during reaching downward and across the body , in both directions , were tracked using electromagnetic sensors . Analyses were conducted to explore the amplitudes , velocities and timings of 3D segmental movements and to compare controls with subjects with recurrent , but asymptomatic lumbar or lumbosacral pain . FINDINGS We detected significant differences in the amplitude and timing of movement in the lower thoracic region , with the RLBP group restricting movement and demonstrating compensatory increased motion at the hip . The lumbar region displayed no significant between-group differences . The order in which the spinal segments achieved peak velocity in cross-reaching was reversed in RLBP compared to controls , with lumbar motion leading in controls and lagging in RLBP . INTERPRETATION Subjects with a history of RLBP show a number of altered kinematic features during reaching activities which are not related to the presence or intensity of pain , but which suggest adaptive changes to movement control",
"PURPOSE Roman chair exercises are popular for improving back muscle endurance but do not specifically target back muscles . This study aim ed to determine whether an adaptation of the Roman chair exercise would induce more fatigue in back muscles than in hip extensors . METHODS For this study , 16 healthy subjects and 18 patients with nonspecific chronic low back pain performed trunk flexion-extension cycles until exhaustion in a Roman chair with hips flexed at 40 ° . Surface EMG signals were recorded bilaterally on four back muscles and two hip extensors ( gluteus maximus and biceps femoris ) . Motion analysis of the trunk segments ( pelvis , lumbar , and thoracic spines ) was also carried out . RESULTS In both groups , EMG revealed clear evidence of muscle fatigue for the gluteus maximus , less clear evidence of fatigue for the lower back muscles , and motor unit recruitment ( without fatigue ) for the upper back muscles and biceps femoris . A change of muscle activation pattern was emphasized throughout the exercise bout , with some lower back muscles showing an increase followed by a decrease or leveling off of activation and with upper back muscles showing an increased activation at the end . Kinematic analyses revealed a progressive decrease ( 11 ° ) in the lumbar range of motion ( ROM ) and a progressive increase in hip ( 2 ° ) and thoracic ( 7 ° ) ROM during the exercise bout . CONCLUSIONS Roman chairs allow more freedom to change the kinematics of the spine during the exercise ( less lumbar and more thoracic motion ) to delay lower back muscle fatigue by sharing the load between the lower and upper back muscles . Even with adaptations to reduce hip extensors fatigue , this may make this exercise not as specific as wanted for fatiguing lower back muscles",
"Study Design . Transverse pelvis and thorax rotations were studied during walking in 39 patients with nonspecific low back pain and 19 healthy participants . Objectives . To gain insight into the consequences of low back pain for gait and to identify clinical ly useful measures for characterizing the quality of walking in patients with low back pain . Summary of Background Data . Gait studies in patients with low back pain have reported a decrease in walking velocity . In normal gait , in-phase pelvis-thorax coordination ( synchronicity ) evolves toward antiphase coordination ( counterrotation ) as walking velocity increases . This study examined the effect of walking velocity on pelvis and thorax rotations in patients with low back pain . Methods . Amplitudes of pelvis and thorax rotations were calculated , and spectral analyses were performed . Pelvis-thorax coordination was characterized in terms of relative Fourier phase , and coupling strength was assessed by means of cross-spectral analysis . Results . In comparison with healthy participants , relative Fourier phase was significantly smaller in low back pain patients for walking velocities of 3.8 km/h and higher , whereas coupling strength was significantly higher for velocities from 1.4 to 3.0 km/h . No significant group differences were found in amplitude or spectral content of individual pelvis and thorax rotations . Conclusion . In comparison with healthy participants , the gait of patients with low back pain was characterized by a more rigid , less flexible pelvis-thorax coordination in the absence of significant differences in the kinematics of the component rotations . This result suggests that coordination measures are more adequate in assessing quality of walking in patients with low back pain than are kinematic measures pertaining to the individual segment rotations , and that conservative therapy should use methods aim ed at improving intersegmental coordination"
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Background / objectives Nonnutritive sweeteners ( NNSs ) are zero- or low-calorie alternatives to nutritive sweeteners , such as table sugars . A systematic review and meta- analysis of r and omized controlled trials was conducted to quantitatively synthesize existing scientific evidence on the glycemic impact of NNSs . Subjects/ methods PubMed and Web of Science data bases were search ed . Two authors screened the titles and abstract s of c and i date publications . The third author was consulted to resolve discrepancies . Twenty-nine r and omized controlled trials , with a total of 741 participants , were included and their quality assessed . NNSs under examination included aspartame , saccharin , steviosides , and sucralose . The review followed the PRISMA guidelines . Results Meta- analysis was performed to estimate and track the trajectory of blood glucose concentrations over time after NNS consumption , and to test differential effects by type of NNS and participants ’ age , weight , and disease status . In comparison with the baseline , NNS consumption was not found to increase blood glucose level , and its concentration gradually declined over the course of observation following NNS consumption . The glycemic impact of NNS consumption did not differ by type of NNS but to some extent varied by participants ’ age , body weight , and diabetic status . Conclusions NNS consumption was not found to elevate blood glucose level . Future studies are warranted to assess the health implication s of frequent and chronic NNS consumption and eluci date the underlying biological mechanisms
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"The present study investigated the extent of expectancy in the ability of glucose to affect cognitive performance . Using a within-subjects design , subjects ( n 26 ) completed four experimental sessions ( in counterbalanced order and after an initial practice session ) during which they were given a 500 ml drink 30 min prior to completing a cognitive assessment battery . In addition , all subjects completed a baseline practice session during which they were given no drink . During two of the sessions , subjects were given a drink containing 50 g glucose and on the other two they were given a drink containing aspartame . A balanced placebo design was used , such that for half the sessions subjects were accurately informed as to the content of the drink ( glucose or aspartame ) , whereas in the other two sessions they were misinformed as to the content of the drink . The task battery comprised a 6 min visual analogue of the Bakan vigilance task , an immediate verbal free-recall task , an immediate verbal recognition memory task and a measure of motor speed ( two-finger tapping ) . Blood glucose and self-reported mood were also recorded at several time points during each session . Glucose administration was found to improve recognition memory times , in direct contrast to previous findings in the literature . Glucose administration also improved performance on the Bakan task ( relative to the control drink ) , but only in sessions where subjects were informed that they would receive glucose and not when they were told that they would receive aspartame . There were no effects either of the nature of the drink or expectancy on the other measures . These results are interpreted in terms of there being some contribution of expectancy concerning the positive effects of glucose on cognition in studies which have not used an equi-sweet dose of aspartame as a control drink",
"To assess whether acute hyperglycemia affects fibrinolytic balance in elderly subjects with normal glucose tolerance ( NGT ) or impaired glucose tolerance ( IGT ) , 40 non-obese elderly subjects ( 20 NGT , age 68 ± 8 years ; and 20 IGT , age 69 ± 11 years ) were studied . On two experimental days , r and omly allocated and spaced 1 week apart , plasma concentrations of glucose , insulin , fibrinogen , tissue plasminogen activator , plasminogen activator inhibitor type 1 and von Willebr and factor ( vWF ) were measured in each subject at baseline ( 0 ) and 30 , 60 , 90 , 120 min after the ingestion of 75 g glucose or a similarly sweet dose of aspartame ( 250 mg ) ( control test ) . In both NGT and IGT elderly subjects , tissue plasminogen activator , plasminogen activator inhibitor type 1 and fibrinogen plasma levels did not significantly change after both oral aspartame and glucose load . In IGT subjects , vWF plasmatic levels decreased after glucose ( not aspartame ) oral load , reaching the minimum level at 90 min after load ( 82.7 ± 7.8 versus 93.7 ± 10.2 , P that acute hyperglycemia does not modify plasma fibrinolysis in elderly subjects . The decrease of plasma concentration of vWF in IGT elderly subjects requires cautious interpretation and further extensive investigations",
"The objective was to compare the effects of ad libitum consumption of commonly consumed meal-time beverages on energy and fluid intakes and post-meal average subjective appetite and blood glucose in healthy adults . In a r and omized controlled design , 29 males and females consumed to satiation an ad libitum pizza meal with one of five beverages in unlimited amount including water ( 0 kcal ) , 1 % milk ( 44 kcal/100 ml ) , regular cola ( 44 kcal/100 ml ) , orange juice ( 44 kcal/100 ml ) and diet cola ( 0 kcal ) . Food and fluid intakes were measured at the meal . Average subjective appetite and blood glucose were measured before and for 2h after the meal . Although energy intake from pizza was similar among all beverage treatments , the amount of fluid consumed ( g ) varied among the beverages with intake of orange juice higher than regular and diet cola , but not different from water or milk . Meal-time ingestion of caloric beverages , milk , orange juice and regular cola , led to higher total meal-time energy intakes compared to either water or diet cola . Post-meal blood glucose area under the curve ( AUC ) was lower after milk than after meals with water , orange juice and regular cola and post-meal average subjective appetite AUC was lower after milk than after meals with water . Meal intakes of nutrients including protein , calcium , phosphorus , zinc , vitamins B12 , A and D were higher at the meal with milk compared to the other beverages . Thus , caloric beverages consumed ad libitum during a meal add to total meal-time energy intake , but 1 % milk favors a lower post-meal blood glucose and average subjective appetite score and adds to nutrient intake",
"OBJECTIVE The goal of this study was to determine the effect of artificial sweeteners on glucose , insulin , and glucagon-like peptide (GLP)-1 in humans . RESEARCH DESIGN AND METHODS For this study , 22 healthy volunteers ( mean age 18.5 ± 4.2 years ) underwent two 75-g oral glucose tolerance tests with frequent measurements of glucose , insulin , and GLP-1 for 180 min . Subjects drank 240 ml of diet soda or carbonated water , in r and omized order , 10 min prior to the glucose load . RESULTS Glucose excursions were similar after ingestion of carbonated water and diet soda . Serum insulin levels tended to be higher after diet soda , without statistical significance . GLP-1 peak and area under the curve ( AUC ) were significantly higher with diet soda ( AUC 24.0 ± 15.2 pmol/l per 180 min ) versus carbonated water ( AUC 16.2 ± 9.0 pmol/l per 180 min ; P = 0.003 ) . CONCLUSIONS Artificial sweeteners synergize with glucose to enhance GLP-1 release in humans . This increase in GLP-1 secretion may be mediated via stimulation of sweet-taste receptors on L-cells by artificial sweetener ",
"Background : Substituting sweeteners with non-nutritive sweeteners ( NNS ) may aid in glycaemic control and body weight management . Limited studies have investigated energy compensation , glycaemic and insulinaemic responses to artificial and natural NNS . Objectives : This study compared the effects of consuming NNS ( artificial versus natural ) and sucrose ( 65 g ) on energy intake , blood glucose and insulin responses . Methods : Thirty healthy male subjects took part in this r and omised , crossover study with four treatments : aspartame- , monk fruit- , stevia- and sucrose-sweetened beverages . On each test day , participants were asked to consume a st and ardised breakfast in the morning , and they were provided with test beverage as a preload in mid-morning and ad libitum lunch was provided an hour after test beverage consumption . Blood glucose and insulin concentrations were measured every 15 min within the first hour of preload consumption and every 30 min for the subsequent 2 h. Participants left the study site 3 h after preload consumption and completed a food diary for the rest of the day . Results : Ad libitum lunch intake was significantly higher for the NNS treatments compared with sucrose ( P=0.010 ) . The energy ' saved ' from replacing sucrose with NNS was fully compensated for at subsequent meals ; hence , no difference in total daily energy intake was found between the treatments ( P=0.831 ) . The sucrose-sweetened beverage led to large spikes in blood glucose and insulin responses within the first hour , whereas these responses were higher for all three NNS beverages following the test lunch . Thus , there were no differences in total area under the curve ( AUC ) for glucose ( P=0.960 ) and insulin ( P=0.216 ) over 3 h between the four test beverages . Conclusions : The consumption of calorie-free beverages sweetened with artificial and natural NNS have minimal influences on total daily energy intake , postpr and ial glucose and insulin compared with a sucrose-sweetened beverage",
"BACKGROUND Macronutrient \" preloads \" can stimulate glucagon-like peptide 1 ( GLP-1 ) and glucose-dependent insulinotropic polypeptide ( GIP ) , slow gastric emptying , and reduce postpr and ial glycemic excursions . After sweet preloads , these effects may be signaled by sodium-glucose cotransporter-1 ( SGLT1 ) , sweet taste receptors , or both . OBJECTIVE We determined the effects of 4 sweet preloads on GIP and GLP-1 release , gastric emptying , and postpr and ial glycemia . DESIGN Ten healthy subjects were studied on 4 separate occasions each . A preload drink containing 40 g glucose , 40 g tagatose/isomalt mixture ( TIM ) , 40 g 3-O-methylglucose ( 3OMG ; a nonmetabolized substrate of SGLT1 ) , or 60 mg sucralose was consumed 15 min before a (13)C-octanoic acid-labeled mashed potato meal . Blood glucose , plasma total GLP-1 and GIP , serum insulin , and gastric emptying were determined . RESULTS Both glucose and 3OMG stimulated GLP-1 and GIP release in advance of the meal ( each P overall postpr and ial GLP-1 response was greater after glucose , 3OMG , and TIM than after sucralose ( P blood glucose and insulin responses in the first 30 min after the meal were greatest after glucose ( each P Gastric emptying was slower after both 3OMG and TIM than after sucralose ( each P healthy humans , SGLT1 substrates stimulate GLP-1 and GIP and slow gastric emptying , regardless of whether they are metabolized , whereas the artificial sweetener sucralose does not . Poorly absorbed sweet tastants ( TIM ) , which probably expose a greater length of gut to nutrients , result in delayed GLP-1 secretion but not in delayed GIP release . These observations have the potential to optimize the use of preloads for glycemic control . This trial was registered at www.actr.org.au as ACTRN12611000775910",
"Blood glucose ( BG ) is usually measured after a caloric restriction of at least 8 h ; however evidence -based recommendations for the duration of a fasting status are missing . Here we analyze the effect of fasting duration on levels of BG to determine the minimal fasting duration to achieve comparable BG levels to conventional fasting measurements . We used data of a cross-sectional study on primary care patients , performed in October 2005 . We included 28,024 individuals ( age-range 18–99 years ; 63 % women ) without known diabetes mellitus and without missing data for BG and fasting status . We computed general linear models , adjusting for age , sex , time of blood withdrawal , systolic blood pressure , waist circumference , total- and HDL-cholesterol , physical activity , smoking , intake of beta-blocker and alcohol . We tested the intra-individual variability with respect to fasting status . Overall , the mean BG differed only slightly between individuals fasting ≥8 h and those fasting h of fasting differences of BG diminished in men to −0.08 mmol/L ( 95%-CI : −0.15 ; −0.01 mmol/L ) , in women to −0.07 mmol/L ( −0.12 ; −0.03 mmol/L ) compared to individuals fasting ≥8 h. Noteworthy , age , time of day of blood withdrawal , physical activity , and intake of hard liquor influenced BG levels considerably . Our data challenge the necessity for a fasting duration of ≥8 h when measuring blood glucose , suggesting a r and om sampling or a fasting duration of 3 h as sufficient . Rather , our study indicates that essentially more effort on the assessment of additional external/internal factors on BG levels is necessary",
"OBJECTIVE In patients with type 2 diabetes , but not type 1 diabetes , abnormal secretion of incretins in response to oral nutrients has been described . In healthy youths , we recently reported accentuated glucagon-like peptide 1 ( GLP-1 ) secretion in response to a diet soda sweetened with sucralose and acesulfame-K. In this study , we examined the effect of diet soda on gut hormones in youths with diabetes . RESEARCH DESIGN AND METHODS Subjects aged 12–25 years with type 1 diabetes ( n = 9 ) or type 2 diabetes ( n = 10 ) , or healthy control participants ( n = 25 ) drank 240 mL cola-flavored caffeine-free diet soda or carbonated water , followed by a 75-g glucose load , in a r and omized , cross-over design . Glucose , C-peptide , GLP-1 , glucose-dependent insulinotropic peptide ( GIP ) , and peptide Tyr-Tyr ( PYY ) were measured for 180 min . Glucose and GLP-1 have previously been reported for the healthy control subjects . RESULTS GLP-1 area under the curve ( AUC ) was 43 % higher after ingestion of diet soda versus carbonated water in individuals with type 1 diabetes ( P = 0.020 ) , similar to control subjects ( 34 % higher , P = 0.029 ) , but was unaffected by diet soda in patients with type 2 diabetes ( P = 0.92 ) . Glucose , C-peptide , GIP , and PYY AUC were not statistically different between the two conditions in any group . CONCLUSIONS Ingestion of diet soda before a glucose load augmented GLP-1 secretion in type 1 diabetic and control subjects but not type 2 diabetic subjects . GIP and PYY secretion were not affected by diet soda . The clinical significance of this increased GLP-1 secretion , and its absence in youths with type 2 diabetes , needs to be determined",
"OBJECTIVE Macronutrient “ preloads ” can reduce postpr and ial glycemia by slowing gastric emptying and stimulating glucagon-like peptide-1 ( GLP-1 ) secretion . An ideal preload would entail minimal additional energy intake and might be optimized by concurrent inhibition of dipeptidyl peptidase-4 ( DPP-4 ) . We evaluated the effects of a low-energy d-xylose preload , with or without sitagliptin , on gastric emptying , plasma intact GLP-1 concentrations , and postpr and ial glycemia in type 2 diabetes . RESEARCH DESIGN AND METHODS Twelve type 2 diabetic patients were studied on four occasions each . After 100 mg sitagliptin ( S ) or placebo ( P ) and an overnight fast , patients consumed a preload drink containing either 50 g d-xylose ( X ) or 80 mg sucralose ( control [ C ] ) , followed after 40 min by a mashed potato meal labeled with 13C-octanoate . Blood was sample d at intervals . Gastric emptying was determined . RESULTS Both peak blood glucose and the amplitude of glycemic excursion were lower after PX and SC than PC ( P overall blood glucose was lower after SX than PC ( P postpr and ial insulin-to-glucose ratio was attenuated ( P gastric emptying was slower ( P Plasma GLP-1 concentrations were higher after d-xylose than control only before the meal ( P d-xylose preload reduces postpr and ial glycemia and enhances the effect of a DPP-4 inhibitor",
"Increases in plasma blood glucose levels modulate memory , mood , and , to some extent , attention in adults . Participants in the present study were administered glucose ( 10 , 100 , and 500 mg/kg , or 50 g ) or placebo ( 23.7 mg saccharin ) shortly prior to completing the test of variables of attention ( TOVA ) , a continuous performance test ( CPT ) commonly used to assess attention for diagnostic purpose s. There were significant increases in blood glucose levels for the 500 mg/kg and 50 g groups , but only the 100 mg/kg group showed significant changes in behavior in comparison to the saccharin group . Specifically , the 100 mg/kg group performed worse on measures of commission errors , post-commission responses , and post-commission response time variability . There were no differences among the groups on other major variables of attention , including omission errors , response time , and response time variability . The results of this study demonstrate that large doses of glucose which increase blood glucose levels do not influence attention , but that a moderate dose ( 100 mg/kg ) selectively impairs measures of impulsivity or disinhibition . Practitioners and research ers should maintain an awareness of dietary effects on attention and continue to examine micronutrients as potential confounds on diagnostic tests of cognition and behavior",
"BACKGROUND Consumption of low-calorie sweeteners ( LCSs ) has increased markedly during the past several decades , yet the prevalence of LCS consumption in recent years is currently unknown . OBJECTIVE The aim of this study was to describe LCS consumption in the United States and to characterize consumption by sociodemographic subgroups , source , frequency , eating occasion , and location . DESIGN Cross-sectional study using National Health and Nutrition Examination Survey data from 2009 to 2012 . The prevalence of LCS consumption was assessed using two 24-hour dietary recalls , while the frequency ( number of times per day ) , occasion ( meal vs snack vs alone ) , and location of LCS consumption ( at home vs away from home ) was assessed using data from the one , in-person , 24-hour dietary recall . PARTICIPANTS National Health and Nutrition Examination Survey participants ( 2 years old or older ) either in 2009 - 2010 ( n=9,047 ) or in 2011 - 2012 ( n=7,939 ) . After excluding participants with implausible energy intake ( n=44 ) , the final sample size was 16,942 . MAIN OUTCOME MEASURES The primary outcome was the proportion of individuals consuming one or more foods , beverages , or packets containing LCSs during at least one of their two dietary recalls . STATISTICAL ANALYSES PERFORMED Data were weighted to provide national estimates and Stata frequency procedures for complex survey design were used for all analyses . RESULTS Our findings were that 25.1 % of children and 41.4 % adults reported consuming LCSs . Most LCS consumers reported use once daily ( 80 % of children , 56 % of adults ) and frequency of consumption increased with body weight in adults . LCS consumption was higher in females compared with males among adults , and in obese individuals , compared with overweight and normal-weight individuals . Individuals of non-Hispanic white race/ethnicity also had higher prevalence of consumption compared with non-Hispanic blacks and Hispanics and those in the highest tertile of income had higher LCS consumption compared with individuals of middle or low income across LCS product categories in adults , and for LCS beverages and LCS foods in children . Most LCS consumers reported consuming LCS with meals ( 64 % of adults , 62 % of children ) and the majority of LCS consumption occurred at home ( 71 % and 72 % among adults and children , respectively ) . CONCLUSIONS LCS consumption is highly prevalent in the United States , among both children and adults . Well-controlled , prospect i ve trials are required to underst and the health impact of this widespread LCS exposure ",
"In humans little is known as to whether taste solutions applied to the tongue elicit cephalic phase insulin release ( CPIR ) . The aim of this study was to re-examine if any effect of different taste solutions on CPIR occurs . Under fasting conditions healthy human subjects sipped , and washed out their mouths with eight taste solutions ( sucrose , saccharin , acetic acid , sodium chloride , quinine hydrochloride , distilled water , starch , and sodium glutamate ) for 45 s and spat them out again . The taste stimuli were not swallowed ; they were applied in a r and omized order , each on a separate day . Blood collection for determination of plasma glucose and plasma insulin concentrations was performed 3 min before and 3 , 5 , 7 and 10 min after taste stimulation . Ratings of quality , intensity and hedonic characteristics were also obtained . A significant increase of plasma insulin concentration was apparent after stimulation with sucrose and saccharin . In conclusion , the current data suggest that the sweeteners sucrose and saccharin activate a CPIR even when applied to the oral cavity only",
"Previous investigations have found that increasing circulating glucose availability can increase memory performance in rodents , healthy humans , and individuals with dementia of the Alzheimer 's type . In this study , patients with schizophrenia , healthy control subjects , and controls with bipolar affective disorder were tested using double-blind treatment with either 50 g anhydrous dextrose plus 4 mg sodium saccharin ( for \" taste \" ) or 23.7 mg saccharin alone , followed by cognitive testing on a complex battery . At this glucose dose , verbal memory performance on a paragraph recall task was increased during the glucose condition relative to the saccharin condition in the patients with schizophrenia ; this effect was not detected in either the psychiatric or normal controls . The results provide preliminary support for the hypothesis that memory performance can be improved in patients with schizophrenia by increasing circulating glucose availability and suggest the importance of further evaluation of therapeutic manipulations of glucose availability",
"Abstract Recent research findings indicate that glucose administration enhances some aspects of cognitive functioning . To date , those studies which have investigated the effects of glucose on memory in human participants have concentrated on its apparent ability to attenuate memory impairment . Relatively little research has been done in humans investigating the effects of glucose on memory performance in young healthy participants in whom no memory deficits exist . Moreover , the work which has been conducted in this population has produced somewhat equivocal findings . In this study , after overnight fasting the influence of a 25 g oral dosage of glucose on a range of measures of memory performance was investigated in healthy young female participants . Two control treatments ( saccharin and water ) were also administered . There was a significant glucose facilitation effect upon performance of long-term verbal free and cued recall tasks which did not vary with test delay . Performance on these free and cued verbal recall measures correlated significantly with blood glucose levels across all participants . No glucose-related facilitation was observed on either a test of short-term verbal memory ( forwards/backwards digit recall ) or a test of long-term non-verbal memory ( complex figure reproduction ) . However , the significant glucose-related effects observed with long-term free and cued recall remained after controlling for participants ’ differential baseline blood glucose levels and individual levels of immediate memory performance . Therefore , memory improvement after glucose ingestion was not merely a consequence of lower baseline blood glucose or lower immediate memory performance in the glucose treatment group . These findings indicate that there may be some fractionation in the memory facilitation effects of glucose : the memory enhancing effect of glucose administration in healthy young adults may be greatest on tests of long-term verbal recall . The results suggest that glucose may enhance retention in and /or retrieval from long-term verbal memory",
"Twelve normal subjects and 10 subjects with non-insulin-dependent diabetes mellitus were given , in r and om order at intervals of ≥ 1 wk , three drinks of the same beverage : one unsweetened , one sweetened with 400 mg aspartame , and one sweetened with 135 mg saccharin . The amount of sweetener approximated that in 1 L of sugar-free soft drink . Plasma glucose , insulin , and glucagon were measured for 3 h after ingestion of the test beverage . Plasma glucose declined slightly throughout the test period , probably due to fasting , with no differences between the three treatments . Neither sweetener affected peak insulin levels in subjects with or without diabetes . Analysis of area under the curve showed that mean insulin levels were statistically significantly higher after aspartame than after saccharin or unsweetened beverage in normal subjects only , but the magnitude of the difference was small and unlikely to be of physiological importance in the absence of differences in glucose levels . Furthermore , the differences could largely be accounted for by a decrease in insulin values after both unsweetened beverage and saccharin , with no change from baseline after aspartame . Glucagon levels showed time-to-time variation but no overall differences . We conclude that ingestion of aspartame- or saccharin-sweetened beverages by fasting subjects , with or without diabetes , did not affect blood glucose homeostasis ",
"Changes in memory performance were examined after intake of a glucose ( 50 g ) or saccharin ( 50 mg ) solution in fasted men and women . Glucoregulation was estimated by using a recovery index to categorize participants within each gender as having poor or good recovery . Memory was assessed with word-learning tasks in which the imagery-evoking value of the words was systematic ally manipulated to yield high- and low-imagery lists . The results showed that men and women characterized as having poor glucose regulation had significantly worse memory performance under the saccharin condition . This decrement was reversed by glucose ingestion . These effects were observed for both low- and high-imagery words . This study supports the hypothesis that poor glucoregulation is associated with poor memory performance even in young healthy participants and that the ingestion of glucose can improve their memory",
"Nonnutritive sweeteners have been used to lower the energy density of foods with the intention of affecting weight loss or weight maintenance . However , some epidemiological and animal evidence indicates an association between weight gain or insulin resistance and artificial sweetener consumption . In the present study , we hypothesized that the nonnutritive sweetener sucralose , a trichlorinated sucrose molecule , would elicit responses similar to water but different from sucrose and sucrose combined with sucralose on subjective and hormonal indications of hunger and short-term glucose homeostasis . Eight female volunteers ( body mass index , 22.16 ± 1.71 kg/m(2 ) ; age , 21.75 ± 2.25 years ) consumed sucrose and /or sucralose in water in a factorial design . Blood sample s were taken at fasting and 30 and 60 minutes after treatment followed by a st and ardized breakfast across treatments , and blood sample s were taken 30 , 60 , 90 , and 120 minutes after breakfast . Plasma was analyzed for glucose , insulin , glucagon , triacylglycerols ( TAG ) , and acylated ghrelin . Perceptions of hunger and other subjective measurements were assessed before each blood sample . No differences were detected in subjective responses , circulating triacylglycerol , or glucagon concentrations among treatments over time . Significant differences were observed in insulin , glucose , and acylated ghrelin concentrations over time only between sucrose-containing treatments and non-sucrose-containing treatments regardless of sucralose consumption . Therefore , sucralose may be a relatively inert nonnutritive sweetener with regard to hunger signaling and short-term glucose homeostasis",
"Rationale Oral glucose has been shown to decrease tobacco craving in many but not all previous studies . Glucose ingestion may facilitates entry of tryptophan ( TRP ) , the unique source of brain serotonin , into the brain , glucose ’s action seems to be opposite of rapid TRP depletion . Therefore , the aim was to assess the effect of high doses of oral glucose on tobacco craving , withdrawal symptoms , plasma TRP and blood serotonin concentrations in temporarily abstinent smokers . Methods Aspartame 0.6 g/200 ml ( A , placebo ) , glucose 32.5 g/200 ml ( G32.5 ) and 75 g/200 ml water ( G75 ) were administered to 12 healthy smokers after an overnight abstinence in a crossover , double blind study . Tobacco craving ( short version of the Tobacco Craving Question naire , TCQ ) , withdrawal symptoms , choice reaction time , affect , blood glucose , plasma insulin , nicotine , cotinine , free and total TRP , and blood serotonin concentrations were assessed during a period of 5 h after administration . Results Blood glucose and plasma insulin increased after G32.5 , G75 and remained unchanged after A. TCQ score increased with A and remained almost unchanged with both doses of glucose ( condition × time interaction : P=0.023 ) . Total withdrawal score increased differently according to sex and condition ( P increased with A and decreased with glucose ( P=0.016 ) . The overall decrease in plasma TRP was 0.31±17 , 0.49±0.19 and 1.44±0.24 mg/l with A , G32.5 and G75 , respectively ( P was lower in women ( n=5 ) than in men ; it showed a condition by time ( P=0.007 ) and a condition by time by sex interaction ( P=0.023 ) . Conclusions Glucose attenuates tobacco craving and withdrawal symptoms in temporarily abstinent smokers . This is accompanied by a decrease in plasma TRP and a sex dependent increase in blood serotonin . Further studies assessing the direct effect of glucose on brain serotonin are needed to ascertain whether a glucose induced reduction in craving is associated with an increase in brain serotonin",
"Social-welfare policies are a modern instantiation of a phenomenon that has pervaded human evolutionary history : re source sharing . Ancestrally , food was a key shared re source in situations of temporary hunger . If evolved human psychology continues to shape how individuals think about current , evolutionarily novel conditions , this invites the prediction that attitudes regarding welfare politics are influenced by short-term fluctuations in hunger . Using blood glucose levels as a physiological indicator of hunger , we tested this prediction in a study in which participants were r and omly assigned to conditions in which they consumed soft drinks containing either carbohydrates or an artificial sweetener . Analyses showed that participants with experimentally induced low blood glucose levels expressed stronger support for social welfare . Using an incentivized measure of actual sharing behavior ( the dictator game ) , we further demonstrated that this increased support for social welfare does not translate into genuinely increased sharing motivations . Rather , we suggest that it is “ cheap talk ” aim ed at increasing the sharing efforts of other individuals",
"We examined changes in cognitive performance following the intake of a glucose ( 50 g ) or saccharin solution ( 50 mg ) in fasted elderly male and female subjects . Glucoregulation was estimated using a recovery index that was used to categorize subjects within each sex as having poor or good recovery . Elderly males with poor recovery performed worse on the Logical Memory subtest of the Wechsler Memory Scale and on the free recall or recognition parts of a work list task . The item analysis of the Logical Memory subtest showed that male subjects with poor recovery remembered less of the last items of the paragraphs after drinking saccharin while the first items were equally remembered by both groups . Glucose improved the performance of the males with good regulation for the first seven items while the performance of males with poor regulation decreased for those items under glucose . The present study support the notion that peripheral glucoregulation can influence memory performance and that the ingestion of glucose can influence certain aspects of memory functioning",
"Aspartame ( L-aspartyl-L-phenylalanine methyl ester ) consumption has been postulated to increase brain phenylalanine levels by increasing the molar ratio of the plasma phenylalanine concentration to the sum of the plasma concentrations of the other large neutral amino acids ( Phe/LNAA ) . Dietary manipulations with carbohydrate or protein can also produce changes in the Phe/LNAA value . To compare the effects of aspartame and carbohydrate on Phe/LNAA , beverages sweetened with aspartame , sucrose , and aspartame plus sucrose , and unsweetened beverage were ingested by 8 healthy , fasted subjects in a r and omized , four-way crossover design . The beverages were sweetened with an amount of aspartame ( 500 mg ) and /or sucrose ( 100 g ) approximately equivalent to that used to sweeten 1 liter of soft drink . The baseline-corrected plasma Phe/LNAA values did not differ significantly following ingestion of aspartame or sucrose . Following aspartame alone , the high mean ratio increased 26 % over baseline 1 h after ingestion . Following sucrose alone , the high mean ratio increased 19 % at 2.5 h. Sucrose increased the Phe/LNAA value due to an insulin-mediated decrease in the plasma LNAA , while aspartame increased the ratio by increasing the plasma Phe concentration . These findings indicate that similar increases in plasma Phe/LNAA occur when healthy , fasting subjects ingest amounts of equivalent sweetness of sucrose or aspartame"
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4116f10a-06ff-11f0-808a-c43d1ab1c353
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New technologies are changing the therapeutical options to do indirect restorations and new adhesive systems are continuously introduced to be used by clinicians . Different interactions between restorations , adhesive systems components , enamel and dentin require having criteria based on the selection of the adhesive system , ensuring the longevity of the restorations and the preservation of the biological remnant . The adhesion force to the dental tissue is one of the indicatives of the behavior of the adhesive systems and influences the behavior of the treatments with direct and indirect restorations . The objective of this search was to find the adhesive systems with the best results in terms of the adhesion strength of indirect restorations on the dental tissues . The search was conducted in two MEDLINE digital data bases ( PubMed ) , and the Cochrane Library with a search strategy based on the combination of MeSH ( Medical Subject Headings ) keywords . This systematic review used the PRISMA guide ( Preferred Reporting Items for Systematic Review s and Meta- Analysis ) . According to this review , the 3-step adhesive systems were the best performing and still are the gold st and ard for the cementing of indirect restorations . In addition , it can be concluded that self-etched adhesive systems reduce the time spent in clinical practice , however at the interface level they behave as permeable membranes more susceptible to degradation
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"Objectives This study was conducted to evaluate a self-adhesive resin luting cement [ RelyX Unicem 3MESPE – RXU ] for luting partial ceramic crowns ( PCCs ) with and without selective enamel etching in a prospect i ve , r and omized clinical trial . Material s and methods Thirty-four patients had received the intended treatment . Two PCCs ( Vita Mark II ; Cerec 3D ; Sirona ) had been placed in a split-mouth design : one with RXU without enamel etching ( RXU ) , the other with RXU with selective enamel etching ( RXU + E ) . Restorations were evaluated at baseline ( BL ) and after 12 , 24 , and 36 months ( USPHS criteria ) . For statistical analysis , the Chi-square test was applied ( α = 0.05 ) . Clinical survival of all restorations ( n = 68 ) after 3 years was determined using Kaplan – Meier analysis . Results Twenty three patients ( 12 male/11 female ) were available for clinical evaluation after 3 years . 19 RXU-PCCs were placed in molars , four in premolars , 18 RXU + E – PCCs in molars , five in premolars . Concerning clinical changes , no significant differences were found between luting strategies RXU/RXU + E at all recalls . Statistically significant changes over time were observed for marginal adaptation and marginal discoloration between BL and 36 m for RXU and RXU + E. For RXU + E , postoperative hypersensitivities decreased significantly from BL ( n = 6 ) to 36 m ( n = 0 ) . Of the 68 restorations originally included , eight RXU and four RXU + E restorations failed . At 3 years , Kaplan – Meier survival of RXU was 72.9 % , that of RXU + E 87.6 % . Survival rates were not statistically significant different . Conclusions Although clinical survival of RXU + E is slightly better at 3 years , restorations of both groups perform similar with respect to clinical changes over time as evaluated by modified USPHS criteria . Clinical relevance The self-adhesive resin cement RXU can be used in conjunction with selective enamel etching , because survival rates of PCCs in the RXU + E group were not lower but , as a trend , even better than without enamel etching",
"OBJECTIVES Clinical ly , the most easy-to-use composite cements are the so-called self-adhesive composite cements ( SAC 's ) . Hardly any data is however today available on the long-term bonding effectiveness of such luting composites . The purpose of this study was to evaluate the bond durability of different composite cements used to lute feldspathic ceramic blocks onto dentine . METHODS Four SAC 's ( Clearfil SA Cement , Kuraray ; G-CEM , GC ; SmartCem2 , Dentsply ; Unicem 3 M ESPE ) , one ' self-etch ' ( Clearfil Esthetic Cement , Kuraray ) and one ' etch- and -rinse ' ( Variolink ll , Ivoclar-Vivadent ) multi-step composite cement were used to lute feldspathic ceramic blocks ( Vita Mark II , Vita ) onto dentine surfaces . Teeth were distributed r and omly in 24 experimental groups according to two different surface-preparation techniques ( ' SMEAR-COVERED ' versus ' SMEAR-FREE ' ) and storage conditions ( ' IMMEDIATE ' versus ' AGED ' ) . Failure patterns were evaluated with a stereomicroscope , and afterwards imaged using Feg-SEM . Two additional specimens were processed for cement-dentine interfacial analysis using TEM . RESULTS A linear mixed effects statistical model revealed significant differences for the variables ' composite cement ' , ' surface preparation ' and ' ageing ' . All self-adhesive composite cements , except Unicem ( 3 M ESPE ) , did bond less favourably to fractured dentine . TEM revealed an ultra-structurally different interaction of the composite cements with ' SMEAR-COVERED ' and ' SMEAR-FREE ' dentine . CONCLUSION All SAC 's suffered most when luted to ' SMEAR-FREE ' ( fractured ) dentine , fortunately of no clinical relevance and most likely due to enhanced water sorption through the open tubules . When luted to ' SMEAR-COVERED ' dentine , all SACs appeared equally effective and durable as the ' etch- and -rinse ' and ' self-etch ' multi-step composite cements . Solely the SAC SmartCem2 ( Dentsply ) appeared clearly less favourable and consistent",
"Purpose To compare the clinical success of a self-adhesive resin cement used in combination with different adhesive bonding systems with that of a conventional dual-cure resin cement . Methods The study was performed with 136 freshly extracted molars embedded in acrylic resin blocks and 136 IPS e.max Press discs . Teeth and discs were r and omly divided into four equal groups and cemented together using either RelyX ARC ( ARC ) , RelyX Unicem ( Unicem ) , RelyX Unicem+Adper-Prompt L-pop ( L-pop ) , or RelyX and Unicem+Total-etch ( Total-etch ) . Shear bond strength measurements were obtained before and after thermocycling . Following bond testing , the surfaces of one sample per subgroup ( thermocycled and non-thermocycled ) , were assessed using scanning electron microscopy ( SEM ) . Results Among the non-thermocylced subgroups , ARC exhibited the highest bond strength values , followed by Total Etch , Unicem and L-pop . ARC also exhibited the highest bond strength values among the thermocycled subgroups , followed by Unicem , Total-etch , and L-pop . SEM analysis clearly revealed the negative effects of thermo-cycling on the mechanical properties of adhesive agents . Conclusions RelyX Unicem may be preferable in many cases because of its simplified application and reduced technique-sensitivity",
"Background To assess the immediate bond strength of a dual-cure adhesive resin cement to the hybridized dentin with different bonding systems . Material and Methods Fifty-six healthy human molars were r and omly divided into 7 groups ( n=8 ) . After 3 longitudinal sections , the central cuts were included in PVC matrix and were su bmi tted to dentin hybridization according to the groups : G1 - etch & rinse system with 3-step ( Apder ™ Scotchbond ™ Multi- Purpose , 3 M ESPE ) , G2 - etch & rinse system with 3-step ( Optibond ™ FL , Kerr ) , G3 - etch & rinse system with 3-step ( All-Bond 3 ® , Bisco ) , G4 - etch & rinse simplified system ( Adper ™ Single Bond 2 , 3 M ESPE ) , G5 - self-etching system with one step ( Bond Force , Tokuyama ) , G6 - universal system in moist dentin ( Single Bond Universal , 3 M ESPE ) , G7 - universal system in dry dentin ( Single Bond Universal , 3 M ESPE ) . Then all groups received the cementing of a self-adhesive resin cement cylinder ( Duo-link , Bisco ) made from a polypropylene matrix . In the evaluation of bond strength , the sample s were subjected to the microshear test and evaluated according to the fracture pattern by optical microscopy . Results The Kruskal-Wallis test suggests a statistically significant difference between groups ( p=0,039 ) , and Tukey for multiple comparisons , indicating a statistically significant difference between G3 and G4 ( p high prevalence of adhesive failures , followed by mixed failure and cohesive in dentin . Conclusions The technique and the system used to dentin hybridization are able to affect the immediate bond strength of resin cement dual adhesive . Key words : Adhesion , adhesive resin cement , adhesive systems , microshear",
"OBJECTIVES The purpose of this study was to investigate the durability of extensive dentin-enamel-bonded posterior ceramic coverages in a 15 years follow-up . METHODS All extensive dentin-enamel-bonded posterior partial and complete all-ceramic coverages placed during the period November 1992-December 1998 were included . In 121 patients , 252 coverages ( IPS Empress ) were placed . The adhesive bonding to dentin and enamel was performed with three 3-step and one 2-step etch and rinse bonding . In 106 restorations the classic Syntac was used in combination with the dual-cured resin composite Variolink . The other restorations were luted with the chemically cured resin composite Bisfil 2B and bonded with 3-step etch and rinse systems , classic Gluma ( 37 ) , Allbond 2 ( 57 ) , Syntac ( 32 ) or the 2-step etch and rinse system , One step ( 20 ) . The ceramics were evaluated yearly by modified USPHS criteria during 15 years . RESULTS Postoperative sensitivity was registered in 4 patients during bite forces lasting for 2 - 4 weeks . Fifty-five of 228 coverages ( 24.1 % ) failed . The mean observation period of the acceptable coverages was 12.6 years ( range 11 - 15 years ) . The main reasons for failure were lost restorations ( 18 ) , ceramic fracture ( 16 ) , and secondary caries ( 11 ) . Significant differences in failure rate were observed between the dentin bonding agents but not between the two luting agents . Ceramic coverages placed on non-vital teeth failed in 39 % and on vital teeth in 20.9 % ( p=0.014 ) . Logistic regression indicated three significant predictors for failure of the coverages : gender and parafunctional habits of the patient and non-vitality of the tooth . SIGNIFICANCE The technique investigated showed advantages like less destruction of healthy tissue , and avoiding of endodontic treatment and /or deep cervical placement of restoration margins to obtain retention",
"Indirect restorations need to be attached with adhesive luting agents to prevent them from becoming dislodged and provide adequate marginal sealing . The aim of this study was to evaluate bond strength to dentin of self-etching resin cements . MATERIAL S AND METHODS 75 flat dentin surfaces were r and omly distributed among 5 groups , according to cements used ; Group 1 : RelyxU100 ( 3M/ESPE ) , Group 2 : Bis Cem ( Bisco ) , Group 3 : Max Cem ( Kerr ) , Group 4 : SeT PP ( SDI ) and Group 5 : Relyx ARC ( 3M/ESPE ) , control . Ceramic test cylinders ( IPS Empress 2 / Ivoclar-Vivadent ) 4.1 mm across were prepared and attached to the dentin surfaces using the different cements . A constant 25N load was applied for 1 minute and they were light-polymerized . Following storage for 24 hours at 100 % humidity and 37 ° C , the specimens were tested for bond strength under shear strain in an Instron testing machine at a crosshead speed of 1 mm/minute ; at 7 , 14 and 21 days . Data were analyzed by ANOVA and Tukey 's test . There were significant differences between material s ( p /time interaction . RelyXARC ( Control Group ) had the highest bond strength ( 15.52 MPa ) . Among the self-etching cements , the best behavior was found for Relyx U100 ( 10.80MPa ) , followed by BisCem ( 6.36 MPa ) , MaxCem ( 5.45 MPa ) and SeTPP ( 3.17 MPa ) . The bond strength of the self-adhesive cements evaluated was lower than that for resin cements which require previous treatment of the dental substrate ( control group ) . This should be taken into account during clinical selection , in particular for tooth preparations with poor retention",
"Objectives . To evaluate microleakage and absolute marginal discrepancy ( AMD ) and to assess correlation between AMD and microleakage with four resin luting cements . Material and Methods . 20 extracted human third molars were prepared for full-coverage crowns . 20 zirconia copings were made ( LAVA , 3 M ESPE ) and cemented . Specimens were r and omly allocated for each used type of cement into 4 groups , RelyX ® ( Rx ) , Multilink ® ( Mk ) , PANAVIA 2.1 ® ( P ) , and Maxcem ® ( Mx ) and immersed in 10 % safranin for 72 hours . 20x magnification lenses were used to observe microleakage areas ( μm2 ) and images software was used to measure AMD areas ( μm ) . Discrepancy and microleakage between the cements were compared with one-way ANOVA test with confidence interval of 95 % . Results . Rx Group showed microleakage has lowest value and AMD has highest value . P Group showed microleakage has the highest value and Mk Group presented AMD has lowest value . There were no significative differences between the cements . There were no linear correlations between microleakage and AMD ; however a complex regression statistical model obtained allowed formulating an association between both variables ( microleakage = AMD0,896 ) . Conclusions . No significative differences were found among 4 types of cements . No linear correlations between AMD and microleakage were found . Clinical Significance . AMD is not easily related to microleakage . Characteristics of cements are fundamental to decreasing of microleakage values ",
"Objectives The aim of this r and omized controlled clinical trial was to evaluate the 4-year clinical performance of a self-adhesive resin cement , RelyX Unicem ( 3 M ESPE ) , used for cementation of ceramic inlays . In addition , the influence of selectively acid-etching enamel prior to luting on the clinical performance of the restorations was assessed . Methods Sixty-two IPS Empress 2 inlays/onlays were placed in 31 patients by two experienced clinicians . The restorations were luted with RelyX Unicem with ( = experimental group : E ) or without ( = control group : NE ) prior enamel etching with phosphoric acid . At baseline , 6 months , and 1 , 2 , and 4 years after placement , the restorations were assessed by two calibrated investigators using modified USPHS criteria . Ten selected sample s of each group were investigated under SEM regarding morphological changes at the cement – inlay interface . Results The recall rate at 4 years was 97 % . Two restorations ( 1 E , 1 NE ) were lost , and one ( E ) had to be replaced due to inlay and tooth fracture result ing in a survival rate of 95 % . No significant differences between the experimental and control group were noticed regarding all criteria ( McNemar , p deterioration in marginal integrity was observed after 4 years as only 5 % ( E = 7 % ; NE = 3 % ) of the restorations exhibited an excellent marginal adaptation . In 90 % of the restorations small , still clinical ly acceptable marginal deficiencies were observed . SEM of the luting gap showed an increased wear of the RelyX Unicem cement over the 4-year period . Conclusions The self-adhesive luting cement RelyX Unicem can be recommended for bonding of ceramic inlays/onlays . Additional selective enamel etching does not improve the clinical performance of the restorations within the 4-year period . Clinical relevance The self-adhesive resin composite RelyX Unicem showed acceptable clinical performance after 4 years of clinical service",
"INTRODUCTION The aim of this in vitro study was to evaluate the influence that resin composite and porcelain veneer restorations , associated or not to fiber post placement , have on fracture resistance and deflection of pulpless anterior teeth . METHODS One hundred twenty freshly extracted human maxillary central incisors were selected . Teeth were r and omly divided into 7 experimental groups ( veneer preparation/resin composite veneer placement/endodontic therapy and resin composite veneer placement/endodontic therapy , fiber post and resin composite veneer placement/porcelain veneer placement/endodontic therapy and porcelain veneer placement/endodontic therapy , fiber post and porcelain veneer placement ) and a control group ( n = 15 ) . Specimens were loaded to fracture recording crown deflection , and data were statistically analyzed . RESULTS Veneer preparations did not significantly influence fracture resistance of incisors . On the contrary , veneer preparation significantly increased specimen deflection values . Fiber posts seemed to significantly increase mean maximum load values for endodontically treated teeth restored with either composite or porcelain veneers . CONCLUSIONS A fiber post restoration can be suggested when endodontic treatment is associated with veneer restoration . Veneer restorations seem to be an optimal choice also for endodontically treated teeth",
"Among the material s used for luting indirect restorations , growing interest has been directed towards the use of self-adhesive resin cements . The aim of this prospect i ve r and omized controlled clinical trial was to evaluate the clinical performance of the self-adhesive resin cement RelyX Unicem ( RXU ) for luting partial ceramic crowns ( PCCs ) . In addition , the influence of selective enamel etching prior to luting ( RXU+E ) was assessed . Two-year results are reported . Thirty-four patients ( 68 PCCs ) had originally received the intended treatment at baseline ( BL ) . Twenty-nine patients ( 14 male , 15 female ) with a total of 58 PCCs participated in the 2-year recall . In each patient , one PCC had been placed with RXU , one PCC with RXU+E. Restorations were evaluated at BL and 24 months after placement using modified United States Public Health Service criteria for postoperative hypersensitivity , anatomic form , marginal adaptation , marginal discoloration , surface texture and recurrent caries . Additionally , the “ percentage failure ” within the 2-year recall period for all restorations ( n = 68 ) was calculated according to ADA Program Guidelines . Target value for acceptability of each procedure was The median patient age was 41 years ( 24–59 years ) . Median PBI was 8 % ( 5–10 % ) . Twenty-two RXU PCCs were placed in molars , seven in premolars . Twenty-one RXU+E PCCs were placed in molars , eight in premolars . Statistically significant changes were observed for marginal adaptation ( MA ) and marginal discoloration ( MD ) between BL and 2 years but not between the two groups ( RXU , RXU+E ) . Percentage of alfa values at BL for MA ( RXU , 97 % and RXU+E , 100 % ) and for MD ( RXU , 97 % and RXU+E , 97 % ) decreased to RXU , 14 % and RXU+E , 28 % for MA and to RXU , 50 % and RXU+E , 59 % for MD after 24 months . Within the observation period , three failures were recorded with RXU ( 5.1 % failure ) , one failure was recorded for RXU+E ( 1.7 % failure ) , but a significant influence of selective enamel etching on failure could not be verified . Although the results of the present study reveal a slight tendency for more favourable results if selective enamel etching is applied prior to insertion of ceramic PCCs with a self-adhesive luting material , longer-term evaluation is needed to confirm this . Additional selective enamel etching with a self-adhesive luting material does not considerably improve clinical performance of the restorations within the observation period reported , neither does it impose a hazard with respect to postoperative hypersensitivity",
"STATEMENT OF PROBLEM Cementation of inlay restoration is critical . Because of its high organic content , dentin is a less favorable substrate for bonding than enamel . Therefore it is important to improve dentin adhesion when placing ceramic inlay restorations . PURPOSE The purpose of this study was to compare the dentin bond strengths of 2 different ceramic inlay systems after cementation with 3 different techniques and 1 bonding system . MATERIAL AND METHODS One hundred twenty freshly extracted caries- and restoration-free molar teeth used in this study were stored in saline solution at room temperature . St and ardized Class I preparations were made in all teeth . Each preparation had a length of 6 mm , a width of 3 mm , a depth of 2 mm , and 6-degree convergence of the walls . Teeth were r and omly assigned to 2 groups of 60 each to evaluate the bonding of 2 ceramic systems , Ceramco II ( Group I ) and IPS Empress 2 ( Group II ) , to dentin . Each of the 2 groups were further divided into 3 cementation technique groups of 20 each ( Group I A , B , and C and Group II A , B , and C ) . Groups I A and B and Groups II A and B used dentin bonding agent ( DBA ) Clearfil Liner Bond 2V , and resin cement ( Panavia F ) . Groups I C and II C served as control groups and used Panavia F without the dentin-bonding agent . In Groups I A and II A , the DBA was applied immediately after the completion of the preparations ( D-DBA ) . Impressions were then made , and the ceramic inlays were fabricated according to the manufacturers ' guidelines . In Groups I B and II B the DBA was applied just before luting the inlay restorations ( I-DBA ) . In Groups I C and II C , no bonding agent was used before the cementation of the inlay restorations ( No DBA ) . Cementation procedures followed a st and ard protocol . After cementation , specimens were stored in distilled water at 37 degrees C for 24 hours . The teeth were sectioned both mesial-distally and buccal-lingually along their long axis into three 1.2 x 1.2 mm wide |-shaped sections . The specimens were then subjected to microtensile testing at a crosshead speed of 1 mm/min , and the maximum load at fracture ( in kilograms ) was recorded . Two-way analysis of variance and Tukey honestly significant difference tests were used to evaluate the results ( P Scanning electron microscopy analysis was used to examine the details of the bonding interface . The fractured surfaces were observed with a stereomicroscope at original magnification x22 to identify the mode of fracture . RESULTS Although no significant difference was found among the 2 ceramic systems with regard to dentin bond strengths ( P>.05 ) , the difference between the cementation techniques was found to be significant ( P dentin bond strength in the D-DBA technique had a significantly higher mean ( 40.27 + /- 8.55 Kg ) than the I-DBA ( 30.20 + /- 6.78 Kg ) and No DBA techniques ( 32.43 + /- 8.58 Kg ) . As a result of scanning electron microscopy analysis , a distinct and thicker hybrid zone with more , and longer resin tags were found in specimens treated with the D-DBA technique than with the other 2 techniques . Most failures ( 353 of 360 ) were adhesive in nature at the bonding resin/dentin interface . Only 7 specimens showed cohesive failure within the bonding resin . CONCLUSION Within the limitations of this in vitro study , the cementation of the ceramic inlays tested with the D-DBA technique used result ed in higher bond strengths to dentin",
"OBJECTIVE To evaluate prospect ively the longevity of ceramic inlay/onlay restorations placed in a web-based practice -based research network and to investigate risk factors associated with restoration failures . MATERIAL S AND METHODS Data were collected by a practice -based research network called Ceramic Success Analysis ( CSA ) . 5791 inlay/onlay ceramic restorations were placed in 5523 patients by 167 dentists between 1994 and 2014 in their dental practice s. For each restoration specific information related to the tooth , procedures and material s used were recorded . Annual failure rates ( AFRs ) were calculated and variables associated with failure were assessed by a multivariate Cox-regression analysis with shared frailty . RESULTS The mean observation time was 3 years ( maximum 15 years ) of clinical service , and AFRs at 3 and 10 years follow up were calculated as 1.0 % and 1.6 % . Restorations with cervical outline in dentin showed a 78 % higher risk for failure compared to restorations with margins in enamel . The presence of a liner or base of glass-ionomer cement result ed in a risk for failure twice as large as that of restorations without liner or base material . Restorations performed with simplified adhesive systems ( 2-step etch- and -rinse and 1-step self-etch ) presented a risk of failure 142 % higher than restorations performed with adhesives with bonding resin as a separate step ( 3-step etch- and -rinse and 2-step self-etch ) . 220 failures were recorded and the most predominant reason for failure was fracture of the restoration or tooth ( 44.5 % ) . CONCLUSIONS Ceramic inlay/onlay restorations made from several glass ceramic material s and applied by a large number of dentists showed a good survival . Deep cervical cavity outline , presence of a glass ionomer lining cement , and use of simplified adhesive systems were risk factors for survival"
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4116f146-06ff-11f0-808a-c43d1ab1c353
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Balance is considered a risk factor for several injuries and consequently a focus of many strengthening , injury prevention , and rehabilitation programs . There are several studies that have evaluated the ability of balance training to improve balance ability in a healthy population with no general consensus . We conducted a systematic review to evaluate the body of evidence regarding the effectiveness of balance training on improving various forms of balance ability in a healthy population . Three electronic data bases and the reference lists of selected articles were search ed . Studies were included that evaluated balance ability before and after healthy subjects performed a multisession balance training program . Two individuals review ed all articles and agreed upon the selection criteria . Sixteen articles were selected , abstract ed , and review ed . Means and measures of variability were recorded to calculate effect sizes , and study quality was assessed using the PEDro instrument . There is strong evidence to suggest that balance training can improve static balance ability on stable and unstable surfaces , as well as dynamic balance ability . Elite athletes have the potential to improve static balance on an unstable surface and dynamic balance ability , but a ceiling effect appears to occur with stable balance ability on a stable surface . Balance training programs performed at least 10 minutes per day , 3 days per week , for 4 weeks that incorporate various methods of balance training appear to improve balance ability . Types of balance training included the use of tilt boards , unstable surfaces , and dynamic body movements while maintaining a static stance
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"Objective To assess the effect of a neuromuscular training program on the incidence of anterior cruciate ligament injuries in female team h and ball players . Design Prospect i ve intervention study . Setting Female team h and ball : Division I – III in Norway . Participants Players from the three top divisions : control season ( 1998–1999 ) , 60 teams ( 942 players ) ; first intervention season ( 1999–2000 ) , 58 teams ( 855 players ) ; second intervention season ( 2000–2001 ) , 52 teams ( 850 players ) . InterventionA five-phase program ( duration , 15 min ) with three different balance exercises focusing on neuromuscular control and planting/l and ing skills was developed and introduced to the players in the autumn of 1999 and revised before the start of the season in 2000 . The teams were instructed in the program and supplied with an instructional video , poster , six balance mats , and six wobble boards . Additionally , a physical therapist was attached to each team to follow up with the intervention program during the second intervention period . Main Outcome Measures The number of anterior cruciate ligament injuries during the three seasons and compliance with the program . Results There were 29 anterior cruciate ligament injuries during the control season , 23 injuries during the first intervention season ( OR , 0.87 ; CI , 0.50–1.52 ; p = 0.62 ) , and 17 injuries during the second intervention season ( OR , 0.64 ; CI , 0.35–1.18 ; p = 0.15 ) . In the elite division , there were 13 injuries during the control season , six injuries during the first intervention season ( OR , 0.51 ; CI , 0.19–1.35 ; p = 0.17 ) , and five injuries in the second intervention season ( OR , 0.37 ; CI , 0.13–1.05 ; p = 0.06 ) . For the entire cohort , there was no difference in injury rates during the second intervention season between those who complied and those who did not comply ( OR , 0.52 ; CI , 0.15–1.82 ; p = 0.31 ) . In the elite division , the risk of injury was reduced among those who completed the anterior cruciate ligament injury prevention program ( OR , 0.06 ; CI , 0.01–0.54 ; p = 0.01 ) compared with those who did not . Conclusions This study shows that it is possible to prevent anterior cruciate ligament injuries with specific neuromuscular training",
"STUDY DESIGN Controlled single-group pretest/posttest design . OBJECTIVE The purpose of this study was to determine if a 6-week neuromuscular training program design ed to decrease the incidence of anterior cruciate ligament ( ACL ) injuries would improve single-limb postural stability in young female athletes . We hypothesized neuromuscular training would result in an improvement in postural stability , with the greatest improvement taking place in the medial-lateral direction . BACKGROUND Balance training has become a common component of programs design ed to prevent ACL injury . Rehabilitation programs can improve postural stability following ACL injury and reconstruction ; however , there is limited information available which quantifies improvement of postural stability following neuromuscular training design ed to prevent ACL injuries in a healthy population . METHODS AND MEASURES Forty-one healthy female high school athletes ( mean age , 15.3 years ; age range , 13 - 17 years ) participated in this study . Single-limb postural stability for both lower extremities was assessed with a Biodex Stability System . The neuromuscular training program consisted of three 90-minute training sessions per week for 6 weeks . Following the completion of the training program , each subject was re-evaluated to determine change in total , anterior-posterior , and medial-lateral single-limb stability . Two-way analysis of variance models were used to determine differences between pretraining and posttraining and between limbs . RESULTS The subjects showed a significant improvement in single-limb total stability ( P = .004 ) and anterior-posterior stability ( P = .001 ) , but not medial-lateral stability ( P = .650 ) for both the right and left lower extremity following training . In addition , the subjects demonstrated significantly better total postural stability on the right side as compared to the left ( P = .026 ) . CONCLUSIONS A 6-week neuromuscular training program design ed to decrease the incidence of ACL injuries improves objective measures of total and anterior-posterior single-limb postural stability in high school female athletes",
"Background : Sport is the leading cause of injury requiring medical attention among adolescents . We studied the effectiveness of a home-based balance-training program using a wobble board in improving static and dynamic balance and reducing sports-related injuries among healthy adolescents . Methods : In this cluster r and omized controlled trial , we r and omly selected 10 of 15 high schools in Calgary to participate in the fall of 2001 . We then recruited students from physical education classes and r and omly assigned them , by school , to either the intervention ( n = 66 ) or the control ( n = 61 ) group . Students in the intervention group participated in a daily 6-week and then a weekly 6-month home-based balance-training program using a wobble board . Students at the control schools received testing only . The primary outcome measures were timed static and dynamic balance , 20-m shuttle run and vertical jump , which were measured at baseline and biweekly for 6 weeks . Self-reported injury data were collected over the 6-month follow-up period . Results : At 6 weeks , improvements in static and dynamic balance were observed in the intervention group but not in the control group ( difference in static balance 20.7 seconds , 95 % confidence interval [ CI ] 10.8 to 30.6 seconds ; difference in dynamic balance 2.3 seconds , 95 % CI 0.7 to 4.0 seconds ) . There was evidence of a protective effect of balance training in over 6 months ( relative risk of injury 0.2 , 95 % CI 0.05 to 0.88 ) . The number needed to treat to avoid 1 injury over 6 months was 8 ( 95 % CI 4 to 35 ) . Interpretation : Balance training using a wobble board is effective in improving static and dynamic balance and reducing sports-related injuries among healthy adolescents",
"STUDY DESIGN A nonr and omized 2-group pretest-posttest design . OBJECTIVES To determine the effects of a 4-week balance training program during stance on a single leg . BACKGROUND Individuals who have experienced multiple episodes of inversion ankle sprains often participate in balance training programs . Balance training is performed to treat existing proprioceptive deficits and to restore ankle joint stability , presumably by retraining altered afferent neuromuscular pathways . The effectiveness of such programs on individuals with functionally unstable ankles has yet to be established . METHODS AND MEASURES Prior to and following training , subjects with self-reported functionally unstable ankles ( 5 women and 8 men , mean age = 21.9 + /- 3.1 years ) and nonimpaired subjects ( 6 women and 7 men , mean age = 21.2 + /- 2.5 years ) completed a static balance assessment for both limbs as well as the ankle joint functional assessment tool question naire ( AJFAT ) . The subjects from both groups participated in a unilateral , multilevel , static and dynamic balance training program 3 times a week for 4 weeks . Subjects from the experimental group trained only the involved limb , and the nonimpaired group trained a r and omly selected limb . A stability index ( SI ) was calculated during the balance assessment to indicate the amount of platform motion . Compared to low stability indices , high stability indices indicate greater platform motion during stance and therefore less stability . RESULTS Following training , subjects from both groups demonstrated significant improvements in balance ability . When balance was assessed at a low resistance to platform tilt ( stability level 2 ) , the posttraining scores of both the subjects with unstable ankles ( mean SI = 2.63 + /- 1.92 ) and the nonimpaired subjects ( mean SI = 2.69 + /- 2.32 ) were significantly better than their pretraining scores ( mean SIs = 5.93 + /- 3.65 and 4.67 + /- 3.43 , respectively ) . Assessed at a high resistance to platform tilt ( stability level 6 ) , the posttraining scores of both subjects with unstable ankles ( mean SI = 1.27 + /- 0.66 ) and the nonimpaired subjects ( mean SI = 1.37 + /- 0.66 ) were significantly better than their pretraining scores ( mean SIs = 2.30 + /- 1.88 and 2.04 + /- 1.43 , respectively ) . Additionally , the posttraining AJFAT scores of subjects with unstable ankles ( 25.78 + /- 3.80 ) and the nonimpaired subjects ( 29.15 + /- 5.27 ) were significantly greater than their pretraining scores ( 17.11 + /- 3.44 and 22.92 + /- 5.22 , respectively ) , indicating an overall improvement in perceived ankle joint functional stability . CONCLUSIONS This study suggests that balance training is an effective means of improving joint proprioception and single-leg st and ing ability in subjects with unstable and nonimpaired ankles",
" Young female players in European h and ball have a very high injury incidence , up to 50 injuries per 1000 hours of game . More than half of these injuries happen without any external cause . The aim of the study was to investigate the effect of an intervention programme design ed to reduce the number of injuries in young female players in European h and ball , with special emphasis on injuries in the lower extremities . The programme was created using elite athlete training programmes and those design ed for rehabilitation of injured athletes with functional instability of their ankles and rupture of the anterior cruciate ligament . It included the use of an ankle disk for 10 - 15 min at all practice sessions , for one 10-month season ( August 1995-May 1996 ) . Twenty-two teams participated in the study , and were r and omly assigned to the intervention or control group . Eleven teams with 111 players were r and omised to the intervention group and 11 teams with 126 players to the control group . Data were analysed using a t-test for continuous variables , chi2- analysis and Fisher 's exact test for dichotomous variables and multivariate methods to determine odds-ratios . The results indicated that using the intervention programme decreased the numbers of both traumatic and overuse injuries significantly . The differences in injuries between the groups were 80 % during games and 71 % during practice . In addition , the players in the control group had a 5.9 times higher risk of acquiring an injury than the players in the intervention group",
"Abstract Objective To investigate the effect of a structured warm-up programme design ed to reduce the incidence of knee and ankle injuries in young people participating in sports . Design Cluster r and omised controlled trial with clubs as the unit of r and omisation . Setting 120 team h and ball clubs from central and eastern Norway ( 61 clubs in the intervention group , 59 in the control group ) followed for one league season ( eight months ) . Participants 1837 players aged 15 - 17 years ; 958 players ( 808 female and 150 male ) in the intervention group ; 879 players ( 778 female and 101 male ) in the control group . Intervention A structured warm-up programme to improve running , cutting , and l and ing technique as well as neuromuscular control , balance , and strength . Main outcome measure The rate of acute injuries to the knee or ankle . Results During the season , 129 acute knee or ankle injuries occurred , 81 injuries in the control group ( 0.9 ( SE 0.09 ) injuries per 1000 player hours ; 0.3 ( SE 0.17 ) in training v 5.3 ( SE 0.06 ) during matches ) and 48 injuries in the intervention group ( 0.5 ( SE 0.11 ) injuries per 1000 player hours ; 0.2 ( SE 0.18 ) in training v 2.5 ( SE 0.06 ) during matches ) . Fewer injured players were in the intervention group than in the control group ( 46 ( 4.8 % ) v ( 76 ( 8.6 % ) ; relative risk intervention group v control group 0.53 , 95 % confidence interval 0.35 to 0.81 ) . Conclusion A structured programme of warm-up exercises can prevent knee and ankle injuries in young people playing sports . Preventive training should therefore be introduced as an integral part of youth sports programmes",
"Objective Introduction of a neuromuscular training program will increase muscle strength , balance , and proprioception in elite female h and ball players . Design Prospect i ve intervention study . Participants Thirty-five female team h and ball players from 2 teams in the elite division participated . Their mean age was 23 ( ±2.5 ) years , and their mean weight was 69.2 ( ±7.3 ) kg . They had played h and ball for 14.9 ( ±3.2 ) years , 4.7 ( ±2.8 ) years at the top level . The total number of training hours per week was 10 to 11 . InterventionBased on earlier studies and knowledge about common risk situations in team h and ball , an anterior cruciate ligament ( ACL ) injury prevention program with 3 different sets of exercises was developed , each set with a 5-step progression from simple to more challenging exercises . The teams were instructed to use the program a minimum of 3 times a week during a training period of 5 to 7 weeks , and then once a week during the season . The duration of each training session was approximately 15 minutes . Main outcome measures Balance ( KAT 2000 ) , proprioception ( threshold to detection of passive motion ) , muscle strength ( Cybex 6000 ) , and 3 functional knee tests . The players were tested pretraining ( test 1 ) and 8 weeks ( test 2 ) and 12 months ( test 3 ) after the training started . Results There was a significant improvement in dynamic balance between test 1 and test 2 , with a balance index ( BI ) of 924 ( ±225 ) and 778 ( ±174 ) , respectively ( P = 0.01 ) . The effect on dynamic balance was maintained 1 year after training ( BI , 730 ± 156 ) . For static balance , no statistically significant changes were found . For the other variables measured , there were no statistical differences during the study period . Conclusion The ACL injury prevention training program improved dynamic balance in an elite team h and ball players",
"Background : Risk factors for soccer injuries and possibilities for prevention have been discussed by several authors , but only a few have investigated the effectiveness of preventive interventions . Purpose : The aim of the present study was to evaluate the effects of a prevention program on the incidence of soccer injuries in male youth amateur players . Study Design : Prospect i ve controlled intervention study . Methods : Seven soccer teams took part in a prevention program that focused on education and supervision of coaches and players , while seven other teams were instructed to train and play soccer as usual . Over 1 year all injuries were documented weekly by physicians . Complete weekly injury reports were available for 194 players . Results : The incidence of injury per 1000 hours of training and playing soccer was 6.7 in the intervention group and 8.5 in the control group , which equates to 21 % fewer injuries in the intervention group . The greatest effects were observed for mild injuries , overuse injuries , and injuries incurred during training . The prevention program had greater effects in low-skill than in high-skill teams . Conclusions : The incidence of soccer injuries can be reduced by preventive interventions , especially in low skill level youth teams . Coaches and players need better education regarding injury prevention strategies and should include such interventions as part of their regular training",
"The purpose of the present study was to investigate the effects of a soccer training session on the balance ability of the players and assess whether the effectiveness of a balance program is affected by its performance before or after the regular soccer training . Thirty-nine soccer players were r and omly divided into three subject groups ( n=13 each ) , one control group ( C group ) , one training group that followed a balance program ( 12 weeks , 3 times per week , 20 min per session ) before the regular soccer training ( TxB group ) , and one training group that performed the same balance program after the soccer training ( TxA group ) . St and ard testing balance boards and the Biodex Stability System were used to assess balance ability in the C , TxB , and TxA groups at baseline ( T0 ) and after completing the balance program ( T12 ) . The same tests and additional isokinetic knee joint moment measurements were carried out in the TxB and TxA groups pre- and post-soccer training . Two main results were obtained : ( 1 ) No differences ( p>0.05 ) were found in balance ability and knee joint moment production between pre- and post-soccer training . ( 2 ) The balance program increased ( p balance ability in the TxB and TxA groups , and the improvement in the TxA group was greater ( p<0.05 ) than that in the TxB group post-soccer training . Result ( 1 ) is in contrast to the notion of a link between fatigue induced by a soccer training session or game and injury caused by impaired balance , and result ( 2 ) has implication s for athletic training and rehabilitation",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"Background Ankle sprains are the most common musculoskeletal injuries that occur in athletes , and they have a profound impact on health care costs and re sources . Hypothesis A balance training program can reduce the risk of ankle sprains in high school athletes . Study Design R and omized controlled clinical trial ; Level of evidence , 1 . Methods Seven hundred and sixty-five high school soccer and basketball players ( 523 girls and 242 boys ) were r and omly assigned to either an intervention group ( 27 teams , 373 subjects ) that participated in a balance training program or to a control group ( 28 teams , 392 subjects ) that performed only st and ard conditioning exercises . On-site athletic trainers recorded athlete exposures and sprains . Results The rate of ankle sprains was significantly lower for subjects in the intervention group ( 6.1 % , 1.13 of 1000 exposures vs 9.9 % , 1.87 of 1000 exposures ; P = .04 ) . Athletes with a history of an ankle sprain had a 2-fold increased risk of sustaining a sprain ( risk ratio , 2.14 ) , whereas athletes who performed the intervention program decreased their risk of a sprain by one half ( risk ratio , 0.56 ) . The ankle sprain rate for athletes without previous sprains was 4.3 % in the intervention group and 7.7 % in the control group , but this difference was not significant ( P = .059 ) . Conclusion A balance training program will significantly reduce the risk of ankle sprains in high school soccer and basketball players",
"Objectives : To compare the effect of a neuromuscular training program and a basic exercise program on postural control in figure skaters . Design : Two groups ; parallel design ; prospect i ve , r and omized controlled trial . Setting : Postural control laboratory , arenas , September 2001 to December 2002 . Participants : Forty-four young , healthy figure skaters ( 18 years ± 3 years ) . Interventions : Participants were r and omly assigned to receive a neuromuscular training program ( n = 22 ) or a basic exercise training program ( n = 22 ) . Both programs were completed 3 times per week for 4 weeks , and each session was supervised . Main Outcome Measurements : Participants completed baseline and postintervention measures of postural control on a force plate . Postural control was quantified as the center of pressure ( CoP ) path length during tests of single-limb st and ing balance that mimicked figure skating skills and challenged the postural control system to varying degrees . The primary outcome measure was the CoP path length observed during a l and ing jump test completed with eyes closed . Results : The post intervention CoP path lengths during the more challenging tests were significantly ( P the l and ing jump test completed with eyes closed , the percent improvement in the neuromuscular trained group was significantly greater ( mean = 21.0 ± 22.0 % ) than the basic exercise trained group ( mean = −4.9 ± 24.9 % ; P neuromuscular training can significantly improve postural control in figure skaters , whereas basic exercise training does not",
"According to research , proprioceptive training enables injured subjects to reduce proprioceptive deficits and increase postural control . However , the effects of proprioceptive training have not been research ed in healthy subjects . This study investigated the effects of Biomechanical Ankle Platform System ( BAPS ) training on postural sway of healthy subjects ( N = 28 ) . Subjects were pretested and posttested using the Kistler force platform while performing a single limb stance . The subjects stood on their dominant leg with the opposite hip and knee held in a self-selected position . Subjects trained the dominant leg three times per week for 10 weeks on the BAPS . Experimental subjects showed significant improvements in both the medial-lateral and anterior-posterior parameters of postural sway when compared with a control group . In conclusion , 10 weeks of proprioceptive ankle disk training significantly decreased postural sway in both the medial-lateral and anterior-posterior directions",
"INTRODUCTION The prevention of injuries in all sports calls for a structured plan . The plan consists , as earlier described , of four steps . We have previously presented studies incorporating all four steps . The studies have shown that it is possible to prevent most injuries in young female players in European h and ball by applying a training programme combining the use of an ankle disc with functional strength training . In the previous studies we were not able to discriminate whether the preventive effect was due to the functional strength training or the training with the ankle disc . The aim of this study was to compare a programme with ankle disc and functional strength training with a programme with functional strength training only . METHODS Twenty h and ball teams were asked to participate , and 16 of 20 h and ball teams agreed to participate . The teams were cluster r and omised to either the programme with or without an ankle disc . RESULTS The group using the programme without the ankle disc had a significantly higher number of traumatic injuries ( 16 vs. 6 ) . The incidences of traumatic injuries in the ankle disc group were 2.4 ( 95 % CI 0.7 ; 6.2 ) injuries per 1000 h of match and 0.2 ( 95 % CI 0.02 ; 0.7 ) injuries per 1000 h of practice . In the group without ankle disc the incidences were 6.9 ( 95 % CI 3.3 ; 12.7 ) injuries per 1000 h of match and 0.6 ( 95 % CI 0.2 ; 1.3 ) injuries per 1000 h of practice . A significantly higher multivariate odds ratio ( 4.8 ) was found in the group not using the ankle disc . In addition the group using the ankle disc had significantly fewer moderate and major injuries . CONCLUSION By adding ankle disc training to a training programme with functional strength training , it is possible to reduce the number of injuries significantly , especially the number of moderate and major injuries",
"CONTEXT Improving postural stability through balance training may prevent ankle sprains . Exercise S and als may increase the dem and s placed on ankle muscles during rehabilitation , which could improve postural stability . OBJECTIVE To examine the effects of functional balance training , with and without the use of Exercise S and als , on postural stability in subjects with stable or unstable ankles . DESIGN Prospect i ve , nonr and omized clinical trial . SETTING Sports medicine research laboratory . PATIENTS OR OTHER PARTICIPANTS Sixteen subjects with functional ankle instability and 16 subjects with no history of ankle sprains . INTERVENTION(S ) Subjects were assigned to an Exercise S and al functional balance training group or a shoe functional balance training group . Subjects trained 3 times per week for 8 weeks and then performed a single-limb stance posttest . MAIN OUTCOME MEASURE(S ) Subjects were required to remain as motionless as possible during a single-limb stance pretest . Anterior-posterior and medial-lateral center-of-pressure excursions were measured . RESULTS Exercise S and al balance training improved anterior-posterior postural stability in both ankle groups ( P medial-lateral postural stability in stable and unstable ankles ( P Postural stability improved after subjects performed functional balance training programs , both with and without Exercise S and als . Training with Exercise S and als might not be any more effective in improving postural stability than performing functional balance training without Exercise S and als . However , Exercise S and als did not impair postural stability and , consequently , might serve as an alternative therapy to improve postural stability",
"To assess the influence of training on the maintenance of equilibrium on a tilting platform , 13 young healthy male athletes aged 19 to 33 years were r and omly divided into experimental ( n = 7 ) and control ( n = 6 ) groups . Two experimental sessions were performed before and after a specific 4-wk . training by the experimental group . Subjects stood upright on a tilting platform . The athletes were asked to maintain the platform as horizontal as possible during a 30-sec . test . The three-dimensional movements of the platform versus the ground were recorded by using a computerized optoelectronic digitiser . The platform plane was calculated and its directrix computed . The area of oscillation and instantaneous angular velocity of the directrix at st and ardized height were calculated . In both groups the area of oscillation and the angular velocity were reduced in Session 2 , but the reduction was significant only in the experimental group . Specific training can significantly improve skill at maintaining equilibrium in young healthy sport performers"
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Purpose High fasting blood glucose ( FBG ) can lead to chronic diseases such as diabetes mellitus , cardiovascular and kidney diseases . Consuming probiotics or synbiotics may improve FBG . A systematic review and meta- analysis of controlled trials was conducted to clarify the effect of probiotic and synbiotic consumption on FBG levels . Methods PubMed , Scopus , Cochrane Library , and Cumulative Index to Nursing and Allied Health Literature data bases were search ed for relevant studies based on eligibility criteria . R and omized or non-r and omized controlled trials which investigated the efficacy of probiotics or synbiotics on the FBG of adults were included . Studies were excluded if they were review articles and study protocol s , or if the supplement dosage was not clearly mentioned . Results A total of fourteen studies ( eighteen trials ) were included in the analysis . R and om-effects meta-analyses were conducted for the mean difference in FBG . Overall reduction in FBG observed from consumption of probiotics and synbiotics was borderline statistically significant ( −0.18 mmol/L 95 % CI −0.37 , 0.00 ; p = 0.05 ) . Neither probiotic nor synbiotic subgroup analysis revealed a significant reduction in FBG . The result of subgroup analysis for baseline FBG level ≥7 mmol/L showed a reduction in FBG of 0.68 mmol/L ( −1.07 , −0.29 ; ρ that probiotic and synbiotic supplementation may be beneficial in lowering FBG in adults with high baseline FBG ( ≥7 mmol/L ) and that multispecies probiotics may have more impact on FBG than single species
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"To our knowledge , no reports are available indicating the favorable effects of synbiotic bread consumption on blood lipid profiles among patients with type 2 diabetes mellitus ( T2DM ) . This study was conducted to evaluate the effects of the daily consumption of synbiotic bread on blood lipid profiles of patients with T2DM . This r and omized double-blinded controlled clinical trial was performed with 78 diabetic patients , aged 35–70 years . After a 2-week run-in period , subjects were r and omly assigned to consume either synbiotic ( n = 26 ) , probiotic ( n = 26 ) or control bread ( n = 26 ) for 8 weeks . The synbiotic bread contained viable and heat-resistant probiotic Lactobacillus sporogenes ( 1 × 108 CFU ) and 0.07 g inulin ( HPX ) as prebiotic per 1 g. The probiotic bread contained L. sporogenes ( 1 × 108 CFU ) per 1 g. Patients were asked to consume the synbiotic , probiotic and control breads three times a day in a 40 g package for a total of 120 g/day . Biochemical measurements including blood lipid profiles were conducted before and after 8 weeks of intervention . Consumption of the synbiotic bread , compared to the probiotic and control breads , led to a significant decrease in serum TAG ( P = 0.005 ) , VLDL-C ( P = 0.005 ) , TC/HDL-C ( P = 0.002 ) and a significant increase in serum HDL-C levels ( P = 0.01 ) . No significant effect of synbiotic bread consumption on FPG , TC , LDL-C and non-HDL-C levels was seen compared to the probiotic and control breads ( P > 0.05 ) . Trial registry code : http://www.i rct .ir I RCT 201311215623N13",
"Background Lactobacillus gasseri BNR17 is a type of probiotic strain isolated from human breast milk . A study was reported regarding the fact that BNR17 was an inhibitor of obesity and diabetic activities in the human body through previous animal experiments . This study was furthered to investigate the effect of BNR17 , a probiotic strain isolated from human breast milk , on obese and overweight adults . Methods Sixty-two obese volunteers aged 19 to 60 with body mass index ≥ 23 kg/m2 and fasting blood sugar ≥ 100 mg/dL participated in a placebo controlled , r and omized , and double-blind trial . For 12 weeks , 57 participants were given either placebo or BNR17 and were tested by measuring body fat , body weight , various biochemical parameters , vital signs , and computed tomography at the start of the study and at weeks 4 , 8 , and 12 . The subjects assumed usual daily activities without having to make behavioral or dietary modifications during the course of the study . Results At the 12th week , a slight reduction in body weight was noted in the BNR17 group , but there were no significant weight changes between groups . Decrease of waist and hip circumferences in the BNR17 group was more pronounced than those in the placebo group . The two groups had no special or severe adverse reactions . Conclusion Despite there being no change in behavior or diet , administration of only the supplement of BNR17 reduced weight and waist and hip circumference . However , there were no significant differences between the two groups . These findings warrant a subsequent longer-term prospect i ve clinical investigation with a large population",
"Background : Non-alcoholic steatohepatitis ( NASH ) is a clinicopathological entity that is being recognized more frequently in recent years . This study aim ed to evaluate the effects of Metformin , with and without a probiotic supplement on liver aminotransferases in patients with NASH . Methods : Sixty four patients 18 - 75 years with NASH confirmed by biopsy and histological assessment were enrolled to study . Patients were r and omized to one of the following treatments for 6 months : Group I , probiotic ( Protexin two tablets per day ) plus Metformin 500 mg two tablets per day ( Met/Pro ) , or group II , Metformin 500 mg two tablets per day plus two placebo tablet ( Met/P ) . After 6 month alanine aminotransferase ( ALT ) , aspartate aminotransferase , and ultrasound grading of NASH were assessed . Results : In group I , serum alanine aminotransferase ( ALT : 133.7 ± 70 vs. 45.2 ± 32.5 ; P 0.00 ) , and aspartate aminotransferase activity ( AST : 123.1 ± 72 vs. 44.2 ± 33.9 ; P and ultrasound grading of NASH ( P while serum alanine aminotransferase ( ALT ) was not significantly reduced ( 118.4 ± 67.9 vs. 112.5 ± 68.7 ; P ( AST : 125.3 ± 71 vs. 113.4 ± 71 ; P did fall significantly ( P fell significantly in both groups . Conclusions : Probiotic combination with Metformin improves liver aminotransferases better than metformin alone in patients with NASH",
"Background : Diabetes is a global health problem in the world . Probiotic food has anti-diabetic property . The aim of this trial was to determine the effect of probiotic fermented milk ( kefir ) on glucose and lipid profile control in patients with type 2 diabetes mellitus . Methods : This r and omized double-blind placebo-controlled clinical trial was conducted on 60 diabetic patients aged 35 to 65 years . Patients were r and omly and equally ( n=30 ) assigned to consume either probiotic fermented milk ( kefir ) or conventional fermented milk ( dough ) for 8 weeks . Probiotic group consumed 600 ml/day probiotic fermented milk containing Lactobacillus casei , Lactobacillus acidophilus and Bifidobacteria and control group consumed 600 ml/day conventional fermented milk . Blood sample s tested for fasting blood glucose , HbA1C , triglyceride ( TG ) , total cholesterol , HDL-C and LDL-C at the baseline and end of the study . Results : The comparison of fasting blood glucose between two groups after intervention was statistically significant ( P=0.01 ) . After intervention , reduced HbA1C compared with the baseline value in probiotic fermented milk group was statistically significant ( P=0.001 ) , also the HbA1C level significantly decreased in probiotic group in comparison with control group ( P=0.02 ) adjusting for serum levels of glucose , baseline values of HbA1c and energy intake according to ANCOVA model . Serum triglyceride , total cholesterol , LDL-cholesterol and HDL- cholesterol levels were not shown significant differences between and within the groups after intervention . Conclusion : Probiotic fermented milk can be useful as a complementary or adjuvant therapy in the treatment of diabetes",
"Background Lactobacillus gasseri SBT2055 ( LG2055 ) inhibits dietary fat absorption in rats and exerts preventive effects on abdominal adiposity in rats and humans . The present study aim ed to evaluate the effects of LG2055 on postpr and ial serum lipid responses in Japanese subjects with hypertriacylglycerolemia after the intake of oral fat-loading test ( OFLT ) meals . Methods We conducted a single-blind , placebo-controlled , within-subject , repeated-measure intervention trial . Twenty subjects initially ingested the fermented milk ( FM ) without LG2055 for 4 weeks ( control FM period ) , followed by a 4-week washout period , and then consumed FM containing LG2055 for 4 weeks ( active FM period ) . The subjects were asked to consume FM at 200 g/day . At the end of each 4-week period , an 8-h OFLT was conducted . Blood sample s were collected at fasting and every hour for 8 h after OFLT meal intake . Thereafter , postpr and ial serum non-esterified fatty acid ( NEFA ) and triacylglycerol ( TAG ) levels and fasting blood parameters were measured . Results The OFLT showed that the postpr and ial serum NEFA levels from 120 to 480 min and the postpr and ial serum TAG level at 120 min in the active FM period were significantly ( P fasting serum NEFA level in the active FM period significantly ( P LG2055 reduced postpr and ial and fasting serum NEFA levels , suggesting its possible contribution to the reduction of the risk for obesity and type 2 diabetes mellitus . Trial registration",
"To evaluate the effects of probiotic ( VSL#3 ) and omega-3 fatty acid on insulin sensitivity , blood lipids , and inflammation , we conducted a clinical trial in 60 overweight ( BMI > 25 ) , healthy adults , aged 40–60 years . After initial screening the subjects were r and omized into four groups with 15 per group . The four groups received , respectively , placebo , omega-3 fatty acid , probiotic VSL#3 , or both omega-3 and probiotic , for 6 weeks . Blood and fecal sample s were collected at baseline and after 6 weeks . The probiotic ( VSL#3 ) supplemented group had significant reduction in total cholesterol , triglyceride , LDL , and VLDL and had increased HDL ( P VSL#3 improved insulin sensitivity ( P decreased hsCRP , and favorably affected the composition of gut microbiota . Omega-3 had significant effect on insulin sensitivity and hsCRP but had no effect on gut microbiota . Addition of omega-3 fatty acid with VSL#3 had more pronounced effect on HDL , insulin sensitivity and hsCRP . Subjects with low HDL , insulin resistance , and high hsCRP had significantly lower total lactobacilli and bifidobacteria count and higher E. coli and bacteroides count ",
"Introduction : The role of inflammatory cytokines in diabetes and its complications has been shown in some studies . The purpose of this study was to compare the effect of probiotic and conventional yogurt on inflammatory markers in patients with type 2 diabetes . Methods : Forty-four patients with type 2 diabetes were participated in this r and omized , double-blind controlled clinical trial and assigned to two intervention and control groups . The subjects in the intervention group consumed 300 g/d probiotic yogurt and subjects in the control group consumed 300 g/d conventional yogurt for 8 weeks . Anthropometric indices , dietary intakes , and serum levels of glucose , HbA1c , IL-6 , TNF-α and hs-CRP were evaluated at the beginning and end of the intervention . Results : For anthropometric indices and dietary intakes , no significant differences were seen within and between groups post intervention ( p > 0.05 ) . The consumption of probiotic yogurt caused significant decrease in HbA1c and TNF-α levels ( p= 0.032 and p= 0.040 , respectively ) in the intervention group . Conclusion : It is suggested that probiotic yogurt may be used as an alternative prevention approach and treatment method to control diabetic complications ",
"Background Gut lactobacilli can affect the metabolic functions of healthy humans . We tested whether a 1500 kcal/d diet supplemented with cheese containing the probiotic Lactobacillus plantarum TENSIA ( Deutsche Sammlung für Mikroorganismen , DSM 21380 ) could reduce some symptoms of metabolic syndrome in Russian adults with obesity and hypertension . Methods In this 3-week , r and omized , double-blind , placebo-controlled , parallel pilot study , 25 subjects ingested probiotic cheese and 15 ingested control cheese . Fifty grams of each cheese provided 175 kcal of energy . Blood pressure ( BP ) , anthropometric characteristics , markers of liver and kidney function , metabolic indices ( plasma glucose , lipids , and cholesterol ) , and urine polyamines were measured . Counts of fecal lactobacilli and L. plantarum TENSIA were evaluated using molecular methods . The data were analyzed by t-test for independent sample s and Spearman ’s partial correlation analysis . Results The probiotic L. plantarum TENSIA was present in variable amounts ( 529.6 ± 232.5 gene copies ) in 16/25 ( 64 % ) study subjects . Body mass index ( BMI ) was significantly reduced ( p = 0.031 ) in the probiotic cheese group versus the control cheese group . The changes in BMI were closely associated with the water content of the body ( r = 0.570 , p = 0.0007 ) when adjusted for sex and age . Higher values of intestinal lactobacilli after probiotic cheese consumption were associated with higher BMI ( r = 0.383 , p = 0.0305 ) and urinary putrescine content ( r = 0.475 , p = 0.006 ) . In patients simultaneously treated with BP-lowering drugs , similar reductions of BP were observed in both groups . A positive association was detected between TENSIA colonization and the extent of change of morning diastolic BP ( r = 0.617 , p = 0.0248 ) and a trend toward lower values of morning systolic BP ( r = −0.527 , p = 0.0640 ) at the end of the study after adjusting for BMI , age , and sex . Conclusion In a pilot study of obese hypertensive patients , a hypocaloric diet supplemented with a probiotic cheese helps to reduce BMI and arterial BP values , recognized symptoms of metabolic syndrome . Trial registration Current Controlled Trials IS RCT",
"Probiotic organisms have shown promise in treating diseases . Previously , we have reported on the efficacy of microencapsulated Lactobacillus reuteri NCIMB 30242 in a yogurt formulation at lowering serum cholesterol levels in otherwise healthy hypercholesterolemic adults . This study investigates the safety and toxicology of oral ingestion of microencapsulated L. reuteri NCIMB 30242 in a yogurt formulation . A r and omized group of 120 subjects received a dose of 5 × 10(10 ) CFU microencapsulated L. reuteri NCIMB 30242 in yogurt ( n=59 ) or placebo yogurt ( n=61 ) twice/day for 6 weeks . Clinical chemistry and hematological parameters of safety were analyzed . Fecal sample s were collected at these time points for the analysis of deconjugated bile acids . The frequency , duration and intensity of adverse events ( AEs ) and clinical significance of safety parameters were recorded for both groups . No clinical ly significant differences between the probiotic yogurt and placebo yogurt treated groups were detected in either the blood clinical chemistry or hematology results and there was no significant increase in fecal deconjugated bile acids ( P>0.05 ) between treated and control groups . The frequency and intensity of AEs was similar in the two groups . These results demonstrate the safe use of this formulation in food",
"OBJECTIVE Oxidative stress plays a major role in the pathogenesis and progression of diabetes . Among various functional foods with an antioxidant effect , probiotic foods have been reported to repress oxidative stress . The objective of this clinical trial was to assess the effects of probiotic and conventional yogurt on blood glucose and antioxidant status in type 2 diabetic patients . METHODS Sixty-four patients with type 2 diabetes mellitus , 30 to 60 y old , were assigned to two groups in this r and omized , double-blind , controlled clinical trial . The patients in the intervention group consumed 300 g/d of probiotic yogurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 and those in the control group consumed 300 g/d of conventional yogurt for 6 wk . Fasting blood sample s , 24-h dietary recalls , and anthropometric measurements were collected at the baseline and at the end of the trial . RESULTS Probiotic yogurt significantly decreased fasting blood glucose ( P hemoglobin A1c ( P erythrocyte superoxide dismutase and glutathione peroxidase activities and total antioxidant status ( P serum malondialdehyde concentration significantly decreased compared with the baseline value in both groups ( P insulin concentration and erythrocyte catalase activity within either group ( P > 0.05 ) . CONCLUSION The consumption of probiotic yogurt improved fasting blood glucose and antioxidant status in type 2 diabetic patients . These results suggest that probiotic yogurt is a promising agent for diabetes management",
"BACKGROUND Type 2 diabetes mellitus is increasingly common , primarily because of increases in the prevalence of a sedentary lifestyle and obesity . Whether type 2 diabetes can be prevented by interventions that affect the lifestyles of subjects at high risk for the disease is not known . METHODS We r and omly assigned 522 middle-aged , overweight subjects ( 172 men and 350 women ; mean age , 55 years ; mean body-mass index [ weight in kilograms divided by the square of the height in meters ] , 31 ) with impaired glucose tolerance to either the intervention group or the control group . Each subject in the intervention group received individualized counseling aim ed at reducing weight , total intake of fat , and intake of saturated fat and increasing intake of fiber and physical activity . An oral glucose-tolerance test was performed annually ; the diagnosis of diabetes was confirmed by a second test . The mean duration of follow-up was 3.2 years . RESULTS The mean ( + /-SD ) amount of weight lost between base line and the end of year 1 was 4.2+/-5.1 kg in the intervention group and 0.8+/-3.7 kg in the control group ; the net loss by the end of year 2 was 3.5+/-5.5 kg in the intervention group and 0.8+/-4.4 kg in the control group ( P cumulative incidence of diabetes after four years was 11 percent ( 95 percent confidence interval , 6 to 15 percent ) in the intervention group and 23 percent ( 95 percent confidence interval , 17 to 29 percent ) in the control group . During the trial , the risk of diabetes was reduced by 58 percent ( P the incidence of diabetes was directly associated with changes in lifestyle . CONCLUSIONS Type 2 diabetes can be prevented by changes in the lifestyles of high-risk subjects",
"Background / Objectives : Evidence from animal and in vitro models suggest a role of probiotic bacteria in improving glycaemic control and delaying the onset of type 2 diabetes . However , the evidence from controlled trials in humans is limited . The objective was to determine if the probiotic bacteria L. acidophilus La5 and B. animalis subsp lactis Bb12 , supplemented in a whole food ( yoghurt ) or isolated ( capsules ) form , can improve biomarkers of glycaemic control . Subjects/ methods : Following a 3-week washout period , 156 overweight men and women over 55 years ( mean age : 67±8 years ; mean body mass index ( 31±4 kg/m2 ) were r and omized to a 6-week double-blinded parallel study . The four intervention groups were : ( A ) probiotic yoghurt plus probiotic capsules ; ( B ) probiotic yoghurt plus placebo capsules ; ( C ) control milk plus probiotic capsules ; and ( D ) control milk plus placebo capsules . Outcome measurements , including fasting glucose , insulin , glycated haemoglobin and Homoeostasis Model Assessment of Insulin Resistance ( HOMA-IR ) , were performed at baseline and week 6 . Results : Relative to the milk-control group , probiotic yoghurt result ed in a significantly higher HOMA-IR ( 0.32±0.15 , P=0.038 ) , but did not have a significant effect on the other three measures of glycaemic control ( P>0.05 ) . Relative to placebo capsules , probiotic capsules result ed in a significantly higher fasting glucose ( 0.15±0.07 mmol/l , P=0.037 ) , with no significant effect on the other three measures of glycaemic control ( P>0.05 ) . Further analyses did not identify other variables as contributing to these adverse findings . Conclusions : Data from this study does not support the hypothesis that L. acidophilus La5 and B. animalis subsp lactis Bb12 , either in isolated form or as part of a whole food , benefit short-term glycaemic control . Indeed , there is weak data for an adverse effect of these strains on glucose homoeostasis ",
"Abstract Objective : To determine the relation between exposure to glycaemia over time and the risk of macrovascular or microvascular complications in patients with type 2 diabetes . Design : Prospect i ve observational study . Setting : 23 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Participants : 4585 white , Asian Indian , and Afro-Caribbean UKPDS patients , whether r and omised or not to treatment , were included in analyses of incidence ; of these , 3642 were included in analyses of relative risk . Outcome measures : Primary predefined aggregate clinical outcomes : any end point or deaths related to diabetes and all cause mortality . Secondary aggregate outcomes : myocardial infa rct ion , stroke , amputation ( including death from peripheral vascular disease ) , and microvascular disease ( predominantly retinal photo-coagulation ) . Single end points : non-fatal heart failure and cataract extraction . Risk reduction associated with a 1 % reduction in up date d mean HbA1c adjusted for possible confounders at diagnosis of diabetes . Results : The incidence of clinical complications was significantly associated with glycaemia . Each 1 % reduction in up date d mean HbA1c was associated with reductions in risk of 21 % for any end point related to diabetes ( 95 % confidence interval 17 % to 24 % , P deaths related to diabetes ( 15 % to 27 % , P myocardial infa rct ion ( 8 % to 21 % , P microvascular complications ( 33 % to 41 % , P patients with type 2 diabetes the risk of diabetic complications was strongly associated with previous hyperglycaemia . Any reduction in HbA1c is likely to reduce the risk of complications , with the lowest risk being in those with HbA1c values in the normal range ( < 6.0 % )",
"Summary The action of gliclazide , a sulphonylurea with beneficial extrapancreatic effects in diabetes , may be enhanced by administering probiotics . The aim of this study was to investigate the influence of probiotics on gliclazide pharmacokinetics and the effect of both probiotics and gliclazide on blood glucose levels in healthy and diabetic rats . Male Wistar rats ( 2 to 3 months , weight 350 ± 50 g ) were r and omly allocated to 4 groups ( n = 10 ) , two of which were treated with alloxan i.v . 30 mg/kg to induce diabetes . One group of healthy and one group of diabetic rats were then gavaged with probiotics ( 75 mg/kg ) for three days after which a gliclazide suspension ( 20 mg/kg ) was administered by gavage to all groups . Blood sample s were collected from the tail vein at various time points for 10 hours post-administration for the determination of blood glucose and gliclazide serum concentrations . It was found that probiotic treatment had no effect on blood glucose levels in healthy rats , but it reduced them ( up to 2-fold;p reduced gliclazide bioavailability in healthy rats ( 3-fold ) whereas it increased gliclazide bioavailability in diabetic rats ( 2-fold;p ) . Gliclazide had no effect on blood glucose levels in either healthy or diabetic rats despite the changes in its bioavailability . In conclusion , the probiotic treatment of diabetic rats increases gliclazide bioavailability and lowers blood glucose levels by insulin-independent mechanisms , suggesting that the administration of probiotics may be beneficial as adjunct therapy in the treatment of diabetes",
"INTRODUCTION Hyperglycaemia at levels above 15 mmol/l has been shown to impair cognitive functions in type 2 diabetic patients , while effects of mild hyperglycaemia and acute euglycaemia on mood and cognition have rarely been compared . We examined mood and cognitive functions in patients with T2DM during acute euglycaemia in comparison with moderate hyperglycaemia . METHODS One euglycaemic ( 5 mmol/l ) and one hyperglycaemic clamp ( 10.5 mmol/l ) of 90 min each were performed in 15 T2DM patients in a balanced , single-blind , within-subject comparison . Mood , cognitive functions ( assessed via short-term memory and attention tests ) and symptoms related to glycaemic changes were assessed during a baseline period and during both glycaemic plateaus . In addition , patients estimated their blood glucose level and counterregulatory hormones were measured . RESULTS None of the assessed aspects of cognitive functions differed between conditions ( all p > or = 0.2 ) . Patients rated higher on the well-being scale ( p=0.04 ) and tended to feel less anger ( p=0.08 ) during hyperglycaemia . Self-estimated blood glucose levels were higher during the hyper- than euglycaemic condition ( 8.6 + /- 2.5 vs 7.2 + /- 1.2 mmol/l ; p Counterregulatory hormone levels did not differ ( all p>0.25 ) . CONCLUSIONS Data indicate that T2DM patients are not cognitively impaired by moderate hyperglycaemia ( 10.5 mmol/l ) , pointing to the possibility of a glycaemic threshold for cognitive impairments at higher glycaemic levels",
"Objective : The administration of a fermentable dietary fibre ( oligofructose ) in rats increases satietogenic gut peptides and lowered spontaneous energy intake . The aim of the study was to assess the relevance of those effects of oligofructose on satiety and energy intake in humans . Design : Single-blinded , crossover , placebo-controlled design , pilot study .Subjects : Volunteers included five men and five women aged 21–39 years , BMI ranging from 18.5 to 27.4 kg/m2 , were r and omly assigned as described below . Interventions : Subjects were included in two 2-week experimental phases during which they received either fibre ( oligofructose ( OFS ) ) or placebo ( dextrine maltose ( DM ) ) ; a 2-week washout period was included between crossover phases . In total , 8 g OFS or 8 g DM were ingested twice daily ( 16 g/day in total ) . Energy intake , hunger , satiety , fullness and prospect i ve food consumption were assessed with analogue scales at the end of each experimental phase . Results : During breakfast , OFS significantly increases the satiety ( P=0.04 ) without any difference on other sensations as compared to DM treatment periods . After lunch , no significant differences are observed between treatment period . At dinner , OFS significantly increases satiety ( P=0.04 ) , reduces hunger ( P=0.04 ) and prospect i ve food consumption ( P=0.05 ) . The energy intake at breakfast and lunch are significantly lower ( P=0.01 , 0.03 , respectively ) after OFS treatment than after DM treatment . Total energy intake per day is 5 % lower during OFS than in DM period . Conclusion : Oligofructose treatment increases satiety following breakfast and dinner , reduces hunger and prospect i ve food consumption following dinner . This pilot study presents a rationale to propose oligofructose supplements in the management of food intake in overweight and obese patients .Sponsorship : This project is supported by an FSR grant from the Université catholique de Louvain",
"BACKGROUND Rodent studies show that oligofructose promotes weight loss , stimulates satiety hormone secretion , reduces energy intake , and improves lipid profiles . OBJECTIVE Our objective was to examine the effects of oligofructose supplementation on body weight and satiety hormone concentrations in overweight and obese adults . DESIGN This study was a r and omized , double-blind , placebo-controlled trial . Forty-eight otherwise healthy adults with a body mass index ( in kg/m2 ) > 25 were r and omly assigned to receive 21 g oligofructose/d or a placebo ( maltodextrin ) for 12 wk . Body composition ( by dual-energy X-ray absorptiometry ) ; meal tolerance tests , including satiety hormone response ; food intake ; and subjective appetite ratings were determined . RESULTS There was a reduction in body weight of 1.03 + /- 0.43 kg with oligofructose supplementation , whereas the control group experienced an increase in body weight of 0.45 + /- 0.31 kg over 12 wk ( P = 0.01 ) . A lower area under the curve ( AUC ) for ghrelin ( P = 0.004 ) and a higher AUC for peptide YY ( PYY ) with oligofructose ( P = 0.03 ) coincided with a reduction in self-reported caloric intake ( P Glucose decreased in the oligofructose group and increased in the control group between initial and final tests ( P Insulin concentrations mirrored this pattern ( P Oligofructose supplementation did not affect plasma active glucagon-like peptide 1 secretion . According to a visual analog scale design ed to assess side effects , oligofructose was well tolerated . CONCLUSIONS Independent of other lifestyle changes , oligofructose supplementation has the potential to promote weight loss and improve glucose regulation in overweight adults . Suppressed ghrelin and enhanced PYY may contribute in part to the reduction in energy intake . The trial was registered at clinical trials.gov as NCT00522353",
"BACKGROUND We have previously shown that gut microbial fermentation of prebiotics promotes satiety and lowers hunger and energy intake in humans . In rodents , these effects are associated with an increase in plasma gut peptide concentrations , which are involved in appetite regulation and glucose homeostasis . OBJECTIVE Our aim was to examine the effects of prebiotic supplementation on satiety and related hormones during a test meal for human volunteers by using a noninvasive micro method for blood sampling to measure plasma gut peptide concentrations . DESIGN This study was a r and omized , double-blind , parallel , placebo-controlled trial . A total of 10 healthy adults ( 5 men and 5 women ) were r and omly assigned to groups that received either 16 g prebiotics/d or 16 g dextrin maltose/d for 2 wk . Meal tolerance tests were performed in the morning to measure the following : hydrogen breath test , satiety , glucose homeostasis , and related hormone response . RESULTS We show that the prebiotic treatment increased breath-hydrogen excretion ( a marker of gut microbiota fermentation ) by approximately 3-fold and lowered hunger rates . Prebiotics increased plasma glucagon-like peptide 1 and peptide YY concentrations , whereas postpr and ial plasma glucose responses decreased after the st and ardized meal . The areas under the curve for plasma glucagon-like peptide 1 and breath-hydrogen excretion measured after the meal ( 0 - 60 min ) were significantly correlated ( r = 0.85 , P = 0.007 ) . The glucose response was inversely correlated with the breath-hydrogen excretion areas under the curve ( 0 - 180 min ; r = -0.73 , P = 0.02 ) . CONCLUSION Prebiotic supplementation was associated with an increase in plasma gut peptide concentrations ( glucagon-like peptide 1 and peptide YY ) , which may contribute in part to changes in appetite sensation and glucose excursion responses after a meal in healthy subjects"
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BACKGROUND AND OBJECTIVES CVD is an important global healthcare issue ; it is the leading cause of global mortality , with an increasing incidence identified in both developed and developing countries . It is also an extremely costly disease for healthcare systems unless managed effectively . In this review we aim ed to : - Assess the effect of computer-assisted versus oral- and -written history taking on the quality of collected information for the prevention and management of CVD . - Assess the effect of computer-assisted versus oral- and -written history taking on the prevention and management of CVD . METHODS A systematic review of r and omised controlled trials that included participants of 16 years or older at the beginning of the study , who were at risk of CVD ( prevention ) or were either previously diagnosed with CVD ( management ) . We search ed all major data bases . We assessed risk of bias using the Cochrane Collaboration tool . RESULTS Two studies met the inclusion criteria . One comparing the two methods of history-taking for the prevention of cardiovascular disease n = 75 . The study shows that generally the patients in the experimental group underwent more laboratory procedures , had more biomarker readings recorded and /or were given ( or had review ed ) , more dietary changes than the control group . The other study compares the two methods of history-taking for the management of cardiovascular disease ( n = 479 ) . The study showed that the computerized decision aid appears to increase the proportion of patients who responded to invitations to discuss CVD prevention with their doctor . The Computer- Assisted History Taking Systems ( CAHTS ) increased the proportion of patients who discussed CHD risk reduction with their doctor from 24 % to 40 % and increased the proportion who had a specific plan to reduce their risk from 24 % to 37 % . DISCUSSION With only one study meeting the inclusion criteria , for prevention of CVD and one study for management of CVD we did not gather sufficient evidence to address all of the objectives of the review . We were unable to report on most of the secondary patient outcomes in our protocol . CONCLUSIONS We tentatively conclude that CAHTS can provide individually-tailored information about CVD prevention . However , further primary studies are needed to confirm these findings . We can not draw any conclusions in relation to any other clinical outcomes at this stage . There is a need to develop an evidence base to support the effective development and use of CAHTS in this area of practice . In the absence of evidence on effectiveness , the implementation of computer-assisted history taking may only rely on the clinicians ' tacit knowledge , published monographs and viewpoint articles
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"Abstract Background Low utilization of effective coronary heart disease ( CHD ) prevention strategies may be due to many factors , but chief among them is the lack of patient involvement in prevention decisions . We undertook this study to test the effectiveness of an individually-tailored , computerized decision aid about CHD on patients ' discussion s with their doctor and their plans for CHD prevention . Methods We conducted a pilot r and omized trial in a convenience sample of adults with no previous history of cardiovascular disease to test the effectiveness of an individually-tailored , computerized decision aid about CHD prevention against a risk factor list that patients could present to their doctor . Results We enrolled 75 adults . Mean age was 53 . 59 % were female , 73 % white , and 23 % African-American . 66 % had some college education . 43 % had a 10-year CHD risk of 0–5 % , 25 % a risk of 6–10 % , 24 % a risk of 11–20 % , and 5 % a risk of > 20 % . 78 % had at least one option to reduce their CHD risk , but only 45 % accurately identified the strategies best supported by evidence . 41 patients received the decision aid , 34 received usual care . In unadjusted analysis , the decision aid increased the proportion of patients who discussed CHD risk reduction with their doctor from 24 % to 40 % ( absolute difference 16 % ; 95 % CI -4 % to + 37 % ) and increased the proportion who had a specific plan to reduce their risk from 24 % to 37 % ( absolute difference 13 % ; 95 % CI -7 % to + 34 % ) . In pre-post testing , the decision aid also appeared to increase the proportion of patients with plans to intervene on their CHD risk ( absolute increase ranging from 21 % to 47 % for planned medication use and 5 % to 16 % for planned behavioral interventions ) . Conclusion Our study confirms patients ' limited knowledge about their CHD risk and effective risk reduction options and provides preliminary evidence that an individually-tailored decision aid about CHD prevention might be expected to increase patients ' discussion s about CHD prevention with their doctor and their plans for CHD risk reduction . These findings should be replicated in studies with a larger sample size and patients at overall higher risk of CHD . Trial Registration : Clinical Trials.gov",
"BACKGROUND Home telehealth programs often focus on a single disease , yet many patients who need monitoring have multiple conditions . This study evaluated secondary outcomes from a clinical trial evaluating the efficacy of home telehealth to improve outcomes of patients with co-morbid diabetes and hypertension . SUBJECTS AND METHODS A single-center r and omized controlled clinical trial compared two remote monitoring intensity levels ( low and high ) and usual care in patients with type 2 diabetes and hypertension being treated in primary care . Secondary outcomes assessed were knowledge ( diabetes , hypertension , medications ) , self-efficacy , adherence ( diabetes , medications ) , and patient perceptions of the intervention mode . RESULTS Knowledge scores improved in the high-intensity intervention group participants , but upon further analysis , we found the intervention effect was not mediated by gain in knowledge . No significant differences were found across the groups in self-efficacy , adherence , or patient perceptions of the intervention mode . CONCLUSIONS Home telehealth can enhance detection of key clinical symptoms that occur between regular physician visits . While our intervention improved glycemic and blood pressure control , the mechanism of the effect for this improvement was not clear",
"BACKGROUND The Coronary Health Assessment Study ( CHAS ) was developed to determine the feasibility of using patient-specific , multifactorial computerized coronary risk profiles as a clinical decision aid to support primary prevention of CHD . METHODS Study participants included 253 community based physicians , r and omized into profile and control groups , and 958 of their patients . The profile group physicians received coronary risk profiles for their patients within 10 working days after the baseline patient assessment providing early feedback . The control group received their profiles only if the patient was clinical ly reevaluated during a 3-month follow-up visit . Patients ' coronary risk factors were evaluated at baseline and at follow-up . RESULTS The profile group had a significantly higher ( P ratio of high-risk/low-risk patients who returned for a follow-up visit compared to the control group ( 1.23 vs 0.77 ) . The patients in the profile group also had significantly ( P reductions in total cholesterol ( -0.5 vs -0.1 mmol/L ) , LDL cholesterol ( -0.4 vs 0.0 mmol/L ) , the total cholesterol/ HDL ratio ( -0.6 vs -0.2 ) , and the predicted 8-year coronary risk ( -1.8 vs -0.3 % ) . CONCLUSIONS Computer-generated coronary risk profiles can be effective in assisting physicians to identify high-risk patients . Their use is also associated with significantly greater improvements in the serum lipid profiles and the overall coronary risk of these patients",
"BACKGROUND Computerized decision support systems ( CDSSs ) linked with electronic medical records ( EMRs ) are promoted as an effective means of improving patient care . However , very few high- quality studies are set in routine , community-based clinical care , and no consistent evidence of an effect on patient outcomes has been found . METHODS A r and omized controlled trial among EMR-using primary care practice s in Ontario , Canada . Patients 55 years or older with previous vascular events , diabetes mellitus , hypertension , or hypercholesterolemia were r and omized to the Computerization of Medical Practice s for the Enhancement of Therapeutic Effectiveness ( COMPETE III ) CDSS intervention or to usual care . The intervention included personally tailored electronic vascular risk monitoring and treatment advice shared between the physician and patient , risk calculation , and a clinical re source . The primary outcome was a composite score of 8 recommended process outcomes at 1 year . Data collectors were blinded to group allocation . Analysis used the intention-to-treat principle with multiple imputation for missing data . RESULTS We r and omized and included in the analysis 1102 patients in 49 community-based physician practice s ( 53.4 % female ; mean age , 69.1 years ; 28.0 % with a previous vascular event ) . The intervention group ( 545 [ 49.5 % ] ) had a significantly greater improvement in mean process composite , with a difference of 4.70 ( P continuity of care ( 4.18 ; P ability to improve their vascular health ( 3.07 ; P -vascular events , clinical variables , and quality of life-were not improved . CONCLUSION Despite favorable review s and important improvements in the complex processes required to reduce vascular risk , clinical outcomes remain unchanged",
"OBJECTIVE To conduct a 1-year r and omized clinical trial to evaluate a remote comprehensive diabetes self-management education ( DSME ) intervention , Diabetes TeleCare , administered by a dietitian and nurse/certified diabetes educator ( CDE ) in the setting of a federally qualified health center ( FQHC ) in rural South Carolina . RESEARCH DESIGN AND METHODS Participants were recruited from three member health centers of an FQHC and were r and omized to either Diabetes TeleCare , a 12-month , 13-session curriculum delivered using telehealth strategies , or usual care . RESULTS Mixed linear regression model results for repeated measures showed a significant reduction in glycated hemoglobin ( GHb ) in the Diabetes TeleCare group from baseline to 6 and 12 months ( 9.4 ± 0.3 , 8.3 ± 0.3 , and 8.2 ± 0.4 , respectively ) compared with usual care ( 8.8 ± 0.3 , 8.6 ± 0.3 , and 8.6 ± 0.3 , respectively ) . LDL cholesterol was reduced at 12 months in the Diabetes TeleCare group compared with usual care . Although not part of the original study design , GHb was reduced from baseline to 12 and 24 months in the Diabetes TeleCare group ( 9.2 ± 0.4 , 7.4 ± 0.5 , and 7.6 ± 0.5 , respectively ) compared with usual care ( 8.7 ± 0.4 , 8.1 ± 0.4 , and 8.1 ± 0.5 , respectively ) in a post hoc analysis of a subset of the r and omized sample who completed a 24-month follow-up visit . CONCLUSIONS Telehealth effectively created access to successfully conduct a 1-year remote DSME by a nurse CDE and dietitian that improved metabolic control and reduced cardiovascular risk in an ethnically diverse and rural population",
"To assess the effectiveness of a portable electronic diary as a data collection device for overactive bladder symptoms , and to evaluate its level of patient acceptability compared with a conventional paper‐based voiding diary",
"OBJECTIVES . Parents and children often overreport adherence to treatment regimens , which in turn complicates interpretation and application of clinical trial findings . The objective of this investigation was to test the effect of reporting mode on accuracy of inhaled corticosteroid-adherence reporting in children with asthma and their parents under conditions similar to those of an asthma clinical trial . PATIENTS AND METHODS . Participants included 104 children who were being treated with an inhaled corticosteroid delivered by a metered-dose inhaler for asthma diagnosed by their health care provider . Each parent and child dyad was r and omly assigned to 1 of 3 self-report adherence- assessment modes : ( 1 ) audio computer-assisted self-interviewing ; ( 2 ) face-to-face interview with study staff ; or ( 3 ) self-administered paper- and -pencil question naire . At the 4 monthly visits , the parent and child were interviewed separately and asked questions about adherence on the previous day and in the past week . Electronic devices were attached to the each participant 's metered-dose inhaler to provide an objective record of actual daily medication activations . RESULTS . Both children and parents greatly overreported their inhaled corticosteroid adherence when queried about either time frame ( 1 day or 1 week ) in any of the 3 interview modes . One of 3 responses reported full adherence when no medication had been taken . Inconsistent with the study hypothesis , discrepancy between self-report and objective ly measured adherence was greatest in the computer-interview condition . In the optimal circumstance where children were interviewed by study staff about their adherence within the previous 24 hours , reported adherence was within the ±25 % accuracy range for only half of the participants . Larger discrepancy scores were observed for both parents and children when reporting by computer or question naire . CONCLUSIONS . Under the best of conditions in this study , accuracy of self-report was insufficient to provide a st and -alone measure of adherence . Verification of treatment adherence by objective measures remains necessary",
"Background Efficacious strategies for the primary prevention of coronary heart disease ( CHD ) are underused , and , when used , have low adherence . Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice . Methods We conducted a r and omized trial of a CHD prevention intervention ( including a computerized decision aid and automated tailored adherence messages ) at one university general internal medicine practice . After obtaining informed consent and collecting baseline data , we r and omized patients ( men and women age 40 - 79 with no prior history of cardiovascular disease ) to either the intervention or usual care . We then saw them for two additional study visits over 3 months . For intervention participants , we administered the decision aid at the primary study visit ( 1 week after baseline visit ) and then mailed 3 tailored adherence reminders at 2 , 4 , and 6 weeks . We assessed our outcomes ( including the predicted likelihood of angina , myocardial infa rct ion , and CHD death over 10 years ( CHD risk ) and self-reported adherence ) between groups at 3 month follow-up . Data collection occurred from June 2007 through December 2009 . All study procedures were IRB approved . Results We r and omized 160 eligible patients ( 81 intervention ; 79 control ) and followed 96 % to study conclusion . Mean predicted CHD risk at baseline was 11.3 % . The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points ( 95 % CI 8 % to 42 % ) , with the biggest effect for aspirin . It also changed predicted CHD risk by -1.1 % ( 95 % CI -0.16 % to -2 % ) , with a larger effect in a pre-specified subgroup of high risk patients . Conclusion A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk . Clinical trials registration number Clinical Trials.gov :",
"Surveys of risk behaviors have been hobbled by their reliance on respondents to report accurately about engaging in behaviors that are highly sensitive and may be illegal . An audio computer-assisted self-interviewing ( audio-CASI ) technology for measuring those behaviors was tested with 1690 respondents in the 1995 National Survey of Adolescent Males . The respondents were r and omly assigned to answer questions using either audio-CASI or a more traditional self-administered question naire . Estimates of the prevalence of male-male sex , injection drug use , and sexual contact with intravenous drug users were higher by factors of 3 or more when audio-CASI was used . Increased reporting was also found for several other risk behaviors",
"OBJECTIVES We compared reports of sexual behaviors given in st and ard face-to-face interviews with reports given in audio computer-assisted self-interviews ( ACASIs ) and culturally specific interactive interviews among adolescents in India . We sought to determine which of the interview methods leads to higher reporting of sexual behaviors among economically disadvantaged 15 - 19-year-olds in urban India . METHODS We conducted a r and omized trial in which each participant ( 583 boys and 475 girls ) was assigned to 2 interview methods : face-to-face interview and ACASI or interactive interview . We used matched case-control analyses to assess differences in the individual 's reporting on the 2 methods . RESULTS Female participants consistently reported fewer sexual behaviors in ACASIs than in face-to-face interviews , whereas male participants ' reports differed according to type of sexual behavior and interview mode . Both male and female participants reported more sexual behaviors during interactive interviews than during face-to-face interviews . Twenty-eight percent of male participants reported having engaged in heterosexual intercourse in interactive interviews , as compared with 20 % in face-to-face interviews ( P young people were more likely to report sexual behaviors in culturally specific interactive interviews than in face-to-face interviews . By contrast , ACASIs did not uniformly lead to higher reporting levels than did face-to-face interviews",
"OBJECTIVE Demographic , behavioral , and diagnostic information should routinely be collected from clients with severe mental illness , and data gathering should employ the most efficient techniques available . Surveys are increasingly conducted via Web-based computer-assisted interviewing ( CAI ) , but this technique is not well vali date d for patients with severe mental illness . A r and omized clinical trial of 245 clients was carried out to compare face-to face and computer-assisted interviewing ( 233 clients completed two surveys ) . METHODS Self-report data were collected on demographic characteristics , substance abuse , risk behaviors for blood-borne diseases , trauma history , and posttraumatic stress disorder . Each client was assessed twice and r and omly assigned to one of the four possible combinations of interviewer and computer ( computer and computer , N=53 ; computer and interviewer , N=56 ; interviewer and computer , N=59 ; and interviewer and interviewer , N=65 ) . The two formats were compared on feasibility , client preference , cost , reliability , convergent validity , and criterion validity . RESULTS This study demonstrated the feasibility of CAI across a variety of inpatient and outpatient setting s. All participants who began the CAI process completed the interview and responded to over 95 % of the survey items . Participants liked using the computers as well as they liked face-to-face interviews , and they completed the CAI as quickly . CAI produced data as reliable and valid as face-to-face interviews produced and was less expensive , and results were available more quickly . The two formats were similar in criterion validity . CONCLUSIONS CAI appears to be a viable technology for gathering clinical data from the population with severe mental illness and for transforming such information into a useful , quickly accessible form to aid in clinical decision making",
"BACKGROUND The primary care evaluation of chest pain represents a significant diagnostic challenge . OBJECTIVE To determine if electronic alerts to physicians can improve the quality and safety of chest pain evaluations . DESIGN AND PARTICIPANTS R and omized , controlled trial conducted between November 2008 and January 2010 among 292 primary care clinicians caring for 7,083 adult patients with chest pain and no history of cardiovascular disease . INTERVENTIONClinicians received alerts within the electronic health record during office visits for chest pain . One alert recommended performance of an electrocardiogram and administration of aspirin for high risk patients ( Framingham Risk Score ( FRS ) ≥ 10 % ) , and a second alert recommended against performance of cardiac stress testing for low risk patients ( FRS included performance of an electrocardiogram and administration of aspirin therapy for high risk patients ; and avoidance of cardiac stress testing for low risk patients .KEY RESULTS The majority ( 81 % ) of patients with chest pain were classified as low risk . High risk patients were more likely than low risk patients to be evaluated in the emergency department ( 11 % versus 5 % , p hospitalized ( 7 % versus 3 % , p occurred among 26 ( 0.4 % ) patients , more commonly among high risk compared to low risk patients ( 1.1 % versus 0.2 % , p performing electrocardiograms ( 51 % versus 48 % , p = 0.33 ) or administering aspirin ( 20 % versus 18 % , p = 0.43 ) . Among low risk patients , there was no difference between intervention and control groups in rates of cardiac stress testing ( 10 % versus 9 % , p = 0.40 ) . CONCLUSIONS Primary care management of chest pain is suboptimal for both high and low risk patients . Electronic alerts do not increase risk-appropriate care for these patients",
"Automated and on-dem and decision support systems integrated into an electronic medical record have proven to be an effective implementation strategy for guidelines . Cholgate is a r and omized controlled trial comparing the effect of automated and on-dem and decision support on the management of cardiovascular disease factors in primary care",
"A total of 278 hypertensive patients in three clinics were r and omly allocated to have their medical records held in a computer system ( 136 ) or on st and ard hospital notes ( 142 ) . For the computer system the doctor completed a structured input form , and the information on symptoms , physical findings , and diagnoses was more complete than that in the st and ard notes . This result ed in certain symptoms and risk factors being recognised more often when the computer system was used . The hypertension clinics ' routines were not disrupted by the introduction of a computer-held system , and follow-up consultation times were not affected by the type of records kept , although the first consultation took eight minutes longer when computer documents were completed . The patients remained in the trial for one year and clinical management was assessed from blood pressure control , drop-out rates , and the frequency of performing investigations . These estimates of management showed no significant difference between the two groups , but the attempt to tailor the computer system to help management made the system acceptable to the doctors using it . The computer system continues to be used and is providing data for research into hypertension",
"This study describes the influence of a computerized medical record summary system in three disease areas ( hypertension , obesity and renal disease ) observed in the course of a controlled , r and omized and prospect i ve study of 479 Northwestern University Clinic patients . Experimental patients , who had available automated record summaries , and control patients , who had available only the manual record , were compared on several medical tests and procedures whose yearly occurrence was considered good medical practice for this patient population , and were compared as well on several measures of outcome of medical care . Evidence suggesting better care and outcome of care among patients with computerized record summaries available is presented",
"PURPOSE We wanted to determine the impact of automated family history assessment and tailored messages for coronary heart disease , stroke , diabetes , colorectal , breast , and ovarian cancer on preventive behaviors compared with a st and ard preventive message . METHODS The study was a cluster-r and omized clinical trial that included 41 primary care practice s , the majority in the Midwest , using Family Healthware , a self-administered , Web-based tool that assesses familial risk for the diseases and provides personalized risk-tailored messages . Patients in the control group received an age- and sex-specific health message related to lifestyle and screening . Smoking cessation , fruit and vegetable intake , physical activity , aspirin use , blood pressure , and cholesterol and blood glucose screening were assessed at baseline and 6 months after the intervention . RESULTS Of 4,248 participants , 3,344 ( 78 % ) completed the study . Participants were white ( 91 % ) , female ( 70 % ) , and insured ( 97 % ) , and had a mean age of 50.6 years ( range 35–65 years ) . Intervention participants were more likely to increase daily fruit and vegetable consumption from 5 or fewer servings a day to 5 or more servings a day ( OR = 1.29 ; 95 % confidence interval [ CI ] , 1.05–1.58 ) and to increase physical activity ( OR = 1.47 ; 95 % CI , 1.08–1.98 ) to 5 to 6 times a week for 30 minutes or more a week . The absolute differences in proportion were 3 % and 4 % , respectively . Intervention participants were less likely to move from not having cholesterol screening in the last 5 years to having their cholesterol measured within 5 years ( OR = 0.34 ; 95 % CI , 0.17–0.67 ) , with an absolute difference of 15 % . CONCLUSIONS Messages tailored to an individual ’s familial risk for 6 common diseases modestly increased self-reported physical activity and fruit and vegetable intake but reduced the likelihood of receiving cholesterol screening",
"Electronic decision-support tools may help to improve management of hyperlipidemia and other chronic diseases . This study examined the impact of lipid management tools integrated into an electronic medical record ( EMR ) in primary care practice s. This r and omized controlled trial was conducted in a national network of physicians who use an outpatient EMR . Adult primary care physicians were r and omized by office to receive an electronic form that was embedded in the EMR . The form contained prompts regarding suboptimal care based on Adult Treatment Panel-III ( ATP-III ) guidelines , as well as reporting tools to identify patients outside of office visits whose lipid management was suboptimal . All active patients , ages 20 - 79 years , whose physicians participated in the study , were categorized as high , moderate , or low cardiovascular risk , and the proportion who were tested for hyperlipidemia , at lipid goal , and on lipid-lowering medications if not at goal were measured according to ATP-III guidelines . A total of 105 physicians from 25 offices and 64,150 patients were included in the study . Outcomes improved for most measures from before to 1 year after the intervention ( November 1 , 2005 to October 31 , 2006 ) . However , after controlling for confounding variables and for clustering in multilevel modeling , only up-to- date lipid testing for high-risk patients was statistically better in the intervention group as compared to the control group ( adjusted odds ratio 15.0 , P quality of lipid management after implementing an EMR-based disease management intervention in primary care setting s. Future studies may need to examine more comprehensive interventions that include office staff in a team approach to care",
"PURPOSE We compared the completeness of data collection using paper forms and using electronic forms loaded on h and held computers in an office-based patient interview survey conducted within the American Academy of Family Physicians National Research Network . METHODS We asked 19 medical assistants and nurses in family practice s to administer a survey about pneumococcal immunizations to 60 older adults each , 30 using paper forms and 30 using electronic forms on h and held computers . By r and om assignment , the interviewers used either the paper or electronic form first . Using multilevel analyses adjusted for patient characteristics and clustering of forms by practice , we analyzed the completeness of the data . RESULTS A total of 1,003 of the expected 1,140 forms were returned to the data center . The overall return rate was better for paper forms ( 537 of 570 , 94 % ) than for electronic forms ( 466 of 570 , 82 % ) because of technical difficulties experienced with electronic data collection and stolen or lost h and held computers . Errors of omission on the returned forms , however , were more common using paper forms . Of the returned forms , only 3 % of those gathered electronically had errors of omission , compared with 35 % of those gathered on paper . Similarly , only 0.04 % of total survey items were missing on the electronic forms , compared with 3.5 % of the survey items using paper forms . CONCLUSIONS Although h and held computers produced more complete data than the paper method for the returned forms , they were not superior because of the large amount of missing data due to technical difficulties with the h and -held computers or loss or theft . Other hardware solutions , such as tablet computers or cell phones linked via a wireless network directly to a Web site , may be better electronic solutions for the future"
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4116f204-06ff-11f0-808a-c43d1ab1c353
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Results of previous clinical trials evaluating the effect of pycnogenol supplementation on blood pressure ( BP ) are controversial . Therefore , we aim ed to assess the impact of pycnogenol on BP through a systematic review of literature and meta- analysis of available r and omized , double-blind , placebo-controlled clinical studies ( r and omized clinical trials [ RCTs ] ) . Literature search included SCOPUS , PubMed - Medline , ISI Web of Science , and Google Scholar data bases up to January 10 , 2019 to identify RCTs investigating the impact of pycnogenol on BP . Two investigators independently extracted data on study characteristics , methods , and outcomes . This systematic review and meta- analysis is registered in International Prospect i ve Register of Systematic Review s ( PROSPERO ) under number CRD42018112172 . Overall , the impact of pycnogenol on BP was reported in 7 trials involving 626 participants . Meta- analysis did not suggest any significant improvement in systolic BP ( weighted mean difference [ WMD ] : −0.028 mm Hg ; 95 % confidence interval [ CI ] : −0.182 to 0.127 ; P = .726 ; I2 = 46 % ) , diastolic BP ( WMD : −0.144 mm Hg ; 95 % CI : −0.299 to 0.010 ; P = .067 ; I2 = 0 % ) , mean arterial pressure ( WMD : −0.091 mm Hg ; 95 % CI : −0.246 to 0.063 ; P = .246 ; I2 = 0 % ) , and pulse pressure ( WMD : −0.003 mm Hg ; 95 % CI : −0.151 to 0.158 ; P = .966 ; I2 = 0 % ) following pycnogenol treatment . Results persisted in the leave-one-out sensitivity analysis . Therefore , the present meta- analysis does not suggest any significant effect of pycnogenol on BP
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"Introduction There is a growing interest in nutraceuticals improving cardiovascular risk factor levels and related organ damage . Methods This double-blind , placebo-controlled r and omized clinical trial aims to compare the effect of a combined nutraceutical containing red yeast rice ( 10 mg ) , phytosterols ( 800 mg ) , and l-tyrosol ( 5 mg ) on lipid profile , blood pressure , endothelial function , and arterial stiffness in a group of 60 patients with polygenic hypercholesterolemia resistant to Mediterranean diet . Results After 8 weeks of treatment , when compared to the placebo group , the active treated patients experienced a more favorable percentage change in total cholesterol ( −16.3 % vs 9.9 % , P LDL-C ( −23.4 % vs −13.2 % , P ) , and hepatic steatosis index ( −2.8 % , P , ALT ( −27.7 % , P 0.001 ) , AST ( −13.8 % , P = 0.004 ) , and serum uric acid ( −12.3 % , P = 0.005 ) were reduced by the tested nutraceutical compound both compared to r and omization and to placebo , which did not affect these parameters ( P hemodynamic parameters , there was a decrease of systolic blood pressure ( −5.6 % ) with the active treatment not observed with placebo ( P placebo ) and endothelial reactivity improved , too ( −13.2 % , P , the estimated 10-year cardiovascular risk score improved by 1.19 % ( SE 0.4 % ) ( P = 0.01 ) in the nutraceutical-treated patients . Conclusion The tested nutraceutical association is able to improve the positive effects of a Mediterranean diet on a large number of CV risk factors and consequently of the estimated CV risk . Trial registration Clinical Trials.gov identifier NCT02492464 . Funding IBSA Farmaceutici",
"BACKGROUND Although modifiable cardiovascular disease risk factors are common , some patients eschew conventional drug treatments in favor of natural alternatives . Pine bark extract , a dietary supplement source of antioxidant oligomeric proanthocyanidin complexes , has multiple putative cardiovascular benefits . Studies published to date about the supplement have notable method ological limitations . METHODS We r and omized 130 individuals with increased cardiovascular disease risk to take 200 mg of a water-based extract of pine bark ( n = 64 ; Toyo-FVG , Toyo Bio-Pharma , Torrance , California ; Shinyaku Co , Ltd , Saga , Japan ; also marketed as Flavagenol in Japan ) or placebo ( n = 66 ) once per day . Blood pressure , our primary outcome , and other cardiovascular disease risk factors were measured at baseline and at 6 and 12 weeks . Statistical analyses were conducted using regression models . RESULTS Baseline characteristics did not differ between the study groups . Over the 12-week intervention , the sum of systolic and diastolic blood pressures decreased by 1.0 mm Hg ( 95 % confidence interval , -4.2 to 2.1 mm Hg ) in the pine bark extract-treated group and by 1.9 mm Hg ( -5.5 to 1.7 mm Hg ) in the placebo group ( P = .87 ) . Other outcomes were likewise not significantly different , including body mass index , lipid panel measures , liver transaminase test results , lipoprotein cholesterol particle size , and levels of insulin , lipoprotein(a ) , fasting glucose , and high-sensitivity C-reactive protein . There were no subgroups for whom intake of pine bark extract affected cardiovascular disease risk factors . CONCLUSIONS This pine bark extract ( at a dosage of 200 mg/d ) was safe but was not associated with improvement in cardiovascular disease risk factors . Although variations among participants , dosages , and chemical preparations could contribute to different findings compared with past studies , our results are consistent with a general failure of antioxidants to demonstrate cardiovascular benefits . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00425945",
"AIMS Extracts from pine tree bark containing a variety of flavonoids have been used in traditional medicine . Pycnogenol is a proprietary bark extract of the French maritime pine tree ( Pinus pinaster ssp . atlantica ) that exerts antioxidative , anti-inflammatory , and anti-platelet effects . However , the effects of Pycnogenol on endothelial dysfunction , a precursor of atherosclerosis and cardiovascular events , remain still elusive . METHODS AND RESULTS Twenty-three patients with coronary artery disease ( CAD ) completed this r and omized , double-blind , placebo-controlled cross-over study . Patients received Pycnogenol ( 200 mg/day ) for 8 weeks followed by placebo or vice versa on top of st and ard cardiovascular therapy . Between the two treatment periods , a 2-week washout period was scheduled . At baseline and after each treatment period , endothelial function , non-invasively assessed by flow-mediated dilatation ( FMD ) of the brachial artery using high-resolution ultrasound , biomarkers of oxidative stress and inflammation , platelet adhesion , and 24 h blood pressure monitoring were evaluated . In CAD patients , Pycnogenol treatment was associated with an improvement of FMD from 5.3 ± 2.6 to 7.0 ± 3.1 ( P observed with placebo ( 5.4 ± 2.4 to 4.7 ± 2.0 ; P = 0.051 ) . This difference between study groups was significant [ estimated treatment effect 2.75 ; 95 % confidence interval ( CI ) : 1.75 , 3.75 , P 0.0001 ] . 15-F(2t)-Isoprostane , an index of oxidative stress , significantly decreased from 0.71 ± 0.09 to 0.66 ± 0.13 after Pycnogenol treatment , while no change was observed in the placebo group ( mean difference 0.06 pg/mL with an associated 95 % CI ( 0.01 , 0.11 ) , P = 0.012 ] . Inflammation markers , platelet adhesion , and blood pressure did not change after treatment with Pycnogenol or placebo . CONCLUSION This study provides the first evidence that the antioxidant Pycnogenol improves endothelial function in patients with CAD by reducing oxidative stress",
" Pycnogenol ® , an extract of bark from the French maritime pine , Pinus pinaster Ait . , consists of a concentrate of water-soluble polyphenols . Pycnogenol ® contains the bioflavonoids catechin and taxifolin as well as phenolcarbonic acids . Antioxidants , such as bioflavonoids , enhance endothelial nitric oxide ( NO ) synthase expression and subsequent NO release from endothelial cells . The purpose of this study was to determine Pycnogenol ® 's effects on endothelium-dependent vasodilation in humans . This was a double-blind , r and omized , placebo and active drug study . We evaluated forearm blood flow ( FBF ) responses to acetylcholine ( ACh ) , an endothelium-dependent vasodilator , and to sodium nitroprusside ( SNP ) , an endothelium-independent vasodilator , in healthy young men before and after 2 weeks of daily oral administration of Pycnogenol ® ( 180 mg/day ) ( n=8 ) or placebo ( n=8 ) . FBF was measured by using strain-gauge plethysmography . Neither the placebo nor Pycnogenol ® altered forearm or systemic hemodynamics . Pycnogenol ® , but not placebo , augmented FBF response to ACh , from 13.1±7.0 to 18.5±4.0 mL/min per 100 mL tissue ( p was similar before and after 2 weeks of treatment in the control and Pycnogenol ® groups . The administration of NG-monomethyl-L-arginine , an NO synthase inhibitor , completely abolished Pycnogenol ® -induced augmentation of the FBF response to ACh . These findings suggest that Pycnogenol ® augments endothelium-dependent vasodilation by increasing in NO production . Pycnogenol ® would be useful for treating various diseases whose pathogeneses involve endothelial dysfunction",
"BACKGROUND The aim of the study was the evaluation of the efficacy of Pycnogenol ® in peri-menopausal women in controlling homocysteine and C-reactive protein ( CRP ) levels , borderline cardiovascular risk factors , oxidative stress ( OS ) and symptoms associated to menopausal transition ( MT ) . METHODS Pycnogenol ® , 100mg/day , was used as a supplement for 8 weeks by a group of 35 women . A comparable group of 35 women with identical cardiovascular risk factors was included as the control group . All women were instructed to participate in a best management plan of menopause . RESULTS The two groups were comparable . All women completed the eight weeks study . Only minor deviations from the best management plan were observed . At inclusion , both groups were similar in respect to risk factors . Supplementation with Pycnogenol ® decreased the slightly elevated cholesterol and triglycerides after 8 weeks ( P the fasting glucose levels were normalized ( P borderline increased blood pressure was reduced to normal values at 8 weeks ( P ) . Plasma free radicals dropped significantly by 22 % ( P decreased sharply by 43 % and 60 % , respectively ( P menopausal symptoms , scored by The Menopausal Symptoms Question naire 34 , improved significantly following supplementation with Pycnogenol ® . The supplementation was well tolerated . CONCLUSIONS The supplementation with Pycnogenol ® improved the quality of life of perimenopausal women and normalized a series of cardiovascular risk factors , especially factors connected to cardiovascular events , as homocysteine and CRP",
"The study examines the effects of the antioxidant flavonoid Pycnogenol on a range of cognitive and biochemical measures in healthy elderly individuals . The study used a double-blind , placebo-controlled , matched-pair design , with 101 elderly participants ( 60—85 years ) consuming a daily dose of 150 mg of Pycnogenol for a three-month treatment period . Participants were assessed at baseline , then at 1 , 2 , and 3 months of the treatment . The control ( placebo ) and Pycnogenol groups were matched by age , sex , body mass index , micronutrient intake , and intelligence . The cognitive tasks comprised measures of attention , working memory , episodic memory , and psychomotor performance . The biological measures comprised levels of clinical hepatic enzymes , serum lipid profile , human growth hormone , and lipid peroxidation products . Statistically significant interactions were found for memory-based cognitive variables and lipid peroxidation products , with the Pycnogenol group displaying improved working memory and decreased concentrations of F2-isoprostanes relative to the control group"
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BACKGROUND Test procedures that were developed to assess somatosensory abnormalities should possess optimal psychometric properties ( PMPs ) to be used in clinical practice . The aim of this systematic review was to evaluate the literature to assess the level of evidence for PMPs of test procedures investigated in individuals with peripheral joint pain ( PJP ) . METHODS A comprehensive electronic literature search was conducted in 7 data bases from inception to March 2016 . The Quality Appraisal for Reliability Studies ( QAREL ) checklist and the Consensus-based St and ards for the Selection of Health Status Measurement Instruments ( COSMIN ) tool were used to assess risk for bias of the included studies . Level of evidence was evaluated based on the method ological quality and the quality of the measurement properties . RESULTS Forty-one studies related to PJP were included . The majority of included studies were considered to be of insufficient method ological quality , and the level of evidence for PMPs varied across different test procedures . The level of evidence for PMPs varied across different test procedures in different types of PJP . H and -held pressure algometry is the only test procedure that showed moderate positive evidence of intrarater reliability , agreement , and responsiveness , simultaneously , when it was investigated in patients with chronic knee osteoarthritis . CONCLUSIONS This systematic review identified that the level of evidence for PMPs varied across different testing procedures to assess somatosensory abnormalities for different PJP population s. Further research with st and ardized protocol s is recommended to further investigate the predictive ability and responsiveness of reported test procedures in order to warrant their extended utility in clinical practice
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"& NA ; The large inter‐individual variability in the magnitude of analgesia in response to opioids and the high prevalence of adverse events associated with their use underline the clinical importance of being able to predict who will or will not respond to opioid treatment . The present study used both static and dynamic quantitative sensory testing ( QST ) on 40 healthy volunteers in order to test whether this methodology can predict the analgesic effects of oral oxycodone , as compared to a placebo , on latency to onset , pain intensity , and tolerance to the cold pressor test ( CPT ) . Static QST consisted of measuring heat and cold pain thresholds . Dynamic QST included measurements of the magnitude of the diffuse noxious inhibitory control (DNIC)‐like effect and of temporal summation ( TS ) . Results showed that oxycodone , but not the placebo , significantly elevated the latency and tolerance to cold pain and significantly reduced pain intensity . The static QST results showed that heat pain thresholds predicted the magnitude of reduction in pain intensity in response to oxycodone treatment ( F(1,22 ) = 5.63 , p = 0.027 , R2 = 0.17 ) . The dynamic QST results showed that TS predicted the effect of oxycodone on the tolerance to CPT ( F(1,38 ) = 9.11 , p = 0.005 , R2 = 0.17 ) . These results suggest that both static and dynamic QST have the potential to be useful in the prediction of the response to opioid treatment",
"Summary Pain responses to 2 types of preoperative heat stimuli were not independent clinical ly relevant predictors for postoperative pain after total knee arthroplasty . ABSTRACT It has been estimated that up to 54 % of the variance in postoperative pain experience may be predicted with preoperative pain responses to experimental stimuli , with suprathreshold heat pain as the most consistent test modality . This study aim ed to explore whether 2 heat test paradigms could predict postoperative pain after total knee arthroplasty ( TKA ) . Patients scheduled for elective , unilateral , primary TKA under spinal anesthesia were consecutively included in this prospect i ve , observational study . Perioperative analgesia was st and ardized for all patients . Outcomes were postoperative pain during walk : from 6 to 24 hours ( primary ) , from postoperative day ( POD ) 1 to 7 ( secondary ) , and from POD 14 to 30 ( tertiary ) . Two preoperative tonic heat stimuli with 47 ° C were used ; short ( 5 seconds ) and long ( 7 minutes ) stimulation upon which patients rated their pain response on an electronic visual analog scale . Multivariate stepwise linear and logistic regressions analyses were carried out , including 8 potential preoperative explanatory variables ( among these anxiety , depression , preoperative pain , and pain catastrophizing ) to assess pain response to preoperative heat pain stimulation as an independent predictor for postoperative pain . A total of 100 patients were included , and 3 were later excluded . A weak correlation [ rho ( 95 % confidence interval ) ; P value ] was observed between pain from POD 1 to 7 and pain response to short [ rho = 0.25(0.04 to 0.44 ) ; P = .02 ] and to long [ rho = 0.27 ( 0.07 to 0.46 ) ; P = .01 ] heat pain stimulation . However , these positive correlations were not supported by the linear and logistic regression analyses , in which only anxiety , preoperative pain , and pain catastrophizing were significant explanatory variables ( but with low R‐squares ; 0.05 to 0.08 ) . Pain responses to 2 types of preoperative heat stimuli were not independent clinical ly relevant predictors for postoperative pain after TKA",
"Several lines of evidence suggest that mental motor imagery is subserved by the same cognitive operations and brain structures that underlie action . Additionally , motor imagery is informed by the anticipated sensory consequences of action , including pain . We reasoned that motor imagery could provide a useful measure of chronic leg or foot pain . Forty subjects with leg pain ( 19 bilateral , 11 right , and 10 left leg pain ) , 42 subjects with chronic pain not involving the legs , and 38 controls were shown 12 different line drawings of the right or left foot and asked to indicate which foot was depicted . Previous work suggests that subjects perform this task by mentally rotating their foot to match the visually presented stimulus . All groups of subjects were slower and less accurate with stimuli that required a greater degree of mental rotation of their foot . Subjects with leg pain were both slower and less accurate than normal and pain control subjects in responding to drawings of a painful extremity . Furthermore , subjects with leg pain exhibited a significantly greater decrement in performance for stimuli that required larger amplitude mental rotations . These data suggest that motor imagery may provide important insights into the nature of the pain experience",
"Purpose Pressure algometry ( PA ) may provide an objective and st and ardised tool in assessing palpation pain over the tibia . The purpose of this study was to analyse the intra-rater repeatability of PA and to determine whether tibial tenderness in healthy runners differ from runners with medial tibial stress syndrome ( MTSS ) . Methods Pressure algometry was performed on 20 asymptomatic runners ( 40 legs ) and 9 MTSS patients ( 14 symptomatic legs ) at st and ardised locations along the medial border of the tibia . Intra-rater reliability was assessed in 10 r and omly selected asymptomatic runners through repeated measurements 2 weeks later . Results Intra-rater reliability was moderate to excellent ( ICC 0.53–0.90 ) in asymptomatic runners . Pain pressure threshold ( PPT ) was significantly reduced at 2/9–5/9 of the distance from the medial malleolus to the medial tibial condyle ( p = 0.002–0.022 ) . There was evidence of a statistically significant association between both height and weight , and PPT from the 3/9 ( r = 0.416 , p = 0.008 ) to 7/9 ( r = 0.334 , p = 0.035 ) and 3/9 ( r = 0.448 , p = 0.004 ) to 6/9 ( r = 0.337 , p = 0.034 ) area , respectively . In both MTSS patients and healthy runners , there was evidence of lower PPT in females compared to males ( p = 0.0001–0.049 ) and a negative association between age and PPT ( p = 0.001–0.033 ) . MTSS patients had significantly lower PPT at the 3/9 site ( p = 0.048 ) compared to asymptomatic runners . Conclusion Pain pressure threshold algometry can be incorporated into MTSS clinical assessment to objective ly assess pain and monitor progress . The presence of reduced medial tibial PPT in asymptomatic runners suggests that clinicians may not need to await resolution of medial tibia tenderness before allowing return to sport in MTSS patients .Level of evidence III",
"OBJECTIVE To evaluate the interobserver reproducibility of the assessment of severity of complaints , grip strength , and pressure pain threshold in patients with lateral epicondylitis in primary care . DESIGN Two physiotherapists assessed independently , and in r and omized order , the severity of complaints scored on an 11-point numeric rating scale , pain-free grip strength , maximum grip strength , and pressure pain threshold . SETTING Primary care center in the Netherl and s. PARTICIPANTS Fifty patients were assessed by both physiotherapists . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Intraclass correlation coefficients ( ICCs ) and 95 % confidence intervals ( CIs ) were calculated to assess interobserver reliability . The Bl and and Altman method was used to assess interobserver agreement , which included calculation of the mean difference between the observers ( d ) , the 95 % CI for d , the st and ard deviation of the differences , and the 95 % limits of agreement . Finally , the smallest detectable difference ( SDD ) was calculated . RESULTS The ICC for the severity of complaints was.90 . The ICCs for the pain-free grip strength and maximum grip strength were.97 and .98 , respectively . The pressure pain threshold showed a lower reliability ( ICC=.77 ) . The interobserver agreement for all outcome measures was good , but systematic differences in assessment between the physiotherapists were found for the maximum grip strength and pressure pain threshold . For pressure pain threshold , the SDD was clearly larger than the predefined acceptable difference of 10 % of the total range of measurement . CONCLUSIONS The interobserver reliability of severity of complaints and grip strength was excellent , whereas the pressure pain threshold showed unsatisfactory reliability . Grip strength and overall assessment of the severity of complaints are useful and reliable measures for the assessment of lateral epicondylitis . Pain-free grip strength , in particular , is relatively easy to perform and has been shown to be associated with other measures of functional disability in patients with lateral epicondylitis . We , therefore , recommend the use of pain-free grip strength in both research and clinical practice",
"Physiotherapists frequently use manipulative therapy techniques to treat dysfunction and pain result ing from ankle sprain . This study investigated whether a Mulligan 's mobilization with movement ( MWM ) technique improves talocrural dorsiflexion , a major impairment following ankle sprain , and relieves pain in subacute population s. Fourteen subjects with subacute grade II lateral ankle sprains served as their own control in a repeated measures , double-blind r and omized controlled trial that measured the initial effects of the MWM treatment on weight bearing dorsiflexion and pressure and thermal pain threshold . The subacute ankle sprain group studied displayed deficits in dorsiflexion and local pressure pain threshold in the symptomatic ankle . Significant improvements in dorsiflexion occurred initially post-MWM ( F(2,26 ) = 7.82 , P = 0.002 ) , but no significant changes in pressure or thermal pain threshold were observed after the treatment condition . Results indicate that the MWM treatment for ankle dorsiflexion has a mechanical rather than hypoalgesic effect in subacute ankle sprains . The mechanism by which this occurs requires investigation if we are to better underst and the role of manipulative therapy in ankle sprain management",
"Background : Predictors of outcome in lateral epicondylalgia , which is mainly characterized as a mechanical hyperalgesia , are largely limited to sociodemographic and symptomatic factors . Quantitative sensory testing is used to study altered pain processing in various chronic pain conditions and may be of prognostic relevance . Methods : The predictive capacity of early measures of physical and psychological impairment on pain and disability and mechanical hyperalgesia , were examined using data from 41 patients assigned to placebo in a prospect i ve r and omized controlled trial of unilateral lateral epicondylalgia . Quantitative sensory testing ( pressure , cold pain thresholds ) , motor function ( pain-free grip ) , and psychological factors ( Tampa Scale of Kinesiophobia , Hospital Anxiety and Depression Scale ) were measured at baseline . The outcome measures were the Patient-rated Tennis Elbow Evaluation ( PRTEE ) scale and pressure pain threshold ( PPT ) measured by digital algometry at the affected elbow . Backward stepwise linear regression was used to predict PRTEE and PPT scores at 2 and 12 months . Results : Cold pain threshold was the only consistent predictor for both PRTEE ( P PRTEE at 2 months , whereas female sex was the strongest single predictor of PPT ( P pain and disability and mechanical hyperalgesia , respectively . Discussion : Early assessment of cold pain threshold could be a useful clinical tool to help identify patients at risk of poorer outcomes and might provide direction for future research into mechanism-based treatment approaches for these patients",
"AIMS The coadministration of subantinociceptive doses of oxycodone with morphine has recently been shown to result in a synergistic antinociceptive effect in rats . The present study was aim ed to investigate the possibility that coadministration of morphine and oxycodone can produce a similar synergistic effect in humans exposed to an experimental model of cold pressor test ( CPT ) . METHODS The enriched enrollment design was used to exclude ' stoic ' and ' placebo responders ' in a single-blind fashion . ' Nonstoic ' , placebo ' nonresponder ' female volunteers ( n = 30 ) were r and omly assigned to receive 0.5 mg kg(-1 ) oral morphine sulphate , 0.5 mg kg(-1 ) oral oxycodone hydrochloride , and the combination of 0.25 mg kg(-1 ) morphine sulphate with 0.25 mg kg(-1 ) oxycodone hydrochloride , 1 week apart from each other , in a double-blind crossover design . Latency to pain onset ( threshold ) , pain intensity ( VAS ) , and pain tolerance ( time until removal of the h and from the water ) were measured six times over a 3-h period , subsequent to the administration of each medication , and were used to assess their antinociceptive effect . RESULTS The combination produced a significantly higher effect on latency to pain onset than that of morphine alone [ difference in mean postbaseline value 2.2 ; 95 % confidence interval ( CI ) 0.48 , 3.9 ; P = 0.01 ] but the effect was nonsignificantly smaller that that of oxycodone alone . Similarly , the effect of the combination on pain tolerance was significantly larger than that of morphine alone ( combination difference 8.4 ; 95 % CI 2.5 , 14.3 ; P = 0.007 ) , whereas oxycodone alone caused a nonsignificantly larger effect than that of the combination treatment . Comparisons of pain magnitude failed to show any significant differences between the three treatments . CONCLUSIONS These results indicate that at the doses tested , morphine and oxycodone do not produce synergistic antinociceptive effects in healthy humans exposed to the CPT",
"Objectives : Von Frey monofilaments ( VFM ) and Electronic von Frey are used as quantitative sensory testing to explore mechanical hyperalgesia . The aim of the study was to determine VFM and Electronic von Frey reproducibility and the time required for testing undamaged areas in volunteers and surgical in-hospital patients . Methods : Prospect i ve study in 2 groups of individuals without neurological disorders and not receiving treatments that alter sensorial response . Group 1 was formed by 30 healthy volunteers and group 2 by 28 patients after knee arthroplasty who received unilateral femoral block as postoperative analgesia . Testing was performed by 2 trained investigators in the forearm and abdominal wall and repeated 24 hours later . Pain threshold was determined as the VMF or the pressure rate applied with the Electronic von Frey referred to as unpleasant . The time used in each test was measured . Intraobserver and interobserver reproducibility were analyzed by means of Kappa and Lin coefficients . Results : Intraobserver and interobserver reproducibility for VFM was only fair or moderate in both groups ( Kappa Intraobserver reproducibility for Electronic von Frey was good in Group 1 ( Lin 0.61 to 0.8 ) and almost perfect in Group 2 ( Lin>0.8 ) . No differences were found between the 2 tested areas . Time used was 6.03 and 3.16 minutes for VFM and Electronic von Frey , respectively . Discussion : Exploration of mechanical allodynia in postoperative patients requires rapid and reliable quantitative sensory testing . Electronic von Frey was more reliable and rapid than VFM in exploring mechanical pain thresholds in undamaged areas in volunteers and patients . Further studies are required to confirm whether these results can be extrapolated to areas affected by surgery",
"& NA ; Quantitative sensory testing ( QST ) is an instrument to assess positive and negative sensory signs , helping to identify mechanisms underlying pathologic pain conditions . In this study , we evaluated the test – retest reliability ( TR‐R ) and the interobserver reliability ( IO‐R ) of QST in patients with sensory disturbances of different etiologies . In 4 centres , 60 patients ( 37 male and 23 female , 56.4 ± 1.9 years ) with lesions or diseases of the somatosensory system were included . QST comprised 13 parameters including detection and pain thresholds for thermal and mechanical stimuli . QST was performed in the clinical ly most affected test area and a less or unaffected control area in a morning and an afternoon session on 2 consecutive days by examiner pairs ( 4 QSTs/patient ) . For both , TR‐R and IO‐R , there were high correlations ( r = 0.80–0.93 ) at the affected test area , except for wind‐up ratio ( TR‐R : r = 0.67 ; IO‐R : r = 0.56 ) and paradoxical heat sensations ( TR‐R : r = 0.35 ; IO‐R : r = 0.44 ) . Mean IO‐R ( r = 0.83 , 31 % unexplained variance ) was slightly lower than TR‐R ( r = 0.86 , 26 % unexplained variance , P 43 ) , reliabilities were significantly better in the test area ( TR‐R : r = 0.86 ; IO‐R : r = 0.83 ) than in the control area ( TR‐R : r = 0.79 ; IO‐R : r = 0.71 , each P of QST . We conclude that st and ardized QST performed by trained examiners is a valuable diagnostic instrument with good test – retest and interobserver reliability within 2 days . With st and ardized training , observer bias is much lower than r and om variance . Quantitative sensory testing performed by trained examiners is a valuable diagnostic instrument with good interobserver and test – retest reliability for use in patients with sensory disturbances of different etiologies to help identify mechanisms of neuropathic and non‐neuropathic pain",
"Study Design . Prospect i ve , within-subjects , observational experimental design . Objectives . To determine the pattern of pain response to noxious stimulation of the intervertebral disc . Summary of Background Data . Experimental studies have demonstrated that noxious stimulation of interspinous ligaments , facet joints , and paravertebral muscles causes referred pain into the extremity , with the distal extent of radiation dependent on the intensity of stimulation . Analogous studies have not been performed on the lumbar intervertebral disc . Methods . A total of 25 consecutive patients meeting inclusion criteria completed a pain diagram before undergoing the intradiscal electrothermal annuloplasty procedure . The location , intensity , and familiarity of any pain provoked during disc heating were correlated with presenting symptoms and duration of heating . Results . During disc heating , 68 % of patients reported exact reproduction of their presenting pain , in both pain quality and location . None of the patients experienced unfamiliar pain during the procedure . The pattern of pain reproduction was consistent ; pain originated proximally and progressed distally as stimulus intensity increased . Conclusion . Noxious stimulation of the intervertebral disc may result in low back and referred extremity in patients presenting with these symptoms . The distal extent of pain produced depends on the intensity of stimulation . Disc stimulation may reproduce pain that extends to below the knee",
"Background and Purpose : Knee osteoarthritis ( OA ) is associated with reduced muscle strength and pain sensitization . The purpose of this study was to determine intrarater reliability and agreement ( measurement error ) of isometric knee extensor and flexor muscle strength assessed using h and held dynamometry and of pressure pain thresholds ( PPT ; a measure of pain sensitization ) from the knee , the leg , and the forearm assessed using h and held algometry in knee OA . Methods : A total of 20 subjects with knee OA participated in 2 sessions separated by 1 week . The highest of 4 examinations and the mean of the 3 highest examinations of muscle strength and the first and the mean of 2 PPT examinations were applied in the statistical analyses . Intrarater reliability was assessed using a 2-way r and om-effects model , consistency-type intraclass correlation coefficient , whereas agreement was assessed using 95 % limits of agreement ( LOA ) as a percentage of the mean ( LOA% ) . Results : Intraclass correlation coefficients for muscle strength were between 0.78 and 0.91 when using the highest examination and were between 0.86 and 0.94 when using the mean of the 3 highest examinations . Intraclass correlation coefficients for PPT were between 0.53 and 0.87 when using the first examination and were between 0.84 and 0.91 when using the mean of 2 examinations . Agreement ( LOA% ) for muscle strength ranged from 38.3 % to 47.3 % when using the highest examination and from 40.4 % to 53.3 % when using the mean of the 3 highest examinations . Agreement for PPT ranged from 54.2 % to 80.6 % when using the first examination and from 50.6 % to 58.9 % when using the mean of 2 PPT examinations . Discussion : A tendency toward improved intraclass correlation coefficients and LOA% ( only for PPTs ) was found when using the mean of more than 1 examination for both muscle strength and PPTs . Intrarater reliability was high to very high , whereas the LOA/LOA% indicated relatively high measurement errors . Conclusions : Examination of muscle strength and PPTs in knee OA is reliable , but affected by the measurement error , which is important to consider when reporting the results of clinical trials and in clinical practice",
"Total knee arthroplasty has provided dramatic improvements in function and pain for the majority of patients with knee arthritis , yet a significant proportion of patients remain dissatisfied with their results . We performed a prospect i ve analysis of 215 patients undergoing TKA who underwent a comprehensive array of evaluations to discover whether any preoperative assessment could predict high pain scores and functional limitations postoperatively . Patients with severe pain with a simple knee range-of-motion test prior to TKA had a 10 times higher likelihood of moderate to severe pain at 6 months . A simple test of pain intensity with active flexion and extension preoperatively was a significant predictor of postoperative pain at 6 months after surgery . Strategies to address this particular patient group may improve satisfaction rates of TKA"
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Objective : Antidepressants ( ADs ) are the mainstay of treatment for major depressive disorder ( MDD ) . Despite their widespread usage , a consensus does not exist as to the timing of clinical ly significant symptomatic improvement during an AD trial . The objective of this review is to provide practitioners with empirically based recommendations pertaining to the optimal duration of index ( initial ) AD therapy before a clinical intervention is warranted . Methods : We conducted a non systematic review , using a combination of a MeSH key word search , Google Scholar , and the Scopus data base . Our search strategy focused on research papers reporting on the early symptomatic response to AD therapy . Results : Available evidence suggests that there are several sub population s that exist within whole-group data assigned to an AD treatment . Among the responder subgroups , an early responder group ( that is , less than 3 weeks ) and later responder group ( that is , 3 weeks or more ) are identified . People who exhibit early partial symptomatic improvement are more likely to respond to therapy thereafter . However , the interpretability of extant evidence is complicated by the use of disparate statistical approaches with differing computational complexity and sample heterogeneity . Conclusions : Response outcomes in MDD are heterogeneous . Available data suggest that people may respond early , late , and ( or ) continuously over time , and may represent distinct sub population s that provide a proximate indication for treatment response outcomes . Notwithst and ing , a pragmatic recommendation would be to consider a treatment intervention ( for example , dosage optimization and [ or ] augmentation ) if , after 3 to 4 weeks , symptomatic improvement is insufficient
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"Background : Symptomatic remission is the optimal outcome in depression . A brief , vali date d tool for symptom measurement that can indicate when remission has occurred in mental health and primary care setting s is unavailable . We evaluated a 7-item abbreviated version ( HAMD-7 ) of the 17-item Hamilton Depression Rating Scale ( HAMD-17 ) in a r and omized controlled clinical trial of patients with major depressive disorder being cared for in primary care setting s. Methods : We enrolled 454 patients across 47 primary care setting s who met DSM-IV-TR criteria for a major depressive disorder . Of these , 410 patients requiring antidepressant medication were r and omized to have their symptoms rated with either HAMD-7 ( n = 205 ) or HAMD-17 ( n = 205 ) as the primary measurement tool . The primary outcome was the proportion of patients who achieved a-priori defined responses to 8 weeks of therapy using each instrument . Results : Of the 205 participants per group , 67 % of those evaluated with HAMD-7 were classified as having responded to therapy ( defined as a ≥ 50 % reduction from the pretreatment score ) , compared with 74 % of those evaluated with HAMD-17 ( p = 0.43 ) . The difference between the groups ' changes in scores from baseline ( pretreatment ) to endpoint was significant ( p HAMD-7 depression scale is equivalent to the HAMD-17 in assessing remission in patients with a major depressive disorder undergoing drug therapy",
"This study was aim ed at resolving the time course of clinical action of antidepressants ( ADs ) and the type of early behavioral changes that precede recovery in treatment-responsive depressed patients . The first goal was to identify , during the first 2 weeks of treatment , the onset of clinical actions of the selective serotonin reuptake inhibitor ( SSRI ) , paroxetine , and the selective noradrenergic reuptake inhibitor , desipramine ( DMI ) . The second aim was to test the hypothesis that the two pharmacologic subtypes would induce different early behavioral changes in treatment-responsive patients . The design was a r and omized , parallel group , placebo-controlled , double-blind study for 6 weeks of treatment following a 1-week washout period . The study utilized measures of the major behavioral components of the depressive disorder as well as overall severity . The results indicated that the onset of clinical actions of DMI ranged from 3 to 13 days , averaged 13 days for paroxetine , and was 16–42 days for placebo . Furthermore , as hypothesized , the different types of ADs initially impacted different behavioral aspects of the disorder . After 1 week of treatment , DMI produced greater reductions in motor retardation and depressed mood than did paroxetine and placebo , and this difference persisted at the second week of treatment . Early improvement in depressed mood – motor retardation differentiated patients who responded to DMI after 6 weeks of treatment from those that did not . Paroxetine initially reduced anxiety more in responders than in nonresponders , and by the second week , significantly improved depressed mood and distressed expression in responders to a greater extent . Depressed patients who responded to placebo showed no consistent early pattern of behavior improvement . Early drug-specific behavioral changes were highly predictive of ultimate clinical response to the different ADs , results that could eventually be applied directly to clinical practice",
"Background In Major Depressive Disorder ( MDD ) , treatment outcomes with currently available strategies are often disappointing . Therefore , it is sensible to develop new strategies to increase remission rates in acutely depressed patients . Many studies reported that true drug response can be observed within 14 days ( early improvement ) of antidepressant treatment . The identical time course of symptom amelioration after early improvement in patients treated with antidepressants of all classes or with placebo strongly suggests a common biological mechanism , which is not specific for a particular antidepressant medication . However , the biology underlying early improvement and final treatment response is not understood and there is no established biological marker as yet , which can predict treatment response for the individual patient before initiation or during the course of antidepressant treatment . Peripheral blood markers and executive functions are particularly promising c and i date s as markers for the onset of action and thus the prediction of final treatment outcome in MDD . Methods / Design The present paper presents the rationale s , objectives and methods of a multi-centre study applying close-meshed repetitive measurements of peripheral blood and neuropsychological parameters in patients with MDD and healthy controls during a study period of eight weeks for the identification of biomarkers for the onset of antidepressants ' action in patients with MDD . Peripheral blood parameters and depression severity are assessed in weekly intervals from baseline to week 8 , executive performance in bi-weekly intervals . Patients are participating in a r and omized controlled multi-level clinical trial , healthy controls are matched according to mean age , sex and general intelligence . Discussion This investigation will help to identify a biomarker or a set of biomarkers with decision-making quality in the treatment of MDD in order to increase the currently disappointing remission rates of antidepressant treatment . Trial Registration Clinical Trials.gov :",
" This post hoc analysis of a multicenter , single‐arm , open‐label trial ( the Attributes of Response in Depressed Patients Switched to Treatment with Duloxetine [ ARDENT ] study ) assessed the relationship between functional improvement in the Sheehan Disability Scale ( SDS ) and clinical outcomes of mood , pain , and anxiety over 8 weeks after switching treatment to duloxetine in patients with major depressive disorder",
"OBJECTIVE Acute administration of an antidepressant increases positive affective processing in healthy volunteers , an effect that may be relevant to the therapeutic actions of these medications . The authors investigated whether this effect is apparent in depressed patients early in treatment , prior to changes in mood and symptoms . METHOD In a double-blind , placebo-controlled , between-groups r and omized design , the authors examined the effect of a single 4-mg dose of the norepinephrine reuptake inhibitor reboxetine on emotional processing . Thirty-three depressed patients were recruited through primary care clinics and the community and matched to 31 healthy comparison subjects . Three hours after dosing , participants were given a battery of emotional processing tasks comprising facial expression recognition , emotional categorization , and memory . Ratings of mood , anxiety , and side effects were also obtained before and after treatment . RESULTS Depressed patients who received placebo showed reduced recognition of positive facial expressions , decreased speed in responding to positive self-relevant personality adjectives , and reduced memory for this positive information compared to healthy volunteers receiving placebo . However , this effect was reversed in patients who received a single dose of reboxetine , despite the absence of changes in subjective ratings of mood or anxiety . CONCLUSIONS Antidepressant drug administration modulates emotional processing in depressed patients very early in treatment , before changes occur in mood and symptoms . This effect may ameliorate the negative biases in information processing that characterize mood and anxiety disorders . It also suggests a mechanism of action compatible with cognitive theories of depression",
"BACKGROUND Response and remission defined by cut-off values on the last observed depression severity score are commonly used as outcome criteria in clinical trials , but ignore the time course of symptomatic change and may lead to inefficient analyses . We explore alternative categorization of outcome by naturally occurring trajectories of symptom change . METHOD Growth mixture models were applied to repeated measurements of depression severity in 807 participants with major depression treated for 12 weeks with escitalopram or nortriptyline in the part-r and omized Genome-based Therapeutic Drugs for Depression study . Latent trajectory classes were vali date d as outcomes in drug efficacy comparison and pharmacogenetic analyses . RESULTS The final two-piece growth mixture model categorized participants into a majority ( 75 % ) following a gradual improvement trajectory and the remainder following a trajectory with rapid initial improvement . The rapid improvement trajectory was over-represented among nortriptyline-treated participants and showed an antidepressant-specific pattern of pharmacogenetic associations . In contrast , conventional response and remission favoured escitalopram and produced chance results in pharmacogenetic analyses . Controlling for drop-out reduced drug differences on response and remission but did not affect latent trajectory results . CONCLUSIONS Latent trajectory mixture models capture heterogeneity in the development of clinical response after the initiation of antidepressants and provide an outcome that is distinct from traditional endpoint measures . It differentiates between antidepressants with different modes of action and is robust against bias due to differential discontinuation",
"OBJECTIVE Selective serotonin reuptake inhibitors ( SSRIs ) are widely used to treat depression , but the rates , timing , and baseline predictors of remission in \" real world \" patients are not established . The authors ' primary objectives in this study were to evaluate the effectiveness of citalopram , an SSRI , using measurement-based care in actual practice , and to identify predictors of symptom remission in out patients with major depressive disorder . METHOD This clinical study included out patients with major depressive disorder who were treated in 23 psychiatric and 18 primary care \" real world \" setting s. The patients received flexible doses of citalopram prescribed by clinicians for up to 14 weeks . The clinicians were assisted by a clinical research coordinator in the application of measurement-based care , which included the routine measurement of symptoms and side effects at each treatment visit and the use of a treatment manual that described when and how to modify medication doses based on these measures . Remission was defined as an exit score of 17-item Hamilton Depression Rating Scale ( HAM-D ) ( primary outcome ) or a score of 16-item Quick Inventory of Depressive Symptomatology , Self-Report ( QIDS-SR ) ( secondary outcome ) . Response was defined as a reduction of > or=50 % in baseline QIDS-SR score . RESULTS Nearly 80 % of the 2,876 out patients in the analyzed sample had chronic or recurrent major depression ; most also had a number of comorbid general medical and psychiatric conditions . The mean exit citalopram dose was 41.8 mg/day . Remission rates were 28 % ( HAM-D ) and 33 % ( QIDS-SR ) . The response rate was 47 % ( QIDS-SR ) . Patients in primary and psychiatric care setting s did not differ in remission or response rates . A substantial portion of participants who achieved either response or remission at study exit did so at or after 8 weeks of treatment . Participants who were Caucasian , female , employed , or had higher levels of education or income had higher HAM-D remission rates ; longer index episodes , more concurrent psychiatric disorders ( especially anxiety disorders or drug abuse ) , more general medical disorders , and lower baseline function and quality of life were associated with lower HAM-D remission rates . CONCLUSIONS The response and remission rates in this highly generalizable sample with substantial axis I and axis III comorbidity closely resemble those seen in 8-week efficacy trials . The systematic use of easily implemented measurement-based care procedures may have assisted in achieving these results",
"Background : This study was design ed to assess clinical and functional outcomes associated with switching to duloxetine treatment in patients with major depressive disorder ( MDD ) experiencing emotional and painful physical symptoms in their current episode . Methods : In this 8-week , multinational , multicentre , single-arm , open-label clinical trial , 242 MDD patients were switched to duloxetine 60 mg/day after selective serotonin reuptake inhibitor ( SSRI ) or serotonin and norepinephrine reuptake inhibitor ( SNRI ) treatment . The primary analysis compared mean change from baseline in Brief Pain Inventory – Modified Short Form ( BPI-SF ) interference score between initial responders [ ≥ 50 % reduction from baseline on the 17-item Hamilton Depression Rating Scale ( HAMD17 ) Maier subscale ] and initial non-responders after 4 weeks . Initial responders continued with duloxetine 60 mg/day . Initial non-responders received duloxetine 120 mg/day for the remaining 4 weeks . Depression , pain , anxiety and functional outcomes were also compared after 8 weeks . Results : BPI-SF interference decreased from baseline in initial responders ( n = 108 ) and initial non-responders ( n = 85 ) after 4 weeks of duloxetine treatment , with greater reductions in initial responders [ BPI-SF mean difference in reduction : 1.01 ( 95 % CI 0.42–1.61 ) ; p 0.001 ] . Reductions in pain interference favouring initial responders were also apparent after 8 weeks [ 0.68 ( 95 % CI : 0.03–1.33 ) ; p = 0.042 ] . Depression , pain , anxiety and function improved over 8 weeks across patient groups . Conclusions : Elements of core mood and pain are important residual symptoms following poor treatment response in MDD . Early improvement in these symptoms after switching to duloxetine indicated an increased chance of functional recovery",
"CONTEXT The high percentage of failed clinical trials in depression may be due to high placebo response rates and the failure of st and ard statistical approaches to capture heterogeneity in treatment response . OBJECTIVE To assess whether growth mixture modeling can provide insights into antidepressant and placebo responses in clinical trials of patients with major depression . DESIGN We reanalyzed clinical trials of duloxetine to identify distinct trajectories of Hamilton Scale for Depression ( HAM-D ) scores during treatment . We analyzed the trajectories in the entire sample and then separately in all active arms and in all placebo arms . Effects of duloxetine hydrochloride , selective serotonin reuptake inhibitor ( SSRI ) , and covariates on the probability of following a particular trajectory were assessed . Outcomes in different trajectories were compared using mixed-effects models . SETTING Seven r and omized double-blind clinical trials of duloxetine vs placebo and comparator SSRI . Patients A total of 2515 patients with major depression . INTERVENTIONS Duloxetine and comparator SSRI . Main Outcome Measure Total score on the HAM-D. RESULTS In the entire sample and in the antidepressant-treated sub sample , we identified trajectories of responders ( 76.3 % of the sample ) and nonresponders ( 23.7 % of the sample ) . However , placebo-treated patients were characterized by a single response trajectory . Duloxetine and SSRI did not differ in efficacy , and compared with placebo they significantly decreased the odds of following the nonresponder trajectory . Antidepressant responders had significantly better HAM-D scores over time than placebo-treated patients , but antidepressant nonresponders had significantly worse HAM-D scores over time than the placebo-treated patients . CONCLUSIONS Most patients treated with serotonergic antidepressants showed a clinical trajectory over time that is superior to that of placebo-treated patients . However , some patients receiving these medications did more poorly than patients receiving placebo . These data highlight the importance of ongoing monitoring of medication risks and benefits during serotonergic antidepressant treatment . They should further stimulate the search for biomarkers or other predictors of responder status in guiding antidepressant treatment",
"The purpose of this study was to develop a method for differentiating specific ( \" true \" ) and nonspecific antidepressant drug response for the individual patient . Patterns of clinical response , based on weekly global ratings of clinical status , were generated for each of 185 patients participating in six-week placebo-controlled drug trials . We hypothesized and found that substantially more patients receiving active than placebo medication displayed treatment response patterns characterized both by two-week or greater delay in onset of initial improvement and nonfluctuating persistence of improvement once achieved . Identification of a distinctive pattern of clinical response to an active drug has both research and clinical applications . Pattern analysis may contribute to underst and ing the nature of drug mechanisms of action , may clarify some ambiguous treatment study outcomes , and in the individual case , may facilitate clinical management",
"Data from three six-week placebo-controlled r and omized antidepressant trials were pooled to test the hypothesis that a four-week trial is insufficient to reach a determination of drug failure in depressed patients . We compared global clinical ratings at weekly intervals for patients receiving drug and patients receiving placebo and calculated the proportion of patients whose clinical status changed over time . We predicted , and found , that a significant proportion of patients who showed no clear-cut response at four weeks would show much improvement at six weeks in drug but not placebo conditions . Baseline Research Diagnostic Criteria diagnosis , baseline illness severity , and drug dose adjustments after four weeks did not predict either late clinical improvement or relapse between four and six weeks . Additional placebo-controlled studies are needed to replicate our findings concerning the advantage of extending trials to five or six weeks in sample s of patients of various depressive subtypes",
"OBJECTIVES Timing issues of antidepressant drug response are of major clinical relevance , given our current inability to predict when a particular patient will respond to a particular treatment . METHOD We detailed the time characteristics of recovery in a study of 2848 patients ( diagnosed according to DSM-III-R/DSM-IV criteria as having major depressive disorder or major depressive episode ) who were treated with 7 different anti-depressants and placebo . A 2-dimensional cure model was used to disentangle the 2 central aspects of psychotropic drug response : the proportion of patients in whom a therapeutic response is induced ( incidence ) and the time to onset of improvement ( latency ) . R and om-effects models were applied to quantify unexplained heterogeneity . Patients were recruited between June 1982 and May 1998 . RESULTS Our analyses yielded no indication for a delayed onset of antidepressant drug response . Rather , we found highly individual time characteristics of recovery along with a continuous distribution of the time spans to onset of improvement under treatment with all active compounds and placebo . The mean + /- SD time to onset of improvement was 13 + /- 1 days and to response was 19 + /- 1 days . Effective antidepressants appeared to trigger and maintain conditions necessary for recovery from the disorder . Odds-ratio analysis based on a r and om-effects model revealed that early improvers were at least 3 times more likely to become sustained responders with a pooled OR of 9.25 , 95 % CI = 7.79 to 10.98 . CONCLUSIONS Affectively ill patients are likely to possess a common , biological , \" resilience\"-like component that largely controls recovery from depression . Once triggered , recovery appears to follow a pattern similar to the course observed with placebo , despite marked pharmacologic differences of the triggers . These findings may pave the way for new classes of psychotropic drugs specifically design ed to support health-oriented processes underlying the natural resilience of patients",
"OBJECTIVE Although the newer antidepressants are widely used , little is known about how long it takes to see their full effect . The authors sought to determine how many weeks a fluoxetine trial with no improvement should continue before treatment is changed . METHOD The data involved 840 patients in a 12-week open trial of fluoxetine , 20 mg/day , followed by a blinded , placebo-controlled discontinuation study . Outcomes at 4 , 6 , 8 , 10 , and 12 weeks were classified as nonresponse , partial response , response , and remission and were based on Hamilton Depression Rating Scale scores . The rate of remission at week 12 was calculated for each group of patients without remission at the earlier time points . The time to relapse during weeks 13 - 26 of the discontinuation study was examined in patients taking placebo and fluoxetine in relation to status at week 6 . RESULTS Patients unimproved at week 6 had a remission rate at week 12 of 31%-41 % . For patients with remission at week 12 , level of improvement at week 6 did not affect prognosis in weeks 13 - 26 . Of the unimproved patients at week 8 , 23 % had remissions by week 12 . The week 12 remission rate for unimproved patients at week 4 was clearly high enough to justify continued treatment ; the rate for unimproved patients at week 10 was too low . CONCLUSIONS These data suggest that nonresponse to fluoxetine should not be declared until 8 weeks of treatment have elapsed . Practitioners should discuss trial length with patients at the beginning of treatment",
"OBJECTIVE The purpose of this study was to quantify the proportion of patients who show no response to a fixed dose of fluoxetine after 2 , 4 , and 6 weeks of treatment and then respond by week 8 . METHOD In an open trial , 143 out patients who met DSM-III-R criteria for major depressive disorder were treated with a regimen of fluoxetine , 20 mg/day . The authors analyzed the proportion of patients who had less than a 20 % decrease from baseline in their scores on the Hamilton Rating Scale for Depression after 2 , 4 , and 6 weeks and who went on to have a 50 % or greater reduction by week 8 . A last-observation-carried-forward strategy was used to calculate conditional probabilities of 8-week response . Kaplan-Meier survival analysis was used to estimate probabilities of response at week 8 given degrees of response at week 2 . RESULTS Eighty-two subjects ( 57.3 % ) who started the trial responded by week 8 . Of those subjects who showed no improvement at weeks 2 , 4 , and 6 , the proportions of responders at week 8 were 36.4 % , 18.9 % , and 6.5 % , respectively . The Kaplan-Meier estimate of 8-week response given nonresponse at week 2 was 0.45 . CONCLUSIONS The proportion of patients with no response to antidepressant treatment by 4 or 6 weeks who responded by week 8 was substantially less than that for subjects who had at least a partial response . Nonresponse as early as week 2 predicted 8-week outcome",
"BACKGROUND In healthy volunteers , exposure to antidepressants increases the recognition of positive face emotions and decreases recognition of negative emotions . It has been proposed that this may underlie therapeutic effects of antidepressants , but to date this has not been tested in clinical population s. METHOD Recognition of facial emotions was measured at baseline ( N=108 ) and after 2 ( N=59 ) and 6 weeks ( N=69 ) of treatment in depressed primary care patients who had been r and omised to treatment with either citalopram ( SSRI ) or reboxetine ( NaRI ) in an open-label study . Changes in emotional processing were compared to clinical outcome after 6 weeks of treatment . RESULTS Significant increases in recognition accuracy of disgust , happiness and surprise occurred by two-weeks of treatment with both antidepressants , and did not further change at 6 weeks . There was a significant correlation between the increased accuracy in recognition of happy faces over the first two-weeks of treatment and the clinical improvement after six-weeks of treatment . LIMITATIONS There was no control group and changes over time may be due to practice effects . CONCLUSIONS Antidepressants altered emotional processing in depressed patients with some similarities to the effects seen in healthy volunteers . The largest effect seen was increased recognition of disgust that may be specific to depressed patients . The correlation between increased accurate recognition of happy faces at two-weeks of treatment and clinical outcome at six-weeks of treatment suggests that early changes in emotional processing may underlie clinical response to antidepressants",
"BACKGROUND Delayed onset of efficacy of antidepressants and a high proportion of depressed patients being poor or non-responders to antidepressants are well known clinical challenges . Therefore , it seems to be necessary to identify predictors for response and - even more important - for remission . It has been suggested that reduction of depressive symptoms at an early stage of antidepressant treatment may predict treatment outcome . Our objective was to test , if this hypothesis derived from r and omized controlled studies ( RCTs ) in out patients , would be confirmed in a large naturalistic study in a cohort of in patients with major depression . Patients were treated with various antidepressants and co-medication according to the protocol based on evidence -based clinical guidelines . METHODS This was a large naturalistic prospect i ve study . All patients ( N=795 ) were hospitalized and met DSM-IV criteria for major depression according to a structured clinical interview ( SCID ) . Assessment s were conducted biweekly . Several definitions of early improvement ( 20 % , 25 % and 30 % reduction in HAMD-21 baseline total scores ) at two different visits were tested . Sensitivity , specificity and predictive values were calculated for the different definitions of early improvement . ROC-analyses as well as logistic regression models have been performed . Response was defined as 50 % improvement of the total baseline HAMD-21 score and remission as a score of time to response was analyzed by computing Kaplan-Meier survival estimates for the \" best \" early improvement definition in comparison to non early improvement . Subgroup analyses were conducted to test whether the results were consistent across treatment subgroups . RESULTS 48.8 % of patients in our sample were remitters . The overall response rate was 79.6 % . A 20 % reduction of HAMD-21 total baseline score at Day 14 provided a sensitivity of 75 % and a specificity of 59 % for response prediction . This definition of early improvement was an even more sensitive predictor for remission ( 80 % ) with a limited specificity ( 43 % ) . The AUC value of about 0.68 for early response ( 20 % improvement ) indicates good predictability for both time intervals tested ( Day 14 and Day 28 ) and changed only marginally with increased percentages in score reduction ( AUC=0.71 and 0.73 , respectively ) . More than one third ( 37 % ) of all patients who had not improved at Day 14 showed not response in the later treatment course ( this was the case for nearly half of all patients ( 43 % ) at Day 28 ) . Similar results were obtained by Kaplan-Meier survival analyses . Log-rank test showed significantly longer time to response in patients with non-early improvement ( p later response and remission , even in hospitalized patients suffering from a more severe degree of depression . Since we used a naturalistic study design , the data may be considered as a replication of previous results drawn from RCTs in a naturalistic environment . We found a global antidepressant effect which was consistent across treatment subgroups regarding sensitivity values . However , we are aware of the inability of effectiveness studies to draw causal treatment relationships from the uncontrolled approach . Nevertheless , the replication of previous results might indicate that a drug switch during treatment in case of lack of early improvement could be accelerated",
"BACKGROUND There is substantial evidence that early improvement ( EI ) under antidepressant treatment is a clinical ly useful predictor of later treatment outcome in patients with major depressive disorders . The aim of this study was to test whether EI can also be used as a predictor for treatment outcome in patients with mild major , minor or subsyndromal depression , i.e. patients , who are typically treated by general practitioners . METHODS Analyses were carried out using data from 223 patients of a 10-weeks r and omized , placebo-controlled trial comparing the effectiveness of sertraline and cognitive-behavioural therapy ( CBT ) in patients with mild major , minor or subsyndromal depression . EI was defined as a reduction of > or = 20 % on the 17-item Hamilton Rating Scale for Depression ( HAMD-17 ) compared with baseline within the first 2 weeks of treatment . The predictive value of EI for stable response at week 8 and 10 ( > or = 50 % HAMD-17 sum score reduction at weeks 8 and 10 ) and stable remission ( HAMD-17 sum score sertraline- and CBT-treatment group , EI was a highly sensitive predictor for later stable response ( 76 % and 82 % , respectively ) and stable remission ( 70 % and 75 % , respectively ) . In patients without EI , only a small proportion of sertraline or CBT-treated patients achieved stable response ( 20.9 % and 5.9 % , respectively ) or stable remission ( 18.6 % and 8.8 % , respectively ) . Patients with EI were by far more likely to achieve stable response or stable remission than patients without as indicated by high odds ratios ( 95 % confidence interval ) of 8.1 ( 3.0 - 21.8 ) and 3.8 ( 1.4 - 10.1 ) for sertraline , and 11.1 ( 2.1 - 58.4 ) and 7.2 ( 1.7 - 30.8 ) for CBT-treated patients , respectively . LIMITATIONS Sample sizes were relatively low in different treatment groups . CONCLUSION The identification of early improvement might be useful in clinical decision making in the early course of treatment of patients with mild major , minor and subthreshold depression"
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4116f2b8-06ff-11f0-808a-c43d1ab1c353
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Asthma is a major public health issue . The co-occurrence of the high prevalence of asthma and vitamin D deficiency documented globally in recent decades has prompted several investigations into a possible association between the two conditions . The objective of this paper was to synthesize the evidence from studies that have measured the association between serum vitamin D and asthma incidence , prevalence , severity and exacerbations . A systematic search of the literature was performed in PubMed , and the available evidence was summarized both qualitatively and by meta- analysis . Only English language , observational studies measuring serum levels of 25(OH)D as the exposure were included , as this is the most robust measure of vitamin D levels . The search identified 23 manuscripts : two case-control , 12 cohort and nine cross-sectional studies . Collectively , the evidence suggests that higher serum levels of 25(OH)D are associated with a reduced risk of asthma exacerbations , but there was little evidence to suggest an association with asthma incidence , prevalence or severity . A significant amount of heterogeneity between study methodology and results restricted the scope for meta- analysis . These results suggest that vitamin D supplementation may be effective for the prevention of asthma exacerbations , but the findings need to be confirmed by clinical trials
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"There is intense interest in the role of vitamin D in the development of asthma and allergies . However , studies differ on whether a higher vitamin D intake or status in pregnancy or at birth is protective against asthma and allergies . To address this uncertainty , the Vitamin D Antenatal Asthma Reduction Trial ( VDAART ) was developed . VDAART is a r and omized , double-blind , placebo-controlled trial of vitamin D supplementation in pregnant women to determine whether prenatal supplementation can prevent the development of asthma and allergies in women 's offspring . A secondary aim is to determine whether vitamin D supplementation can prevent the development of pregnancy complications , such as preeclampsia , preterm birth , and gestational diabetes . Women were r and omized to the treatment arm of 4000IU/day of vitamin D3 plus a daily multivitamin that contained 400IU of vitamin D3 or the placebo arm of placebo plus a multivitamin that contained 400IU daily of vitamin D3 . Women who were between the gestational ages of 10 and 18 weeks were r and omized from three clinical centers across the United States - Boston Medical Center , Washington University in St. Louis , and Kaiser Permanente Southern California Region ( San Diego , CA ) . Supplementation took place throughout pregnancy . Monthly monitoring of urinary calcium to creatinine ratio was performed in addition to medical record review for adverse events . Offspring are being evaluated quarterly through question naires and yearly during in-person visits until the 3rd birthday of the child . Ancillary studies will investigate neonatal T-regulatory cell function , maternal vaginal flora , and maternal and child intestinal flora",
"BACKGROUND Asthma exacerbations , most often caused by respiratory tract infections , are the leading causes of asthma morbidity and comprise a significant proportion of asthma-related costs . Vitamin D status might play a role in preventing asthma exacerbations . OBJECTIVES We sought to assess the relationship between serum vitamin D levels and subsequent severe asthma exacerbations . METHODS We measured 25-hydroxyvitamin D levels in sera collected from 1024 children with mild-to-moderate persistent asthma at the time of enrollment in a multicenter clinical trial of children r and omized to receive budesonide , nedocromil , or placebo ( as-needed beta-agonists ) : the Childhood Asthma Management Program . Using multivariable modeling , we examined the relationship between baseline vitamin D levels and the odds of any hospitalization or emergency department visit over the 4 years of the trial . RESULTS Thirty-five percent of all subjects were vitamin D insufficient , as defined by a level of 30 ng/mL or less 25-hydroxyvitamin D. Mean vitamin D levels were lowest in African American subjects and highest in white subjects . After adjusting for age , sex , body mass index , income , and treatment group , insufficient vitamin D status was associated with a higher odds of any hospitalization or emergency department visit ( odds ratio , 1.5 ; 95 % CI , 1.1 - 1.9 ; P = .01 ) . CONCLUSION Vitamin D insufficiency is common in this population of North American children with mild-to-moderate persistent asthma and is associated with higher odds of severe exacerbation over a 4-year period",
"BACKGROUND Decreased 25-hydroxyvitamin D [ 25(OH)D ] concentrations have been associated with an increased prevalence and severity of asthma and a lower response to inhaled corticosteroids . OBJECTIVE The objective was to determine the association between serum 25(OH)D concentrations and asthma prevalence , severity , and response to asthma treatment . DESIGN Secondary analyses were conducted in 2 sample s of adolescents 12 - 20 y of age : 1 ) NHANES 2001 - 2006 ( n = 6487 ) , a cross-sectional nationally representative sample of the US population , and 2 ) a cohort of inner-city adolescents with asthma managed prospect ively for 46 wk with guidelines -based therapy in the Asthma Control Evaluation ( ACE ; n = 226 ) trial . RESULTS Mean ( ±SD ) serum 25(OH)D concentrations in the NHANES and ACE sample s were lower in African Americans than in non-African Americans ( NHANES : 14.9 ± 6.5 compared with 23.0 ± 8.4 ng/mL , P , mean concentrations did not differ between participants without and with asthma ( African Americans : 14.9 ± 6.4 compared with 15.0 ± 6.6 ng/mL , respectively , P = 0.87 ; non-African Americans : 23.0 ± 8.5 compared with 23.6 ± 8.2 ng/mL , respectively , P = 0.16 ) . In the ACE models that used either a predefined cutoff ( regression , 25(OH)D concentrations showed either no relation or minor contradictory correlations with indicators of asthma severity , treatment requirements , spirometry , or atopy/inflammation . CONCLUSION In 2 sample s of adolescents , overall serum 25(OH)D concentrations were low and were not consistently associated with the presence of asthma , multiple asthma characteristics , asthma morbidity , or response to treatment . The ACE trial was registered at clinical trials.gov as NCT0011441",
"Objective : To investigate whether exposure to high maternal concentrations of 25(OH)-vitamin D in pregnancy poses any risk to the child . Design : Prospect i ve study . Setting : Princess Anne Maternity Hospital , Southampton , UK.Subjects : A group of 596 pregnant women were recruited . A total of 466 ( 78 % ) children were examined at birth , 440 ( 74 % ) at age 9 months and 178 ( 30 % ) at age 9 years . Methods : Maternal 25 (OH)-vitamin D concentrations were measured in late pregnancy . Anthropometry of the child was recorded at birth , 9 months and 9 years . At 9 months , atopic eczema was assessed . At 9 years , children had an echocardiogram and a dual energy x-ray absorptiometry scan , blood pressure , arterial compliance and carotid intima-media thickness were measured and intelligence and psychological function assessed . Results : There were no associations between maternal 25(OH)-vitamin D concentrations and the child 's body size or measures of the child 's intelligence , psychological health or cardiovascular system . Children whose mothers had a 25(OH)-vitamin D concentration in pregnancy > 75 nmol/l had an increased risk of eczema on examination at 9 months ( OR 3.26 , 95 % CI 1.15–9.29 , P=0.025 ) and asthma at age 9 years ( OR 5.40 , 95 % CI , 1.09–26.65 , P=0.038 ) compared to children whose mothers had a concentration of child 's intelligence , psychological health or cardiovascular system ; there could be an increased risk of atopic disorders , but this needs confirmation in other studies .Sponsorship : The study was supported by the Medical Research Council and WellChild ( previously known as Children Nationwide )",
"Objective To define the therapeutic role of vitamin D in children with moderate to severe bronchial asthma as an adjunct to st and ard treatment . Methods Hundred asthmatic children of either sex , attending the respiratory and asthma clinic were enroled in the study . Diagnosis was made on the basis of history and clinical examination . R and omization was done using sealed opaque envelop method . In addition to the treatment as per GINA guidelines , one group received oral vitamin D3 ( Cholecalciferol ) 60,000 IU per month for 6 mo and the other group received placebo powder in the form of glucose sachet with a double blinded design . Monthly follow up of every patient was done and during every visit change in severity , level of control , Peak expiratory flow rate ( PEFR ) , steroid dosage , number of exacerbations and number of emergency visits were assessed . Results Monthly doses of 60,000 IU vitamin D significantly reduced the number of exacerbations as compared to placebo ( p = 0.011 ) . PEFR significantly increased in the treatment group ( p = 0.000 ) . Monthly doses of vitamin D significantly reduced the requirement of steroids ( p = 0.013 ) and emergency visits ( p = 0.015 ) . Control of asthma was achieved earlier in patients who received monthly vitamin D. Vitamin D significantly reduced the level of severity of asthma patients over 6 mo of treatment ( p = 0.016 ) . Conclusions Vitamin D has a definite role in the management of moderate to severe persistent bronchial asthma as an adjunct to st and ard treatment",
"IMPORTANCE In asthma and other diseases , vitamin D insufficiency is associated with adverse outcomes . It is not known if supplementing inhaled corticosteroids with oral vitamin D3 improves outcomes in patients with asthma and vitamin D insufficiency . OBJECTIVE To evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels . DESIGN , SETTING , AND PARTICIPANTS The VIDA ( Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma ) r and omized , double-blind , parallel , placebo-controlled trial study ing adult patients with symptomatic asthma and a serum 25-hydroxyvitamin D level of less than 30 ng/mL was conducted across 9 academic US medical centers in the National Heart , Lung , and Blood Institute 's AsthmaNet network , with enrollment starting in April 2011 and follow-up complete by January 2014 . After a run-in period that included treatment with an inhaled corticosteroid , 408 patients were r and omized . INTERVENTIONS Oral vitamin D3 ( 100,000 IU once , then 4000 IU/d for 28 weeks ; n = 201 ) or placebo ( n = 207 ) was added to inhaled ciclesonide ( 320 µg/d ) . If asthma control was achieved after 12 weeks , ciclesonide was tapered to 160 µg/d for 8 weeks , then to 80 µg/d for 8 weeks if asthma control was maintained . MAIN OUTCOMES AND MEASURES The primary outcome was time to first asthma treatment failure ( a composite outcome of decline in lung function and increases in use of β-agonists , systemic corticosteroids , and health care ) . RESULTS Treatment with vitamin D3 did not alter the rate of first treatment failure during 28 weeks ( 28 % [ 95 % CI , 21%-34 % ] with vitamin D3 vs 29 % [ 95 % CI , 23%-35 % ] with placebo ; adjusted hazard ratio , 0.9 [ 95 % CI , 0.6 - 1.3 ] ) . Of 14 prespecified secondary outcomes , 9 were analyzed , including asthma exacerbation ; of those 9 , the only statistically significant outcome was a small difference in the overall dose of ciclesonide required to maintain asthma control ( 111.3 µg/d [ 95 % CI , 102.2 - 120.4 µg/d ] in the vitamin D3 group vs 126.2 µg/d [ 95 % CI , 117.2 - 135.3 µg/d ] in the placebo group ; difference of 14.9 µg/d [ 95 % CI , 2.1 - 27.7 µg/d ] ) . CONCLUSIONS AND RELEVANCE Vitamin D3 did not reduce the rate of first treatment failure or exacerbation in adults with persistent asthma and vitamin D insufficiency . These findings do not support a strategy of therapeutic vitamin D3 supplementation in patients with symptomatic asthma . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01248065",
"BACKGROUND Research suggests an influence of micronutrients on childhood asthma . So far , evidence mainly originates from cross-sectional studies using nutrient intake data , which is not an accurate measure of nutrient status . This study aim ed to investigate the cross-sectional and prospect i ve associations between serum concentrations of magnesium , vitamin D , selenium , and zinc and prevalence of ( severe ) asthma , atopy , and bronchial hyperresponsiveness ( BHR ) in childhood . METHODS In the Prevention and Incidence of Asthma and Mite Allergy birth cohort study , serum nutrient concentrations were available for a 4-yr-old subgroup ( n = 372 ) and for a different 8-yr-old subgroup ( n = 328 ) . Yearly question naires inquired about asthma prevalence until 8 yr of age . Allergic sensitization was measured at 4 and 8 yr of age ; BHR was measured at 8 yr of age . Data were analyzed with logistic regression and generalized estimating equations models . RESULTS There was a consistent ( non-significant ) inverse association between serum magnesium concentrations and asthma prevalence . Serum vitamin D concentrations measured at age 4 were inversely associated with asthma at ages 4 - 8 [ e.g. , cross-sectional association between vitamin D tertile 3 vs. 1 and severe asthma : odds ratio ( OR ) : 0.49 , 95 % confidence interval ( CI ) : 0.25 - 0.95 ] , whereas vitamin D measured at age 8 was positively associated with asthma at age 8 ( e.g. , cross-sectional association between vitamin D tertile 3 vs. 1 and severe asthma : OR : 2.14 , 95 % CI : 0.67 - 6.82 ) . CONCLUSIONS Our study contributes to the evidence that children with higher serum magnesium concentrations are less likely to have asthma . The associations between serum vitamin D concentrations and asthma were age-dependent"
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4116f2f4-06ff-11f0-808a-c43d1ab1c353
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A systematic review was conducted to summarize the evidence currently available from r and omized controlled trials ( RCTs ) concerning the effect of iron intake of infants , children and adolescents on measures of cognitive development and function . The Cochrane Library , MEDLINE and Embase were search ed up to and including February 2010 . Studies were also identified by checking the bibliographies of the articles retrieved . All RCTs with an adequate control group in which iron supply was provided by natural food sources , fortified foods , formula or supplements to infants , children or adolescents until the age of 18 years were considered for inclusion . No language restrictions were applied . Fourteen studies met the selection criteria . Twelve out of these 14 studies had a high or moderate risk of bias . A large degree of heterogeneity of study population s , iron dosages and outcome measures precluded performing a quantitative meta- analysis . Overall , the studies suggest a modest positive effect of iron supplementation on cognition and psychomotor outcomes in anemic infants and children after supplementation periods of at least 2 months of duration
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"To assess the effects of iron therapy on developmental test scores in infants with iron deficiency anemia , 68 Guatemalan babies 6 to 24 months of age , with and without mild iron deficiency anemia , were tested with the Bayley Scales of Infant Development before and after one week of oral iron treatment . The two major findings of the study were developmental deficits in the anemic group prior to treatment , and lack of rapid improvement with short-term oral iron therapy . The mean pretreatment Mental Development Index of the anemic group was significantly lower than that of nonanemic infants . The anemic group 's pretreatment Psychomotor Development Index was also lower than that of the nonanemic control group . In a double-blind r and omized study , six to eight days of oral iron therapy did not reverse these deficits . Consequently , the deficits of the anemic group can not be unequivocably attributed to iron lack . However , no significant differences were found between anemic and nonanemic groups in birth histories , socioeconomic level , or general nutritional status which might otherwise explain the lower developmental test scores of the anemic babies ",
"Many studies have reported comparable hemoglobin response in subjects given intermittent and daily iron supplements . However , the effect of intermittent iron supplementation on impaired cognitive function , one of the serious consequences of iron deficiency among children , has not been studied . We investigated the effects of 1 d/wk ( weekly ) and 5 d/wk ( daily ) iron supplementation on changes in results of intelligence quotient ( IQ ) , Thai language , and mathematics tests among Thai primary schoolchildren . A double-blind , r and omized , placebo-controlled trial was conducted . Primary schoolchildren ( n = 397 ) were r and omly assigned to receive iron supplements daily or weekly or placebo . Ferrous sulfate ( 300 mg ) or placebo tablets were given under direct observation by the research er for 16 wk . Changes in IQ , and Thai language and mathematics scores were then compared . The increases in hemoglobin concentration were comparable in the weekly and daily iron supplementation groups but serum ferritin increased more in the children supplemented daily . Children receiving daily iron supplements , however , had a significantly lower increase in IQ ( 3 + /- 12 points ) than those receiving the supplement weekly ( 6 + /- 12 points ) or placebo ( 6 + /- 12 points ) , whereas the last-mentioned two groups did not differ . Z-scores of Thai language and mathematics test results did not differ among the groups . We conclude that weekly iron supplementation is the regimen of choice in this study community",
"The present study investigates the effect of iron supplementation on measures of school performance among 78 iron-deficient anemic and 41 nonanemic children in an economically deprived rural area in Central Java , Indonesia . All the subjects were treated for ancylostomiasis before iron supplementation . They were r and omly assigned to either an iron or placebo group . Hematological and behavioral measurements were obtained immediately before ( T1 ) and after ( T2 ) the iron and placebo treatments . Iron treatment for a 3-mo period result ed in substantive increases in mean Hgb , Hct , and transferrin saturation among the iron-deficient anemic children . Furthermore , changes in the iron status of iron-deficient anemic children were associated with significant changes in the school achievement test scores of iron-deficient anemic children . T2 evaluation of achievement test scores indicated that the difference between iron-treated anemic and nonanemic children was still statistically significant . However , when T1 scores were entered as a covariate , iron-deficient anemic subjects treated with iron obtained significantly higher delta achievement scores . Findings from the present study indicate that iron supplementation among iron-deficient anemic children benefits learning processes as measured by the school achievement test scores",
"BACKGROUND Deficiencies of iron and zinc are associated with delayed development , growth faltering , and increased infectious-disease morbidity during infancy and childhood . Combined iron and zinc supplementation may therefore be a logical preventive strategy . OBJECTIVE The objective of the study was to compare the effects of combined iron and zinc supplementation in infancy with the effects of iron and zinc as single micronutrients on growth , psychomotor development , and incidence of infectious disease . DESIGN Indonesian infants ( n = 680 ) were r and omly assigned to daily supplementation with 10 mg Fe ( Fe group ) , 10 mg Zn ( Zn group ) , 10 mg Fe and 10 mg Zn ( Fe+Zn group ) , or placebo from 6 to 12 mo of age . Anthropometric indexes , developmental indexes ( Bayley Scales of Infant Development ; BSID ) , and morbidity were recorded . RESULTS At 12 mo , two-factor analysis of variance showed a significant interaction between iron and zinc for weight-for-age z score , knee-heel length , and BSID psychomotor development . Weight-for-age z score was higher in the Zn group than in the placebo and Fe+Zn groups , knee-heel length was higher in the Zn and Fe groups than in the placebo group , and the BSID psychomotor development index was higher in the Fe group than in the placebo group . No significant effect on morbidity was found . CONCLUSIONS Single supplementation with zinc significantly improved growth , and single supplementation with iron significantly improved growth and psychomotor development , but combined supplementation with iron and zinc had no significant effect on growth or development . Combined , simultaneous supplementation with iron and zinc to infants can not be routinely recommended at the iron-to-zinc ratio used in this study",
"The effects of oral iron supplementation on blood iron levels and learning achievement in 130 rural Indonesian school children were assessed in this double-blind study . The children were classified into anemic and nonanemic groups according to their initial hemoglobin and transferrin saturation levels and were r and omly assigned to either iron or placebo treatment for 3 mo . Hematological , anthropometric , and learning-achievement data were collected before ( T1 ) and after ( T2 ) the treatment period and 3 mo later . The means and st and ard deviations suggest that supplementation with 10 mg ferrous sulfate per kilogram body weight per day for 3 mo result ed in an apparent improvement in anemic subjects ' hematological status and learning-achievement scores . No tests of statistical comparisons are reported",
"A double-blind clinical trial was conducted in Indonesia to assess effects of iron supplementation on performance of iron-depleted and iron-deficient anemic children in discrimination and oddity learning tasks . Half these children received elemental Fe for 8 wk ; the others received a placebo . There were significant changes from pre- to postintervention evaluations in ferritin , transferrin saturation , free erythrocyte protoporphyrin , and hemoglobin among the anemic and iron-depleted children ; no changes were observed among the placebos or any of the iron-replete children . The magnitude of hematological changes in anemic children treated with iron was small ; yet , after treatment the children 's mean ferritin , transferrin saturation , and hemoglobin values were above the cutoff points used for the definition of iron-deficiency anemia ( IDA ) . Pre- and posttreatment psychological test data show that IDA produces alterations in cognitive processes related to visual attention and concept acquisition , alterations reversed with iron treatment",
"Objective : To examine effects of iron supplementation on vigilance , attention and conceptual learning in preschool children in Greece . Design : R and omized Double-Blind Placebo Controlled trial of iron . R and omization stratified by iron status and day care center ( DCC ) . Setting : Nine public DCCs in Athens , Greece . Subjects : In all , 49 3–4-y olds ( 21 anemic , 28 good iron status ) with birth weight not less than 2500 g , currently healthy ; benign past medical history , IQ ≥1 s.d . below the age-adjusted mean , serum Pb ≤200 ppb ( none exceeded 50 ppb ) , and height , weight and head circumference for age ≥10th percentile . Anemia defined as : ( 1 ) pretreatment Hgb Hgb rise of > 10 g/l ( T2–T0 ) with iron supplementation . Good iron status was defined as baseline levels of Hgb > 120 g/l and either TS > 20 % or serum ferritin > 12 μg/l . Intervention : The intervention consisted of a 2–month supplementation of 15 mg iron ( and MV ) vs placebo ( MV alone ) . Results : After iron treatment , the anemic subjects made significantly fewer errors of commission ( 14 % higher specificity , P higher accuracy ( P more efficient ( mean difference=1.09 , P given placebo . These effects of iron were not found among preschoolers with good iron status . No effects of iron treatment were found on the Oddity Learning task . Conclusions : This study demonstrated that iron supplementation of iron-deficient anemic preschoolers results in an improvement in discrimination , specifically selective attention . Sponsorship : University of California , Davis and Nutricia Corporation",
"BACKGROUND Previous studies on the cognitive effects of iron treatment have focused on anemic or non-anemic iron-deficient infants . The effect of iron supplementation on cognitive development among iron-sufficient infants has not been studied . The aim of the present study was to examine the effect of iron supplementation on performance in the Bayley Scales of Infant Development ( BSID ) and anthropometric measurement in 6-month-old iron-sufficient healthy infants . METHODS Healthy , iron-sufficient infants who were 6 months of age and were attending the Well Baby Clinic were considered for enrollment . Infants were r and omly assigned to take ferrous sulfate supplementation ( 1 mg/kg per day ) or no supplementation and were followed for 3 months . Anthropometric measurement , hematologic status and BSID were evaluated on admission and after 3 months . RESULTS Seven infants in the intervention group and nine in the control group completed the study . No significant differences were observed in anthropometric measurements and complete blood counts between the two groups after the 3 month study period . The mean transferrin saturation ( TS ) level decreased significantly in the control group during the study period ( from 15.3+/-2.6 to 7.8+/-5.1 % ; P = 0.0117 ) , but no such reduction was seen in the intervention group . At the end of the study , the TS of the control group was found to be significantly lower than that of the intervention group ( 7.8+/-5.1 vs. 19.9+/-7.9 % , respectively ; P = 0.0033 ) . The BSID scores of infants in both groups were within the normal range on admission and at the end of the study period . CONCLUSIONS Short-term iron supplementation did not change developmental test scores despite the hematologic response in iron-sufficient healthy infants . The high prevelance of iron-deficiency anemia and its relationship with adverse developmental outcome suggests that prevention of iron-deficiency anemia with prophylaxis needs to be emphasized , rather than treatment",
"Four studies examined impacts of iron supplementation on school children of various ages and both sexes . The first study investigated impact of iron-folic acid supplements for 60 d on cognition in 94 boys and girls aged 5 - 8 y. Improvement in total scores of the anemics was significantly higher than the nonanemics in 7 - 8-y-old children only . The second study assessed impacts of supplementation on cognition in 14 pairs of 5 - 6-y-old anemic boys , with clear beneficial effects on cognitive function . The third study investigated effects of varying dosages of elemental iron on cognitive function in 48 boys aged 8 - 15 y , with different levels of improvement . The fourth study investigated impacts of iron supplementation on 163 anemic girls aged 8 - 15 y with treatment and evaluations at 4 and 8 mo , with significantly improved scores in cognitive function after the eighth month",
"This double-blind clinical trial was conducted in Thail and to assess the impact of iron treatment on the IQ and educational attainment of 1358 9 - 11-y-old children . The children were classified into one of three groups : iron replete , iron depleted , and iron-deficient anemic . The Raven Progressive Matrices was used to measure IQ . A Thai language and a math test were administered to assess school attainment . A 50-mg/d tablet of ferrous sulphate was given for 2 wk and a 100 mg/d tablet , for 14 wk . An anthelminthic drug was given on the day of the blood test before treatment and 3 mo after the intervention started . There is evidence of a positive association between iron status and IQ and a language school achievement test but there is no support for the internal validity of the hypothesis that this association is causal",
"BACKGROUND Up to 25 % of adolescent girls in the USA are iron deficient . This double-blind , placebo-controlled clinical trial assessed the effects of iron supplementation on cognitive function in adolescent girls with non-anaemic iron deficiency . METHODS 716 girls who enrolled at four Baltimore high schools were screened for non-anaemic iron deficiency ( serum ferritin Participants were r and omly assigned oral ferrous sulphate ( 650 mg twice daily ) or placebo for 8 weeks . The effect of iron treatment was assessed by question naires and haematological and cognitive tests , which were done before treatment started and repeated after the intervention . We used four tests of attention and memory to measure cognitive functioning . Intention-to-treat and per- protocol analyses were done . FINDINGS Of the 81 enrolled girls with non-anaemic iron deficiency , 78 ( 96 % ) completed the study ( 39 in each group ) . Five girls ( three control , two treatment ) developed anaemia during the intervention and were excluded from the analyses . Thus , 73 girls were included in the per- protocol analysis . Ethnic distribution , mean age , serum ferritin concentrations , haemoglobin concentrations , and cognitive test scores of the groups did not differ significantly at baseline . Postintervention haematological measures of iron status were significantly improved in the treatment group ( serum ferritin 27.3 vs 12.1 micrograms/L , p iron performed better on a test of verbal learning and memory than girls in the control group ( p this urban population of non-anaemic iron-deficient adolescent girls , iron supplementation improved verbal learning and memory",
"The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . To encourage dissemination of the CONSORT 2010 Statement , this article is freely accessible on bmj.com and will also be published in the Lancet , Obstetrics and Gynecology , PLoS Medicine , Annals of Internal Medicine , Open Medicine , Journal of Clinical Epidemiology , BMC Medicine , and Trials"
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BACKGROUND Seasonal affective disorder ( SAD ) is a seasonal pattern of recurrent major depressive episodes that most commonly occurs during autumn or winter and remits in spring . The prevalence of SAD ranges from 1.5 % to 9 % , depending on latitude . The predictable seasonal aspect of SAD provides a promising opportunity for prevention . This review - one of four review s on efficacy and safety of interventions to prevent SAD - focuses on light therapy as a preventive intervention . Light therapy is a non-pharmacological treatment that exposes people to artificial light . Mode of delivery ( e.g. visors , light boxes ) and form of light ( e.g. bright white light ) vary . OBJECTIVES To assess the efficacy and safety of light therapy ( in comparison with no treatment , other types of light therapy , second-generation antidepressants , melatonin , agomelatine , psychological therapies , lifestyle interventions and negative ion generators ) in preventing SAD and improving patient-centred outcomes among adults with a history of SAD . SEARCH METHODS A search of the Specialised Register of the Cochrane Depression , Anxiety and Neuorosis Review Group ( CCDANCTR ) included all years to 11 August 2015 . The CCDANCTR contains reports of relevant r and omised controlled trials derived from EMBASE ( 1974 to date ) , MEDLINE ( 1950 to date ) , PsycINFO ( 1967 to date ) and the Cochrane Central Register of Controlled Trails ( CENTRAL ) . Furthermore , we search ed the Cumulative Index to Nursing and Allied Health Literature ( CINAHL ) , Web of Knowledge , The Cochrane Library and the Allied and Complementary Medicine Data base ( AMED ) ( to 26 May 2014 ) . We also conducted a grey literature search and h and search ed the reference lists of all included studies and pertinent review articles . SELECTION CRITERIA For efficacy , we included r and omised controlled trials on adults with a history of winter-type SAD who were free of symptoms at the beginning of the study . For adverse events , we also intended to include non-r and omised studies . We intended to include studies that compared any type of light therapy ( e.g. bright white light , administered by visors or light boxes , infrared light , dawn stimulation ) versus no treatment/placebo , second-generation antidepressants ( SGAs ) , psychological therapies , melatonin , agomelatine , lifestyle changes , negative ion generators or another of the aforementioned light therapies . We also planned to include studies that looked at light therapy in combination with any comparator intervention and compared this with the same comparator intervention as monotherapy . DATA COLLECTION AND ANALYSIS Two review authors screened abstract s and full-text publications against the inclusion criteria . Two review authors independently abstract ed data and assessed risk of bias of included studies . MAIN RESULTS We identified 2986 citations after de-duplication of search results . We excluded 2895 records during title and abstract review . We assessed 91 full-text papers for inclusion in the review , but only one study providing data from 46 people met our eligibility criteria . The included r and omised controlled trial ( RCT ) had method ological limitations . We rated it as having high risk of performance and detection bias because of lack of blinding , and as having high risk of attrition bias because study authors did not report reasons for dropouts and did not integrate data from dropouts into the analysis .The included RCT compared preventive use of bright white light ( 2500 lux via visors ) , infrared light ( 0.18 lux via visors ) and no light treatment . Overall , both forms of preventive light therapy reduced the incidence of SAD numerically compared with no light therapy . In all , 43 % ( 6/14 ) of participants in the bright light group developed SAD , as well as 33 % ( 5/15 ) in the infrared light group and 67 % ( 6/9 ) in the non-treatment group . Bright light therapy reduced the risk of SAD incidence by 36 % ; however , the 95 % confidence interval ( CI ) was very broad and included both possible effect sizes in favour of bright light therapy and those in favour of no light therapy ( risk ratio ( RR ) 0.64 , 95 % CI 0.30 to 1.38 ) . Infrared light reduced the risk of SAD by 50 % compared with no light therapy , but in this case also the CI was too broad to allow precise estimations of effect size ( RR 0.50 , 95 % CI 0.21 to 1.17 ) . Comparison of both forms of preventive light therapy versus each other yielded similar rates of incidence of depressive episodes in both groups ( RR 1.29 , 95 % CI 0.50 to 3.28 ) . The quality of evidence for all outcomes was very low . Reasons for downgrading evidence quality included high risk of bias of the included study , imprecision and other limitations , such as self rating of outcomes , lack of checking of compliance throughout the study duration and insufficient reporting of participant characteristics . Investigators provided no information on adverse events . We could find no studies that compared light therapy versus other interventions of interest such as SGA , psychological therapies , melatonin or agomelatine . AUTHORS ' CONCLUSIONS Evidence on light therapy as preventive treatment for patients with a history of SAD is limited . Method ological limitations and the small sample size of the only available study have precluded review author conclusions on effects of light therapy for SAD . Given that comparative evidence for light therapy versus other preventive options is limited , the decision for or against initiating preventive treatment of SAD and the treatment selected should be strongly based on patient preferences
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"The effectiveness of light therapy in seasonal affective disorder ( SAD ) was evaluated in 105 subjects across five centers . Three intensities of light ( 60 lux , 600 lux , and 3500 lux ) were used in a 2-week r and omized , parallel design . There was no significant difference in antidepressant efficacy of the three intensities of light . All three intensities produced a similar frequency of antidepressant response to each other and to that reported in previous studies . There were site differences in the severity of depression during light treatment , but diagnosis and medication status did not affect antidepressant response . These findings suggest that light therapy has an antidepressant action by a nonspecific effect or that light is biologically active in the treatment of SAD across a wide range of intensities",
" Fifty-five patients with winter seasonal affective disorder ( SAD ) were treated with a light visor , a newly developed portable light-delivery system , in a controlled parallel design . A dim ( 400 lux ) visor was compared with a bright ( 6000 lux ) visor for either 30 or 60 minutes in the morning for 1 week . Response rates for these two treatments were 36 % and 56 % , respectively ; the duration of treatment sessions did not affect outcome . There was no evidence that the brighter visor was superior in efficacy to the dimmer one . Significantly greater relapse occurred following withdrawal of the dimmer visor . Alterative explanations for these findings are that the light visor is acting as a placebo or that it is equally effective over a wide range of intensities",
"Background There are controversies about the most effective treatment to eradicate first growth of Pseudomonas aeruginosa ( P aeruginosa ) from the lower airways of patients with cystic fibrosis ( CF ) . UK guidelines recommend oral treatment , but some advocate intravenous ( IV ) treatment . The objective of this study was to assess the feasibility of conducting a r and omised controlled trial comparing two treatment strategies to eradicate P aeruginosa in CF patients . Methods /Principal Findings Two surveys were conducted . Survey [ 1 ] included clinicians who were responsible for the treatment of individuals with CF , to assess their clinical practice , opinions and numbers of potentially eligible patients . Survey [ 2 ] included adults and young people aged 13 years or more with CF and parents of children with CF aged less than 13 years , identified at six UK CF centres , who fulfilled eligibility criteria for the proposed clinical trial , to assess their views about the interventions and their willingness to participate in the trial . Generally clinicians treat first or new growth of P aeruginosa with oral antibiotics , but 90 % reported that they would consider IV treatment of first isolation of P aeruginosa . 74 % of clinicians would consider recruiting their patients and 45 % of consumers would consider entry for themselves or their children into a trial comparing oral with intravenous antibiotics . The median rate per annum for first or new growths of P aeruginosa in adults was 3 % ( range 1 % to 9 % ) and in children was 10 % ( range 3 % to 23 % ) . If the trial was conducted across the UK , with a consent rate of 45 % , then the number of eligible patients per annum who would be willing to take part in a study would be approximately 41 adults and 203 children . Conclusions This work demonstrates the importance of feasibility studies in preparation for multicentre clinical trials . It confirmed the uncertainty amongst clinicians and patients about the clinical question , enabled assessment of the number of potentially eligible patients , the proportion of patients and clinicians prepared to participate and aspects of trial design which might encourage this . It showed that a clinical trial was feasible , but only if patients were recruited from across United Kingdom",
" In patients with winter seasonal affective disorder ( SAD ) the onset of a depressive episode is probably associated with the decreasing amount of light during the autumn . A highly predictable onset of a recurrent depressive episode with seasonal pattern provides a rationale for testing the efficacy of bright-light treatment as a preventive measure . Twelve out- patients with winter SAD were assigned to start bright light treatment either when they were well , or not to start it until the first symptoms of depression had already emerged . The severity of depressive symptoms was prospect ively rated for a parallel r and omized comparison . Bright light given well in advance of the emerging symptoms prevented a depressive episode . Clinical remission was significantly more frequent in the former subgroup of the patients in January and in March . To sum up , bright light can be successfully administered as prophylactic treatment for the prevention of winter SAD",
"The objectives of this prospect i ve study were to investigate the influence of comorbid disorders and that of continuation light treatment on remission rates and on a subsequent onset of a depressive episode in out patients ( n = 20 ) with winter depression . The effects of light treatment were evaluated by the structured clinical interviews and by the self-ratings of mood scored monthly for a follow-up period of 1 year . The remission rates of the patients ( n = 8) who proceeded light treatment until the late winter were not significantly different from those of the patients ( n = 6 ) who stopped treatment early during the winter . A more extensive variation in the rates during the year was observed in the former group of patients among whom the comorbid avoidant personality was more frequent , indicating an increased risk of an earlier onset of a depressive episode",
" Of 39 diagnosed Seasonal Affective Disorder ( SAD ) patients who were interviewed 2 - 5 years after participation in a light therapy trial , 10 continued to have recurrent major depressive episodes in winter , and 17 manifested sub-syndromal SAD ( 2 patients also had recurrent brief depression , seasonal type ) . 8 patients had recovered , and 4 had shifted in symptomatology . Thus , over a number of years , the clinical diagnosis changed for the better in 64 % of the patients , suggesting that SAD is not a prodromal form of a more chronic major affective disorder , and that light therapy ( and perhaps also light-oriented behaviour ) reduced the incidence and depth of subsequent depressive episodes . Further evidence for this was the large reduction in use of conventional antidepressant drugs ( from 17 to 1 ) during the follow-up period . Diagnosis of SAD was stable and reliable",
"Seasonal affective disorder ( SAD ) is a syndrome characterized by recurrent depressions that occur annually at the same time each year . We describe 29 patients with SAD ; most of them had a bipolar affective disorder , especially bipolar II , and their depressions were generally characterized by hypersomnia , overeating , and carbohydrate craving and seemed to respond to changes in climate and latitude . Sleep recordings in nine depressed patients confirmed the presence of hypersomnia and showed increased sleep latency and reduced slow-wave ( delta ) sleep . Preliminary studies in 11 patients suggest that extending the photoperiod with bright artificial light has an antidepressant effect ",
"Background Seasonal affective disorder ( SAD ) is a subtype of recurrent depression involving major depressive episodes during the fall and /or winter months that remit in the spring . The central public health challenge in the management of SAD is prevention of winter depression recurrence . Light therapy ( LT ) is the established and best available acute SAD treatment . However , long-term compliance with daily LT from first symptom through spontaneous springtime remission every fall/winter season is poor . Time-limited alternative treatments with effects that endure beyond the cessation of acute treatment are needed to prevent the annual recurrence of SAD . Methods / design This is an NIMH-funded R01-level r and omized clinical trial to test the efficacy of a novel , SAD-tailored cognitive-behavioral group therapy ( CBT ) against LT in a head-to-head comparison on next winter outcomes . This project is design ed to test for a clinical ly meaningful difference between CBT and LT on depression recurrence in the next winter ( the primary outcome ) . This is a concurrent two-arm study that will r and omize 160 currently symptomatic community adults with major depression , recurrent with seasonal pattern , to CBT or LT . After 6 weeks of treatment in the initial winter , participants are followed in the subsequent summer , the next winter , and two winters later . Key method ological issues surround timing study procedures for a predictably recurrent and time-limited disorder with a focus on long-term outcomes . Discussion The chosen design answers the primary question of whether prior exposure to CBT is associated with a substantially lower likelihood of depression recurrence the next winter than LT . This design does not test the relative contributions of the cognitive-behavioral treatment components vs. nonspecific factors to CBT ’s outcomes and is not adequately powered to test for differences or equivalence between cells at treatment endpoint . Alternative design s addressing these limitations would have required more patients , increased costs , and reduced power to detect a difference in the primary outcome .Trial registration Clinical trials.gov identifier",
"Seasonal affective disorder ( SAD ) , winter type , is characterized by the occurrence of depression in autumn/winter , followed by a complete recovery in spring/summer . In SAD patients , some atyp- ical symptoms are highly characteristic , such as hypersomnia , carbohydrate craving , weight gain , fatigue , and loss of social inter- actions ( Rosenthal et ai 1984 ) . The repeated occurrence of symp- toms during successive winters is one of the diagnostic criteria , l ~ lot every SAD patient becomes depressed every year , however . In prospect i ve studies it was found that 70,4 % of the SAD diagnosed subjects who were followed from a symptom-free moment at the end of September , became depressed during the following winter ( Meesters et al 1991 ; 1993a ) , In a previous study it was found that severe winter depression can be prevented by light treatment administered at the first signs of an emerging winter depression , that is , the moment subjects reported complaints of slight depression ( Meesters et al 1991 ; 1993a ) . In the present study , the question was raised whether light exposure given at the beginning of the winter season , when sub- jeers are still free of symptoms , could be successful in preventing the development of a winter depressmn during the rest of the season . Such a ueatment , which might prevent depression alto- gether , would be highly advantageous",
"BACKGROUND The suppression of melatonin by light at 00.30 hours has been shown to be greater in winter than in summer on patients with seasonal affective disorder ( SAD ) but not in matched normal controls . METHOD In this study 12 patients with SAD and 12 matched normal controls were exposed to morning light therapy in the winter . Melatonin profiles and sensitivity to light were measured before and after treatment . RESULTS The SAD but not the normal group showed a phase advance of melatonin rhythms in response to phototherapy . There was an association between phase position and phase shift in the SAD but not in the normal group . CONCLUSIONS There may be instability of circadian rhythms in SAD mediated by a high-amplitude phase response curve , rather than a fixed phase abnormality as had been previously suggested . This instability may be secondary to impaired serotoninergic function in the afferent pathways to the suprachiasmatic nuclei",
"OBJECTIVE Light therapy and antidepressants have shown comparable efficacy in separate studies of seasonal affective disorder treatment , but few studies have directly compared the two treatments . This study compared the effectiveness of light therapy and an antidepressant within a single trial . METHOD This double-blind , r and omized , controlled trial was conducted in four Canadian centers over three winter seasons . Patients met DSM-IV criteria for major depressive disorder with a seasonal ( winter ) pattern and had scores > or = 23 on the 24-item Hamilton Depression Rating Scale . After a baseline observation week , eligible patients were r and omly assigned to 8 weeks of double-blind treatment with either 1 ) 10,000-lux light treatment and a placebo capsule , or 2 ) 100-lux light treatment ( placebo light ) and fluoxetine , 20 mg/day . Light treatment was applied for 30 minutes/day in the morning with a fluorescent white-light box ; placebo light boxes used neutral density filters . RESULTS A total of 96 patients were r and omly assigned to a treatment condition . Intent-to-treat analysis showed overall improvement with time , with no differences between treatments . There were also no differences between the light and fluoxetine treatment groups in clinical response rates ( 67 % for each group ) or remission rates ( 50 % and 54 % , respectively ) . Post hoc testing found that light-treated patients had greater improvement at 1 week but not at other time points . Fluoxetine was associated with greater treatment-emergent adverse events ( agitation , sleep disturbance , palpitations ) , but both treatments were generally well-tolerated with no differences in overall number of adverse effects . CONCLUSIONS Light treatment showed earlier response onset and lower rate of some adverse events relative to fluoxetine , but there were no other significant differences in outcome between light therapy and antidepressant medication . Although limited by lack of a double-placebo condition , this study supports the effectiveness and tolerability of both treatments for seasonal affective disorder and suggests that other clinical factors , including patient preference , should guide selection of first-line treatment",
"Background Depression frequently occurs in the elderly and in patients suffering from dementia . Its cause is largely unknown , but several studies point to a possible contribution of circadian rhythm disturbances . Post-mortem studies on aging , dementia and depression show impaired functioning of the suprachiasmatic nucleus ( SCN ) which is thought to be involved in the increased prevalence of day-night rhythm perturbations in these conditions . Bright light enhances neuronal activity in the SCN . Bright light therapy has beneficial effects on rhythms and mood in institutionalized moderate to advanced demented elderly . In spite of the fact that this is a potentially safe and inexpensive treatment option , no previous clinical trial evaluated the use of long-term daily light therapy to prevent worsening of sleep-wake rhythms and depressive symptoms in early to moderately demented home-dwelling elderly . Methods / Design This study investigates whether long-term daily bright light prevents worsening of sleep-wake rhythms and depressive symptoms in elderly people with memory complaints . Patients with early Alzheimer 's Disease ( AD ) , Mild Cognitive Impairment ( MCI ) and Subjective Memory Complaints ( SMC ) , between the ages of 50 and 75 , are included in a r and omized double-blind placebo-controlled trial . For the duration of two years , patients are exposed to ~10,000 lux in the active condition or ~300 lux in the placebo condition , daily , for two half-hour sessions at fixed times in the morning and evening . Neuropsychological , behavioral , physiological and endocrine measures are assessed at baseline and follow-up every five to six months . Discussion If bright light therapy attenuates the worsening of sleep-wake rhythms and depressive symptoms , it will provide a measure that is easy to implement in the homes of elderly people with memory complaints , to complement treatments with cholinesterase inhibitors , sleep medication or anti-depressants or as a st and -alone treatment . Trial registration IS RCT",
"The administration of light at the development of the first signs of a winter depression appears to prevent it from developing into a full-blown depression . Not a single patient from a group of 16 treated this way became severely depressed during the remaining part of the winter season , whereas 5 out of 11 from the non-treated control group did",
"BACKGROUND Studies of light therapy have not been conducted previously in primary care . AIMS To evaluate light therapy in primary care . METHOD Fifty-seven participants with seasonal affective disorder were r and omly allocated to 4 weeks of bright white or dim red light . Baseline expectations for treatment were assessed . Outcome was assessed with the Structured Interview Guide for the Hamilton Depression Scale , Seasonal Affective Disorder Version . RESULTS Both groups showed decreases in symptom scores of more than 40 % . There were no differences in proportions of responders in either group , regardless of the remission criteria applied , with around 60 % ( 74 % white light , 57 % red light ) meeting broad criteria for response and 31 % ( 30 % white light , 33 % red light ) meeting strict criteria . There were no differences in treatment expectations . CONCLUSIONS Primary care patients with seasonal affective disorder improve after light therapy , but bright white light is not associated with greater improvements",
"BACKGROUND Sixty-eight patients with seasonal affective disorder participated in a 10,000-lux light treatment study in which two questions were addressed : do response rates differ when the light is applied at different times of the day and does short-term rank ordering of morning and evening light influence response rates ? METHOD Three groups of patients received a 4-day light treatment : ( I ) in the morning ( 8.00 - 8.30 a.m. , n = 14 ) , ( II ) in the afternoon ( 1.00 - 1.30 p.m. , n = 15 ) or ( III ) in the evening ( 8.00 - 8.30 p.m. , n = 12 ) . Two additional groups of patients received two days of morning light treatment followed by two days of evening light ( IV , n = 13 ) or vice versa ( V , n = 14 ) . RESULTS Response rates for groups I , II and III were 69 , 57 and 80 % respectively , with no significant differences between them . Response rates for groups IV and V were 67 and 50 % respectively ; this difference was not significant and these percentages did not differ significantly from those of groups I and III . CONCLUSIONS The results indicate that the timing of light treatment is not critical and that short-term rank ordering of morning and evening light does not influence therapeutic outcome",
"This placebo-controlled , double-blind , 1-year pilot study aim ed at investigating possible clinical advantages of combining initial light therapy with the selective serotonin reuptake inhibitor ( SSRI ) citalopram as well as the effects of continuous long-term administration of this drug in patients with seasonal affective disorder ( SAD ) . Eight physically healthy women who met the DSM-III-R criteria for SAD were included in the study . Four women were r and omized to the citalopram group receiving 40 mg citalopram daily from the first of 10 light treatment days and throughout the 1-year study . The remaining four women were allocated to the placebo group using the same double-blind repeated measures design . The clinical outcome was measured by using three versions of the Comprehensive Psychopathological Rating Scale ( CPRS ) and Visual Analog Scales ( VAS ) , respectively . Taking the initial rating scores into account in covariance analyses , no statistically significant group difference was found during the light treatment period . However , during the follow-up period the full version of the CPRS and the self-rating version of CPRS and the VAS-scales for global condition and depressed mood were statistically significantly lower in the citalopram group compared with the placebo group . Thus , in this small but carefully observed sample of SAD- patients combining initial light therapy and long-term citalopram treatment was clinical ly more effective over time than the placebo combination . Our findings support the notion that light therapy with concomitant and continued SSRI ( citalopram ) treatment is a useful strategy to achieve beneficial long-term effects in patients with the SAD syndrome",
"Melatonin , at the same doses used to treat circadian-rhythm related sleep disturbances , had no effect on the depressive symptoms in seasonal affective disorder ( SAD ) patients , whether given early ( 7 a.m. ) or late ( 11 p.m. ) for a week . Slight improvements in sleep were seen with nighttime administration . The circadian rhythmicity of urinary 6-sulphatoxymelatonin was not modified in any way . Melatonin at this dosage ( 5 mg/day ) or at these two times is therefore not a potential alternative treatment for SAD ; light remains the therapy of choice",
"BACKGROUND Seasonal affective disorder ( SAD ) can cause significant distress and impairment . No antidepressant studies have previously attempted to prevent the onset of autumn-winter depression . METHODS Three prospect i ve , r and omized , placebo-controlled prevention trials were conducted on 1042 SAD patients , enrolled in autumn and treated while still well , across the northern US and Canada . Patients received either bupropion XL 150 - 300 mg or placebo daily by mouth from enrollment until spring and were then followed off medications for 8 additional weeks . Primary efficacy variables were end-of-treatment depression-free rates and survival distributions of depressive recurrence . RESULTS Despite a reported average of 13 previous seasonal depressive episodes , almost 60 % of patients had never previously been treated for depression . Major depression recurrence rates during the three studies for bupropion XL and placebo groups were 19 % versus 30 % ( p = 0.026 ) , 13 % versus 21 % ( p = 0.049 ) , and 16 % versus 31 % ; yielding a relative risk reduction across the three studies of 44 % for patients taking bupropion XL . Survival analyses for depression onset also favored bupropion XL over placebo ( p = .081 , .057 , and recurrence of seasonal major depressive episodes by beginning bupropion treatment early in the season while patients are still well",
"BACKGROUND Thirty-eight patients with SAD participated in a light visor study addressing two questions . 1 . Can the development of a depressive episode be prevented by daily exposure to bright light started before symptom onset in early fall and continued throughout the winter ? 2 . Does the light have to be visible in order to have beneficial effects ? METHODS Three groups participated in the study : I ( n = 14 ) received bright white light ( 2500 lux ) ; II , ( n = 15 ) received infrared light ( 0.18 lux ) ; III ( n = 9 , control group ) did not receive any light treatment at all . RESULTS Infrared light is just as effective as bright white light . Both are more effective than the control condition . CONCLUSIONS Light visors can be effectively used to prevent the development of SAD . The fact that exposure to infrared light was as effective as exposure to bright white light questions the specific role of visible light in the treatment of SAD",
"The central public health challenge in the management of seasonal affective disorder ( SAD ) is prevention of depression recurrence each fall/winter season . The need for time-limited treatments with enduring effects is underscored by question able long-term compliance with clinical practice guidelines recommending daily light therapy during the symptomatic months each year . We previously developed a SAD-tailored group cognitive-behavioral therapy ( CBT ) and tested its acute efficacy in 2 pilot studies . Here , we report an intent-to-treat ( ITT ) analysis of outcomes during the subsequent winter season ( i.e. , approximately 1 year after acute treatment ) using participants r and omized to CBT , light therapy , and combination treatment across our pilot studies ( N=69 ) . We used multiple imputation to estimate next winter outcomes for the 17 individuals who dropped out during treatment , were withdrawn from protocol , or were lost to follow-up . The CBT ( 7.0 % ) and combination treatment ( 5.5 % ) groups had significantly smaller proportions of winter depression recurrences than the light therapy group ( 36.7 % ) . CBT alone , but not combination treatment , was also associated with significantly lower interviewer- and patient-rated depression severity at 1 year as compared to light therapy alone . Among completers who provided 1-year data , all statistically significant differences between the CBT and light therapy groups persisted after adjustment for ongoing treatment with light therapy , antidepressants , and psychotherapy . If these findings are replicated , CBT could represent a more effective , practical , and palatable approach to long-term SAD management than light therapy",
"The Seasonal Pattern Assessment Question naire ( SPAQ ) was mailed to a sample population balanced for sex and r and omly selected from local telephone directories in four areas : Nashua , NH , New York , NY , Montgomery County , MD , and Sarasota , FL . On the basis of responses to this question naire , prevalence rates of winter seasonal affective disorder ( winter SAD ) , summer seasonal affective disorder ( summer SAD ) , and subsyndromal winter SAD were estimated for the four areas . Rates of winter SAD and subsyndromal SAD were found to be significantly higher at the more northern latitudes , while no correlation was found between latitude and summer SAD . The positive correlation between latitude and prevalence of winter SAD applied predominantly to the age groups over 35",
"OBJECTIVE The purpose of the study was to ascertain whether phototherapy light visors provide an effective treatment for seasonal affective disorder . Previous studies have demonstrated a moderate response rate but have failed to find any difference in efficacy between light intensities . METHOD Subjects were r and omly assigned to receive , over a 2-week treatment period , 30 minutes of morning phototherapy with a light visor that emitted either a dim ( 30-lux ) red light or a bright ( 600-lux ) white light . Raters were blind to treatment , and patients were unaware of the alternatives . Response was assessed by using the structured 21-item Hamilton Depression Rating Scale , with an eight-item addendum for atypical depressive symptoms . Fifty-seven patients were enrolled across two sites . RESULTS Patients assigned to the different visors had similar baseline depression scores and similar expectations of outcome . Hamilton depression scale scores declined by 34.6 % for subjects given bright white light and by 40.9 % for subjects given dim red light . Scores for atypical depressive symptoms fell by 44.1 % for patients assigned the bright white light visors and by 49.0 % for patients assigned the dim red light visors . Altogether , 39.3 % of the patients who received red light and 41.4 % of the patients who received bright white light showed a full clinical response . CONCLUSIONS There were no significant differences in therapeutic response between patients who were treated with red or white light . The results of this study suggest that the phototherapy light visor may function as an elaborate placebo . Alternative explanations , however , are considered",
"This first controlled psychotherapy trial for seasonal affective disorder ( SAD ) compared SAD-tailored cognitive-behavioral therapy ( CBT ) , light therapy ( LT ) , and their combination to a concurrent wait-list control . Adults ( N = 61 ) with major depression , recurrent with seasonal pattern , were r and omized to one of four 6-week conditions : CBT ( 1.5-hr twice-weekly group therapy ) , LT ( 10,000-lux for 90-min/day with administration time individually adjusted ) , combined CBT + LT , or a minimal contact/delayed LT control ( MCDT ; LT following 6 weeks of monitoring ) . CBT , LT , and CBT + LT significantly and comparably improved depression severity relative to MCDT in intent-to-treat and completer sample s. CBT + LT ( 73 % ) had a significantly higher remission rate than MCDT ( 20 % ) . Using prospect ively measured summer mood status to estimate the \" functional \" population , CBT + LT also had a significantly larger proportion of participants with clinical ly significant change over treatment compared with MCDT . The LT condition outcomes virtually replicated results from prior trials . CBT , alone or combined with LT , holds promise as an efficacious SAD treatment and warrants further study . If replicated , CBT + LT 's remission rate would represent a clinical ly meaningful improvement over the 53 % observed across LT studies",
"BACKGROUND The best available treatment for seasonal affective disorder ( SAD ) is light therapy . Yet , this treatment does not prevent recurrence of depression in subsequent seasons . The aim of the study is to gain preliminary insight in the efficacy of Mindfulness Based Cognitive Therapy ( MBCT ) in the prevention of SAD recurrence . METHODS This is a r and omized controlled pilot study , in which SAD patients in remission were r and omly allocated to an individual format of MBCT or a control condition ( i.e. treatment as usual ) . MBCT was given between May and June 2011 , when there was no presence of depressive symptoms . The Inventory for Depressive Symptomatology Self-Report ( IDS-SR ) , which patients received on a weekly basis from September 2011 to April 2012 , was used to assess moment of recurrence ( ≥20 ) and severity at moment of recurrence . RESULTS 23 SAD patients were r and omized to MBCT and 23 to the control condition . Kaplan-Meier survival curve showed that the groups did not differ in moment of recurrence ( χ²(1).41 , p=.52 ) . T-tests showed no group difference in mean IDS-SR scores at moment of recurrence ( t(31)=-.52 , p=.61 ) . LIMITATIONS The results are limited by small sample size ( n=46 ) and missing data of weekly IDS-SR assessment s. CONCLUSION The findings of this pilot RCT suggest that individual MBCT is not effective in preventing a SAD recurrence when offered in a symptom free period ( i.e. spring )",
"The following test of the circadian phase-shift hypothesis for patients with winter depression ( seasonal affective disorder , or SAD ) uses low-dose melatonin administration in the morning or afternoon/evening to induce phase delays or phase advances , respectively , without causing sleepiness . Correlations between depression ratings and circadian phase revealed a therapeutic window for optimal alignment of circadian rhythms that also appears to be useful for phase-typing SAD patients for the purpose of administering treatment at the correct time . These analyses also provide estimates of the circadian component of SAD that may apply to the antidepressant mechanism of action of appropriately timed bright light exposure , the treatment of choice . SAD may be the first psychiatric disorder in which a physiological marker correlates with symptom severity before , and in the course of , treatment in the same patients . The findings support the phase-shift hypothesis for SAD , as well as suggest a way to assess the circadian component of other psychiatric , sleep , and chronobiologic disorders",
"The authors investigated the outcome of an alternating time schedule versus two fixed schedules ( either morning or evening ) of bright light treatment for seasonal affective disorder . The subjects were 31 patients who met DSM-III-R criteria for major depression with a seasonal pattern . No statistically significant difference was observed among patients in the three groups for response criteria after 1 week of treatment . These results support the use of more flexible phototherapy schedules"
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4116f36c-06ff-11f0-808a-c43d1ab1c353
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Background Epidemiologic studies suggest an association between vitamin D deficiency and atopic diseases , including asthma . The objective of this study was to systematic ally review the benefits and harms of vitamin D supplementation in children with asthma . Methods We used st and ard Cochrane systematic review methodology . The search strategy included an electronic search in February 2013 of MEDLINE and EMBASE . Two review ers completed in duplicate and independently study selection , data abstract ion , and assessment of risk of bias . We pooled the results of trials using a r and om-effects model . We assessed the quality of evidence by outcome using the GRADE methodology . Results Four trials with a total of 149 children met eligibility criteria . The trials had major method ological limitations . Given the four studies reporting on asthma symptoms used different instruments to measure that outcome , we opted not to conduct a meta- analysis . Three of those studies reported improvement in asthma symptoms in the vitamin D supplemented group study , while the fourth reported no effect ( very low quality evidence ) . For the lung function outcome , a meta- analysis of two trials assessing post treatment FEV-1 found a mean difference of 0.54 liters per second ( 95 % CI -5.28 ; 4.19 ; low quality evidence ) . For the vitamin D level outcome , a meta- analysis of three trials found a mean difference of 6.56 ng/ml ( 95 % CI -0.64 ; 13.77 ; very low quality evidence ) . Conclusions The available very low to low quality evidence does not confirm or rule out beneficial effects of vitamin D supplementation in children with asthma . Large-scale , well- design ed and executed r and omized controlled trials are needed to better underst and the effectiveness and safety of vitamin D in children with asthma
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"Our objective was to assess whether administration of 25-OH-vitamin D to children with asthma treated with inhaled dry-powder budesonide 400 microg daily affects short-term growth or markers of bone turnover . We utilized a r and omized , double-blind , two-period crossover trial with run-in and washout periods of 2 weeks and treatment periods of 4 weeks duration . The setting was an Outpatient clinic in a secondary referral center . Subjects included 14 boys and 3 girls with a mean age of 11.7 ( range , 6.1 - 14.4 ) years . Interventions included 15 microg ( 600 IU ) 25-OH-vitamin D ( cholecalciferol ) in one tablet ABCDin(R ) once daily in the morning . Primary outcome measures were : lower leg growth rate , serum osteocalcin , and serum markers of type I collagen turnover , i.e. , the amino terminal propeptide of type I procollagen ( PINP ) , the carboxy terminal propeptide of type I procollagen ( PICP ) ( formation markers ) , and the carboxy terminal pyridinoline cross-linked telopeptide of type I collagen ( ICTP ) ( degradation markers ) . Secondary outcome measures were parameters of asthma control and serum 25-OH-vitamin D. Lower leg growth rate was 0.22 mm/week during vitamin D and 0.25 mm/week during placebo treatment ( NS ) . Osteocalcin was 59.9 and 57.8 microg/l during vitamin D and placebo treatment , respectively , PINP 574 and 565 microg/l , PICP 381 and 382 microg/l , and ICTP 11.5 and 11.1 microg/l , respectively ( NS ) . Serum 25-OH-vitamin D was 76.3 nmol/l and 48.2 nmol/l , respectively ( P measures of pulmonary function . In conclusion , administration of 25-OH-vitamin D does not affect short-term growth or markers of bone turnover in children with asthma treated with inhaled dry-powder budesonide 400 microg daily",
"BACKGROUND Early vitamin supplementation is given routinely to infants in many countries , but it is unclear whether this affects the risk of allergic diseases . OBJECTIVES We sought to study the association between early-life supplementation of vitamins A and D in water-soluble form or in peanut oil and allergic diseases up to 4 years of age . METHODS A prospect i ve birth cohort of 4089 newborn infants was followed for 4 years using parental question naires repeatedly to collect information on exposure and health . At 4 years , the response rate was 90 % , and allergen-specific IgE levels to food and airborne allergens were measured in 2614 of the participating children . RESULTS Vitamins A and D were given to 98 % of the children in infancy , and vitamins based in peanut oil dominated ( 90 % ) . Children supplemented with vitamins A and D in water-soluble form during the first year of life had an almost 2-fold increased risk of asthma ( adjusted odds ratio [ OD ] , 2.18 ; 95 % CI , 1.45 - 3.28 ) , food hypersensitivity ( adjusted OR , 1.89 ; 95 % CI , 1.33 - 2.65 ) , and sensitization to common food and airborne allergens ( adjusted OR , 1.88 ; 95 % CI , 1.34 - 2.64 ) at age 4 years compared with those receiving vitamins in peanut oil . No increased risk of IgE antibodies to peanut was seen in children receiving vitamins in peanut oil . CONCLUSION Supplementation of vitamins A and D in water-soluble form seems to increase the risk of allergic disease up to the age of 4 years compared with supplementation with the same vitamins given in peanut oil . CLINICAL IMPLICATION S Vitamins A and D in oil does not seem to increase the risk of allergic disease during childhood",
"It is now generally accepted that vitamin D deficiency is a worldwide health problem that affects not only musculoskeletal health but also a wide range of acute and chronic diseases . However , there remains cynicism about the lack of r and omized controlled trials to support the association studies regarding the nonskeletal health benefits of vitamin D. This review was obtained by search ing English- language studies published up to April 1 , 2013 , in PubMed , MEDLINE , and the Cochrane Central Register of Controlled Trials ( search terms : vitamin D and supplementation ) and focuses on recent challenges regarding the definition of vitamin D deficiency and how to achieve optimal serum 25-hydroxyvitamin D concentrations from dietary sources , supplements , and sun exposure . The effect of vitamin D on fetal programming epigenetics and gene regulation could potentially explain why vitamin D has been reported to have such wide-ranging health benefits throughout life . There is potentially a great upside to increasing the vitamin D status of children and adults worldwide for improving musculoskeletal health and reducing the risk of chronic illnesses , including some cancers , autoimmune diseases , infectious diseases , type 2 diabetes mellitus , neurocognitive disorders , and mortality "
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4116f3da-06ff-11f0-808a-c43d1ab1c353
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PURPOSE OF REVIEW Patients with atrial fibrillation and heart failure experience an increased morbidity and mortality from the hemodynamic consequences of atrial fibrillation and an increased stroke risk . Consequently , there has been increased attention to procedural alternatives to pharmacologic rhythm control and anticoagulation for stroke prevention . This review aims to evaluate the evidence for atrial fibrillation ablation and left atrial appendage closure in heart failure patients . RECENT FINDINGS Several r and omized control trials and systematic review s demonstrate the safety and efficacy of atrial fibrillation ablation in patients with heart failure and left ventricular systolic dysfunction . In multiple trials , these patients have shown clinical benefit from atrial fibrillation ablation including improved left ventricular systolic function , quality of life , and clinical heart failure symptoms . The evidence of clinical benefit of atrial fibrillation ablation in heart failure patients with preserved ejection fraction remains limited . Only a h and ful of r and omized controlled trials have been performed evaluating left atrial appendage closure , and there is insufficient data regarding the safety and efficacy of these procedures in heart failure patients . SUMMARY Atrial fibrillation ablation in heart failure patients remains well tolerated with an overall efficacy comparable to atrial fibrillation ablation in patients without heart failure . There is consistent evidence for the clinical benefit of atrial fibrillation ablation in heart failure patients with left ventricular systolic dysfunction and limited evidence for atrial fibrillation ablation in heart failure patients with preserved ejection fraction . Currently , there is insufficient data regarding the safety and efficacy of left atrial appendage closure devices in heart failure patients
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"AIMS In congestive heart failure ( CHF ) patients with persistent atrial fibrillation ( AF ) , direct current cardioversion ( DCC ) may reveal participation of tachycardiamediated process to left ventricular ( LV ) dysfunction by restoring sinus rhythm ( SR ) . However , if DCC fails to restore SR , patients ' management remains challenging . The aim of the study was to assess the AF catheter ablation benefit in a selected group of CHF patients with LV ejection fraction ( LVEF ) METHODS AND RESULTS Between January 2008 and September 2011 , among 129 CHF patients with persistent AF referred to our institution , 34 ( 63.8 ± 9-year old , 24 men ) presented AF refractory to DCC with an estimated high likelihood of tachycardia-mediated LV dysfunction according to a specific set of criteria . These 34 patients underwent stepwise AF ablation and were closely followed up . After a mean 1.9 AF ablation procedures per patient and 17.6 ± 7 months after the last procedure , all patients were in SR . The New York Heart Association class improved from 2.8 ± 0.3 to 1 ± 0.2 ( P ) and the LVEF increased from 30.4 ± 6 to 54.6 ± 6 % ( P CONCLUSION Atrial fibrillation catheter ablation in selected CHF patients with persistent AF refractory to DCC and without any other evidence for secondary LV dysfunction leads to a substantial LVEF improvement in the majority of them . However , redo procedures are frequent in order to achieve mid-term SR maintenance",
"AIMS During radiofrequency ( RF ) delivery , lesion volume is highly dependent on contact force ( CF ) . It has recently been shown that changes of bipolar electrogram ( EGM ) predict transmurality . We hypothesized that there is a correlation between CF and EGM criteria of transmural lesion ( TL ) during RF . METHODS AND RESULTS We prospect ively studied consecutive 512 RF applications from atrial fibrillation ablation procedures . A force-sensing ablation catheter ( Tacticath ( ® ) , Endosense ) was used to continuously measure CF and force-time integral ( FTI ) during each RF application . Distal bipolar EGM was analysed before , during , and after each RF application . Depending on initial EGM morphology , transmurality of lesions was defined by : ( i ) disappearance of the positivity after RF when there was QR morphology , ( ii ) diminution > 75 % of the positivity when there was QRS morphology , or ( iii ) disappearance of the R ' positivity when there was RSR ' morphology . Electrogram criteria were vali date d by electrophysiologists blinded to force measurements . Force-time integral was higher in TL than in non-transmural lesions ( NTLs ) : 652 ± 248 vs. 212 ± 140 gs ( P was higher in TL than in NTL : 26.3 ± 12.5 vs. 11.3 ± 10.3 g ( P TL was an FTI ≥ 392 gs [ sensitivity 0.89 , specificity ( Sp ) 0.93 , positive predictive value ( PPV ) 0.98 , and negative predictive value 0.67 ] and a higher FTI ( > 700 gs ) warrants transmurality of RF atrial lesions ( 100 % Sp and PPV ) . CONCLUSION Contact force and FTI during RF are correlated with TL . During RF delivery , a target FTI > 392 gs can be used as an endpoint",
"Small , single-center studies suggest that catheter ablation of atrial fibrillation ( AF ) can improve ventricular function and reduce symptoms in patients with left ventricular ( LV ) dysfunction . However , ablation has not been compared with a pharmacologic strategy for AF . The authors evaluated patients with AF and symptomatic LV dysfunction ( ejection fraction pulmonary vein isolation ( PVI ) . They compared these patients with a matched cohort treated medically for AF and LV dysfunction via a retrospective case-control method . Fifteen patients ( 14 men , 56+/-11 years , 10 [ 67 % ] paroxysmal AF ) with AF for 4+/-3 years underwent PVI . Baseline ejection fraction was 37%+/-6 % and New York Heart Association ( NYHA ) class was 2.0+/-1.0 . Fifteen controls ( 13 men , 63+/-14 years , 11 [ 73 % ] paroxysmal AF ) with AF for 5+/-4 years were treated medically for AF . Baseline ejection fraction was 34%+/-11 % and NYHA class was 2.0+/-0.7 . The groups were similar in all respects . During a follow-up of 16+/-13 months after complete PVI , ejection fraction improved ( P=.001 ) to 50%+/-13 % and normalized in 8 patients ( 53 % ) . NYHA class improved to 1.3+/-0.5 ( P=.01 ) . In the medically treated group , after follow-up of 16+/-12 months , no improvement in ejection fraction ( 36%+/-12 % ) or NYHA class ( 1.8+/-0.7 ) was seen . Compared with pharmacologic therapy , PVI significantly improved LV function and NYHA class in patients with AF and symptomatic LV dysfunction . These provocative findings provide potent rationale for a r and omized clinical trial comparing ablation with pharmacologic therapy",
"OBJECTIVES This study sought to investigate the efficacy and safety of catheter ablation for atrial fibrillation ( AF ) in patients with heart failure with preserved ejection fraction ( HFPEF ) . BACKGROUND AF is a precipitating factor for clinical deterioration of HFPEF . METHODS Catheter ablation for AF was performed in a consecutive 74 patients with compensated HFPEF ( left ventricular [ LV ] ejection fraction > 50 % ) . AF-free probability after catheter ablation and factors relating to maintenance of sinus rhythm were investigated . LV strain and strain rate were assessed by echocardiography at baseline and over 12 months after ablation . RESULTS During a 34 ± 16-month follow-up period , single- and multiple-procedure drug-free success rates were 27 % ( n = 20 ) and 45 % ( n = 33 ) , respectively . Multiple procedures and pharmaceutically assisted success rate was 73 % ( n = 54 ) . No major complications occurred during follow-up . Multivariate Cox regression analyses revealed that AF type ( other than long-st and ing persistent AF ) and lack of hypertension were independently associated with maintenance of sinus rhythm ( hazard ratio [ HR ] : 1.81 , 95 % confidence interval [ CI ] : 1.03 to 3.17 , p = 0.04 ; HR : 0.49 , 95 % CI : 0.24 to 0.96 , p = 0.04 , respectively ) . LV systolic indices ( LV ejection fraction , LV strain/strain rate at systole ) and diastolic indices ( E/E ' , ratio of LV strain rate at diastole with early transmitral flow ) were improved only in patients maintaining sinus rhythm at follow-up . CONCLUSIONS Our results suggest that AF can be effectively and safely treated with a composite of repeat procedures and pharmaceuticals in patients with HFPEF . However , the current study was a single-arm analysis ; therefore , larger r and omized control studies are needed to verify the benefit of AF ablation in this cohort",
"OBJECTIVES We aim ed to determine the safety and efficacy of pulmonary vein isolation ( PVI ) in atrial fibrillation ( AF ) patients with impaired left ventricular ( LV ) systolic function . BACKGROUND To date , PVI has been performed primarily in patients with normal LV function . Yet , many AF patients have impaired LV systolic function . The outcomes of PVI in patients with impaired LV systolic function are unknown . METHODS We included 377 consecutive patients undergoing PVI between December 2000 and January 2003 . Ninety-four patients had impaired LV function ( ejection fraction [ EF ] The control group was the remaining 283 patients who had a normal EF . End points included AF recurrence and changes in EF and quality of life ( QoL ) . RESULTS Mean EF was 36 % in our study group , compared with 54 % in controls . After initial PVI , 73 % of patients with impaired EF and 87 % of patients with normal EF were free of AF recurrence at 14 + /- 6 months ( p = 0.03 ) . In the study group , there was a nonsignificant increase in EF of 4.6 % and significant improvement in QoL. Complication rates were low and included a 1 % risk of pulmonary vein stenosis . CONCLUSIONS Although the AF recurrence rate after initial PVI in impaired EF patients was higher than in normal EF subjects , nearly three-fourths of patients with impaired EF remained AF-free . Although our sample size was nonr and omized , our results suggest PVI may be a feasible therapeutic option in AF patients with impaired EF . R and omized studies with more patients and longer follow-up are warranted",
"Atrial fibrillation ( AF ) represents the most common sustained cardiac arrhythmia in patients with heart failure ( HF ) . AF in HF patients is associated with worsening of symptoms and also results in a substantial increase in mortality . Although HF patients in sinus rhythm have a better outcome than patients with AF , several r and omized studies investigating pharmacological rhythm control versus rate control have shown no advantage of one strategy over the other in terms of patient outcomes . Catheter-based ablation therapy is a newer therapeutic option with a rapidly evolving and changing role in the management of this arrhythmia . In the present review , the authors discuss the epidemiology , pathophysiology and prognostic significance of AF in patients with HF . Exclusively addressed are studies investigating catheter-based ablation for rhythm-control and rate-control therapies in the management of AF in HF patients",
"Background and Purpose — More than 2 million Americans have atrial fibrillation , and without antithrombotic therapy , their stroke rate is increased 5-fold . In r and omized controlled trials , warfarin prevented 65 % of ischemic strokes ( hazard ratio [ HR ] , 0.35 ; 95 % CI , 0.26 to 0.48 ) compared with no antithrombotic therapy . However , the effectiveness of warfarin therapy outside of clinical trials is unknown , especially in black and Hispanic population s. Our goal was to quantify use of warfarin therapy , frequency of International Normalized Ratio monitoring , and effectiveness for stroke prophylaxis in Medicare beneficiaries with atrial fibrillation . Methods — This was a cohort study of Medicare beneficiaries with atrial fibrillation who were hospitalized between March 1998 and April 1999 in all 50 US states . The primary outcome was incident hospitalizations for ischemic stroke based on vali date d International Classification of Diseases , 9th Revision , Clinical Modification codes . Results — Two thirds of ideal anticoagulation c and i date s were prescribed warfarin on hospital discharge . In unadjusted analyses , the stroke rates per 100 patient years of warfarin therapy were 5.2 in ( non-Hispanic ) white Medicare beneficiaries , 10.6 in black beneficiaries , and 12.2 in Hispanic beneficiaries . After adjusting for comorbid conditions , warfarin prescription was more frequent and monitoring more regular in white Medicare beneficiaries than in black or Hispanic beneficiaries ( P Warfarin use was associated with 35 % fewer ischemic strokes ( HR , 0.65 ; 95 % CI , 0.55 to 0.76 ) compared with no antithrombotic therapy but was less effective in black and Hispanic beneficiaries ( P for interaction=0.048 ) . Conclusions — The use , monitoring , and effectiveness of warfarin therapy are suboptimal in Medicare beneficiaries , especially in black and Hispanic beneficiaries",
"BACKGROUND Transcatheter left atrial appendage ( LAA ) ligation may represent an alternative to oral anticoagulation for stroke prevention in atrial fibrillation . OBJECTIVES This study sought to assess the early safety and efficacy of transcatheter ligation of the LAA for stroke prevention in atrial fibrillation . METHODS This was a retrospective , multicenter study of consecutive patients undergoing LAA ligation with the Lariat device at 8 U.S. sites . The primary endpoint was procedural success , defined as device success ( suture deployment and ( death , myocardial infa rct ion , stroke , Bleeding Academic Research Consortium bleeding type 3 or greater , or cardiac surgery ) . Post-discharge management was per operator discretion . RESULTS A total of 154 patients were enrolled . Median CHADS2 score ( congestive heart failure , hypertension , age ≥ 75 years , diabetes mellitus , prior stroke , transient ischemic attack , or thromboembolism [ doubled ] ) was 3 ( interquartile range : 2 to 4 ) . Device success was 94 % , and procedural success was 86 % . A major complication occurred in 15 patients ( 9.7 % ) . There were 14 major bleeds ( 9.1 % ) , driven by the need for transfusion ( 4.5 % ) . Significant pericardial effusion occurred in 16 patients ( 10.4 % ) . Follow-up was available in 134 patients at a median of 112 days ( interquartile range : 50 to 270 days ) : Death , myocardial infa rct ion , or stroke occurred in 4 patients ( 2.9 % ) . Among 63 patients with acute closure and transesophageal echocardiography follow-up , there were 3 thrombi ( 4.8 % ) and 13 ( 20 % ) with residual leak . CONCLUSIONS In this initial multicenter experience of LAA ligation with the Lariat device , the rate of acute closure was high , but procedural success was limited by bleeding . A prospect i ve r and omized trial is required to adequately define clinical efficacy , optimal post-procedure medical therapy , and the effect of operator experience on procedural safety",
"Objective To determine whether or not radiofrequency ablation ( RFA ) for persistent atrial fibrillation in patients with advanced heart failure leads to improvements in cardiac function . Setting Patients were recruited from heart failure outpatient clinics in Scotl and . Design and intervention Patients with advanced heart failure and severe left ventricular dysfunction were r and omised to RFA ( rhythm control ) or continued medical treatment ( rate control ) . Patients were followed up for a minimum of 6 months . Main outcome measure Change in left ventricular ejection fraction ( LVEF ) measured by cardiovascular MRI . Results 22 patients were r and omised to RFA and 19 to medical treatment . In the RFA group , 50 % of patients were in sinus rhythm at the end of the study ( compared with none in the medical treatment group ) . The increase in cardiovascular magnetic resonance ( CMR ) LVEF in the RFA group was 4.5±11.1 % compared with 2.8±6.7 % in the medical treatment group ( p=0.6 ) . The RFA group had a greater increase in radionuclide LVEF ( a prespecified secondary end point ) than patients in the medical treatment group ( + 8.2±12.0 % vs + 1.4±5.9 % ; p=0.032 ) . RFA did not improve N-terminal pro-B-type natriuretic peptide , 6 min walk distance or quality of life . The rate of serious complications related to RFA was 15 % . Conclusions RFA result ed in long-term restoration of sinus rhythm in only 50 % of patients . RFA did not improve CMR LVEF compared with a strategy of rate control . RFA did improve radionuclide LVEF but did not improve other secondary outcomes and was associated with a significant rate of serious complications . Clinical trials registration number NCT00292162",
"Background —Restoring sinus rhythm in patients with heart failure ( HF ) and atrial fibrillation ( AF ) may improve left ventricular ( LV ) function and HF symptoms . We sought to compare the effect of a catheter ablation strategy with that of a medical rate control strategy in patients with persistent AF and HF . Methods and Results — Patients with persistent AF , symptomatic HF , and LV ejection fraction catheter ablation or medical rate control . The primary end-point was the difference between groups in LV ejection fraction at 6 months . Baseline LV ejection fraction was 32±8 % in the ablation group and 34±12 % in the medical group . Twenty-six patients underwent catheter ablation , and 24 patients were rate controlled . Freedom from AF was achieved in 21/26 ( 81 % ) at 6 months off antiarrhythmic drugs . LV ejection fraction at 6 months in the ablation group was 40±12 % compared with 31±13 % in the rate control group ( P=0.015 ) . Ablation was associated with better peak oxygen consumption ( 22±6 versus 18±6 mL/kg per minute ; P=0.014 ) and Minnesota living with HF question naire score ( 24±22 versus 47±22 ; P=0.001 ) compared with rate control . Conclusions —Catheter ablation is effective in restoring sinus rhythm in selected patients with persistent AF and HF , and can improve LV function , functional capacity , and HF symptoms compared with rate control . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier :",
"OBJECTIVES This study assessed the feasibility of implanting a device in the left atrial appendage ( LAA ) in patients with atrial fibrillation ( AF ) to prevent thromboembolic stroke . BACKGROUND Meta-analyses confirmed that in cases of left atrial thrombus in nonrheumatic AF patients approximately 90 % of them are in the LAA . METHODS The WATCHMAN Left Atrial Appendage System ( Atritech Inc. , Plymouth , Minnesota ) is a nitinol device implanted percutaneously to seal the LAA . Patients were followed by clinical and transesophageal echocardiography at 45 days and 6 months with annual clinical follow-up thereafter . RESULTS Sixty-six patients underwent device implantation . Mean follow-up was 740 + /- 341 days . At 45 days , 93 % ( 54 of 58 ) devices showed successful sealing of LAA according to protocol . Two patients experienced device embolization , both successfully retrieved percutaneously . No embolizations occurred in 53 patients enrolled after modification of fixation barbs . There were 2 cardiac tamponades , 1 air embolism , and 1 delivery wire fracture ( first generation ) with surgical explantation but no long-term sequelae for the patient . Four patients developed a flat thrombus layer on the device at 6 months that resolved with additional anticoagulation . Two patients experienced transient ischemic attack , 1 without visible thrombus . There were 2 deaths , neither device related . Autopsy documented a stable , fully endothelialized device 9 months after implantation . No strokes occurred during follow-up despite > 90 % of patients with discontinuation of anticoagulation . CONCLUSIONS Preliminary data suggest LAA occlusion with the WATCHMAN System to be safe and feasible . A r and omized study is ongoing comparing oral anticoagulation with percutaneous closure",
"AIMS Beneficial effects of atrial fibrillation ( AF ) ablation have been demonstrated in patients with congestive heart failure ( CHF ) and significantly impaired left ventricular ejection fraction ( LVEF ) . However , the impact of pulmonary vein isolation ( PVI ) on cardiac function in patients with paroxysmal AF and impaired LVEF remains under discussion . This study aim ed to evaluate the impact of PVI for paroxysmal AF on cardiac function in patients with impaired LVEF using cardiac magnetic resonance imaging ( CMRI ) . METHODS AND RESULTS A total number of 70 patients with paroxysmal AF and episodes scanned on a 1.5-T-CMRI before and 6 months after PVI during sinus rhythm . End-diastolic volume , end-systolic volume , and LVEF were determined by epicardial and endocardial measurements . Patients were categorized into two groups regarding cardiac function as assessed by CMRI : group 1 patients ( n = 18 ) with an LVEF 50 % ( group 2 , n = 52 ) . Group 1 patients demonstrated a significant lower success rate than patients of group 2 after a follow-up of 152 + /- 40 days ( 50 vs. 73 % , P cardiac function after AF ablation ( 41 + /- 6 vs. 51 + /- 12 % , P = 0.004 ) , whereas group 2 patients did not show significant differences ( 60 + /- 6 vs. 59 + /- 9 % , P = 0.22 ) after a 6 months follow-up . CONCLUSION Pulmonary vein isolation improves cardiac function in patients with paroxysmal AF and impaired LVEF . These data suggest that an impaired LV function can be partially attributed to AF with short-lasting paroxysms",
"Aims The objective of the study was to analyse the influence of left ventricular ( LV ) ejection fraction ( EF ) on the outcomes of atrial fibrillation ( AF ) ablation after a first procedure . Pre-procedural predictors of recurrences after AF ablation can be useful for patient information and selection of c and i date s. The independent influence of LV systolic dysfunction on recurrence rate has not been studied . Methods and results A case – control study ( 1:1 ) was conducted with a total of 72 patients : 36 cases ( depressed LVEF ) and 36 controls ( normal LVEF ) . Patients were matched by left atrial diameter ( LAD ) , the presence of arterial hypertension , and other variables that might influence the results ( age , gender and paroxysmal vs. persistent AF ) . There were no statistical differences in the variables used to perform the matching . Patients with depressed LVEF had higher LV end diastolic diameter ( 55.6 ± 6.2 vs. 52.4 ± 5.5 , P = 0.03 ) , higher LV end systolic diameter ( 40.3 ± 6.9 vs. 32.6 ± 4.3 , P months , survival analysis for AF recurrences showed no differences between patients with depressed vs. normal LVEF ( 50.0 vs. 55.6 % , log rank = 0.82 ) . Cox regression analysis revealed LAD to be the only variable correlated to recurrence [ OR 1.11 ( 1.01–1.22 ) , P = 0.03 ] . Analysis at 6 months showed a significant increase in LVEF ( 43.23 ± 7.61 to 51.12 ± 13.53 % , P = 0.01 ) for the case group . Conclusion LV systolic dysfunction by itself is not a predictor of outcome after AF ablation . LAD independently correlates with outcome in patients with low or normal LVEF",
"OBJECTIVES The aim of this study was to determine the independent hemodynamic effects of an irregular sequence of ventricular cycle lengths in patients with atrial fibrillation ( AF ) . BACKGROUND Atrial fibrillation may reduce cardiac output by several possible mechanisms , including loss of the atrial contribution to left ventricular filling , valvular regurgitation , increased ventricular rate or irregular RR intervals . This study was design ed to evaluate the effects of an irregular RR interval , independent of the average ventricular rate , on cardiac hemodynamic data during AF . METHODS Sixteen patients with AF were studied invasively . During intrinsically conducted AF ( mean rate 102 + /- 22 beats/ min ) , the right ventricular apex electrogram was recorded onto frequency-modulated ( FM ) tape . After atrioventricular node ablation , the right ventricular apex was stimulated in three pacing modes in r and omized sequence : 1 ) VVI at 60 beats/min ; 2 ) VVI at the same average rate as during intrinsically conducted AF ( 102 + /- 22 beats/min ) ; and 3 ) during VVT pacing in which the pacemaker was triggered by playback of the FM tape recording of the right ventricular apex electrogram previously recorded during intrinsically conducted AF ( VVT 102 + /- 22 beats/min ) . RESULTS Compared with VVI pacing at the same average rate , an irregular sequence of RR intervals decreased cardiac output ( 4.4 + /- 1.6 vs. 5.2 + /- 2.4 liters/min , p pulmonary capillary wedge pressure ( 17 + /- 7 vs. 14 + /- 6 mm Hg , p right atrial pressure ( 10 + /- 6 vs. 8 + /- 4 mm Hg , p hemodynamic consequences that are independent of heart rate",
"Background — The efficacy of radiofrequency ablation for atrial fibrillation ( AF ) in patients with left ventricular ( LV ) systolic dysfunction and isolated diastolic dysfunction is uncertain . Methods and Results — A prospect i ve cohort of patients with normal and abnormal LV function underwent ablation for antiarrhythmic drug (AAD)-refractory AF . Three groups were compared : 111 patients with systolic dysfunction , defined as LV ejection fraction ( LVEF ) ⩽40 % ; 157 patients with isolated diastolic dysfunction but preserved LVEF ≥50 % ; and 100 patients with normal LV function . The primary end point was AAD-free AF elimination at 1 year after ablation . This end point was achieved in 62 % of patients with systolic dysfunction , 75 % of those with diastolic dysfunction , and 84 % of controls ( P=0.007 ) . AF control on or off AADs was achieved in 76 % of patients with systolic dysfunction , 85 % of those with diastolic dysfunction , and 89 % of controls ( P=0.08 ) . In the systolic dysfunction group , 49 % experienced an increase in LVEF by ≥5 % after ablation , of which 64 % achieved normal LVEF . In the diastolic dysfunction group , 30 % of patients demonstrated at least 1 grade improvement in diastolic dysfunction . Multivariable analysis demonstrated an increased relative risk of arrhythmia recurrence of 1.8 ( 95 % CI , 1.1 to 3.1 ; P=0.02 ) in systolic dysfunction and 1.7 ( 1.0 to 2.7 ; P=0.04 ) in isolated diastolic dysfunction compared with normal function . Conclusions — Although an ablative approach for AF in patients with systolic or diastolic dysfunction is associated with an increased long-term recurrence risk , there is potential for substantial quality -of-life improvement and LV functional benefit",
"BACKGROUND Pulmonary-vein isolation is increasingly being used to treat atrial fibrillation in patients with heart failure . METHODS In this prospect i ve , multicenter clinical trial , we r and omly assigned patients with symptomatic , drug-resistant atrial fibrillation , an ejection fraction of 40 % or less , and New York Heart Association class II or III heart failure to undergo either pulmonary-vein isolation or atrioventricular-node ablation with biventricular pacing . All patients completed the Minnesota Living with Heart Failure question naire ( scores range from 0 to 105 , with a higher score indicating a worse quality of life ) and underwent echocardiography and a 6-minute walk test ( the composite primary end point ) . Over a 6-month period , patients were monitored for both symptomatic and asymptomatic episodes of atrial fibrillation . RESULTS In all , 41 patients underwent pulmonary-vein isolation , and 40 underwent atrioventricular-node ablation with biventricular pacing ; none were lost to follow-up at 6 months . The composite primary end point favored the group that underwent pulmonary-vein isolation , with an improved question naire score at 6 months ( 60 , vs. 82 in the group that underwent atrioventricular-node ablation with biventricular pacing ; P 6-minute-walk distance ( 340 m vs. 297 m , P ejection fraction ( 35 % vs. 28 % , P underwent pulmonary-vein isolation , 88 % of patients receiving antiarrhythmic drugs and 71 % of those not receiving such drugs were free of atrial fibrillation at 6 months . In the group that underwent pulmonary-vein isolation , pulmonary-vein stenosis developed in two patients , pericardial effusion in one , and pulmonary edema in another ; in the group that underwent atrioventricular-node ablation with biventricular pacing , lead dislodgment was found in one patient and pneumothorax in another . CONCLUSIONS Pulmonary-vein isolation was superior to atrioventricular-node ablation with biventricular pacing in patients with heart failure who had drug-refractory atrial fibrillation . ( Clinical Trials.gov number , NCT00599976 .",
"To assess the potential improvement in left ventricular ejection fraction after cardioversion of chronic atrial fibrillation to sinus rhythm in idiopathic dilated cardiomyopathy , we studied prospect ively 17 patients , aged 58 + /- 6 years , by radionuclide angiocardiography at rest . Left ventricular ejection fraction was determined before treatment and at a mean delay of 4.7 months after cardioversion . Return to sinus rhythm was obtained in 12 patients , pharmacologically or by electrical cardioversion . Five patients remained in atrial fibrillation . No clinical , echocardiographic or haemodynamic finding could predict the success of cardioversion . In chronic atrial fibrillation , the ejection fraction did not change significantly : 30.0 + /- 9.1 % ( 19 to 44 % ) at the first evaluation and 29.5 + /- 8.3 % ( 22 to 41 % ) after 4.7 months . After successful cardioversion , left ventricular ejection fraction improved from 32.1 + /- 5.3 % ( 24 to 41 % ) to 52.9 + /- 9.7 % ( 37 to 71 % ) ( P less than 0.001 ) . The difference was 20.8 + /- 11.3 % and left ventricular ejection fraction was normalized in 50 % ( 6/12 ) of the patients . There was a significant reduction in the cardiothoracic ratio on chest X-rays and of the left ventricular end-diastolic diameter on echocardiography ; fractional shortening increased ( 27.7 + /- 4.3 % vs 20.3 + /- 2.7 % , P less than 0.01 ) . A third evaluation was realized after a mean delay of 11.7 months in the patients with successful cardioversion . Sinus rhythm was present in 83 % ( 10/12 ) of the patients : seven patients were reevaluated by radionuclide angiography . The improvement in left ventricular function observed at the 4.7 months evaluation was still present . In two patients with recurrence of atrial fibrillation , there was a severe deterioration of left ventricular systolic function . ( ABSTRACT TRUNCATED AT 250 WORDS",
"INTRODUCTION Congestive heart failure ( CHF ) and atrial fibrillation ( AF ) are frequently linked , and when associated produce additive deleterious effects . In this prospect i ve study , the effects of catheter ablation for AF in patients with impaired left ventricular ( LV ) function are presented . METHODS Baseline data and clinical outcome have been prospect ively collected in 105 consecutive patients who underwent pulmonary vein ablation for the control of AF . We evaluated 40 patients affected by LV dysfunction with ejection fraction (EF) and compared them to the remaining 65 patients with normal ventricular function in terms of changes in LV function , maintenance of sinus rhythm , and quality of life during follow-up . RESULTS After a mean follow-up of 14+/-2 months , 87 % of patients with impaired LV function and 92 % of patients with normal ventricular function were in sinus rhythm , with or without antiarrhythmic therapy ( P = NS ) . A significant improvement in LVEF and fractional shortening was documented in patients with CHF ( 33+/-2 % vs 47+/-3 % , and 19+/-4 % vs 30+/-3 % , P exercise capacity and quality of life documented better improvements in patients with CHF compared to patients without CHF . CONCLUSIONS Catheter ablation in patients with LV dysfunction is feasible , not associated with higher procedural complications , and provides a significant improvement in LV performance , symptoms , and quality of life during follow-up",
"BACKGROUND Catheter ablation is important for treatment of paroxysmal atrial fibrillation ( PAF ) . Limited animal and human studies suggest a correlation between electrode-tissue contact and radiofrequency lesion generation . OBJECTIVES The study sought to assess the safety and effectiveness of an irrigated , contact force (CF)-sensing catheter in the treatment of drug refractory symptomatic PAF . METHODS A prospect i ve , multicenter , nonr and omized study was conducted . Enrollment criteria included : ≥3 symptomatic episodes of PAF within 6 months of enrollment and failure of ≥1 antiarrhythmic drug ( Class I to IV ) . Ablation included pulmonary vein isolation with confirmed entrance block as procedural endpoint . RESULTS A total of 172 patients were enrolled at 21 sites , where 161 patients had a study catheter inserted and 160 patients underwent radiofrequency application . Procedural-related serious adverse events occurring within 7 days of the procedure included tamponade ( n = 4 ) , pericarditis ( n = 3 ) , heart block ( n = 1 , prior to radiofrequency application ) , and vascular access complications ( n = 4 ) . By Kaplan-Meier analyses , 12-month freedom from atrial fibrillation/atrial flutter/atrial tachycardia recurrence was 72.5 % . The average CF per procedure was 17.9 ± 9.4 g. When the CF employed was between investigator selected working ranges ≥80 % of the time during therapy , outcomes were 4.25 times more likely to be successful ( p = 0.0054 ; 95 % confidence interval : 1.53 to 11.79 ) . CONCLUSIONS The SMART-AF trial demonstrated that this irrigated CF-sensing catheter is safe and effective for the treatment of drug refractory symptomatic PAF , with no unanticipated device-related adverse events . The increased percent of time within investigator-targeted CF ranges correlates with increased freedom from arrhythmia recurrence . Stable CF during radiofrequency application increases the likelihood of 12-month success . ( THERMOCOOL ® SMARTTOUCH ® Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation ; NCT01385202 )",
"OBJECTIVES We assessed the risk of adverse cardiovascular ( CV ) outcomes associated with atrial fibrillation ( AF ) in the C and esartan in Heart failure- Assessment of Reduction in Mortality and morbidity ( CHARM ) program , which enrolled patients with chronic heart failure ( CHF ) and a broad range of ejection fractions ( EFs ) . BACKGROUND Atrial fibrillation is associated with an increased risk of adverse CV outcomes in patients with CHF and reduced EF . The risk of AF in patients with CHF and preserved left ventricular ejection fraction ( PEF ) is unknown . METHODS A total of 7,599 patients with symptomatic CHF were r and omized to c and esartan or placebo . Patients were divided by baseline EF ( 40 % ) in low or preserved EF groups . Major outcomes were cardiovascular death or hospitalization for worsening heart failure , and all-cause mortality . Median follow-up was 37.7 months . RESULTS A total of 670 ( 17 % ) patients in the low EF group and 478 ( 19 % ) in the PEF group had AF at baseline . Atrial fibrillation predicted a high risk of cardiovascular morbidity and mortality regardless of baseline EF . Patients with AF and low EF had the highest absolute risk for adverse CV outcomes . However , AF was associated with greater relative increased risk of the major outcomes in patients with PEF than in patients with low EF : hazard ratio 1.72 ( 95 % confidence interval [ CI ] 1.45 to 2.06 ) versus 1.29 ( 95 % CI 1.14 to 1.46 ) , respectively . The same was true for the risk of all-cause mortality . C and esartan was associated with similar treatment effects regardless of baseline rhythm . CONCLUSIONS Atrial fibrillation is associated with an increased risk of CV outcomes in patients with CHF and either reduced EF or PEF . C and esartan improved outcomes similarly regardless of baseline rhythm",
"OBJECTIVES This study sought to compare catheter ablation with rate control for persistent atrial fibrillation ( AF ) in heart failure ( HF ) . BACKGROUND The optimal therapy for AF in HF is unclear . Drug-based rhythm control has not proved clinical ly beneficial . Catheter ablation improves cardiac function in patients with HF , but impact on physiological performance has not been formally evaluated in a r and omized trial . METHODS In a r and omized , open-label , blinded-endpoint clinical trial , adults with symptomatic HF , radionuclide left ventricular ejection fraction ( EF ) ≤35 % , and persistent AF were assigned to undergo catheter ablation or rate control . Primary outcome was 12-month change in peak oxygen consumption . Secondary endpoints were quality of life , B-type natriuretic peptide , 6-min walk distance , and EF . Results were analyzed by intention-to-treat . RESULTS Fifty-two patients ( age 63 ± 9 years , EF 24 ± 8 % ) were r and omized , 26 each to ablation and rate control . At 12 months , 88 % of ablation patients maintained sinus rhythm ( single-procedure success 68 % ) . Under rate control , rate criteria were achieved in 96 % . The primary endpoint , peak oxygen consumption , significantly increased in the ablation arm compared with rate control ( difference + 3.07 ml/kg/min , 95 % confidence interval : 0.56 to 5.59 , p = 0.018 ) . The change was not evident at 3 months ( + 0.79 ml/kg/min , 95 % confidence interval : -1.01 to 2.60 , p = 0.38 ) . Ablation improved Minnesota score ( p = 0.019 ) and B-type natriuretic peptide ( p = 0.045 ) and showed nonsignificant trends toward improved 6-min walk distance ( p = 0.095 ) and EF ( p = 0.055 ) . CONCLUSIONS This first r and omized trial of ablation versus rate control to focus on objective exercise performance in AF and HF shows significant benefit from ablation , a strategy that also improves symptoms and neurohormonal status . The effects develop over 12 months , consistent with progressive amelioration of the HF syndrome . ( A R and omised Trial to Assess Catheter Ablation Versus Rate Control in the Management of Persistent Atrial Fibrillation in Chronic Heart Failure ; NCT00878384 )",
"BACKGROUND Pericardial suture ligation of the left atrial appendage ( LAA ) may be an alternative to endoluminal devices for stroke prevention in patients with atrial fibrillation , but multicenter safety and efficacy data in high-risk patients with contraindications to oral anticoagulation are lacking . OBJECTIVE The purpose of this study was to report the outcomes of consecutive cases of pericardial suture ligation of the LAA in high-risk patients performed at 4 centers . METHODS The cohort included 41 consecutive patients who underwent LAA closure with the LARIAT system . Epicardial and transeptal access was obtained , and the epicardial snare was advanced over an endo-epicardial magnetic-tipped guidewire to close the LAA . Transesophageal echocardiography was used to confirm LAA exclusion . RESULTS Mean age was 75 ± 10 years , mean CHADS2 score was 3.0 ± 1.3 , and mean HAS-BLED score was 4.4 ± 1.4 . These patients accumulated 24.6 person-years of follow-up . Acute LAA closure was achieved in 38 patients ( 93 % ) . Transesophageal echocardiography or computerized tomographic angiography performed up to 3.3 ± 0.8 months after the procedure demonstrated LAA leakage in 24 % of patients . One patient ( 2 % ) had a transient ischemic attack , and 8 ( 20 % ) developed pericardial effusions requiring pericardiocentesis . Four cases ( 9 % ) were complicated by perforation of the LAA , with 2 of these patients requiring open surgical correction . CONCLUSION This multicenter experience revealed that pericardial suture ligation with the LARIAT system is technically feasible and acutely efficacious . However , additional improvements are required to minimize the rate of pericardial complications . A r and omized study is warranted to accurately define the long-term efficacy and safety profile of percutaneous epicardial suture ligation ",
"BACKGROUND It is common practice to restore and maintain sinus rhythm in patients with atrial fibrillation and heart failure . This approach is based in part on data indicating that atrial fibrillation is a predictor of death in patients with heart failure and suggesting that the suppression of atrial fibrillation may favorably affect the outcome . However , the benefits and risks of this approach have not been adequately studied . METHODS We conducted a multicenter , r and omized trial comparing the maintenance of sinus rhythm ( rhythm control ) with control of the ventricular rate ( rate control ) in patients with a left ventricular ejection fraction of 35 % or less , symptoms of congestive heart failure , and a history of atrial fibrillation . The primary outcome was the time to death from cardiovascular causes . RESULTS A total of 1376 patients were enrolled ( 682 in the rhythm-control group and 694 in the rate-control group ) and were followed for a mean of 37 months . Of these patients , 182 ( 27 % ) in the rhythm-control group died from cardiovascular causes , as compared with 175 ( 25 % ) in the rate-control group ( hazard ratio in the rhythm-control group , 1.06 ; 95 % confidence interval , 0.86 to 1.30 ; P=0.59 by the log-rank test ) . Secondary outcomes were similar in the two groups , including death from any cause ( 32 % in the rhythm-control group and 33 % in the rate-control group ) , stroke ( 3 % and 4 % , respectively ) , worsening heart failure ( 28 % and 31 % ) , and the composite of death from cardiovascular causes , stroke , or worsening heart failure ( 43 % and 46 % ) . There were also no significant differences favoring either strategy in any predefined subgroup . CONCLUSIONS In patients with atrial fibrillation and congestive heart failure , a routine strategy of rhythm control does not reduce the rate of death from cardiovascular causes , as compared with a rate-control strategy . ( Clinical Trials.gov number , NCT00597077 .",
"BACKGROUND Congestive heart failure and atrial fibrillation often coexist , and each adversely affects the other with respect to management and prognosis . We prospect ively evaluated the effect of catheter ablation for atrial fibrillation on left ventricular function in patients with heart failure . METHODS We studied 58 consecutive patients with congestive heart failure and a left ventricular ejection fraction of less than 45 percent who were undergoing catheter ablation for atrial fibrillation . We selected as controls 58 patients without congestive heart failure who were undergoing ablation for atrial fibrillation , matched according to age , sex , and classification of atrial fibrillation . We evaluated the patients ' left ventricular function and dimensions , symptom score , exercise capacity , and quality of life at baseline and at months 1 , 3 , 6 , and 12 . RESULTS After a mean ( + /-SD ) of 12+/-7 months , 78 percent of the patients with congestive heart failure and 84 percent of the controls remained in sinus rhythm ( P=0.34 ) ( 69 percent and 71 percent , respectively , were in sinus rhythm without the administration of antiarrhythmic drugs ) . The patients with congestive heart failure had significant improvement in left ventricular function ( increases in the ejection fraction and fractional shortening of 21+/-13 percent and 11+/-7 percent , respectively ; P left ventricular dimensions ( decreases in the diastolic and systolic diameters of 6+/-6 mm and 8+/-7 mm , respectively ; P=0.03 and P exercise capacity , symptoms , and quality of life . The ejection fraction improved significantly not only in patients without concurrent structural heart disease ( 24+/-10 percent , P catheter ablation without the use of drugs in patients with congestive heart failure and atrial fibrillation significantly improve cardiac function , symptoms , exercise capacity , and quality of life",
"CONTEXT Antiarrhythmic drugs are commonly used for prevention of recurrent atrial fibrillation ( AF ) despite inconsistent efficacy and frequent adverse effects . Catheter ablation has been proposed as an alternative treatment for paroxysmal AF . OBJECTIVE To determine the efficacy of catheter ablation compared with antiarrhythmic drug therapy ( ADT ) in treating symptomatic paroxysmal AF . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve , multicenter , r and omized ( 2:1 ) , unblinded , Bayesian- design ed study conducted at 19 hospitals of 167 patients who did not respond to at least 1 antiarrhythmic drug and who experienced at least 3 AF episodes within 6 months before r and omization . Enrollment occurred between October 25 , 2004 , and October 11 , 2007 , with the last follow-up on January 19 , 2009 . INTERVENTION Catheter ablation ( n = 106 ) or ADT ( n = 61 ) , with assessment for effectiveness in a comparable 9-month follow-up period . MAIN OUTCOME MEASURES Time to protocol -defined treatment failure . The proportion of patients who experienced major treatment-related adverse events within 30 days of catheter ablation or ADT was also reported . RESULTS At the end of the 9-month effectiveness evaluation period , 66 % of patients in the catheter ablation group remained free from protocol -defined treatment failure compared with 16 % of patients treated with ADT . The hazard ratio of catheter ablation to ADT was 0.30 ( 95 % confidence interval , 0.19 - 0.47 ; P 30-day treatment-related adverse events occurred in 5 of 57 patients ( 8.8 % ) treated with ADT and 5 of 103 patients ( 4.9 % ) treated with catheter ablation . Mean quality of life scores improved significantly in patients treated by catheter ablation compared with ADT at 3 months ; improvement was maintained during the course of the study . CONCLUSION Among patients with paroxysmal AF who had not responded to at least 1 antiarrhythmic drug , the use of catheter ablation compared with ADT result ed in a longer time to treatment failure during the 9-month follow-up period . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00116428"
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Previous systematic review s have demonstrated better results with enamel matrix derivative proteins ( EMDP ) as compared with open flap debridement ( OFD ) for the management of infrabony periodontal defects ( IPD ) . The aim of this study was to determine whether these differences vary according to the follow-up and quality of the studies . Cochrane Central Register of Controlled Trials , Medline / PubMed , Lilacs , Embase and Web of Science electronic data bases were search ed up to August 2013 for r and omized clinical trials . Eligible outcomes were changes in probing depth ( PD ) , clinical attachment level (CAL),gingival recession ( GR ) and bone changes ( BC ) . Studies with follow-up of 12 months showed differences of 0.97 mm ( CI95 % 0.52 - 1.43 ) and 1.19 mm ( CI95 % 0.77 - 1.60 ) for PD and CAL , respectively , favorable for EMDP . Studies with follow-up ≥ 24 months presented advantages of 1.11 mm ( CI95 % 0.74 -1.48 ) for CAL and 0.83 mm ( CI95 % 0.19 -1.48 ) for PD , with use of EMDP . Considering the quality of studies , those with low risk of bias showed lower difference between groups , presenting 0.8 mm ( CI95 % 0.24 - 1.36 ) for CAL , favorable for EMDP and without differences for PS ( 0.51 mm , CI95 % -0.21 - 1.23 ) . In conclusion , follow-up time ( 2 years ) and the risk of bias influence the results of treatment with EMDP in IPD
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"The aim of the present clinical trial was to test tolerability during 2 treatments with EMDOGAIN in a large number of patients . An open , controlled study design in 10 Swedish specialist clinics was chosen , with a test group of 107 patients treated with EMDOGAIN in connection with periodontal surgery at 2 surgical test sites per patient . The procedures were performed 2 to 6 weeks apart on one-rooted teeth with at least 4 mm deep intraosseous lesions . A control group of 33 patients underwent flap surgery without EMDOGAIN at 1 comparable site . In total , 214 test and 33 control surgeries were performed . Serum sample s were obtained from test patients for analysis of total and specific antibody levels . 10 of the patients had sample s taken before and after the first surgery , 56 other sample s were taken after one treatment with EMDOGAIN , and 63 after 2 treatments . None of the sample s , not even from allergy-prone patients after 2 treatments , indicated deviations from established baseline ranges . This indicates that the immunogenic potential of EMDOGAIN is extremely low when applied in conjunction with periodontal surgery . Comparison between the test and control groups demonstrated the same type and frequency of postsurgical experiences , i.e. , reactions caused by the surgical procedure itself . Clinical probing and radiographic evaluation was performed at baseline and 8 months postsurgery . About half of the patients ( 44 test and 21 control ) were also evaluated after 3 years . There was a significant difference between the test and control results at 8 months postsurgery , and this difference had increased further at the 3 year follow-up . The 2.5 - 3 mm increase in attachment and bone level after treatment with EMDOGAIN was of the same magnitude as seen in the studies with split-mouth design aim ing for test of effectiveness of EMDOGAIN",
"The aim of the present clinical trial was to compare the long-term effect of EMDOGAIN treatment as an adjunct to modified widman flap ( MWF ) surgery with the effect of MWF and placebo treatment . The investigation was a placebo-controlled , r and omized multicenter trial involving 33 subjects with 34 paired test and control sites . The protocol required 2 interproximal sites , appropriately separated , in the same jaw with probing pocket depths > or = 6 mm and an associated intrabony defect with a depth of > or = 4 mm and a width of > or = 2 mm as measured on a radiograph . Only predominantly 1- and 2-wall defects were included . Clinical attachment gain and radiographic bone gain were used as primary outcome variables . Assessment s were made at baseline , 8 , 16 and 36 months . Mean values for clinical attachment level gain in test and control sites at 8 months were 2.1 mm and 1.5 mm , respectively ; at 16 months , 2.3 mm and 1.7 mm , respectively ; and at 36 months 2.2 mm and 1.7 mm , respectively ; and the differences were statistically significantly different at each time point ( p radiographic bone level continued to increase over the 36 months at the EMDOGAIN-treated sites , while it remained close to the baseline level at the control sites . The statistically significant ( p radiographic bone gain at 36 months of 2.6 mm at EMDOGAIN-treated sites corresponded to 36 % gain of initial bone loss or 66 % defect fill . The present trial has demonstrated that topical application of EMDOGAIN onto diseased root surfaces associated with intrabony defects during MWF periodontal surgery will promote an increased gain of radiographic bone and clinical attachment compared to control ( placebo application ) surgery in the same patient . There was no evidence to indicate any clinical adverse effects from application of EMDOGAIN conjunction with periodontal surgery",
"OBJECTIVES The aims of this controlled study were to clinical ly and radiographically evaluate the effect of a microsurgical approach for the treatment of intra-bony defects with and without an enamel matrix derivative ( EMD ) . Parts of this study population were already published by Wachtel and colleagues in 2003 . MATERIAL AND METHODS Seventy intra-bony defects were r and omly assigned to a microsurgical access flap with application of EMD ( test group ) and on the contra-lateral side to a microsurgical access flap alone ( control group ) . Clinical and radiographic parameters were assessed at baseline and after 6 and 12 months . RESULTS Both test and control treatments result ed in a statistically significant mean clinical attachment level ( CAL ) gain , probing pocket depth ( PPD ) reduction and radiographic bone fill . The test group yielded statistically significantly more CAL gain , PPD reduction and radiographic bone fill than the control group . Gingival recession increase after 12 months averaged 0.5 and 0.7 mm for the test and control groups , and did not reach statistical significance . Two weeks after surgery , primary wound closure was maintained in 91 % of the test sites and 97 % of the control sites . CONCLUSION The combination of a microsurgical access flap with EMD seems to be superior to open flap debridement in terms of PPD reduction , CAL gain and radiographic bone fill . In the test as well as the control group , primary wound closure was successfully achieved",
"The aim of this prospect i ve multicenter controlled clinical study was to evaluate the efficacy of Emdogain ( Biora ) , an enamel matrix derivative ( EMD ) , when combined with surgical treatment of periodontal angular defects , as compared to surgery alone , for up to 24 months of follow-up . The study was performed at six Italian universities and 11 private practice s. Patients with one- , two- , or three-wall angular defects were enrolled if intrabony defect depth ( IBD ) was 4 mm or more and probing pocket depth ( PPD ) was at least 6 mm . They were r and omly allocated to either test or control groups . The test group was treated by the simplified papilla preservation ( SPP ) flap plus Emdogain after root conditioning with ethylenediaminetetraacetic acid . The control group was treated by SPP alone . Plaque Index , Gingival Index , PPD , and periodontal attachment level ( PAL ) at surgical sites were assessed at the presurgical examination ( baseline ) . IBD was measured intraoperatively after debridement . IBD was also evaluated with a computer-aided technique , from periapical radiographs . Plaque Index , Gingival Index , PPD , PAL , and IBD were assessed at 12 and 24 months postsurgery . Data were further divided in two subgroups according to baseline IBD ( 6 mm or less and more than 6 mm ) . The differences between each follow-up and baseline , and between groups at each follow-up , for the above parameters were evaluated by st and ard statistical methods . One hundred fifty-three patients were recruited , accounting for 195 intrabony defects : 83 patients ( 108 defects ) and 70 patients ( 87 defects ) were allocated to the test and control groups , respectively . All parameters were improved at both 12 and 24 months , compared to baseline in both groups . In the test group , IBD , PPD , and PAL at 12 months were significantly better than these parameters in the control group . The test subgroup with IBD of more than 6 mm at baseline displayed a better outcome when compared to the 6 mm or less IBD subgroup . No significant adverse events related to the use of Emdogain were reported . The use of EMD as an adjunct to periodontal surgery in the treatment of angular defects significantly enhanced the rate and degree of periodontal regeneration . The control group also displayed significant tissue regeneration , but at a slower rate compared to the Emdogain group . The surgical procedure itself , with its goal of maximum preservation of the regenerative potential of periodontal tissues , proved to be effective in the treatment of periodontal angular defects . Pockets with IBD greater than 6 mm showed major improvement when treated with Emdogain",
"BACKGROUND This r and omized , double-masked , placebo-controlled clinical trial evaluated the effect of enamel matrix derivative ( EMD ) on clinical and radiographic parameters of periodontal intrabony defects . METHODS A split-mouth design was used in 16 chronic periodontitis patients who had similar defects ( > or = 6 mm of probing depth ) . Both groups underwent scaling and root planing and were acid-etched with EDTA . The test sites received the EMD solution and the controls a placebo . Clinical examinations of all 16 patients and radiographs of 14 patients were available at baseline and 6 and 12 months after surgery . Clinical outcomes included probing depth ( PD ) and clinical attachment level ( CAL ) ; radiographic analysis was performed using computerized linear measurements . Intergroup comparisons were performed by paired sample s t test , and over time comparisons were made by general linear model ( alpha = 0.05 ) . RESULTS A statistically significant improvement over time for PD and CAL and a decrease of the vertical component of the defect was detected in both groups . Comparisons between groups revealed at baseline a mean+/-SD value of CAL of 12.93+/-2.00 and 13.47+/-2.93 for test and control groups , respectively . These values decreased to 10.92+/-1.92 and 11.31+/-1.86 after 12 months for test and control . No statistically significant differences could be observed between groups . PD displayed similar results from 7.57+/-1.02 and 7.38+/-1.16 for test and control groups at baseline to 3.40+/-1.82 and 2.99+/-1.07 after 12 months . If the data are divided into smokers and non-smokers , no differences are observed . CONCLUSION Use of EMD did not result in more improvement in clinical and radiographic parameters compared to the placebo",
"PURPOSE To evaluate the efficacy of Emdogain versus placebo ( its carrier ) for the treatment of deep infrabony defects . MATERIAL S AND METHODS Thirty patients with an infrabony defect of at least 4 mm deep and at least 2 mm wide were r and omly allocated for treatment with either Emdogain or placebo ( the Emdogain carrier ) . The treating clinician was completely blinded to the therapy provided and performed all evaluations blindly up to the third year of follow-up . Outcome measures were tooth loss , complications , post-operative healing , patient 's satisfaction with treatment and aesthetics , changes in probing attachment levels ( PAL ) , probing pocket depths ( PPD ) , gingival recessions ( REC ) and radiographic bone levels ( RAD ) . RESULTS One year after treatment , both therapies had significantly improved clinical outcome measures : placebo group PAL gain = 3.3 mm , PPD reduction = 3.9 mm , and RAD gain = 2.5 mm ; Emdogain group PAL gain = 3.4 mm , PPD reduction = 4.2 mm , and RAD gain = 2.5 mm . Both therapies induced statistically significant gingival recession ( 0.6 mm in the placebo and 0.8 mm in the Emdogain group ) . There were no statistically significant differences between groups for any of the outcomes tested . No teeth had to be extracted up to 3 years after treatment . CONCLUSIONS There does not appear to be any clinical advantage when using Emdogain over its carrier ( placebo ) in the treatment of deep and wide infrabony defects",
"BACKGROUND , AIMS The purpose of the present study was to compare the efficacy of 3 different surgical procedures in the treatment of infrabony defects : guided tissue regeneration ( GTR ) with non-resorbable membranes , Widman modified flap ( WMF ) and enamel matrix derivative ( EMD ) . METHOD 30 patients with an infrabony component > or = 4 mm were selected . 10 were treated with exp and ed polytetrafluorethylene ( ePTFE ( Gore - Tex W. L. Gore and Associates , Flagstaff , AZ , USA ) ) membranes , 10 with WMF and 10 with enamel matrix derivatives ( Emdogain ( U Biora AB Malm , Sweden ) ) . The efficacy of each treatment modality was investigated through regression analysis . Probing attachment level ( PAL ) gain , probing depth ( PD ) reduction and gingival recession ( REC ) variation were analyzed . RESULTS Both Emdogain ( enamel matrix derivative ) and ePTFE treatment show significant better results as compared to the WMF procedure in which there were no significant changes in PAL gain and PD reduction at baseline and 1 year after surgery . CONCLUSIONS Results from our analysis suggest that there is no statistically significant difference in PAL gain between GTR and EMD . The clinical outcomes of this pilot study may be of little significance , considering the small number of patients , but it has provided an important base for a controlled clinical trial ( with a larger number of patients ) which is currently in progress",
"OBJECTIVES Application of the guided tissue regeneration ( GTR ) principle and utilization of enamel matrix derivative ( EMD ) have both been shown to result in periodontal regeneration . While clinical investigations have demonstrated that the use of a microsurgical concept in combination with the GTR technique positively affects the percentage of primary closure and the amount of tissue preservation , no such information is available for EMD-treated periodontal defects . It was the aim of the present investigation to assess the clinical effect of the microsurgical access flap and EMD treatment with an emphasis on the evaluation of early wound healing . MATERIAL AND METHODS Eleven patients displaying at least one pair of intrabony periodontal defects with an intrabony component of > or =3 mm participated in the study . At baseline and at 6 and 12 months after surgery , the following clinical parameters were assessed by a blinded examiner : oral hygiene status ( API ) , gingival inflammation ( BOP ) , probing pocket depth ( PPD ) , clinical attachment level ( CAL ) and gingival recession ( GR ) . Defects were r and omly assigned to test or control treatment , which both consisted of a microsurgical access flap procedure design ed for maximum tissue preservation . The exposed root surfaces of the test sites were conditioned with a 24 % EDTA gel followed by EMD ( Emdogain(R ) ) application . Primary flap closure was achieved by a 2-layered suturing technique . Postoperative healing was evaluated by a newly introduced early wound-healing index ( EHI ) at 1 and 2 weeks after surgery . RESULTS Both test and control treatment result ed in a statistically significant mean CAL gain of 2.8 and 2.0 mm at 6 months , and 3.6 and 1.7 mm at 12 months , respectively ( p CAL gain between the two treatment modalities were statistically significant at both time points ( p GR values after 12 months averaged 0.3 and 0.4 mm for test and control sites , respectively , and did not reach statistical significance ( p > or = 0.05 ) . Two weeks after surgery , primary closure was maintained in 89 % of the test sites and in 96 % of the control sites . CONCLUSION Both treatment modalities using the microsurgical flap procedure result ed in a high percentage of primary flap closure and maximum tissue preservation . In terms of PPD reduction and CAL gain , the combination with EMD application appeared to be superior to the microsurgical access flap alone",
"OBJECTIVES The purpose of the present study was to evaluate the clinical effects of non-surgical periodontal treatment , supplemented with enamel matrix derivative ( EMD ) and /or systemic antibiotics , in deep periodontal pockets of patients with chronic periodontitis . METHODS This was a r and omized , placebo-controlled longitudinal clinical trial of 12 months duration . Using a split-mouth design , 16 subjects were r and omly assigned to scaling and root planing ( SRP ) with EMD or placebo in contra-lateral dentition areas . One half of the subjects received 250 mg metronidazole and 375 mg amoxicillin three times a day for 7 days and the other half received a placebo . One inter-proximal periodontal lesion was chosen as study site in each of the contra-lateral quadrants . RESULTS Subjects treated with systemic antibiotics yielded significantly better clinical results than those treated with placebo . In these cases , probing pocket depth was reduced significantly more after 6 months ( 3.0+/-2.1 mm versus 1.6+/-1.4 mm , p=0.05 ) , and the mean clinical attachment gain was significantly greater after 6 months ( 2.3+/-1.9 mm versus 0.7+/-1.6 mm , p=0.02 ) and 12 months ( 2.3+/-3.5 mm versus 0.4+/-3.8 mm , p=0.02 ) . Sites treated with the antibiotics plus EMD gained the largest amount of clinical attachment . There was no significant benefit of EMD adjunctive to SRP in subjects not treated with antibiotics . CONCLUSIONS The present study supports the notion that optimal repair and regeneration of the periodontium requires suppression of the microbiota causing periodontal disease",
"BACKGROUND Previous studies have demonstrated that enamel matrix derivative ( EMD ) has the ability to improve clinical parameters when used to treat intraosseous defects . The purpose of the present study was to compare at 12 months postsurgery sites treated with open flap debridement ( OFD ) alone to those treated with OFD and EMD . METHODS Twenty-three subjects with at least 2 intrabony defects were chosen . Fifty-three defects received EMD in conjunction with OFD . Thirty-one defects in these same 23 subjects were treated with OFD alone . Stents were fabricated to serve as fixed reference points . Re-entries were performed at least 1 year after initial surgery . Soft tissue measurements were recorded prior to initial surgery and prior to re-entry for gingival ( GI ) and plaque ( PI ) indices , probing depth ( PD ) , gingival margin position , and clinical attachment level ( CAL ) . Hard tissue measurements were recorded during the initial and re-entry surgery for level of crestal bone and depth of defect . Statistical analysis was conducted using the method of generalized estimating equations to determine changes in GI , PI , PD , CAL , fill of the osseous defect , and crestal resorption . Percent of defect fill was also calculated . RESULTS In all categories , treatment with EMD ( test ) was superior to treatment without EMD ( control ) . Average PI and GI were not significantly different either initially or prior to re-entry . The average PD reduction was 2.7 mm greater with EMD than controls . The average CAL gains were 1.5 mm greater , and the average fill of osseous defect 2.4 mm greater with EMD than controls . The average percent of defect fill after adjusting for crestal bone loss was more than 3 times greater for EMD versus control-treated sites ( 74 % defect fill with EMD versus 23 % defect fill for control sites ) . CONCLUSIONS This study indicates that treatment of periodontal intraosseous defects with EMD is clinical ly superior to treatment without EMD ( open flap debridement ) in every parameter evaluated . Re-entry data demonstrate that percent fill of osseous defects treated with EMD compares favorably with the treatment results utilizing bone grafts or membrane barriers , according to published literature",
"BACKGROUND There is limited information available from clinical trials regarding the performance of enamel matrix derivative ( EMD ) in the treatment of periodontal intrabony defects . This r and omized , double-blind , placebo-controlled , split-mouth study was design ed to compare the clinical and radiographical effects of EMD treatment to that of placebo-controlled treatment for intrabony defects . METHODS Sixteen patients were included , each of whom had 1 or 2 pairs of intrabony defects located contralaterally in the same arch . Thirty-six intrabony defects were r and omly assigned treatment with flap surgery plus EMD or flap surgery plus placebo . At baseline and at the 12-month follow-up evaluation visit , clinical and radiographic measurements were determined . Data were statistically analyzed using the Wilcoxon-signed rank test ( alpha = 0.05 ) . RESULTS At the 12-month visit , bleeding on probing for the EMD group was 0.11 + /- 0.32 compared to the placebo group , 0.61 + /- 0.50 ( P Probing depth reduction was greater in the EMD group ( 3.00 + /- 0.97 mm ) compared to the placebo group ( 2.22 + /- 0.81 mm ) ( P Mean values for clinical attachment gain in the EMD and the placebo groups were 1.72 + /- 1.07 mm and 0.83 + /- 0.86 mm , respectively ( P Vertical relative attachment gain was 38.5 + /- 22.6 % in the EMD group and 21.4 + /- 25.2 % in the placebo group ( P Radiographic bone density gain was greater in the EMD ( 20.2 + /- 16.6 % ) compared to the placebo group ( -3.94 + /- 23.3 % ) ( P EMD , compared to flap surgery with placebo , produced a significantly more favorable clinical improvement in intrabony periodontal defects",
"OBJECTIVE To evaluate a comparison of open-flap debridement ( OFD ) with or without the use of enamel matrix proteins ( EMP ) for the treatment of infrabony defects . METHOD AND MATERIAL S Ten volunteers ( 38 infrabony defects ) were r and omized to receive OFD+EMP ( test site ) and OFD ( control site ) . Clinical outcomes included mean changes in Plaque Index , Gingival Index , probing pocket depth ( PPD ) , relative attachment level ( RAL ) , gingival recession , width of keratinized tissue , and dental mobility at baseline and at 24 months . RESULTS A significant reduction of 4.21+/-0.97 mm was observed in PPD for the OFD+EMP group ( from 6.30+/-0.99 mm to 2.09+/-0.97 mm ) and of 3.28+/-1.23 mm for the OFD group ( from 6.13+/-0.88 mm to 2.85+/-1.42 mm ) ( P reduction in PPD was statistically significantly greater for OFD+EMP compared to OFD ( P=.03 ) . The mean RAL decreased from 13.26+/-1.88 mm to 7.57+/-2.05 mm for the OFD+EMP group ( a gain of 5.69+/-1.96 mm ) and from 13.37+/-1.71 mm to 8.13+/-1.34 mm ( P Gingival recession was higher in the OFD+EMP group than in the OFD group . The mean keratinized tissue significantly decreased from 4.41+/-1.39 mm to 3.63+/-1.54 mm for OFD flap group ( P RAL and PPD . Within groups , there was a significant reduction in keratinized tissue for OFD and a significant postoperative recession for the OFD + EMP group . Infrabony defects treated with OFD + EMP showed significantly more PPD reduction when compared to OFD",
"AIMS This three-arm study compared the clinical and radiographic efficacy of the modified minimally invasive surgical technique ( M-MIST ) alone and combined with enamel matrix derivative ( EMD ) or EMD plus bone mineral derived xenograph ( BMDX ) , in the treatment of isolated , inter-dental intra-bony defects . MATERIAL S AND METHODS Forty-five deep isolated intra-bony defects in 45 patients were included , accessed with the M-MIST and r and omly assigned to three balanced experimental groups . The M-MIST consisted of a small buccal flap without elevation of the defect-associated papilla . After removal of the granulation tissue by sharp dissection and root instrumentation the regenerative material was applied , when indicated , before obtaining primary closure with a single internal modified mattress suture . Surgery was performed with the aid of an operating microscope and microsurgical instruments . Outcomes were evaluated as pocket depth reduction , attachment level gain , radiographic bone fill and patient-related outcomes . RESULTS Primary wound closure was maintained in all treated sites with the exception of one M-MIST EMD+BMDX site . No patient reported intra-operative or post-operative pain . Within group differences between baseline and 1 year were statistically significant in the three groups in terms of probing pocket depth reduction , clinical attachment level ( CAL ) gain and bone fill ( p CAL gains of 4.1±1.4 mm were observed in the M-MIST control group , 4.1±1.2 mm in the EMD group and 3.7±1.3 mm in the EMD+BMDX one . The percentage radiographic bone fill of the intra-bony component was 77±19 % in the M-MIST control group , 71±18 % in the EMD group and 78±27 % in the EMD+BMDX group . CONCLUSIONS M-MIST with or without regenerative material s result ed in significant clinical and radiographic improvements . While this initial study did not have sufficient power to detect inter-group CAL differences < 0.96 mm , the observed outcomes were remarkably similar and warrant further investigations",
"AIMS Aim of this r and omized , long-term clinical trial was to compare clinical - and patient-based outcomes following periodontal regeneration or extraction and replacement of hopeless teeth with chronic perio-endo lesions and /or attachment loss to or beyond the apex . METHODS Fifty patients presenting with generalized severe periodontitis and at least one hopeless tooth to be extracted for periodontal reasons were entered in this study . The test treatment consisted in the application of a regenerative strategy to 25 hopeless teeth . The control treatment consisted in the extraction of the 25 hopeless teeth and their replacement with conventional or implant-supported fixed partial dentures . RESULTS In the control group , 14 teeth were replaced with implant-supported restorations , eight with tooth-supported bridges , two with Maryl and bridges , while one was not replaced . All fixed partial dentures survived the 5-year follow-up period and 83 % were free from biological complications . In the test group , 23 of the 25 regenerated teeth showed important clinical improvements : the two teeth with unsatisfactory outcomes were extracted at 1 year . The 23 successfully regenerated teeth ( 92 % ) were in good health and function at 5-year examination visit and 84 % did not develop biological complications during the recall period . All patients consistently reported comfort in function at the experimental test and control units . In the test group , average clinical attachment level gains were 7.7±2.8 mm , radiographic bone gain 8.5±3.1 mm , probing pocket depth ( PPD ) reduction 8.8±3 mm . Residual PPDs were 4±1.7 mm . Most of the regenerated teeth showed a decrease in tooth mobility . CONCLUSIONS Regenerative therapy can be applied at hopeless teeth and has the potential to change their prognosis ; it is a suitable alternative to extraction of severely compromised teeth with intra-bony defects to or beyond the root apex ",
"The goal of this investigation was to evaluate histologically and histometrically the healing process in dehiscence-type defects treated by enamel matrix derivative ( EMD ) . Five adult female beagle dogs were used . Buccal osseous dehiscences were surgically created on the maxillary canines and the second and fourth premolars . Thirty defect sites were r and omly assigned to treatment and control groups ( 15 defect sites for each group ) . The treatment group received EMD application , while the control groups received no EMD . After 4 months of healing , the dogs were sacrificed and tissue blocks were prepared . Histometric parameters were employed to evaluate the type of periodontal tissues that formed in the defects . All created dehiscence defects in the test sites treated by EMD had formed functional connective tissue fibers inserted into regenerated cellular cementum . The mean amount of apicocoronal regenerated cementum was 3.74 + /- 0.43 mm in EMD- treated sites , whereas the control sites had not formed cementum in the created dehiscence defects ( P EMD alone effectively promoted new cementum and functionally oriented connective tissue formation",
"OBJECTIVES To compare clinical outcomes of three different modalities of treatment for deep intra-bony defects . MATERIAL AND METHODS Fifty-six patients were paralleled for clinical parameters and r and omly assigned to treatment . They displayed one angular defect each with an intra-bony component > or =3 mm , probing pocket depth ( PPD ) and probing attachment level ( PAL ) > or = 7 mm , and plaque index ( PI ) . Nineteen defects were treated , respectively , with enamel matrix derivative (EMD)+tricalcium phosphate ( TCP ) or EMD alone and 18 defects with modified Widman flap ( MWF ) . Primary flap closure was used in all three groups . PI , gingival index , bleeding on probing , PPD , PAL , and recession ( REC ) were measured before and 12 months after treatment . RESULTS Treatment with EMD alone yielded a 3.9+/-1.3 mm PPD decrease and a 3.7+/-1.0 mm PAL gain ( p EMD+beta-TCP produced a 4.1+/-1.2 mm PPD reduction and a 4.0+/-1.0 mm PAL gain ( p REC increased by 0.7+/-1.3 mm . After MWF treatment , attachment gain was 2.1+/-1.4 mm ( p PPD reduction was 3.8+/-1.8 mm , whereas REC increased by 1.5+/-0.7 mm ( p=0.042 versus EMD ) . CONCLUSION Both EMD treatments showed similar clinical effects , with significant PAL gain and a significantly lower REC increase in comparison with MWF treatment",
"The aim of the present study was to evaluate histologically in humans the healing of advanced intrabony defects following treatment with enamel matrix proteins ( EMD ) or guided tissue regeneration ( GTR ) . Fourteen patients , each of them displaying 1 advanced intrabony defect around teeth scheduled for extraction were included in the study . The defects were treated r and omly either with an enamel matrix protein derivative ( Emdogain , BIORA AB , Malmö , Sweden ) or with a bioabsorbable membrane ( Resolut , Regenerative Material , W.L. Gore & Assoc . , Flagstaff , Arizona , USA ) . At baseline the mean probing pocket depth ( PPD ) in the EMD group was 11.3 + /- 1.8 mm and the mean clinical attachment level ( CAL ) 12.1 + /- 2.0 mm , whereas in the GTR group the mean PPD was 11.4 + /- 2.2 mm and the mean CAL 13.3 + /- 2.3 mm . Healing was uneventful in all cases . Neither allergic reactions against EMD or the bioabsorbable membrane , nor suppuration or abscesses were observed . The clinical results revealed at 6 months in the EMD group a mean PPD of 5.6 + /- 1.3 mm and a mean CAL of 9.1 + /- 1.5 mm . In the GTR group the mean PPD was 5.6 + /- 1.3 mm and the mean CAL 10.1 + /- 1.5 mm . The histological analysis showed in the EMD group a mean 2.6 + /- 1.0 mm of new attachment ( i.e. new cementum with inserting collagen fibers ) and a mean 0.9 + /- 1.0 mm of new bone . In this group , the formation of new attachment was not always followed by bone regeneration . In the GTR group , the mean new attachment was 2.4 + /- 1.0 mm and the mean new bone 2.1 + /- 1.0 mm . In every case treated with GTR , the formation of new attachment was followed by a varying amount of new bone . After both types of regenerative treatment the newly formed cementum displayed a predominantly cellular character . The findings of the present study indicate that the treatment of intrabony defects with enamel matrix proteins or with bioabsorbable membranes enhances the formation of a new connective tissue attachment in humans",
"THE PURPOSE OF THIS STUDY was to assess periodontal regenerative techniques in intrabony defects utilizing a bioabsorbable , polylactic acid ( PLA ) barrier or the non-resorbable , exp and ed polytetrafluoroethylene ( ePTFE ) barrier . Thirty patients ( 26 to 64 years old ) each with one radiographically evident intrabony periodontal lesion of probing depth > or = 6 mm participated in a 12-month controlled clinical trial . The subjects were r and omly divided into two independent groups . The test group ( n = 16 ) received a PLA barrier . The control group ( n = 14 ) received an ePTFE barrier . Plaque index ( PI ) , gingival index ( GI ) , probing depth ( PD ) , clinical attachment level ( CAL ) , and bone fill were recorded by a single calibrated examiner not involved with the surgical treatment prior to surgery , and at 6 , 9 , and 12 months postsurgery . The treatment results were statistically analyzed utilizing two sets of data . The \" averaged-site \" data set consisted of values computed from the averaging of measurements from all sites encompassing the defect . The second data set was comprised of only the deepest measurement of the defect . Statistical tests used to analyze these data sets included the t-test and paired t-test for parametric data and the Wilcoxon rank sum test and the Wilcoxon signed rank test for non-parametric data . Analyses with both the averaged-site data and deepest-site data result ed in significant improvements in PD reductions , CAL , and bone fill , after 12 months of healing with both the PLA and ePTFE barrier devices . Comparisons of healing response between treatments found no significant differences when the averaged-site data were analyzed . When only the deepest site of the defect was considered , the control group result ed in significantly more attachment gain ( ePTFE , 3.36 mm ; PLA , 1.75 mm ; P shallower probing depths ( ePTFE , 3.29 mm ; PLA , 4.69 mm ; P PLA or ePTFE barriers in GTR procedures yielded comparable clinical results ; however , in this study , data analysis using the deepest site of the defect found , after 12 months of healing , significantly more attachment gain and shallower probing depths with ePTFE",
"AIM This prospect i ve multicentre r and omized controlled clinical trial was design ed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of enamel matrix proteins ( EMD ) . MATERIAL AND METHODS 172 patients with advanced chronic periodontitis were recruited in 12 centers in 7 countries . All patients had at least one intrabony defect of > or = 3 mm . Heavy smokers ( > or = 20 cigarettes/day ) were excluded . The surgical procedures included access for root instrumentation using either the simplified or the modified papilla preservation flap in order to obtain optimal tissue adaptation and primary closure . After debridement , roots were conditioned for 2 min with a gel containing 24 % EDTA . EMD was applied in the test subjects , and omitted in the controls . Postsurgically , a strict plaque control protocol was followed . At baseline and 1 year following the interventions , clinical attachment levels ( CAL ) , pocket probing depths ( PPD ) , recession ( REC ) , full-mouth plaque scores and full-mouth bleeding scores were assessed . A total of 166 patients were available for the 1-year follow-up . RESULTS At baseline , 86 test and 86 control patients presented with similar subject and defect characteristics . On average , the test defects gained 3.1+/-1.5 mm of CAL , while the control defects yielded a significantly lower CAL gain of 2.5+/-1.5 mm . Pocket reduction was also significantly higher in the test group ( 3.9+/-1.7 mm ) when compared to the controls ( 3.3+/-1.7 mm ) . A multivariate analysis indicated that the treatment , the clinical centers , cigarette smoking , baseline PPD , and defect corticalisation significantly influenced CAL gains . A frequency distribution analysis of the studied outcomes indicated that EMD increased the predictability of clinical ly significant results ( CAL gains > or = 4 mm ) and decreased the probability of obtaining negligible or no gains in CAL ( CAL gains EMD offers an additional benefit in terms of CAL gains , PPD reductions and predictability of outcomes with respect to papilla preservation flaps alone",
"BACKGROUND A growing flow of recent evidence indicates enamel matrix derivative ( EMD , Emdogain ) as a useful tool for the regeneration of periodontal tissues . This prospect i ve clinical study aim ed to evaluate the efficacy of EMD combined with surgical treatment of periodontal intra-bony defects , as compared with surgery alone , up to 24 months of follow-up . METHODS Twenty-four intra-bony defects were treated in 24 patients in a single clinical centre . Each defect had intra-bony depth ( IBD ) > or = 4 mm and probing pocket depth ( PPD ) > or = 6 mm . Patients were r and omly assigned to either test or control group . Plaque index ( PI ) , gingival index ( GI ) , PPD and periodontal attachment level ( PAL ) were assessed at baseline pre-surgical examination at the site to be treated . Full mouth plaque score ( FMPS ) and full mouth bleeding score ( FMBS ) were also evaluated . Twelve patients were treated by simplified papilla preservation flap technique ( control group ) , while 12 patients were treated with the same surgical technique plus EMD after ethylenediamine tetraacetic acid root conditioning ( test group ) . Any probing at the involved sites was avoided in the first year post-surgery . Radiographs were taken at baseline , 12 and 24 months after surgery using customized bite blocks . Intra-bony defect depth ( IBD ) and angle ( IBA ) were measured from X-rays by a computer-aided technique . At 12 and 24 months post-surgery , FMPS , FMBS , PI , GI , PPD , PAL and radiographic IBD and IBA were assessed . The difference between each follow-up and baseline , and between groups at each follow-up was evaluated for the above parameters by st and ard statistical methods . RESULTS In both groups , clinical and radiographic parameters were improved at either 12 or 24 months when compared with baseline . The test group displayed better outcomes when compared with the control group for IBD , PPD , and PAL gain at 12 months , and only for PAL and IBD gain at 24 months . No adverse event related to the use of EMD was reported . CONCLUSIONS The surgical procedure used in the present study , aim ing for maximum preservation of the regenerative potential of periodontal tissues , showed per se excellent results . The use of EMD as an adjunct to periodontal surgery in the treatment of angular defects possibly enhances periodontal regeneration rate",
"AIM There is evidence that regenerative treatment of intra-bony and m and ibular class II furcation defects with access flap and an application of an enamel matrix protein derivative ( EMD ) can result in a clinical benefit compared with access flap alone . The aim of this pilot study was to check if the results of access flap surgery in suprabony defects are improved by additional application of EMD . MATERIAL AND METHODS Thirty-nine adult subjects with supra-alveolar-type defects were r and omly assigned to a test ( n=25 ) and a control group ( n=14 ) . Seventy teeth were treated with EMD ; 28 teeth were treated by access flap . Probing depth ( PD ) , clinical attachment level and bleeding on probing were evaluated at baseline and after 12 months . RESULTS PD of the operated teeth was improved in both groups ( p attachment gain was 2.72+/-1.80 mm at sites with an initial PD > or=7 mm in the test group and 0.78+/-0.62 mm in the control group ( p=0.004 ) . In the test group the mean attachment gain was 0.97+/-0.92 mm ( p mean reduction of PD was 1.55+/-0.90 mm ( p EMD during surgical treatment of periodontitis of supra-alveolar pockets , especially in deeper pockets",
"Abstract Introduction . Emdogain ® represents an extracellular matrix derivative that controls and promotes periodontal regeneration . Several studies have demonstrated that the treatment of periodontal defects with Emdogain ® leads to improvements in clinical parameters . However , long-time clinical trials establishing clinical usefulness of Emdogain ® are scarce . Therefore , the present r and omized split mouth , controlled study was undertaken to evaluate the effectiveness of Emdogain ® as an adjunct to open flap debridement for the treatment of intra-bony defects over a period of 5 years . Material s and methods . The study population consisted of 15 chronic periodontitis patients with bilateral interproximal osseous defects . The test group was treated by open flap debridement with EDTA 24 % ( PrefGel ® ) followed by enamel matrix derivative ( Emdogain ® ) . The control group was treated by open flap debridement with EDTA 24 % ( PrefGel ® ) . Results . After 1 and 5 years , both the test and control groups showed significant mean PPD reduction . A greater reduction in mean Probing Pocket Depth ( PPD ) was observed in the test group ( 3.84 ± 1.05 ) as compared to the control group ( 1.92 ± 0.35 ) . The mean Clinical Attachment Level ( CAL ) gain of 3.18 ± 0.87 mm was observed in the test group , while the control group displayed mean CAL gain of 1.60 ± 0.54 mm . The observed differences were found to be statistically significant in both the groups ( p was significantly increased at 12 months post-surgery in test group ( 66.66 ± 7.8 % ) as compared to control group ( 31.71 ± 4.1 % ) . Conclusion . The treatment with Emdogain result ed in a significantly higher CAL gain and PPD reduction in comparison with OFD and PrefGel ®"
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Purpose Men who are survivors of prostate cancer report a variety of psychological and physical factors contributing to a lower quality of life , and physical activity can assist to mitigate these issues . This review aims to provide a summary of physical activity behaviour change trials targeting prostate cancer survivors , assess the feasibility of these interventions and , if possible , identify intervention and study characteristics associated with significant intervention effects . Method Four data bases ( PubMed , CINAHL , PsycINFO and EMBASE ) were systematic ally search ed for r and omised controlled trials containing at least one behavioural outcome relating to physical activity published up until July 2016 . Forward and backwards , h and , key author citation search ing and known research were also considered . Results From a total of 13 , 828 titles , the search result ed in 12 studies ( 6 prostate cancer only and 6 mixed cancer interventions ) , eight of which found positive results most often related immediately to post-intervention aerobic activity . Factors relating to efficacy were not conclusive due to the heterogeneity of studies and lack of cancer-specific data in mixed cancer trials . Future research focusing on intervention reach , maintenance of intervention effects and resistance training outcomes is needed . Conclusion There is preliminary evidence to suggest that a variety of physical activity behaviour change interventions targeting men with a history of prostate cancer can be efficacious , at least in the short term . Experimental studies are required to identify key intervention features . Implication s for Cancer SurvivorsPhysical activity interventions can assist prostate cancer survivors in relation to short-term lifestyle change , though more evidence is required to improve the clarity of factors related to efficacy
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"Goals of workProstate cancer patients receiving and rogen deprivation therapy ( ADT ) are vulnerable to a number of potentially debilitating side effects , which can significantly impact quality of life . The role of alternate therapies , such as physical activity ( PA ) , in attenuating these side effects is largely understudied for such a large population . Thus , the purpose of this study was to investigate the effects of PA intervention for men receiving ADT on PA behavior , quality of life , and fitness measures . Patients and methods One hundred participants were r and omized into an intervention ( n = 53 ) or a wait-list control group ( n = 47 ) , with 11 dropping out of the intervention group and 23 dropping out of the wait-list control group prior to post-testing . The intervention consisted of both an individually tailored home-based aerobic and light resistant training program and weekly group sessions . PA , quality of life , fitness , and physiological outcomes were assessed pre and post the 16-week intervention . Results Significant increases in PA , supported by changes in girth measures and blood pressure , support the beneficial impact of the intervention . Positive trends were also evident for depression and fatigue . However , due to the high dropout rate , these results must be interpreted with caution . Conclusions PA effectively attenuates many of the side effects of ADT and should be recommended to prostate survivors as an alternate therapy . Determining the maintenance of this behavior change will be important for underst and ing how the long-term benefits of increased activity levels may alleviate the late effects of ADT",
"Background Physical activity improves health in prostate cancer survivors ; however , participation rates are low . Purpose This study aims to determine the effects of an implementation intention intervention on physical activity and quality of life in prostate cancer survivors . Methods Prostate cancer survivors ( N = 423 ) were r and omly assigned to a st and ard physical activity recommendation , a self-administered implementation intention , or a telephone-assisted implementation intention . Physical activity and quality of life were assessed at baseline , 1 , and 3 months . Results Analyses of covariance using multiple imputation showed that physical activity at 1 month increased by 86 min/week in the st and ard physical activity recommendation group compared with 168 min/week in the self-administered implementation intention group ( P = 0.023 ) and 105 min/week in the telephone-assisted implementation intention group ( P = 0.35 ) . Conclusions A self-administered implementation intention intervention result ed in a meaningful short-term increase in physical activity . Supplementation with additional intervention strategies and more frequent intervention may improve longer-term exercise . ( Clinical Trials.gov number NCT01410656 )",
"Background Physical activity ( PA ) behavior change interventions among cancer survivors have used face-to-face , telephone , email , and print-based methods . However , computer-tailored , Internet-delivered programs may be a more viable option to achieve PA behavior change . Objective The objective of this study is to test the feasibility and preliminary efficacy of a Web-based PA behavior change program among cancer survivors . Methods Nova Scotian cancer survivors ( N=415 ) who previously expressed interest in a research study were approached . Interested participants were asked to complete an online assessment of PA and quality of life ( QOL ) before being r and omized to either a theory-based PA behavior change program using the PA tracking website UWALK ( UCAN ; n=48 ) or usual care ( UC ; n=47 ) . After the intervention ( 9 weeks ) , participants completed another online assessment of PA and QOL as well as measures to evaluate the program and website . Descriptive analyses from surveys and Web analytic software were used to assess feasibility and mean change scores were used to test efficacy . Results Of all contacted survivors , 95 ( 22.3 % , 95/415 ) completed baseline measures and were r and omized with 84 ( 88 % , 84/95 ) completing the 9-week assessment . The behavior change program and website were rated highly on the satisfaction items . Average logins were 10.3 ( 1.1 per week ) and 26.0 % ( 111/432 ) of the weekly modules were completed . Most participants ( 71 % , 29/41 ) indicated they were more aware of their daily PA levels and 68 % ( 28/41 ) found the site easily navigable . Adjusted group differences in total exercise minutes favored the UCAN group by an increase of 42 minutes ( 95 % CI -65 to 150 ; P=.44 , d=0.17 ) . Results were more pronounced , though still nonsignificant , among those not meeting guidelines at baseline where UCAN increased PA by 52 minutes compared to a decrease of 15 minutes in UC ( adjusted between group difference=75 , 95 % CI -95 to 244 ; P=.38 , d=0.27 ) . Conclusions We found that Internet-delivery may be a feasible alternative to more costly methods to promote PA among Nova Scotian cancer survivors . Moreover , there was a trend toward increased PA among those in the UCAN group , especially among those who were not meeting PA guidelines at baseline . Future research should focus on recruiting inactive cancer survivors and engaging them in the website to determine the optimal potential of Web-based interventions for promoting PA in cancer survivors",
"Background Males experience a shorter life expectancy and higher rates of chronic diseases compared to their female counterparts . To improve health outcomes among males , interventions specifically developed for males that target their health behaviors are needed . Information technology (IT)-based interventions may be a promising intervention approach in this population group , however , little is known about how to maximize engagement and retention in Web-based programs . Objective The current study sought to explore attributes hypothesized to influence user engagement among a sub sample of participants from the ManUp study , a r and omized controlled trial testing the efficacy of an interactive Web-based intervention for promoting physical activity and nutrition among middle-aged males . Methods Semistructured interviews were conducted and audiotaped with 20 of the ManUp participants . Interview questions were based on a conceptual model of engagement and centered on why participants took part in the study , what they liked and did not like about the intervention they received , and how they think the intervention could be improved . Interview recordings were transcribed and coded into themes . Results There were five themes that were identified in the study . These themes were : ( 1 ) users ’ motives , ( 2 ) users ’ desired outcomes , ( 3 ) users ’ positive experiences , ( 4 ) users ’ negative emotions , and ( 5 ) attributes desired by user . Conclusions There is little research in the field that has explored user experiences in human-computer interactions and how such experiences may relate to engagement , especially among males . Although not conclusive , the current study provides some insight into what personal attributes of middle-aged males ( such as their key motives and goals for participating ) and attributes of the intervention material s ( such as usability , control , and interactivity ) may impact on user engagement in this group . These findings will be helpful for informing the design and implementation of future health behavior interventions for males . Trial Registration Australian New Zeal and Clinical Trials Registry : ACTRN12611000081910 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?ACTRN=12611000081910 ( Archived by WebCite at http://www.webcitation.org/6M4lBlvCA )",
"PURPOSE Diet and exercise interventions have been tested in cancer survivors as a means to reduce late effects and comorbidity , but few have assessed adherence and health outcomes long term . METHODS Between July 2005 and May 2007 , the Reach Out to Enhance Wellness ( RENEW ) trial accrued 641 locoregionally staged , long-term ( ≥ 5 years from diagnosis ) colorectal , breast , and prostate cancer survivors in the United States ( 21 states ) , Canada , and the United Kingdom . All participants were sedentary ( The trial tested a diet-exercise intervention delivered via mailed print material s and telephone counseling . RENEW used a wait-list control , cross-over design ( ie , participants received the year-long intervention immediately or after a 1-year delay ) , which allowed the opportunity to assess program efficacy ( previously reported primary outcome ) , durability , and reproducibility ( reported herein ) . Measures included diet quality ( DQ ) , PA , BMI , and physical function ( PF ) . RESULTS No significant relapse was observed in the immediate-intervention arm for DQ , PA , and BMI ; however , rates of functional decline increased when the intervention ceased . From year 1 to year 2 , significant improvements were observed in the delayed-intervention arm ; mean change scores in behaviors and BMI and PF slopes were as follows : DQ score , 5.2 ( 95 % CI , 3.4 to 7.0 ) ; PA , 45.8 min/wk ( 95 % CI , 26.9 to 64.6 min/wk ) ; BMI , -0.56 ( 95 % CI , -0.75 to -0.36 ) ; and Short Form-36 PF , -1.02 versus -5.52 ( P experienced significant improvements in DQ , PA , and BMI from baseline to 2-year follow-up ( P Older cancer survivors respond favorably to lifestyle interventions and make durable changes in DQ and PA that contribute to sustained weight loss . These changes positively reorient functional decline trajectories during intervention delivery",
"Background Prostate cancer can negatively impact quality of life of the patient and his spouse caregiver , but interventions rarely target the health of both partners simultaneously . We tested the feasibility and preliminary efficacy of a partnered strength training program on the physical and mental health of prostate cancer survivors ( PCS ) and spouse caregivers . Methods Sixty-four couples were r and omly assigned to 6 months of partnered strength training ( Exercising Together , N = 32 ) or usual care ( UC , N = 32 ) . Objective measures included body composition ( lean , fat and trunk fat mass ( kg ) , and % body fat ) by DXA , upper and lower body muscle strength by 1-repetition maximum , and physical function by the physical performance battery ( PPB ) . Self-reported measures included the physical and mental health summary scales and physical function and fatigue subscales of the SF-36 and physical activity with the CHAMPS question naire . Results Couple retention rates were 100 % for Exercising Together and 84 % for UC . Median attendance of couples to Exercising Together sessions was 75 % . Men in Exercising Together became stronger in the upper body ( p more physically active ( p increased muscle mass ( p = 0.05 ) and improved upper ( p 0.01 ) and lower body ( p ( p = 0.01 ) more than UC . Conclusions Exercising Together is a novel couples-based approach to exercise that was feasible and improved several health outcomes for both PCS and their spouses . Implication s for cancer survivorsA couples-based approach should be considered in cancer survivorship programs so that outcomes can mutually benefit both partners . Trial registration Clinical Trials.gov",
"Background Physical activity and consuming a healthy diet have clear benefits to the physical and psychosocial health of cancer survivors , with guidelines recognising the importance of these behaviors for cancer survivors . Interventions to promote physical activity and improve dietary behaviors among cancer survivors and carers are needed . The aim of this study was to determine the effects of a group-based , face-to-face multiple health behavior change intervention on behavioral outcomes among cancer survivors of mixed diagnoses and carers . Methods The Exercise and Nutrition Routine Improving Cancer Health ( ENRICH ) intervention was evaluated using a two-group pragmatic r and omized controlled trial . Cancer survivors and carers ( n = 174 ) were r and omly allocated to the face-to-face , group-based intervention ( six , theory-based two-hour sessions delivered over 8 weeks targeting healthy eating and physical activity [ PA ] ) or wait-list control ( after completion of 20-week data collection ) . Assessment of the primary outcome ( pedometer-assessed mean daily step counts ) and secondary outcomes ( diet and alcohol intake [ Food Frequency Question naire ] , self-reported PA , weight , body mass index , and waist circumference ) were assessed at baseline , 8- and 20-weeks . Results There was a significant difference between the change over time in the intervention group and the control group . At 20 weeks , the intervention group had increased by 478 steps , and the control group had decreased by 1282 steps ; this represented an adjusted mean difference of 1761 steps ( 184 to 3337 ; P = 0.0028 ) . Significant intervention effects for secondary outcomes , included a half serving increase in vegetable intake ( difference 39 g/day ; 95 % CI : 12 to 67 ; P = 0.02 ) , weight loss ( kg ) ( difference -1.5 kg ; 95 % CI , -2.6 to -0.3 ; P = 0.014 ) and change in body mass index ( kg/m2 ) ( difference -0.55 kg/m2 ; 95 % CI , -0.97 to -0.13 ; P = 0.012 ) . No significant intervention effects were found for self-reported PA , total sitting time , waist circumference , fruit , energy , fibre , alcohol , meat , or fat consumption . Conclusions The ENRICH intervention was effective for improving PA , weight , body mass index , and vegetable consumption even with the inclusion of multiple cancer types and carers . As an example of successful research translation , the Cancer Council NSW has subsequently adopted ENRICH as a state-wide program . Trial registration Australian New Zeal and Clinical Trials Register identifier : ANZCTRN1260901086257",
"Abstract Background Despite evidence that physical activity improves the health and well-being of prostate cancer survivors , many men do not engage in sufficient levels of activity . The primary aim of this study ( ENGAGE ) is to determine the efficacy of a referral and physical activity program among survivors of prostate cancer , in terms of increasing participation in physical activity . Secondary aims are to determine the effects of the physical activity program on psychological well-being , quality of life and objective physical functioning . The influence of individual and environmental mediators on participation in physical activity will also be determined . Methods / Design This study is a cluster r and omised controlled trial . Clinicians of prostate cancer survivors will be r and omised into either the intervention or control condition . Clinicians in the intervention condition will refer eligible patients ( n = 110 ) to participate in an exercise program , comprising 12 weeks of supervised exercise sessions and unsupervised physical activity . Clinicians allocated to the control condition will provide usual care to eligible patients ( n = 110 ) , which does not involve the recommendation of the physical activity program . Participants will be assessed at baseline , 12 weeks , 6 months , and 12 months on physical activity , quality of life , anxiety , depression , self-efficacy , outcome expectations , goals , and socio-structural factors . Discussion The findings of this study have implication s for clinicians and patients with different cancer types or other chronic health conditions . It will contribute to our underst and ing on the potential impact of clinicians promoting physical activity to patients and the long term health benefits of participating in physical activity programs . Trial registration Australia and New Zeal and Clinical Trials Register ( ANZCTR ) : ACTRN12610000609055 Deakin University Human Research Ethics Approval 2011 -",
"PURPOSE To examine the effect of progressive resistance training on muscle function , functional performance , balance , body composition , and muscle thickness in men receiving and rogen deprivation for prostate cancer . METHODS Ten men aged 59 - 82 yr on and rogen deprivation for localized prostate cancer undertook progressive resistance training for 20 wk at 6- to 12-repetition maximum ( RM ) for 12 upper- and lower-body exercises in a university exercise rehabilitation clinic . Outcome measures included muscle strength and muscle endurance for the upper and lower body , functional performance ( repeated chair rise , usual and fast 6-m walk , 6-m backwards walk , stair climb , and 400-m walk time ) , and balance by sensory organization test . Body composition was measured by dual-energy x-ray absorptiometry and muscle thickness at four anatomical sites by B-mode ultrasound . Blood sample s were assessed for prostate specific antigen ( PSA ) , testosterone , growth hormone ( GH ) , cortisol , and hemoglobin . RESULTS Muscle strength ( chest press , 40.5 % ; seated row , 41.9 % ; leg press , 96.3 % ; P muscle endurance ( chest press , 114.9 % ; leg press , 167.1 % ; P 6-m usual walk ( 14.1 % ) , 6-m backwards walk ( 22.3 % ) , chair rise ( 26.8 % ) , stair climbing ( 10.4 % ) , 400-m walk ( 7.4 % ) , and balance ( 7.8 % ) . Muscle thickness increased ( P Whole-body lean mass was preserved with no change in fat mass . There were no significant changes in PSA , testosterone , GH , cortisol , or hemoglobin . CONCLUSIONS Progressive resistance exercise has beneficial effects on muscle strength , functional performance and balance in older men receiving and rogen deprivation for prostate cancer and should be considered to preserve body composition and reduce treatment side effects",
"Purpose Few studies have investigated long-term effects of physical activity ( PA ) interventions . The goal of this study was to evaluate whether or not increased levels of moderate to vigorous physical activity ( MVPA ) were maintained by cancer survivors 1 year after receipt of two home-based interventions . Methods The FRESH START trial r and omized 543 breast and prostate cancer survivors to 1-of-2 mailed print diet and exercise interventions : sequentially-tailored vs. st and ardized ( attention control ) . Each arm received eight mailings over a 1-year period , with follow-up at 1 and 2 years . This analysis focuses solely on the 400 participants who had suboptimal levels of MVPA at baseline ( measured by the 7-Day Physical Activity Recall ) and who completed the 2-year study . Results Median minutes of MVPA at baseline , 1-year and 2-year follow-up in the tailored intervention arm were as follows : 0 , 90 , and 60 min/week , respectively . The corresponding values in the attention control group were 0 , 30 , and 30 min/week . Significant improvements in MVPA from baseline to 2-year follow-up were observed in both study arms ( p mailed-print exercise interventions result in significant and sustainable improvements in MVPA among newly diagnosed cancer survivors that are observed well after the intervention is complete . While tailored interventions , as compared to st and ardized material s , appear to produce superior improvements in MVPA initially , these differences diminish over time",
"Background According to the CONSORT statement , significance testing of baseline differences in r and omized controlled trials should not be performed . In fact , this practice has been discouraged by numerous authors throughout the last forty years . During that time span , reporting of baseline differences has substantially decreased in the leading general medical journals . Our own experience in the field of nutrition behavior research however , is that co- authors , review ers and even editors are still very persistent in their dem and for these tests . The aim of this paper is therefore to negate this dem and by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published . Discussion Testing for baseline differences is often propagated because of the belief that it shows whether r and omization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses . Especially the latter argument is flawed , because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding . In addition , including prognostic variables as covariates can increase the precision of the effect estimate . This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and , less importantly , to inclusion of irrelevant covariates in the analysis . We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases , to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only . We propose to adjust for known or anticipated important prognostic variables . These could or should be pre-specified in trial protocol s. Subsequently , authors should report results from the fully adjusted as well as crude analyses , especially for dichotomous and time to event data . Summary Based on our arguments , which were illustrated by our findings , we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore",
"Background The Exercise and Nutrition Routine Improving Cancer Health ( ENRICH ) study is investigating a novel lifestyle intervention aim ed at improving the health behaviors of adult cancer survivors and their carers . The main purpose of the study is to determine the efficacy of lifestyle education and skill development delivered via group-based sessions on the physical activity and dietary behaviors of participants . This article describes the intervention development , study design , and participant recruitment . Methods / Design ENRICH is a r and omized controlled trial , conducted in Australia , with two arms : an intervention group participating in six , two-hour face-to-face sessions held over eight weeks , and a wait-list control group . Intervention sessions are co-facilitated by an exercise physiologist and dietician . Content includes healthy eating education , and a home-based walking ( utilizing a pedometer ) and resistance training program ( utilizing elastic tubing resistance devices ) . The program was developed with reference to social cognitive theory and chronic disease self-management models . The study population consists of cancer survivors ( post active-treatment ) and their carers recruited through community-based advertising and referral from health professionals . The primary outcome is seven-days of sealed pedometry . Secondary outcomes include : self-reported physical activity levels , dietary intake , sedentary behavior , waist circumference , body mass index , quality of life , and perceived social support . The outcomes will be measured at baseline ( one week prior to attending the program ) , eight-weeks ( at completion of intervention sessions ) , and 20-weeks . The intervention group will also be invited to complete 12-month follow-up data collection . Process evaluation data will be obtained from participants by question naire and attendance records . Discussion No trials are yet available that have evaluated the efficacy of group-based lifestyle education and skill development amongst mixed groups of cancer survivors and their carers . The results will have implication s for the planning and provision of health and support services during the cancer survivorship phase . Clinical Trials Registration Australian New Zeal and Clinical Trials Register identifier : ANZCTRN12609001086257",
"PURPOSE Cancer survivors are at increased risk for cardiovascular disease , diabetes , osteoporosis , and second primary tumors . Healthful lifestyle practice s may improve the health and well-being of survivors . The FRESH START trial tested the efficacy of sequentially tailored versus st and ardized mailed material s on improving cancer survivors ' diet and exercise behaviors . METHODS Five hundred forty-three individuals with newly diagnosed locoregional breast or prostate cancer were recruited from 39 states and two provinces within North America . Participants were r and omly assigned either to a 10-month program of tailored mailed print material s promoting fruit and vegetable ( F&V ) consumption , reducing total/saturated fat intake , and /or increasing exercise or to a 10-month program of nontailored mailed material s on diet and exercise available in the public domain . Telephone surveys conducted at baseline and 1 year assessed body mass index ( BMI ) , dietary consumption , physical activity , and other psychosocial/behavioral indices . Clinical assessment s were conducted on a 23 % sub sample ; information was used to vali date self-reports . RESULTS Five hundred nineteen participants completed the 1-year follow-up ( 4.4 % attrition ; sample characteristics : 57 + /- 10.8 years old , 83 % white , 56 % female , 64 % overweight/obese , and 0 % underweight ) . Although both arms significantly improved their lifestyle behaviors ( P Mailed material interventions , especially those that are tailored , are effective in promoting healthful lifestyle changes among cancer survivors . Further study is needed to determine sustainability , cost to benefit , and generalizability to other cancer population",
"Background Despite increasing numbers of cancer survivors and evidence that diet and physical activity improves the health of cancer survivors , most do not meet guidelines . Some social cognitive theory (SCT)-based interventions have increased physical activity behavior , however few have used objective physical activity measures . The Exercise and Nutrition Routine Improving Cancer Health ( ENRICH ) r and omized controlled trial reported a significant intervention effect for the primary outcome of pedometer-assessed step counts at post-test ( 8-weeks ) and follow-up ( 20-weeks ) . The aim of this study was to test whether the SCT constructs operationalized in the ENRICH intervention were mediators of physical activity behavior change . Methods R and omized controlled trial with 174 cancer survivors and carers assessed at baseline , post-test ( 8-weeks ) , and follow-up ( 20-weeks ) . Participants were r and omized to the ENRICH six session face-to-face healthy lifestyle program , or to a wait-list control . Hypothesized SCT mediators of physical activity behavior change ( self-efficacy , behavioral goal , outcome expectations , impediments , and social expectations ) were assessed using valid and reliable scales . Mediation was assessed using the Preacher and Hayes SPSS INDIRECT macro . Results At eight weeks , there was a significant intervention effect on behavioral goal ( A = 9.12 , p = 0.031 ) and outcome expectations ( A = 0.25 , p = 0.042 ) . At 20 weeks , the intervention had a significant effect on self-efficacy ( A = 0.31 , p = 0.049 ) and behavioral goal ( A = 13.15 , p = 0.011 ) . Only changes in social support were significantly associated with changes in step counts at eight weeks ( B = 633.81 , p = 0.023 ) . Behavioral goal was the only SCT construct that had a significant mediating effect on step counts , and explained 22 % of the intervention effect at 20 weeks ( AB = 397.9 , 95 % CI 81.5–1025.5 ) . Conclusions SCT constructs had limited impact on objective ly-assessed step counts in a multiple health behavior change intervention for cancer survivors and their carers . Behavioral goal measured post-intervention was a significant mediator of pedometer-assessed step counts at 3-months after intervention completion , and explained 22 % of the intervention effect . Future research should examine the separate impact of goals and planning , as well as examining mediators of behavior maintenance in physical activity interventions targeting cancer survivors . Trial registration Australian and New Zeal and Clinical Trials registry ANZCTRN1260901086257",
"Background Underst and ing reasons for non-participation in health studies can help guide recruitment strategies and inform research ers about potential sources of bias in their study sample . Whilst there is a paucity of literature regarding this issue , it remains highly plausible that men and women may have varied reasons for declining an invitation to participate in research . We aim ed to investigate sex-differences in the reasons for non-participation at baseline of the Geelong Osteoporosis Study ( GOS ) . Methods The GOS , a prospect i ve cohort study , r and omly recruited men and women aged 20 years and over from a region in south-eastern Australia using Commonwealth electoral rolls ( 2001–06 and 1993–97 , respectively ) . Reasons for non-participation ( n=1,200 ) were documented during the two recruitment periods . We used the Pearson ’s chi squared test to explore differences in the reasons for non-participation between men and women . Results Non-participation in the male cohort was greater than in the female cohort ( 32.9 % vs. 22.9 % ; p reasons provided for non-participation ( p time constraints ( men 26.3 % vs. women 10.4 % ) , frailty/inability to cope with or underst and the study ( men 18.7 % vs. women 30.6 % ) , and reluctance over medical testing ( men 1.1 % vs women 9.9 % ) . No sex-differences were observed for non-participation related to personal reason/disinterest , and language - or travel-related reasons . Conclusions Improving participation rates in epidemiological studies may require different recruitment strategies for men and women in order to address sex-specific concerns about participating in research",
"Objective : To evaluate the feasibility and efficacy of the ‘ Healthy Dads , Healthy Kids ’ ( HDHK ) program , which was design ed to help overweight fathers lose weight and be a role model of positive health behaviors for their children . Design : R and omized controlled trial . Participants : A total of 53 overweight/obese men ( mean ( s.d . ) age=40.6 ( 7.1 ) years ; body mass index ( BMI ) = 33.2 ( 3.9 ) ) and their primary school-aged children ( n=71 , 54 % boys ; mean ( s.d . ) age=8.2 ( 2.0 ) years ) were r and omly assigned ( family unit ) to either ( i ) the HDHK program ( n=27 fathers , n=39 children ) or ( ii ) a wait-list control group ( n=26 fathers , n=32 children).Intervention : Fathers in the 3-month program attended eight face-to-face education sessions . Children attended three of these sessions . Outcomes : The primary outcome was fathers ’ weight . Fathers and their children were assessed at baseline , and at 3- and 6-month follow-up , for weight , waist circumference , BMI , blood pressure , resting heart rate ( RHR ) , objective ly measured physical activity and self-reported dietary intake . Results : Intention-to-treat analysis revealed significant between-group differences at 6 months for weight loss ( P HDHK fathers losing more weight ( −7.6 kg ; 95 % confidence interval ( CI ) −9.2 , −6.0 ; d=0.54 ) than control group fathers ( 0.0 kg ; 95 % CI −1.4 , 1.6 ) . Significant treatment effects ( P found for waist circumference ( d=0.62 ) , BMI ( d=0.53 ) , systolic blood pressure ( d=0.92 ) , RHR ( d=0.66 ) and physical activity ( d=0.91 ) , but not for dietary intake . In children , significant treatment effects ( P for physical activity ( d=0.74 ) , RHR ( d=0.51 ) and dietary intake ( d=0.84 ) . Conclusion : The HDHK program result ed in significant weight loss and improved health-related outcomes in fathers and improved eating and physical activity among children . Targeting fathers is a novel and efficacious approach to improving health behavior in their children",
"Prostate cancer can threaten quality of life for the patient and his spouse and the quality of his marital relationship . The purpose of our study is to evaluate the effects of \" Exercising Together \" - a partnered strength training program for married couples coping with prostate cancer - on the physical and emotional health of prostate cancer survivors ( PCS ) and their spouses and on marital quality . We are conducting a 6-month r and omized controlled trial with two groups : 1 ) Exercising Together - a progressive , supervised strength training program and 2 ) a usual care control condition . The primary aims of this exploratory study are to : 1 ) Determine the effect of partnered strength training on physical and emotional health ( muscle strength , physical function , body composition and self-report physical and mental health ) in PCS , 2 ) Determine the effect of partnered strength training on physical and emotional health in spouses and 3 ) Explore the effect of partnered strength training on marital quality ( incongruence , communication , relationship quality , intimacy ) of the PCS and spouse . Target accrual has been met in this study with 64 couples enrolled and r and omized to exercise ( n=32 ) or usual care ( n=32 ) groups . This study is the first to examine the feasibility of this exercise format in both the chronically ill patient and spouse and explore benefits at the individual and couple level",
"PURPOSE FRESH START is a r and omized controlled trial that will test whether a personally tailored , distance-medicine-based program will increase exercise and fruit and vegetable consumption , and decrease fat intake of individuals recently diagnosed with breast or prostate cancer . METHODS Early-stage breast and prostate cancer cases ( N= 530 ) will be identified within 9 months of diagnosis from hospital cancer registries and large oncologic practice s throughout the United States . These individuals will be sent a letter of invitation and screened for eligibility . After a baseline telephone interview , participants will be r and omized into one of two arms that receive material s aim ed at increasing exercise and fruit and vegetable intake , and decreasing dietary fat : 1 ) . an experimental arm that receives a workbook and a series of six 4-page newsletters delivered every 7 wk and personally tailored on type of cancer , cancer coping style , race , age , self-efficacy , stage of readiness , and barriers and /or progress toward goal behavior ( i.e. , > or= 30 min of exercise at least 5 d.wk , > or= 5 servings of vegetables and fruit per day , and series of nontailored health brochures . Follow-up interviews scheduled 1 and 2 yr postbaseline will determine short- and long-term efficacy and the effects of the interventions on other endpoints ( quality of life , perceived health , etc . ) . Factors , such as gender , race , and social support , also will be explored to determine potential interactions with program efficacy . CONCLUSION Given the growing number of cancer survivors , distance-medicine-based interventions addressing multiple behaviors and targeting this high-risk group have the potential to make a positive and broad public health impact",
"BACKGROUND Active for Life After Cancer is a r and omized trial evaluating the efficacy of a 6-month group-based lifestyle physical activity program ( Lifestyle ) for prostate cancer patients to improve quality of life ( QOL ) including physical and emotional functioning compared to a group-based Educational Support Program and a St and ard Care Program ( no group ) . METHOD A total of 134 prostate cancer patients receiving continuous and rogen-ablation were r and omly assigned to one of the three study conditions . RESULTS Results indicated no significant improvements in QOL at 6 or 12 months . Both group-based programs were positively received and yielded good attendance and retention . Lifestyle participants demonstrated significant improvements in most theoretical mediators proposed by the Transtheoretical Model and Social Cognitive Theory to affect physical activity . Despite these improvements , no significant changes were found for most physical activity measures . CONCLUSIONS Results suggest a lifestyle program focusing on cognitive-behavioral skills training alone is insufficient for promoting routine physical activity in these patients",
"Abstract Introduction . The aim of cancer rehabilitation is to enable patients to attain and maintain optimal physical , psychological and social functioning . We evaluated the effect on health behavior , BMI and self-rated health of a residential psychosocial rehabilitation course for cancer patients . Material and methods . Patients with a primary cancer of the breast , prostate , colon or rectum were r and omized to either a six-day multi-focus psychosocial residential rehabilitation intervention that included lectures , discussion s and peer group discussion s on issues related to treatment and life with cancer or to usual care . The end points were changes in smoking , alcohol consumption , physical activity , body mass index and self-rated health between baseline and follow-up after one and six months . The primary analyses included all participants who received their allocated condition . The two follow-up times were analyzed separately in general linear and logistic regression models for continuous and dichotomous outcomes , respectively . The analyses were adjusted for baseline outcome score , cancer site , time since diagnosis , age and education . Results . Of the 507 participants who were r and omly assigned , 452 were included in the analysis , of whom 404 completed the one month and 394 completed the six month assessment . The intervention group showed slightly more positive changes in health behavior , BMI and self-rated health than the usual care group , but the differences between the groups were small and not significant . Discussion . Participation in a six-day cancer rehabilitation course did not significantly influence health behavior , BMI or self-rated health among cancer patients",
"Purpose The purpose of this study was to compare the medical , demographic and social cognitive correlates of physical activity ( PA ) in breast ( BCS ) , prostate ( PCS ) and colorectal ( CRCS ) cancer survivors . Methods A stratified r and om sample of 2062 BC , PC and CRC survivors diagnosed between 2003 and 2011 was identified by the Nova Scotia Cancer Registry ( NSCR ) and mailed a question naire assessing PA , social – cognitive constructs from the theory of planned behaviour ( TPB ) , and demographic and medical variables . Structural equation modelling was used to conduct path analyses of the TPB within each cancer survivor group and an invariance analysis was used to compare the TPB across groups . Results A total of 741 completed surveys were analysed . Overall , 42 % of cancer survivors were meeting PA guidelines with no differences among the cancer sites . Treatment-related variables were strong correlates of PA in PC survivors but not for BC or CRC . Body mass index was strongly associated with PA in BC survivors but not PC or CRC . Path analyses within each cancer survivor group showed that intention was significantly associated with PA for CRCS only ; planning was significantly associated with PA for BCS and PCS only ; and perceived behavioural control ( PBC ) was significantly associated with PA for PCS only . For intention , PBC and instrumental attitude ( IA ) were significant correlates in all three cancer survivor groups whereas affective attitude ( AA ) was significant for BCS and CRCS only ; and descriptive norm ( DN ) was significant for PCS and CRCS only . Invariance analyses revealed significantly stronger relationships for ( a ) intention to planning for BCS compared to PCS , ( b ) affective attitude to intention for CRCS compared to PCS , and ( c ) planning to PA for PCS compared to CRCS . Conclusions Although BC , PC , and CRC survivors have similar levels of PA , the correlates of their PA may differ . These findings may inform cancer site-specific interventions to promote PA in cancer survivors",
"The objectives were to ( 1 ) prospect ively evaluate fatigue utilizing vali date d instruments in patients with localized prostate cancer , and ( 2 ) examine the relationships between fatigue , depression , quality of life , and sleep disturbance . The instruments used included : Piper Fatigue Scale , Beck Depression Inventory , Epworth Sleepiness Scale , and Functional Assessment of Cancer Therapy for Prostate Scale . Data on cancer stage , prostate specific antigen levels , hematocrit , patient 's body weight and radiation dosage were recorded . Patients were evaluated preradiotherapy , middle of radiotherapy , completion of radiotherapy , and at 4 - 5 weeks follow-up . Thirty-six veterans with localized prostate cancer were studied . Mean age was 66.9 years ( range 55 - 79 ) . Duration of treatment was 7 - 8 weeks . Univariate procedure and Wilcoxon Signed Rank-test were used to examine changes in pretreatment scores for each of the three subsequent study periods . To adjust for multiple comparisons Bonferroni test was used . Spearman Correlations were calculated among parameters . No significant changes were noted in mean scores of hematocrit and body weight during the study period . On the Piper Fatigue Scale , adjusted for multiple comparisons , the median scores were significantly higher at completion of radiotherapy as compared with preradiotherapy values . Three patients ( 8 % ) were experienced fatigue according to Piper Fatigue Scale before treatment as compared to nine patients ( 25 % ) at completion of radiotherapy . On Prostate Cancer Specific and Physical Well Being subscales of the Functional Assessment for Prostate Cancer Therapy , the scores were significantly lower at middle and completion of radiotherapy than at pretreatment . At preradiotherapy , middle of radiotherapy , completion of radiotherapy and follow-up evaluation , patients scoring higher on the Piper Fatigue Scale were more likely to report a poorer quality of Physical Well Being on Functional Assessment of Cancer Therapy for Prostates . No significant changes were noted in the Beck Depression Inventory and Epworth Sleepiness Scale scores during treatment . Eight patients scored 10 or more on the Beck Depression Inventory before starting radiotherapy , suggesting depressive symptomatology . Of these , only seven patients scored 10 or more at completion of treatment . The incidence of fatigue is lower in our study than in previously published data . A relationship exists between fatigue scores and physical well being subscale scores . Higher scores on the Piper Fatigue Scale at the completion of radiotherapy , as well as no changes on depression and sleepiness scales , suggest that fatigue may not be the result of depression or sleep disturbance . Based upon our previous work , we propose that the physical expression of fatigue may be secondary to a decline in neuromuscular efficiency and enhanced muscle fatigue",
"The U.S. population is aging , bringing with it an increased prevalence of chronic disease and concomitant declines in physical function . The risk of developing cancer increases significantly with age , and functional decline is much more likely once a cancer diagnosis is rendered . Thus , functional status in later life is a key concern , one that is heightened among elders who have been diagnosed with cancer . To date , however , there have been few trials that have exclusively addressed issues related to cancer survivorship among older cancer patients , and to our knowledge , none has focused on preserving or enhancing physical functioning . This paper describes the study design and method ological considerations of a r and omized controlled trial to determine if a personally tailored workbook and telephone counseling program can positively affect physical activity and dietary behaviors and ultimately the physical functioning of up to 420 older men and women newly diagnosed with breast or prostate cancer . This trial is unique because the cancer diagnosis is used not only as a marker of risk for functional decline , but also as a \" teachable moment \" - an opportune time when elders may be more receptive to making beneficial lifestyle changes . Undoubtedly , as cure rates for cancer increase and intersect with ever-growing numbers of elderly , there will be numerous opportunities to provide and test interventions within this vulnerable population and to target functional status as a primary outcome . In reporting our methods , we hope to give others \" a leg up , \" so that they can hurdle with greater ease the barriers we experienced , and thus advance the field more rapidly",
"BACKGROUND This study examined whether changes in self-efficacy explain the effects of a mailed print intervention on long-term dietary practice s of breast and prostate cancer survivors . The relationship between change in self-efficacy and long-term physical activity ( PA ) also was examined . METHODS Breast and prostate cancer survivors ( N = 543 ) from 39 US states and two Canadian provinces participated in the FRESH START intervention trial . Participants were r and omly assigned to receive a 10-month program of mailed print material s on diet and PA available in the public domain or a 10-month program of tailored material s design ed to increase fruit and vegetable ( F&V ) intake , decrease fat intake , and /or increase PA . Changes in self-efficacy for F&V intake and fat restriction were analyzed as potential mediators of the intervention 's effects on diet at 2-year follow-up . Because we previously found that change in self-efficacy for PA did not vary by group assignment , the relationship between change in self-efficacy and PA at 2-year follow-up was examined across study conditions . RESULTS Results suggest that change in self-efficacy for fat restriction partially explained the intervention 's effect on fat intake ( mean indirect effect = -0.28 ) , and change in self-efficacy for F&V consumption partially explained the intervention 's effect on daily F&V intake ( mean indirect effect = .11 ) . Change in self-efficacy for fat restriction partially accounted for the intervention 's impact on overall diet quality among men only ( mean indirect effect = 0.60 ) . Finally , change in self-efficacy for PA predicted PA at 2-year follow-up . CONCLUSIONS Findings suggest that self-efficacy may influence long-term maintenance of healthy lifestyle practice s among cancer survivors",
"PURPOSE Declines in physical functioning ( PF ) among elderly cancer patients threaten quality of life and the ability to maintain independence . Adherence to healthy lifestyle behaviors may prevent functional decline . PATIENTS AND METHODS Project Leading the Way in Exercise and Diet ( LEAD ) , an intervention development study of the Pepper Older Americans Independence Center , aim ed to determine whether breast and prostate cancer survivors ( age 65 + years ) assigned to a 6-month home-based diet and exercise intervention experienced improvements in PF when compared with an attention control arm receiving general health information . An accrual target was set at 420 , and PF ( Short Form-36 subscale ) , physical activity ( Community Healthy Activities Models Program for Seniors ) , and diet quality ( index from 3-day recalls ) were assessed at baseline and at 6 and 12 months ( 6 months after intervention ) . RESULTS This developmental project did not achieve its accrual target ( N = 182 ) ; however , PF change scores were in the direction and of the magnitude projected . Baseline to 6-month change scores in the intervention versus the control arms were as follows : PF , + 3.1 v -0.5 ( P = .23 ) ; physical activity energy expenditure , + 111 kcal/wk v -400 kcal/wk ( P = .13 ) ; and diet quality index , + 2.2 v -2.9 ( P = .003 ) , respectively . Differences between arms diminished during the postintervention period . CONCLUSION These findings suggest that home-based diet and exercise interventions hold promise in improving lifestyle behaviors among older cancer survivors , changes that trend toward improved PF . Future studies should incorporate larger sample sizes and interventions that sustain long-term effects and also take into account secular trends ; these efforts will require adequate planning and re sources to overcome the numerous barriers to intervening in this difficult to reach yet vulnerable population",
"PURPOSE To assess long-term quality of life ( QoL ) impact of treatments in localized prostate cancer patients treated with radical prostatectomy , external beam radiotherapy or brachytherapy . MATERIAL AND METHODS Observational , prospect i ve cohort study with pre-treatment QoL evaluation and follow-up until five years after treatment . 704 patients with low or intermediate risk localized prostate cancer were consecutively recruited in 2003 - 2005 . QoL was measured by the EPIC question naire , with urinary irritative-obstructive , incontinence , bowel , sexual , and hormonal scores ( ranging 0 - 100 ) . RESULTS Brachytherapy 's QoL impact was restricted to the urinary domain , Generalized Estimating Equation models showed score changes at five years of -12.0 ( 95 % CI=-15.0 , -9.0 ) in incontinence and -5.3 ( 95 % CI=-7.5 , -3.1 ) in irritative-obstructive scales . Compared to brachytherapy , radical prostatectomy fared + 3.3 ( 95 % CI=+0.0 , + 6.5 ) points better in irritative-obstructive but -17.1 ( 95 % CI=-22.7 , -11.5 ) worse in incontinence . Sexual deterioration was observed in radical prostatectomy ( -19.1 ; 95 % CI=-25.1 , -13.1 ) and external radiotherapy groups ( -7.5 ; 95 % CI=-12.5 , -2.5 ) . CONCLUSIONS Brachytherapy is the treatment causing the least impact on QoL except for moderate urinary irritative-obstructive symptoms . Our study provides novel long-term valuable information for clinical decision making , supporting brachytherapy as a possible alternative to radical prostatectomy for patients seeking an attempted curative treatment , while limiting the risk for urinary incontinence and sexual impact on",
"Prostate cancer patients receiving and rogen ablation therapy experience significant physical and psychological sequelae associated with their disease and treatment . Because physical activity improves physical and psychological well-being , a lifestyle physical activity intervention may help slow or reverse the associated decline in quality of life ( QOL ) . No studies have evaluated an intervention to improve multiple QOL domains in patients receiving and rogen ablation therapy . Active for Life After Cancer is a three-group r and omized controlled trial design ed to evaluate the effectiveness of a lifestyle physical activity intervention ( Lifestyle Program ) in improving QOL . The Lifestyle Program , a 6-month behavioral skills training group , is compared to an Educational Support Program and St and ard Care . The purpose of this paper is to describe the design of the r and omized trial and present baseline data that will characterize the QOL of the sample . Challenges to recruitment for the trial also will be presented and discussed",
"OBJECTIVE Cure rates for cancer are increasing , especially for breast , prostate , and colorectal cancer . Despite positive trends in survivorship , a cancer diagnosis can trigger accelerated functional decline that can threaten independence , reduce quality -of-life and increase healthcare costs , especially among the elderly who comprise the majority of survivors . Lifestyle interventions may hold promise in reorienting functional decline in older cancer survivors , but few studies have been conducted . METHODS We describe the design and methods of a r and omized controlled trial , RENEW ( Reach out to ENhancE Wellness ) , that tests whether a home-based multi-behavior intervention focused on exercise , and including a low saturated fat , plant-based diet , would improve physical functioning among 641 older , long-term ( > or=5 years post-diagnosis ) survivors of breast , prostate , or colorectal cancer . Challenges to recruitment are examined . RESULTS Twenty thous and and fifteen cases were approached , and screened using a two-step screening process to assure eligibility . This population of long-term , elderly cancer survivors had lower rates of response ( approximately 11 % ) and higher rates of in eligibility ( approximately 70 % ) than our previous intervention studies conducted on adults with newly diagnosed cancer . Significantly higher response rates were noted among survivors who were White , younger , and more proximal to diagnosis and breast cancer survivors ( p-values Older cancer survivors represent a vulnerable population for whom lifestyle interventions may hold promise . RENEW may provide guidance in allocating limited re sources in order to maximize recruitment efforts aim ed at this needy , but hard-to-reach population",
"BACKGROUND Whether physical activity has benefits against prostate cancer incidence or progression is unclear . Therefore , we assessed physical activity in relation to prostate cancer incidence , mortality , and Gleason histologic grade . METHODS We used data from the Health Professionals Follow-up Study , a prospect i ve cohort study , to determine the number of cases of incident , advanced ( seminal vesicle invasion , metastasis , or fatal ) , fatal , and high- grade prostate cancer in a cohort of 47,620 US male health professionals , followed up from February 1 , 1986 , to January 31 , 2000 . RESULTS During 14 years of follow-up , we documented 2892 new cases of prostate cancer , including 482 advanced cases ( 280 of which were fatal ) . For total prostate cancer , no association was observed for total , vigorous , and nonvigorous physical activity . In men 65 years or older , we observed a lower risk in the highest category of vigorous activity for advanced ( multivariable relative risk , 0.33 ; 95 % confidence interval , 0.17 - 0.62 , for more than 29 vs 0 metabolic equivalent hours ) and for fatal ( relative risk , 0.26 ; 95 % confidence interval , 0.11 - 0.66 ) prostate cancer . No associations were observed in younger men . Differential screening by prostate-specific antigen or a reduction in physical activity due to undiagnosed prostate cancer did not appear to account for the results . Among cases , men with high levels of physical activity were less likely to be diagnosed with poorly differentiated cancers ( Gleason grade > or = 7 ) . CONCLUSION Although the mechanisms are not yet understood , these findings suggest that regular vigorous activity could slow the progression of prostate cancer and might be recommended to reduce mortality from prostate cancer , particularly given the many other documented benefits of exercise",
"CONTEXT Five-year survival rates for early stage colorectal , breast , and prostate cancer currently exceed 90 % and are increasing . Cancer survivors are at greater risk for second malignancies , other comorbidities , and accelerated functional decline . Lifestyle interventions may provide benefit , but it is unknown whether long-term cancer survivors can modify their lifestyle behaviors sufficiently to improve functional status . OBJECTIVE To determine whether a telephone counseling and mailed print material -based diet and exercise intervention is effective in reorienting functional decline in older , overweight cancer survivors . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial of 641 overweight ( body mass index > or = 25 and or = 5 years ) survivors ( aged 65 - 91 years ) of colorectal , breast , and prostate cancer , who were r and omly assigned to an intervention group ( n = 319 ) or delayed intervention ( control ) group ( n = 322 ) in Canada , the United Kingdom , and 21 US states . Individuals were recruited for the Reach out to Enhance Wellness ( RENEW ) trial from July 1 , 2005 , through May 17 , 2007 . INTERVENTION A 12-month , home-based tailored program of telephone counseling and mailed material s promoting exercise , improved diet quality , and modest weight loss . The control group was wait-listed for 12 months . MAIN OUTCOME MEASURES Change in self-reported physical function on the Short-Form 36 physical function subscale ( score range , 0 - 100 ; a high score indicates better functioning ) from baseline to 12 months was the primary end point . Secondary outcomes included changes in function on the basic and advanced lower extremity function subscales of the Late Life Function and Disability Index ( score range , 0 - 100 ) , physical activity , body mass index , and overall health-related quality of life . RESULTS The mean baseline Short-Form 36 physical function score was 75.7 . At the 12-month follow-up , the mean function scores declined less rapidly in the intervention group ( -2.15 ; 95 % confidence interval [ CI ] , -0.36 to -3.93 ) compared with the control group ( -4.84 ; 95 % CI , -3.04 to -6.63 ) ( P = .03 ) . The mean baseline basic lower extremity function score was 78.2 . The mean changes in basic lower extremity function were 0.34 ( 95 % CI , -0.84 to 1.52 ) in the intervention group compared with -1.89 ( 95 % CI , -0.70 to -3.09 ) in the control group ( P = .005 ) . Physical activity , dietary behaviors , and overall quality of life increased significantly in the intervention group compared with the control group , and weight loss also was greater ( 2.06 kg [ 95 % CI , 1.69 to 2.43 kg ] vs 0.92 kg [ 95 % CI , 0.51 to 1.33 kg ] , respectively ; P Among older , long-term survivors of colorectal , breast , and prostate cancer , a diet and exercise intervention reduced the rate of self-reported functional decline compared with no intervention . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00303875",
"BACKGROUND And rogen deprivation therapy ( ADT ) can decrease the physical performance ( PP ) of older men with prostate cancer ( PC ) . METHODS We conducted a three-arm r and omized pilot study ( n=19 ) comparing a home-based walking and resistance intervention ( EXCAP ) and a technology-mediated walking and resistance intervention using Wii-Fit to a usual-care arm in men ≥70 years with PC receiving ADT . The intervention lasted for 6 weeks , with follow-up at 12 weeks . The primary pre-specified outcome was change in Short Physical Performance Battery ( SPPB ) score . Mixed effects regression models were used to assess change in outcomes over time . RESULTS Mean participant age was 70 years ( range : 67 - 93 ) . Eight patients were r and omized to the Wii-Fit arm , 6 to the EXCAP arm , and 5 to the usual-care arm . SPPB scores remained nearly constant in the usual-care arm ( β=-0.12 ; p=0.79 ) , while individuals in the EXCAP arm had on average a 1.2 point increase at each follow-up ( β=1.20 ; 95 % CI : 0.36 , 2.06 ) . The Wii-fit arm had a non-significant increase in SPPB score over time relative to usual-care ( β=0.32 ; 95 % CI -0.43 , 1.06 ; p=0.46 ) . Individuals in the EXCAP arm had an increase in steps per day over time compared to the usual-care arm ( p-value=0.006 ) ; the EXCAP arm had an increase of 2720 steps ( 95 % CI : 1313 , 4128 ) while the usual-care arm had an increase of 97 steps ( 95 % CI : -1140 , 1333 ) . Participants in the Wii-Fit arm had an increase of 1020 steps ( 95 % CI : -474 , 1238 , p=0.710 ) . Other outcomes ( i.e. , h and grip strength , lean muscle mass , and chest press repetitions ) were not statistically significant . CONCLUSIONS A home-based aerobic and resistance exercise program , EXCAP , shows promise for improving PP in older men with PC on ADT"
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Purpose The objective of this systematic review was to assess the three-dimensional changes in bone tissue after immediate installation of a single implant in a fresh extraction socket in the anterior maxilla . Methods After defining a strategy , an electronic search was carried out using the data bases PubMed , Embase , LILACS , Web of Science , Cochrane , and Scopus . In addition , the gray literature was also research ed using Google Scholar and ProQuest . Two review ers independently screened for eligible studies , assessed the method ological quality , and extracted the data . The inclusion criteria were observational studies and experimental studies that assessed bone response after the immediate installation of a single implant in a fresh extraction socket , immediately loaded or not , in the region between the maxillary canines . Studies were included in any language , with no publication date restrictions and with a minimum of 6 months of follow-up after the surgical procedure . Results From a total of 3272 articles , only 12 studies met the inclusion criteria and were selected for the review . Bone remodeling after immediate installation of a dental implant was assessed using st and ardized periapical radiographs and cone beam computed tomography ( CBCT ) . Conclusion It can be concluded that bone remodeling occurs after tooth extraction and immediate implant installation
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"OBJECTIVES To evaluate healing of marginal defects in immediate transmucosal implants grafted with anorganic bovine bone , and to assess mucosal and radiographic outcomes 3 - 4 years following restoration . MATERIAL AND METHODS Thirty immediate transmucosal implants in maxillary anterior extraction sites of 30 patients r and omly received BioOss ( N=10 ; BG ) , BioOss and resorbable collagen membrane ( N=10 ; BG+M ) or no graft ( N=10 ; control ) . RESULTS Vertical defect height ( VDH ) reductions of 81.2+/-5 % , 70.5+/-17.4 % and 68.2+/-16.6 % , and horizontal defect depth ( HDD ) reductions of 71.7+/-34.3 % , 81.7+/-33.7 % and 55+/-28.4 % were observed for BG , BG+M and control groups , respectively , with no significant inter-group differences . Horizontal resorption was significantly greater in control group ( 48.3+/-9.5 % ) when compared with BG ( 15.8+/-16.9 % ) and BG+M ( 20+/-21.9 % ) groups ( P=0.000 ) . Ten sites ( 33.3 % ) exhibited recession of the mucosa after 6 months ; eight ( 26.7 % ) had an unsatisfactory esthetic result post-restoration due to recession . Mucosal recession was significantly associated ( P=0.032 ) with buccally positioned implants ( HDD 1.1+/-0.3 mm ) when compared with lingually positioned implants ( HDD 2.3+/-0.6 mm ) . In 19 patients followed for a mean of 4.0+/-0.7 years , marginal mucosa and bone levels remained stable following restoration . CONCLUSION BioOss significantly reduced horizontal resorption of buccal bone . There is a risk of mucosal recession and adverse soft tissue esthetics with immediate implant placement . However , this risk may be reduced by avoiding a buccal position of the implant in the extraction socket",
"BACKGROUND The width of the facial alveolar bone wall is crucial for long-term successful esthetic outcomes of implants immediately placed into extraction sockets . A threshold of 2 mm is recommended to minimize buccal vertical bone resorption . AIM To assess the width of the facial alveolar bone wall using cone-beam computed tomography images ( CBCT ) . MATERIAL AND METHODS Retrospective CBCT images were acquired from a representative sample of Asians using the i-CAT classic system with a 0.4-mm voxel size . At r and om , 200 CBCT images were selected according to predefined criteria . The DICOM file was imported into the i-CAT Vision software . In the panoramic screen , the middle of each tooth was selected , and in the sagittal window , the middle cross section was selected for performing the measurements using a computer . The vertical distance from the alveolar crest ( BC ) - cemento-enamel junction ( CEJ ) was measured . The width of the facial alveolar bone wall was measured at three locations : 1 , 3 , and 5 mm apical to BC . Descriptive statistics , frequency analyses , and multi-level comparisons were performed . RESULTS The sample consisted of 74 men and 126 women ( mean age of 37.2 years ; range 17 - 82 years ) . A total of 3618 teeth were assessed . There was no significant difference between the values of right and left sides , or between genders . However , statistically significant differences were observed between age groups at all levels . The distance from CEJ to BC varied from 0.4 to 4 mm , with an overall tendency to increase with age . The mean width of the facial alveolar bone wall at anterior teeth was 0.9 mm and increased toward posterior regions . Rarely , a width of 2 mm was yielded ( 0.6 - 1.8 % for anterior teeth , 0.7 - 30.8 % for posterior teeth ) . At a 5-mm distance from BC , minimal widths of facial alveolar bone were identified for the anterior teeth . The frequency of dehiscence ranged from 9.9 % to 51.6 % for anterior and 3.1 % to 53.6 % for posterior teeth , respectively . CONCLUSION A thin facial alveolar bone wall was usually present in both jaws . Hence , for most patients , adjunctive bone augmentation may be needed when installing implants in areas of esthetic concern",
"PURPOSE The aim of this study was to compare bone healing and crestal bone changes following immediate ( I m ) versus delayed ( De ) placement of titanium dental implants with acid-etched surfaces ( Osseotite ) in extraction sockets . MATERIAL S AND METHODS Forty-six patients were r and omly allocated to the I m or De group ( n = 23 per group ) and received 1 implant at the incisor , canine , or premolar region of the maxilla or the m and ible . The implants were placed an average of 10 days following tooth extraction in the I m group and approximately 3 months after extraction in the De group . The widths ( parallel and perpendicular to the implant ) and the depth of marginal bone defects around the implants were measured clinical ly just after placement and 3 months later at the abutment surgery . The crestal bone changes mesially and distally to the implants were evaluated radiographically by linear measurements . RESULTS The survival rates were 91 % in the I m group and 96 % in the De group . In the I m group , the mean reductions in parallel width , perpendicular width , and depth of the largest defect of each implant amounted to 48 % ( from 4.4 to 2.3 mm ) , 59 % ( from 2.2 to 0.9 mm ) , and 48 % ( from 6.9 to 3.6 mm ) , respectively . The corresponding mean reductions in the De group amounted to 39 % ( from 3.1 to 1.9 mm ) , 77 % ( from 1.3 to 0.3 mm ) , and 34 % ( from 4.4 to 2.9 mm ) . The reduction over time was statistically significant in both groups ( P degree of bone healing was achieved in the infrabony defects ( > 60 % for depth ) than in dehiscence-type defects ( approximately 25 % ) . Furthermore , 70 % of the 3-wall infrabony defects with a parallel width of up to 5 mm , a depth of maximum 4 mm , and a perpendicular width of maximum 2 mm had a capacity of spontaneous healing within a period of 3 months . DISCUSSION AND CONCLUSION New bone formation occurs in infrabony defects associated with immediately placed implants in extraction sockets",
"Twenty-one c.p . titanium screw-shaped implants were immediately installed after extraction and thorough curettage of the alveoli in 15 patients . Granules of deproteinized bovine bone of 0.25 - 1.0 mm diameter were used to fill the remaining defect when the distance of the defect wall to the implant surface was > 3 mm . Dimensional measurements of the defect height and width were made with a pocket probe . Fourteen sites in the upper jaw and 7 sites in the lower jaw were thus treated . The mean defect depth varied between 7 mm vestibularly and 10 mm mesially . The mucoperiosteal flaps were hermetically closed . At re-entry , the particles were packed and firmly attached but still distinguishable from the surrounding bone . Of the 21 sites treated , 5 sites had an exposure of the implant cover screw during the healing period . An exposure of the granular material occurred in 4 sites , but loss of granules in only 3 . Even in these sites no signs of infection or inflammation of the soft tissues were observed . At re-entry after 6 months , 10 sites were completely and 9 partially filled . For the partial fills , the mean remaining defect height was 1.6 mm ( range : 0.6 - 3.0 mm ) . Two sites showed an increased defect of respectively 2.4 and 4.8 mm . No fixtures were lost . The present results indicate that deproteinized bovine bone is a safe filling material to fill remaining defects around implants installed in fresh extraction sockets",
"PURPOSE This 1-year prospect i ve study evaluated the implant success rate , peri-implant tissue response , and esthetic outcome of immediately placed and provisionalized maxillary anterior single implants . MATERIAL S AND METHODS Thirty-five patients ( 8 men , 27 women ) with a mean age of 36.5 years ( range 18 to 65 ) were included in this study . Thirty-five threaded , hydroxyapatite-coated implants were placed and provisionalized immediately after each failing tooth had been removed . The definitive restoration was placed 6 months later . The patients were evaluated clinical ly and radiographically at implant placement and at 3 , 6 , and 12 months after implant placement . RESULTS At 12 months , all implants remained osseointegrated . The mean marginal bone change from the time of implant placement to 12 months was -0.26 + /- 0.40 mm mesially and -0.22 + /- 0.28 mm distally . No significant differences in the Plaque Index scores were noted at different time intervals . The mean midfacial gingival level and mesial and distal papilla level changes from pretreatment to 12 months were -0.55 + /- 0.53 mm , -0.53 + /- 0.39 mm , and -0.39 + /- 0.40 mm , respectively . All patients were very satisfied with the esthetic outcome and none had noticed any changes at the gingival level . DISCUSSION Although marginal bone and gingival level changes were statistically significant from pretreatment to 12 months of follow-up , they were well within clinical expectations . CONCLUSION The results of this study suggest that favorable implant success rates , peri-implant tissue responses , and esthetic outcomes can be achieved with immediately placed and provisionalized maxillary anterior single implants",
"The aim of the present clinical study was to evaluate the placement of transmucosal implants into fresh extraction sockets and their immediate restoration with temporary crowns . A series of 22 cases with a 12-month follow-up is presented . Twenty-two patients ( 15 women and 7 men ; mean age 39 years ) who needed a single tooth replaced because of vertical or horizontal root fracture , caries , endodontic lesions , or periodontal disease were treated with immediate post extraction implant placement . The implant was then restored with a screw-retained prosthetic restoration within 24 hours . Radiographic assessment s were made at baseline and 12 months after implant placement . Clinical parameters , such as plaque score , mucositis score , probing attachment level , mucosal margin position , variation of gingival level , and variation of papilla position , were also measured at baseline and after 12 months of follow-up . At 12 months , no implants had failed . Radiographic examination revealed mean bone resorption of 0.5 mm at 12 months compared to baseline . The mean variation of gingival level , compared to the neighboring teeth , was -0.75 mm . Probing attachment levels were 0.79 , 0.45 , and 0.54 mm at proximal , buccal , and lingual sites , respectively . The values for the mucosal margin position were 2.9 , 2.2 , and 2.4 mm at proximal , buccal , and lingual sites , respectively . Regarding variation of papilla position , according to Jemt 's index , 27 papillae presented with a score of 2 ( 61 % ) and 17 with a score of 3 ( 39 % ) . An examination of oral hygiene and peri-implant soft tissue conditions at the 12-month follow-up visit revealed an overall frequency of plaque-carrying implant surfaces of 13 % . Furthermore , mucositis ( score 2 ) was not observed at any of the peri-implant units . Primary implant stability did not significantly increase over time . The immediate restoration of dental implants placed into fresh extraction sockets was shown to be a safe and predictable procedure . The success rate and radiographic and clinical results were comparable to those obtained following the st and ard protocol . Within the limits of the present investigation , immediate restoration of single-tooth implants placed in fresh extraction sockets can be considered a valuable option to replace a missing tooth . However , long-term clinical trials are needed to confirm the present results",
"BACKGROUND Single-rooted teeth deemed not restorable via conventional means may be c and i date s for implant placement at the time of tooth extraction . Immediate implant placements are believed to preserve soft and hard tissue form and contours , reduce the need for augmentation procedures , minimize surgical exposure of the patient , reduce treatment time and improve esthetic outcomes . METHOD This retrospective review analyzed the esthetic outcomes of 42 non-adjacent single-unit implant restorations completed using an immediate implant surgical placement protocol . RESULTS The mean time in function was 18.9 months ( range 6 - 50 months ) and the majority of implants placed had a restorative platform diameter of 4.1 and 4.8 mm . A highly significant change in crown height due to marginal tissue recession of 0.9 + /- 0.78 mm ( P=0.000 ) was recorded for all sites , with no difference seen between implant systems ( P=0.837 ) . Thin tissue biotype showed slightly greater recession than thick tissue biotype ( 1 + /- 0.9 vs. 0.7 + /- 0.57 mm , respectively ) ; however , this difference was not statistically significant ( P=0.187 ) . Implants with a buccal shoulder position showed three times more recession than implants with a lingual shoulder position ( 1.8 + /- 0.83 vs. 0.6 + /- 0.55 mm , respectively ) with the difference being highly statistically significant ( P=0.000 ) . CONCLUSIONS Immediate implant placement requires very careful case selection and high surgical skill levels if esthetic outcomes are to be achieved . Long-term prospect i ve studies on tissue stability and esthetic outcomes are needed",
"PURPOSE The purpose of the study was to compare the clinical and aesthetic outcome of single post-extractive implants versus implants placed in a preserved socket after 4 months of healing in the anterior maxilla . All of the implants were immediately non-occlusally loaded . MATERIAL S AND METHODS A total of 50 patients were treated in the two groups of study . The Delayed Group had a maxillary tooth ( premolar , canine , lateral or central incisor ) removed , with immediate socket grafting , followed by implant placement and provisionalisation 4 months later . The Immediate Group had immediate implant placement and provisionalisation . Outcome measures were implant failures , biological and biomechanical complications , peri-implant radiographic bone level changes , and gingival aesthetics . RESULTS At the 12-month follow-up , two implants failed in the Immediate Group ( 8 % ) versus one in the Delayed Group ( 4 % ) , with a comparable rate of implant failure ( P = 0.55 ) . No complications occurred for either group . The 12-month peri-implant bone resorption was similar in both groups ( P = 0.23 ) : 0.71 mm ( 95 % CI 0.45 , 0.97 ) in the Immediate Group versus 0.60 mm ( 95 % CI 0.38 , 0.82 ) in the Delayed Group . The mean difference in bone resorption was 0.13 mm ( 95 % CI -0.21 , 0.47 ) . An ideal gingival marginal level was reached most frequently in the Delayed Group ( 83.3 % versus 52.1 % , P = 0.04 ) . Rates of full closure of the papilla were similar between the two groups ( 82.6 % for the Immediate Group versus 62.5 % for the Delayed Group , P = 0.12 ) . CONCLUSIONS Given the limitation that this was not a r and omised controlled trial , there were no differences in complications or crestal bone response at immediate post-extractive implants when compared to delayed implants . A delayed protocol might be considered in the aesthetic zone due to the gingival recession that occurs after post-extractive implant placement",
"PURPOSE This is a follow-up of an earlier 1-year prospect i ve study on implant success rates and the peri-implant response after immediate placement and provisionalization of single implants in the esthetic zone . The effects of gingival biotype on the peri-implant tissues were also evaluated . MATERIAL S AND METHODS Thirty-five patients were evaluated clinical ly and radiographically at presurgical examination ( T0 ) , immediately after immediate implant placement and provisionalization ( T1 ) , 1 year after implant surgery ( T2 ) , and the latest follow-up appointment ( T3 ) . Data were analyzed using t tests and repeated- measures analysis of variance at the significance level of alpha = .05 . RESULTS After a mean follow-up time of 4 years ( range , 2 to 8.2 years ) , all implants remained in function . At T3 , the mean mesial and distal marginal bone level changes were significantly greater than those observed at T2 . At T3 , the mean mesial and distal papilla level changes were significantly smaller than those observed at T2 , whereas the mean facial gingival level change was significantly greater than that observed at T2 . Sites with a thick gingival biotype exhibited significantly smaller changes in facial gingival levels than sites with a thin gingival biotype at both T2 and T3 . CONCLUSIONS Favorable implant success rates and peri-implant tissue responses can be achieved with this procedure . While the results suggest the possibility of spontaneous papilla regeneration over time following this procedure , continuing recession of the facial gingival tissue was also observed . The effect of gingival biotype on peri-implant tissue response seemed to be limited only to facial gingival recession and did not influence interproximal papilla or proximal marginal bone levels",
"BACKGROUND The success of osseointegrated implants ad modum Brånemark for single-tooth restorations is documented . Future developments should aim at improving the benefits to patients by decreasing treatment time , minimizing surgical stages , and maximizing esthetic outcomes . Using knowledge from studies of immediate implant placement , one-stage , immediate loading protocol s , the authors developed the immediate provisional . PURPOSE The purpose of this study was to develop a protocol to provide an immediate solution for restoring a single missing tooth in the esthetic zone . The protocol should be simple , predictable , cost effective , and allow the use of other techniques to improve esthetic outcome . MATERIAL S AND METHOD This prospect i ve clinical study included 24 patients treated from August 1999 to October 2000 . Single-tooth implant replacement was done according to immediate provisional protocol . Thirteen of the 24 patients had immediate implant placement after tooth extraction . All implants were placed in the esthetic zone . During surgery , emphasis was placed on obtaining primary stability by achieving bicortical anchorage and maximum insertion torque of at least 40 Ncm . CeraOne ( Nobel Biocare ) abutments were used , and provisional crowns were fabricated immediately before wound closure . The occlusion was protected by adjacent teeth . RESULTS Within the follow-up period of between 1 month and 15 months , all fixtures in the 24 patients were stable . Crestal bone loss greater than one thread-width was not detected . The esthetic result was considered satisfactory by all patients . CONCLUSIONS The implant placement and restoration protocol used in this study showed promising initial results for both the immediate implant and healed extraction site groups . The desirable goals of patient satisfaction , excellent esthetic outcomes , and no increase in treatment cost were achieved in this protocol . Further studies to eluci date the potential of the immediate provisional protocol are justified",
"The aim of this study was to measure changes in buccal alveolar crestal bone levels after immediate placement and loading of dental implants with Morse taper prosthetic abutments after tooth extraction . This study followed the STROBE guidelines regarding prospect i ve cohort studies . The sample comprised 12 patients with a mean age of 45 years , in whom a central or upper lateral incisor was indicated for extraction . Prior to extraction , computed tomography ( CT ) analysis was carried out to assess the presence of the buccal bone crest . CT scans were performed at 24 h and at 6 months after immediate implant placement and immediate loading . The distance from the most apical point of the implant platform to the buccal bone crest was assessed at the two time points . The buccal bone crest height was evaluated at three points in the mesio-distal direction : ( 1 ) the centre point of the alveolus , ( 2 ) 1 mm mesial to the centre point , and ( 3 ) 1 mm distal to the centre point . The values obtained were subjected to statistical analysis , comparing the distances from the bone crest to the implant platform for the two time points . After 6 months there was a statistically significant , non-uniform reduction in height at the level of the crest of the buccal bone in the cervical direction . It is concluded that the buccal bone crest of the immediate implants that replaced the maxillary incisors underwent apical resorption when subjected to immediate loading",
"OBJECTIVES The aim of this prospect i ve study was to evaluate clinical ly and radiographically the success and esthetic result of immediate implant placement at the time of extraction . MATERIAL AND METHODS Twelve patients with 14 titanium screw-shaped implants ( 13 - 16 mm length and 4.3 or 5 mm diameters ) were placed in the extraction sockets . Defects after implant placement were recorded , and then filled up with deproteinized bovine bone mineral , bioabsorbable collagen membrane , and absorbable pins . The defect was again re-evaluated at second-stage surgery . Clinical and radiographic parameters of the peri-implant conditions were assessed at the moment of prosthesis placement and at 1-year follow-up . RESULTS The cumulative implant survival and success rate was 100 % after a 1-year observation period . Analysis of the esthetic result showed that the mean pink esthetic score ( PES ) was 11.1 ( SD 1.35 ) at 1-year follow-up . At 1 year , 64.3 % papillae had a score of 2 and the remaining 35.7 % score 3 according to the Jemt ( 1997 ) papillary index . Optimal value of width of the keratinized mucosa was recorded in 13 ( 92.9 % ) implant cases in both periods of follow-up . At 1-year follow-up , the linear distance between implant-shoulder to the bone peaks remains stable with a mean of 2.62+/-0.2 mm at the mesial and 2.9+/-0.58 mm at the distal aspect . CONCLUSION Careful evaluation of potential extraction sites before immediate implant installation promotes optimal implant esthetics",
"OBJECTIVE To compare the peri-implant soft tissue dimensions after insertion of single-implant crowns in the anterior maxilla . MATERIAL S AND METHODS Twenty patients were accepted according to well-defined inclusion criteria and r and omized to porcelain-fused-to-metal ( PFM ) or all-ceramic groups . Follow-up was at : Baseline ( B ) , Crown Insertion ( CI ) , 1-year ( 1Y ) , and 2-year ( 2Y ) . The following parameters were statistically analysed : distance implant shoulder to marginal peri-implant mucosa ( DIM ) , papilla height ( PH ) , width of keratinized mucosa ( KM ) , crestal bone level ( CBL ) , full mouth plaque score ( FMPS ) , full mouth bleeding score ( FMBS ) , and probing pocket depth . RESULTS Between groups measurements for DIM , PH , KM , CBL , FMPS , and FMBS showed no statistically significant differences except the distal CBLs to adjacent tooth . DIM ( mid-facial ) decreased from B to CI remaining stable at 1Y and 2Y ( p-value 0.0014 ) . DIM mesial and distal aspects significantly increased from B to CI showing signs of stability at the 2Y . PH between B and CI increased at the mesial site and at the distal site , thereafter , peri-implant soft tissues were stable at the 2Y . CONCLUSION The insertion of an implant crown affects the peri-implant mucosa morphology by an apical displacement at the mid-facial aspect and coronal at mesial and distal sites"
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OBJECTIVE To define the optimal treatment for women with stage III or locally advanced breast cancer ( LABC ) . EVIDENCE Systematic review of English- language literature retrieved from MEDLINE ( 1984 to June 2002 ) and CANCERLIT ( 1983 to June 2002 ) . A non systematic review of the literature was continued through December 2003 . RECOMMENDATIONS The management of LABC requires a combined modality treatment approach involving surgery , radiotherapy and systemic therapy . Systemic therapy : chemotherapy . Operable tumours . Patients with operable stage IIIA disease should be offered chemotherapy . They should receive adjuvant chemotherapy following surgery , or primary chemotherapy followed by locoregional management . Chemotherapy should contain an anthracycline . Acceptable regimens are 6 cycles of FAC , CAF , CEF or FEC . Taxanes are under intense investigation . Inoperable tumours . Patients with stage IIIB or IIIC disease , including those with inflammatory breast cancer and those with isolated ipsilateral internal mammary or supraclavicular lymph-node involvement , should be treated with primary anthracycline-based chemotherapy . Acceptable chemotherapy regimens are FAC , CAF , CEF or FEC . Taxanes are under intense investigation . Patients with stage IIIB or IIIC disease who respond to primary chemotherapy should be treated until the response plateaus or to a maximum of 6 cycles ( minimum 4 cycles ) . Patients with stage IIIB disease should then undergo definitive surgery and irradiation . The locoregional management of patients with stage IIIC disease who respond to chemotherapy should be individualized . In patients with stage IIIB or IIIC disease who achieve maximum response with fewer than 6 cycles , further adjuvant chemotherapy can be given following surgery and irradiation . Patients whose tumours do not respond to primary chemotherapy can be treated with taxane chemotherapy or can proceed directly to irradiation followed by modified radical mastectomy , if feasible . Systemic therapy : hormonal therapy . Operable and inoperable tumours . Tamoxifen for 5 years should be recommended to pre- and postmenopausal women whose tumours are hormone responsive . Locoregional management . Operable tumours . Patients with stage IIIA disease should receive both modified radical mastectomy ( MRM ) and locoregional radiotherapy if feasible . They may be managed with MRM followed by chemotherapy and locoregional radiotherapy , or chemotherapy first followed by MRM and locoregional radiotherapy . Breast-conserving surgery is currently not a st and ard approach . Locoregional radiotherapy should be delivered to the chest wall and to the supraclavicular and axillary nodes . The role of internal mammary irradiation is unclear . Inoperable tumours . Patients with stage IIIB disease who respond to chemotherapy should receive surgery plus locoregional radiotherapy . The locoregional management of patients with stage IIIC disease who respond to chemotherapy is unclear and should be individualized . Patients whose disease remains inoperable following chemotherapy should receive locoregional radiotherapy with subsequent surgery , if feasible . VALIDATION The authors ' original text was revised by members of the Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer . Subsequently , feedback was provided by 9 oncologists from across Canada . The final document was approved by the steering committee . SPONSOR The Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer was convened by Health Canada . Completion date : December 2003
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"PURPOSE This study was design ed to determine whether increasing the dose of doxorubicin in or adding paclitaxel to a st and ard adjuvant chemotherapy regimen for breast cancer patients would prolong time to recurrence and survival . PATIENTS AND METHODS After surgical treatment , 3,121 women with operable breast cancer and involved lymph nodes were r and omly assigned to receive a combination of cyclophosphamide ( C ) , 600 mg/m(2 ) , with one of three doses of doxorubicin ( A ) , 60 , 75 , or 90 mg/m(2 ) , for four cycles followed by either no further therapy or four cycles of paclitaxel at 175 mg/m(2 ) . Tamoxifen was given to 94 % of patients with hormone receptor-positive tumors . RESULTS There was no evidence of a doxorubicin dose effect . At 5 years , disease-free survival was 69 % , 66 % , and 67 % for patients r and omly assigned to 60 , 75 , and 90 mg/m(2 ) , respectively . The hazard reductions from adding paclitaxel to CA were 17 % for recurrence ( adjusted Wald chi(2 ) P = .0023 ; unadjusted Wilcoxon P = .0011 ) and 18 % for death ( adjusted P = .0064 ; unadjusted P = .0098 ) . At 5 years , the disease-free survival ( + /- SE ) was 65 % ( + /- 1 ) and 70 % ( + /- 1 ) , and overall survival was 77 % ( + /- 1 ) and 80 % ( + /- 1 ) after CA alone or CA plus paclitaxel , respectively . The effects of adding paclitaxel were not significantly different in subsets defined by the protocol , but in an unplanned subset analysis , the hazard ratio of CA plus paclitaxel versus CA alone was 0.72 ( 95 % confidence interval , 0.59 to 0.86 ) for those with estrogen receptor-negative tumors and only 0.91 ( 95 % confidence interval , 0.78 to 1.07 ) for patients with estrogen receptor-positive tumors , almost all of whom received adjuvant tamoxifen . The additional toxicity from adding four cycles of paclitaxel was generally modest . CONCLUSION The addition of four cycles of paclitaxel after the completion of a st and ard course of CA improves the disease-free and overall survival of patients with early breast cancer",
"PURPOSE To determine the influence of the epirubicin dose in operable node-positive breast cancer patients with factors of poor prognosis . PATIENTS AND METHODS Between April 1990 and July 1993 , 565 operable breast cancer patients with either more than three positive nodes or between one and three positive nodes with Scarff Bloom Richardson grade > or = 2 and hormone receptor negativity were r and omized after surgery to receive either fluorouracil 500 mg/m(2 ) , epirubicin 50 mg/m(2 ) , and cyclophosphamide 500 mg/m(2 ) every 21 days for six cycles ( FEC 50 ) or the same regimen except with epirubicin dose of 100 mg/m(2 ) ( FEC 100 ) . Postmenopausal patients received tamoxifen 30 mg/d for 3 years at the beginning of chemotherapy . Radiotherapy was delivered at the end of chemotherapy in both groups . RESULTS The median follow-up was 67 months . The 5-year disease-free survival ( DFS ) was 54.8 % with FEC 50 and 66.3 % with FEC 100 ( P = .03 ) . The 5-year overall survival ( OS ) was 65.3 % and 77.4 % , respectively ( P = .007 ) . The mean relative dose-intensity was similar in the two groups ( 90.3 % and 86.1 % , respectively ) . Neutropenia and anemia were significantly more frequent in FEC 100 ( P nausea-vomiting ( P = .008 ) and stomatitis and alopecia ( P grade 3 infection occurred only with FEC 100 , and no toxic deaths occurred . Three cases of acute cardiac toxicity were observed ( FEC50 = 1 , FEC100 = 2 ) and 10 patients ( FEC50 = 6 , FEC100 = 4 ) presented delayed cardiac dysfunctions . Two cases of secondary leukemia were observed ( acute lymphatic leukemia with FEC 50 and acute myelogenous leukemia with FEC 100 ) . CONCLUSION After 5 years of follow-up , the increased epirubicin dose led to a significant benefit in terms of DFS and OS , with a high survival rate among patients with poor-prognosis breast cancer",
"A r and omized trial of the effect of adjuvant CMF chemotherapy in patients with Stage III breast cancer receiving primary local radiation or local radiation plus surgery , failed to reveal a survival benefit from early systemic treatment . The subset of premenopausal patients receiving chemotherapy did , however , show a significant prolongation of disease-free survival from 23 to 55 months . Overall survival of this subgroup was not increased . The study included the use of two dose levels of CMF to assess whether higher chemotherapy doses would be more effective . No dose effect was observed . Initial local control with radiation therapy or radiation plus surgery was achieved in the majority ( 90.9 % ) . Distal recurrence and death from metastatic disease were the major causes of treatment failure . Treatment benefit among premenopausal patients was mainly delayed onset of distal metastatic disease . Among premenopausal patients , salvage therapy for metastatic disease appeared more effective in those not previously exposed to systemic treatment",
"In a prospect i ve r and omized study , the efficacy of two combined modality approaches ( chemotherapy plus radiotherapy or chemotherapy plus mastectomy ) was tested in a total of 132 women with locally advanced breast cancer . Chemotherapy consisted of Adriamycin plus vincristine ( AV ) administered for three cycles before either local-regional modality and subsequently for seven additional cycles . Although a higher proportion of women achieved complete remission after mastectomy ( 100 % ) compared to women given radiotherapy ( 60 % ) , the total response rate at the end of combined modality was identical ( 75 % ) . There was no significant difference between the two treatment groups in terms of patterns of treatment failure , median duration of response , and total survival . Treatment was not influenced by menopausal or estrogen receptor status . Two patients of the surgical group showed Adriamycin-induced cardiomyopathy after cumulative doses less than 500 mg/m2 . The results of present study failed to indicate that surgery per se improved the overall results including local control , over radiotherapy in a combined modality setting",
"The aim of this study was to test the hypothesis of Goldie and Coldman that the use of non-cross-resistant regimens of chemotherapy could lead to maximal anti-tumour effect . We compared st and ard CMF ( cyclophosphamide , methotrexate , fluorouracil ) with alternating CMF/EV ( epirubicin , vincristine ) in the adjuvant therapy of early breast cancer . Stage II premenopausal node-positive or post-menopausal node-positive oestrogen receptor-negative and stage III breast cancer patients were eligible for the study . From January 1985 to December 1990 , 220 patients were r and omised ( 115 to CMF and 105 to CMF/EV ) . Toxicity was mild ; neurotoxicity , vomiting and hair loss were more frequent in the CMF/EV group , while permanent amenorrhoea , diarrhoea , stomach ache and minor infections occurred more often in the CMF arm . At a follow-up of 48 months , 113 patients ( 51.4 % ) had had recurrence ( 62 on CMF and 51 on CMF/EV ) and 54 ( 24.5 % ) had died ( 30 on CMF and 24 on CMF/EV ) . There was no significant difference in disease-free and overall survival between the two arms . After adjusting for menopausal status and stage , the relative risk ( RR ) of recurrence for CMF/EV patients was 0.93 ( 95 % CL 0.64 - 1.35 ) , while the RR of death was 0.85 ( 95 % CL 0.49 - 1.47 ) . In conclusion , the Goldie-Coldman model of alternating therapy is not confirmed in this trial of adjuvant therapy of early breast cancer , although in view of its design a difference of less than 20 % in 3 year disease-free survival could not be excluded",
"The National Surgical Adjuvant Breast and Bowel Project ( NSABP ) implemented protocol B-15 to compare 2 months of Adriamycin ( doxorubicin ; Adria Laboratories , Columbus , OH ) and cyclophosphamide ( AC ) with 6 months of conventional cyclophosphamide , methotrexate , and fluorouracil ( CMF ) in patients with breast cancer nonresponsive to tamoxifen ( TAM , T ) . A second aim was to determine whether AC followed in 6 months by intravenous ( IV ) CMF was more effective than AC without reinduction therapy . Through 3 years of follow-up , findings from 2,194 patients indicate no significant difference in disease-free survival ( DFS , P = .5 ) , distant disease-free survival ( DDFS , P = .5 ) or survival ( S , P = .8 ) among the three groups . Since the outcome from AC and CMF was almost identical , the issue arises concerning which regimen is more appropriate for the treatment of breast cancer patients . AC seems preferable since , following total mastectomy , AC was completed on day 63 versus day 154 for conventional CMF ; patients visited health professionals three times as often for conventional CMF as for AC ; women on AC received therapy on each of 4 days versus on each of 84 days for conventional CMF ; and nausea-control medication was given for about 84 days to conventional CMF patients versus for about 12 days to patients on AC . The difference in the amount of alopecia between the two treatment groups was less than anticipated . While alopecia was almost universally observed following AC therapy , 71 % of the CMF patients also had hair loss and , in 41 % , the loss was greater than 50 % . This study and NSABP B-16 , which evaluates the worth of AC therapy in TAM-responsive patients , indicate the merit of 2 months of AC therapy for all positive-node breast cancer patients",
"PURPOSE To determine the relative efficacy of an intensive cyclophosphamide , epirubicin , and fluorouracil ( CEF ) adjuvant chemotherapy regimen compared with cyclophosphamide , methotrexate , and fluorouracil ( CMF ) in node-positive breast cancer . PATIENTS AND METHODS Premenopausal women with node-positive breast cancer were r and omly allocated to receive either cyclophosphamide 100 mg/m2 orally days 1 through 14 ; methotrexate 40 mg/m2 intravenously ( i.v . ) days 1 and 8 ; and fluorouracil 600 mg/m2 i.v . days 1 and 8 or cyclophosphomide 75 mg/m2 orally days 1 through 14 ; epirubicin 60 mg/m2 i.v . days 1 and 8 ; and fluorouracil 500 mg/m2 i.v . days 1 and 8 . Each cycle was administered monthly for 6 months . Patients administered CEF received antibiotic prophylaxis with cotrimoxazole two tablets twice a day for the duration of chemotherapy . RESULTS The median follow-up was 59 months . One hundred sixty-nine of the 359 CMF patients developed recurrence compared with 132 of the 351 CEF patients . The corresponding 5-year relapse-free survival rates were 53 % and 63 % , respectively ( P = .009 ) . One hundred seven CMF patients died compared with 85 CEF patients . The corresponding 5-year actuarial survival rates were 70 % and 77 % , respectively ( P = .03 ) . The rate of hospitalization for febrile neutropenia was 1.1 % in the CMF group compared with 8.5 % in the CEF group . There was one case of congestive heart failure in a patient who received CMF compared with none in the CEF group . Acute leukemia occurred in five patients in the CEF group . CONCLUSION The results of this trial show the superiority of CEF over CMF in terms of both disease-free and overall survival in premenopausal women with axillary node-positive breast cancer",
"PURPOSE To assess patient and tumor characteristics associated with a complete pathologic response ( pCR ) in both the breast and axillary lymph node specimens and the outcome of patients found to have a pCR after neoadjuvant chemotherapy for locally advanced breast cancer ( LABC ) . PATIENTS AND METHODS Three hundred seventy-two LABC patients received treatment in two prospect i ve neoadjuvant trials using four cycles of doxorubicin-containing chemotherapy . Patients had a total mastectomy with axillary dissection or segmental mastectomy and axillary dissection followed by four or more cycles of additional chemotherapy . Patients then received irradiation treatment of the chest-wall or breast and regional lymphatics . Median follow-up was 58 months ( range , 8 to 99 months ) . RESULTS The initial nodal status , age , and stage distribution of patients with a pCR were not significantly different from those of patients with less than a pCR ( P>.05 ) . Patients with a pCR had initial tumors that were more likely to be estrogen receptor (ER)-negative ( P ER status and nuclear grade were independent of initial tumor size . Sixteen percent of the patients in this study ( n = 60 ) had a pathologic complete primary tumor response . Twelve percent of patients ( n = 43 ) had no microscopic evidence of invasive cancer in their breast and axillary specimens . A pathologic complete primary tumor response was predictive of a complete axillary lymph node response ( P 5-year overall and disease-free survival rates were significantly higher in the group who had a pCR ( 89 % and 87 % , respectively ) than in the group who had less than a pCR ( 64 % and 58 % , respectively ; P Neoadjuvant chemotherapy has the capacity to completely clear the breast and axillary lymph nodes of invasive tumor before surgery . Patients with LABC who have a pCR in the breast and axillary nodes have a significantly improved disease-free survival rate . However , a pCR does not entirely eliminate recurrence . Further efforts should focus on elucidating the molecular mechanisms associated with this response",
"PURPOSE To evaluate in a r and omized clinical trial systemic chemoendocrine therapy used as primary ( neo-adjuvant ) treatment before surgery in women with primary operable breast cancer . PATIENTS AND METHODS Patients aged less than 70 years with clinical ly palpable , primary operable breast cancer diagnostically confirmed by fine-needle aspiration cytology ( FNAC ) and suitable for treatment with surgery , radiotherapy , cytotoxic chemotherapy , and tamoxifen were considered eligible . Patients r and omized to neoadjuvant treatment received four cycles of chemo-therapy for 3 months before surgery followed by another four cycles after surgery , and were compared with patients r and omized to adjuvant therapy who received eight cycles of chemotherapy over 6 months after surgery . RESULTS Of 212 patients who were r and omized to receive either adjuvant ( n = 107 ) or neoadjuvant ( n = 105 ) chemoendocrine therapy , 200 are now assessable for response . The two groups are comparable for age , menopausal status , disease stage , and surgical requirements . The overall clinical response rate was 85 % , with a complete histologic response rate of 10 % . There was a significant reduction in the requirement for mastectomy in patients who received neoadjuvant treatment ( 13 % ) as compared with those who received adjuvant therapy ( 28 % ) ( P Symptomatic and hematologic acute toxicity was low and similar for adjuvant and neoadjuvant therapy . The median follow-up period for patients in this trial is 28 months , during which time four patients have relapsed locally and 20 , including one of the local relapses , have developed metastatic disease , 19 of whom have died . The follow-up period is too brief to evaluate relapse rate or survival duration . CONCLUSION This trial confirms previous reports of a high rate of response to neoadjuvant therapy , but is the first to include small primary cancers and to show , in the context of a r and omized trial , a reduction in the requirement for mastectomy . Until disease-free and overall survival data are available from the larger National Surgical Adjuvant Breast and Bowel Project (NSABP)-18 trial , such neoadjuvant treatment can not be recommended outside of a clinical trial",
"The purpose of this study was to test the role of radiotherapy following total mastectomy , axillary dissection , and adjuvant systemic therapy in the management of operable locally advanced breast carcinoma",
"PURPOSE To assess the long-term contribution of adjuvant chemotherapy ( CT ) and hormonal therapy ( HT ) in patients with locally advanced breast cancer , and to evaluate the impact of time of analysis on the results during accrual and up to 8 years after closure of a r and omized phase III trial . MATERIAL S AND METHODS In a trial using a factorial design , 410 patients were r and omized between radiotherapy ( RT ) alone , RT plus CT , RT plus HT , and RT plus HT plus CT . RESULTS CT and HT each produced a significant prolongation of the time to locoregional tumor recurrence and to distant progression of disease , with the combined treatments providing the greatest therapeutic effect . At the time of trial closure , a significant improvement of survival was observed in patients who received CT ( P = .004 ) ; however , with a longer follow-up duration , this effect disappeared ( P > .05 ) . HT did not initially appear to improve survival ( P = .16 ) ; however , in the latest analysis with a long-term follow-up duration , a significant improvement of survival was seen ( P = .02 ) . A consistent 25 % reduction in the death hazards ratio has been seen at all evaluations since trial closure in patients who received HT . The best survival results were observed in patients who received RT , HT , and CT ( P = .02 ) , with a reduction of 35 % in the death hazards ratio . CONCLUSION An improvement in survival attributable to HT has been shown in patients with locally advanced breast cancer . The greatest therapeutic effect was seen in the treatment group that received both CT and HT . The improvement obtained with HT became apparent only after long-term follow-up evaluation",
"A potential advantage of primary over adjuvant chemotherapy in breast cancer survival had been proposed on theoretical grounds . In 1994 , early results of the S6‐trial comparing primary chemotherapy vs. adjuvant chemotherapy for operable breast cancer in 390 premenopausal patients had shown significant improvement in survival of the primary chemotherapy arm ( p=0.04 ) . An up date d analysis conducted in 1995 showed the disappearance of this difference between the two arms (p=0.18).In the present analysis , we investigated the potential short and long‐term benefits attributable to primary chemotherapy by applying weighted logrank tests design ed to assess specifically these effects . Results were compared to those obtained with the classical logrank test . At a median follow‐up of 105 months , a significant short‐term survival benefit ( p=0.02 ) in favor of the primary chemotherapy has been shown . However , no long‐term survival benefit ( p=0.36 ) could be documented . The classical logrank test had revealed no significant difference ( p=0.24 ) between the two groups but the proportional hazard assumption being rejected ( p=0.04 ) , the efficiency of this test can be question ed . Results using the present analysis suggested that primary chemotherapy delayed early death rates , without significantly modifying long‐term event rates . It emphasizes that a short‐term effect which is not necessarily associated with a long‐term benefit may be seen at an early evaluation and disappear later on",
"PURPOSE Using a 2 x 2 factorial design , we studied the adjuvant chemotherapy of women with axillary node-positive breast cancer to compare sequential doxorubicin ( A ) , paclitaxel ( T ) , and cyclophosphamide ( C ) with concurrent doxorubicin and cyclophosphamide ( AC ) followed by paclitaxel ( T ) for disease-free ( DFS ) and overall survival ( OS ) ; to determine whether the dose density of the agents improves DFS and OS ; and to compare toxicities . PATIENTS AND METHODS A total of 2,005 female patients were r and omly assigned to receive one of the following regimens : ( I ) sequential A x 4 ( doses ) -- > T x 4 -- > C x 4 with doses every 3 weeks , ( II ) sequential A x 4 -- > T x 4 -- > C x 4 every 2 weeks with filgrastim , ( III ) concurrent AC x 4 -- > T x 4 every 3 weeks , or ( IV ) concurrent AC x 4 -- > T x 4 every 2 weeks with filgrastim . RESULTS A protocol -specified analysis was performed at a median follow-up of 36 months : 315 patients had experienced relapse or died , compared with 515 expected treatment failures . Dose-dense treatment improved the primary end point , DFS ( risk ratio [ RR ] = 0.74 ; P = .010 ) , and OS ( RR = 0.69 ; P = .013 ) . Four-year DFS was 82 % for the dose-dense regimens and 75 % for the others . There was no difference in either DFS or OS between the concurrent and sequential schedules . There was no interaction between density and sequence . Severe neutropenia was less frequent in patients who received the dose-dense regimens . CONCLUSION Dose density improves clinical outcomes significantly , despite the lower than expected number of events at this time . Sequential chemotherapy is as effective as concurrent chemotherapy",
"National Surgical Adjuvant Breast and Bowel Project ( NSABP ) Protocol B-18 was initiated in 1988 to determine whether four cycles of doxorubicin/cyclophosphamide given preoperatively improve survival and disease-free survival ( DFS ) when compared with the same chemotherapy given postoperatively . Secondary aims included the evaluation of preoperative chemotherapy in downstaging the primary breast tumor and involved axillary lymph nodes , the comparison of lumpectomy rates and rates of ipsilateral breast tumor recurrence ( IBTR ) in the two treatment groups , and the assessment of the correlation between primary tumor response and outcome . Initially published findings were based on a follow-up of 5 years ; this report up date s results through 9 years of follow-up . There continue to be no statistically significant overall differences in survival or DFS between the two treatment groups . Survival at 9 years is 70 % in the postoperative group and 69 % in the preoperative group ( P = .80 ) . DFS is 53 % in postoperative patients and 55 % in preoperative patients ( P = .50 ) . A statistically significant correlation persists between primary tumor response and outcome , and this correlation has become statistically stronger with longer follow-up . Patients assigned to preoperative chemotherapy received notably more lumpectomies than postoperative patients , especially among patients with tumors greater than 5 cm at study entry . Although the rate of IBTR was slightly higher in the preoperative group ( 10.7 % versus 7.6 % ) , this difference was not statistically significant . Marginally statistically significant treatment-by-age interactions appear to be emerging for survival and DFS , suggesting that younger patients may benefit from preoperative therapy , whereas the reverse may be true for older patients",
"Over the past 30 years there has been an increased use of neoadjuvant ( or primary ) chemotherapy for treating patients with breast cancer . However , while it is clear that chemotherapy given in the adjuvant setting after surgery does prolong patients ' overall and disease-free survival , the evidence that chemotherapy in the neoadjuvant setting also increases survival remains unproven . In the Aberdeen study , 162 patients with large and locally advanced breast cancer underwent 4 cycles of CVAP ( cyclophosphamide/vincristine/doxorubicin/prednisone ) primary chemotherapy . Patients with a complete or partial response were then r and omized to either 4 further cycles of CVAP or 4 cycles of docetaxel ( 100 mg/m2 ) . It was shown that the addition of sequential docetaxel ( 100 mg/m2 ) to CVAP neoadjuvant chemotherapy result ed in a significantly enhanced clinical response rate ( 94 % vs. 64 % ) and a substantially increased complete histopathological response rate ( 34 % vs. 16 % ) when compared to patients receiving CVAP alone . Furthermore , patients receiving docetaxel had an increased breast conservation rate ( 67 % vs. 48 % ) and an increased survival at a median follow-up of 3 years . It is important to note that this was a small study , and the survival results should be interpreted with caution . The results are encouraging , however , and further studies are urgently required",
"BACKGROUND Radiotherapy after mastectomy to treat early breast cancer has been known since the 1940s to reduce rates of local relapse . However , the routine use of postoperative radiotherapy began to decline in the 1980s because it failed to improve overall survival . We prospect ively tested the efficacy of combining radiotherapy with chemotherapy . METHODS From 1978 through 1986 , 318 premenopausal women with node-positive breast cancer were r and omly assigned , after modified radical mastectomy , to receive chemotherapy plus radiotherapy or chemotherapy alone . Radiotherapy was given to the chest wall and locoregional lymph nodes between the fourth and fifth cycles of cyclophosphamide , methotrexate , and fluorouracil . RESULTS After 15 years of follow-up , the women assigned to chemotherapy plus radiotherapy had a 33 percent reduction in the rate of recurrence ( relative risk , 0.67 ; 95 percent confidence interval , 0.50 to 0.90 ) and a 29 percent reduction in mortality from breast cancer ( relative risk , 0.71 ; 95 percent confidence interval , 0.51 to 0.99 ) , as compared with the women treated with chemotherapy alone . CONCLUSIONS Radiotherapy combined with chemotherapy after modified radical mastectomy decreases rates of locoregional and systemic relapse and reduces mortality from breast cancer",
"PURPOSE To determine , in women with primary operable breast cancer , if preoperative doxorubicin ( Adriamycin ) and cyclophosphamide ( Cytoxan ; AC ) therapy yields a better outcome than postoperative AC therapy , if a relationship exists between outcome and tumor response to preoperative chemotherapy , and if such therapy results in the performance of more lumpectomies . PATIENTS AND METHODS Women ( 1,523 ) enrolled onto National Surgical Adjuvant Breast and Bowel Project ( NSABP ) B-18 were r and omly assigned to preoperative or postoperative AC therapy . Clinical tumor response to preoperative therapy was grade d as complete ( cCR ) , partial ( cPR ) , or no response ( cNR ) . Tumors with a cCR were further categorized as either pathologic complete response ( pCR ) or invasive cells ( pINV ) . Disease-free survival ( DFS ) , distant disease-free survival ( DDFS ) , and survival were estimated through 5 years and compared between treatment groups . In the preoperative arm , proportional-hazards models were used to investigate the relationship between outcome and tumor response . RESULTS There was no significant difference in DFS , DDFS , or survival ( P = .99 , .70 , and .83 , respectively ) among patients in either group . More patients treated preoperatively than postoperatively underwent lumpectomy and radiation therapy ( 67.8 % v 59.8 % , respectively ) . Rates of ipsilateral breast tumor recurrence ( IBTR ) after lumpectomy were similar in both groups ( 7.9 % and 5.8 % , respectively ; P = .23 ) . Outcome was better in women whose tumors showed a pCR than in those with a pINV , cPR , or cNR ( relapse-free survival [ RFS ] rates , 85.7 % , 76.9 % , 68.1 % , and 63.9 % , respectively ; P Preoperative chemotherapy is as effective as postoperative chemotherapy , permits more lumpectomies , is appropriate for the treatment of certain patients with stages I and II disease , and can be used to study breast cancer biology . Tumor response to preoperative chemotherapy correlates with outcome and could be a surrogate for evaluating the effect of chemotherapy on micrometastases ; however , knowledge of such a response provided little prognostic information beyond that which result ed from postoperative therapy",
"We have previously reported the early results of a r and omized cross-over study of radical radiotherapy vs tamoxifen in patients with locally advanced breast cancer . This study has now recruited 143 patients with a median time from r and omization of almost 10 years for both groups . Seventy-three patients received 20 mg tamoxifen twice daily , and 70 had primary radiotherapy at a dose of 40 Gy , which is a lower dose than currently administered . The treatment groups were similar in age , size of tumour and oestrogen receptor status . There was no significant difference between the two treatment groups for the combined initial response and static disease rates ( 89 % for radiotherapy and 78 % for tamoxifen , P = 0.15 ) . The median duration of initial response was 12 months for both groups . When patients crossed over to the alternative therapy on local relapse , there was no difference in response/static disease rates ( P = 0.34 ) and duration of response ( P = 0.76 ) . A non-significant prolongation of the metastatic-free interval in favour of tamoxifen ( P = 0.08 ) was identified , although there was no difference in survival outcome ( P = 0.38 ) . This study shows that in this group of patients primary tamoxifen offers a similar clinical benefit to primary radiotherapy at a dose of 40 Gy , and is therefore an acceptable alternative primary treatment",
"Forty-one women with non-metastatic but locally advanced breast cancer were treated by modified radical or radical mastectomy , and were then r and omized to receive one of two adjuvant chemotherapy regimens . Regimen A consisted of 6 months of cyclophosphamide , adriamycin , and fluorouracil ( CAF ) followed by 6 months of cyclophosphamide , methotrexate , fluorouracil , vincristine , and prednisone ( CMFVP ) . Regimen B was 12 months of CMFVP . Patients were stratified for estrogen-receptor status , and all patients with a positive estrogen receptor value received tamoxifen 20 mg bid in addition to the chemotherapy . Eight of 21 patients radomized to Regimen A are alive and free of disease , whereas only 1 of 20 patients on Regimen B is well . A trend toward improved disease-free survival favoring Regimen A was observed ( P = .05 ) , although a significant difference in overall survival has not been demonstrated . Our findings support the continued study of adriamycin-containing regimens in the adjuvant setting and in combined modality therapy of locally advanced breast cancer",
"PURPOSE To evaluate the duration and dose intensity of epirubicin-based regimens in premenopausal patients with lymph node-positive breast cancer . PATIENTS AND METHODS Between 1986 and 1990 , 621 patients with operable breast cancer were r and omly assigned to receive fluorouracil ( Roche SA , Basel , Switzerl and ) 500 mg/m2 , epirubicin ( Pharmacia SA , Milan , Italy ) 50 mg/m2 , and cyclophosphamide ( Asta Medica AG , Frankfurt , Germany ) 500 mg/m2 every 21 days ( FEC 50 ) for six cycles ( 6 FEC 50 ) ; FEC 50 for three cycles ( 3 FEC 50 ) ; or the same regimen with epirubicin 75 mg/m2 ( FEC 75 ) for three cycles ( 3 FEC 75 ) . All patients in the three arms received chest wall irradiation at the end of the third cycle . RESULTS After a 131-month median follow-up , the 10-year disease-free survival ( DFS ) was 53.4 % , 42.5 % , and 43.6 % ( P = .05 ) in the three arms , respectively . Pairwise comparisons demonstrate that 6 FEC 50 was superior both to 3 FEC 50 ( P = .02 ) and to 3 FEC 75 ( P = .05 ) . The 10-year overall survival ( OS ) for the 6 FEC 50 arm was 64.3 % , for the 3 FEC 50 arm it was 56.6 % , and for the 3 FEC 75 arm , it was 59.7 % ( P = .25 ) , respectively . Pairwise comparisons demonstrate that 6 FEC 50 was more effective than 3 FEC 50 ( P = .10 ) . Cox regression analysis demonstrates that OS was significantly better in the 6 FEC 50 than in the 3 FEC 50 arm ( P = .046 ) . No severe infections ( grade 3 to 4 ) , acute cardiac toxicity , or deaths from toxicity have been observed . Only five patients developed delayed cardiac dysfunctions , and three patients developed acute myeloblastic leukemia . CONCLUSION After a long-term follow-up in an adjuvant setting , the benefit of six cycles of FEC 50 compared with three cycles , whatever the dose , is highly significant in terms of DFS . As regards OS , the group receiving six cycles of FEC 50 has significantly better results than the group receiving three cycles of FEC 50 ",
"BACKGROUND A prospect i ve r and omised trial was undertaken to evaluate the role of neoadjuvant chemoendocrine therapy prior to surgery in primary operable breast cancer . PATIENTS AND METHODS Three hundred nine women ( median age 56 years , range 27 - 70 ) with primary operable breast cancer confirmed on fine needle aspiration ( FNA ) cytology were recruited to this study . They were treated with a combination of mitozantrone and methotrexate ( + /- mitomycin-C ) combined with tamoxifen ( 2MT ) . Patients received eight cycles of 2MT ( four prior to surgery in the neoadjuvant group ) and tamoxifen for five years with appropriate surgery and radiotherapy . The two groups were comparable for age , menopausal status , stage and surgical requirements . RESULTS The clinical response rates to neoadjuvant therapy were as follows : 22 % complete response ( CR ) , 29 % minimal residual disease ( MRD ) , 33 % partial response ( PR ) , 15 % no change ( NC ) and only two patients had clinical evidence of progressive disease . Surgical requirements were reduced from 31 patients ( 22 % ) of the adjuvant group having mastectomy to 14 ( 10 % ) in the neoadjuvant group ( P local relapse , metastatic relapse or overall survival . Symptomatic and haematologic acute toxicity was low and similar for adjuvant and neoadjuvant therapy . CONCLUSION This r and omised trial has shown a significant reduction in the surgical requirements for mastectomy , after treatment with neoadjuvant chemoendocrine therapy , with no deterioration in local or distal relapse",
"PURPOSE Primary chemotherapy was administered to patients with tumors that measured > or = 2.5 cm in largest diameter to decrease the size of the primary tumor and allow for effective local and distant control while avoiding mastectomy . PATIENTS AND METHODS Two prospect i ve nonr and omized studies were performed that used different regimens of primary chemotherapy followed by breast-sparing surgery in the presence of objective tumor remission . Additional postoperative chemotherapy was given to women at high risk of disease relapse . The median follow-up duration was 65 months . RESULTS A total of 536 assessable patients were enrolled , and the main characteristics were fairly comparable between the two trials . Following primary chemotherapy , 85 % of patients could be subjected to breast-sparing surgery ; in 14 patients ( 3 % ) , surgical specimens failed to show any residual neoplastic cell . In the final multivariate analysis , the histologically assessed extent of axillary node involvement ( P degree of response to primary chemotherapy ( P = .034 ) , represented the significant variables able to influence 8-year relapse-free survival . In women subjected to a breast-conserving approach , the cumulative risk of local relapse as first event alone was 6.8 % ( 95 % confidence interval , 3.9 % to 8.8 % ) . CONCLUSION Current findings indicate that primary chemotherapy can be safely administered in women with large tumors ( > 5.0 cm ) and can allow breast-sparing surgery in a high fraction of patients ( 62 % ) . However , to assess effectively the worthiness of this approach on long-term results , properlyconceived large r and omized studies with newer and more effective drug regimens are warranted",
"BACKGROUND Neoadjuvant chemotherapy improves overall survival and renders possible breast-conserving treatment in locally advanced breast cancer . It was necessary for this method to be evaluated in operable breast tumors too large to be treated immediately by conserving surgery . Initial results of this r and omized trial were published in Annals of Oncology ( 1991 ) . PATIENTS AND METHODS Women with T2 > 3 cm or T3 N0 - 1 M0 breast tumors were treated by either initial mastectomy followed by adjuvant chemotherapy , or neoadjuvant chemotherapy followed by adjusted locoregional treatment . Chemotherapy was the same in the two arms . The prognostic and predictive factors of response to chemotherapy were analyzed . RESULTS Conserving treatments were performed in 63 % at the end of neoadjuvant chemotherapy and this rate had decreased to 45 % at the median follow-up of 124 months . Survivals are identical in the two treatment groups . Initial clinical tumor size 40 % are predictive of tumor response to chemotherapy by uni- and multivariate analyses . For outcome prediction , c-erb-B2 > 0 % is the independent prognostic factor for overall and metastasis-free survivals . CONCLUSION Breast-conserving therapy can be performed in more than half of all cases without alteration of survival , despite a non-negligible rate of local recurrences",
"One hundred thirteen evaluable patients with previously untreated stage III breast carcinoma were treated with three monthly cycles of cyclophosphamide ( CYC ) , doxorubicin ( DOX ) , 5-fluorouracil ( 5-FU ) , vincristine ( VCR ) , and prednisone ( PRED ) ( CAFVP ) . Subsequently , 91 ( 81 % ) were deemed operable . Patients were then r and omized to receive surgery or radiotherapy ( RT ) to determine which of these modalities afforded better local tumor control . All patients also received 2 additional years of CAFVP in a further attempt to eradicate local disease and systemic micrometastases . Forty-one of the r and omized patients have relapsed . Approximately half of the initial relapses in each arm were local . The overall duration of disease control was similar following either modality , with a median of 29.2 months for surgery patients and 24.4 months for RT patients . Similarly , there was no major difference in survival related to r and omized treatment with an overall median of 39 months ( median follow-up 37 months ) . Pre- or perimenopausal status and inflammatory disease were associated with shorter disease control and survival . Treatment was generally well tolerated and toxicity was acceptable . This study demonstrates that prolonged control of stage III breast carcinoma can be achieved with combined modality therapy in which cytotoxic chemotherapy precedes and follows treatment directly primarily at the breast tumor , using either surgery or RT . Nevertheless , new regimens must be design ed if significant advances that may lead to the cure of this disease are to be achieved",
"BACKGROUND Postmastectomy radiotherapy is associated with a lower locoregional recurrence rate and improved disease-free and overall survival when combined with chemotherapy in premenopausal high-risk breast-cancer patients . However , whether the same benefits apply also in postmenopausal women treated with adjuvant tamoxifen for similar high-risk cancer is unclear . In a r and omised trial among postmenopausal women who had undergone mastectomy , we compared adjuvant tamoxifen alone with tamoxifen plus postoperative radiotherapy . METHODS Between 1982 and 1990 , postmenopausal women with high-risk breast cancer ( stage II or III ) were r and omly assigned adjuvant tamoxifen ( 30 mg daily for 1 year ) alone ( 689 ) or with postoperative radiotherapy to the chest wall and regional lymph nodes ( 686 ) . Median follow-up was 123 months . The endpoints were first site of recurrence ( locoregional recurrence , distant metastases , or both ) , and disease-free and overall survival . FINDINGS Locoregional recurrence occurred in 52 ( 8 % ) of the radiotherapy plus tamoxifen group and 242 ( 35 % ) of the tamoxifen only group ( p Disease-free survival was 36 % in the radiotherapy plus tamoxifen group and 24 % in the tamoxifen alone group ( p Overall survival was also higher in the radiotherapy group ( 385 vs 434 deaths ; survival 45 vs 36 % at 10 years , p=0.03 ) . INTERPRETATION Postoperative radiotherapy decreased the risk of locoregional recurrence and was associated with improved survival in high-risk postmenopausal breast-cancer patients after mastectomy and limited axillary dissection , with 1 year of adjuvant tamoxifen treatment . Improved survival in high-risk breast cancer can best be achieved by a strategy of both locoregional and systemic tumour control",
"BACKGROUND In the adjuvant setting , tamoxifen is the established treatment for postmenopausal women with hormone-sensitive breast cancer . However , it is associated with several side-effects including endometrial cancer and thromboembolic disorders . We aim ed to compare the safety and efficacy outcomes of tamoxifen with those of anastrozole alone and the combination of anastrozole plus tamoxifen for 5 years . METHODS Participants were postmenopausal patients with invasive operable breast cancer who had completed primary therapy and were eligible to receive adjuvant hormonal therapy . The primary endpoints were disease-free survival and occurrence of adverse events . Analysis for efficacy was by intention to treat . FINDINGS 9366 patients were recruited , of whom 3125 were r and omly assigned anastrozole , 3116 tamoxifen , and 3125 combination . Median follow-up was 33.3 months . 7839 ( 84 % ) patients were known to be hormone-receptor-positive . Disease-free survival at 3 years was 89.4 % on anastrozole and 87.4 % on tamoxifen ( hazard ratio 0.83 [ 95 % CI 0.71 - 0.96 ] , p=0.013 ) . Results with the combination were not significantly different from those with tamoxifen alone ( 87.2 % , 1.02 [ 0.89 - 1.18 ] , p=0.8 ) . The improvement in disease-free survival with anastrozole was seen in the subgroup of hormone-receptor-positive patients , but not the receptor-negative patients . Incidence of contralateral breast cancer was significantly lower with anastrozole than with tamoxifen ( odds ratio 0.42 [ 0.22 - 0.79 ] , p=0.007 ) . Anastrozole was significantly better tolerated than tamoxifen with respect to endometrial cancer ( p=0.02 ) , vaginal bleeding and discharge ( p cerebrovascular events ( p=0.0006 ) , venous thromboembolic events ( p=0.0006 ) , and hot flushes ( p tolerated than anastrozole with respect to musculoskeletal disorders and fractures ( p Anastrozole is an effective and well tolerated endocrine option for the treatment of postmenopausal patients with hormone-sensitive early breast cancer . Longer follow-up is required before a final benefit : risk assessment can be made",
"A prospect i ve r and omized trial was conducted comparing the clinical response of 78 previously untreated patients with advanced metastatic breast cancer to a combination of cyclophosphamide , methotrexate , and 5‐fluorouracil ( CMF ) or to a combination of cyclophosphamide , adriamycin , and 5‐fluorouracil ( CAF ) . Sixty‐two percent of the patients receiving CMF responded to treatment compared to an 82 % response rate for the patients receiving CAF . Although within acceptable limits , hematologic and GI toxicity was greater with CAF . There was no significant difference in the duration of response to the two regimens . Therefore , the therapeutic difference between the two therapies is a higher initial response rate to the adriamycin containing regimen",
"The aim of this study was to investigate initial treatment of locally advanced breast cancer . Patients were r and omised to \" multimodal \" therapy ( pre-operative chemotherapy , Patey mastectomy , flap irradiation and adjuvant hormone therapy ) ( n = 55 ) , or initial \" hormone \" therapy ( n = 53 ) with further therapy upon tumour progression . The objective response to chemotherapy was 57 % ( 31/54 ) after four cycles . Of patients on hormone therapy , 36 % ( 19/53 ) had an objective response and 32 % ( 17/53 ) disease stasis at a 6 month assessment . At a median 30 months follow-up , there was no notable difference in development of metastases or survival : only 6 patients have uncontrolled loco-regional relapse ( 4 \" hormonal \" , 2 \" multimodal \" ) . The number of treatments per patient required for this loco-regional control was lower in the \" hormone \" group ( mean 2.13 versus 4.20 in the \" multimodal \" group ) . This small study has shown that the use of consecutive therapies , with the aim of tumour control , does not appear to compromise outcome in comparison with initial \" multi-modal \" therapy . Adopting such a policy may allow some patients to avoid unnecessary treatments",
"One hundred twenty pathologically confirmed operable Stage III breast cancer patients were r and omized to receive either postoperative radiotherapy or chemotherapy , or a combination of these , with or without levamisole immunotherapy . Radiotherapy was given to regional lymph nodes and chest wall . Chemotherapy consisted of six cycles of vincristine , doxorubicin , and cyclophosphamide . Radiotherapy provided local and chemotherapy systemic control over the tumor , but the best patient‐saving results were achieved with a combination of radiotherapy and chemotherapy . This clinical trial was commenced in 1976 , and the first 60 of 120 patients also received oral levamisole , 150 mg/day , on 2 consecutive days weekly as immunotherapy . All patients were followed for at least 5 years . At this stage levamisole seems to increase disease‐free and overall survival in all three treatment arms ( radiotherapy , chemotherapy , combined treatment ) . Significance is reached in disease‐free survival ( P = 0.035 ) and overall survival , adjusted for all other treatment modalities ( P = 0.019 )",
"PURPOSE To compare the efficacy of neoadjuvant ( NA ) docetaxel ( DOC ) with anthracycline-based therapy and determine the efficacy of NA DOC in patients with breast cancer initially failing to respond to anthracycline-based NA chemotherapy ( CT ) . PATIENTS AND METHODS Patients with large or locally advanced breast cancer received four pulses of cyclophosphamide 1,000 mg/m(2 ) , doxorubicin 50 mg/m(2 ) , vincristine 1.5 mg/m(2 ) , and prednisolone 40 mg ( 4 x CVAP ) for 5 days . Clinical tumor response was assessed . Those who responded ( complete response [ CR ] or partial response [ PR ] ) were r and omized to receive further 4 x CVAP or 4 x DOC ( 100 mg/m(2 ) ) . All nonresponders received 4 x DOC . RESULTS One hundred sixty-two patients were enrolled ; 145 patients completed eight cycles of NA CT . One hundred two patients ( 66 % ) achieved a clinical response ( PR or CR ) after 4 x CVAP . After r and omization , 50 patients received 4 x CVAP and 47 patients received 4 x DOC . In patients who received eight cycles of CT , the clinical CR ( cCR ) and clinical PR ( cPR ) ( 94 % v 66 % ) and pathologic CR ( pCR ) ( 34 % v 16 % ) response rates were higher ( P = .001 and P = .04 ) in those who received further DOC . Intention-to-treat analysis demonstrated cCR and cPR ( 85 % v 64 % ; P = .03 ) and pCR ( 31 % v 15 % ; P = .06 ) . Axillary lymph node examination revealed residual tumor in 33 % of patients who received 8 x CVAP and 38 % of patients who received further DOC . In patients who failed to respond to the initial CVAP , 4 x DOC result ed in a cCR and cPR rate of 55 % and a pCR rate of 2 % . Forty-four percent of these patients had residual tumor within axillary lymph nodes . CONCLUSION NA DOC result ed in substantial improvement in responses to DOC",
"One hundred and seven patients with locally advanced breast cancer were prospect ively referred for multimodality treatment on protocol using chemohormonal therapy to maximal response followed by local treatment and maintenance therapy . Forty-eight patients ( 45 % ) were diagnosed with Stage IIIA disease , 46 ( 43 % ) with Stage IIIB inflammatory cancer , and 13 ( 12 % ) with Stage IIIB non-inflammatory disease . Induction therapy consisted of cyclophosphamide , doxorubicin , methotrexate , and 5-fluorouracil with hormonal synchronization using tamoxifen and conjugated estrogens . Local treatment was determined by response to chemotherapy . Patients with a clinical parital response underwent mastectomy followed by local-regional radiotherapy while patients with a clinical complete response were biopsied for pathologic correlation . Those with residual disease received mastectomy followed by radiotherapy while those with a pathologic complete response received radiation only to the intact breast and regional nodes . With a median follow-up of 64 months , patients with IIIA disease had a significantly lower local-regional failure rate compared to IIIB inflammatory patients , with the 5-year actuarial local-regional failure rate as only site of first failure 3 % for IIIA disease versus 21 % for IIIB inflammatory cancer ( p = .02 ) , and local-regional failure as any component of first failure 12 % versus 36 % ( p = .01 ) , respectively . When local-regional failure was analyzed by repeat biopsy , 5/31 ( 16 % ) patients with a pathologic complete response treated with radiation only developed a local-regional failure versus 2/53 ( 4 % ) with residual disease treated with mastectomy and postoperative radiotherapy . The 5-year actuarial local-regional failure rate as first site of failure was 23 % for radiation only versus 5 % for mastectomy and post-operative radiotherapy ( p = .07 ) . The response to chemotherapy did not reliably predict local-regional control . Both relapse-free survival and overall survival were significantly better for IIIA versus IIIB patients ; stratification by repeat biopsy did not however , significantly affect either relapse-free or overall survival",
"BACKGROUND Adjuvant chemotherapy is widely used for breast cancer and is known to extend survival . Some clinicians seek a greater survival benefit by increasing the intensity of the dose , whereas others lower it to diminish toxicity . METHODS The Cancer and Leukemia Group B ( CALGB ) conducted a r and omized trial of different levels of doses and dose intensity ( dose per unit of time ) of adjuvant chemotherapy in 1572 women with node-positive , stage II breast cancer who were assigned to three treatment groups . One group received 400 mg of cyclophosphamide per square meter of body-surface area and 40 mg of doxorubicin per square meter once every 28 days and 400 mg of fluorouracil per square meter twice every 28 days , for six cycles . Another group received 50 percent higher doses of the three drugs ( 600 mg , 60 mg , and 600 mg , respectively ) but for only four cycles , so that the total dose was identical in these two groups but the dose intensity was higher in the first . The third group of women received half the total dose used in the other two groups and at half the dose intensity used in the second group . RESULTS After a median of 3.4 years of follow-up , the women treated with a high or moderate dose intensity had significantly longer disease-free survival ( P overall survival ( P = 0.004 ) than those treated with a low dose intensity , in three-way log-rank comparisons . However , the difference in survival between the two groups treated with a moderate or high dose intensity was not significant . These results are consistent with either a dose-response effect or a threshold level of the dose or dose intensity . CONCLUSIONS The doses of chemotherapy used to treat breast cancer , especially early breast cancer , should not be reduced if the maximal benefit is to be achieved",
"The aim of this study was to assess a potential advantage in survival by neoadjuvant as compared to adjuvant chemotherapy . 414 premenopausal patients with T2-T3 N0-N1 M0 breast cancer were r and omised to receive either four cycles of neoadjuvant chemotherapy ( cyclophosphamide , doxorubicin , 5-fluorouracil ) , followed by local-regional treatment ( group I ) or four cycles of adjuvant chemotherapy after primary irradiation + /- surgery ( group II ) . Surgery was limited to those patients with a persisting mass after irradiation , and aim ed to be as conservative as possible . 390 patients were evaluable . With a median follow-up of 54 months , we observed a statistically significant difference ( P = 0.039 ) in survival in favour of the neoadjuvant chemotherapy group . A similar trend was seen when the time to metastatic recurrence was evaluated ( P = 0.09 ) . At this stage , no difference in disease-free interval or local recurrence between these two groups could be observed . The mean total dose of chemotherapy administered was similar in both groups . On average , group I had more intensive chemotherapy regimes ( doxorubicin P = 0.02 ) but fewer treatment courses ( P = 0.008 ) as compared to the treated patients in group II . Haematological tolerance was reduced when chemotherapy succeeded to exclusive irradiation . Breast conservation was identical for both groups at the end of primary treatment ( 82 and 77 % for groups I and II , respectively ) . Of the 191 evaluable patients in the neoadjuvant treatment arm , 65 % had an objective response ( > 50 % regression ) following four cycles of chemotherapy . The objective response rate to primary irradiation ( 55 Gy ) was 85 % . Improved survival figures in the neoadjuvant treatment arm could be the result of the early initiation of chemotherapy , but we can not exclude that this difference might be attributable to a slightly more aggressive treatment . So far , the trend in favour of decreased metastases was not statistically significant . The local control appeared similar in both subgroups",
"BACKGROUND Irradiation after mastectomy can reduce locoregional recurrences in women with breast cancer , but whether it prolongs survival remains controversial . We conducted a r and omized trial of radiotherapy after mastectomy in high-risk premenopausal women , all of whom also received adjuvant systemic chemotherapy with cyclophosphamide , methotrexate , and fluorouracil ( CMF ) . METHODS A total of 1708 women who had undergone mastectomy for pathological stage II or III breast cancer were r and omly assigned to receive eight cycles of CMF plus irradiation of the chest wall and regional lymph nodes ( 852 women ) or nine cycles of CMF alone ( 856 women ) . The median length of follow-up was 114 months . The end points were locoregional recurrence , distant metastases , disease-free survival , and overall survival . RESULTS The frequency of locoregional recurrence alone or with distant metastases was 9 percent among the women who received radiotherapy plus CMF and 32 percent among those who received CMF alone ( P probability of survival free of disease after 10 years was 48 percent among the women assigned to radiotherapy plus CMF and 34 percent among those treated only with CMF ( P Overall survival at 10 years was 54 percent among those given radiotherapy and CMF and 45 percent among those who received CMF alone ( P irradiation after mastectomy significantly improved disease-free survival and overall survival , irrespective of tumor size , the number of positive nodes , or the histopathological grade . CONCLUSIONS The addition of postoperative irradiation to mastectomy and adjuvant chemotherapy reduces locoregional recurrences and prolongs survival in high-risk premenopausal women with breast cancer",
"PURPOSE To evaluate whether preoperative neoadjuvant chemotherapy in patients with primary operable breast cancer results in better overall survival ( OS ) and relapse-free survival rates and whether preoperative chemotherapy permits more breast-conserving surgery procedures than postoperative chemotherapy . PATIENTS AND METHODS Six hundred ninety-eight breast cancer patients ( T1c , T2 , T3 , T4b , N0 to 1 , and M0 ) were enrolled onto a r and omized phase III trial that compared four cycles of fluorouracil , epirubicin , and cyclophosphamide administered preoperatively versus the same regimen administered postoperatively ( the first cycle administered within 36 hours after surgery ) . Patients were followed up for OS , progression-free survival ( PFS ) , and locoregional recurrence ( LRR ) . RESULTS At a median follow-up of 56 months , there was no significant difference in terms of OS ( hazards ratio , 1.16 ; P = .38 ) , PFS ( hazards ratio , 1.15 ; P = .27 ) , and time to LRR ( hazards ratio , 1.13 ; P = .61 ) . Fifty-seven patients ( 23 % ) were downstaged by the preoperative chemotherapy , whereas 14 patients ( 18 % ) underwent mastectomy and not the planned breast-conserving therapy . CONCLUSION The use of preoperative chemotherapy yields similar results in terms of PFS , OS , and locoregional control compared with conventional postoperative chemotherapy . In addition , preoperative chemotherapy enables more patients to be treated with breast-conserving surgery . Because preoperative chemotherapy does not improve disease outcome compared with postoperative chemotherapy , future trials should involve quality -of-life studies to investigate whether patients will benefit from this treatment modality",
"A r and omized prospect i ve trial was conducted to compare Tamoxifen and combination chemotherapy ( 5-fluorouracil , doxorubicin and cyclophosphamide ) as adjuvant treatment for patients with locally advanced ( Stage III ) breast cancer . At the end of 5 years , no significant difference could be found in the disease-free period for both groups",
"PURPOSE To compare prospect ively the antitumor activity of single-agent paclitaxel to the three-drug combination of fluorouracil , doxorubicin , and cyclophosphamide ( FAC ) as neoadjuvant therapy in patients with operable breast cancer . PATIENTS AND METHODS Patients with T1 - 3N0 - 1M0 disease were r and omized to receive either paclitaxel ( 250 mg/m(2 ) ) as 24-hour infusion or FAC in st and ard doses at every-3-week intervals . Each patient was treated with four cycles of preoperative chemotherapy . Clinical response and extent of residual disease in the breast and lymph nodes was assessed after four cycles of induction chemotherapy . RESULTS A total of 174 patients were registered , and 87 were r and omized to each arm of the study . Clinical response , ie , complete and partial responses , was similar in both arms of the study . Three patients in the FAC arm and one patient in the paclitaxel subgroup had progressive disease . The extent of residual disease by intent-to-treat analysis at the time of surgery was similar between the two arms of the study . CONCLUSION The results of this prospect i ve study demonstrated that single-agent paclitaxel as neoadjuvant therapy has significant antitumor activity , and this was clinical ly comparable to FAC . Similar fractions of patients had clinical complete and partial responses , and very few patients had no response to either therapy . The value of alternate non-cross-resistant therapies as used in this protocol on the clinical course of this disease would require longer follow-up",
"PURPOSE The National Surgical Adjuvant Breast and Bowel Project Protocol B-27 was design ed to determine the effect of adding docetaxel after four cycles of preoperative doxorubicin and cyclophosphamide ( AC ) on clinical and pathological response rates and on disease-free and overall survival of women with operable breast cancer . PATIENTS AND METHODS Women ( N = 2,411 ) with operable primary breast cancer were r and omly assigned to receive either four cycles of preoperative AC followed by surgery ( group I ) , or four cycles of AC followed by four cycles of docetaxel , followed by surgery ( group II ) , or four cycles of AC followed by surgery and then four cycles of docetaxel ( group III ) . Clinical and pathologic tumor responses to preoperative therapy were assessed . RESULTS Mean tumor size ( 4.5 cm ) and other key characteristics were evenly balanced among the three treatment arms . Grade 4 toxicity was observed in 10.3 % of 2,400 patients during AC treatment , and in 23.4 % of 1584 patients during docetaxel treatment . Compared to preoperative AC alone , preoperative AC followed by docetaxel increased the clinical complete response rate ( 40.1 % v 63.6 % ; P overall clinical response rate ( 85.5 % v 90.7 % ; P pathologic complete response rate ( 13.7 % v 26.1 % ; P proportion of patients with negative nodes ( 50.8 % v 58.2 % ; P Pathologic primary breast tumor response was a significant predictor of pathologic nodal status ( P docetaxel after four cycles of preoperative AC significantly increased clinical and pathologic response rates for operable breast cancer",
"PURPOSE To determine whether preoperative doxorubicin and cyclophosphamide ( AC ) permits more lumpectomies to be performed and decreases the incidence of positive nodes in women with primary breast cancer . PATIENTS AND METHODS Women ( n = 1,523 ) were r and omized to National Surgical Adjuvant Breast and Bowel Project ( NSABP ) B-18 ; 759 eligible patients received postoperative AC and 747 , preoperative AC . The clinical size of breast and axillary tumors was determined before each of four cycles of AC and before surgery . Tumor response to preoperative therapy was clinical ly complete ( cCR ) , partial ( cPR ) , stable ( cSD ) , or progressive disease ( cPD ) . Tissue from patients with a cCR was evaluated for a pathologic complete response ( pCR ) . RESULTS Breast tumor size was reduced in 80 % of patients after preoperative therapy ; 36 % had a cCR . Tumor size and clinical nodal status were independent predictors of cCR . Twenty-six percent of women with a cCR had a pCR . Clinical nodal response occurred in 89 % of node-positive patients : 73 % had a cCR and 44 % of those had a pCR . There was a 37 % increase in the incidence of pathologically negative nodes . Before r and omization , lumpectomy was proposed for 86 % of women with tumors or = 5.1 cm . Clinical tumor size and nodal status influenced the physician 's decision . Overall , 12 % more lumpectomies were performed in the preoperative group ; in women with tumors > or = 5.1 cm , there was a 175 % increase . CONCLUSION Preoperative therapy reduced the size of most breast tumors and decreased the incidence of positive nodes . The greatest increase in lumpectomy after preoperative therapy occurred in women with tumors > or = 5 cm , since women with tumors less than 5 cm were already lumpectomy c and i date s. Preoperative therapy should be considered for the initial management of breast tumors judged too large for lumpectomy",
"From July , 1978 to September , 1981 , 184 patients with localy advanced breast cancer ( T3 ; T4a-b ; any N ; M0 ) regardless of their hormonal receptor status , entered a trial to evaluate the contribution of radiotherapy when added to an intensive preoperative chemoendocrine regimen . Seventy-eight patients were ultimately disqualified . All patients underwent sequentially : ( 1 ) two cycles of chemotherapy : Day 1 - -Oncovin 1.4 mg/m2 , cyclophosphamide 350 mg/m2 , Adriamycin 30 mg/m2 ; Day 2 - -methotrexate 20 mg/m2 , 5-fluorouracil 350 mg/m2 ( in addition , antiestrogens were given to postmenopausal patients ) ; ( 2 ) mastectomy with complete axillary dissection combined with oophorectomy in patients before and one year after menopause ; ( 3 ) radiotherapy r and omly to one-half of the patients ; and ( 4 ) ten additional chemotherapy cycles as above , with antiestrogens to all patients . No serious local sequellae were encountered from mastectomy or radiotherapy , but complications of chemotherapy were numerous , particularly in irradiated patients . One death due to toxicity occurred after preoperative chemotherapy . The results to date suggest that in irradiated patients metastases may become enhanced and that their local disease is not more effectively controlled than in patients not having radiotherapy . Two factors may have been largely responsible for the differences observed between the two groups : the delay of chemotherapy in irradiated patients and the sustained immunosuppression known to occur after mediastinal radiotherapy"
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This systematic review was aim ed at assessing the metabolic effects of testosterone replacement therapy ( TRT ) on hypogonadal men with type 2 diabetes mellitus ( T2DM ) . A literature search was performed using the Cochrane Library , EMBASE and PubMed . Only r and omized controlled trials ( RCTs ) were included in the meta- analysis . Two review ers retrieved articles and evaluated the study quality using an appropriate scoring method . Outcomes including glucose metabolism , lipid parameters , body fat and blood pressure were pooled using a r and om effects model and tested for heterogeneity . We used the Cochrane Collaboration 's Review Manager 5.2 software for statistical analysis . Five RCTs including 351 participants with a mean follow-up time of 6.5-months were identified that strictly met our eligibility criteria . A meta- analysis of the extractable data showed that testosterone reduced fasting plasma glucose levels ( mean difference ( MD ) : -1.10 ; 95 % confidence interval ( CI ) ( -1.88 , -0.31 ) ) , fasting serum insulin levels ( MD : -2.73 ; 95 % CI ( -3.62 , -1.84 ) ) , HbA1c % ( MD : -0.87 ; 95 % CI ( -1.32 , -0.42 ) ) and triglyceride levels ( MD : -0.35 ; 95 % CI ( -0.62 , -0.07 ) ) . The testosterone and control groups demonstrated no significant difference for other outcomes . In conclusion , we found that TRT can improve glycemic control and decrease triglyceride levels of hypogonadal men with T2DM . Considering the limited number of participants and the confounding factors in our systematic review ; additional large , well- design ed RCTs are needed to address the metabolic effects of TRT and its long-term influence on hypogonadal men with T2DM
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"Testosterone increases muscle mass and strength and regulates other physiological processes , but we do not know whether testosterone effects are dose dependent and whether dose requirements for maintaining various and rogen-dependent processes are similar . To determine the effects of grade d doses of testosterone on body composition , muscle size , strength , power , sexual and cognitive functions , prostate-specific antigen ( PSA ) , plasma lipids , hemoglobin , and insulin-like growth factor I ( IGF-I ) levels , 61 eugonadal men , 18 - 35 yr , were r and omized to one of five groups to receive monthly injections of a long-acting gonadotropin-releasing hormone ( GnRH ) agonist , to suppress endogenous testosterone secretion , and weekly injections of 25 , 50 , 125 , 300 , or 600 mg of testosterone enanthate for 20 wk . Energy and protein intakes were st and ardized . The administration of the GnRH agonist plus grade d doses of testosterone result ed in mean nadir testosterone concentrations of 253 , 306 , 542 , 1,345 , and 2,370 ng/dl at the 25- , 50- , 125- , 300- , and 600-mg doses , respectively . Fat-free mass increased dose dependently in men receiving 125 , 300 , or 600 mg of testosterone weekly ( change + 3.4 , 5.2 , and 7.9 kg , respectively ) . The changes in fat-free mass were highly dependent on testosterone dose ( P = 0.0001 ) and correlated with log testosterone concentrations ( r = 0.73 , P = 0.0001 ) . Changes in leg press strength , leg power , thigh and quadriceps muscle volumes , hemoglobin , and IGF-I were positively correlated with testosterone concentrations , whereas changes in fat mass and plasma high-density lipoprotein ( HDL ) cholesterol were negatively correlated . Sexual function , visual-spatial cognition and mood , and PSA levels did not change significantly at any dose . We conclude that changes in circulating testosterone concentrations , induced by GnRH agonist and testosterone administration , are associated with testosterone dose- and concentration-dependent changes in fat-free mass , muscle size , strength and power , fat mass , hemoglobin , HDL cholesterol , and IGF-I levels , in conformity with a single linear dose-response relationship . However , different and rogen-dependent processes have different testosterone dose-response relationships",
"BACKGROUND The incidence of thrombotic cardiovascular disease is greater in men than in premenopausal women . Testosterone has been implicated as a significant risk factor for cardiovascular disease and for acute myocardial infa rct ions and strokes in young male athletes who abuse anabolic steroids . Thromboxane A2 ( TXA2 ) is a vasoconstrictor and platelet proaggregatory agent that has been implicated in the pathogenesis of cardiovascular disease . We therefore tested the hypothesis that testosterone regulates the expression of human platelet TXA2 receptors . METHODS AND RESULTS In a double-blind , placebo-controlled , r and omized , parallel-group study , we determined the effects of testosterone cypionate 200 mg IM given twice , 2 weeks apart , or saline placebo in 16 healthy men . Platelet TXA2 receptor density ( Bmax ) and dissociation constant ( Kd ) were measured by use of the TXA2 mimetic 125I-BOP . Platelet aggregation responses to I-BOP and to thrombin and plasma testosterone concentrations were measured before treatment ( pretreatment phase ) , at 2 and 4 weeks ( active phase ) , and again at 8 weeks ( recovery phase ) . Treatment with testosterone was associated with an increase in the Bmax value from 0.95 + /- 0.13 to 2.10 + /- 0.4 pmol/mg protein ( n = 9 ) , with a peak effect at 4 weeks ( P = .001 ) , returning to baseline by 8 weeks . There was no significant change in Bmax values in the saline-treated group . The Kd values were unchanged . Testosterone treatment was associated with a significant increase in the maximum platelet aggregation response to I-BOP ( P EC50 values were not significantly changed . Platelet TXA2 receptor density was positively correlated ( r = .56 , P Testosterone regulates the expression of platelet TXA2 receptors in humans . This may contribute to the thrombogenicity of and rogenic steroids",
"The objective of this study was to assess the effects of oral testosterone supplementation therapy on glucose homeostasis , obesity and sexual function in middle-aged men with type 2 diabetes and mild and rogen deficiency . Forty-eight middle-aged men , with type 2 diabetes , ( visceral ) obesity and symptoms of and rogen deficiency , were included in this open-label study . Twenty-four subjects received testosterone undecanoate ( TU ; 120 mg daily , for 3 months ) ; 24 subjects received no treatment . Body composition was analyzed by bio-impedance . Parameters of metabolic control were determined . Symptoms of and rogen deficiency and erectile dysfunction were scored by self-administered question naires . TU had a positive effect on ( visceral ) obesity : statistically significant reduction in body weight ( 2.66 % ) , waist-hip ratio ( -3.96 % ) and body fat ( -5.65 % ) ; negligible changes were found in the control group . TU significantly improved metabolic control : decrease in blood glucose values and mean glycated hemoglobin ( HbA1c ) ( from 10.4 to 8.6 % ) . TU treatment significantly improved symptoms of and rogen deficiency ( including erectile dysfunction ) , with virtually no change in the control group . There were no adverse effects on blood pressure or hematological , biochemical and lipid parameters , and no adverse events . Oral TU treatment of type 2 diabetic men with and rogen deficiency improves glucose homeostasis and body composition ( decrease in visceral obesity ) , and improves symptoms of and rogen deficiency ( including erectile dysfunction ) . In these men , the benefit of testosterone supplementation therapy exceeds the correction of symptoms of and rogen deficiency and also includes glucose homeostasis and metabolic control",
"OBJECTIVE Low levels of testosterone in men have been shown to be associated with type 2 diabetes , visceral adiposity , dyslipidaemia and metabolic syndrome . We investigated the effect of testosterone treatment on insulin resistance and glycaemic control in hypogonadal men with type 2 diabetes . DESIGN This was a double-blind placebo-controlled crossover study in 24 hypogonadal men ( 10 treated with insulin ) over the age of 30 years with type 2 diabetes . METHODS Patients were treated with i.m . testosterone 200 mg every 2 weeks or placebo for 3 months in r and om order , followed by a washout period of 1 month before the alternate treatment phase . The primary outcomes were changes in fasting insulin sensitivity ( as measured by homeostatic model index ( HOMA ) in those not on insulin ) , fasting blood glucose and glycated haemoglobin . The secondary outcomes were changes in body composition , fasting lipids and blood pressure . Statistical analysis was performed on the delta values , with the treatment effect of placebo compared against the treatment effect of testosterone . RESULTS Testosterone therapy reduced the HOMA index ( -1.73 + /- 0.67 , P = 0.02 , n = 14 ) , indicating an improved fasting insulin sensitivity . Glycated haemoglobin was also reduced ( -0.37 + /- 0.17 % , P = 0.03 ) , as was the fasting blood glucose ( -1.58 + /- 0.68 mmol/l , P = 0.03 ) . Testosterone treatment result ed in a reduction in visceral adiposity as assessed by waist circumference ( -1.63 + /- 0.71 cm , P = 0.03 ) and waist/hip ratio ( -0.03 + /- 0.01 , P = 0.01 ) . Total cholesterol decreased with testosterone therapy ( -0.4 + /- 0.17 mmol/l , P = 0.03 ) but no effect on blood pressure was observed . CONCLUSIONS Testosterone replacement therapy reduces insulin resistance and improves glycaemic control in hypogonadal men with type 2 diabetes . Improvements in glycaemic control , insulin resistance , cholesterol and visceral adiposity together represent an overall reduction in cardiovascular risk",
"PURPOSE Although prostate cancer specific mortality is decreasing , there is little effect on overall mortality in this population , suggesting the possibility of an increased risk of death from nonprostate cancer related causes . And rogen deprivation therapy could adversely affect cardiovascular health . We investigated changes in lipid and glucose during and rogen deprivation therapy . MATERIAL S AND METHODS We performed an exploratory analysis of pooled data from 3 prospect i ve clinical trials aim ed at achieving medical castration by comparing the gonadotropin releasing hormone antagonist abarelix , the gonadotropin releasing hormone agonist leuprolide acetate and leuprolide acetate plus the anti and rogen bicalutamide . Most patients were treated in the neoadjuvant setting or because of biochemical recurrence . Fasting serum lipid , glucose and hemoglobin A1C were determined in 1,102 men at baseline , and on treatment days 85 and 169 . In the current study men were categorized into 3 treatment groups according to the type of and rogen deprivation therapy , that is leuprolide acetate , leuprolide acetate plus bicalutamide or abarelix , and statin therapy . RESULTS Significant increases in total cholesterol , triglyceride and high density lipoprotein-cholesterol were observed in patients on leuprolide acetate or abarelix but not in patients on leuprolide acetate plus bicalutamide . Consistent changes in low density lipoprotein-cholesterol were not detected . Increased total cholesterol was usually due to an increase in high density lipoprotein-cholesterol . Hemoglobin A1C increased from baseline to day 85 only and there were no significant changes in fasting glucose measurements . The type of and rogen deprivation therapy did not affect these parameters . CONCLUSIONS Short-term and rogen deprivation therapy affects serum lipid and hemoglobin A1C independent of statin therapy",
"CONTEXT Evidence suggests that testosterone ( T ) influences insulin sensitivity in men . The mechanism of this effect is unclear but is thought to involve changes in body composition . OBJECTIVE The aim of this study was to determine whether acute sex steroid withdrawal decreases insulin sensitivity in young , healthy men with idiopathic hypogonadotropic hypogonadism ( IHH ) . DESIGN This was a 2-wk prospect i ve study . SETTING The study was conducted at a General Clinical Research Center . PATIENTS Twelve men with IHH ( age 40.8 + /- 2.8 yr ) were studied : 1 ) on hormone replacement with normal T levels and 2 ) 2 wk after discontinuing therapy . MAIN OUTCOME MEASURES Each evaluation comprised a 75-g oral glucose tolerance test with assessment of insulin sensitivity ( fasting insulin levels , homeostatic model assessment for insulin resistance , and Matsuda insulin sensitivity index ) and insulin secretion ( corrected insulin response ) . Serum cortisol , leptin , adiponectin , free fatty acids , IL-6 , C-reactive protein , and TNF-alpha levels were also measured . RESULTS Body mass index was unchanged ( 27.1 + /- 1.1 to 27.2 + /- 1.1 kg/m(2 ) ) . Serum T levels decreased from 529 + /- 65 to 28 + /- 8 ng/dl ( P Fasting insulin levels increased from 4.9 + /- 0.7 to 6.2 + /- 0.6 microU/ml ( P = 0.005 ) , homeostatic model assessment of insulin resistance increased from 1.07 + /- 0.2 to 1.4 + /- 1.01 ( P insulin sensitivity index decreased from 11.0 + /- 2.3 to 7.5 + /- 0.7 ( P fasting glucose levels to increase , 86.7 + /- 1.3 to 90.8 + /- 1.7 mg/dl ( P = 0.09 ) . IL-6 levels increased from 1.2 + /- 0.2 to 2.4 + /- 0.5 pg/ml ( P TNF-alpha levels decreased from 1.0 + /- 0.1 to 0.6 + /- 0.1 pg/ml ( P sex steroid withdrawal reduces insulin sensitivity in young healthy IHH men . 2 ) The acuity of the hypogonadism and absence of changes in body mass index or leptin levels suggest that sex steroids modulate insulin sensitivity in the absence of apparent or detectable changes in body composition",
"Our underst and ing of the effect of and rogens on insulin action and glucose metabolism is incomplete . Several different models and methods have been used to study and rogen effects , with some studies indicating that higher testosterone levels are associated with increased insulin resistance . In polycystic ovary syndrome , where high testosterone levels are frequently found , affected patients have a higher risk of diabetes . In contrast , increased insulin resistance was found in both hypergonadotropic and hypogonadotropic men with hypo and rogenism , patients with Klinefelter 's syndrome and men with idiopathic gonadotropin deficiency . Insulin resistance is considered to be one of the cornerstones in the state that ultimately leads to clinical ly established type 2 diabetes mellitus . In addition , men with type 2 diabetes have relative hypogonadism . Therefore , supplementation with testosterone might play a role in improving both insulin resistance and hypogonadism . The study population consisted of 11 male patients with type 2 diabetes . Their mean age was 57.7 ± 3.41 years , the body mass index ( BMI ) was 24.4 ± 1.02 kg/m2 , and the waist-to-hip ratio ( W/H ) was 0.91 ± 0.05 . The patients were all treated with oral hypoglycemic agents . The men received and rogen injections every 3 weeks intramuscularly for 12 weeks . The injections were testosterone depot 100 mg/3 weeks . Insulin sensitivity , glucose effectiveness and area under acute insulin response were calculated from \" minimal model \" algorithms . There were no significant differences in the value of BMI , W/H ratios , plasma lipid concentrations , testosterone , homeostasis model assessment ( HOMA ) of insulin sensitivity , and beta-cell function , before and after supplementation of testosterone . Furthermore , the insulin sensitivity ( SI ) ( 1.04 ± 0.25 , 1.11 ± 0.36 x 10−5 min−1/pM ; p = 0.43 ) , glucose effectiveness ( EG ) ( 0.018 ± 0.003 , 0.017 ± 0.002 min−1 ; p = 0.29 ) , and acute insulin response ( AIR ) after a glucose load ( 45.7 ± 24.3 , 50.1 ± 32.5 pM ; p = 0.45 ) did not change significantly after supplementation with testosterone . In our study , there was no improvement of SI , EG , and AIR after 3 months of Testosterone Depot treatment in type 2 diabetes , but we believe that duration and dosage of the and rogen therapy might play an important role in improving insulin sensitivity . The mechanisms by which testosterone causes insulin resistance is unknown , and larger studies on and rogen treatment in type 2 diabetic patients are necessary",
"OBJECTIVE To investigate the effect of testosterone treatment on insulin resistance , glycemic control , and dyslipidemia in Asian Indian men with type 2 diabetes mellitus ( T2DM ) and hypogonadism . METHODS We conducted a double-blind , placebo-controlled , crossover study in 22 men , 25 to 50 years old , with T2DM and hypogonadism . Patients were treated with intramuscularly administered testosterone ( 200 mg every 15 days ) or placebo for 3 months in r and om order , followed by a washout period of 1 month before the alternative treatment phase . The primary outcomes were changes in fasting insulin sensitivity ( as measured by homeostasis model assessment [ HOMA ] in those patients not receiving insulin ) , fasting blood glucose , and hemoglobin A1c . The secondary outcomes were changes in fasting lipids , blood pressure , body mass index , waist circumference , waist-to-hip ratio , and and rogen deficiency symptoms . Statistical analysis was performed on the delta values , with the treatment effect of placebo compared with the effect of testosterone . RESULTS Treatment with testosterone did not significantly influence insulin resistance measured by the HOMA index ( mean treatment effect , 1.67 + /- 4.29 ; confidence interval , -6.91 to 10.25 ; P>.05 ) . Mean change in hemoglobin A1c ( % ) ( -1.75 + /- 5.35 ; -12.46 to 8.95 ) and fasting blood glucose ( mg/dL ) ( 20.20 + /- 67.87 ; -115.54 to 155.94 ) also did not reach statistical significance . Testosterone treatment did not affect fasting lipids , blood pressure , and anthropometric determinations significantly . CONCLUSION In this study , testosterone treatment showed a neutral effect on insulin resistance and glycemic control and failed to improve dyslipidemia , control blood pressure , or reduce visceral fat significantly in Asian Indian men with T2DM and hypogonadism",
"The role of and rogens in cardiovascular disease is uncertain . We aim ed to determine the vascular effects of and rogen suppression in men with prostate cancer . Arterial stiffness ( or ' compliance ' ) was measured in 16 men ( 71+/-9 years , mean+/-S.D. ) prior to , and 3 months after , complete and rogen suppression with gonadotrophin-releasing hormone analogues as treatment for prostate cancer . Fifteen control men ( 70+/-7 years ) also had arterial stiffness studies at baseline and 3 months later . Two measures of arterial stiffness were employed : systemic arterial compliance ( SAC ) was measured by simultaneous recording of aortic flow and carotid artery pressure ( ' area method ' ) , and pulse wave velocities ( PWVs ) were recorded with the ' Complior ' system . The 16 cases underwent glucose-tolerance and fasting-lipids tests on both visits . After 3 months of testosterone suppression , there was a significant fall in SAC , which was not seen in the controls [ mean change+/-S.E.M. , -0.26+/-0.09 a.c.u . ( arbitrary compliance unit ) in the cases versus + 0.06+/-0.11 in the controls ; P = 0.03 ) . Central , but not peripheral , PWVs tended to increase in the cases ( mean change+/-S.E.M. for aorto-femoral PWV , + 0.5+/-0.4 m/s for cases versus -0.3+/-0.3 m/s for controls ; P = 0.08 ) . After testosterone suppression , fasting insulin levels increased from 6.89+/-4.84 m-units/l to 11.34+/-8.16 m-units/l ( mean+/-S.D. ) , total cholesterol increased from 5.32+/-0.77 mmol/l to 5.71+/-0.82 mmol/l and high-density lipoprotein cholesterol increased from 1.05+/-0.24 mmol/l to 1.26+/-0.36 mmol/l ; P body-mass index , serum glucose , low-density lipoprotein cholesterol or triacylglycerol ( triglyceride ) levels . Our results indicate that loss of and rogens in men leads to an increase in aortic stiffness and serum insulin levels , and may therefore adversely affect cardiovascular risk",
"OBJECTIVES To examine the effect of grade d doses of testosterone on physical function and muscle performance in healthy , older men . DESIGN R and omized , double-blind , placebo-controlled clinical trial . SETTING General clinical research center . PARTICIPANTS Community-dwelling healthy men aged 60 to 75 ( N=44 ) . INTERVENTION Monthly treatment with a gonadotropin-releasing hormone agonist plus 25 , 50 , 125 , or 300 mg/wk of intramuscular injections of testosterone enanthate for 20 weeks . MEASUREMENTS Skeletal muscle mass ( SMM ) was estimated using dual-energy X-ray absorptiometry . Leg press strength was measured by one repetition maximum , leg power by Nottingham Leg Rig , and muscle fatigability by repetitions to failure in the leg press exercise . Stair climbing , 6-meter and 400-meter walking speed , and a timed-up- and -go ( TUG ) test were used to assess physical function . RESULTS Significant testosterone dose- and concentration-dependent increases were observed in SMM ( P maximal strength ( P=.001 ) but not muscle fatigability . Leg power also increased dose-dependently ( P=.048 ) . In contrast , changes in self-selected normal and fast walking speed over 6 or 400 meters , stair climbing power , and time for the TUG were not significantly related to testosterone dose , testosterone concentrations , or changes in muscle strength or power , or SMM . CONCLUSION Testosterone administration was associated with dose-dependent increases in SMM , leg strength , and power but did not improve muscle fatigability or physical function . The observation that physical function scores did not improve linearly with strength suggests that these high-functioning older men were already in the asymptotic region of the curve describing the relationship between physical function and strength",
"OBJECTIVES This study investigated the effect of a 12-week long-acting testosterone administration on maximal exercise capacity , ventilatory efficiency , muscle strength , insulin resistance , and baroreflex sensitivity ( BRS ) in elderly patients with chronic heart failure ( CHF ) . BACKGROUND CHF is characterized by a metabolic shift favoring catabolism and impairment in skeletal muscle bulk and function that could be involved in the pathophysiology of heart failure . METHODS Seventy elderly patients with stable CHF-median age 70 years , ejection fraction 31.8 + /- 7%-were r and omly assigned to receive testosterone ( n = 35 , intramuscular injection every 6 weeks ) or placebo ( n = 35 ) , both on top of optimal medical therapy . At baseline and at the end of the study , all patients underwent echocardiogram , cardiopulmonary exercise test , 6-min walk test ( 6MWT ) , quadriceps maximal voluntary contraction ( MVC ) , and isokinetic strength ( peak torque ) and BRS assessment ( sequences technique ) . RESULTS Baseline peak oxygen consumption ( VO(2 ) ) and quadriceps isometric strength showed a direct relation with serum testosterone concentration . Peak VO(2 ) significantly improved in testosterone but was unchanged in placebo . Insulin sensitivity was significantly improved in testosterone . The MVC and peak torque significantly increased in testosterone but not in placebo . The BRS significantly improved in testosterone but not in placebo . Increase in testosterone levels was significantly related to improvement in peak VO(2 ) and MVC . There were no significant changes in left ventricular function either in testosterone or placebo . CONCLUSIONS These results suggest that long-acting testosterone therapy improves exercise capacity , muscle strength , glucose metabolism , and BRS in men with moderately severe CHF . Testosterone benefits seem to be mediated by metabolic and peripheral effects"
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4116f628-06ff-11f0-808a-c43d1ab1c353
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Background s/ Aims The role of prophylactic antibiotics for laparoscopic cholecystectomy in low-risk patients is still unclear . This study aim ed to verify the conclusion of previous meta-analyses concerning the effectiveness of antibiotic prophylaxis for elective laparoscopic cholecystectomy in low-risk patients . Methods Comprehensive literature search es were performed on electric data bases and manual search es . R and omized controlled trials ( RCTs ) , prospect i ve studies , and retrospective studies comparing antibiotic prophylaxis to placebo or no antibiotics in low-risk elective laparoscopic cholecystectomy were included . Results This study included 28 RCTs , three prospect i ve studies , and three retrospective studies . In RCTs , prophylactic antibiotics did not prevent deep surgical site infections ( SSI ) ( RR 1.10 , 95 % confidence interval [ CI ] [ 0.45 - 2.69 ] , p=0.84 ) but reduced SSI ( RR 0.70 , 95 % CI [ 0.53 - 0.94 ] , p=0.02 ) , and superficial SSI ( RR 0.58 , 95 % CI [ 0.42 - 0.82 ] , p=0.01 ) . Prospect i ve studies showed prophylactic antibiotics did not reduce superficial SSI ( RR 0.35 , 95 % CI [ 0.01 - 8.40 ] , p=0.52 ) but reduced SSI ( RR 0.12 , 95 % CI [ 0.04 - 0.35 ] , p=0.0001 ) . In retrospective studies , antibiotic prophylaxis did not reduce SSI ( RR 1.59 , 95 % CI [ 0.30 - 8.32 ] , p=0.58 ) . The pooled data ( 12121 patients ) including RCTs and prospect i ve and retrospective studies showed that prophylactic antibiotics were not effective in preventing deep SSI ( RR 1.01 95 % CI [ 0.46 - 2.21 ] , p=0.98 ) but effective in reducing SSI ( RR 0.67 , 95 % CI [ 0.51 - 0.88 ] , p=0.003 ) and superficial SSI ( RR 0.61 , 95 % CI [ 0.45 - 0.83 ] , p=0.002 ) . Conclusions The use of prophylactic antibiotics is effective for reducing the incidence of SSI and superficial SSI but is not effective for preventing deep SSI in low-risk patients who underwent elective laparoscopic cholecystectomy
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"Background In the absence of r and omized controlled trials with sufficient power to assess the effectiveness of prophylactic antibiotics ( PA ) , the best evidence is provided by large population -based register studies . Methods The Swedish Register of Gallstone Surgery and ERCP ( GallRiks ) started in May 2005 and reached 75 % national coverage in 2007 . During 2006 and 2007 , a total of 16,400 operations were registered in GallRiks . In the present study , all elective procedures performed in 2006–2007 in units performing at least 25 operations annually were included in an analysis of the risk for postoperative infectious complications Results Altogether 10,927 procedures were performed 2006–2007 . Univariate logistic regression analysis revealed a paradoxical increase in postoperative infectious complications requiring antibiotic treatment and postoperative abscess if PA were given ( p PA was seen in this study on elective cholecystectomy . Although a r and omized controlled trial could possibly show a reduction in the risk for postoperative infectious complications not detected in this study , such a reduction must be weighed against the risk of promoting drug resistance by the widespread use of PA",
"Abstract Background There is a variation in the administration of antibiotics prophylaxis to reduce the perceived risk of SSI in patients undergoing non-emergency cholecystectomy . The aim of this study was to determine the effectiveness of antibiotic prophylaxis following non-emergency cholecystectomy to prevent 30-day superficial surgical site infections ( SSIs ) using non-selected , nationally collected , prospect i ve data . Methods Data were extracted from the CholeS study , which examined and independently vali date d the outcomes on consecutive patients following non-emergency cholecystectomy across 166 hospitals in the UK and Irel and . Patients who received antibiotic prophylaxis were exact matched to those who did not on variables associated with antibiotic prophylaxis . The primary outcome of interest was superficial SSI , and secondary outcomes included deep SSI , readmissions , complications and re- interventions within 30 days . Results Out of a total of 7327 patients included in the study , 4468 ( 61 % ) received antibiotic prophylaxis . These were matched to patients who did not receive antibiotic prophylaxis on a range of demographic and surgical factors , leaving 1269 pairs of patients for analysis . Within this cohort , patients receiving antibiotic prophylaxis had significantly lower rates of superficial SSI ( 0.7 % vs. 2.3 % , p = 0.001 ) and all-cause complications ( 5.8 vs. 8.0 % , p = 0.031 ) , but similar rates of deep SSI ( 1.0 vs. 1.4 % , p = 0.473 ) , readmissions ( 5.2 vs. 6.2 % , p = 0.302 ) and re- interventions ( 2.6 vs. 3.7 % , p = 0.093 ) . The number needed to treat to prevent one superficial SSI was 45 ( 95 % confidence interval 24–662 ) . Conclusions Antibiotics appear effective at reducing SSI after non-emergency cholecystectomy . However , due to the high number needed to treat it is unclear whether they provide a worthwhile clinical benefit to patients",
"Background : Acute calculous cholecystitis ( ACC ) is the most common complication of cholelithiasis . Laparoscopic cholecystectomy ( LC ) is the gold st and ard treatment in mild and moderate forms . Currently there is consensus for the use of antibiotics in the preoperative phase of ACC . However , the need for antibiotic therapy after surgery remains undefined with a low level of scientific evidence . Methods : The CHART ( Cholecystectomy Antibiotic R and omised Trial ) study is a single‐center , prospect i ve , double blind , and r and omized trial . Patients with mild to moderate ACC operated by LC were r and omly assigned to receive antibiotic ( amoxicillin/clavulanic acid ) or placebo treatment for 5 consecutive days . The primary endpoint was postoperative infectious complications . Secondary endpoints were as follows : ( 1 ) duration of hospital stay , ( 2 ) readmissions , ( 3 ) reintervention , and ( 4 ) overall mortality . Results : In the per‐ protocol analysis , 6 of 104 patients ( 5.8 % ) in the placebo arm and 6 of 91 patients ( 6.6 % ) in the antibiotic arm developed postoperative infectious complications ( absolute difference 0.82 ( 95 % confidence interval , −5.96 to 7.61 , P = .81 ) . The median hospital stay was 3 days . There was no mortality . There were no differences regarding readmissions and reoperations between the 2 groups . Conclusion : Although this trial failed to show noninferiority of postoperative placebo compared to antibiotic treatment after LC for mild and moderate ACC within a noninferiority margin of 5 % , the use of antibiotics in the postoperative period does not seem justified , because it was not associated with a decrease in the incidence of infectious and other types of morbidity in the present study",
"Background Recent meta-analyses concluded that antibiotic prophylaxis is not warranted in low-risk laparoscopic cholecystectomy . However , most trials in the meta-analyses had a relatively small sample size and were statistically underpowered . In addition , many of the trials mentioned potential cost savings owing to the elimination of prophylactic antibiotics . However , no trial has statistically estimated the cost effectiveness . To evaluate the results of meta-analyses , we conducted a r and omized controlled trial on the role of prophylactic antibiotics in low-risk laparoscopic cholecystectomy with an adequate sample size . Methods From March 2007 to May 2013 , at the Department of Surgery , Kansai Medical University , patients who were scheduled for elective laparoscopic cholecystectomy were r and omly assigned to one of two arms : those who were and were not administered prophylactic antibiotics . The primary endpoint was the occurrence of postoperative infections and secondary endpoints were postoperative hospital stay and medical costs . Findings During the study period , 518 patients were assigned to the Antibiotics group and 519 to the No antibiotics group . Occurrences of surgical site infections , distant infections and overall infections were significantly lower in the Antibiotics group than in the No antibiotics group ( 0.8 vs. 3.7 % , p = 0.001 , OR : 0.205 ( 95%CI : 0.069 to 0.606 ) ; 0.4 vs. 3.1 % , p = 0.0004 , OR : 0.122 ( 95%CI : 0.028 to 0.533 ) ; 1.2 vs. 6.7 % ; p respectively ) . The postoperative hospital stay was significantly shorter in the Antibiotics group ( mean , SD : 3.69±1.56 vs. 4.07±3.00 ; p = 0.01 ) and the postoperative medical costs were significantly lower in the Antibiotics group ( mean , SD : $ 766±341 vs. 832±670 ; p = 0.047 ) . Multivariable analysis showed that independent risk factors for postoperative infectious complications were no prophylactic antibiotics ( p administration of prophylactic antibiotics should be recommended in laparoscopic cholecystectomy to prevent postoperative infectious complications and to reduce medical costs . Trial Registration UMIN Clinical Trials Registry UMIN000003749",
"ABSTRACT Background : Elective laparoscopic cholecystectomy has very low risk for infectious complications , ranging the infection rate from 0.4 % to 1.1 % . Many surgeons still use routine antibiotic prophylaxis Aim : Evaluate the real impact of antibiotic prophylaxis in elective laparoscopic cholecystectomies in low risk patients . Method : Prospect i ve , r and omized and double-blind study . Were evaluated 100 patients that underwent elective laparoscopic cholecystectomy divided in two groups : group A ( n=50 ) , patients that received prophylaxis using intravenous Cephazolin ( 2 g ) during anesthetic induction and group B ( n=50 ) , patients that did n't receive any antibiotic prophylaxis . The outcome evaluated were infeccious complications at surgical site . The patients were review ed seven and 30 days after surgery . Results : There was incidence of 2 % in infection complications in group A and 2 % in group B. There was no statistical significant difference of infectious complications ( p=0,05 ) between the groups . The groups were homogeneous and comparable . Conclusion : The use of the antibiotic prophylaxis in laparoscopic cholecystectomy in low risk patients does n't provide any significant benefit in the decrease of surgical wound infection",
"IMPORTANCE Ninety percent of cases of acute calculous cholecystitis are of mild ( grade I ) or moderate ( grade II ) severity . Although the preoperative and intraoperative antibiotic management of acute calculous cholecystitis has been st and ardized , few data exist on the utility of postoperative antibiotic treatment . OBJECTIVE To determine the effect of postoperative amoxicillin plus clavulanic acid on infection rates after cholecystectomy . DESIGN , SETTING , AND PATIENTS A total of 414 patients treated at 17 medical centers for grade I or II acute calculous cholecystitis and who received 2 g of amoxicillin plus clavulanic acid 3 times a day while in the hospital before and once at the time of surgery were r and omized after surgery to an open-label , noninferiority , r and omized clinical trial between May 2010 and August 2012 . INTERVENTIONS After surgery , no antibiotics or continue with the preoperative antibiotic regimen 3 times daily for 5 days . MAIN OUTCOMES AND MEASURES The proportion of postoperative surgical site or distant infections recorded before or at the 4-week follow-up visit . RESULTS An imputed intention-to-treat analysis of 414 patients showed that the postoperative infection rates were 17 % ( 35 of 207 ) in the nontreatment group and 15 % ( 31 of 207 ) in the antibiotic group ( absolute difference , 1.93 % ; 95 % CI , -8.98 % to 5.12 % ) . In the per- protocol analysis , which involved 338 patients , the corresponding rates were both 13 % ( absolute difference , 0.3 % ; 95 % CI , -5.0 % to 6.3 % ) . Based on a noninferiority margin of 11 % , the lack of postoperative antibiotic treatment was not associated with worse outcomes than antibiotic treatment . Bile cultures showed that 60.9 % were pathogen free . Both groups had similar Clavien complication severity outcomes : 195 patients ( 94.2 % ) in the nontreatment group had a score of 0 to I and 2 patients ( 0.97 % ) had a score of III to V , and 182 patients ( 87.8 % ) in the antibiotic group had a score of 0 to I and 4 patients ( 1.93 % ) had a score of III to V. CONCLUSIONS AND RELEVANCE Among patients with mild or moderate calculous cholecystitis who received preoperative and intraoperative antibiotics , lack of postoperative treatment with amoxicillin plus clavulanic acid did not result in a greater incidence of postoperative infections . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01015417",
"Introduction Accidental rupture of the gallbladder is an event which occurs in up to 20 % of laparoscopic cholecystectomies , mainly in those where dissection is difficult , or during extraction when the gallbladder is withdrawn directly through the laparoscope port . It has been commonly assumed that contamination by bile in the abdominal cavity could be a cause of infection and lead to the formation of a residual abscess or even to surgical wound infection . It is common practice , therefore , for the surgeon to prescribe the application of an antibiotic at the moment when gallbladder perforation occurs . Objective To compare 2 groups of similar patients , to determine whether administration of antibiotics , started during surgery , is actually useful in reducing the risk of residual abscess or infection in the surgical wound . Patients and Method The study considered a total of 166 patients who had suffered accidental perforation of the gallbladder during elective laparoscopic cholecystectomy . This total was divided at r and om into 2 groups : group A ( 80 patients ) who received a dose of 1 g of Cefotaxime at the moment of gallbladder rupture , followed by 2 more doses at intervals of 8 hours in the immediate postoperative period ; and group B ( 86 patients ) who did not receive any antibiotic treatment at all . The dependent variables observed were surgical wound infection and residual abscess : and the control variables were age , sex , length of operation time , intercurrent illnesses , and American Society of Anesthesiologists ( ASA ) classification . Results Two patients ( 2.5 % ) in group A developed a surgical wound infection , against 3 cases ( 3.4 % ) in group B , the result having no statistical significance . No patients developed residual abscess . In a multivariant analysis , the following were identified as independent factors significantly associated with the onset of surgical wound infection ( P diabetes mellitus , being over 60 years of age , operation time lasting longer than 70 minutes , and ASA 3 . Conclusions Routine application of an antibiotic to patients experiencing accidental perforation of the gallbladder during laparoscopic cholecystectomy is not necessary . In the case of patients with diabetes mellitus , those who are older than 60 , or who have an ASA classification of 3 or more , or if the operation itself is likely to last more than 70 minutes , the recommendation is to start antibiotic therapy in the preoperative phase immediately before surgery",
"INTRODUCTION It has been demonstrated previously that the identification of bactibilia during cholecystectomy is associated with the presence of one or more risk factors : acute cholecystitis , common duct stones , emergency surgery , intraoperative findings and age > 70 years . Current evidence -based guidance on antibiotic prophylaxis during laparoscopic cholecystectomy ( LC ) is based on elective procedures and does not take into account these factors . The aim of this study was to assess the effectiveness of a selective antibiotic prophylaxis policy limited to high risk patients undergoing LC with the development of port site infections as the primary endpoint . METHODS One hundred consecutive patients undergoing LC under the care of a single consultant surgeon during a one-year period were studied prospect ively . Data collected included patient demographics ( age , sex ) as well as details of the history of gallstone disease to determine those with complex disease and risk factors for bactibilia . A single dose of antibiotics ( second generation cephalosporin and metronidazole ) was administered on induction to patients with a risk factor present . Information relating to all radiologically or microbiologically confirmed infections was documented . RESULTS Eighty-four of the patients were female and the mean age was 47.7 ±16.0 years . Nineteen LCs were performed as emergencies and the remainder were elective procedures . A risk factor for bactibilia was present in 35 patients . A wound infection was identified in four cases , two of which were Staphylococcus aureus ( one methicillin resistant ) , one was a coagulase negative Staphylococcus and one wound cultured a mixed anaerobic growth . Three of the infections occurred in patients receiving prophylaxis ( 2 staphylococcal and 1 anaerobic ) at intervals of 7 , 14 and 19 days respectively . One patient with a body mass index of 32kg/m² in the ' no prophylaxis ' group developed a coagulase negative staphylococcal infection at 10 days . No intra or extra-abdominal abdominal infections were identified . CONCLUSIONS This study has demonstrated that restricting antibiotic prophylaxis to high risk patients has no detrimental effects in terms of increasing the rate of infections in those with no risk factors . Furthermore , the act of not prescribing to low risk patients will limit costs and the risk of adverse events . It will also reduce the risk of resistance and clostridial infections in this cohort",
"BACKGROUND Some clinicians administer prophylactic antibiotics routinely before laparoscopic cholecystectomy , and the results of some of the studies in the literature support this practice . We conducted a prospect i ve r and omized trial to determine whether administration of prophylactic antibiotics is necessary during routine laparoscopic cholecystectomy in low-risk patients . STUDY DESIGN Two hundred fifty patients without evidence of acute inflammation , common duct stones , or other indications for antibiotics were r and omized to receive three perioperative doses of cefazolin or no prophylaxis and followed up for complications up to 30 days postoperatively . The primary end point was the occurrence of a major infectious complication , defined as that causing a systemic response , delaying discharge , or leading to readmission . Minor infectious problems were also noted , defined as those causing local symptoms only . RESULTS One hundred twenty-eight patients were r and omized to receive prophylactic antibiotics ( PA group ) , 122 to receive none ( NONE group ; two patients in this group were actually given preoperative antibiotics ) . Only one major complication occurred ( in a patient in the NONE group ) , an abscess in the presence of a bile leak , despite the administration of antibiotics when the leak was discovered several days before infectious problems arose . There were four minor problems : two lower urinary tract infections and one superficial wound infection in a NONE patient and one urinary tract infection in a PA patient ( not significant ) ; all were easily managed . The prophylactic antibiotics did not sterilize the bile , and infectious complications were not associated with weight , inflammation found at the time of operation , reported stone or bile spill-age , or conversion to open operation . CONCLUSIONS Prophylactic antibiotics are not necessary for elective laparoscopic cholecystectomy in low-risk patients",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"Laparoscopic cholecystectomy has become the new gold st and ard for management of symptomatic gallstones . Prophylactic antibiotics are used in elective surgery by the majority of surgeons , and their role in biliary tract surgery has been well established for a sub population of high-risk patients . This consensus has been derived from multiple studies involving biliary tract surgery before and in the era of laparoscopic cholecystectomy . But the use of prophylactic antibiotics in laparoscopic cholecystectomy especially in the low-risk group is now controversial and varied among the surgeons all over the world . To study the role of prophylactic antibiotics in laparoscopic cholecystectomy in different risk groups of patients , a prospect i ve study was conducted in the Department of Surgery of Bankura Sammilani Medical College and Hospital from January 2010 to July 2011 . All patients with symptomatic gallstones who underwent elective laparoscopic cholecystectomy during this period are included in this study . One hundred and two patients with symptomatic gallstones were operated on by laparoscopic technique without receiving preoperative antibiotics and studied over a period of 1.5 years . Ages ranged from 11 to 70 years ( mean age of 33 years ) . There were 14 males ( 13.72 % of the patients ) and 88 females ( 86.27 % of the patients ) . There was no wound infection ( class I ) in 99 patients , and class II type of wound infection , i.e. , surgical site infection , occurred in three patients ( i.e. , 2.94 % ) out of a total of 102 patients . Swabs were taken for culture and sensitivity ; Staphylococcus aureus was found in two patients and Streptococcus viridans in one patient . In all three patients , infection occurred at the umbilical port sites , detected on the 3rd and 4th postoperative days . Antibiotic prophylaxis is not necessary in low-risk patients with symptomatic gallstone disease undergoing elective laparoscopic cholecystectomy to prevent postoperative infection-related complications . Preoperative skin preparation with chlorhexidine gluconate scrub may replace the use of prophylactic antibiotics for prevention of infection-related complications in patients undergoing elective laparoscopic cholecystectomy",
"Background In patients with symptomatic cholelithiasis , laparoscopic cholecystectomy ( LC ) is the st and ard method of treatment . Laparoscopic cholecystectomy has a low rate of postoperative infections probably owing to smaller wounds and minimal tissue damage compared with the open procedure . Objectives This study assessed the effect of cefazolin prophylaxis on postoperative infection in patients undergoing elective laparoscopic cholecystectomy . Additionally , we determined the risk factors of cases with postoperative infection . Patients and Methods A total of 753 patients were enrolled in the study . Among these , 206 were excluded from the study . As a result , 547 patients with symptomatic cholelithiasis who underwent elective laparoscopic cholecystectomy were selected for this prospect i ve study . Patients were r and omized consecutively and divided into 2 groups : patients in the cefazolin ( CEF ) group ( n = 278 ) received 1 g of cefazolin and those in the control group ( n = 269 ) received 10 mL of isotonic sodium chloride solution . Patient characteristics and overall surgical outcomes were compared between the groups . All patients were followed for development of postoperative infections . Results Postoperative infections occurred in 4 patients in the CEF group and in 2 patients in the control group ; no significant difference existed in this regard(P = .44 ) . Risk of infection increased in patients with previous cholecystitis and /or endoscopic retro grade cholangiopancreatography ( P patients with ruptured gallbladders , and patients for whom a suction drain was used ( respectively , P elective laparoscopic cholecystectomy patients . There may be an increased risk of infection in patients with previous cholecystitis or endoscopic retro grade cholangiopancreatography . In addition , there was an increased risk of postoperative infection in patients with gallbladder rupture and suction drain use ",
"Background A prophylactic antibiotic is recommended in open cholecystectomy surgeries , but in laparoscopic cholecystectomies such prophylaxis is controversial . Recent review s have not found conclusive evidence that routine prophylaxis , especially in low risk patients , is effective . This clinical trial was undertaken to evaluate the efficacy of cefazolin in reducing surgical site infection SSI in laparoscopic cholecystectomies in a sample not screened for high or low risk patients . Methods A r and omized double-blind controlled trial was conducted in a single university hospital . Scheduled cholecystectomy patients without selection for patient risk factors were r and omized into two groups . Pre-operatively , group A patients received a placebo of 10 ml isotonic sodium chloride , and group B patients received 1 g of cefazolin as a prophylactic antibiotic . All patients underwent a st and ard laparoscopic cholecystectomy , and were followed up for at least 30 days . Results Two hundred ninety-nine patients were r and omized ( 149 in group A and 150 in group B ) . SSI occurred in seven patients ( 2.34 % ) , five ( 1.67 % ) in the placebo group , and two ( 0.67 % ) in the prophylactic antibiotic group . The difference was not statistically significant ( p value = 0.512 ) , and no specific risk factors for post-operative infection were identified . Conclusions A single dose of preoperative prophylactic cefazolin has no significant benefit in reducing the incidence of SSI in laparoscopic cholecystectomy . Whether or not to use a prophylactic depends on the individual patient , and the consideration of the attending surgeon",
"HYPOTHESIS Cephalosporins are widely used and considered to be effective as prophylaxis in biliary surgery . Nevertheless , they lack activity against enterococci . We conducted a study to compare the efficacy of ampicillin-sulbactam vs cefuroxime in preventing surgical site infections following elective cholecystectomy . DESIGN A prospect i ve r and omized controlled trial . SETTING A major tertiary care hospital . PATIENTS Four hundred eighteen r and omized patients ( of 549 total ) , who from July 2002 to August 2004 underwent elective open or laparoscopic cholecystectomy with prospect i ve assessment for development of surgical site infections for 1 month postoperatively . INTERVENTION A single intravenous dose of 1.5 g of cefuroxime ( group A , n = 207 ) or 3 g of ampicillin-sulbactam ( group B , n = 211 ) was administered during induction of anesthesia . Bile and gallbladder mucosal cultures were taken intraoperatively from all patients . MAIN OUTCOME MEASURE Number of postoperative surgical site infections . RESULTS A postoperative surgical site infection was noted in 19 ( 4.5 % ) of 418 patients , 18 from group A and 1 from group B ( P cefuroxime , 15 ( 83.3 % ) of 18 surgical site infections were due to Enterococcus species . Intraoperative bactibilia as well as intraoperative gallbladder rupture were associated with surgical site infections ( P ampicillin-sulbactam favored better compared with cefuroxime for prevention of postoperative surgical site infections due to Enterococcus species after elective cholecystectomy . Ampicillin-sulbactam may be a better agent for antimicrobial prophylaxis in high-risk patients undergoing elective cholecystectomy , especially in a setting where the incidence of enterococcal infections is higher",
"BACKGROUND / AIMS The aim of this study was to evaluate the effect of antibiotic prophylaxis on the development of infectious complications in laparoscopic cholecystectomy . METHODOLOGY A total of 208 patients undergoing elective laparoscopic cholecystectomy were r and omized , double-blinded into one of two treatment arms : 1 ) cefazolin 1 g intravenously after induction of anesthesia and 2 ) no prophylactic antibiotics . The patients were followed-up for infectious complications for 30 days at the out-patient clinic . The data collected included age , sex , body mass index , ultrasonography findings , accompanying diseases , perforation during surgery , stone spillage , operation time , port of gallbladder delivery , suture material used for skin closure , preoperative and length of postoperative hospitalization , bile culture , pathology of the gallbladder , serum biochemical findings including alanine aminotransferase , aspartate aminotransferase , gammaglutamyl transpeptidase , bilirubin , alkaline phosphatase and glucose . RESULTS Overall rate of infection was 3.36 % . Four out of 105 patients who received antibiotics and 3 out of 103 patients who did not receive antibiotics developed infection . The difference was not statistically significant . Obesity and closing the skin with nylon sutures were found to be associated with increased rate of infectious complications . CONCLUSIONS Cefazolin prophylaxis in low risk patients has no effect on postoperative infection rate in laparoscopic cholecystectomy",
"Background Laparoscopic cholecystectomy ( LC ) is one of the most common surgeries in laparoscopic surgery . Although , it is believed that LC has low-risk for post-operative infectious complications , the use of a prophylactic antibiotic is still controversial in elective LC . Objective To determine the impact of prophylactic antibiotics on postoperative infection complications in elective laparoscopic cholecystectomy . Methods In this double-blind , placebo-controlled , r and omized , clinical trial , patients who were c and i date s for elective LC , from March 2012 to 2015 , in four hospitals in Babol , Iran , were studied . Patients were allocated r and omly to two groups , i.e. , group C : Cefazolin ( n = 182 ) and group P : placebo ( n = 247 ) . Group C received 1 g of Cefazolin 30 minutes before anesthesia and and then , six and 12 hours after anesthesia . Group P patients received 10 ml of isotonic sodium chloride solution . Age , gender , type of gallbladder diseases ( stone , polyp , or hydrops ) , the length of post-operative hospitalization , frequency of gallbladder rupture , the duration of surgery , and the kinds of complications associated with infections were collected for each patient in the two groups . The data were analyzed by IBM-SPSS version 20 , using the t-test and the chi-squared test , and a p-value 18 ( 9.9 % ) male versus 22 ( 9 % ) ; p = 0.74 ) , age ( C versus P : 43.75 + 13.30 years versus 40.91 + 13.05 ; p = 0.20 ) , and duration of surgery ( C versus P : 34.97 ± 8.25 min versus 34.11 ± 8.39 ; p = 0.71 ) . There were no significant differences between the two groups in the incidences of post-operative infection ( C versus P : 3 ( 1.7 % ) versus 5 ( 2 % ) ; p = 0.99 ) and rupture of the gallbladder ( C versus P : 14 ( 7.8 % ) versus 17 ( 6.8 % ) ; p = 0.85 ) . No other post-operative systemic infectious complications ( e.g. , sepsis , pneumonia , or urinary tract infection ) were found in either group . Conclusion For patients who underwent laparoscopic cholecystectomy ( LC ) , prophylactic antibiotics had no important role in the prevention of infections ; so these antibiotics apparently are not necessary in treatment , and they are not recommended for patients with laparoscopic cholecystectomy as low-risk selective antibiotics . Trial registration The trial was registered at the Iranian Clinical Trial Registry ( http://www.i rct .ir ) with the I RCT identification number I RCT 2013070413865N1 . Funding This research was supported financially by the Research Council of Babol University of Medical Sciences",
"Background and Objectives : Elective laparoscopic cholecystectomy has a low risk for infectious complications , but many surgeons still use prophylactic antibiotics . The aim of this prospect i ve study was to investigate the necessity and test the efficacy of prophylactic antibiotics on postoperative infection complications in low-risk patients undergoing laparoscopic cholecystectomy . Methods : Low-risk patients were r and omly placed into 2 groups : 68 patients ( group 1 ) received cefazolin 1 g intravenously after induction of anesthesia , and 76 patients ( group 2 ) were not given prophylactic antibiotics . In both groups , septic complications were recorded and compared . Results : Positive bile culture and gallbladder rupture did not significantly increase the rate of surgical site infections . In group 1 , there were 3 ( 4.41 % ) cases of wound infection , 3 ( 4.41 % ) cases of pulmonary infections , and 1 ( 1.47 % ) case of urinary tract infection . In group 2 , there were 2 ( 2.63 % ) cases of wound infection , 2 ( 2.63 % ) case of pulmonary infections , and 3 ( 3.95 % ) cases of urinary tract infection . No significant difference existed in the complication rates . Conclusions : Based on our data , the use of prophylactic antibiotics does not decrease the rate of postoperative infection complications and surgical-site infections and is not necessary in low-risk patients undergoing laparoscopic cholecystectomy",
"BACKGROUND The aim of this prospect i ve r and omized study was to investigate the necessity and impact of prophylactic antibiotics on postoperative infection complications in elective laparoscopic cholecystectomy . METHODS At the time of induction of anesthesia , group A patients ( n = 141 ) received 1 g cefazolin , and group B patients ( control ; n = 136 ) received 10 mL isotonic sodium chloride solution . Patients ' characteristics and general operative outcomes were compared and analyzed . RESULTS The overall rate of infection was 1.1 % for total 277 patients ( 0.7 % for group A patients and 1.5 % for group B patients ) . No significant difference in infection complications was found between these 2 groups . Also any risk factors contributing to infection complications could not be found . CONCLUSIONS We do not recommend the use of prophylactic antibiotics in elective laparoscopic cholecystectomy because they will not decrease the already-low rate of postoperative infectious complications",
"Premise and Objective : Elective laparoscopic cholecystectomy ( LC ) has low risk for post-operative infectious complications ; still most clinicians use persistent post-operative prophylactic antibiotics out of habit , tradition , or simply as defensive practice due to evolving medicolegal implication s of a large number of surgeries being showcased as daycare or next day discharge procedures . This r and omised prospect i ve trial was done to test the need for such prophylaxis in cases of elective LC in a rural/semi-urban setting . Material s and Methods : Two hundred and ten successive patients undergoing elective LC were r and omised into groups receiving single dose of injection ceftriaxone at the time of induction of anaesthesia , ( Group A = 112 cases ) and those who in addition to above received injection ceftriaxone twice daily for 2 days postoperatively ( Group B = 98 cases ) . Post-operative infectious complications between two groups were compared for variables such as age , sex , body mass index and bile/stone spillage . Results : There was no significant difference in surgical site infection rates between the groups for variables such as age , sex , body mass index , duration of symptoms , American Society of Anesthesiologists grade , duration of surgery and hospital stay . Intraoperative spillage of stones ( 9.8 % [ A ] : 5.1 % [ B ] ) did not increase infectious complications even in the presence of positive bile culture ( Group A , N = 7 vs. Group B , N = 3 ) . An operative time of greater than 60 min was found to be associated with increased surgical site infection ( P = 0 . 0006 ) . Conclusion : Single dose of ceftriaxone at the time of induction is adequate prophylaxis following elective LC even in the rural/semi-urban Indian setting and routine continued administration of antibiotic should be ab and oned as it contributes to adverse reactions , drug resistance and unnecessary financial burden",
"The aim of this study was to determine specific pattern of port site microbial colonisation , sensitivity and resistance to different antibiotics of bacteria isolated from port site infection ( PSI ) in low risk patients after elective laparoscopic cholecystectomy in surgical wards at tertiary care hospital of Kashmir . This is a prospect i ve study . The study included 675 consecutive patients of postoperative PSI after elective laparoscopic cholecystectomy for symptomatic cholelithiasis over a period of 12 months . Culture swabs were taken from port sites with signs of PSI and transported to the microbiology laboratory . The positive swab cultures were subjected to antibiotic susceptibility test . The data obtained was analysed by using appropriate statistical analytical tests . The incidence of PSI after elective laparoscopic cholecystectomy is 6·7 % . The commonest organism responsible for PSI is pseudomonas , 19 ( 42·2 % ) cases . Most of the strains of organisms isolated were resistant to commonly used antibiotics in the hospital , pseudomonas was found 100 % resistant to the combination of ampicillin + sulbactum and ceftriaxone and it was sensitive to imipenem , amikacin and vancomycin in 89·47,57 and 52·63 % of cases respectively . Our study will be helpful in choosing effective empirical prophylactic antibiotic therapy in cases of elective laparoscopic cholecystectomy and will have a great impact on morbidity and mortality in them because of PSI",
"HYPOTHESIS The need for antibiotic treatment when performing elective laparoscopic cholecystectomy may not be as important as it is thought . This study assesses the real efficacy of antibiotic prophylaxis in elective laparoscopic cholecystectomy with respect to the postoperative infection rate . DESIGN A prospect i ve r and omized study on the routine use of antibiotic prophylaxis in laparoscopic cholecystectomy . SETTING University teaching hospital , La Sapienza , Italy . PATIENTS Eighty-four patients r and omly placed into 2 groups ( A [ n = 44 ] and B [ n = 40 ] ) immediately before undergoing laparoscopic cholecystectomy . METHODS Before anesthesia was administered , group A received intravenously 2 g of cefotaxime sodium diluted in 100 mL of isotonic sodium chloride solution ; group B , 10 mL of isotonic sodium chloride solution in 100 mL of saline . A gallbladder bile sample for culture was withdrawn intraoperatively from all patients . In both groups , age , sex , weight , duration of surgery , presence of diabetes , American Society of Anesthesiologists patient classification score , preoperative autologous blood donation , antibiotic administration , intraoperative gallbladder rupture , findings from bile culture positive for bacteria , episodes of colic within 30 days before surgery , length of postoperative hospital stay , and number of septic complications were recorded . All data were correlated by univariate and multivariate analyses with the onset of septic phenomena . RESULTS In group A , 3 cases of wound infection , 1 case of subhepatic abscess from bile leakage , and 1 case of urinary tract infection were observed ; group B , 4 cases of wound infection , 1 case of bronchopneumonia , and 2 cases of urinary tract infection . Comparison of data showed no statistically significant difference between the groups . Findings from bile examination in patients with sepsis complications were positive in 5 patients in group A and in 6 in group B ( P = .91 ) . Multivariate analysis showed diabetes mellitus and colic episodes within 30 days before surgery as independent factors significantly associated to the onset of infectious complications . CONCLUSIONS In elective laparoscopic cholecystectomy , antibiotic treatment did not seem to affect the incidence and severity of infections or the degree of bile contamination",
"Summary This study is one of the first in the literature with the aim of assessing the effectiveness of antimicrobial prophylaxis with a single preoperative dose of long-acting ceftriaxone in a retrospective analysis of 3,603 patients undergoing laparoscopic cholecystectomy . All patients who underwent laparoscopic cholecystectomy between October 1990 and December 1997 were review ed . Antimicrobial prophylaxis with a single dose of ceftriaxone ( 1 g ) was given intravenously at the induction of anesthesia . Patients were closely monitored for infections until 4 weeks after surgery . Postoperative infections occurred in 44 of the 3,603 patients undergoing laparoscopic cholecystectomy , with an infection rate of 1.22 % . The infectious complications mainly comprised wound infections ( n=13 ) but also included intra-abdominal abscesses ( n=3 ) , pneumonia ( n=9 ) , urinary tract infections ( n=3 ) and other infections ( n=16 ) . The results of this retrospective and non-r and omized study , show that a single-shot regimen containing ceftriaxone may be a cost-effective measure in preventing postoperative infections in patients undergoing laparoscopic cholecystectomy",
"Abstract Background . The aim of this study was to assess the benefit from antibiotic prophylaxis ( AP ) during cholecystectomy in a population -based cohort study . Methods . All cholecystectomies performed in Uppsala County , 2003–2005 , were registered prospect ively according to a st and ardized protocol . High-risk procedures ( HP ) were defined as operations for acute cholecystitis and procedures including exploration of the common bile duct . Infections requiring surgical or percutaneous drainage and non-surgical infections that prolonged hospital stay were defined as major infectious complications ( IC ) . Results . Altogether 1171 patients underwent cholecystectomy . AP was given to 130 of 867 ( 15 % ) of the patients undergoing low-risk procedures ( LP ) and 205 of 304 ( 67 % ) of those undergoing H-R P. Major IC were seen in 6 of 205 ( 3 % ) of the patients undergoing H-R P with AP and 1 of 99 of the patients undergoing H-R P without AP . No major IC was seen after L-R P. Minor IC were seen after 5 of 205 ( 2 % ) HP with AP , 1 of 99 ( 1 % ) HP without AP , 0 of 130 ( 0 % ) LP with AP , and 2 of 737 ( 0.3 % ) LP without AP . In univariate logistic analysis , the overall risk for IC was found to be higher with AP ( p AP in uncomplicated procedures . The effectiveness of antibiotic prophylaxis in complicated cholecystectomy must be evaluated in r and omized controlled trials",
"A prospect i ve , r and omised and double blind study was undertaken to compare the prophylactic efficacy of ciprofloxacin and cefuroxime in 155 patients undergoing elective cholecystectomy . Patients with past history of jaundice or presence of jaundice , diabetes mellitus , common bile duct stones and previous biliary tract surgery were excluded . Patients were allocated to the following groups : group A-no antibiotic ( n = 30 ) ; group B-ciprofloxacin ( 200 mg i/v before surgical incision and a second dose after 12 hrs ) ( n + 45 ) ; group C-ciprofloxacin given only post operatively ( 200 mg i/v , 12 hourly X 2 days followed by oral 500 mg twice daily X 3 days ) ( n = 35 ) ; group D-cefuroxime ( 750 mg i/v before surgical incision and a second dose after 12 hrs ) ( n = 45 ) . Efficacy of the antibiotic was defined as a patient being free of post operative wound infection . Maximum numbers of infection occurred in group A ( 26.67 % ) and group C ( 25.71 % ) . The incidence of wound infection was significantly lower when ciprofloxacin was used as prophylaxis ( group B ) than when used post operatively ( group C ) only ( P ciprofloxacin ( group B ) and cefuroxime ( group D ) as prophylaxis had significantly reduced incidence of infection ( 4.44 % and 6/67 % respectively ) ; no statistically significant difference was found between these groups . Ciprofloxacin could be used as prophylactic antimicrobial in elective cholecystectomy in developing countries because of its effectiveness , economy and ready availability",
"BACKGROUND Elective cholecystectomy for symptomatic gall stone disease carries low risk of postoperative infective complications . Yet the routine use of prophylactic antibiotic is in vogue in many centres . The aim of this study was to find out the efficacy of antibiotic prophylaxis in preventing postoperative infective complications in low risk elective laparoscopic cholecystectomy patients . METHOD R and omised controlled trial was carried out in our hospital from 1st Nov 2009 to 15th Oct 2011 . A total of 350 patients were included in the study and were divided into Group A ( n = 177 ) . and Group B ( n = 173 ) . Group A was given single dose of injection Celfuroxime 1.5 gm as prophylactic antibiotic at the time of induction of anaesthesia , and Group B was not given any antibiotic . In both groups , age , sex , duration of surgery , American Society of Anesthesiologists classification , duration of surgery and length of hospital stay were recorded . Patients were followed-up weekly for 4 weeks and rates of superficial surgical site infections as well as intra-abdominal infections were recorded . RESULTS There were no significant differences in both groups in terms of age , sex , duration of surgery , length of hospital stay . Eight ( 4.5 % ) cases of superficial surgical site infection were noted in Group A and 7 ( 4.0 % ) in Group B which was insignificant statistically ( p > 0.05 ) . CONCLUSION In low risk patients antibiotic prophylaxis does not seem to affect the incidence of postoperative infective complications in elective laparoscopic cholecystectomy . The use of prophylactic antibiotics should be reserved for high risk patients undergoing laparoscopic cholecystectomy",
"The incidence of surgical infections after laparoscopic cholecystectomy is reported to be laparoscopic cholecystectomy , comparing ceftriaxone vs ceftazidime . From Jan 1 to Dec 31 2002 a consecutive series of 242 cholecystectomies were performed , consisting in 18 open cholecystectomies and 224 laparoscopic cholecystectomies , 7 of which ( 3.1 % ) were converted to open cholecystectomies for technical and /or anatomical reasons . One hundred and eleven patients received 1 g i.v . ceftazidime 1 h before surgery , and 105 patients 1 g i.v . ceftriaxone on an alternate basis . Thirty-nine patients ( 17.4 % ) with acute cholecystitis received at least one booster dose at the end of the operation ; 30 out of 39 were given further therapy for 2 - 3 days , i.e. 1 g i.v . bid . Twenty-two patients treated elsewhere with ceftriaxone or ceftazidime before surgery were transferred to another prophylactic regimen . The final diagnosis in the laparoscopic cholecystectomy group was 219 bile stones , 3 adenomas , and 2 occult carcinomas . We had 4 complications ( 1.8 % of 217 laparoscopic cholecystectomies ) , 2 of which were minor ( infection of the umbilical access by S. aureus ) and 2 major ( 1 biliary fistula [ accessory duct ] and 1 acute pancreatitis ) , both treated conservatively . Positive bile cultures ( 27 cases ) were unrelated to the clinical course . The incidence of infections after laparoscopic cholecystectomy in our prospect i ve series was Ceftriaxone is confirmed as the gold st and ard in biliary tract surgery , but ceftazidime was equivalent ( no statistical difference between the two antibiotics , P=0.59 NS ) . Ultra-short prophylaxis is enough in most cases , except in cholecystitis . We found no correlation between positive bile cultures and surgical infections after laparoscopic cholecystectomy . The umbilicus was the preferred site of infection in obese patients after the laparoscopic procedure . Major complications are usually related to technical pitfalls",
"BACKGROUND Antibiotic prophylaxis is routinely administered in laparoscopic cholecystetomy but its role is debatable . METHODS From January 2004 to August 2008 , 417 patients were r and omized into 208 in antibiotic group ( AG ) and 209 in non antibiotic group ( NAG ) . AG received one dose each of injection ciprofloxacin ( 200 mg ) and metronidazole ( 500 mg ) preoperatively . NAG was given only intravenous fluids . Besides routine care , all underwent abdominal sonography and liver function tests at least once during the 30 postoperative days . RESULT Age , sex and co-morbidity distribution were similar in both the groups . One patient who was on weekly 5 mg methotraxate ( NAG ) had erythema around umbilical port . Other three having umbilical discharge recovered without antibiotics . Nine patients had subhepatic collection ( 5 AG and 4 NAG ) . One from NAG underwent re-laparoscopy and drainage . Ten patients had fever . Two from AG had basal lung collapse and were given antibiotics . CONCLUSION Antibiotic prophylaxis is not needed for laparoscopic cholecystectomy",
"BACKGROUND Laparoscopic cholecystectomy ( LC ) is the gold st and ard for the treatment of symptomatic gallbladder stones . As infections are rare in uncomplicated LC , it is widely accepted that prophylactic antibiotics need not be administered , and guidelines do not support routine antibiotic prophylaxis during elective LC . However , routine antibiotic prophylaxis for elective LC is still popular in many clinical setting s. We investigated this situation in our department . METHOD This r and omized double-blind controlled study included 570 patients who underwent LC between March 2007 and February 2010 . The exclusion criteria were antibiotic intake before surgery , steroid treatment , and the presence of pancreatitis , cholangitis , obstructive jaundice , cephalosporin allergy , or pregnancy . The patients were r and omized into three groups . Group 1 ( n = 193 ) received physiologic saline as placebo , Group 2 ( n = 191 ) received a first-generation cephalosporin ( cefazolin ; 1 g ) , and Group 3 ( n = 186 ) received a second-generation cephalosporin ( cefuroksim aksetil ; 750 mg ) . Bile and epigastric and umbilical port tissue sample s were harvested for culture . All patients were observed until the end of the fourth week after surgery . Patient age , sex , weight , American Society of Anesthesiologists ( ASA ) score , diabetes mellitus , smoking history , history of biliary colic in the past month , length of the hospital stay before the operation , operational findings ( acute or chronic cholecystitis ) , operation duration , use of drainage , type of prophylaxis administered if any , culture results , surgical site infection ( SSI ) development , and time to SSI development along with associated treatments were evaluated . RESULTS There was no statistically significant difference between the groups with respect to any of the demographic and clinical features analyzed in this study . The SSI rate was 1.2 % in total , and in Groups 1 , 2 , and 3 , it was 1.5 % , 1.04 % , and 1.07 % , respectively . There was no statistical difference regarding SSI among the groups ( p = 1.00 ) . Superficial SSI was observed in all groups , and in all patients , the site of infection was the entrance to the epigastric port through which the gallbladder had been removed . CONCLUSIONS Surgical site infection is rare after LC , and antibiotic prophylaxis does not appear to affect the outcome significantly . Moreover , factors such as positive bile cultures , history of biliary attack , ASA score , diabetes , obesity , and smoking do not have any effect on SSI development . Thus , we conclude that antibiotic prophylaxis is not needed for elective LC",
"HYPOTHESIS Prophylactic antibiotic treatment in elective laparoscopic cholecystectomy does not lower the already low infection rate associated with this procedure . DESIGN AND SETTING Prospect i ve double-blind r and omized trial at a community-based training hospital . PATIENTS Four hundred fifty patients undergoing elective laparoscopic cholecystectomy were r and omized into 1 of 3 treatment arms : ( 1 ) preoperative cefotetan disodium , 1 g intravenously ; ( 2 ) preoperative cefazolin , 1 g intravenously ; and ( 3 ) intravenous placebo . There were no demographic differences between groups in age , smoking history , American Society of Anesthesiologists score , infection risk class , time of antibiotic administration prior to surgery , and type of skin preparation . INTERVENTIONS Laparoscopic cholecystectomy was attempted in all cases ; however , 10 patients required conversion to an open cholecystectomy and they were included in the statistical analysis . Preoperatively , all patients were r and omized in a blinded manner and received cefotetan , cefazolin , or placebo intravenously . RESULTS There were 10 postoperative infections . In the cefotetan group , there were 3 cases of superficial surgical site infections . In the cefazolin group , there were 2 superficial surgical site infections-1 pneumonia and 1 rhinosinusitis . In the placebo group , there were 2 superficial surgical site infections and 1 urinary tract infection . The overall infection rate in this series was 2.4 % . Follow-up was performed at routine postoperative visits and by telephone contact . Data were evaluated using the chi2 test and analysis of variance with Duncan post hoc test ( P antibiotics does not decrease the rate of wound infections in elective laparoscopic cholecystectomy",
"OBJECTIVE To establish the incidence of infection after laparoscopic cholecystectomy , and assess the need for antibiotic prophylaxis . DESIGN Prospect i ve open study . SETTING University teaching hospital , United Kingdom . SUBJECTS 253 consecutive patients undergoing laparoscopic cholecystectomy between September 1990 and January 1993 . INTERVENTIONS A single intravenous dose of cefuroxime 1.5 g at induction of general anaesthesia . MAIN OUTCOME MEASURES Infective complications . RESULTS Patients were review ed at two weeks and 12 months . At two weeks there had been two wound infections ( one resolved spontaneously and the other required removal of a gallstone from the subcutaneous tissue ) , two chest infections ( treated with antibiotics orally and physiotherapy ) , and one subhepatic abscess ( drained percutaneously under ultrasonographic control ) . No other complications were reported at 12 months . CONCLUSIONS Routine antibiotic prophylaxis may be unnecessary during elective laparoscopic cholecystectomy , but a r and omised controlled trial is necessary to confirm this",
"BACKGROUND Laparoscopic cholecystectomy uses smaller incision and trocars that lessen the contamination and exposure of wound , result ing in less infection . However , the antibiotic prophylaxis is still widely practice d , like in our institute , a continuation of the era of open surgery . Recent studies reveal no advantage of routine use of antibiotic , and there is growing consensus against it . Besides cost , antibiotic increases emergence of multidrug resistance . Because of the controversies , we conducted this clinical trial . METHODS This r and omized clinical trial , conducted from October 1 , 2009 to September 31 , 2010 at Patan Hospital , included 154 patients in prophylactic antibiotic group ( GrAP ) with cefazolin 1 g IV as per existing practice and 156 in no antibiotic group ( GrAPn ) . Symptomatic laparoscopic cholecystectomy patients of American Society of Anesthesiologist ( ASA ) 1 and 2 ( without diabetes ) were included . Patients with complicated gall stones ( cholangitis , choledocholithiasis , and pancreatitis ) and who required conversion were excluded . Wound was observed during follow-up within 1 week . Data on patient characteristics , use of antibiotic , bile spillage , and postoperative wound infection were entered in pre design ed proforma . Microsoft Excel was used to analyze the data . RESULTS In total , 310 patients were eligible for analysis , 154 in GrAP and 156 in GrAPn . Both groups were comparable in patient demographic and clinical characteristics such as average age ( 40.3 vs. 41.6 years ) and sex ( female 77.6 % vs. 78.6 % ) . Overall wound infection occurred in 4.8 % ( 15/310 ) . There was no significant difference in wound infections among the two groups ( p = 0.442 ) : GrAP 3.9 % and GrAPn 5.8 % . There was no mortality in this series . CONCLUSION Routine preoperative antibiotic prophylaxis is not necessary in low-risk symptomatic gallstone patients undergoing laparoscopic cholecystectomy",
"This prospect i ve study was conducted to investigate the efficacy of single-dose Ceftazidime as a prophylactic antibiotic to prevent surgical site infections in low-risk patients undergoing LC . Two hundred patients included in the study were r and omly divided into two groups ( 100 each ) : G1 : patients received intravenous Ceftazidime within 60 minutes prior to surgery and G2 : received intravenous placebo ( 10 ml isotonic sodium chloride 0.9 % solution ) . All patients were invited for examination 10 , 20 and 30 days post-operatively and any post-operative complications were recorded and managed . Preoperatively ; there was no significant differences existed between the 2 groups regarding sex , age ; body mass index and ASA score . Also , the duration of LC surgery , incidence of intra-operative gallbladder perforations and spill of bile or stones , incidents of intra-operative bleeding from either cystic artery or gall bladder liver bed and mean postoperative hospital stay were found not significantly different between the 2 groups . Post operatively there was no statistical difference regarding the surgical site infection between the two groups",
"BACKGROUND To assess the result of antibiotic prophylaxis in low-risk patients undergoing elective laparoscopic cholecystectomy with respect to the postoperative septic complications . METHOD One hundred and two low-risk patients were r and omized into 1 of 2 treatment arms ( 1 ) cefazolin 1 g intravenously after induction of anesthesia ( PA group ) and ( 2 ) no prophylactic antibiotics ( NONE group ) . Laparoscopic cholecystectomy was attempted in all cases . The patients were followed-up for postoperative septic complications for at least 30 days at the out-patient clinic or by telephone contact . In both groups , sex , age , weight , American Society of Anesthesiologists patient classification score , operative time , surgical techniques , number of port sites , intraoperative cholangiograms , intraoperative gallbladder rupture , postoperative hospital stay , and postoperative septic complications were compared . The statistical analysis of data performed by computer program SPSS 10.0 for Windows was based on the Independent- Sample s T Test or the Pearson Chi-Square ( 2-sided ) . RESULTS There was only one minor problem of superficial wound infection in the NONE group . Comparison of data showed no statistically significant difference between the groups . CONCLUSION Antibiotic Prophylaxis may not be necessary in low-risk patients undergoing elective laparoscopic cholecystectomy",
"Purpose The average rate of surgical site infections ( SSIs ) for laparoscopic cholecystectomy ( LC ) has been reported in the literature to be between 0.4 % and 6.3 % . Also , these recent review s have concluded that a prophylactic antibiotics for elective LCs in low-risk patients is not useful , but there were no results in high-risk patients . Methods The aim of this study was to investigate the role of a single dose of first-generation cephalosporin as a prophylactic antibiotic for patients undergoing elective LC , regardless of patient risk . This r and omized clinical trial was conducted from October 2013 to December 2014 by single surgeon at our hospital . Patients were r and omized into two groups by following method . Odd-numbered patients ( group A ) received 1-g cefazolin intravenously within 30 minutes before incision , whereas even-numbered patients ( group B ) received normal saline intravenously instead of prophylactic antibiotics , with the aim of including 100 patients in each group . SSIs were recorded and compared between the groups . Results There were no differences in preoperative demographics and postoperative findings between the groups . There were no superficial and deep SSIs in either group , 9 cases of superficial seromas developed ( 4.5 % ) in the cohort : 4 in group A ( 4 % ) and 5 in group B ( 5 % ) . There were no significant associations between SSIs and the use of prophylactic antibiotics in either group . Additionally , the high-risk group did not show a significantly increased rate of SSIs . Conclusion Based on our study , prophylactic antibiotics are not necessary in elective LC , regardless of patient risk",
"Septic complications are rare following laparoscopic cholecystectomy if prophylactic antibiotics are given , as demonstrated in previous studies . Antibiotic treatment may be unnecessary and , therefore , undesirable , so we compared two forms of prophylaxis : a cephalosporin antibiotic and bag extraction of the dissected gallbladder . A total of 76 patients undergoing laparoscopic cholecystectomy were r and omised to either receive an antibiotic or to have their gallbladder removed from the abdomen in a plastic bag . Complicated cases were excluded . There was a total of 6 wound infections ( 7.9 % ) , 3 in each of the study groups . All these were associated with skin commensals . There were no other septic complications . Bacteriological studies grouped the organisms isolated from the bile and the wound as potential pathogens and likely commensals . A total of 10 potential pathogens were isolated , 9 of which were found in the group receiving antibiotics . We conclude that septic sequelae of uncomplicated laparoscopic cholecystectomy are uncommon , but clearly not entirely prevented by antibiotic or mechanical prophylaxis . Prophylactic antibiotics may not be required in uncomplicated laparoscopic cholecystectomy . Further study is warranted",
"BACKGROUND The aim of this clinical trial was to determine whether prophylactic antibiotics could prevent surgical site infection ( SSI ) after laparoscopic cholecystectomy and to identify any risk factors for infection . METHODS The study included 100 patients undergoing laparoscopic cholecystectomy . They were r and omized to receive either a single dose of ceftriaxone ( Group A ; n = 50 ) or physiologic saline as placebo ( Group B ; n = 50 ) after the induction of anesthesia . Patient demographics and clinical and surgical outcomes were recorded . RESULTS The incidence of SSI was similar in the two groups : 2 patients in group A and 4 patients in group B ( chi(2 ) = 0.71 ; p = 0.40 ) . None of the factors studied was associated with surgical site infection statistically , as shown by binary logistic regression analysis . CONCLUSION A single dose of prophylactic antibiotic failed to decrease the likelihood of SSI after laparoscopic cholecystectomy",
"At present the use of prophylactic antibiotics in elective laparoscopic cholecystectomy is controversial . This prospect i ve study was carried out to define the role of prophylactic antibiotics in elective laparoscopic cholecystectomy to prevent postoperative infection . Ninety three patients were r and omly placed in two groups . Group A comprised of 40 while group B consisted of 53 patients . Patients in Group A received 1.5 grams of second generation cephalosporin ( cefuroxime sodium ) diluted in 100ml of normal saline , at the time of induction of anesthesia . Group B patients received an equal volume of normal saline only . A sample of gall bladder bile was collected by direct gall bladder puncture intra-operatively for aerobic and anaerobic culture . Age , sex , weight of the patient , American Society of Anesthesiologists classification grade , presence of diabetes mellitus , episodes of colic 30 days preceding surgery , intra-operative gall bladder rupture , stone and / or bile spillage , results of bile culture , gall bladder histology , length of hospital stay , and number of septic complications were recorded and analyzed . In group A , one patient ( 2.5 % ) had post operative wound infection and in group B , two patients ( 3.8 % ) had post operative infection which was statistically similar ( p>0.1 ) . There was no difference between the two groups in terms of demographic , intra operative and post operative denominators . Therefore the study concluded that prophylactic antibiotics did not have a significant role to play in prevention of postoperative wound infection in elective laparoscopic cholecystectomy",
"A retrospective chart review was done to determine the infection rate and the use of prophylactic antibiotics in consecutive laparoscopic cholecystectomies done in a single community . Incisional infections were discovered in 11 of 566 cases , 10 of whom had received prophylactic antibiotics . The infected patients were significantly older , had longer procedures , and had more comorbidity than the uninfected patients . They were also more likely to have a palpable mass preoperatively and past biliary surgery . A second , prospect i ve study was done to evaluate the efficacy of the use of antibiotic prophylaxis in low-risk patients . Fifty-three patients were r and omized into two double-blinded groups . No incisional infections occurred in either group within 30 days postoperatively . This suggests prophylactic antibiotics are not needed to prevent infections for low-risk patients undergoing laparoscopic cholecystectomy",
"BACKGROUND Postoperative infection following cholecystectomy poses a significant threat to recovery , with major cost repercussions . Though antimicrobial prophylaxis is commonly practice d , its value - particularly in laparoscopic cholecystectomy - has not yet been adequately documented . METHOD In a prospect i ve multicenter quality assurance study in 28 German hospitals , an analysis of data collected on 4,477 patients undergoing conventional ( n = 1,349 ) or laparoscopic ( n = 3,128 ) cholecystectomy was performed ; 2,217 patients received and 2,260 did not obtain perioperative antibiotic cover . RESULTS Postoperative infections occurred in a total of 136 patients , with infection rates of 5.0 % in those without prophylaxis , 0.8 % in those on ceftriaxone , and 1.2 % in those on other antibiotic regimens . Patients receiving prophylaxis fared significantly better than those with no prophylaxis in terms of the rate of postoperative wound infections , chest infections , other complications , reoperation and mortality . CONCLUSION Neither laparoscopic nor conventional open cholecystectomy should be performed without adequate perioperative antimicrobial prophylaxis in future , especially since such measures also reduce hospital stay and hence the costs"
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We aim ed to conduct a systematic review of the evidence for structured , home-based exercise programmes ( HEPs ) in patients with intermittent claudication . The Medline , PsycINFO , EMBASE , and Cochrane data bases were search ed up to April 2013 for terms related to walking , self-management , and intermittent claudication . Descriptive , method ological and outcome data were extracted from eligible articles . Trial quality was assessed using the GRADE system . Seventeen studies were included with 1,457 participants . Six studies compared HEPs with supervised exercise training , five compared HEPs with usual care/observation control , and seven evaluated HEPs in a single-group design . Trial heterogeneity prevented meta- analysis . Nevertheless , there was " low-level " evidence that HEPs can improve walking capacity and quality of life in patients with intermittent claudication when compared with baseline or in comparison to usual care/observation control . In addition , improvements with HEPs may be inferior to those evoked by supervised exercise training . Considerable uncertainty exists regarding the long-term clinical and cost effectiveness of HEPs in patients with intermittent claudication . Thus , more robust trials are needed to build evidence about these interventions . Nevertheless , clinicians should consider using structured interventions to promote self-managed walking in patients with intermittent claudication , as opposed to simple " go home and walk " advice , when supervised exercise training is unavailable or impractical
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"Supervised , hospital-based exercise rehabilitation programs are effective for improving functional status for patients with claudication due to peripheral arterial occlusive disease . However , it has been suggested that unsupervised , home-based exercise programs , which have been relatively little evaluated , would be equally efficacious as compared with hospital-based programs . The authors tested the hypothesis that a hospital-based exercise rehabilitation program would improve treadmill exercise perfor mance more than a home-based program . Of 20 consecutively enrolled patients with claudication , 10 were r and omly placed into a supervised , hospital-based program and 10 into an unsupervised , home-based program for a three-month period . Exercise perfor mance was evaluated by treadmill testing using a grade d protocol . In addition , func tional status was evaluated by the Walking Impairment Question naire ( WIQ ) and the Medical Outcomes Study SF-20 question naire ( MOS ) . Patients in the hospital-based program were treated with treadmill walking three times a week for one hour/visit . Patients in the home-based program were instructed to walk at least three times a week and were contacted weekly to provide encouragement and to record compliance with ( continued on next page ) the program . Patients in the hospital-based group improved peak walking time by 137 % , pain-free walking time by 150 % , and peak oxygen consumption by 19 % ( all P walking distance and speed according to WIQ data ( both P MOS physical functioning score in the hospital-based group improved by 20 percentage points ( P exercise performance measured on the treadmill . Improvement in the ability to walk on the treadmill was greater in the hospital-based than the home- based program ( P ability to walk distances was the only question naire measure that improved in persons who received the home-based program ( P improving treadmill exercise performance than an unsupervised , home-based program",
"BACKGROUND Patients with intermittent claudication ( IC ) could benefit from low-cost , effective rehabilitative programs . This retrospective study evaluates compliance , impact on Quality of Life ( QoL ) and cost-effectiveness of a hospital prescribed , at-home performed ( Test-in/Train-out ) rehabilitative program for patients with IC . METHODS AND RESULTS Two-hundred and eighty-nine patients with IC ( 71 ± 10.1 years , M = 210 ) were enrolled for a 2-year period . Two daily 10-min home walking sessions at maximal asymptomatic speed were prescribed , with serial check-ups at the hospital . Compliance with the program was assessed by assigning a score of 1 ( lowest compliance ) to 4 ( highest compliance ) . The SF-36 question naire and a constant-load treadmill test were used to evaluate QoL and Initial/Absolute Claudication Distance , respectively . Both direct and indirect costs of the program were considered for cost-effectiveness analysis . Two-hundred and fifty patients ( 70.5 ± 9.2 years , M = 191 ) , at Fontaine 's II-B stage ( 86 % ) , were included in the study . No adverse events were reported . The average compliance score was 3.1 . At discharge , both SF-36 domains and walking performance significantly increased ( P performed . Direct and indirect costs represented 93 % and 7 % of the total costs , respectively . The average costs of a visit and of a therapy cycle were C68.93 and C507.20 , respectively . The cost to walk an additional meter before stopping was C9.22 . CONCLUSIONS A Test-in/Train-out program provided favourable patient compliance , QoL impact and cost-effectiveness in patients with IC ",
"Background — This prospect i ve , r and omized , controlled clinical trial compared changes in exercise performance and daily ambulatory activity in peripheral artery disease patients with intermittent claudication after a home-based exercise program , a supervised exercise program , and usual-care control . Methods and Results — Of the 119 patients r and omized , 29 completed home-based exercise , 33 completed supervised exercise , and 30 completed usual-care control . Both exercise programs consisted of intermittent walking to nearly maximal claudication pain for 12 weeks . Patients wore a step activity monitor during each exercise session . Primary outcome measures included claudication onset time and peak walking time obtained from a treadmill exercise test ; secondary outcome measures included daily ambulatory cadences measured during a 7-day monitoring period . Adherence to home-based and supervised exercise was similar ( P=0.712 ) and exceeded 80 % . Both exercise programs increased claudication onset time ( P peak walking time ( P home-based exercise increased daily average cadence ( P0.05 ) . The changes in claudication onset time and peak walking time were similar between the 2 exercise groups ( P>0.05 ) , whereas the change in daily average cadence was greater with home-based exercise ( P home-based exercise program , quantified with a step activity monitor , has high adherence and is efficacious in improving claudication measures similar to a st and ard supervised exercise program . Furthermore , home-based exercise appears more efficacious in increasing daily ambulatory activity in the community setting than supervised exercise . Clinical Trial Registration — URL : http://www . Clinical Trials . Gov . Unique identifier : NCT00618670",
"OBJECTIVE Determine the efficacy of a home-based walking intervention to improve walking ability and quality of life in people with diabetes and peripheral arterial disease ( PAD ) . RESEARCH DESIGN AND METHODS We conducted a r and omized , controlled , single-blind trial within university-affiliated clinics in our local community . We r and omized 145 participants ( 45 women ) with diabetes and PAD to our intervention — a 6-month behavioral intervention targeting levels of readiness to engage in routine walking for exercise — versus attention control . Our primary outcome was 6-month change in maximal treadmill walking distance . Secondary outcomes included 3-month change in maximal walking distance , lower limb function ( i.e. , walking impairment scores ) , quality of life ( Medical Outcomes Short Form Survey ) , exercise behaviors , depressive symptoms , and self-efficacy at 3 and 6 months . RESULTS The mean age of participants was 66.5 ( SD 10.1 ) years . Intervention and control groups did not differ significantly in 6-month change in maximal treadmill walking distance ( average [ SE ] 24.5 [ 19.6 ] meters vs. 39.2 [ 19.6 ] meters ; P = 0.60 ) . Among secondary outcomes , for the intervention and control groups , respectively , average walking speed scores increased by 5.7 [ 2.2 ] units and decreased by 1.9 [ 2.8 ] units ( P = 0.03 ) ; the mental health quality of life subscale score increased by 3.2 [ 1.5 ] and decreased by 2.4 [ 1.5 ] units ( P = 0.01 ) . CONCLUSIONS A home-based walking intervention did not improve walking distance but did improve walking speed and quality of life in people with diabetes and PAD . Clinicians should consider recommending home-based walking therapy for such patients",
"Intermittent claudication ( IC ) is a mild stage of peripheral arterial disease that affects between 3 % and 7 % of the population and up to 1 in 5 patients over the age of 75 years . Risk factors such as hypertension , hyperlipidemia , diabetes , smoking , and genetics increase the incidence of peripheral arterial disease . Patients with IC have limitations in functional capacity and can benefit from regular exercise . Walking is the preferred mode of exercise and improves the symptoms of claudication in several ways . Vascular nurses can play an important role during exercise therapy . A personalized , home-based exercise program can be developed , and nurses can assist and motivate patients during follow-up periods . Helping patients to quit smoking and control other risk-factor modifications ( ie , high blood pressure and lipid levels ) also has high priority in daily practice of the vascular nurse . This prospect i ve study will illustrate the results of prescribed home-based exercise training by a vascular nurse on the maximum painless walking distance for patients with IC and will be applied to subgroups of vascular pathology",
"People with lower extremity peripheral artery disease ( PAD ) have greater functional impairment and faster functional decline than those without PAD . We describe methods for the Group Oriented Arterial Leg Study ( GOALS ) , an ongoing r and omized controlled clinical trial design ed to determine whether a Group-Mediated Cognitive Behavioral ( GMCB ) intervention improves functional performance in PAD participants , compared to a health education control condition . In GOALS , PAD participants were r and omized to either an intervention or a health education control condition in a parallel design . Both conditions consist of weekly group sessions with other PAD participants . In the intervention , cognitive behavioral techniques are used to assist participants in setting and adhering to home-based walking exercise goals . Participants are encouraged to walk for exercise at home at least 5 days/week . In the control condition , participants receive lectures on health-related topics . After 6 months of on-site weekly sessions , participants are transitioned to telephone follow-up for another 6 months . Participants in the intervention are asked to continue home walking exercise . The primary outcome is change in six-minute walk performance between baseline and six-month follow-up . Secondary outcomes include change in six-minute walk performance at 12-month follow-up , and change in treadmill walking performance , the Walking Impairment Question naire , quality of life , and physical activity at six and 12-month follow-up . In conclusion , if our group-mediated cognitive behavioral intervention is associated with improved walking performance in individuals with PAD , results will have major public health implication s for the large and growing number of people with PAD",
"PURPOSE In a pilot study , the hypothesis was tested that a home-based walking exercise program with structured coaching would improve walking performance and adherence in patients with intermittent claudication ( IC ) . METHODS Thirty-one IC patients with a rest ankle-brachial pressure index started a 24-wk walking program in the home environment . They were coached according to the Health Counseling Model ( HCM ) . Patients were instructed to walk at least 9 bouts.wk-1 and to walk through the pain . The main effect measures were pain-free ( initial claudication distance ( ICD ) ) and maximum walking distance ( absolute claudication distance ( ACD ) ) measured with a grade d treadmill test , a corridor exercise test , a walking-diary , and the score on the Walking Impairment Question naire ( WIQ ) . RESULTS Twenty-four participants completed the program . The reported walking frequency was 7.4 times.wk-1 . The average ICD improved from 289 m ( 95 % CI , 209 - 369 ) to 347 m ( 95 % CI , 244 - 449 ) ( P average ACD improved from 490 m ( 95 % CI , 397 - 583 ) to 544 m ( 95 % CI , 438 - 650 ) and from 564 m ( 95 % CI , 412 - 717 ) to 726 m ( 95 % CI , 546 - 906 ) ( P average maximum distance reported in the walking-diary improved from 957 m ( 95 % CI , 291 - 1623 ) to 1294 m ( 95 % CI , 646 - 1941 ) . The score of the walking distance on the WIQ improved from 57 % ( 95 % CI , 42 - 71 % ) to 60 % ( 95 % CI , 46 - 74 % ) . CONCLUSION IC patients improved their average ICD and ACD . The walking exercise program in the home environment with coaching according to the HCM seems a promising intervention to be tested in a r and omized controlled trial",
"OBJECTIVES To evaluate an unsupervised home-based exercise programme for physiological , functional , and quality of life impact in patients with symptomatic peripheral arterial disease . DESIGN Prospect i ve cohort with exercise intervention . MATERIAL S Human performance laboratory with non-invasive haemodynamic assessment facilities . METHODS Forty-seven patients with symptomatic peripheral arterial disease ( mean age 67.6+/-7 years , 33 males ) participated in an unsupervised home-based exercise programme . Heart rate ( HR ) , ankle brachial blood pressure index ( ABPI ) , leg blood flow ( BF ) , and blood lactate were measured before and after a grade d treadmill walk at baseline and after the 12-week exercise programme . Maximum walking distance ( MWD ) during the treadmill walk was measured at baseline and 12 weeks . Exercise compliance , functional parameters , and quality of life ( VascuQoL ) were assessed by question naire . RESULTS MWD , leg BF , and VascuQoL scores increased significantly , while resting HR , exercise HR , and end of walk rate-pressure-product ( RPP ) decreased significantly after 12 weeks . Exercise compliance was significantly correlated with increase in MWD ( r=0.89 , p QOL score improvement ( r=0.61 , p exercise programme generated improvements in walking distance and leg blood flow without detectable increases in cardiorespiratory work . Exercise compliance is related to MWD and VascuQoL score in a dose-response manner",
"PURPOSE This study was performed to test the effectiveness of a formal supervised exercise program against a home-based exercise program for both walking ability and quality of life endpoints . METHODS Patients with arterial claudication were r and omized to either a 12-week supervised exercise program ( SUPEX ) with weekly lectures relating to peripheral vascular disease or to a home exercise group ( HOMEX ) who attended an identical lecture program and received weekly exercise instruction . The study population included 29 men and 26 women , with a mean age of 69.1 + /- 8.1 years . Forty-seven patients completed the 12-week program , 46 were available for testing at completion , and 38 for 6-month testing . Claudication pain time ( CPT ) and maximum walking time ( MWT ) on a progressive treadmill exercise test were assessed at baseline , program completion , and 6 months . The Medical Outcomes Study Short Form-36 ( SF-36 ) was administered at these intervals to assess effects on quality of life . RESULTS Each group improved ( p CPT and MWT at the completion of the 12-week program , which was sustained at the 6-month follow-up . Increase in HOMEX CPT from baseline ( 3.6 + /- 2.73 minutes ) to 6-month follow-up ( 6.6 + /- 3.17 minutes ) was less than for the SUPEX group ( 3.8 + /- 2.74 to 11.2 + /- 4.02 minutes , respectively ) ; similar results were obtained for MWT . At both completion and 6 months , there was a significant intergroup difference for CPT and MWT ( p health perception based on the SF-36 demonstrated improvement ( p Physical Function Subscale , Bodily Pain Subscale , and Physical Composite Score . There were no between-group differences on the subsets of the SF-36 at the three assessment intervals . CONCLUSIONS Supervised exercise programs provide superior increased walking ability in the noninterventional therapy of arterial claudication , and both supervised and home based exercise therapy result in improved SF-36 functional measures . The lack of intergroup differences in these measures may be a result of the high degree of interaction with healthcare providers in the HOMEX group . Although a supervised program results in optimal walking benefits , a highly structured home-based program provides similar functional improvement and may be a satisfactory alternative for patients with lesser walking requirements",
"In a non-r and omized , open-label study results after a structured institution-based peripheral arterial occlusive disease ( PAD ) rehabilitation program were compared with the results of training at home . Three groups were compared : group 1 ( n = 19 ) PAD rehabilitation ; group 2 ( n = 19 ) PAD rehabilitation + clopidogrel 75 mg once daily ; group 3 ( n = 21 ) home-based training . The training period was 3 months for all groups , which was followed by a 3-month observation phase ( without prescribed training ) . The rehabilitation program consisted of 3 training hours per week . Background variables , demographics , and baseline claudication distances were comparable between groups . After 3 months of training the absolute claudication distances ( ACD ) improved by 82.7 % , 131.4 % , and 5.4 % for groups 1 , 2 and 3 . The initial claudication distances ( ICD ) changed by 163.8 % , 200.6 % , and 44.4 % , respectively . All changes , except the ACD result for group 3 , were statistically significant ( p 0.05 ) . Structured training groups ( 1 and 2 ) performed significantly better than group 3 ( p 0.05 ) . When results from groups 1 and 2 were pooled , ACDs changed from 493.3 218.1 to 1026.0 468.9 m , 546.0 378.8 m [ 95 % CI 417.8 - 674.2 m ] ; p 0.05 . ICDs improved from 175.3 110.8 m to 493.1 326.7 m , 320.8 315.9 m [ 95 % CI 213.9 - 427.7 m ] ; p 0.05 . The difference between the pooled mean results of the structured training groups and the results of group 3 amounted to 474.3 m [ 95 % CI 270.2 - 678.4 m ] and 242.4 m [ 95 % CI 99.0 - 385.7 m ] , for ACD and ICD , respectively . Structured , supervised PAD rehabilitation is a highly efficacious treatment for intermittent claudication and may be regarded as the present gold st and ard among conservative treatment options",
"PURPOSE This study was performed to test the efficacy of a supervised , hospital-based exercise program compared with a home-based exercise program involving minimal supervision , for both walking ability and quality of life measures in patients with exercise-limiting intermittent leg claudication . METHODS Twenty-one patients were assigned r and omly to 12 weeks of supervised exercise or to a home-based exercise group . After 12 weeks the participants in the supervised group transitioned to a home-based program . Both groups were then reevaluated at the end of 24 weeks . The initial claudication distance ( ICD ) and absolute claudication distance ( ACD ) on progressive treadmill exercise was measured at baseline , 12 weeks , and 24 weeks . Additionally , self-reported quality of life status was evaluated using the MOS SF-36 question naire . RESULTS Each group improved ( P ACD from baseline to 12 weeks , which was sustained at the 24-week follow-up . Both groups experienced similar long-term improvements ( P ACD ( 521.5 + /- 253.4 meters to 741.9 + /- 365.6 meters for the supervised group , 532.2 + /- 263.5 meters to 715.0 + /- 394.4 meters in the home group , P not significant , between groups ) . The supervised group experienced a greater improvement ( P ICD after 12 weeks than the home group but not at 24 weeks . The on-site group also experienced significant improvements in ICD after 24 weeks ( P self-reported physical function or mental health as assessed by the MOS SF-36 . CONCLUSION A structured exercise program was more effective in improving the ICD over a 24-week period than a less formal , home-based program . However , if patients are screened properly and receive adequate instruction , a home-based program can be a safe , low-cost alternative providing similar long-term ( 24 weeks ) exercise benefits in ACD",
"This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . \" Quality \" as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence",
"Arm cranking is a useful alternative exercise modality for improving walking performance in patients with intermittent claudication ; however , the mechanisms of such an improvement are poorly understood . The main aim of the present study was to investigate the effects of arm-crank exercise training on lower-limb O2 delivery in patients with intermittent claudication . A total of 57 patients with intermittent claudication ( age , 70+/-8 years ; mean+/-S.D. ) were r and omized to an arm-crank exercise group or a non-exercise control group . The exercise group trained twice weekly for 12 weeks . At baseline and 12 weeks , patients completed incremental tests to maximum exercise tolerance on both an arm-crank ergometer and a treadmill . Respiratory variables were measured breath-by-breath to determine peak VO2 ( O2 uptake ) and ventilatory threshold . Near-IR spectroscopy was used in the treadmill test to determine changes in calf muscle StO2 ( tissue O2 saturation ) . Patients also completed a square-wave treadmill-walking protocol to determine VO2 kinetics . A total of 51 patients completed the study . In the exercise group , higher maximum walking distances ( from 496+/-250 to 661+/-324 m ) and peak VO2 values ( from 17.2+/-2.7 to 18.2+/-3.4 ml.kg-1 of body mass.min-1 ) were recorded in the incremental treadmill test ( P time to minimum StO2 ( from 268+/-305 s to 410+/-366 s ) , a speeding of VO2 kinetics ( from 44.7+/-10.4 to 41.3+/-14.4 s ) and an increase in submaximal StO2 during treadmill walking ( P walking performance after arm-crank exercise training in patients with intermittent claudication is attributable , at least in part , to improved lower-limb O2 delivery",
"BACKGROUND Exercise training reduces walking disability in peripheral arterial disease ( PAD ) . This non-r and omized study evaluates the effects on walking ability and hemodynamic parameters of a novel approach to home-based rehabilitation , the test in -train out program ( Ti-To ) , compared with the traditional home-based free walking exercise ( Tr-E ) . METHODS AND RESULTS A total of 143 patients with claudication ( 117 men , average age 68+/-10 years ) , were included in a Ti-To ( n=83 ) or Tr-E program ( n=60 ) . Evaluations , which were carried out upon entry and at 1 , 2 , 3 , 4 and 6 months , included : self-reported claudication , walking ability ( ie , absolute claudication distance , pain threshold speed ) , resting/exercise heart rates ( HR ) , systolic/diastolic brachial pressure ( SBP/DBP ) , ankle pressure ( AP ) , ankle-brachial index ( ABI ) . Ti-To involved 2 daily 10-min home walking sessions at maximal asymptomatic speed and the patient attending monthly check-ups at hospital . Tr-E involved 20 - 30 min of daily walking at self-selected speeds up to pain tolerance . A total of 126 patients ( Ti-To , n=74 ; Tr-E , n=52 ) completed the program . Ti-To induced better relief from claudication ( p=0.001 ) . Functional parameters improved significantly for both groups ( p SBP and exercise HR decreased significantly in both groups , with Ti-To improving resting HR ( p=0.0002 ) , DBP ( p=0.003 ) , lowest AP worse limb ( p=0.004 ) and ABI worse limb ( p=0.0002 ) . CONCLUSIONS In patients with PAD , a Ti-To program had more positive effects on perceived claudication , and functional and hemodynamic parameters than did a Tr-E program"
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INTRODUCTION Vortioxetine is a structurally novel medication that has recently been approved for treatment of major depressive disorder ( MDD ) . This medication is a serotonin reuptake inhibitor that also has a number of other potentially relevant effects on serotoninergic receptors , which may differentiate the drug 's effects from those of current first-line antidepressants , such as selective serotonin reuptake inhibitors ( SSRIs ) and serotonin norepinephrine reuptake inhibitors ( SNRIs ) . AREAS COVERED This article will review the basic clinical pharmacology of vortioxetine , summarize the major clinical trials that were performed prior to approval by the US Food and Drug Administration ( FDA ) , discuss relevant post-marketing studies of this drug , and offer expert commentary on the significance of this new agent in clinical practice . Pre-approval studies were identified as all r and omized , placebo-controlled studies of vortioxetine listed on clinical trials.gov . Other referenced studies were identified via a MEDLINE data base literature search in August 2015 using the key search terms , vortioxetine and Lu AA21004 , combined with additional terms that included pharmacological profile , pharmacokinetics , drug interactions , adverse effects , side effects , safety , major depression , and major depressive disorder . We identified relevant systematic review s , meta-analyses , r and omized trials and pre clinical studies of importance . EXPERT OPINION Results of placebo-controlled trials suggest efficacy and an overall safety profile comparable to existing first-line antidepressants . The most common side effects are nausea , vomiting and constipation . Results of several studies indicate that vortioxetine may have therapeutic effects on cognition ( e.g. , memory and executive functioning ) that exceed that of st and ard antidepressants . Disadvantages include cost and the current paucity of long-term efficacy data from large clinical trials . The authors suggest that vortioxetine is currently a good second-line antidepressant option and shows promise , pending additional long-term data , to become a first-line antidepressant option
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"OBJECTIVE To evaluate the efficacy , and further establish the safety profile , of oral once-daily vilazodone , a potent and selective serotonin 1A receptor partial agonist and reuptake inhibitor , in the treatment of major depressive disorder ( MDD ) . METHOD This phase 3 , r and omized , double-blind , placebo-controlled , 8-week study ( conducted March 2008-February 2009 ) enrolled 481 adults with DSM-IV-TR-defined MDD . Patients received vilazodone ( titrated to 40 mg/d ) or placebo . The primary efficacy endpoint was change in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score from baseline to end of treatment . Secondary efficacy measures included MADRS and 17-item Hamilton Depression Rating Scale ( HDRS-17 ) response and change in HDRS-17 , HDRS-21 , Hamilton Anxiety Rating Scale ( HARS ) , Clinical Global Impressions-Severity of Illness ( CGI-S ) , and Clinical Global Impressions-Improvement ( CGI-I ) scores . The Changes in Sexual Functioning Question naire ( CSFQ ) was administered at baseline and week 8 . RESULTS Vilazodone-treated patients had significantly greater improvement ( P = .009 ) according to the MADRS than placebo patients ( intent-to-treat ; least-squares mean changes : -13.3 , -10.8 ) . MADRS response rates were significantly higher with vilazodone than placebo ( 44 % vs 30 % , P = .002 ) . Remission rates for vilazodone were not significantly different based on the MADRS ( vilazodone , 27.3 % vs placebo , 20.3 % ; P = .066 ) or HDRS-17 ( vilazodone , 24.2 % vs placebo , 17.7 % ; P = .088 ) . Vilazodone-treated patients had significantly greater improvements from baseline in HDRS-17 ( P = .026 ) , HDRS-21 ( P = .029 ) , HARS ( P = .037 ) , CGI-S ( P = .004 ) , and CGI-I ( P = .004 ) scores than placebo patients . Rates of discontinuation due to adverse events were 5.1 % ( vilazodone ) and 1.7 % ( placebo ) . The most common adverse events ( vilazodone vs placebo ) were diarrhea ( 31 % vs 11 % ) , nausea ( 26 % vs 6 % ) , and headache ( 13 % vs 10 % ) . Treatment-related effects on sexual function as measured by the CSFQ were small and similar to placebo . Effects on weight were no different from placebo . CONCLUSIONS Vilazodone 40 mg/d was well tolerated and effective in adult patients with MDD . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00683592",
"Objective This r and omised , double-blind , 12-week study compared efficacy and tolerability of flexible-dose treatment with vortioxetine ( 10–20 mg/day ) versus agomelatine ( 25–50 mg/day ) in major depressive disorder patients with inadequate response to selective serotonin reuptake inhibitor (SSRI)/serotonin – noradrenaline reuptake inhibitor ( SNRI ) monotherapy . Methods Patients were switched directly from SSRI/SNRI to vortioxetine or agomelatine . Primary endpoint was change from baseline to week 8 in the Montgomery – Åsberg Depression Rating Scale ( MADRS ) total score analysed by mixed model for repeated measurements , using a noninferiority test followed by a superiority test . Secondary endpoints included response and remission rates , anxiety symptoms ( Hamilton Anxiety Rating Scale ) , Clinical Global Impression , overall functioning ( Sheehan Disability Scale ) , health-related quality of life ( EuroQol 5 Dimensions ) , productivity ( work limitation question naire ) and family functioning ( Depression and Family Functioning Scale ) . Results Primary endpoint noninferiority was established and vortioxetine ( n = 252 ) was superior to agomelatine ( n = 241 ) by 2.2 MADRS points ( p 0.01 ) . Vortioxetine was also significantly superior in response and remission rates at weeks 8 and 12 ; MADRS , Hamilton Anxiety Rating Scale , Clinical Global Impression , Sheehan Disability Scale and EuroQol 5 Dimensions scores at week 4 onwards ; work limitation question naire at week 8 and Depression and Family Functioning Scale at weeks 8 and 12 . Fewer patients withdrew because of adverse events with vortioxetine ( 5.9 % vs 9.5 % ) . Adverse events ( incidence ≥5 % ) were nausea , headache , dizziness and somnolence . Conclusions Vortioxetine was noninferior and significantly superior to agomelatine in major depressive disorder patients with previous inadequate response to a single course of SSRI/SNRI monotherapy . Vortioxetine was safe and well tolerated",
"CONTEXT Vortioxetine ( Lu AA21004 ) is an antidepressant with a mechanism of action thought to be related to a combination of 2 pharmacologic actions : direct modulation of several receptors and inhibition of the serotonin transporter . OBJECTIVE To evaluate the efficacy of vortioxetine 10 and 20 mg once daily in out patients with major depressive disorder . DESIGN , SETTING , AND PARTICIPANTS This 8-week , multicenter , r and omized , double-blind , placebo-controlled , parallel-group study was conducted from July 2010 to January 2012 among adults with a primary diagnosis of recurrent major depressive disorder ( DSM-IV-TR ) . INTERVENTION Eligible subjects were r and omized in 1:1:1 ratio to 1 of 3 treatment arms : vortioxetine 10 mg , vortioxetine 20 mg , or placebo once daily for 8 weeks . Subjects who completed the 8-week trial entered a 2-week blinded discontinuation period to assess potential discontinuation symptoms . MAIN OUTCOME MEASURE The primary endpoint was the least squares mean change in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score from baseline . Key secondary outcomes were analyzed in the following prespecified sequential order : MADRS response ( ≥ 50 % decrease from baseline in total score ) , Clinical Global Impressions-Improvement score , change from baseline in MADRS total score in subjects with baseline Hamilton Anxiety Rating Scale score ≥ 20 , MADRS remission ( total score ≤ 10 ) , and change from baseline in Sheehan Disability Scale total score ( all at week 8) . RESULTS A total of 462 subjects were r and omized to placebo ( n = 157 ) , vortioxetine 10 mg ( n = 155 ) , and vortioxetine 20 mg ( n = 150 ) . Mean ( SE ) reductions from baseline in MADRS total score ( week 8) were -10.77 ( ± 0.807 ) , -12.96 ( ± 0.832 ) , and -14.41 ( ± 0.845 ) for the placebo , vortioxetine 10 mg ( P = .058 vs placebo ) , and vortioxetine 20 mg ( P = .002 vs placebo ) groups . MADRS response/remission was achieved in 28.4%/14.2 % , 33.8%/21.4 % , and 39.2%/22.3 % of subjects , respectively , in the 3 groups . Only MADRS response for vortioxetine 20 mg significantly separated from placebo ( P = .044 ) . Treatment was well tolerated , with the most frequently reported adverse events consisting of nausea , headache , diarrhea , and dizziness . CONCLUSIONS Vortioxetine 20 mg significantly reduced MADRS total score at 8 weeks in this study population . Overall , vortioxetine was well tolerated in this study . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01163266",
" Rationale Vortioxetine has reduced depressive symptoms in adults with major depressive disorder ( MDD ) in multiple clinical trials . Objectives The aim of this study is to evaluate the efficacy , safety , and tolerability of vortioxetine 15 and 20 mg vs placebo in adults with MDD . Methods Patients were r and omized 1:1:1:1 to vortioxetine 15 mg , vortioxetine 20 mg , duloxetine 60 mg ( active reference ) , or placebo . The primary efficacy endpoint was mean change in Montgomery – Åsberg Depression Rating Scale ( MADRS ) total score at week 8 ( MMRM ) . Safety/tolerability assessment s included physical examinations , vital signs , laboratory evaluations , electrocardiograms , adverse events ( AEs ) , Columbia – Suicide Severity Rating Scale , Arizona Sexual Experiences Scale , and Discontinuation – Emergent Signs and Symptoms checklist . Results Six hundred and fourteen patients were r and omized . Mean changes in MADRS scores were −12.83 ( ±0.834 ) , −14.30 ( ±0.890 ) , −15.57 ( ±0.880 ) , and −16.90 ( ±0.884 ) for placebo , vortioxetine 15 mg ( P = .224 ) , vortioxetine 20 mg ( P = .023 ) , and duloxetine 60 mg ( P respectively . AEs reported by ≥5 % of vortioxetine patients included nausea , headache , diarrhea , dizziness , dry mouth , constipation , vomiting , insomnia , fatigue , and upper respiratory infection . Treatment-emergent sexual dysfunction , suicidal ideation or behavior , and discontinuation symptoms were not significantly different between vortioxetine and placebo . Conclusions Vortioxetine 20 mg significantly reduced MADRS total scores after 8 weeks of treatment . Both vortioxetine doses were well tolerated . Clinical trial registration Clinical Trials.gov identifier NCT01153009 ; www . clinical",
"The efficacy and tolerability of Lu AA21004 in the prevention of relapse of major depressive disorder ( MDD ) in patients in remission after acute treatment was evaluated . Patients ( n=639 ) aged 18–75 years with a primary diagnosis of MDD with a current major depressive episode ( MDE ) ≥4 weeks ’ duration , at least one prior MDE and a MADRS total score ≥26 received 12-week , open-label Lu AA21004 at 5 or 10mg/day . Patients in remission ( MADRS ≤10 ) at both weeks 10 and 12 were assigned to double-blind treatment with either placebo or Lu AA21004 ( fixed dose from Week 8) . Patients ( n=396 ) were treated , after r and om assignment to placebo ( n=192 ) or Lu AA21004 ( n=204 ) . The primary analysis of time to relapse ( full- analysis set , Cox proportional hazard model ) showed a statistically significant difference in favour of Lu AA21004 versus placebo with a hazard ratio of 2.01 ( 95 % confidence interval : 1.26–3.21 ; p=0.0035 ) . The proportion of patients who relapsed was 13 % in the Lu AA21004 group ( n=27 ) and 26 % in the placebo group ( n=50 ) . The withdrawal rates due to adverse events were 8 % ( open-label ) , and 3 % ( placebo ) and 8 % ( Lu AA21004 ) ( double-blind ) . Thus , Lu AA21004 was effective in preventing relapse of MDD and was well tolerated as maintenance treatment",
"Owing to the lack of biologically based clinical measures and reliable biomarkers for many indications within the CNS area , the use of imaging tools , such as lig and -based positron emission tomography ( PET ) , has become more and more important in the development of new CNS drugs . A well-grounded and reliable relationship between the plasma concentration of the drug and the occupancy of the receptor ⁄ transporter is a powerful tool to investigate the mechanism of action of a new drug and to guide dose selection",
"The efficacy of vortioxetine 10 and 20 mg/d vs. placebo on cognitive function and depression in adults with recurrent moderate-to-severe major depressive disorder ( MDD ) was evaluated . Patients ( 18–65 yr , N = 602 ) were r and omized ( 1:1:1 ) to vortioxetine 10 or 20 mg/d or placebo for 8 wk in a double-blind multi-national study . Cognitive function was assessed with objective neuropsychological tests of executive function , processing speed , attention and learning and memory , and a subjective cognitive measure . The primary outcome measure was change from baseline to week 8 in a composite z-score comprising the Digit Symbol Substitution Test ( DSST ) and Rey Auditory Verbal Learning Test ( RAVLT ) scores . Depressive symptoms were assessed using the Montgomery-Åsberg Depression Rating Scale ( MADRS ) . In the pre-defined primary efficacy analysis , both doses of vortioxetine were significantly better than placebo , with mean treatment differences vs. placebo of 0.36 ( vortioxetine 10 mg , p 0.33 ( vortioxetine 20 mg , p composite cognition score . Significant improvement vs. placebo was observed for vortioxetine on most of the secondary objectives and subjective patient-reported cognitive measures . The differences to placebo in the MADRS total score at week 8 were −4.7 ( 10 mg : p of vortioxetine on cognition is largely a direct treatment effect . No safety concern emerged with vortioxetine . Vortioxetine significantly improved objective and subjective measures of cognitive function in adults with recurrent MDD and these effects were largely independent of its effect on improving depressive symptoms ",
"Anxiety symptoms are prevalent in patients with major depressive disorder . A post-hoc analysis of two phase III trials was conducted to evaluate the efficacy of vilazodone on depression-related anxiety . Using the 17-item Hamilton Depression Rating Scale ( HAMD17 ) Anxiety/Somatization subscale , patients were classified as anxious or nonanxious . Improvements in depressive symptoms were based on least squares mean changes in HAMD17 and Montgomery – Asberg Depression Rating Scale total scores . Anxiety symptoms in the anxious subgroup were evaluated using Hamilton Anxiety Rating Scale ( HAMA ) total and subscale ( Psychic Anxiety , Somatic Anxiety ) scores , HAMD17 Anxiety/Somatization subscale and item ( Psychic Anxiety , Somatic Anxiety ) scores , and the Montgomery – Asberg Depression Rating Scale Inner Tension item score . Most of the pooled study population [ 82.0 % ( 708/863 ) ] was classified with anxious depression . After 8 weeks of treatment , least squares mean differences between vilazodone and placebo for changes in HAMA total and HAMD17 Anxiety/Somatization subscale scores were −1.82 ( 95 % confidence interval −2.81 to −0.83 ; P with vilazodone were also found on all other anxiety-related measures , except the HAMA Somatic Anxiety subscale . Vilazodone may be effective in treating patients with major depressive disorder who exhibit somatic and /or psychic symptoms of anxiety",
"BACKGROUND This 8-week , r and omized , double-blind , placebo-controlled study , conducted August 2010-May 2012 in the United States , evaluated the safety and efficacy of vortioxetine 10 mg and 15 mg in patients with major depressive disorder ( MDD ) . The mechanism of action of vortioxetine is thought to be related to direct modulation of serotonin ( 5-HT ) receptor activity and inhibition of the serotonin transporter . METHOD Adults aged 18 - 75 years with MDD ( DSM-IV-TR ) and Montgomery-Asberg Depression Rating Scale ( MADRS ) total score ≥ 26 were r and omized ( 1:1:1 ) to receive vortioxetine 10 mg or 15 mg or placebo once daily , with the primary efficacy end point being change from baseline at week 8 in MADRS analyzed by mixed model for repeated measures . Adverse events were recorded during the study , suicidal ideation and behavior were assessed using the Columbia-Suicide Severity Rating Scale ( C-SSRS ) , and sexual dysfunction was assessed using the Arizona Sexual Experience ( ASEX ) scale . RESULTS Of the 1,111 subjects screened , 469 subjects were r and omized : 160 to placebo , 157 to vortioxetine 10 mg , and 152 to vortioxetine 15 mg . Differences from placebo in the primary efficacy end point were not statistically significant for vortioxetine 10 mg or vortioxetine 15 mg . Nausea , headache , dry mouth , constipation , diarrhea , vomiting , dizziness , and flatulence were reported in ≥ 5 % of subjects receiving vortioxetine . Discontinuation due to adverse events occurred in 7 subjects ( 4.4 % ) in the placebo group , 8 ( 5.2 % ) in the vortioxetine 10 mg group , and 12 ( 7.9 % ) in the vortioxetine 15 mg group . ASEX total scores were similar across groups . There were no clinical ly significant trends within or between treatment groups on the C-SSRS , laboratory values , electrocardiogram , or vital sign parameters . CONCLUSIONS In this study , vortioxetine did not differ significantly from placebo on MADRS total score after 8 weeks of treatment in MDD subjects . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01179516",
"Patients with major depressive disorder often experience relapse after responding to treatment ; therefore , maintenance therapy with antidepressants is recommended for maintaining response or remission . This multicenter , open-label , flexible-dose , 52-week extension study evaluated the long-term safety , tolerability , and maintenance of efficacy in study participants who had completed one of two r and omized , double-blind , placebo-controlled , 8-week dose-ranging vortioxetine trials in study participants with major depressive disorder . At the open-label baseline , all study participants were switched to vortioxetine 5 mg/day for the first week , with subsequent dose adjustments from 2.5 to 10 mg/day on the basis of response and tolerability . Treatment with vortioxetine for 52 weeks was well tolerated , with no new safety signals identified . Among the 834 evaluable study participants , treatment-emergent adverse events were reported in 70.6 % , with the most common in the combined ( all doses ) population of nausea ( 15.2 % ) , headache ( 12.4 % ) , nasopharyngitis ( 9.8 % ) , diarrhea ( 7.2 % ) , and dizziness ( 6.8 % ) . The rate of adverse events related to sexual dysfunction was low and weight gain was minimal . Laboratory values , vital signs , ECGs , physical examinations , and Columbia-Suicide Severity Rating Scale results showed no trends of clinical concern . The change in the severity of depressive and anxiety symptoms was maintained throughout the study as reflected by a 24-item Hamilton Depression Scale total score of 8.2 at week 52 ( from 17.6 at open-label baseline ) in the observed case data set",
"The efficacy , safety , and tolerability of Lu AA21004 vs. placebo using venlafaxine XR as active reference in patients with DSM-IV-TR major depressive disorder ( MDD ) were evaluated . Lu AA21004 is a novel antidepressant that is a 5-HT3 and 5-HT7 receptor antagonist , 5-HT1A receptor agonist , 5-HT1B receptor partial agonist and inhibitor of the 5-HT transporter in recombinant cell lines . In this 6-wk , multi-site study , 429 patients were r and omly assigned ( 1:1:1:1 ) to 5 or 10 mg Lu AA21004 , placebo or 225 mg venlafaxine XR . All patients had a baseline Montgomery – Åsberg Depression Rating Scale ( MADRS ) total score ⩾30 . The primary efficacy analysis was based on the MADRS total score adjusting for multiplicity using a hierarchical testing procedure starting with the highest dose vs. placebo . Lu AA21004 was statistically significantly superior to placebo ( n=105 ) in mean change from baseline in MADRS total score at week 6 ( p points . Venlafaxine XR ( n=112 ) was also significantly superior to placebo at week 6 ( p 30 patients withdrew due to adverse events ( AEs ) – placebo : four ( 4 % ) ; 5 mg Lu AA21004 : three ( 3 % ) ; 10 mg Lu AA21004 : seven ( 7 % ) ; and venlafaxine : 16 ( 14 % ) . The most common AEs were nausea , headache , hyperhidrosis , and dry mouth . No clinical ly relevant changes over time were seen in the clinical laboratory results , vital signs , weight , or ECG parameters . In this study , treatment with 5 mg and 10 mg Lu AA21004 for 6 wk was efficacious and well tolerated in patients with MDD",
"INTRODUCTION Sexual dysfunction is common with serotonergic antidepressants , including selective serotonin reuptake inhibitors ( SSRIs ) and serotonin-norepinephrine reuptake inhibitors ( SNRIs ) , and does not resolve in most patients . Vortioxetine , an antidepressant with a multimodal mechanism of action , has shown low rates of sexual dysfunction in previous major depressive disorder ( MDD ) trials . AIM This study compared the effects of vortioxetine and escitalopram on sexual functioning in adults with well-treated MDD experiencing treatment-emergent sexual dysfunction ( TESD ) . METHODS Participants treated with , and responding to , citalopram , paroxetine , or sertraline were r and omized to switch to either vortioxetine ( 10/20 mg ; n = 225 ) or escitalopram ( 10/20 mg ; n = 222 ) for 8 weeks . Sexual function was assessed using the Changes in Sexual Functioning Question naire Short Form ( CSFQ-14 ) , and antidepressant efficacy was assessed using the Montgomery-Åsberg Depression Rating Scale ( MADRS ) , Clinical Global Impressions ( CGI ) scale , and Profile of Mood States brief form ( POMS-brief ) . Safety and tolerability were also assessed . MAIN OUTCOME MEASURES The primary endpoint was change from baseline in the CSFQ-14 total score after 8 weeks of treatment . The MADRS , CGI , and POMS-brief were used to assess antidepressant efficacy . Safety was assessed via adverse events , vital signs , electrocardiograms , laboratory values , weight , and physical examination findings . RESULTS Vortioxetine showed significantly greater improvements in CSFQ-14 total score ( 8.8 ± 0.64 , mean ± st and ard error ) vs. escitalopram ( 6.6 ± 0.64 ; P = 0.013 ) . Benefits vs. escitalopram were significant on four of five dimensions and all three phases of sexual functioning assessed by the CSFQ-14 ( P 0.05 ) . Antidepressant efficacy continued in both groups , with similar , but slight , improvements in MADRS and CGI scores . Vortioxetine and escitalopram had similar clinical efficacy profiles in this study , with safety profiles similar to previous trials . Nausea ( n = 9 , 4.0 % ) was the most common treatment-emergent adverse event leading to discontinuation of vortioxetine . CONCLUSION Switching antidepressant therapy to vortioxetine may be beneficial for patients experiencing sexual dysfunction during antidepressant therapy with SSRIs ",
"OBJECTIVE To investigate the efficacy , safety , and clinical benefit of a once-daily formulation of trazodone ( Trazodone Contramid((c ) ) OAD ) in the treatment of major depressive disorder . DESIGN / PARTICIPANTS In this double-blind study , 412 patients with major depressive disorder ( Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria ) were r and omized 1:1 to receive either Trazodone Contramid OAD ( 150 to 375 mg ) or placebo . Treatment was titrated over two weeks to each individual optimal dose . Patients then continued six weeks of treatment ; further dose adjustments were allowed based on efficacy and tolerability . MEASUREMENTS The primary end point was change in the 17-item Hamilton Depression Rating Scale total score from baseline to last study visit . Secondary end points included Hamilton Depression Rating Scale responders/remitters , change in Montgomery-Asberg Depression Rating Scale , Clinician and Patient Global Improvement Scales , and quality of sleep . RESULTS From the end of titration to the end of the six-week treatment period , the mean maximum daily dose of the intent-to-treat population was 310 mg for the active group and 355 mg for the placebo group . There was a statistically significant difference between trazodone and placebo on the mean HAMD-17 score ( -11.4 vs. -9.3 , P=0.012 ) . A significant difference was present as early as Week 1 and was maintained at all subsequent study visits . Many secondary end points supported these findings , including improvements in quality of sleep . The most frequent adverse events were the same for both the treatment and placebo groups : headache and somnolence . There were no serious adverse events that were considered related to treatment . There were no clinical ly significant electrocardiogram or laboratory abnormalities . CONCLUSIONS The trazodone Contramid formulation was more effective than placebo in major depressive disorder and was well tolerated",
"Abstract Objective : The primary objective of this study was to evaluate the safety and tolerability of the investigational drug vortioxetine ( Lu AA21004 ) in the long-term treatment of patients with major depressive disorder . Methods : Patients entered this 52-week , open-label extension study after completing an 8-week lead-in study . Safety and tolerability were evaluated at regular intervals on the basis of spontaneously reported adverse events ( AEs ) , clinical safety laboratory tests , vital signs , ECG and physical examination . Effectiveness of treatment was assessed using the Montgomery – Åsberg Depression Rating Scale ( MADRS ) total score . Results : A total of 535 patients were treated and 61.3 % ( n = 328 ) completed the study , result ing in 393 patient years of exposure to vortioxetine . AEs reported by ≥10 % of patients were nausea , headache , and nasopharyngitis . Taken together , six patients had eight AEs related to sexual dysfunction . There were no clinical ly significant safety findings with respect to mean changes of vital signs , weight , ECG parameters , or clinical laboratory values . Patients entered the extension study with a mean MADRS total score of 13.5 ± 8.7 . The mean MADRS total score decreased ( improved ) by approximately 8 points to 5.5 ± 6.0 at Week 52 ( OC ) . By the end of the study , the proportion of responders had increased from 63 % to 94 % ( OC ) , as had the proportion in remission ( MADRS ≤10 ) , increasing from 42 % to 83 % ( OC ) . Patients in remission ( n = 226 ) at the start of this study had a relapse rate ( MADRS ≥22 ) of 9.7 % . Conclusions : As with all open-label studies , the conclusions that can be drawn are limited by the lack of a placebo control , making it difficult to assess causality of any changes in outcome measures . However , on the basis of these findings , vortioxetine ( 2.5 , 5 , 10 mg/day ) demonstrated a favourable safety and tolerability profile and maintained effectiveness over 12 months of treatment . Trial Registration : Clinical Trials.gov identifier : NCT00694304",
"Abstract Objective : Vortioxetine ( Lu AA21004 ) is an investigational antidepressant . In vitro studies indicate that vortioxetine is a 5-HT3 , 5-HT7 , and 5-HT1D receptor antagonist , 5-HT1B receptor partial agonist , 5-HT1A receptor agonist and inhibitor of the 5-HT transporter . This trial assessed the efficacy and tolerability of 2.5 and 5 mg vortioxetine for the treatment of MDD . Research design and methods : Adults ( N = 611 ) with MDD were r and omized to 8 weeks of double-blind treatment with placebo , vortioxetine ( 2.5 or 5 mg ) or active reference ( duloxetine 60 mg ) . The primary measure was change from baseline in the 24-item Hamilton Depression Scale ( HAM-D24 ) . Secondary endpoints included responder rate , Clinical Global Impression Scale-Global Improvement scale ( CGI-I ) , and remission rate . Participants were monitored for adverse events ( AEs ) , and treatment-emergent sexual dysfunction using the Arizona Sexual Experiences ( ASEX ) scale . Results : Both doses of vortioxetine were associated with declines in HAM-D24 total scores compared to placebo but were not statistically significant . At 8 weeks , changes from baseline were [ mean ( SE ) ] : −10.50 ( 0.76 ) placebo , −12.04 ( 0.74 ) 2.5 mg vortioxetine , and −11.08 ( 0.74 ) 5 mg vortioxetine . Secondary outcome measures in the vortioxetine groups , including responder rate , CGI-I , and remission rate , were also not significantly different from placebo . Duloxetine treatment was associated with declines in HAM-D24 total score [ −13.47(0.75 ) ; p = 0.005 ] as well as significant improvements in secondary outcome measures versus placebo ( p ≤ 0.05 ) . The most common AEs for vortioxetine were nausea , dry mouth , and headache . Rates of sexual dysfunction ( ASEX ) were 51.0 % , 37.5 % , 46.9 % , and 33.3 % in the vortioxetine 2.5 mg , vortioxetine 5 mg , duloxetine , and placebo groups , respectively . Conclusions : In this study of adults with MDD treated for 8 weeks with vortioxetine 2.5 mg or 5 mg per day , reductions in depression symptoms were not statistically significant compared with placebo . Study limitations are discussed , including patient characteristics , MDD severity , drug dosing , and aspects of trial design . Both doses of vortioxetine were well tolerated . This trial has been registered at clinical trials.gov #",
"Objective : To review the mechanism of selective serotonin reuptake inhibitor (SSRI)–mediated serotonergic neurotransmission , focusing on serotonin 1A ( 5-HT1A ) autoreceptors , which are proposed to be involved in delaying therapeutic efficacy . Vilazodone was specifically design ed to function both as an SSRI and a partial agonist at 5-HT1A receptors . This combined mechanism is proposed to decrease time to efficacy , minimize sexual side effects , and provide concomitant anxiolytic properties . Data Sources : A PubMed search of all English- language articles from January 1990 to January 2013 was conducted using the search terms depression and 5-HT1A , depression and buspirone , depression and pindolol , and vilazodone . Study Selection : We found 47 articles and abstract s that were selected for inclusion on the basis of information about the pharmacology of 5-HT1A receptors and the clinical data on pindolol , buspirone , and vilazodone in depression . Data Extraction : This review summarizes current literature involving antidepressant activity , the role of 5-HT1A autoreceptors , and clinical trials involving serotonin reuptake inhibition in conjunction with 5-HT1A agonists and partial agonists , with a focus on vilazodone . Results : Vilazodone has demonstrated efficacy in 2 large , r and omized , double-blind , placebo-controlled trials in major depressive disorder . Results suggest that vilazodone has a low incidence of sexual side effects and is effective in patients with high levels of anxiety . A pooled analysis shows evidence of significant symptom reduction after only 1 week of therapy . Conclusions : If future studies corroborate the clinical benefits attributed to its mechanism of action , vilazodone may show potential advantages in terms of onset of action , sexual side effects , and anxiolytic activity in patients with major depressive disorder",
"OBJECTIVE Clinical guidelines recommend that antidepressant treatment should be continued for a minimum of 6 months following response in depression and anxiety disorders . However , adherence to antidepressants is low . This prospect i ve cohort study investigated the influence of patients ' antidepressant concerns , treatment preferences , and illness perceptions on adherence to antidepressants over a 6-month period . METHOD A cohort of 178 patients aged 18 to 74 years and newly issued with a prescription for antidepressants to treat any condition was followed up prospect ively at 5 primary care practice s in Southeast Engl and . Adherence was measured through self-report and prescription refill data . Patient perceptions were quantified using vali date d outcome measures , the Beliefs about Medicine Question naire and the Illness Perception Question naire , at 4 timepoints . Patient treatment preferences were recorded using a specially design ed question naire . Data collection took place between September 2000 and May 2002 . RESULTS Of 147 participants ( 83 % ) who completed the study , 19 % persisted with antidepressants in accordance with guideline recommendations throughout the 6-month period . Specific concern about antidepressant side effects ( OR = 3.30 , 95 % CI = 2.20 to 4.97 ) and general worry about taking antidepressants ( OR = 1.65 , 95 % CI = 1.13 to 2.40 ) were independent predictors of antidepressant nonuse . Preference for different treatment/uncertainty about preferred treatment was also a strong predictor ( OR = 3.82 , 95 % CI = 1.35 to 10.77 ) . However , illness perceptions were not associated with adherence . CONCLUSIONS Concerns about antidepressants and a mismatch between patients ' preferred and prescribed treatment act as significant barriers to sustained adherence . This study highlights the central role of the patient-physician partnership in exploring antidepressant concerns , working with treatment preferences , and providing supportive continued management . The findings may inform the development of interventions within primary care programs to enhance commitment to treatment for common mental disorders",
"OBJECTIVE The efficacy and tolerability of vilazodone , a combined selective serotonin reuptake inhibitor and partial 5-hydroxytryptamine-1A ( 5-HT(1A ) ) receptor agonist , were evaluated in adult patients with major depressive disorder ( MDD ) . METHOD This was a r and omized , double-blind , placebo-controlled trial conducted from February 2006 to May 2007 . Patients aged 18 through 65 years with MDD ( DSM-IV criteria ) and a baseline 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) score of > or= 22 were r and omly assigned to vilazodone or placebo for 8 weeks . Vilazodone was titrated from 10 mg to 40 mg once a day over 2 weeks . Efficacy was assessed by mean change from baseline to week 8 on the Montgomery-Asberg Depression Rating Scale ( MADRS ) , HAM-D-17 , and Hamilton Rating Scale for Anxiety . Response rates were determined at week 8 for the MADRS , HAM-D-17 , and Clinical Global Impressions-Severity of Illness ( CGI-S ) and -Improvement ( CGI-I ) scales . Data were analyzed using a modified last-observation-carried-forward method in the intention-to-treat ( ITT ) sample . The Arizona Sexual Experience Scale ( ASEX ) was also measured at baseline and week 8 . RESULTS Of 410 r and omly assigned patients , 198 receiving vilazodone and 199 receiving placebo were included in the ITT population . The mean changes in MADRS and HAM-D-17 total scores from baseline to week 8 were significantly ( p = .001 and p = .022 , respectively ) greater with vilazodone than with placebo . Significant ( p improvements in MADRS and HAM-D-17 scores were noted at week 1 , the earliest time point measured . Response rates were significantly higher with vilazodone than with placebo on the MADRS ( p = .007 ) , HAM-D-17 ( p = .011 ) , and CGI-I ( p = .001 ) . Treatment-emergent adverse events with vilazodone included diarrhea , nausea , and somnolence ; most adverse events were of mild or moderate intensity . There were no clinical ly significant differences for either gender in ASEX scores at end of treatment . CONCLUSIONS Vilazodone is effective for the treatment of MDD in adults , with symptom relief starting at 1 week , and is well tolerated at a dose of 40 mg/day . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00285376",
"The efficacy and tolerability of Lu AA21004 at 5 mg/day , a novel multimodal antidepressant , were assessed in elderly patients with recurrent major depressive disorder . Patients were r and omly assigned ( 1 : 1 : 1 ) to Lu AA21004 5 mg/day , duloxetine 60 mg/day ( reference ) or to placebo in an 8-week double-blind study . The primary efficacy measure was the 24-item Hamilton Depression Scale ( HAM-D24 ) total score ( analysis of covariance , last observation carried forward ) . Patients ( mean age 70.6 years ) had a mean baseline HAM-D24 score of 29.0 . Lu AA21004 showed significantly ( P=0.0011 ) greater improvement on the primary efficacy endpoint compared with placebo at week 8 ( 3.3 points ) . Duloxetine also showed superiority to placebo at week 8 , thereby validating the study . HAM-D24 response ( 53.2 vs. 35.2 % ) and HAM-D17 remission ( 29.2 vs. 19.3 % ) rates at endpoint were higher for Lu AA21004 than for placebo . Lu AA21004 showed superiority to placebo in cognition tests of speed of processing , verbal learning and memory . The withdrawal rate due to adverse events was 5.8 % ( Lu AA21004 ) , 9.9 % ( duloxetine ) and 2.8 % ( placebo ) . Whereas nausea was the only adverse event with a significantly higher incidence on treatment with Lu AA21004 ( 21.8 % ) compared with placebo ( 8.3 % ) , the incidence of nausea , constipation , dry mouth , hyperhidrosis and somnolence was higher for duloxetine . In conclusion , Lu AA21004 was efficacious and well tolerated in the treatment of elderly patients with recurrent major depressive disorder",
"INTRODUCTION Vilazodone is a potent serotonin ( 5-HT ) reuptake inhibitor and 5-HT₁A receptor partial agonist approved by the US Food and Drug Administration for the treatment of major depressive disorder ( MDD ) in adults . This study evaluated the efficacy and tolerability of vilazodone in the treatment of MDD . METHOD This 8-week , r and omized ( 1:1 ) , double-blind , placebo-controlled , parallel-group , fixed-dose study conducted from January 2012 to February 2013 compared vilazodone 40 mg/d with placebo in out patients with DSM-IV-TR-diagnosed MDD . The primary efficacy measure was Montgomery-Asberg Depression Rating Scale ( MADRS ) total score change from baseline to week 8 analyzed by a mixed-effects model for repeated measures on the intent-to-treat population ( placebo = 252 , vilazodone = 253 ) . Secondary efficacy outcomes were Clinical Global Impressions-Severity of Illness ( CGI-S ) Scale score change from baseline and MADRS sustained response rate ( total score ≤ 12 for at least the last 2 consecutive double-blind visits ) . RESULTS Approximately 83 % of patients completed the study . Least squares mean differences ( 95 % CI ) were statistically significant for vilazodone versus placebo on MADRS ( -5.117 [ -6.886 to -3.347 ] , P .00001 ) and CGI-S ( -0.622 [ -0.845 to -0.399 ] , P versus placebo occurred at week 2 and persisted for the study duration . The MADRS sustained response rate was 17 % for placebo and 27 % for vilazodone ( P Patients taking vilazodone versus placebo had higher rates of diarrhea and nausea ; most incidences were mild in severity . Weight increase and sexual dysfunction adverse events were low in both groups . CONCLUSIONS A large and significant treatment effect on the MADRS and statistically significant improvement on the CGI-S demonstrated meaningful depressive symptom improvements . Vilazodone was generally well tolerated . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01473394",
"The efficacy , safety , and tolerability of Lu AA21004 versus placebo , using duloxetine as active reference , in patients with DSM-IV-TR diagnosed major depressive disorder ( MDD ) were evaluated in this 8-week , multi-site study . Patients ( n=766 ) had a baseline Montgomery-Åsberg Depression Rating Scale ( MADRS ) total score ≥26 and were r and omly assigned ( 1:1:1:1:1 ) to 2.5 , 5 or 10 mg Lu AA21004 , placebo , or 60 mg duloxetine . The 5 mg and 10 mg doses of Lu AA21004 were tested separately versus placebo at p≤0.025 in a pre-specified order . In the pre-defined primary efficacy analysis [ mean change from baseline in MADRS total score at Week 8 , full analysis set , ANCOVA , last observation carried forward ( LOCF ) ] , the differences to placebo ( n=145 ) of -1.7 ( Lu AA21004 5 mg , n=155 ) and -1.5 points ( Lu AA21004 10 mg , n=151 ) were not statistically significant ; nor were those for Lu AA21004 2.5 mg ( -1.4 points , n=155 ) or duloxetine ( -2.0 points , n=149 ) . Using mixed model , repeated measures ( MMRM ) analyses of the primary endpoint and most secondary endpoints were supportive of likely efficacy for Lu AA21004 5 mg and 10 mg and duloxetine . Treatment-emergent adverse events led to the withdrawal of 72 patients : 8 % ( placebo ) , 12 % ( duloxetine ) , and 6 % , 11 % and 9 % in the Lu AA21004 groups ( 2.5 mg , 5 mg and 10 mg , respectively ) . The most common adverse events were nausea , headache , dizziness , and dry mouth . No clinical ly relevant changes were seen in vital signs , weight , ECG , or laboratory results . In summary , none of the active treatment groups , including duloxetine , separated from placebo in the primary analysis in this ' failed ' study . Findings on secondary outcome measures , using MMRM instead of LOCF , were supportive of likely efficacy for Lu AA21004 5 mg and 10 mg and duloxetine . Lu AA21004 ( 2.5 , 5 and 10 mg ) was well tolerated",
"OBJECTIVE Lu AA21004 is an investigational multimodal antidepressant . This r and omized controlled trial evaluated the efficacy and tolerability of multiple doses of Lu AA21004 versus placebo in adults with major depressive disorder ( MDD ) . METHOD Adults diagnosed with MDD ( based on DSM-IV-TR criteria ) with a Montgomery-Asberg Depression Rating Scale ( MADRS ) score ≥ 26 were r and omly assigned ( 1:1:1:1 ) to receive Lu AA21004 1 mg , 5 mg , or 10 mg or placebo for 8 weeks ( between August 2008 and August 2009 ) . The primary endpoint was reduction in 24-Item Hamilton Depression Rating Scale ( HDRS-24 ) total score after 8 weeks of treatment compared with placebo for Lu AA21004 10 mg . Additional outcomes included response and remission rates , Sheehan Disability Scale ( SDS ) , Clinical Global Impressions-Global Improvement scale ( CGI-I ) , MADRS total score , and HDRS-24 total score in subjects with baseline Hamilton Anxiety Rating Scale ( HARS ) score ≥ 20 . Adverse events were assessed throughout the study . RESULTS A total of 560 subjects ( mean age = 46.4 years ) were r and omized . There was a statistically significant reduction from baseline in HDRS-24 total score at week 8 for Lu AA21004 10 mg vs placebo ( P in HDRS-24 total score , response and remission rates , CGI-I score , MADRS total score , and HDRS-24 total score in subjects with baseline HARS score ≥ 20 at week 8 for all Lu AA21004 treatment groups vs placebo . No significant differences were seen in SDS scores between any dose of Lu AA21004 and placebo . The most common adverse events were nausea , headache , and dizziness . CONCLUSIONS After 8 weeks of treatment with Lu AA21004 10 mg , there was a significant reduction in HDRS-24 total score compared with placebo in adults with MDD . Lu AA21004 was well tolerated in this study . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00735709"
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BACKGROUND Several studies have recently reported on the correlation between objective behavioral features collected via mobile and wearable devices and depressive mood symptoms in patients with affective disorders ( unipolar and bipolar disorders ) . However , individual studies have reported on different and sometimes contradicting results , and no quantitative systematic review of the correlation between objective behavioral features and depressive mood symptoms has been published . OBJECTIVE The objectives of this systematic review were to ( 1 ) provide an overview of the correlations between objective behavioral features and depressive mood symptoms reported in the literature and ( 2 ) investigate the strength and statistical significance of these correlations across studies . The answers to these questions could potentially help identify which objective features have shown most promising results across studies . METHODS We conducted a systematic review of the scientific literature , reported according to the preferred reporting items for systematic review s and meta-analyses guidelines . IEEE Xplore , ACM Digital Library , Web of Sciences , PsychINFO , PubMed , DBLP computer science bibliography , HTA , DARE , Scopus , and Science Direct were search ed and supplemented by h and examination of reference lists . The search ended on April 27 , 2017 , and was limited to studies published between 2007 and 2017 . RESULTS A total of 46 studies were eligible for the review . These studies identified and investigated 85 unique objective behavioral features , covering 17 various sensor data inputs . These features were divided into 7 categories . Several features were found to have statistically significant and consistent correlation directionality with mood assessment ( eg , the amount of home stay , sleep duration , and vigorous activity ) , while others showed directionality discrepancies across the studies ( eg , amount of text messages [ short message service ] sent , time spent between locations , and frequency of mobile phone screen activity ) . CONCLUSIONS Several studies showed consistent and statistically significant correlations between objective behavioral features collected via mobile and wearable devices and depressive mood symptoms . Hence , continuous and everyday monitoring of behavioral aspects in affective disorders could be a promising supplementary objective measure for estimating depressive mood symptoms . However , the evidence is limited by method ological issues in individual studies and by a lack of st and ardization of ( 1 ) the collected objective features , ( 2 ) the mood assessment methodology , and ( 3 ) the statistical methods applied . Therefore , consistency in data collection and analysis in future studies is needed , making replication studies as well as meta-analyses possible
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[
"Background Mobile phone sensors can be used to develop context -aware systems that automatically detect when patients require assistance . Mobile phones can also provide ecological momentary interventions that deliver tailored assistance during problematic situations . However , such approaches have not yet been used to treat major depressive disorder . Objective The purpose of this study was to investigate the technical feasibility , functional reliability , and patient satisfaction with Mobilyze ! , a mobile phone- and Internet-based intervention including ecological momentary intervention and context sensing . Methods We developed a mobile phone application and supporting architecture , in which machine learning models ( ie , learners ) predicted patients ’ mood , emotions , cognitive/motivational states , activities , environmental context , and social context based on at least 38 concurrent phone sensor values ( eg , global positioning system , ambient light , recent calls ) . The website included feedback graphs illustrating correlations between patients ’ self-reported states , as well as didactics and tools teaching patients behavioral activation concepts . Brief telephone calls and emails with a clinician were used to promote adherence . We enrolled 8 adults with major depressive disorder in a single-arm pilot study to receive Mobilyze ! and complete clinical assessment s for 8 weeks . Results Promising accuracy rates ( 60 % to 91 % ) were achieved by learners predicting categorical context ual states ( eg , location ) . For states rated on scales ( eg , mood ) , predictive capability was poor . Participants were satisfied with the phone application and improved significantly on self-reported depressive symptoms ( betaweek = –.82 , P interview measures of depressive symptoms ( betaweek = –.81 , P criteria for major depressive disorder diagnosis ( bweek = –.65 , P = .03 , per- protocol remission rate = 85.71 % ) . Comorbid anxiety symptoms also decreased ( betaweek = –.71 , P Mobilyze ! is a scalable , feasible intervention with preliminary evidence of efficacy . To our knowledge , it is the first ecological momentary intervention for unipolar depression , as well as one of the first attempts to use context sensing to identify mental health-related states . Several lessons learned regarding technical functionality , data mining , and software development process are discussed . Trial Registration Clinical trials.gov NCT01107041 ; http:// clinical trials.gov/ct2/show/NCT01107041 ( Archived by WebCite at http://www.webcitation.org/60CVjPH0n",
"Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results",
"OBJECTIVES Recent research indicates that Heart Rate Variability ( HRV ) is affected in Bipolar Disorders ( BD ) patients . To determine whether such alterations are a mere expression of the current mood state or rather contain longitudinal information on BD course , we examined the potential influence of states adjacent in time upon HRV features measured in a target mood state . METHODS Longitudinal evaluation of HRV was obtained in eight BD patients by using a wearable monitoring system developed within the PSYCHE project . We extracted time-domain , frequency-domain and non-linear HRV-features and trained a Support Vector Machine ( SVM ) to classify HRV-features according to mood state . To evaluate the influence of adjacent mood states , we trained SVM with different HRV-feature sets : 1 ) belonging to each mood state considered alone ; 2 ) belonging to each mood state and normalized using information from the preceding mood state ; 3 ) belonging to each mood state and normalized using information from the preceding and subsequent mood states ; 4 ) belonging to each mood state and normalized using information from two r and omly chosen states . RESULTS SVM classification accuracy within a target state was significantly greater when HRV-features from the previous and subsequent mood states were considered . CONCLUSIONS Although preliminary and in need of replications our results suggest for the first time that psychophysiological states in BD contain information related to the subsequent ones . Such characteristic may be used to improve clinical management and to develop algorithms to predict clinical course and mood switches in individual patients",
"Background Relapse prevention in bipolar disorder can be improved by monitoring symptoms in patients ' daily life . Smartphone apps are easy-to-use , low-cost tools that can be used to assess this information . To date , few studies have examined the usefulness of smartphone data for monitoring symptoms in bipolar disorder . Objective We present results from a pilot test of a smartphone-based monitoring system , Social Information Monitoring for Patients with Bipolar Affective Disorder ( SIMBA ) , that tracked daily mood , physical activity , and social communication in 13 patients . The objective of this study was to investigate whether smartphone measurements predicted clinical symptoms levels and clinical symptom change . The hypotheses that smartphone measurements are ( 1 ) negatively related to clinical depressive symptoms and ( 2 ) positively related to clinical manic symptoms were tested . Methods Clinical rating scales were administered to assess clinical depressive and manic symptoms . Patients used a smartphone with the monitoring app for up to 12 months . R and om-coefficient multilevel models were computed to analyze the relationship between smartphone data and externally rated manic and depressive symptoms . Overall clinical symptom levels and clinical symptom changes were predicted by separating between-patient and within-patient effects . Using established clinical thresholds from the literature , marginal effect plots displayed clinical relevance of smartphone data . Results Overall symptom levels and change in clinical symptoms were related to smartphone measures . Higher overall levels of clinical depressive symptoms were predicted by lower self-reported mood measured by the smartphone ( beta=-.56 , P clinical depressive symptoms was predicted by a decline in social communication ( ie , outgoing text messages : beta=-.28 , P physical activity as measured by the smartphone ( ie , cell tower movements : beta=-.11 , P=.03 ) . Higher overall levels of clinical manic symptoms were predicted by lower physical activity on the smartphone ( ie , distance travelled : beta=-.37 , P social communication ( beta=.48 , P=.03 ) . An increase in clinical manic symptoms was predicted by a decrease in physical activity on the smartphone ( beta=-.17 , P smartphones have the potential to monitor bipolar disorder symptoms in patients ’ daily life . Further validation of monitoring tools in a larger sample is needed . Conclusions are limited by the low prevalence of manic and depressive symptoms in the study sample . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 05663421 ; http://www.controlled-trials.com/IS RCT N05663421 ( Archived by WebCite at http://www.webcitation.org/6d9wsibJB",
" Objective : This paper aims to identify periods of depression using geolocation movements recorded from mobile phones in a prospect i ve community study of individuals with bipolar disorder ( BD ) . M ethods : Anonymized geographic location recordings from 22 BD participants and 14 healthy controls ( HC ) were collected over 3 months . Participants reported their depressive symptomatology using a weekly question naire ( QIDS-SR 16 ) . Recorded location data were preprocessed by detecting and removing imprecise data points and features were extracted to assess the level and regularity of geographic movements of the participant . A subset of features were selected using a wrapper feature selection method and presented to 1 ) a linear regression model and a quadratic generalized linear model with a logistic link function for question naire score estimation ; and 2 ) a quadratic discriminant analysis classifier for depression detection in BD participants based on their question naire responses . R esults : HC participants did not report depressive symptoms and their features showed similar distributions to nondepressed BD participants . Question naire score estimation using geolocation-derived features from BD participants demonstrated an optimal mean absolute error rate of 3.73 , while depression detection demonstrated an optimal ( median $\\pm$ IQR ) $\\text{F}_{1}$ score of 0.857 $\\pm$ 0.022 using five features ( classification accuracy : 0.849 $\\pm$ 0.016 ; sensitivity : 0.839 $\\pm$ 0.014 ; specificity : 0.872 $\\pm$ 0.047 ) . C onclusion : These results demonstrate a strong link between geographic movements and depression in bipolar disorder . S ignificance : To our knowledge , this is the first community study of passively recorded objective markers of depression in bipolar disorder of this scale . The techniques could help individuals monitor their depression and enable healthcare providers to detect those in need of care or treatment",
"Background Because of the quick development and widespread use of mobile phones , and their vast effect on communication and interactions , it is important to study possible negative health effects of mobile phone exposure . The overall aim of this study was to investigate whether there are associations between psychosocial aspects of mobile phone use and mental health symptoms in a prospect i ve cohort of young adults . Methods The study group consisted of young adults 20 - 24 years old ( n = 4156 ) , who responded to a question naire at baseline and 1-year follow-up . Mobile phone exposure variables included frequency of use , but also more qualitative variables : dem and s on availability , perceived stressfulness of accessibility , being awakened at night by the mobile phone , and personal overuse of the mobile phone . Mental health outcomes included current stress , sleep disorders , and symptoms of depression . Prevalence ratios ( PRs ) were calculated for cross-sectional and prospect i ve associations between exposure variables and mental health outcomes for men and women separately . Results There were cross-sectional associations between high compared to low mobile phone use and stress , sleep disturbances , and symptoms of depression for the men and women . When excluding respondents reporting mental health symptoms at baseline , high mobile phone use was associated with sleep disturbances and symptoms of depression for the men and symptoms of depression for the women at 1-year follow-up . All qualitative variables had cross-sectional associations with mental health outcomes . In prospect i ve analysis , overuse was associated with stress and sleep disturbances for women , and high accessibility stress was associated with stress , sleep disturbances , and symptoms of depression for both men and women . Conclusions High frequency of mobile phone use at baseline was a risk factor for mental health outcomes at 1-year follow-up among the young adults . The risk for reporting mental health symptoms at follow-up was greatest among those who had perceived accessibility via mobile phones to be stressful . Public health prevention strategies focusing on attitudes could include information and advice , helping young adults to set limits for their own and others ' accessibility",
"OBJECTIVE To examine the effects of a free-living , sedentary behavior-inducing r and omized controlled intervention on depression and mood profile . PATIENTS AND METHODS Participants who were confirmed to be active via self-report and accelerometry were r and omly assigned to either a sedentary behavior intervention group ( n=26 ) or a control group ( n=13 ) by using a 2:1 sample size ratio for intervention and control groups . The intervention group was asked to eliminate all exercise and minimize steps to 5000 or less steps/d for 1 week , whereas the control group was asked to continue normal physical activity levels for 1 week . Both groups completed a depression ( Patient Health Question naire-9 ) and mood ( Profile of Moods States ) survey preintervention and immediately postintervention . The intervention group was asked to resume normal physical activity levels for 1 week postintervention and then completed the assessment s for a third time . All data collection occurred between September 1 , 2015 , and December 1 , 2015 . RESULTS Patient Health Question naire-9 group × time interaction analysis revealed that depression scores significantly increased from visit 1 to visit 2 ( F=11.85 ; P=.001 ) . Paired t tests comparing depression scores from visit 2 to visit 3 exhibited a significant decrease from visit 2 to visit 3 ( P Profile of Moods States group × time interaction analysis paralleled depression results ; mood scores significantly increased from visit 1 to visit 2 ( F=10.03 ; P=.003 ) and significantly decreased from visit 2 to visit 3 ( P effects on depression and mood . To prevent mental health decline in active individuals , consistent regular physical activity may be necessary",
"Changes in speech have been suggested as sensitive and valid measures of depression and mania in bipolar disorder . The present study aim ed at investigating ( 1 ) voice features collected during phone calls as objective markers of affective states in bipolar disorder and ( 2 ) if combining voice features with automatically generated objective smartphone data on behavioral activities ( for example , number of text messages and phone calls per day ) and electronic self-monitored data ( mood ) on illness activity would increase the accuracy as a marker of affective states . Using smartphones , voice features , automatically generated objective smartphone data on behavioral activities and electronic self-monitored data were collected from 28 out patients with bipolar disorder in naturalistic setting s on a daily basis during a period of 12 weeks . Depressive and manic symptoms were assessed using the Hamilton Depression Rating Scale 17-item and the Young Mania Rating Scale , respectively , by a research er blinded to smartphone data . Data were analyzed using r and om forest algorithms . Affective states were classified using voice features extracted during everyday life phone calls . Voice features were found to be more accurate , sensitive and specific in the classification of manic or mixed states with an area under the curve (AUC)=0.89 compared with an AUC=0.78 for the classification of depressive states . Combining voice features with automatically generated objective smartphone data on behavioral activities and electronic self-monitored data increased the accuracy , sensitivity and specificity of classification of affective states slightly . Voice features collected in naturalistic setting s using smartphones may be used as objective state markers in patients with bipolar disorder"
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4116f79a-06ff-11f0-808a-c43d1ab1c353
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Difficulties in set-shifting are commonly reported in both autism spectrum disorder ( ASD ) and anorexia nervosa ( AN ) population s. Despite this , it is not known whether this cognitive profile persists across different ages , or whether the profiles seen in ASD and AN are comparable . This systematic review and meta-analyses aim ed to compare the set-shifting profiles , as measured by the Wisconsin Card Sorting Test ( WCST ) in adults and younger people with either ASD or AN , relative to healthy controls ( HCs ) and to statistically compare performance on the WCST between ASD and AN . In all , 24 studies on ASD and 22 studies on AN were identified . In ASD , there were significant differences between the clinical group and HCs , with the ASD group making significantly more perseverative errors , indicating greater difficulty in set-shifting [ pooled effect size of d = 0.67 , 95 % confidence interval ( CI ) 0.53 - 0.81 , p ⩽ 0.001 ] . This effect was consistent across the age span . For AN studies , there was a significant difference between adults with AN and HCs ( d = 0.52 , 95 % CI 0.36 - 0.68 , p ⩽ 0.001 ) but a non-significant effect in child studies ( d = 0.25 , 95 % CI -0.05 to 0.55 , z = 1.66 , p = 0.096 ) . Meta-regression indicated no effect of diagnosis ( AN or ASD ) on performance in adult studies but there was a non-significant trend ( p = 0.053 ) towards children with ASD performing worse than children with AN . While difficulties with set-shifting appear to be stable in ASD , there may be differences between children and adults with AN , which warrant further investigation
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"BACKGROUND People with autism spectrum disorders ( ASDs ) experience executive function ( EF ) deficits . There is an urgent need for effective interventions , but in spite of the increasing research focus on computerized cognitive training , this has not been studied in ASD . Hence , we investigated two EF training conditions in children with ASD . METHODS In a r and omized controlled trial , children with ASD ( n = 121 , 8 - 12 years , IQ > 80 ) were r and omly assigned to an adaptive working memory ( WM ) training , an adaptive cognitive flexibility-training , or a non-adaptive control training ( mock-training ) . Braingame Brian , a computerized EF-training with game-elements , was used . Outcome measures ( pretraining , post-training , and 6-week-follow-up ) were near-transfer to trained EFs , far-transfer to other EFs ( sustained attention and inhibition ) , and parent 's ratings of daily life EFs , social behavior , attention deficit hyperactivity disorder (ADHD)-behavior , and quality of life . RESULTS Attrition-rate was 26 % . Children in all conditions who completed the training improved in WM , cognitive flexibility , attention , and on parent 's ratings , but not in inhibition . There were no significant differential intervention effects , although children in the WM condition showed a trend toward improvement on near-transfer WM and ADHD-behavior , and children in the cognitive flexibility condition showed a trend toward improvement on near-transfer flexibility . CONCLUSION Although children in the WM condition tended to improve more in WM and ADHD-behavior , the lack of differential improvement on most outcome measures , the absence of a clear effect of the adaptive training compared to the mock-training , and the high attrition rate suggest that the training in its present form is probably not suitable for children with ASD",
"It has been proposed that deficient executive functions , such as flexibility , set maintenance , organization , planning , and working memory , may be primary cognitive deficits of autism ( Hughes , Russell , & Robbins , 1994 ; Ozonoff , Pennington , & Rogers , 1991 ) . Executive deficits may also play a part in several other developmental and neurological disorders , however ( Ozonoff , 1997 ; Pennington & Ozonoff , 1996 ) , including attentiondeficit hyperactivity disorder ( ADHD ; Chelune , Ferguson , Koon , & Dickey , 1986 ) and Tourette syndrome ( TS ; Bornstein , 1990 ; Gladstone el al. , 1993 ) . This finding has raised the so-called \" discriminant validity question \" ( Pennington , 1994 ; Pennington & Ozonoff , 1996 ) : That is , how can disorders differing in behavioral phenotype share the same cognitive underpinnings ? One answer to this question is that specific types of executive impairment may be associated with specific neurodevelopmental disorders . Since the class of executive behaviors is large and diverse , it is important to clarify precisely which functions are impaired in each disorder . We hypothesized that when the broad domain of executive function was parsed into specific components ( e.g. , planning , flexibility , inhibition ) , different disorders would demonstrate different executive profiles . Three measures , the Wisconsin Card Sorting Task ( WCST ) , the Tower of Hanoi ( TOH ) , and the Stroop Color-Word Test , have traditionally been used to measure executive function deficits in neurodevelopmental disorders . The WCST ( Grant & Berg , 1948 ; Heaton , Chelune , Talley , Kay , & Curtiss , 1993 ) was design ed primarily to test flexibility , the TOH ( Borys , Spitz ,",
"Objective : Prospect i ve study of attention , executive functions , and mentalizing abilities in a representative sample of teenage-onset anorexia nervosa ( AN ) . Method : A total of 51 AN cases recruited after community screening were contrasted with 51 matched comparison cases 18 years after AN onset . Neuropsychological tests had been done at 21 , 24 , and 32 years ( 18 years after AN onset ) . Results : The AN-group had more attention , executive function , and mentalizing problems . Some of these problems had been present at all three follow-up occasions . Conclusions : AN is associated with a range of neuropsychological problems that are present long after the eating disorder per se is no longer an important feature",
"BACKGROUND Unstuck and On Target ( UOT ) is an executive function ( EF ) intervention for children with autism spectrum disorders ( ASD ) targeting insistence on sameness , flexibility , goal - setting , and planning through a cognitive-behavioral program of self-regulatory scripts , guided/faded practice , and visual/verbal cueing . UOT is context ually-based because it is implemented in school and at home , the context s in which a child uses EF skills . METHODS To evaluate the effectiveness of UOT compared with a social skills intervention ( SS ) , 3rd-5th grade rs with ASD ( mean IQ = 108 ; UOT n = 47 ; SS n = 20 ) received interventions delivered by school staff in small group sessions . Students were matched for gender , age , race , IQ , ASD symptomotolgy , medication status , and parents ' education . Interventions were matched for ' dose ' of intervention and training . Measures of pre-post change included classroom observations , parent/teacher report , and direct child measures of problem-solving , EF , and social skills . Schools were r and omized and evaluators , but not parents or teachers , were blinded to intervention type . RESULTS Interventions were administered with high fidelity . Children in both groups improved with intervention , but mean change scores from pre- to postintervention indicated significantly greater improvements for UOT than SS groups in : problem-solving , flexibility , and planning/organizing . Also , classroom observations revealed that participants in UOT made greater improvements than SS participants in their ability to follow rules , make transitions , and be flexible . Children in both groups made equivalent improvements in social skills . CONCLUSIONS These data support the effectiveness of the first context ually-based EF intervention for children with ASD . UOT improved classroom behavior , flexibility , and problem-solving in children with ASD . Individuals with variable background /training in ASD successfully implemented UOT in mainstream educational setting"
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We aim ed to synthesis e evidence to assess the effect and safety of NaFeEDTA on Hb and serum ferritin in Fe-deficient population s. We performed a systematic review , identifying potential studies by search ing the electronic data bases of Medline , Cochrane Library , Embase , WHO Library and China National Knowledge Infrastructure . We also h and - search ed relevant conference proceedings and reference lists . Finally , we contacted experts in the field . The selection criteria included r and omised or quasi-r and omised controlled trials of NaFeEDTA compared with placebo . Hb , serum ferritin and adverse effects were outcomes of interest . Inclusion decisions , quality assessment and data extraction were performed by two review ers independently . Seven studies met the inclusion criteria . All included studies assessed the effect of NaFeEDTA on Hb concentration , four studies assessed the effect on serum ferritin concentration , and one study on serum Zn concentration . After the intervention , Hb concentration and serum ferritin concentration were both higher in the NaFeEDTA group compared with the control group . For Hb , data from six studies could be pooled and the pooled estimate ( weighted mean difference ) was 8.56 ( 95 % CI 2.21 , 14.90 ) g/l ( P = 0.008 ) . For serum ferritin , data from four studies could be pooled and the pooled difference was 1.58 ( 95 % CI 1.20 , 2.09 ) microg/l ( P baseline Hb level was associated with a greater increase in Hb concentration . No significant difference in serum Zn concentration was found . We concluded that NaFeEDTA increased both Hb concentration and serum ferritin concentration substantially in Fe-deficient population s , and could be an effective Fe preparation to combat Fe deficiency
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"BACKGROUND Iron-fortified school breakfasts have been introduced in Peru to combat childhood iron deficiency . OBJECTIVE We evaluated whether iron absorption from a school breakfast meal was improved by increasing the ascorbic acid content or by adding an alternative enhancer of iron absorption , Na2EDTA . DESIGN In a crossover design , iron absorption from test meals was evaluated by erythrocyte incorporation of 58Fe and 57Fe . The test meals ( wheat bread and a drink containing cereal , milk , and soy ) contained 14 mg added Fe ( as ferrous sulfate ) including 2.0 - 2.6 mg 58Fe or 4.0 - 7.0 mg 57Fe . RESULTS Geometric mean iron absorption increased significantly from 5.1 % to 8.2 % after the molar ratio of ascorbic acid to fortification iron was increased from 0.6:1 to 1.6:1 ( P Geometric mean iron absorption increased significantly from 2.9 % to 3.8 % , from 2.2 % to 3.5 % , and from 2.4 % to 3.7 % after addition of Na2EDTA at molar ratios relative to fortification iron of 0.3:1 , 0.7:1 , and 1:1 , respectively , compared with test meals containing no added enhancers ( P Iron absorption after addition of ascorbic acid ( molar ratio 0.6:1 ) was not significantly different from that after addition of Na2EDTA ( molar ratio 0.7:1 ) . CONCLUSIONS Ascorbic acid and Na2EDTA did not differ significantly in their enhancing effects on iron absorption at molar ratios of 0.6:1 to 0.7:1 relative to fortification iron . Additional ascorbic acid ( molar ratio 1.6:1 ) increased iron absorption significantly . Increasing the molar ratio of Na2EDTA to fortification iron from 0.3:1 to 1:1 had no effect on iron absorption",
"BACKGROUND Iron deficiency anemia and recurrent infections are common among children of low socioeconomic status . OBJECTIVE The objective was to evaluate the effects of iron supplementation on iron status and morbidity in children with or without infection . DESIGN Children aged 5 - 10 y were recruited for a r and omized , controlled , double-blind study from out patients attending the Children 's Hospital , Colombo , Sri Lanka . Clinical , inflammatory , nutritional , and iron statuses were determined at baseline and after the intervention . Children with a history of recurrent upper respiratory tract infections ( URTIs ) and with laboratory and clinical evidence of a current URTI constituted the infection group ( n = 179 ) , and children without infection constituted the control group ( n = 184 ) . Subjects in both groups were supplemented with ferrous sulfate ( 60 mg Fe ) or placebo once daily for 8 wk . Morbidity from URTIs , the number of gastrointestinal infections , and compliance were recorded every 2 wk . RESULTS The overall prevalence of anemia was 52.6 % . Iron supplementation significantly improved iron status by increasing hemoglobin ( P ferritin ( P iron status in the children who received placebo . In both the infection group and the control group , the mean number of URTI episodes and the total number of days sick with an URTI during the period of intervention were significantly lower ( P iron supplements than in those who received placebo . CONCLUSION Iron supplementation significantly improves iron status and reduces morbidity from URTIs in children with or without infection ",
"A targeted , double-blind controlled iron fortification trial using Fe(111)-EDTA in masala ( curry powder ) was directed towards an Fe-deficient Indian population for 2 y. The Fe status of the fortified group improved more than that of control subjects . Improvement reached significance over control subjects for females in hemoglobin ( p = 0.0005 ) , ferritin ( p = 0.0002 ) , and body Fe stores ( p = 0.001 ) and for males in ferritin ( p = 0.04 ) . The prevalence of Fe-deficiency anemia ( IDA ) decreased from 22 to 5 % in fortified females . Premenopausal women , multipara women , and women with prolonged menstruation or initial IDA benefitted most from fortification . The mean increase in body Fe stores in females with initial IDA was 9.0 + /- 1.3 mmol , representing an increased absorption of 12 mumol/d . Fortified subjects with normal Fe status did not accumulate excessive body Fe and there was no alteration in serum Zn concentrations . Targeted fortification is a safe and effective means of combatting Fe deficiency",
"We studied the effect of iron supplementation on the iron status of mothers and on biochemical iron status and clinical and anthropometric measures in their infants . The subjects were 197 pregnant women selected at 28 wk + /- 21 d of gestation at a mother- and -child health center in Niamey , Niger . Ninety-nine women received 100 mg elemental Fe/d throughout the remainder of their pregnancies and 98 received placebo . The prevalence of anemia and iron deficiency decreased markedly during the last trimester of pregnancy in the iron-supplemented group but remained constant in the placebo group . Three months after delivery , the prevalence of anemia was significantly higher in the placebo group . At delivery , there were no differences between the two groups in cord blood iron variables . Three months after delivery , serum ferritin concentrations were significantly higher in infants of women in the iron-supplemented group . Mean length and Apgar scores were significantly higher in infants with mothers in the iron group than in those with mothers in the placebo group",
"BACKGROUND Fish sauce is consumed daily by a large proportion of the Vietnamese population and could therefore be a potentially useful food vehicle for iron-fortification programs . OBJECTIVE We evaluated the efficacy of iron-fortified fish sauce in improving the iron status of anemic women . DESIGN In a r and omized , double-masked study of 152 anemic ( hemoglobin concentration of 81 - 119 g/L ) women , a meal based on noodles or rice was served 6 d/wk with 10 mL fish sauce containing either 10 mg Fe as NaFeEDTA ( iron-fortified group ) or no added iron ( control group ) . Concentrations of hemoglobin , serum ferritin ( SF ) , and serum transferrin receptor ( TfR ) were measured at baseline and after 3 and 6 mo . RESULTS After 6 mo , hemoglobin and SF concentrations were higher and TfR concentrations were lower in the iron-fortified group than in the control group [ hemoglobin : 116.3 + /- 8.7 ( + /- SD ) compared with 107.6 + /- 11.0 g/L ( P iron deficiency ( SF 8.5 mg/L ) and iron deficiency anemia ( iron deficiency with hemoglobin iron-fortified fish sauce significantly reduced the prevalence of iron deficiency anemia in Vietnamese women during the 6-mo intervention . Fortifying fish sauce with iron by using a water-soluble , highly bioavailable compound ( NaFeEDTA ) is a promising strategy for combating iron deficiency anemia in Vietnam",
"A 32-mo-long , double-blind field study involving one highl and control community receiving only vitamin A-fortified sugar and three vitamin A- and FeNaEDTA-sugar-fortified communities , two in the lowl and s and one in the highl and s of Guatemala , was undertaken to test the effectiveness of this approach in controlling iron deficiency . The communities ' population ranged between 1200 and 17000 . Sugar fortified with 1 g FeNaEDTA and 15 mg retinol as retinyl palmitate/kg was stable , did not segregate , and was well accepted by the communities . The impact of fortification on iron nutrition was estimated at 8 , 20 , and 32 mo of intervention . All pregnant women and subjects with severe anemia received supplements or treatment and were excluded from the analysis . Iron stores in the fortified communities increased significantly except for women 18 - 48 y of age in one lowl and community and > 49 y in the highl and community . Iron stores in the control community remained unchanged except for a rise among adult males",
"The dose-dependent inhibitory effect of sodium phytate on iron absorption was studied in man by serving wheat rolls containing no phytates and rolls to which various amounts ( seven dose levels between 2 and 250 mg expressed as phytate phosphorus ) were added just before serving . Fe in the two kinds of rolls was labeled with two radioisotopes of Fe ( 55Fe , 59Fe ) and the rolls were served on alternate days . The inhibition of Fe absorption was strongly related to the amount of phytate added ; 2 mg inhibited absorption by 18 % , ( p less than 0.001 ) , 25 mg by 64 % ( p less than 0.001 ) , and 250 mg by 82 % ( p less than 0.001 ) . The addition of ascorbic acid significantly counteracted the inhibition whereas the corresponding effect of meat was less well defined and only seen at the highest phytate level . The marked inhibition of Fe absorption by phytates and the significant counteracting effect of ascorbic acid have wide nutritional implication",
"One cost-effective strategy for controlling iron deficiency is the fortification of staple foods or condiments with iron . We evaluated the effectiveness of fortifying fish sauce with NaFeEDTA for improving iron status in women of childbearing age in Vietnam in a double-blind intervention with r and omization by village . All families in the selected villages were supplied with fish sauce that was either unfortified ( Group C , 10 villages ) or fortified with NaFeEDTA [ 9 mmol ( 500 mg ) Fe/L , Group F , 11 villages ] for 18 mo . The effect of fortification was assessed in the 576 women ( n = 288/group ) by measuring hemoglobin and serum ferritin ( SF ) at 6 , 12 , and 18 mo . Analysis of the group x time interaction using a repeated- measures test for each response demonstrated a significant effect of fortification on hemoglobin ( P = 0.039 ) and log SF ( P prevalence of iron deficiency ( SF prevalence of anemia ( hemoglobin NaFeEDTA fortification of fish sauce is an effective method for reducing the prevalence of iron deficiency in women in Vietnam",
"Serum ferritin has been measured by a two-site immunoradiometnic assay employing antibody-coated polystyrene tubes . Normal values were established by performing measurements in male and female subjects between 20 and 50 years of age in whom iron-deficient erythropoiesis was excluded on the basis of transferrin saturation and red cell protoporphyrin . The serum fernitin was log-normally distributed with a geometric mean of 94 ng/ml in 174 males and 34 ng/ml in 152 females . Additional studies were performed in 83 healthy women to determine the relationshipbetween serum ferritin and iron stores measured by radioiron absorption . A high correlation between these measurements indicates that the serum ferritin is a useful survey tool for the initial assessment and prospect i ve monitoring of iron stores in a normal population . Am . J. Clin . Nutr . 27 : 681 -687 , 1974",
"The objective of this research was to study the effectiveness of NaFeEDTA-fortified soy sauce for controlling iron deficiency in a high-risk population . This was an 18-month , r and omized , placebo-controlled intervention trial in 14,000 residents aged three years or older in Bijie City , Guizhou Province , China , using sodium-iron ethylene diamine tetraacetate (NaFeEDTA)-fortified soy sauce ( 29.6 mg Fe/100 ml ) . The study data included measurements of food consumption , hemoglobin , serum ferritin , and serum retinol . The results showed that the diet consisted primarily of cereals , fruits , and vegetables , with very little meat . Food consumption remained unchanged during the study period and was similar in the fortified and control groups . The average daily soy sauce consumption of the group consuming the fortified product was 16.4 ml per person , which provided 4.9 mg of iron from NaFeEDTA . At the end of the trial , all age and sex subgroups receiving NaFeEDTA had significantly higher hemoglobin levels , a lower prevalence of anemia , and higher plasma ferritin levels than the controls . The effects became statistically significant after six months of intervention and were maintained throughout the study period . We conclude that NaFeEDTA-fortified soy sauce was highly effective in controlling iron deficiency and reducing the prevalence of iron-deficiency anemia in men , women , and children . NaFeEDTA-fortified soy sauce is affordable and was well accepted by the study population",
"The therapeutic effects of NaFeEDTA-fortified soy sauce on anaemic students were investigated . Three hundred and four iron-deficient anaemic school children ( 11 - 17 years ) were r and omly assigned to three treatment groups : control group ( consuming non-fortified soy sauce ) , low-NaFeEDTA group ( consuming fortified soy sauce , providing 5 mg Fe/day ) and high-NaFeEDTA group ( consuming fortified soy sauce , providing 20 mg Fe/day ) . Blood haemoglobin ( Hb ) levels were determined before and after 1 month , 2 months and 3 months of intervention . In addition , serum iron ( SI ) , serum ferritin ( SF ) , free erythrocytic porphyrin ( FEP ) , total iron binding capability ( TIBC ) and transferritin ( TF ) were measured before and after consumption of soy sauce for 3 months . The results obtained herein show that the parameters measured were not changed remarkably within the 3-month intervention in the control group ( P increased Hb , SI , SF and TF levels and decreased TIBC and FEP levels were observed in both the high-NaFeEDTA group ( P effectiveness of iron intervention in the low-NaFeEDTA group and high-NaFeEDTA group had no statistical significance after 3 months . It was concluded that nutritional intervention for anaemic students using NaFeEDTA-fortified soy sauce could play a positive role in the improvement of iron status and control of anaemia",
"Cluster r and omized controlled trials ( C RCTs ) are attractive in setting s in which individual r and omization is difficult or impossible . This issue is common when study ing several health problems in developing countries . The authors aim ed to assess empirically the extent to which the prerequisite design and analysis aspects of cluster r and omization were taken into account and reported properly in C RCTs conducted in sub-Saharan Africa . C RCTs published in the last three decades were evaluated by using a checklist based on the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement . The authors identified 51 eligible C RCTs ; 40 of them ( 78 % ) had been published after 1990 . Only 10 ( 20 % ) studies took clustering into account in sample size or power calculations , and only 19 ( 37 % ) took clustering into account in the analysis . Intracluster correlation coefficients and design effects were reported in only one ( 2 % ) and three ( 6 % ) trials , respectively . An increasing number of C RCTs are conducted in sub-Saharan Africa , but many are not analyzed and reported properly . The special features stemming from cluster r and omization need to be addressed in the design , analysis , and reporting of these studies"
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Background Little is known about the most effective occupational health and safety ( OHS ) interventions to reduce upper extremity musculoskeletal disorders ( MSDs ) and injuries . Methods A systematic review used a best evidence synthesis approach to address the question : “ do occupational health and safety interventions have an effect on upper extremity musculoskeletal symptoms , signs , disorders , injuries , cl aims and lost time ? ” Results The search identified 36 studies of sufficient method ological quality to be included in data extraction and evidence synthesis . Overall , a mixed level of evidence was found for OHS interventions . Levels of evidence for interventions associated with positive effects were : Moderate evidence for arm supports ; and Limited evidence for ergonomics training plus workstation adjustments , new chair and rest breaks . Levels of evidence for interventions associated with “ no effect ” were : Strong evidence for workstation adjustment alone ; Moderate evidence for biofeedback training and job stress management training ; and Limited evidence for cognitive behavioral training . No interventions were associated with “ negative effects ” . Conclusion It is difficult to make strong evidence d-based recommendations about what practitioners should do to prevent or manage upper extremity MSDs . There is a paucity of high quality OHS interventions evaluating upper extremity MSDs and none focused on traumatic injury outcomes or workplace m and ated pre-placement screening exams . We recommend that worksites not engage in OHS activities that include only workstation adjustments . However , when combined with ergonomics training , there is limited evidence that workstation adjustments are beneficial . A practice to consider is using arm supports to reduce upper extremity MSDs
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"BACKGROUND This study exp and ed previous NIOSH-IRS research examining the effects of rest breaks and stretching exercises on symptoms and performance in data -entry workers . METHODS All workers spent 4 weeks with conventional breaks ( two 15 min breaks per day ) and 4 weeks with supplementary breaks ( two 15 min breaks plus four 5 min breaks per day ) . One-half were assigned at r and om to a group instructed to perform brief stretching exercises during breaks . The remainder comprised the \" no stretching \" ( control ) group . RESULTS 51 workers ( stretch group n = 21 ; no stretch group n = 30 ) completed the study symptom question naires . Discomfort and eyestrain were significantly lower with supplementary breaks , and supplementary breaks attenuated accumulation of discomfort and eyestrain during work sessions . Data -entry speed was significantly faster with supplementary breaks so that work output was maintained , despite replacing 20 min of work time with break time . In the stretch group , workers reported stretching during only 25 % of conventional breaks and 39 % of supplementary breaks , and no significant effects of stretching on discomfort or performance were observed . CONCLUSIONS These results provide further converging evidence that supplementary breaks reliably minimize discomfort and eyestrain without impairing productivity . Low compliance in performing stretches prevented valid assessment of stretching effects . Further research on stretching exercises and exercise compliance is warranted",
"In practice the secondary prevention of work-related upper extremity ( WRUE ) symptoms generally targets biomechanical risk factors . Psychosocial risk factors have also been shown to play an important role in the development of WRUE symptom severity and future disability . The addition of a stress management component to biomechanically focused interventions may result in greater improvements in WRUE symptoms and functional limitations than intervening in the biomechanical risk factors alone . Seventy office workers with WRUE symptoms were r and omly assigned to an ergonomics intervention group ( assessment and modification of work station and stretching exercises ) or a combined ergonomic and job stress intervention group ( ergonomic intervention plus two 1-h workshops on the identification and management of workplace stress ) . Baseline , 3- and 12-month follow-up measures of observed ergonomic risks and self-reported ergonomic risks , job stress , pain , symptoms , functional limitation , and general physical and mental health were obtained from all participants . While both groups experienced significant decreases in pain , symptoms , and functional limitation from baseline to three months with improvements continuing to 12 months post baseline , no significant differences between groups were observed for any outcome measures . Findings indicate that the additional two-session job stress management component did not significantly enhance the short- or long-term improvements brought about by the ergonomic intervention alone",
"BACKGROUND High rates of work-related injuries are seen among health care workers involved in lifting and transferring patients . We studied the effects of a participatory worker-management ergonomics team among hospital orderlies . METHODS This prospect i ve intervention trial examined work injuries and other outcomes before and after the intervention , with other hospital employees used as a concurrent control . All orderlies in a 1,200-bed urban hospital were studied using passively collected data ( mean employment during study period 100 - 110 orderlies ) ; 67 orderlies ( preintervention ) and 88 orderlies ( postintervention ) also completed a question naire . The intervention was the formation of a participatory ergonomics team with three orderlies , one supervisor , and technical advisors . This team design ed and implemented changes in training and work practice s. RESULTS The 2-year postintervention period was marked by decreased risks of work injury ( RR = 0.50 , 95 % CI 0.35 - 0.72 ) , lost time injury ( RR = 0.26 , 95 % CI 0.14 - 0.48 ) , and injury with three or more days of time loss ( RR = 0.19 , 95 % CI 0.07 - 0.53 ) . Total lost days declined from 136.2 to 23.0 annually per 100 full-time worker equivalents ( FTE ) . Annual workers ' compensation costs declined from $ 237/FTE to $ 139/FTE . The proportion of workers with musculoskeletal symptoms declined and there were statistically significant improvements in job satisfaction , perceived psychosocial stressors , and social support among the orderlies . CONCLUSION Substantial improvements in health and safety were seen following implementation of a participatory ergonomics program",
"This study examined the effects of supplementary rest breaks on musculoskeletal discomfort , eyestrain , mood , and performance in data -entry workers . Two rest break schedules were compared in a within-subjects design . Workers alternated between a ‘ conventional ’ and a ‘ supplementary ’ schedule in 4-week intervals . The conventional schedule contained a 15-min break during the first half of the work shift and a 15-min break during the second half of the shift . The supplementary schedule contained the same two 15-min breaks , and a 5-min break during each hour which otherwise did not contain a break , for a total of 20 extra minutes of break time . Results are based on data from 42 workers . They indicated that discomfort in several areas of the body , and eyestrain , were significantly lower under the supplementary than under the conventional schedule . While symptoms increased from pre- to post-work periods under both schedules , the magnitude of the increases was significantly less under the supplementary schedule . In addition , increases in discomfort of the right forearm , wrist and h and over the course of the work week under the conventional schedule were eliminated under the supplementary schedule . These beneficial effects were obtained without reductions in data -entry performance",
"Health and safety literature stresses the value of programs aim ed at preventing musculoskeletal injuries . The concepts of empowerment learning are often recommended as guidelines for worker education yet these approaches are largely untested . The present study compares the traditional approach involving lecture and discussion with a participatory method . A sample of 102 participants employed at a central ized reservation facility was used . Participants were r and omly assigned to either the traditional education group or the participatory education group . Data collection utilized surveys completed by study participants and observational checklists completed by a trained observer . Data were collected prior to intervention and at approximately 3 , 6 , and 12 months post intervention . Results of data analysis provide no evidence that participatory methods are more effective than traditional methods in encouraging workers to position their work equipment correctly or to maintain good working postures to prevent musculoskeletal injuries",
"Three groups of data entry female visual display terminal ( VDT ) workers from Norway ( n = 30 ) , Pol and ( n = 33 ) and the USA ( n = 29 ) were compared . Before intervention , the Norwegian group reported more neck pain compared with the Polish group . The Polish group reported less shoulder pain than both the U.S. and the Norwegian groups . The clinical examination documented fewer symptoms and signs of musculoskeletal illness among the Polish participants compared with the Norwegian and the U.S. groups . After intervention , the Norwegian group reported a reduction in neck pain while the U.S. group reported a reduction in shoulder pain . The Polish group reported an increase in neck , shoulder and forearm pain at follow-up compared to after intervention . The Polish group recorded higher flexion of the upper arm at follow-up parallel with an increase of pain in the upper part of the body . Visual discomfort showed variable results in the 3 countries",
"This r and omized clinical trial evaluated the effects of keyboard keyswitch design on computer users with h and paresthesias . Twenty computer users were matched and r and omly assigned to keyboard A ( n = 10 ) or B ( n = 10 ) . The keyboards were of conventional layout and differed in keyswitch design . Various outcome measures were assessed during the 12 weeks of use . Subjects assigned keyboard A experienced a decrease in h and pain between weeks 6 and 12 when compared with keyboard B subjects ( P = 0.05 ) and demonstrated an improvement in the Phalen test time ( right h and , P = 0.006 ; left h and , P = 0.06 ) . Keyboard assignment had no significant effect on change in h and function or median nerve latency . We conclude that use of keyboard A for 12 weeks led to a reduction in h and pain and an improved physical examination finding when compared with keyboard B. There was no corresponding improvement in h and function or median nerve latency",
" A group of routine data entry operators ( female ) was included in the Polish MEPS ( musculoskeletal — eyestrain— psychosocial — stress ) study . Before the intervention , ergonomic assessment revealed improper working conditions such as inadequate lighting , uncomfortable chairs , and lack of forearm and wrist support while medical examination revealed that trapezius muscle load along with upper arm , head and back angles were higher than advisable . Subjects complained about neck and shoulder pain , visual problems , and psychosocial conditions . The ergonomic intervention included installation of new luminaires and Venetian blinds , new chairs , repair of ventilators , and optometric corrections . The results after the intervention showed mainly improvement in chair comfort , lighting conditions , visual strain , and sitting posture . However , financial limitations did not allow satisfactory completion of the intervention leading to a mixed interpretation of the results",
"Background : Call centre work with computers is associated with increased rates of upper body pain and musculoskeletal disorders . Methods : This one year , r and omised controlled intervention trial evaluated the effects of a wide forearm support surface and a trackball on upper body pain severity and incident musculoskeletal disorders among 182 call centre operators at a large healthcare company . Participants were r and omised to receive ( 1 ) ergonomics training only , ( 2 ) training plus a trackball , ( 3 ) training plus a forearm support , or ( 4 ) training plus a trackball and forearm support . Outcome measures were weekly pain severity scores and diagnosis of incident musculoskeletal disorder in the upper extremities or the neck/shoulder region based on physical examination performed by a physician blinded to intervention . Analyses using Cox proportional hazard models and linear regression models adjusted for demographic factors , baseline pain levels , and psychosocial job factors . Results : Post-intervention , 63 participants were diagnosed with one or more incident musculoskeletal disorders . Hazard rate ratios showed a protective effect of the armboard for neck/shoulder disorders ( HR = 0.49 , 95 % CI 0.24 to 0.97 ) after adjusting for baseline pain levels and demographic and psychosocial factors . The armboard also significantly reduced neck/shoulder pain ( p = 0.01 ) and right upper extremity pain ( p = 0.002 ) in comparison to the control group . A return-on-investment model predicted a full return of armboard and installation costs within 10.6 months . Conclusion : Providing a large forearm support combined with ergonomic training is an effective intervention to prevent upper body musculoskeletal disorders and reduce upper body pain associated with computer work among call centre employees",
"The effects of two different prevention programmes on : ( 1 ) reported neck , shoulder and back pain , ( 2 ) perceived physical exertion at work and perceived work-related psychosocial factors , were evaluated by question naires after 12 and 18 months . Female nursing aides and assistant nurses ( n = 282 ) working in the home-care services , were r and omly assigned to one of three groups for : ( 1 ) individually design ed physical training programme , ( 2 ) work-place stress management , ( 3 ) control group . Results revealed no significant differences between the three groups . However , improvements in low back pain were registered within both intervention groups for up to 18 months . Perceived physical exertion at work was reduced in the physical training group . Improvements in neck and shoulder pain did not differ within the three groups . Dissatisfaction with work-related , psychosocial factors was generally increased in all groups . As the aetiology of neck , shoulder and back disorders is multifactorial , a combination of the two intervention programmes might be preferable and should be further studied",
"Sixteen full-time clerical and office workers participated in this prospect i ve parallel-r and omized trial . Intervention consisted of four hours of individualized training through a multi-faceted injury prevention program . In Phase I , musculoskeletal symptoms , stress , and energy levels were measured before and after intervention . Differences between Group A ( intervention ) and Group B ( control ) were described ; pre to post differences between members within each group were also described . In Phase II , there were a greater number of statistically and clinical ly relevant differences within Group A at week 16 ( eleven weeks following intervention ) than at week five ( immediately post-intervention ) . The eyes , neck , shoulder , elbow-forearm , and wrist-h and were impacted most positively by intervention , however , the frequency and intensity of headaches increased . Stress and energy level differences were minimal . Group B workers received intervention during weeks 18 - 21 . Differences in average measures from pre to immediately post-intervention were greater within Group B than Group A. Both groups reported fewer sick days during the month of intervention than during pre and post-intervention months",
"Background and Purpose The purpose of this study was to evaluate the efficacy of a preventive ergonomic intervention , which was provided by physical therapists , on spinal and upper-extremity work-related posture and symptom complaints of workers who use video display terminals ( VDT ) . Subjects Two hundred employees who spent at least 20 hours per week at a VDT were r and omly divided into 2 groups . Group E received the ergonomic intervention and an informative brochure , and group I received only the brochure . Methods Both groups were evaluated at the beginning of the study and at a follow-up 5 months later . The following tools were used : a pain drawing and the Rapid Entire Body Assessment ( REBA ) method to assess spinal and upper-extremity work-related posture . Results Group E had a lower REBA score and reduced lower back , neck , and shoulder symptoms compared with group I. Discussion and Conclusion The results suggest that a personalized preventive ergonomic intervention can improve spinal and upper-extremity work-related posture and musculoskeletal symptoms for workers who use VDTs",
"The Norwegian MEPS ( musculoskeletal — eyestrain — psychosocial — stress ) study included 3 groups : data entry , data dialogue ( female ) and data dialogue ( male ) . Before intervention , the data entry group reported significantly more symptoms and signs of musculoskeletal illness and had longer periods in front of the video display terminal ( VDT ) without a break . The ergonomic intervention consisted mainly of ergonomic information and training . After intervention , the data dialogue female group reported a significant reduction in shoulder pain in parallel with a reduction in trapezius load . Increasing the underst and ing in how to adjust the work st and and chair may have been contributing factors to reducing the pain level . There was a significant reduction in eye problems in all groups ; the greatest reduction in eye symptoms was seen in the groups who had new optometric corrections",
"Objective : To investigate the effects of ambulant myofeedback training including ergonomic counselling ( Mfb ) and ergonomic counselling alone ( EC ) , on work-related neck-shoulder pain and disability . Methods : Seventy-nine female computer workers reporting neck-shoulder complaints were r and omly assigned to Mfb or EC and received four weeks of intervention . Pain intensity in neck , shoulders , and upper back , and pain disability , were measured at baseline , immediately after intervention , and at three and six months follow-up . Results : Pain intensity and disability had significantly decreased immediately after four weeks Mfb or EC , and the effects remained at follow up . No differences were observed between the Mfb and EC group for outcome and subjects in both intervention groups showed comparable chances for improvement in pain intensity and disability . Conclusions : Pain intensity and disability significantly reduced after both interventions and this effect remained at follow-up . No differences were observed between the two intervention groups",
"OBJECTIVES This study evaluated the effects on work-related neck and upper-limb disorders among computer workers stimulated ( by a software program ) to take regular breaks and perform physical exercises . Possible effects on sick leave and productivity were studied as well . A r and omized controlled design was used with cluster r and omization . Altogether 268 computer workers with complaints in the neck or an upper limb from 22 office locations were r and omized into a control group , one intervention group stimulated to take extra breaks and one intervention group stimulated to perform exercises during the extra breaks during an 8-weekperiod . Question naires were administered before and after the intervention , and questions were generated by the software during the intervention period . Computer usage was recorded online . RESULTS The data on self-reported recovery suggested a favorable effect ; more subjects in the intervention groups than in the control group reported recovery ( 55 % versus 34 % ) from their complaints and fewer reported deterioration ( 4 % versus 20 % ) . However , a comparison between the reported pre- and postintervention scores on the severity and frequency of the complaints showed no significant differences in the change among the three groups . No effects on sick leave were observed . The subjects in the intervention groups showed higher productivity . CONCLUSIONS The use of a software program stimulating workers to take regular breaks contributes to perceived recovery from neck or upper-limb complaints . There seems to be no additional effects from performing physical exercises during these breaks",
"OBJECTIVE To evaluate the effectiveness of a program design ed to reduce back pain in nursing aides . METHODS Female nursing aides from a university hospital who had suffered episodes of back pain for at least six months were included in the study . Participants were r and omly divided into a control group and an intervention group . The intervention program involved a set of exercises and an educational component stressing the ergonomic aspect , administered twice a week during working hours for four months . All subjects answered a structured question naire and the intensity of pain was assessed before and after the program using a visual analogue scale ( VAS ) . Student 's t-test or the Wilcoxon Rank Sum Test for independent sample s , and Chi-square test or the Exact Fisher test for categorical analysis , were used . The McNemar test and the Wilcoxon matched pairs test were used to compare the periods before and after the program . RESULTS There was a statistically significant decrease in the frequency of cervical pain in the last two months and in the last seven days in the intervention group . There was also a reduction in cervical pain intensity in the two periods ( 2 months , 7 days ) and lumbar pain intensity in the last 7 days . CONCLUSIONS The results suggest that a program of regular exercise with an emphasis on ergonomics can reduce musculoskeletal symptoms in nursing personnel",
"Study Design . A retrospective and prospect i ve cohort . Objectives . To compare the effectiveness of occupational intervention , early intervention , and st and ard care in the management of Worker ’s Compensation injury cl aims . Summary of Background Data . The current management of occupational back pain and work-related upper extremity disorders with either st and ard care or early intervention appears to be ineffective . Methods . A retrospective cohort compared injury cl aim incidence , duration , and costs between one company with access to st and ard care and another similar company with access to early intervention . A prospect i ve cohort looked at the effect of one company changing from st and ard care to occupational management in comparison with the control group with early intervention . Survival analysis was used to attempt to explain differences in injury cl aim duration . Results . St and ard care result ed in lower injury cl aim incidence , duration , and costs than early intervention , whereas occupational management result ed in lower injury cl aim incidence , duration , and costs than st and ard care . The covariates of physical therapist involvement , chiropractor involvement , injury severity , and relationship between Worker ’s Compensation and the employer were associated with delayed time to cl aim closure in the company with access to early intervention with the most important covariate being physical therapist involvement ( hazard rate ratio 19.88 , 95 % confidence interval 7.95–39.77 ) . Only the covariate of injury severity was associated with delayed time to cl aim closure in the company with access to occupational management ( hazard rate ratio 1.67 , 95 % confidence interval 1.05–27.20 ) . Conclusions . It is recommended that an occupational management approach , in comparison with st and ard care or early intervention , be considered for management of occupational injuries",
"A prospect i ve epidemiological field study covering a 2 years period has earlier been published . The study has a parallel group design with two intervention groups ( T and S ) and one control group ( C ) of Visual Display Unit ( VDU ) operators . The present paper covers the period from 2 to 6 years of the study . After 3.5 years , the C group got the same intervention in terms of new lighting system , new workplaces and at last an optometric examination and corrections if needed . The C group reported a significant reduction in visual discomfort after interventions while the two groups ( T and S ) continued to report significant reduction of visual discomfort after 6 years . By supporting the forearm on the table top , the C group reported significant reduction of shoulder and neck pain while the T group reported significant reduction in shoulder and back pain after 6 years . Organizational and psychosocial factors at work and outside work did not show any significant changes during the study period",
"Aims : To examine the effect of two workstation and postural interventions on the incidence of musculoskeletal symptoms among computer users . Methods : R and omised controlled trial of two distinct workstation and postural interventions ( an alternate intervention and a conventional intervention ) among 376 persons using computer keyboards for more than 15 hours per week . The incidence of neck/shoulder symptoms and h and /arm symptoms during six months of follow up among individuals in the intervention groups was compared to the incidence in computer users who did not receive an intervention ( comparison group ) . For individuals in the intervention groups , study staff adjusted workstations , where possible , and trained individuals to assume the intervention postures . Individuals reported musculoskeletal symptoms in a weekly diary . Participants who reported discomfort intensity of 6 or greater on a 0–10 visual analogue scale or who reported musculoskeletal symptoms requiring use of analgesic medication were considered symptomatic . Results : There were no significant differences in the incidence of musculoskeletal symptoms among the three intervention groups . Twenty two ( 18.5 % ) participants in the alternate intervention group , 25 ( 20.2 % ) in the conventional intervention group , and 25 ( 21.7 % ) in the comparison group developed incident arm or h and symptoms . Thirty eight ( 33.3 % ) participants in the alternate intervention group , 36 ( 31.0 % ) in the conventional intervention group , and 33 ( 30.3 % ) in the comparison group developed incident neck or shoulder symptoms . Compliance with all components of the intervention was attained for only 25–38 % of individuals , due mainly to the inflexibility of workstation configurations . Conclusions : This study provides evidence that two specific workplace postural interventions are unlikely to reduce the risk of upper extremity musculoskeletal symptoms among computer users",
"This pilot study investigated whether group training , in which participants become role models and coaches , would reduce discomfort as compared to a nontreatment Control Group . Sixteen experimental participants participated in 6 weekly 2-hr group sessions of a Healthy Computing program whereas 12 control participants received no training . None of the participants reported symptoms to their supervisors nor were they receiving medical treatment for repetitive strain injury prior to the program . The program included training in ergonomic principles , psychophysiological awareness and control , sEMG practice at the workstation , and coaching coworkers . Using two-tailed t tests to analyze the data , the Experimental Group reported ( 1 ) a significant overall reduction in most body symptoms as compared to the Control Group and ( 2 ) a significant increase in positive work-style habits , such as taking breaks at the computer , as compared to the Control Group . This study suggests that employees could possibly improve health and work style patterns based on a holistic training program delivered in a group format followed by individual practice",
"The United States MEPS ( musculoskeletal — eyestrain — psychosocial — stress ) study consisted of 1 group of 28 female data entry operators . The intervention was in 3 parts : workstation re design ( including advanced ergonomic chairs , motorized adjustable workstations , advanced adjustable keyboards , adjustable copyholders , adjustable footrests , monitor support surfaces ) and ergonomic training/coaching and corrective lenses . After the intervention , statistically significant reductions in physical signs ( trigger points , neck and shoulder mobility ) , subjective reports of intensity and frequency of musculoskeletal pain , and subjective reports of visual problems were observed . Static load during the work sample , as assessed by experts , improved after the intervention as did measured postural angles of head and trunk and subjective assessment of users of ergonomic characteristics of the workplaces . For all of these measures , improvements observed 1 month after intervention were also observed in the 1-year follow-up . Trapezius load , as assessed by electromyography ( EMG ) , decreased after intervention , but then increased in the follow-up . The increase was interpreted as a calibration problem",
"OBJECTIVES The aim of this study was to investigate the effect of raised bricklaying on physical workload , reported musculoskeletal disorders , sickness absence , and job satisfaction . METHODS A controlled intervention study with a follow-up period of 10 months was performed among 202 bricklayers from 25 construction companies . RESULTS The introduction of devices for raised bricklaying decreased the physical load on the lower back and , to a less extent , on the shoulders and upper extremities . Although raised bricklaying had no effect on the number of lifts , decreases in trunk bending lowered the biomechanical moment . The results showed no decrease in reported musculoskeletal symptoms as a result of the adoption of raised bricklaying . Irrespective of the reason(s ) , the percentage of bricklayers in the intervention group reporting sickness absence was significantly lower than the same percentage in the control group . The results also showed that , in general , the bricklayers in this study were very satisfied with the use of devices for raised bricklaying . CONCLUSIONS Controlled intervention studies on ergonomic improvements are rare . This study shows that the introduction of an ergonomic improvement in the construction industry may reduce physical load and the incidence of sickness absence",
"We investigated , on behalf of a large electronics manufacturer , two types of worker training interventions for their efficacy in preventing unnecessary muscle tension and the symptoms of work-related musculoskeletal disorders . The first intervention , Muscle Learning Therapy ( MLT ) , used electromyographic ( sEMG ) feedback and operant conditioning to decrease muscle tension during complex work tasks . The second intervention used adult learning and cognitive behavioral techniques in small group discussion to advance the worker 's capabilities for symptom and stress management and problem-solving . Workers were r and omly assigned to a control group or one of the two treatment conditions . Prior to training , baseline data were collected using symptom diaries and sEMG recordings of the trapezius and forearm muscles of the left and right arms . The training interventions were conducted for 6 weeks with reinforcement training provided at 18 and 32 weeks post-baseline . Follow-up data were collected after the initial 6-week training period and at 32 weeks , prior to the reinforcement training . Symptom outcomes demonstrated significant differences at 6 weeks , increasing in severity for the control group and declining modestly for the educational group , with little change for the MLT group . These differences were not maintained at further follow-up . The MLT group was consistently effective in reducing muscle tension in the trapezius areas after 6 and 32 weeks , and was partially effective for the forearms . Further testing is recommended of these training interventions , especially with the inclusion of strategic , periodic reinforcement of the worker 's learning",
"Using a computer keyboard with the forearms unsupported has been proposed as a causal factor for neck/shoulder and arm/h and diagnoses . Recent laboratory and field studies have demonstrated that forearm support might be preferable to working in the traditional \" floating \" posture . The aim of this study was to determine whether providing forearm support when using a normal computer workstation would decrease musculoskeletal discomfort in intensive computer users in a call centre . A r and omised controlled study ( n = 59 ) , of 6 weeks duration was conducted . Thirty participants ( Group 1 ) were allocated to forearm support using the desk surface with the remainder ( Group 2 ) acting as a control group . At 6 weeks , the control group was also set up with forearm support . Both groups were then monitored for another 6 weeks . Question naires were used at 1 , 6 and 12 weeks to obtain information about discomfort , workstation setup , working posture and comfort . Nine participants ( Group 1 n = 6 , Group 2 n = 3 ) withdrew within a week of commencing forearm support either due to discomfort or difficulty in maintaining the posture . At 6 weeks , the group using forearm support generated significantly fewer reports of discomfort in the neck and back , although the difference between the groups was not statistically significant . At 12 weeks , there were fewer reports of neck , back and wrist discomfort when preintervention discomfort was compared with post intervention discomfort . These findings indicate that for the majority of users , forearm support may be preferable to the \" floating \" posture implicit in current guidelines for computer workstation setup",
"The purpose of this study was to describe , and analyse the effect of an intervention on , the biomechanical workload in the neck and shoulder region of female hairdressers . Arm elevation was measured by inclinometers and muscular load of m. trapezius by electromyography . The intervention comprised working technique recommendations , e.g. to work with less elevated arms and more relaxed muscles . The subjects were r and omised between two different intensity levels of the intervention , one with written information only and the other with additional personal follow-up . The effect of the intervention was evaluated after 1 - 2 months . The hairdressers worked with their arms elevated 60 degrees or more for approximately 13 % of the total working time and 16 % during the specific hairdressing tasks . The intervention group including personal follow-up instructions had a reduction in workload from 4.0 % to 2.5 % of hairdressing time with highly elevated right upper arm , i.e. above 90 degrees . No effect was detected on muscular load or neck and shoulder symptoms after the intervention",
"Microbreaks are scheduled rest breaks taken to prevent the onset or progression of cumulative trauma disorders in the computerized workstation environment . The authors examined the benefit of microbreaks by investigating myoelectric signal ( MES ) behavior , perceived discomfort , and worker productivity while individuals performed their usual keying work . Participants were r and omly assigned to one of three experimental groups . Each participant provided data from working sessions where they took no breaks , and from working sessions where they took breaks according to their group assignment : microbreaks at their own discretion ( control ) , microbreaks at 20 min intervals , and microbreaks at 40 min intervals . Four main muscle areas were studied : the cervical extensors , the lumbar erector spinae , the upper trapezius/supraspinatus , and the wrist and finger extensors . The authors have previously shown that when computer workers remained seated at their workstation , the muscles performing sustained postural contractions displayed a cyclic trend in the mean frequency ( MNF ) of the MES ( McLean et al. , J. Electrophysiol . Kinesiol . 10 ( 1 ) ( 2000 ) 33 ) . The data provided evidence ( p microbreak protocol s were associated with a higher frequency of MNF cycling at the wrist extensors , at the neck when microbreaks were taken by the control and 40 min protocol groups , and at the back when breaks were taken by the 20 and 40 min protocol groups . No significant change in the frequency of MNF cycling was noted at the shoulder . It was determined ( p microbreaks had a positive effect on reducing discomfort in all areas studied during computer terminal work , particularly when breaks were taken at 20 min intervals . Finally , microbreaks showed no evidence of a detrimental effect on worker productivity . The underlying cause of MNF cycling , and its relationship to the development of discomfort or cumulative trauma disorders remains to be determined",
"OBJECTIVES This study evaluated the effect of an ergonomic training program on workstation changes and on the prevalence of musculoskeletal disorders among video display unit ( VDU ) users at a large university . METHODS A pretest-posttest design with a reference group was used with r and om allocation of administrative and geographic units . In each group , the measurements involved direct observation of the workstations , a self-administered question naire , and a physical examination . The measurements were performed 2 weeks before and 6 months after the training in parallel in both groups . The study population was composed of 627 workers ( 81 % of those eligible ) . RESULTS The prevalence of all 3 of the postural stressors evaluated decreased in the experimental group after the training . In the reference group , 2 of the 3 stressors decreased in frequency but to a less extent . Some of these beneficial changes were more frequent in workers under 40 years of age . The prevalence of musculoskeletal disorders decreased among the workers under 40 years of age in the experimental group , from 29 % to 13 % determined by question naire and from 19 % to 3 % determined by physical examination . In other groups , there was no significant change in the prevalence of musculoskeletal disorders . CONCLUSIONS Improvements in postural stressors occurred more frequently in the experimental group , and these beneficial changes tended to be more frequent in workers under 40 years of age . Improvements in musculoskeletal disorders occurred in the experimental group among the workers under 40 years of age",
"Objectives : The aim of this intervention study was to determine the effects of an alternative mouse and /or a forearm support board on the change in upper body discomfort scores and the development of incident musculoskeletal disorders . Methods : This r and omised controlled intervention trial followed 206 engineers for one year . Participants were r and omised to receive ( 1 ) a conventional mouse only , ( 2 ) an alternative mouse only , ( 3 ) a forearm support board , or ( 4 ) an alternative mouse plus forearm support board . Outcome measures included weekly upper body discomfort scores and incident musculoskeletal disorders . Results : During the study , 42 participants were diagnosed with an incident musculoskeletal disorder . The group that received the forearm support board experienced a reduction in their right upper extremity discomfort ( beta-coefficient −0.35 , 95 % CI −0.67 to −0.03 ) in comparison to those who did not receive a forearm board . The group that received the alternative mouse had a protective , but non-significant ( p = 0.20 ) , effect on incident cases of right upper extremity musculoskeletal disorders ( HR 0.57 , 95 % CI 0.24 to 1.34 ) and a non-significant reduction in neck/shoulder discomfort ( beta-coefficient −0.23 , 95 % CI −0.056 to 0.10 ) in comparison to those who received a conventional mouse . Conclusions : In engineers who use a computer for more than 20 h per week , a forearm support board may reduce right upper extremity discomfort attributed to computer use",
"A prospect i ve longitudinal study was carried out to investigate the occurrence of upper limb disorders in an electromechanical plant between 1980 and 1988 . It included clinical and epidemiological studies , measurement of vibration produced by the power tools used , ergonomic assessment of the works and time and motion studies . Simultaneously during the same period remedial actions were taken through multidisciplinary interventions when the specific causal factors were known . The study shows the clinical entities of the disorder , identifies the risk factors and evaluates the results of the interventions . It assists in establishing a cause and effect relationship for the condition and demonstrates the way a preventive strategy could be developed",
"The risk for the development of musculoskeletal disorders and associated conditions in clerical and office workers is well documented . The majority of work injury prevention programs for this population were single-faceted ( education , workstation re design , or task modification ) and yielded both positive and negative findings . This pilot study was conducted with 16 full-time clerical and office workers at a small private college . In a r and omized control trial , the intervention group received four hours of individualized training through a multi-faceted injury prevention program . Between group differences in musculoskeletal symptom frequency and intensity and perceived stress and energy levels existed , although were statistically insignificant . There was a statistically significant decrease in Lower Back ache/pain from pre to post measures for the intervention group",
"Eighty computer users with musculoskeletal disorders participated in a six-month , r and omized , placebo-controlled trial evaluating the effects of four computer keyboards on clinical findings , pain severity , functional h and status , and comfort . The alternative geometry keyboards tested were : the Apple Adjustable Keyboard ™ [ kb1 ] , Comfort Keyboard System ™ [ kb2 ] , Microsoft Natural Keyboard ™ [ kb3 ] and placebo . Compared to placebo , kb3 and to a lesser extent kb1 groups demonstrated an improving trend in pain severity and h and function following six months of keyboard use . However , there was no corresponding consistent improvement in clinical findings in the alternative geometry keyboard groups compared to the placebo group . Overall , there was a significant correlation between improvement of pain severity and greater satisfaction with the keyboards . These results provide evidence that keyboard users may experience a reduction in h and pain after several months of use of some alternative geometry keyboards",
"Objective . To investigate the prevalence and to identify causes of musculoskeletal pain ( MSP ) among reindeer herding Sami , and to evaluate the impact on the MSP symptoms elicited by an intervention-prevention programme ( IP programme ) . Study Design . A prospect i ve cohort study in which alterations in MSP symptoms were documented over a two-year period . Methods . Data were collected from 51 reindeer herders ( 26 men , 25 women ) before and after a two-year IP programme . Information on MSP characteristics ( affected body regions , pain duration and pain intensity ) and exposure to a number of physical and psychosocial risk factors were collected as part of comprehensive health examinations . Clinical examinations and interviews complemented self-reported data collected through question naires . Results . MSP symptoms were prevalent , both among women and men . High exposure to physical risk factors , to a large extent related to extensive use of snowmobiles and motorcycles , was the main cause of MSP among men , while psychosocial risk factors were suggested to be more important among women . About one-third of the reindeer herders reported fewer MSP symptoms as a result of the IP programme . Conclusions . This pilot study suggests that it is possible to reduce the number and the severity of the MSP symptoms among reindeer herders by implementing suitably tailored intervention-prevention measures",
"Study Design . R and omized controlled trial ( RCT ) . Objectives . To compare the effectiveness of training and equipment to reduce musculoskeletal injuries , increase comfort , and reduce physical dem and s on staff performing patient lifts and transfers at a large acute care hospital . Summary of Background Data . Back injury to nursing staff during patient h and ling tasks is a major issue in health care . The value of mechanical assistive devices in reducing injuries to these workers is unclear . Methods . This three-armed RCT consisted of a “ control arm , ” a “ safe lifting ” arm , and a “ no strenuous lifting ” arm . A medical , surgical , and rehabilitation ward were each r and omly assigned to each arm . Both intervention arms received intensive training in back care , patient assessment , and h and ling techniques . Hence , the “ safe lifting ” arm used improved patient h and ling techniques using manual equipment , whereas the “ no strenuous lifting ” arm aim ed to eliminate manual patient h and ling through use of additional mechanical and other assistive equipment . Results . Frequency of manual patient h and ling tasks was significantly decreased on the “ no strenuous lifting ” arm . Self-perceived work fatigue , back and shoulder pain , safety , and frequency and intensity of physical discomfort associated with patient h and ling tasks were improved on both intervention arms , but staff on the mechanical equipment arm showed greater improvements . Musculoskeletal injury rates were not significantly altered . Conclusions . The “ no strenuous lifting ” program , which combined training with assured availability of mechanical and other assistive patient h and ling equipment , most effectively improved comfort with patient h and ling , decreased staff fatigue , and decreased physical dem and s. The fact that injury rates were not statistically significantly reduced may reflect the less sensitive nature of this indicator compared with the subjective indicators",
"The study was initiated to evaluate the effect of pain-reducing therapies on factors previously associated with work-related shoulder and neck pain , namely increased muscle activity in the upper trapezius and perceived general tension . Thirty-three women in three groups were assessed before and after an intervention period and by question naire 6 months later . The purpose of this study was primarily to investigate associations between upper trapezius muscle activity , perceived general tension and pain , and secondly , to compare effects of individually based physiotherapy and group exercise for workers with shoulder and neck myalgia . All three groups reported a significant alleviation of pain and perceived general tension , while the electromyographically ( EMG ) recorded upper trapezius muscle activity level remained unchanged or increased . Improvements were similar in all three treatment groups , but individual-based therapies were rated more beneficial on subjective measures . Significant correlation was found between pain and perceived general tension ( r = 0.66 , p < 0.01 ) , while there was no correlation between pain or perceived general tension and recorded muscle activity",
"& NA ; The purpose of the study was to examine the effects of a workplace physical exercise intervention on the perceived intensity of headache and the intensity of symptoms in the neck and shoulders , as well as on the extension and flexion strength of the upper extremities . The study was a cluster r and omized controlled trial . The cross‐over design consisted of physical exercise intervention ( 15 weeks ) and no‐intervention ( 15 weeks ) . The subjects ( n=53 ) were office workers ( mean age 46.6 ( SD 8.4 ) ) who reported headache ( n=41 ) symptoms in the neck ( n=37 ) or shoulders ( n=41 ) , which had restricted their daily activities during the last 12 months . Pain symptoms were measured using the Borg CR10 scale and muscular strength with a 5RM test . Statistical analyses were based on linear mixed models . Physical exercise intervention result ed in a slight , but statistically significant , decrease in the intensity of headache and neck symptoms , as well as an increase in the extension strength of the upper extremities . The mean decrease in headache during the 5‐week period was 0.64 CR10 ( 95 % CI 0.28–1.00 ) ( P=0.001 ) or 49 % ( 95 % CI 22–77 ) , and 0.42 CR10 ( 95 % CI 0.11–0.72 ) ( P=0.002 ) or 49 % ( 95 % CI 13–85 ) in the intensity of neck symptoms . The mean increase in the extension strength of the upper extremities was 1.3 kg ( 95 % CI 0.5–2.1 ) ( P=0.001 ) or 4 % ( 95 % CI 1–6 ) . The intervention had no effect on the intensity of shoulder symptoms or the flexion strength of the upper extremities . Specific exercise may be clinical ly important to alleviate headache and neck symptoms ",
"There is evidence that performing job tasks involving repetition , vibration , sustained posture or forceful movement may contribute to symptoms of work related upper extremity disorders . Typing is one such activity ; symptoms that develop as a result of this activity can affect performance of work , self-care and leisure occupations . Studies investigating the impact of ergonomic keyboards on symptom reduction are limited , and little research exists regarding the reduction of key activation force as an intervention . Methods : This r and omized , prospect i ve study used a sample of 68 symptomatic workers employed by a single company . One group received a commercially available ergonomic keyboard , a second group used a modified version of the same keyboard design ed to reduce activation force , vibration and key travel . We measured symptoms and clinical signs , functional status , and device satisfaction in both groups over a six-month study period . Results : Between-groups analyses indicated that the groups performed similarly on the outcomes of interest . Repeated-measure analysis identified a reduction of symptoms , an improvement in functional status , preference for and increased satisfaction with the intervention keyboards , and maintenance of typing speed and accuracy for both groups . Conclusions",
"The objective of this study was to evaluate an auto-instructional preventive programme design ed to allow the subjects to identify critical aspects related to their work and musculoskeletal comfort , and provide them with some simple alternatives for controlling the identified problems . The programme was evaluated by 36 secretaries and bank clerks through their symptom perception before and after the programme . The results showed that the symptoms increased in number and severity . The programme seemed to have helped the participants to become aware of the ergonomic problems present in their job and to link these problems to physical symptoms . Self-administered preventive programmes can lead to clearly negative results when applied as the only measure to control musculoskeletal symptoms",
"The effects of group gymnastics on neck pain were studied among 44 women in a printing company . A r and omized cross-over design was used with two groups matched according to the work task , frequency of symptoms , and age . The treatment consisted of gymnastics for 45 min once a week for 10 weeks . Neck pain was rated by visual analogue scale and pressure pain sensitivity of the neck muscles was measured with an algometer . The results showed no clear effects of the group gymnastics program . An equal and significant reduction in pain ratings was seen in both groups after the first intervention in the spring . Recurrence of symptoms was seen in both groups in September , and no significant reduction in pain occurred during the second intervention in the autumn . The results suggest a seasonal variation in neck symptoms which has to be considered when planning or evaluating intervention studies",
"OBJECTIVE The purpose of this study was to evaluate the effectiveness of an active ergonomics training ( AET ) program in computer users . Two constructs from the social-cognitive theory were adopted to provide a more comprehensive assessment of the proximal markers of behavior change . METHOD Eighty-seven symptomatic and asymptomatic employees who worked at a computer for a minimum of 10 hours per week took part in a prospect i ve r and omized controlled study . Subjects participated in a six-hour training intervention at their workplace . Key elements of the AET intervention were skill development in workstation analysis , active participation , and implementation of multiple prevention strategies . RESULTS After receiving AET , risk factor exposure was significantly reduced for participants at higher risk [ F(1,82 ) = 6.42 , p knowledge [ F(1,74 ) = 8.39 , p self-efficacy [ F(1,73 ) = 6.95 , p outcome expectations [ F(1,75 ) = 8.75 , p AET intervention had significantly less upper back pain intensity ( z = -2.03 , p pain frequency ( z = -2.70 , p pain duration ( z = -3.25 , p work postures , work practice s , risk factor exposure , and pain",
"OBJECTIVES This study evaluated the effect of an intensive ergonomic approach and education on workstation changes and musculoskeletal disorders among workers who used a video display unit ( VDU ) . METHODS A r and omized controlled design was used . The subjects ( N=124 ) were allocated into three groups ( intensive ergonomics , ergonomic education , reference ) using stratified r and om sampling . The evaluation involved question naires , a diary of discomfort , measurements of workload , and an ergonomic rating of the workstations . The assessment s were made 2 weeks before the intervention and after 2 and 10 months of follow-up . RESULTS The intensive and training groups showed less musculoskeletal discomfort than the reference group after 2 months of follow-up . Positive effects on discomfort were seen primarily for the shoulder , neck , and upper back areas . No significant differences were found for the strain levels or prevalence of pain . After the intervention the ergonomic level was distinctly higher in the intensive ergonomic group than in the education or reference group . CONCLUSIONS Both the intensive ergonomics approach and education in ergonomics help reduce discomfort in VDU work . In attempts to improve the physical ergonomics of VDU workstations , the best result will be achieved with cooperative planning in which both workers and practitioners are actively involved",
"Study Design . This is a 4-month r and omized controlled trial to evaluate the effect of chair design on neck/shoulder pain among sewing machine operators . Objective . Determine whether a chair with a curved seat pan leads to improved changes in monthly neck/shoulder pain scores compared with a control intervention . Summary of Background Data . Sewing machine operators experience a high prevalence and severity of neck and shoulder pain in comparison to other working population s probably due to the sustained shoulder abduction and neck and upper back flexion required of the task . An adjustable height task chair that supports a forward sitting posture may reduce these posture-related risk factors and reduce neck/shoulder pain . Material s and Methods . A total of 277 sewing machine operators with neck/shoulder pain were assigned to receive 1 ) miscellaneous items ( control group ) , 2 ) a chair with a flat seat pan plus miscellaneous items , or 3 ) a chair with a curved seat pan plus miscellaneous items . Participants completed a monthly question naire assessing neck/shoulder pain severity . Results . Based on estimates of pain score changes from a repeat- measures linear regression , participants who received the flat seat chair experienced a decline in pain of 0.14 ( 95 % confidence interval , 0.07–0.22 ) points per month compared with those in the control group , while those who received the curved seat experienced a decline of 0.34 ( 95 % confidence interval , 0.28–0.41 ) points per month compared with those in the control group . These estimates did not change after adjustment for potential covariates . Conclusions . These findings demonstrate that an adjustable height task chair with a curved seat pan can reduce neck and shoulder pain severity among sewing machine operators",
"The study has a parallel group design with two intervention groups ( T and S ) and one control group ( C ) of VDU operators . Three serial interventions were carried out in the T and S groups , first a new lighting system , then new workplaces and last an optometric examination and corrections if needed . The new lighting gave significantly increased illuminance levels , increased luminances of the room surfaces and better luminance distribution . The two intervention groups reported significant improvement of the lighting conditions , as well as of the visual conditions and significantly reduced visual discomfort and glare . Significant reduction of headache was found in one of the intervention groups . Optometric corrections reduced the visual discomfort in both the intervention groups . When looking at those given new corrections , a significant reduction was found in the T group and a clear tendency was also found in the S group . The C group reported no improvements for any of these health outcomes . The workplace intervention gave the operator the possibility to support the whole forearm and h and on the table top . Before the intervention there were no significant differences between the three groups regarding shoulder pain and static trapezius electromyographic ( EMG ) load . Two years after the intervention , a significant reduction of shoulder pain was reported in the T and S groups in parallel with a significant reduction in static trapezius load , while no such reduction was found in the C group . At the same time , both static trapezius load and shoulder pain were significantly lower in the T and S groups compared with the C group . Pain in the forearm and h and showed no significant changes in any of the groups during the study period . However , there seem to be a relationship between pain in the forearm and h and and the time the operator used the mouse . The C group reported significantly higher intensity of pain and used the mouse significantly more than the S group",
"The effects of Ergorest ® arm supports on wrist angles and musculoskeletal strain in the neck-shoulder-arm region and electrical activity in the shoulder and arm muscles were studied during typing or the use of the mouse in work with a visual display unit ( VDU ) . Twenty-one women were r and omized into 3 groups ( 1 arm support , 2 arm supports , and control ) . Measurements were carried out before and after the 6-week intervention . The wrist extension of the mouse h and , the muscle activity of the trapezius muscle , and the subjective discomfort ratings indicated that 2 arm supports were better than 1 in work with a mouse . The Ergorest ® arm support alleviates muscle and joint strain in VDU work when used for both arms",
"The effects of a downward-tilting ( DT ) keyboard tray on wrist posture , seated posture and self-assessed musculoskeletal discomfort were investigated in a field experiment . Thirty-eight professional office workers were studied . A pretest assessed how they typed using either a conventional keyboard on a desk or on an articulating keyboard tray , and with or without wrist rests . Workers were r and omly allocated to a control ( n = 15 ) or test group ( n = 23 ) that used their existing keyboard in a DT system . A post-test was conducted 3 weeks later . Results showed no significant changes in wrist posture , seated posture or reports of musculoskeletal discomfort for the control group , and approximately 50 % of typing wrist movements put the h and in a neutral zone . There were significant improvements in wrist posture , seated posture and upper body musculoskeletal discomfort for the test group using the DT system . Over 80 % of typing wrist movements put the h and into a neutral zone with the DT arrangement . Reactions to using a conventional keyboard on a DT system were positive",
"The effect of \" neck school \" on neck and shoulder disorders was studied in medical secretaries . A neck school reinforced with compliance enhancing measures ( group B ) was compared with a traditional neck school ( group A ) and a control group ( group C ) . The results show that ergonomical knowledge was good even before the secretaries attended the neck schools and that compliance was significantly higher for group B. When comparisons were made within groups some improvements on neck and shoulder fatigue and pain were noted , particularly for group B. When workload was controlled no significant group differences were found . No differences were noted for range of neck motion , or sick leave in any group . Our conclusion is that neck schools , despite good compliance , appear to be of limited clinical value for prevention of neck and shoulder disorders",
"One hundred and eleven females volunteered to take part in this intervention study of musculoskeletal pain . They all completed a survey of pain among five hundred and eighty-six female hospital staff and presented mild to severe pain in the neck , shoulder and /or low back . They were r and omly assigned to one of the following groups ; Focus on job-stress and psychosocial coping ( Cognitive ) , relaxation training ( Relaxation ) , the combination of the two ( Combined ) or to a control group ( Control ) . Musculoskeletal pain ( intensity and duration ) was assessed by self-report prior to interventions , immediately after interventions , and at a four months follow-up . Results from multivariate analyses of variance as well as covariance ( pre-intervention levels of pain as covariate ) showed that magnitude of pain reduction was dependent upon the interaction between area of the back and type of intervention . These trends were more significant for intensity than for duration scores . They were due to reductions of pain in ( 1 ) neck and shoulders for the Cognitive and Combined groups and ( 2 ) in the low back and shoulders for the Relaxation group . The four month follow-up assessment revealed a significant risk of relapse only for duration of low back pain among subjects in the Combined group . Results from the Cognitive approach to intervention may reflect a causal role for ability to cope with psychosocial job stress in the development of neck and shoulder pain in female hospital staff"
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OBJECTIVE Diabetes appears to increase risk for some cancers , but the association between preexisting diabetes and postoperative mortality in cancer patients is less clear . Our objective was to systematic ally review postoperative mortality in cancer patients with and without preexisting diabetes and summarize results using meta- analysis . R SEARCH DESIGN AND METHODS We search ed the Medical Literature Analysis and Retrieval System Online ( MEDLINE ) and Excerpta Medica Data base ( EMBASE ) for articles published on or before 1 July 2009 , including references of qualifying articles . We included English language investigations of short-term postoperative mortality after initial cancer treatment . Titles , abstract s , and articles were review ed by at least two independent readers . Study population and design , results , and quality components were abstract ed with st and ard protocol s by one review er and checked for accuracy by additional review ers . RESULTS Of 8,828 titles identified in our original search , 20 articles met inclusion criteria for qualitative systematic review . Of these , 15 reported sufficient information to be combined in meta- analysis . Preexisting diabetes was associated with increased odds of postoperative mortality across all cancer types ( OR = 1.85 [ 95 % CI 1.40–2.45 ] ) . The risk associated with preexisting diabetes was attenuated but remained significant when we restricted the meta- analysis to models that controlled for confounders ( 1.51 [ 1.13–2.02 ] ) or when we accounted for publication bias using the trim and fill method ( 1.52 [ 1.13–2.04 ] ) . CONCLUSIONS Compared with their nondiabetic counterparts , cancer patients with preexisting diabetes are ∼50 % more likely to die after surgery . Future research should investigate physiologic pathways to mortality risk and determine whether improvements in perioperative diabetes care can reduce postoperative mortality
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"The outcome of coronary artery bypass grafting ( CABG ) in diabetic patients has traditionally been worse than in non-diabetic patients . Recent studies have suggested an improvement in outcome in diabetic patients undergoing contemporary CABG . However , the direct impact of diabetes on mortality and morbidities following CABG remains unclear . We retrospectively analyzed prospect ively collected data of 2725 CABG patients from January 1998 to December 2005 : one thous and and eighty-five ( 40 % ) diabetics and 1640 ( 60 % ) non-diabetics [ mean age 65+/-11 years , 1882 ( 69 % ) male ] . Subgroup analysis was performed for two study periods ( 1998 - 2002 vs. 2003 - 2005 ) . The overall hospital mortality was 1.8 % [ n=50 ; diabetics : 2.4 % , non-diabetics : 1.5 % ( P=0.07 ) ] . The mortality rate among diabetics decreased from 3.1 % in 1998 - 2002 to 1.0 % in 2003 - 2005 ( P=0.021 ) . Diabetes was not an independent predictor of hospital mortality but predicted the occurrence of deep sternal wound infection ( OR=3.77 ) . Diabetes significantly decreased long-term survival [ 1-year and 5-year survival 94.7+/-0.7 % and 81.9+/-1.4 % for diabetic vs. 95.4+/-0.5 % and 85.9+/-1.0 % for non-diabetic patients ( P=0.01 ) ] . Excellent results following contemporary CABG can be expected in diabetics with a similar mortality compared to non-diabetics . Therefore , our data suggest that diabetes may , in fact , not be a risk factor for adverse outcome following CABG . However , long-term survival in diabetics remains significantly inferior compared to non-diabetics",
"To determine the risk of nephrotoxicity induced by the infusion of radiographic contrast material , we undertook a prospect i ve study of consecutive patients undergoing radiographic procedures with intravascular contrast material . There were three study groups : patients with diabetes mellitus and normal renal function ( n = 85 ) , patients with preexisting renal insufficiency ( serum creatinine level , greater than or equal to 150 mumol per liter ) without diabetes ( n = 101 ) , and patients with both diabetes and renal insufficiency ( n = 34 ) . The control group consisted of patients undergoing CT scanning or abdominal imaging procedures without the infusion of contrast material who had diabetes mellitus ( n = 59 ) , preexisting renal insufficiency ( n = 145 ) , or both ( n = 64 ) . Clinical ly important acute renal failure ( defined as an increase of greater than 50 percent in the serum creatinine level ) attributable to the contrast material did not occur in nondiabetic patients with preexisting renal insufficiency or in diabetics with normal renal function . The incidence of clinical ly important contrast-induced renal failure among the diabetic patients with preexisting renal insufficiency was 8.8 percent ( 95 percent confidence interval , 1.9 to 23.7 percent ) , as compared with 1.6 percent for the controls . The incidence of acute renal insufficiency , more broadly defined as an increase of greater than 25 percent in the serum creatinine level after the infusion of contrast material , was 11.8 percent among all patients with preexisting renal insufficiency . After the exclusion of patients whose acute renal insufficiency could be attributed to other causes , the incidence was 7.0 percent ( 95 percent confidence interval , 3.2 to 12.8 percent ) , as compared with 1.5 percent in the control group . The risk of acute renal insufficiency attributable to the contrast material was therefore 5.5 percent , and the relative risk associated with the infusion of contrast material was 4.7 . These rates were similar whether the osmolarity of the contrast material was high or low . We conclude that there is little risk of clinical ly important nephrotoxicity attributable to contrast material for patients with diabetes and normal renal function or for nondiabetic patients with preexisting renal insufficiency . The risk for those with both diabetes and preexisting renal insufficiency is about 9 percent , which is lower than previously reported",
"BACKGROUND We prospect ively analyzed the postoperative morbidity , mortality rate , and risk factors in 605 patients who underwent thoracotomy for bronchogenic carcinoma . METHODS Patients were categorized by postsurgical tumor stage : I , 287 patients ( 47.4 % ) ; II , 49 patients ( 8.1 % ) ; IIIA , 154 patients ( 25.5 % ) ; IIIB , 80 patients ( 13.2 % ) ; IV , 16 patients ( 2.7 % ) ; unavailable , 19 patients ( 3.1 % ) . Two hundred ninety-four patients ( 48.6 % ) underwent lobectomy , 172 ( 28.4 % ) pneumonectomy , 20 ( 3.3 % ) bilobectomy , 29 ( 4.8 % ) segmentectomy , 27 ( 4.5 % ) wedge resection , and 63 ( 10.4 % ) exploratory thoracotomy . The importance of the factors that influence the morbidity and mortality rates was calculated from their relative risks . Univariate and multivariate methods for a logistic regression model were used for this analysis . RESULTS Postoperative complications developed in 196 patients ( 32.4 % ) ; there were 165 ( 27.3 % ) cases of operation-related complications and 152 ( 25.1 % ) cases of respiratory and cardiovascular complications . The morbidity rate was highest in patients with preexisting vascular disease ( 50.9 % ; odds ratio [ OR ] , 2.20 ) or insulin-dependent diabetes mellitus ( 52.4 % ; OR , 2.77 ) and in patients who underwent pneumonectomy ( 40.1 % ; OR , 1.82 ) . Forty patients ( 6.6 % ) died postoperatively , most commonly of respiratory failure ( 67.5 % ) . The mortality rate was highest in patients with postoperative morbidity ( OR , 31.9 ) or vascular disease ( 15.8 % ; OR , 2.83 ) and in patients who underwent pneumonectomy ( 13.4 % ; OR , 4.9 ) . CONCLUSIONS Postoperative complications are more likely to develop in patients with peripheral vascular disease or insulin-dependent diabetes mellitus , or both . Postoperative mortality was found to be significantly higher in patients with vascular disease and those who underwent pneumonectomy",
"BACKGROUND This study sought to analyze the morbidity and mortality rates after radical gastrectomy for carcinoma , since the operation has been criticized as too morbid for the benefits it may provide . STUDY DESIGN A prospect i ve study of 474 patients who underwent radical gastrectomy was conducted . RESULTS The overall morbidity and mortality rates were 20.1 and 3.0 percent , respectively . The morbidity and mortality rates fell significantly from 27.0 to 15.7 percent ( p = 0.003 ) and 5.5 to 1.1 percent ( p postoperative morbidity . In regard to the extent of lymphadenectomy , relative to R2 resection ( n = 102 ) , the odds ratio for morbidity after R3 resection ( n = 217 ) was 2.13 , and for R4 resection ( n = 155 ) it was 3.12 . Age older than 65 years , total gastrectomy , combined organ(s ) resection , and respiratory system disease were factors that negatively affected operative mortality . CONCLUSIONS These observations suggested that radical gastrectomy can be performed with an acceptable risk of morbidity and mortality in a general hospital",
"OBJECTIVE To analyze the morbidity and mortality after radical and palliative pancreatic cancer surgery in Norway , especially the risk factors . SUMMARY BACKGROUND DATA A prospect i ve multicenter study between 1984 - 1987 including only histologically or cytologically verified adenocarcinoma of the pancreas ( N = 442 ) or the papilla of Vater ( N = 30 ) ; 84 patients ( 19 % ) with pancreatic carcinoma and 24 patients ( 80 % ) with papilla carcinoma underwent radical operations . A palliative procedure was performed in 252 patients ( 53 % ) . METHODS Clinical data , surgical procedures and the following morbidity and mortality were recorded on st and ardized forms . The risk factors were analyzed by a logistic multiple regression model . RESULTS The morbidity , reoperation , and mortality rates were 43 , 18 , and 11 % after radical surgery and 23 , 4 , and 14 % after palliative surgery . Karnofsky 's index was the sole independent risk factor for death after radical surgery . Splenectomy , age , and TNM stage influenced morbidity . Diabetes , Karnofsky 's index , and liver metastases were risk factors in palliative surgery . CONCLUSIONS The morbidity and mortality risks were comparable between total pancreatectomy and a Whipple 's procedure and between biliary and a double bypass . Preoperative biliary drainage had no impact on the risks and may be ab and oned . High age is a relative and a low Karnofsky 's index an absolute contraindication for radical surgery . Nonsurgical palliation of jaundice should be considered according to the presence of independent risk factors",
"OBJECTIVE Although hyperglycemia is hypothesized to increase the short-term risk of infection , this hypothesis has not been well tested in a clinical setting . This study was design ed to assess the relationship of perioperative glycemic control to the subsequent risk of infectious complications . RESEARCH DESIGN AND METHODS A total of 411 adults with diabetes who underwent coronary artery surgery from 1990 to 1995 in the cardiac surgery service of an urban university hospital were included in a nonconcurrent prospect i ve cohort study based on chart review . Perioperative glycemic control was characterized by the mean of six capillary glucose measurements taken during the 36-h interval following surgery . The major outcomes studied were infections of leg and chest wounds , pneumonia , and urinary tract infections . RESULTS Mean postoperative glucose levels ranged from 121 to 352 mg/dl and were divided into quartiles : quartile 1 ( 121 - 206 mg/dl ) , quartile 2 ( 207 - 229 mg/dl ) , quartile 3 ( 230 - 252 mg/dl ) , and quartile 4 ( 253352 mg/dl ) . After simultaneous adjustment for age , sex , race , underlying comorbidity , acute severity of illness , and the length of the stay in the surgical intensive care unit , patients with higher mean capillary glucose readings were at increased risk of developing infections . Compared with people in the lowest quartile of postoperative glucose , those in quartiles 2 ( relative odds of infection [ 95 % CI ] = 1.17 [ 0.57 - 2.40 ] ) , 3 ( 1.86 [ 0.94 - 3.68 ] ) , and 4 ( 1.78 [ 0.86 - 3.47 ] ) were at progressively higher risk for infection ( P = 0.05 for trend ) . CONCLUSIONS In patients with diabetes who undergo coronary artery surgery , postoperative hyperglycemia is an independent predictor of short-term infectious complications . Physicians should consider a glucose concentration target of < or = 200 mg/dl to reduce the risk of infection",
"Diabetes is associated with alterations in liver metabolism and immune response that may influence post-operative recovery and long-term survival after hepatectomy for cancer . Patients with type I or type II diabetes mellitus su bmi tted to a potentially curative hepatic resection for metastatic colorectal cancer were identified from the prospect i ve data base , and compared with patients with hepatic colorectal metastases su bmi tted to resection during the same time interval , but without diabetes mellitus . Data on operative morbidity and mortality and long-term survival were analyzed . Between December 1990 and July 1999 , a total of 727 patients underwent hepatic resection , 61 of whom ( 8.1 % ) had type I and type II diabetes mellitus . Operative mortality in the diabetic patients was significantly greater than in nondiabetic patients ( 8 % vs. 2 % , P patients with diabetes mellitus , four of the five perioperative deaths were due to liver failure after major hepatic resection ( lobectomy or greater ) . All four of these patients had significant parenchymal abnormality ( three with steatosis ) . Long-term survival was identical to that in nondiabetic control subjects . We conclude that the presence of diabetes is associated with a higher incidence of perioperative mortality . In patients with diabetes mellitus and parenchymal steatosis , major hepatic resection should be undertaken with caution",
"BACKGROUND Surgical case-mix is seriously worsening , and the results of surgical revascularization on high-risk cohorts should be continuously evaluated . This study investigates the influence of diabetes mellitus on the short and midterm outcome in the modern era of coronary surgery . METHODS AND RESULTS Patients who underwent first-time coronary artery bypass grafting from April 1996 to October 2003 were classified into diabetic and nondiabetic groups . Data were prospect ively collected and retrospectively analyzed . A total of 5259 patients were studied , and of these 877 ( 17 % ) were diabetic . Patients with diabetes were more likely to be female , have a higher body mass index , be in an advanced New York Heart Association class and Canadian Cardiovascular Society class , have a history of congestive heart failure , have a poor ejection fraction , renal failure , and more extensive coronary artery disease than the nondiabetic group ( P In-hospital mortality was 2.2 % and 1 % for diabetic and nondiabetic patients , respectively ; however , diabetes was not found to be an independent risk factor for in-hospital mortality ( odds ratio = 1.63 ; 95 % confidence interval 0.92 - 2.88 ; P = .089 ) . Postoperative complications were comparable in the two groups , with only renal , neurologic , and gastrointestinal complications significantly associated with diabetes ( all P diabetes mellitus and postoperative infective complications . Diabetes remained an independent predictor of 5-year mortality ( hazard ratio 1.55 ; 95 % confidence interval 1.22 - 1.96 ; P 5-year cardiac-related event-free survival . CONCLUSION Despite a worsening cohort , diabetic patients could be surgically revascularized with low morbidity and mortality , comparable with control patients . The negative effect of diabetes mellitus on the longer-term mortality and morbidity remains a problem"
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4116f948-06ff-11f0-808a-c43d1ab1c353
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Background It is assumed within the accumulated literature that children born of pregnant opioid dependent mothers have impaired neurobehavioral function as a consequence of chronic intrauterine opioid use . Methods Quantitative and systematic review of the literature on the consequences of chronic maternal opioid use during pregnancy on neurobehavioral function of children was conducted using the Meta- analysis of Observational Studies in Epidemiology ( MOOSE ) and the Preferred Reporting Items for Systematic Review s and Meta- Analysis ( PRISMA ) guidelines . We search ed Cinahl , EMBASE , PsychINFO and MEDLINE between the periods of January 1995 to January 2012 . Results There were only 5 studies out of the 200 identified that quantitatively reported on neurobehavioral function of children after maternal opioid use during pregnancy . All 5 were case control studies with the number of exposed subjects within the studies ranging from 33–143 and 45–85 for the controls . This meta- analysis showed no significant impairments , at a non-conservative significance level of p for cognitive , psychomotor or observed behavioural outcomes for chronic intra-uterine exposed infants and pre-school children compared to non-exposed infants and children . However , all domains suggested a trend to poor outcomes in infants/children of opioid using mothers . The magnitude of all possible effects was small according to Cohen ’s benchmark criteria . Conclusions Chronic intra-uterine opioid exposed infants and pre-school children experienced no significant impairment in neurobehavioral outcomes when compared to non-exposed peers , although in all domains there was a trend to poorer outcomes . The findings of this review are limited by the small number of studies analysed , the heterogenous population s and small numbers within the individual studies . Longitudinal studies are needed to determine if any neuropsychological impairments appear after the age of 5 years and to help investigate further the role of environmental risk factors on the effect of ‘ core ’ phenotypes
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"This study tested whether opiate dependence , tobacco smoking , or their combination accompanied impaired performance on the gambling task ( GT ) , which tests decision-making . GT previously detected impairments in patients with lesions of the ventromedial prefrontal cortex and in substance abusers . Four groups were matched on demographic characteristics and intelligence : methadone-maintained smokers ( n = 9 ) and nonsmokers ( n = 9 ) , and control ( i.e. , not opiate-dependent ) smokers ( n = 9 ) and nonsmokers ( n = 10 ) . The Wisconsin Card Sorting Task ( WCST ) was administered to test whether differences in GT performance reflected generalized deficits in prefrontal cortical function . While there were no significant group differences on the WCST , groups differed significantly on GT performance ( F(3,31 ) = 2.95 , P = 0.048 ) , controlling for depressive symptom ratings and childhood attention deficit hyperactivity disorder . Methadone-maintained smokers ( but not nonsmokers ) performed more poorly than either of the two control groups ( P = 0.007 versus smokers ; P = 0.024 versus nonsmokers ) . In a planned analysis of methadone-maintained subjects , smokers scored more poorly on GT than nonsmokers ( F(1,18 ) = 5.64 , P = 0.032 ) and had more treatment failures ( 67 % heroin use during the last 30 days versus 20 % ) . The findings suggest that among opiate-dependent individuals , tobacco smoking may be a marker for a more severe form of substance abuse disorder , reflecting impaired decision-making , as modeled by GT",
"OBJECTIVES Low birthweight has been reported to be associated with lower IQ at school age . Further , some evidence suggests that the association extends across the range of normal birthweights . This study assessed the relationship of birthweight to cognitive development in the Port Pirie birth cohort . METHODS Of 723 singleton live births recruited into a prospect i ve birth cohort study , 601 , 548 , 494 and 375 children were followed at ages 2 , 4 , 7 and 11 - 13 years , respectively . The children 's developmental status was assessed using the Bayley Scales of Infant Development at age 2 years , the McCarthy Scales of Children 's Abilities at age 4 years , and the revised Wechsler Intelligence Scale for Children at ages 7 and 11 - 13 years . The association between birthweight and cognitive function was assessed with multiple linear regression , adjusting for a wide range of possible confounders . RESULTS The mean birthweight was 3386 g ( SD : 517 ) . There was a statistically significant association between birthweight and cognitive performance at age 2 years ( adjusted deficit : 0.97 points per 100 g lighter ; 95 % CI : 0.4 - 1.5 ) , but the magnitude of this association gradually decreased and became statistically non-significant at later childhood . CONCLUSIONS The relationship between birthweight and cognitive development becomes progressively attenuated at increasing age . At older ages , socioenvironmental factors appear to play an increasingly important part in children 's cognitive development",
"Background Flash visual evoked potentials ( VEPs ) were abnormal in a cohort of 100 neonates exposed to maintenance methadone in utero . This prospect i ve cohort study now describes clinical visual and electrophysiological outcomes at 6 months . Methods Visual assessment included modified Atkinson test battery ; strabismus , nystagmus , reduced visual acuity , delayed visual maturation or refractive error ( > 3 dioptres ) defined a fail . Pattern-onset VEPs were recorded to 120′ , 60′ and 15′ checks . Results 81 drug-exposed and 26 comparison infants ( 79 % and 52 % of the original cohorts ) were assessed at a median age of 27 weeks ( range 26–30 ) . 90 % of drug-exposed infants had been additionally exposed to illicit drugs and 41 % to excess alcohol in utero . 40 % of the drug-exposed cohort failed clinical visual assessment : the relative risk of abnormal assessment was 5.1 ( 95 % CI 1.3 to 20 ; p=0.02 ) . Nystagmus was particularly common . VEP peak times were slower and amplitudes smaller in drug-exposed infants , of whom 70 % had one or more abnormal VEP parameter . Abnormal visual outcome at 6 months was not associated with the pattern of additional drug exposure or a history of neonatal abstinence . Conclusions Abnormal visual electrophysiology in infants born to drug-misusing mothers prescribed maintenance methadone persists to 6 months of age , and is associated with abnormal clinical visual assessment",
"Objectives To examine survival and long term cessation of injecting in a cohort of drug users and to assess the influence of opiate substitution treatment on these outcomes . Design Prospect i ve open cohort study . Setting A single primary care facility in Edinburgh . Participants 794 patients with a history of injecting drug use presenting between 1980 and 2007 ; 655 ( 82 % ) were followed up by interview or linkage to primary care records and mortality register , or both , and contributed 10 390 person years at risk ; 557 ( 85 % ) had received opiate substitution treatment . Main outcome measures Duration of injecting : years from first injection to long term cessation , defined as last injection before period of five years of non-injecting ; mortality before cessation ; overall survival . Results In the entire cohort 277 participants achieved long term cessation of injecting , and 228 died . Half of the survivors had poor health related quality of life . Median duration from first injection to death was 24 years for participants with HIV and 41 years for those without HIV . For each additional year of opiate substitution treatment the hazard of death before long term cessation fell 13 % ( 95 % confidence interval 17 % to 9 % ) after adjustment for HIV , sex , calendar period , age at first injection , and history of prison and overdose . Conversely exposure to opiate substitution treatment was inversely related to the chances of achieving long term cessation . Conclusions Opiate substitution treatment in injecting drug users in primary care reduces this risk of mortality , with survival benefits increasing with cumulative exposure to treatment . Treatment does not reduce the overall duration of injecting",
"Objective To investigate the effect of opiate substitution treatment at the beginning and end of treatment and according to duration of treatment . Design Prospect i ve cohort study . Setting UK General Practice Research Data base Participants Primary care patients with a diagnosis of substance misuse prescribed methadone or buprenorphine during 1990 - 2005 . 5577 patients with 267 003 prescriptions for opiate substitution treatment followed-up ( 17 732 years ) until one year after the expiry of their last prescription , the date of death before this time had elapsed , or the date of transfer away from the practice . Main outcome measures Mortality rates and rate ratios comparing periods in and out of treatment adjusted for sex , age , calendar year , and comorbidity ; st and ardised mortality ratios comparing opiate users ’ mortality with general population mortality rates . Results Crude mortality rates were 0.7 per 100 person years on opiate substitution treatment and 1.3 per 100 person years off treatment ; st and ardised mortality ratios were 5.3 ( 95 % confidence interval 4.0 to 6.8 ) on treatment and 10.9 ( 9.0 to 13.1 ) off treatment . Men using opiates had approximately twice the risk of death of women ( morality rate ratio 2.0 , 1.4 to 2.9 ) . In the first two weeks of opiate substitution treatment the crude mortality rate was 1.7 per 100 person years : 3.1 ( 1.5 to 6.6 ) times higher ( after adjustment for sex , age group , calendar period , and comorbidity ) than the rate during the rest of time on treatment . The crude mortality rate was 4.8 per 100 person years in weeks 1 - 2 after treatment stopped , 4.3 in weeks 3 - 4 , and 0.95 during the rest of time off treatment : 9 ( 5.4 to 14.9 ) , 8 ( 4.7 to 13.7 ) , and 1.9 ( 1.3 to 2.8 ) times higher than the baseline risk of mortality during treatment . Opiate substitution treatment has a greater than 85 % chance of reducing overall mortality among opiate users if the average duration approaches or exceeds 12 months . Conclusions Clinicians and patients should be aware of the increased mortality risk at the start of opiate substitution treatment and immediately after stopping treatment . Further research is needed to investigate the effect of average duration of opiate substitution treatment on drug related mortality",
"OBJECTIVE : Maternal smoking has been associated with a reduction in newborn birth weight . We sought to estimate how the pattern of maternal smoking throughout pregnancy influences newborn size . METHODS : One hundred sixty pregnant smoking women were enrolled in a prospect i ve study . We collected data on maternal age , education , prepregnancy body mass index , and parity , as well as alcohol and illicit drug use . Cigarette use was defined as self-reported consumption before pregnancy , at the time of study enrollment , and in the third trimester . Statistical analyses were performed based on bivariate correlations and multiple linear regression . RESULTS : Of the smoking parameters examined , maternal third-trimester cigarette consumption was the strongest predictor of birth weight percentile ( partial r = –0.23 , P reduction in birth weight . Prepregnancy smoking volume was not significantly associated with birth weight percentile in bivariate ( r = –0.06 , P = .47 ) or multivariable analyses . Additional factors contributing to birth weight include gestational age ( partial r = 0.69 , P maternal body mass index ( partial r = 0.23 , P parity ( partial r = 0.16 , P in newborn birth weight . CONCLUSION : Maternal third-trimester cigarette consumption is a strong and independent predictor of birth weight percentile . This supports the hypothesis that reductions in maternal cigarette consumption during pregnancy will result in improved birth weight , regardless of the prepregnancy consumption levels . LEVEL OF EVIDENCE :",
"ABSTRACT . This article presents a Norwegian prospect i ve , longitudinal study of children prenatally exposed to opiates and other substances under conditions of minimal postnatal social risk . Outcome at 4½ years of age is presented . The study reports on the prediction of later intellectual performance , on the basis of the children ’s prenatal , perinatal , and early developmental status , as well as the foster or adoptive parents ’ socioeconomic level . Significant differences were found between the substance-exposed group and the comparison group on the Bayley Scales at age 1 year and on the McCarthy Scales at age 4½ years . The findings showed that although the mean cognitive scores were within normal limits at age 4½ years , a special weakness in the area of visual-motor and perceptual abilities was detected among the substance-exposed children . It is indicated that these areas of performance are especially sensitive to the effect of prenatal adversity . A special vulnerability among the substance-exposed boys , detected at an earlier age , persisted at 4½ years . The study indicates that even if children experience adequate caregiving , the accumulation of biomedical risk factors associated with prenatal substance exposure is still a potential determinant of developmental problems , especially in the area of perceptual-performance functions . The study also hints at differential influences of biomedical and environmental variables on outcome at age 4½ years",
" Groups of subjects whose primary drug of abuse was amphetamine or heroin were compared , together with age- and IQ-matched control subjects . The study consisted of a neuropsychological test battery which included both conventional tests and also computerised tests of recognition memory , spatial working memory , planning , sequence generation , visual discrimination learning , and attentional set-shifting . Many of these tests have previously been shown to be sensitive to cortical damage ( including selective lesions of the temporal or frontal lobes ) and to cognitive deficits in dementia , basal ganglia disease , and neuropsychiatric disorder . Qualitative differences , as well as some commonalities , were found in the profile of cognitive impairment between the two groups . The chronic amphetamine abusers were significantly impaired in performance on the extra-dimensional shift task ( a core component of the Wisconsin Card Sort Test ) whereas in contrast , the heroin abusers were impaired in learning the normally easier intra-dimensional shift component . Both groups were impaired in some of tests of spatial working memory . However , the amphetamine group , unlike the heroin group , were not deficient in an index of strategic performance on this test . The heroin group failed to show significant improvement between two blocks of a sequence generation task after training and additionally exhibited more perseverative behavior on this task . The two groups were profoundly , but equivalently impaired on a test of pattern recognition memory sensitive to temporal lobe dysfunction . These results indicate that chronic drug use may lead to distinct patterns of cognitive impairment that may be associated with dysfunction of different components of cortico-striatal circuitry",
"AIMS Methadone use in pregnancy has been associated with adverse perinatal outcomes and neonatal abstinence syndrome ( NAS ) . This study aim ed to examine perinatal outcomes and NAS in relation to ( i ) concomitant drug use and ( ii ) methadone dose . DESIGN Prospect i ve cohort study . SETTING Two tertiary care maternity hospitals . PARTICIPANTS A total of 117 pregnant women on methadone maintenance treatment recruited between July 2009 and July 2010 . MEASUREMENTS Information on concomitant drug use was recorded with the Addiction Severity Index . Perinatal outcomes included pre-term birth ( small-for-gestational-age ( neonatal unit admission . NAS outcomes included : incidence of medically treated NAS , peak Finnegan score , cumulative dose of NAS treatment and duration of hospitalization . FINDINGS Of the 114 liveborn infants 11 ( 9.6 % ) were born pre-term , 49 ( 42.9 % ) were small-for-gestational-age , 56 ( 49.1 % ) had a neonatal unit admission and 29 ( 25.4 % ) were treated medically for NAS . Neonates exposed to methadone-only had a shorter hospitalization than those exposed to methadone and concomitant drugs ( median 5.0 days versus 6.0 days , P = 0.03 ) . Neonates exposed to methadone doses ≥80 mg required higher cumulative doses of morphine treatment for NAS ( median 13.2 mg versus 19.3 mg , P = 0.03 ) . The incidence and duration of NAS did not differ between the two dosage groups . CONCLUSIONS The incidence and duration of the neonatal abstinence syndrome is not associated with maternal methadone dose , but maternal opiate , benzodiazepine or cocaine use is associated with longer neonatal hospitalization ",
"BACKGROUND Methadone , a full mu-opioid agonist , is the recommended treatment for opioid dependence during pregnancy . However , prenatal exposure to methadone is associated with a neonatal abstinence syndrome ( NAS ) characterized by central nervous system hyperirritability and autonomic nervous system dysfunction , which often requires medication and extended hospitalization . Buprenorphine , a partial mu-opioid agonist , is an alternative treatment for opioid dependence but has not been extensively studied in pregnancy . METHODS We conducted a double-blind , double-dummy , flexible-dosing , r and omized , controlled study in which buprenorphine and methadone were compared for use in the comprehensive care of 175 pregnant women with opioid dependency at eight international sites . Primary outcomes were the number of neonates requiring treatment for NAS , the peak NAS score , the total amount of morphine needed to treat NAS , the length of the hospital stay for neonates , and neonatal head circumference . RESULTS Treatment was discontinued by 16 of the 89 women in the methadone group ( 18 % ) and 28 of the 86 women in the buprenorphine group ( 33 % ) . A comparison of the 131 neonates whose mothers were followed to the end of pregnancy according to treatment group ( with 58 exposed to buprenorphine and 73 exposed to methadone ) showed that the former group required significantly less morphine ( mean dose , 1.1 mg vs. 10.4 mg ; P shorter hospital stay ( 10.0 days vs. 17.5 days , P duration of treatment for the neonatal abstinence syndrome ( 4.1 days vs. 9.9 days , P rates of maternal or neonatal adverse events . CONCLUSIONS These results are consistent with the use of buprenorphine as an acceptable treatment for opioid dependence in pregnant women . ( Funded by the National Institute on Drug Abuse ; Clinical Trials.gov number , NCT00271219 . )",
"This study compared the neurological development of 4 month old infants exposed to buprenorphine or methadone during pregnancy to that of a control group of non-exposed infants . Participants were 30 buprenorphine-maintained women , 22 methadone-maintained women and 33 non opioid-dependent controls , and their infants . Women were enrolled during pregnancy as part of an open-label non-r and omised flexible-dosing longitudinal study . Groups were matched for maternal age , parity , gravida , and tobacco and alcohol use . Infant neurological development was assessed by measuring latency of pattern reversal visual evoked potentials ( VEP ) . One-way between groups analyses of variance ( ANOVA ) were conducted to test the statistical significance of differences between the mean latencies of the peak response to two different sized checkerboard patterns ( 48 ' and 69 ' of retinal arc ) . Infants prenatally exposed to methadone had significantly prolonged latencies , compared with infants in the control group and infants prenatally exposed to buprenorphine , in response to checks of 48 ' and 69 ' . VEP latencies of infants prenatally exposed to buprenorphine did not differ significantly from controls for either check size . After adjustment for covariates , prenatal exposure to methadone remained a significant predictor of VEP response to checks of 48 ' , but not 69 ' . Maternal self-reported used of marijuana during pregnancy made a significant unique contribution to the variance in P1 latencies for both check sizes . Data from this controlled , non-r and omised study suggest that buprenorphine may confer an advantage over methadone as a maintenance drug during pregnancy in terms of infant neural development at 4 months of age",
"Abstract To study the developmental effects of prenatal exposure to opiates , a prospect i ve follow up study of 34 drug-exposed ( opiates and nicotine ) and 42 reference infants ( nicotine exposure only ) was conducted from January 1992 to September 1995 . At the time of delivery , 12 of 34 mothers used opiates without medical control . Twenty-two mothers participated in a methadone maintenance programme . At 1 year , the average Griffiths Developmental Quotient ( DQ ) was lower in the drug-exposed group ( mean : 100.5 vs. references 107.9 ; P “ locomotor ” ( mean 100.8 vs. 111.4 ; P “ intellectual performance ” ( mean 100.8 vs. 108.5 ; P group . Severe developmental retardation mean DQ ( −2 SD ) was diagnosed in 2 drug-exposed infants . Mild developmental retardation ( mean DQ : 1 SD– > 2 SD ) was found in 7 drug-exposed and in 3 reference infants ( P 0.05 ) . Neurological abnormalities were found more frequently in the drug-exposed group ( 11 vs. 3 infants ; P subscales “ hearing and speech ” and “ intellectual performance ” were lower in the uncontrolled drug-using than in the methadone group . The 17 fostered infants showed no difference in developmental outcome compared with the 10 infants living with their biological parents ( mean DQ : 100.0 versus 101.3 ) . Conclusions At 1 year infants prenatally exposed to opiates are at risk for mild psychomotor developmental impairment",
"BACKGROUND This prospect i ve study explores the ongoing impact of early and subsequent maternal depression on offspring behaviour in the early school years . METHODS Seventy five mothers recruited into a longitudinal study were assessed for symptoms of depression when their children were 4 , 12 and 15 months , 4 years and later when the children were 6 - 8 years of age . Mothers , fathers , and school teachers were asked to report on children 's internalising and externalising behaviour problems . RESULTS Exposure to maternal depression during the first postpartum year was related to mother reports of child internalising and externalising problems in the early school years . Although depression in the first year predicted later internalising problems , effects for externalising behaviour problems were mediated by concurrent depression . Relations between concurrent maternal depression and externalising problems were confirmed by teacher ratings . Interestingly , the severity of symptoms at four months was significantly correlated with behaviour problems seven years later . LIMITATIONS Attrition over successive study contacts and therefore limited statistical power is acknowledged . Findings may be a conservative estimate of associations between maternal depression and later child behaviour problems . Also , the high prevalence of depressive symptomatology in the population from which the sample was drawn may limit the generalisability of results . CONCLUSIONS Findings confirm the importance of early identification and treatment for mothers with postnatal depression , given the likelihood of ongoing depression and relations with later child behaviour problems . From a practical point , severity of early symptoms may be a reliable index of those mothers and children at greatest risk"
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4116f9ac-06ff-11f0-808a-c43d1ab1c353
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Background Major psychiatric disorders are growing public health concern that attributed 14 % of the global burden of diseases . The management of major psychiatric disorders is challenging mainly due to medication non-adherence . However , there is a paucity of summarized evidence on the prevalence of psychotropic medication non-adherence and associated factors . Therefore , we aim ed to summarize existing primary studies ’ finding to determine the pooled prevalence and factors associated with psychotropic medication non-adherence . Methods A total of 4504 studies written in English until December 31 , 2017 , were search ed from the main data bases ( n = 3125 ) ( PubMed ( MEDLINE ) , Embase , CINAHL , PsycINFO , and Web of Science ) and other relevant sources ( mainly from Google Scholar , n = 1379 ) . Study selection , screening , and data extraction were carried out independently by two authors . Observational studies that had been conducted among adult patients ( 18 years and older ) with major psychiatric disorders were eligible for the selection process . Critical appraisal of the included studies was carried out using the Newcastle Ottawa Scale . Systematic synthesis of the studies was carried out to summarize factors associated with psychotropic medication non-adherence . Meta- analysis was carried using Stata 14 . R and om effects model was used to compute the pooled prevalence , and sub-group analysis at 95 % confidence interval . Results Forty-six studies were included in the systematic review . Of these , 35 studies ( schizophrenia ( n = 9 ) , depressive ( n = 16 ) , and bipolar ( n = 10 ) disorders ) were included in the meta- analysis . Overall , 49 % of major psychiatric disorder patients were non-adherent to their psychotropic medication . Of these , psychotropic medication non-adherence for schizophrenia , major depressive disorders , and bipolar disorders were 56 % , 50 % , and 44 % , respectively . Individual patient ’s behaviors , lack of social support , clinical or treatment and illness-related , and health system factors influenced psychotropic medication non-adherence . Conclusion Psychotropic medication non-adherence was high . It was influenced by various factors operating at different levels . Therefore , comprehensive intervention strategies should be design ed to address factors associated with psychotropic medication non-adherence . Systematic review registration PROSPERO
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"Introduction Poor adherence to antidepressant treatment is common , and results in increased disability and costs . Several factors are thought to influence patients ’ ability and willingness to adhere . So far , however , consensus is lacking regarding patient characteristics that predict nonadherence . The purpose of this study was to identify predictors of nonadherence to antidepressant treatment that can be ascertained at treatment start . Method The present study used data from a r and omized controlled trial with the main objective of study ing the effect of two different compliance-enhancing programs on treatment adherence and treatment response in 1031 primary care patients with major depression . In this study , logistic regression analyses were performed to examine patient- and illness-related characteristics potentially associated with nonadherence . Results Nonadherence to antidepressant treatment was predicted by age under 35 or over 64 years , presence of personality disorder , sensation-seeking personality traits , substance abuse , and absence of concomitant medications . Conclusion Certain patient- and illness-related characteristics may imply an increased risk of nonadherence to antidepressant treatment . Giving special attention to subjects with such characteristics may improve adherence",
"Introduction Sub-optimal adherence constitutes a significant impediment to the management of severe mental illnesses ( SMIs ) as it negatively impacts on the course of the illness and the treatment outcome . In this study , the levels of adherence , prevalence and the predictors of sub-optimal adherence were assessed in a sub-Saharan African setting . Methods Three hundred and seventy ( 370 ) respondents with diagnoses of schizophrenia , bipolar disorder or severe depression were r and omly enrolled and interviewed at the out-patient department of the Federal Neuropsychiatric Hospital , Maiduguri in northeastern Nigeria . An anonymous sociodemographic question naire and a clinical proforma design ed by the authors , Oslo social support scale and the 8-item Morisky Medication Adherence Scale ( MMAS-8 ) were used for data collection . Results The prevalence of sub-optimal adherence was 55.7 % . The independent predictors of sub-optimal adherence were ; seeking for traditional/ spiritual treatment ( Odds Ratio ( O.R. ) = 6.523 , 95 % C.I. = 3.773 - 11.279 , P = male gender ( O.R. = 3.307 , 95 % C.I. = 1.907 - 5.737 , P = low levels of insight ( O.R. = 1.753 , 95 C.I. = 1.220 - 2.519 , P = 0.002 ) , and low social support levels ( O.R. = 1.528 , 95 % C.I. = 1.097 - 2.129 , P = 0.012 ) . Conclusion Based on the outcome of the study , we recommend the development of psycho-educational programmes on adherence and the active involvement of the relations and significant others in the management of patients with SMIs in sub-Saharan Africa",
"OBJECTIVE Since sustained treatment-adherence is often problematic and may limit clinical outcomes among bipolar disorder ( BPD ) patients , we sought risk factors to guide clinical prediction of nonadherence . METHODS Data were from a 2005 US national sample providing question naire responses by 131 r and omly selected prescribing psychiatrists and their adult BPD patients . We contrasted demographic and clinical factors in treatment-adherent versus nonadherent patients ( strictly defined as missing > or = 1 dose within 10 days ) in univariate analyses followed by multivariate logistic-regression modeling . RESULTS Of 429 DSM-IV BPD patients ( 79 % type-I ; 62 % women ; 17 % minorities ) , 34 % reported missing > or = 1 dose of psychotropic medication within 10 days , 20 % missed entire daily doses at least once , and only 2.5 % missed all doses for 10 days . However , their prescribing psychiatrists considered only 6 % as treatment-nonadherent . Factors significantly associated with nonadherence in multivariate modeling ranked : alcohol-dependence > youth > greater affective morbidity > various side effects > or = comorbid obsessive-compulsive disorder > or = recovering from mania-hypomania . Unrelated were sex , diagnostic subtype , and other comorbidities . Since most patients received > or = 2 psychotropics , potential relationships between treatment-complexity and adherence were obscured . CONCLUSIONS Prevalent treatment-nonadherence among American BPD patients , and striking underestimation of the problem by prescribing clinicians may encourage increasingly complex treatment-regimens of untested value , but added expense , risk of adverse effects , and uncertain impact on treatment-adherence itself",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"BACKGROUND In chronic diseases adherence is a problem . Little is known about adherence to antidepressants after the acute phase in recurrent depression . This study evaluates adherence to antidepressants in the continuation and maintenance phase in remitted recurrently depressed patients . METHODS We prospect ively assessed adherence to continuation and maintenance antidepressant use , the longest phase in antidepressant treatment , over 2 years and the association of adherence with future recurrence in 131 recurrently depressed patients remitted on antidepressants . LIMITATIONS Self reported non-adherence . RESULTS Non-adherence ranged from 39.7 % to 52.7 % ; 20.9 % were always non-adherent , 48.4 % were intermittently non-adherent and 30.8 % were always adherent . Adherence rates did not significantly differ between intermittent and continuous antidepressant users ( 37.2 % vs. 25 % ) . Non-adherence predicted time to recurrence . CONCLUSION Non-adherence to continuation and maintenance antidepressant treatment in recurrent depression is frequent , like in other chronic diseases , and a potential risk of recurrence . Doctors continuously have to be aware of this problem and should keep on discussing it with their patients . Finally , as many patients do n't seem to be able or willing to take AD as prescribed , alternatives to prevent relapse deserve more attention",
"INTRODUCTION . Compliance with antidepressant treatment is a very relevant factor in the outcome of depressive disorders . Poor compliance has been associated with worse outcome , increased rate of relapses and greater cost . This study has aim ed to describe adherence to antidepressant treatment in a sample of primary care patients with a diagnosis of depression in 2007 . METHODS . R and omized sampling was made of patients with depression and antidepressant treatment attended in two primary care teams . Their medical records were review ed to obtain the total number of prescriptions given to patients and the total number of prescriptions dispensed in the pharmacies . The difference between prescriptions written and collected was calculated . A difference of ± 2 was considered as good compliance . Results are shown as percentages . Comparisons were made with the chi-square , Student ’s T and ANOVA tests , where appropriate . RESULTS . The simple was made up of 212 patients . Mean age was 63.2 years ( SD 15.27 ) . In the sample , 66.5 % were treated with only one antidepressant and 24.1 % with two . The percentage of non-compliance was 33.96 % ( 95 % CI : 25.35–40.57 ) . Treatment-adherent patients have a lower percentage of long-term treatment with other drugs . The percentage of treatment-adherent women was higher than non-adherent ( p=0.015 ) . No differences were found in compliance among patients treated in the mental health center . CONCLUSIONS . One third of patients on antidepressant drug treatment were non-compliers because the drugs were not picked up properly from the pharmacies . We need to develop strategies to improve the therapeutic adherence of patients",
"In low-income countries , clinicians must seek strategies to improve treatment adherence that are non-re source intensive and easily integrated into existing treatment structures . We conducted a prospect i ve observational cohort study to investigate the relationship of family engagement in treatment during hospitalisation with post-discharge appointment and medication adherence in 81 patients from a Nigerian psychiatric hospital . After controlling for gender , diagnosis , mental state at discharge , and marital status , family involvement was significantly associated with appointment ( P=0.047 ) but not medication adherence ( P=0.590 ) . Studies are needed to determine whether interventions based on engaging families in treatment can improve post-discharge adherence in this setting",
"OBJECTIVE Nonadherence to prescribed medications is a significant problem in the treatment of mood disorders . Previously proposed adherence models have not been sufficiently accurate in identifying patients who do not adhere to treatment . This study evaluated the importance of the social context in adherence by using a prospect i ve , longitudinal analysis . Specifically , this study evaluated the effects of caregivers ' causal beliefs about depression and their perceptions of stigma on three-month treatment adherence among patients with depression . METHODS Fifty patients with major depressive disorder and their primary caregivers were identified at a psychiatric hospital 's outpatient clinic . Attributions for the causes of depression ( either cognitive and attitudinal or medical and biological ) and perceived stigma were assessed among caregivers at baseline , and patients ' adherence was evaluated three-months after treatment began . RESULTS Data were available for 47 patients at follow-up . Caregivers ' attribution of depression to cognitive and attitudinal problems significantly predicted patients ' decreased adherence . However , the degree of patients ' adherence was not predicted by caregivers ' attributions to medical and biological causes and caregivers ' perceived stigma . CONCLUSIONS The findings stress the importance of patients ' social environment in determining treatment adherence and the necessity of educating caregivers about the impact that their causal attributions have on patients ' behavior . Involving caregivers in treatment may improve their attitude toward patients with depression and , in doing so , enhance patients ' adherence and outcome",
"BACKGROUND The electronic Schizophrenia Treatment Adherence Registry ( e-STAR ) is a prospect i ve , observational study of patients with schizophrenia design ed to evaluate long-term treatment outcomes in routine clinical practice . METHODS Parameters were assessed at baseline and at 3 month intervals for 2 years in patients initiated on risperidone long-acting injection ( RLAI ) ( n=1345 ) or a new oral antipsychotic ( AP ) ( n=277 ; 35.7 % and 36.5 % on risperidone and olanzapine , respectively ) in Spain . Hospitalization prior to therapy was assessed by a retrospective chart review . RESULTS At 24 months , treatment retention ( 81.8 % for RLAI versus 63.4 % for oral APs , p Clinical Global Impression Severity scores ( -1.14 for RLAI versus -0.94 for APs , p=0.0165 ) were significantly higher with RLAI . Compared to the pre-switch period , RLAI patients had greater reductions in the number ( reduction of 0.37 stays per patient versus 0.2 , p days ( 18.74 versus 13.02 , p hospitalizations at 24 months than oral AP patients . CONCLUSIONS This 2 year , prospect i ve , observational study showed that , compared to oral antipsychotics , RLAI was associated with better treatment retention , greater improvement in clinical symptoms and functioning , and greater reduction in hospital stays and days in hospital in patients with schizophrenia . Improved treatment adherence , increased efficacy and reduced hospitalization with RLAI offer the opportunity of substantial therapeutic improvement in schizophrenia",
"OBJECTIVES This study examined concurrent associations and predictors at first indication of nonadherence to antipsychotic medication four years after a first episode of psychosis . METHODS A prospect i ve cohort of 171 patients in urban Irel and with a first episode of psychosis was followed up four years after inception ( follow-up primary analysis , N=84 ; secondary analysis , N=104 ) . RESULTS At the four-year follow-up 76 % were adherent and 24 % were not . Nonadherence was concurrently associated with substance misuse ( p increased symptomatology ( p less insight ( p=.01 ) , lower global functioning ( p negative attitudes toward medication ( p readmissions ( p=.01 ) . Predictors of future nonadherence were substance misuse ( p=.02 ) and duration of untreated psychosis ( p=.04 ) . CONCLUSIONS This prospect i ve investigation confirms previous cross-sectional studies . The association between longer duration of untreated psychosis and nonadherence warrants further research because it could be interpreted as further evidence of the importance of early intervention"
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4116fa06-06ff-11f0-808a-c43d1ab1c353
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Objectives To evaluate and compare the enamel microcracks ( EMCs ) characteristics ( qualitative and quantitative ) in the form of tooth damage before and after debonding from human teeth of in vitro studies . Eligibility criteria Laboratorial studies evaluating EMCs characteristics before and after debonding metal and ceramic brackets from human teeth with intact buccal enamel . Information sources An electronic search of four data bases ( all data bases of the Cochrane Library , CA Web of Science , MEDLINE via PubMed , and Google Scholar ) and additional manual search es were carried out , without language restrictions . Studies published between 2000 and 2017 years were selected . Reference lists of the included articles were screened , and authors were contacted when necessary . Risk of bias The following six parameters were analyzed : blinding of examiner and outcome assessment , incomplete outcome data before bonding and after debonding , selective outcome reporting , and incomplete reporting of EMCs assessment . Included studies Out of 430 potentially eligible studies , 259 were screened by title and abstract , 180 were selected for full-text analysis , 14 were included in the systematic review . Seven studies were selected for the meta- analysis . Synthesis of results The results for EMCs characteristics were expressed as mean differences ( MDs ) with their 95 per cent confidence intervals ( CIs ) , and calculated from r and om-effects meta-analyses . Debonding was associated with the increase in number ( three studies , MD = 3.50 , 95 % CI , 2.13 to 4.87 , P , length ( seven studies , MD = 3.09 mm , 95 % CI , 0.75 - 5.43 , P , and width ( three studies , MD = 0.39 µm , 95 % CI , -0.01 to 0.79 , P = 0.06 ) of EMCs . Considerable statistical heterogeneity was found for two forest plots evaluating the changes of number and length characteristics during debonding . Conclusions There is weak evidence indicating length and width of EMCs increase following bracket removal and the scientific evidence concerning quantitative evaluation of the number parameter before and after debonding is insufficient . However , there is a strong evidence that after debonding the number of EMCs is likely to increase . Registration No registration was performed
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[
"Objectives : The objective of this study was to assess the effect of new bonding techniques on enamel surface . Material s and Methods : Sixty upper central incisors were r and omly divided into two equal groups . In the first group , metal brackets were bonded using TransbondXT and , in the second group , the same brackets were bonded with Maxcem Elite . The shear bond strength ( SBS ) of both agents to enamel was measured and the number and length of enamel cracks before bonding , after debonding and after polishing were compared . The number of visible cracks and the adhesive remnant index ( ARI ) scores in each group were also measured . Results : There were significantly more enamel cracks in the Transbond XT group after debonding and polishing compared to the Maxcem Elite group . There was no significant difference in the length of enamel cracks between the two groups ; but , in each group , a significant increase in the length of enamel cracks was noticeable after debonding . Polishing did not cause any statistically significant change in crack length . The SBS of Maxcem Elite was significantly lower than that of Transbond XT ( 95 % confidence interval ) . Conclusion : Maxcem Elite offers clinical ly acceptable bond strength and can thus be used as a routine adhesive for orthodontic purpose s since it is less likely to damage the enamel",
"Objective : To evaluate shear bond strength ( SBS ) of the orthodontic brackets bonded to fluorosed and nonfluorosed teeth using Light Bond with and without adhesion promoters and compare their enamel damages following debonding . Material s and Methods : In this study , 30 fluorosed ( Thylstrup and Fejerskov Index = 4–5 ) and 30 nonfluorosed teeth were r and omly distributed between two subgroups according to the bonding material s : Group 1 , fluorosed teeth bonded with Light Bond ; Group 2 , fluorosed teeth bonded with adhesion promoters and Light Bond ; Group 3 , nonfluorosed teeth bonded with Light Bond ; Group 4 , nonfluorosed bonded with adhesion promoters and Light Bond . After bonding , the SBS of the brackets was tested with a universal testing machine . Stereomicroscopic evaluation was performed by unbiased stereology in all teeth to determine the amount of adhesive remnants and the number and length of enamel cracks before bonding and after debonding . The data were analyzed using two-way analysis of variance , Kruskal – Wallis , Wilcoxon Signed Rank , and Mann – Whitney test . Results : While fluorosis reduced the SBS of orthodontic bracket ( P = 0.017 ) , Enhance Locus Ceruleus LC significantly increased the SBS of the orthodontic bracket in fluorosed and nonfluorosed teeth ( P = 0.039 ) . Significant increasing in the number and length of enamel crack after debonding was found in all four groups . There were no significant differences in the length of enamel crack increased after debonding among four groups ( P = 0.768 ) while increasing in the number of enamel cracks after debonding was significantly different among the four groups ( P = 0.023 ) . Teeth in Group 2 showed the highest enamel damages among four groups following debonding . Conclusion : Adhesion promoters could improve the bond strength of orthodontic brackets , but conservative debonding methods for decreasing enamel damages would be necessary",
"Background and aims . This in vitro study was design ed to evaluate the effect of composite resin types and orthodontic debonding pliers on the amount of adhesive remnants and enamel damages using a novel method of measurement . Material s and methods . 120 extracted human premolars were r and omly divided into four groups ( n = 30 ) . The st and ard edgewise metallic brackets were bonded to the teeth with light-cured composite resin “ Transbond XT ” in the first and second groups , and No-mix composite resin “ Unite ” in the third and fourth groups . Bracket debonding was carried out with Lift Off Debonding Instrument “ LODI ” ( 3 M Unitek ) in the first and third groups , and with Bracket Removing Pliers ( Dentaurum ) in the second and forth groups . yStereomicroscopic evaluation was performed by unbiased sterelogy . All teeth were evaluated for the amount of adhesive remnants and the number and length of enamel cracks . The obtained data on each step was analyzed by two-way ANOVA , chi-square , Wilcoxon , and Kruskal-Wallis . Results . Teeth in group 4 had the lowest adhesive remnants on the enamel surface ( p number of enamel cracks ( p the length of enamel cracks . Conclusion . Dentaurum debonding pliers with sheer – peel force , when used with the Unite adhesive ( group 4 ) , decreased the amount of adhesive remnants on the enamel surface while it increased enamel damages",
"The objective of this study was to compare 3 orthodontic adhesives in the areas of shear-peel bond strength , location of adhesive failure , and extent of enamel cracking before bonding and after debonding of orthodontic brackets . The adhesives included a composite resin control ( Transbond XT ; 3M/Unitek , St Paul , Minn ) , a resin-modified glass ionomer cement ( Fuji Ortho LC ; GC America Corp , Alsip , Ill ) , and a polyacid-modified composite resin under dry and saliva-contaminated conditions ( Assure ; Reliance Orthodontic Products Inc , Itasca , Ill ) . Metal brackets were bonded to the buccal surfaces of 160 ( 4 groups of 40 ) human premolars . The bonded teeth were stored in deionized water at 37 degrees C for 30 days and thermocycled for 24 hours before debonding with a Universal Instron ( Instron Corp , Canton , Mass ) testing machine . The extent of cracking in the buccal surfaces was evaluated under 16x magnification before bonding and after debonding . Although the bond strength of the composite resin control ( 20.19 MPa ) was significantly greater ( P acceptable shear-peel bond strengths were found for all adhesives ( Fuji Ortho LC = 13.57 MPa , Assure-dry = 10.74 MPa , Assure-wet = 10.99 MPa ) . The bond strength for the Assure adhesive was not significantly affected by saliva contamination . The sample of extracted premolars used in this study displayed a greater frequency of buccal surface enamel cracking ( 46.7 % ) than that reported in the literature for in vivo premolars ( 7.8%-10.2 % ) , which was possibly due to the extraction process . The frequency of enamel cracking in a subset of this sample ( n = 34 ) increased from 46.4 % at prebonding to 62.4 % at postdebonding as a result of the forces of debonding",
"OBJECTIVE To test the None hypothesis that no difference in bracket failure characteristics is noted when use of a new ceramic bracket debonding instrument is compared with the use of conventional pliers . MATERIAL S AND METHODS Thirty maxillary premolars were r and omly assigned to one of two groups . In group 1 , Clarity collapsible ceramic brackets ( 3 M Unitek , Monrovia , Calif ) were debonded with the use of conventional Utility/Weingart ( 3 M Unitek , Monrovia , Calif ) pliers . In group 2 , Clarity brackets were debonded with a new Debonding Instrument ( 3 M Unitek ) . For all teeth , the same bracket bonding system was used . Following debonding , teeth and brackets were examined under 10x magnification for assessment of bracket failure ( fracture ) and of residual adhesive on the enamel surface . Enamel surfaces were visualized with transillumination prior to bonding and after removal of the residual adhesive , so the effect of the debonding forces could be determined . RESULTS The results of Adhesive Remnant Index comparisons indicated that a statistically significant difference ( chi2 = 8.73 ; P = .013 ) in bond failure patterns was apparent when the two groups were compared . Brackets debonded with the new instrument showed a greater tendency for the adhesive to be removed from the tooth during debonding . CONCLUSIONS The hypothesis is rejected . Although the incidence of enamel damage following debonding was similar in the two groups , the use of the new Debonding Instrument decreased the incidence of bracket fracture",
"BACKGROUND Enamel cracks , which may develop during debonding orthodontic brackets , may jeopardise the integrity of the enamel and detract from the appearance of the teeth . AIM To compare the adhesive remnant scores ( ARI ) , the number , lengths and directions of enamel cracks before bonding and after debonding metal orthodontic brackets with three different methods . METHODS Metal brackets were bonded with a self-curing orthodontic adhesive to the buccal surfaces of 75 recently extracted upper and lower premolars . The teeth were r and omly divided into three groups , and the brackets removed either with a side-cutter , a single-blade bracket remover or a two-blade bracket remover . The number , directions and lengths of the enamel cracks before bonding and after debonding were compared . The number of ' pronounced ' cracks ( i.e. cracks that could be identified with the naked eye ) and the ARI scores in each group were also compared . RESULTS After debonding , the number of enamel cracks and pronounced cracks , and the lengths of the enamel cracks increased in all groups ( p ARI scores and the direction of propagation of the enamel cracks were not influenced by the debonding method used ( p = 0.73 ) . CONCLUSIONS Concerns about the enamel damage caused by the three methods of debonding justify caution . Despite widespread use of these methods , it would be sensible to search for methods that result in less enamel damage",
"INTRODUCTION The purpose of this study was to evaluate the shear bond strength of orthodontic brackets and the effect of an enamel bonding agent ( EBA ) on enamel surface after debonding . METHODS Seventy-five extracted maxillary premolars were collected and r and omly divided into 3 groups of 25 . The enamel cracks were surveyed with a stereomicroscope . In the first group , 1 layer of EBA was applied before the adhesive resin . In the second group , 2 layers of EBA were used ; in the third group , no EBA was used . Bonding was followed by incubation for 48 hours at 37 degrees C and thermocycling for 1000 cycles . Debonding was performed with a shear force . The surfaces of the teeth were evaluated , and the length , depth , direction of cracks , and adhesive remnants on the enamel surface were recorded . Data were analyzed by using analysis of variance and paired sample s t tests . RESULTS There were no significant differences between the shear bond strengths ( P = 0.341 ) of the 3 groups , or in the direction , length , and depth of the cracks before and after debonding ( P > 0.05 ) . There was a significant increase in the number of cracks after debonding in the 3 groups ( P evaluation of adhesive remaining on the surface of the teeth indicated that most bond failures occurred at the resin-bracket interface . CONCLUSIONS The use of EBA does not enhance bond strength or provide greater protection to the enamel surface during debonding"
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4116fa56-06ff-11f0-808a-c43d1ab1c353
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Aim : Anticonvulsant medications are frequently used in clinical practice to treat psychiatric disorders in children and adolescents , but the evidence for their efficacy is uncertain . We conducted a systematic review of published r and omized controlled trials ( RCT ) that assessed the psychiatric benefit of anticonvulsants in patients under 18 years of age . Method : The Medline , Scopus , Web of Science , and Clinical Trials.gov data bases were systematic ally search ed for peer- review ed primary publications of RCTs with a minimum of 10 patients per treatment arm through December 2017 . Results : Out of 355 identified non-duplicative publications , 24 met the inclusion criteria . Most RCTs were to treat bipolar disorder ( n = 12 ) or manage recurrent aggression ( n = 9 ) . Few ( n = 3 ) had both a multisite design and adequate statistical power . Valproate was the most frequently studied anticonvulsant ( n = 15 ) . Out of three placebo-controlled RCTs of valproate in bipolar disorder , none showed efficacy . In four RCTs , valproate was inferior to the antipsychotic risperidone . In several small , single-site RCTs , valproate and sulthiame were better than placebo for the management of recurrent aggression . Conclusions : Currently available RCTs do not support the efficacy of anticonvulsants as mood stabilizers in children . There is some preliminary evidence from small RCTs of the efficacy of some anticonvulsants in the control of aggression and behavioral dyscontrol in conduct disorder , autism , and intellectual disability
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"OBJECTIVE The aim of this study was to study valproate efficacy and safety for aggression in children and adolescents with pervasive developmental disorders ( PDD ) . METHODS In this prospect i ve double-blind , placebo-controlled study , 30 subjects ( 20 boys , 10 girls ) 6 - 20 years of age with PDD and significant aggression were r and omized and received treatment with valproate ( VPA ) or placebo ( PBO ) for 8 weeks as out patients . Mean VPA trough blood levels were 75.5 mcg/mL at week 4 and 77.8 mcg/mL at week 8 . RESULTS No treatment difference was observed statistically between VPA and PBO groups . The Aberrant Behavior Checklist -- Community Scale ( ABC-C ) Irritability subscale was the primary outcome measure ( p = 0.65 ) , and CGI -- Improvement ( p = 0.16 ) and OAS ( p = 0.96 ) were secondary outcome measures . Increased appetite and skin rash were significant side effects . Only 1 subject was dropped from the study owing to side effects , notably a spreading skin rash , which then resolved spontaneously . Two subjects receiving VPA developed increased serum ammonia levels , one with an associated parent report of slurred speech and mild cognitive slowing . Post study , of 16 VPA and PBO subjects receiving VPA , 10 subjects demonstrated sustained response , 4 of whom later attempted taper , with significant relapse of aggression . CONCLUSION The present negative findings can not be viewed as conclusive , partly owing to the large placebo response , subject heterogeneity , and size of the groups . Larger studies are needed to exp and upon these findings",
"OBJECTIVE To compare the efficacy and safety of divalproex extended-release ( ER ) to placebo in a 28-day double-blind study of bipolar disorder in children and adolescents and evaluate the safety of divalproex ER in a 6-month open-label extension study . METHOD In the double-blind study , 150 patients ( manic or mixed episode , aged 10 - 17 years ) with baseline Young Mania Rating Scale ( YMRS ) score of 20 or higher were r and omized to once-daily placebo or divalproex ER , which was titrated to clinical response or serum valproate concentration of 80 to 125 microg/mL. Sixty-six patients enrolled in the extension study . RESULTS In the double-blind study , a treatment effect was not observed with divalproex ER based on change in mean YMRS score ( divalproex ER -8.8 [ n = 74 ] ; placebo -7.9 [ n = 70 ] ) or secondary measures . Divalproex was similar to placebo based on incidence of adverse events . Four subjects treated with divalproex ER and three treated with placebo discontinued because of adverse events . Mean ammonia levels increased in the divalproex ER group , but only one patient was symptomatic . In the long-term study , YMRS scores decreased modestly ( 2.2 points from baseline ) . The most common adverse events were headache and vomiting . CONCLUSIONS The results of the study do not provide support for the use of divalproex ER in the treatment of youths with bipolar I disorder , mixed or manic state . Further controlled trials are required to confirm or refute the findings from this study",
"OBJECTIVE This multicenter trial examined the efficacy and safety of oxcarbazepine in the treatment of bipolar disorder in children and adolescents . METHOD A total of 116 out patients 7 to 18 years of age with bipolar I disorder , manic or mixed , were recruited at 20 centers in the United States and r and omly assigned to receive 7 weeks of double-blinded , flexibly dosed treatment with oxcarbazepine ( maximum dose 900 - 2400 mg/day ) or placebo . The primary efficacy measure was the mean change from baseline to endpoint in the Young Mania Rating Scale ( YMRS ) , using the last-observation-carried-forward method . RESULTS Oxcarbazepine ( mean dose=1515 mg/day ) did not significantly improve YMRS scores at endpoint compared with placebo [ adjusted mean change : oxcarbazepine , -10.90 ( N=55 ) ; placebo , -9.79 ( N=55 ) ] . Dizziness , nausea , somnolence , diplopia , fatigue , and rash were each reported in at least 5 % of the patients in the oxcarbazepine group with an incidence at least twice that of the placebo group . The majority of adverse events were mild to moderate and occurred during the titration period . Eleven patients ( 19 % ) in the oxcarbazepine group discontinued the study because of adverse events , compared with two ( 4 % ) in the placebo group . CONCLUSIONS Oxcarbazepine is not significantly superior to placebo in the treatment of bipolar disorder in youths . While the overall adverse event profile was similar to that reported for patients with epilepsy , the incidence of psychiatric adverse events for both the oxcarbazepine and placebo groups was higher than that reported for the epilepsy population",
"OBJECTIVE The objective of this study was to determine the efficacy and safety of valproic acid versus risperidone in children , 3 - 7 years of age , with bipolar I disorder ( BPD ) , during a mixed or manic episode . METHODS Forty-six children with Diagnostic and Statistical Manual of Mental Disorders . 4th ed . , Text Revision ( DSM-IV-TR ) diagnosis of bipolar disorder , manic , hypomanic , or mixed episode , were recruited over a 6 year period from two academic outpatient programs for a double-blinded , placebo-controlled trial in which subjects were r and omized in a 2:2:1 ratio to risperidone solution , valproic acid , or placebo . RESULTS After 6 weeks of treatment , the least-mean Young Mania Rating Scale ( YMRS ) total scores change , adjusted for baseline YMRS scores , from baseline by treatment group was : Valproic acid 10.0±2.46 ( p=0.50 ) ; risperidone 18.82±1.55 ( p=0.008 ) ; and placebo 4.29±3.56 ( F=3.93 , p=0.02 ) . The mixed models for repeated measure ( MMRM ) analysis found a significant difference for risperidone-treated subjects versus placebo treated subjects ( p=0.008 ) but not for valproic acid-treated subjects versus placebo-treated subjects ( p=0.50 ) . Treatment with risperidone over 6 weeks led to increased prolactin levels , liver functions , metabolic measures , and weight/body mass index ( BMI ) . Treatment with valproic acid led to increases in weight/ BMI and decreases in total red blood cells ( RBC ) , hemoglobin , and hematocrit . CONCLUSIONS In this small sample of preschool children with BPD , risperidone demonstrated clear efficacy versus placebo , whereas valproic acid did not . The laboratory and weight findings suggest that younger children with BPD are more sensitive to the effects of both of these psychotropics , and that , therefore , frequent laboratory and weight monitoring are warranted",
"OBJECTIVE To determine whether divalproex sodium ( DVPX ) was superior to lithium carbonate ( Li+ ) in the maintenance monotherapy treatment of youths diagnosed with bipolar disorder who had been previously stabilized on combination Li+ and DVPX ( Li+/DVPX ) pharmacotherapy . METHOD Youths ages 5 - 17 years with bipolar I or II disorder were initially treated with Li /DVPX . Patients meeting remission criteria for four consecutive weeks were then r and omized in a double-blind fashion to treatment with either Li+ or DVPX for up to 76 weeks . Study participation ended if the subject required additional clinical intervention or if the subject did not adhere to study procedures . RESULTS Patients were recruited between July 1998 and May 2002 . One hundred thirty-nine youths with a mean ( SD ) age of 10.8 ( 3.5 ) years were initially treated with Li+/DVPX for a mean ( SD ) duration of 10.7 ( 5.4 ) weeks . Sixty youths were then r and omized to receive monotherapy with Li+ ( n = 30 ) or DVPX ( n = 30 ) . The Li+ and DVPX treatment groups did not differ in survival time until emerging symptoms of relapse ( p = .55 ) or survival time until discontinuation for any reason ( p = .72 ) . CONCLUSIONS DVPX was not found to be superior to Li+ as maintenance treatment in youths who stabilized on combination Li+/DVPX pharmacotherapy",
"OBJECTIVE There is evidence for the efficacy and safety of clonazepam ( CZP ) in adult anxiety disorders , but no formal studies to substantiate clinical reports of similar benefit in children with anxiety disorders . METHOD In this double-blind pilot study , 15 children , aged 7 to 13 years , entered a r and omly assigned , double-blind crossover trial of 4 weeks of CZP ( up to 2 mg/day ) and 4 weeks of placebo . RESULTS Twelve children completed the trial . All but 1 had a diagnosis of separation anxiety disorder , and all but 2 had comorbid diagnoses . Nine children appeared to have moderate to significant clinical improvement , but statistical comparisons on several ratings failed to confirm a trend in favor of CZP . Side effects of drowsiness , irritability , and /or oppositional behavior were notable in 10 children in the CZP phase compared with 5 in the placebo phase . CONCLUSIONS Clonazepam was believed to have clinical benefit for some children , but this was not confirmed statistically in this small sample . Problematic side effects of drowsiness and disinhibition were common and possibly were due to rapid titration",
"The objective of this study was to investigate the effectiveness of levetiracetam for the treatment of tics in children with Tourette syndrome ( TS ) . Levetiracetam , an atypical anticonvulsant , has been suggested in open-label protocol s to be an effective tic-suppressing agent in individuals with TS . A double blind , r and omized , placebo-controlled , cross-over trial was performed to investigate this medication in children with moderate to moderately-severe tics . Subjects received , in a r and omized sequence , 4-weeks of levetiracetam ( maximum dose 30 mg/kg/day ) or placebo , with a 2-week intervening washout period between cycles . Primary outcome measures included two separate scales from the Yale Global Tic Severity Scale ; the Total Tic score and the Total overall score . Measures were assessed at baseline , prior to r and omization , on Day 28 ( end of Phase 1 ) , on Day 42 ( baseline for second phase ) and on Day 70 ( end of Phase 2 ) . Twenty-two subjects ( 21 boys and 1 girl ) with TS , mean age 12.2 + /- 2.3 years , range 8 to 16 years , participated . A mild reduction in tics occurred during both the levetiracetam and placebo treatment phases . There was no significant difference between treatments and no evidence of sequence or cross-over effects . In conclusion , Levetiracetam is not more beneficial than placebo in suppressing tics in children with TS",
"OBJECTIVE The authors sought to replicate open-label findings showing that specific criteria for explosive temper and mood lability identify disruptive youth who improve while receiving the anticonvulsant divalproex sodium . METHOD Twenty outpatient children and adolescents ( ages 10 - 18 ) with a disruptive behavior disorder ( oppositional defiant disorder or conduct disorder ) met the specific criteria for explosive temper and mood lability . They received 6 weeks of divalproex treatment and 6 weeks of placebo by r and om assignment . Independent evaluators blind to group assignment assessed response at the end of each phase . RESULTS At the end of phase 1 , eight of 10 subjects had responded to divalproex ; zero of 10 had responded to placebo . Of the 15 subjects who completed both phases , 12 has superior response taking divalproex . CONCLUSIONS This preliminary study replicates open-label findings showing that divalproex is an efficacious treatment for explosive temper and mood lability in disruptive children and adolescents",
"BACKGROUND New treatments for conduct disorder are sorely needed . We aim ed to test the efficacy of divalproex sodium for the treatment of conduct disorder . METHOD Seventy-one youths with conduct disorder according to DSM-IV criteria were enrolled in a r and omized , controlled , 7-week clinical trial . Subjects were all adolescent males with at least 1 crime conviction . Subjects were r and omized into high- and low-dose conditions and were openly managed by a clinical team . Subjects and independent outcome raters were blinded to condition . Clinical Global Impressions-Severity of Illness ( CGI-S ) and CGI-Improvement ( CGI-I ) ratings , Weinberger Adjustment Inventory ratings , and staff ratings of behavioral privilege were used to assess outcome . RESULTS Intent-to-treat analyses showed significant associations between assignment to the high-dose condition and ratings on the CGI-S ( p = .02 ) and CGI-I ( p = .0008 ) . Self-reported weekly impulse control was significantly better in the high-dose condition ( p self-restraint and treatment condition was of borderline statistical significance ( p blood drug level achieved strengthened the results , as expected . CONCLUSION This preliminary study in a most difficult population suggests a role for divalproex sodium in the treatment of conduct disorder . Divalproex sodium improved self-reported impulse control and self-restraint , variables shown to be predictive of criminal recidivism . Studies are needed of longer-term impact and side-effect profiles . This is one of few controlled psychopharmacologic studies of conduct disorder",
"Autism spectrum disorders ( ASDs ) are neurodevelopmental disorders characterized by social and language deficits and by repetitive behaviors and interests . Irritability/aggression is a significant comorbid symptom in this population , which greatly impacts burden of care . This study examined the effect of divalproex sodium for irritability/aggression in children and adolescents with ASD . This was a 12-week r and omized , double-blind , placebo-controlled trial . All efficacy measures were obtained by an independent evaluator blinded to r and omization condition and side effects . A total of 55 subjects gavetheir consent and 27 were r and omized in a 1 : 1 manner ( mean age 9.46±2.46 , mean nonverbal IQ 63.3±23.9 ) . Two subjects from the active group and one subject from the placebo group discontinued the study because of either a lack of efficacy or side effects ( increased irritability ) . Primary outcome measures were Aberrant Behavior Checklist-Irritability subscale and Clinical Global Impression-Improvement , which focused on irritability . Overall , 62.5 % of divalproex subjects vs 9 % of placebo subjects were responders ( CGI-irritability OR : 16.7 , Fisher 's exact p=0.008 ) . A statistically significant improvement was also noted on the ABC-Irritability subscale ( p=0.048 ) . There was a trend for responders to have higher valproate blood levels compared with nonresponders . This study suggests the efficacy of divalproex for the treatment of irritability in children and adolescents with ASD . Larger sample follow-up studies are warranted",
"OBJECTIVE To determine the comparative efficacy of quetiapine and divalproex for the treatment of adolescent mania . METHOD Fifty adolescents ( ages 12 - 18 years ) with bipolar I disorder , manic or mixed episode , were r and omized to quetiapine ( 400 - 600 mg/day ) or divalproex ( serum level 80 - 120 microg/mL ) for 28 days for this double-blind study , which was conducted from July 2002 through January 2004 . The primary efficacy measure was change in Young Mania Rating Scale ( YMRS ) score across the study period . RESULTS Repeated measures analysis of variance using the last-observation carried forward data indicated no statistically significant group difference in YMRS scores across the 28 days of the study ( p = 0.3 ) . Mixed regression analyses ( comparison of slopes ) revealed that improvement in YMRS scores occurred more rapidly in the quetiapine than in the divalproex group for both the last-observation carried forward ( p = 0.01 ) and observed data ( p = 0.03 ) . Response and remission rates were significantly greater in the quetiapine than in the divalproex group ( p Rates of adverse events did not differ significantly between groups . CONCLUSIONS The results suggest that quetiapine is at least as effective as divalproex in the treatment of acute manic symptoms associated with adolescent bipolar disorder ; however , a quicker reduction of manic symptoms may occur with quetiapine as compared with divalproex . Quetiapine may be useful as monotherapy for the treatment of adolescents with manic or mixed episodes , although placebo-controlled studies are necessary",
"OBJECTIVE To develop effect sizes for 3 mood stabilizers -- lithium , divalproex sodium , and carbamazepine -- for the acute-phase treatment of bipolar I or II disorder , mixed or manic episode , in children and adolescents aged 8 to 18 years . METHOD Forty-two out patients with a mean age of 11.4 years ( 20 with bipolar I disorder and 22 with bipolar II disorder ) were r and omly assigned to 6 weeks of open treatment with either lithium , divalproex sodium , or carbamazepine . The primary efficacy measures were the weekly Clinical Global Impression Improvement scores and the Young Mania Rating Scale ( Y-MRS ) . RESULTS Using a > or = 50 % change from baseline to exit in the Y-MRS scores to define response , the effect size was 1.63 for divalproex sodium , 1.06 for lithium , and 1.00 for carbamazepine . Using this same response measure with the intent-to-treat sample , the response rates were as follows : sodium divalproex , 53 % ; lithium , 38 % ; and carbamazepine , 38 % ( chi 2(2 ) = 0.85 , p = .60 ) . All 3 mood stabilizers were well tolerated , and no serious adverse effects were seen . CONCLUSIONS Divalproex sodium , lithium , and carbamazepine all showed a large effect size in the open treatment of children and adolescents with bipolar I or II disorder in a mixed or manic episode",
"OBJECTIVE This study aim ed to compare the efficacy of lamotrigine versus placebo in 10- to 17-year-olds with bipolar I disorder ( BP-I ) who were receiving conventional bipolar disorder treatment . METHOD In this r and omized withdrawal trial , patients with BP-I of at least moderate severity received lamotrigine during an ≤18-week open-label phase . Patients who maintained a stable lamotrigine dose for ≥2 weeks and Clinical Global Impression-Bipolar Severity of Illness ( CGI-BP[S ] ) score of ≤3 for ≥6 consecutive weeks were r and omized to double-blind lamotrigine or placebo for ≤36 weeks . RESULTS Of 301 patients enrolled , 298 comprised the open-label intention-to-treat population , with 173 ( 58 % ) r and omized . Of these patients , 41 ( 24 % ) completed the study . In the open-label phase , the mean ( SD ) baseline CGI-BP(S ) rating was 4.4 ( 0.57 ) , and the mean ( st and ard error [ SE ] ) time to stabilization was 101 ( 1.6 ) days . During the r and omized phase , mean ( SE ) time to occurrence of a bipolar event ( TOBE ) for lamotrigine versus placebo ( primary endpoint ) was 155 ( 14.7 ) versus 50 ( 3.8 ) , 163 ( 12.2 ) versus 120 ( 12.2 ) , and 136 ( 15.4 ) versus 107 ( 13.8 ) days for the 3 index mood states ( depressed , manic/hypomanic , mixed ) . The primary stratified log-rank analysis of TOBE was not statistically significant ( hazard ratio [ HR ] = 0.63 ; p = .072 ) ; however , the prespecified Cox regression analysis favored lamotrigine ( p = .047 ) . In 13- to 17-year-olds , log-rank analysis of TOBE significantly favored lamotrigine ( HR = 0.46 ; p = .015 ) , but not in 10- to 12-year-olds ( HR = 0.93 ; p = .877 ) . Dermatologic events were reported in 4 % ( open-label phase ) and 2 % ( r and omized phase ) of patients receiving lamotrigine . Suicidality-related adverse events were reported in 7 % ( open-label phase ) and 7 % ( r and omized phase ) of patients receiving lamotrigine . CONCLUSION Although the primary analysis failed to detect a benefit of add-on lamotrigine for BP-I in 10- to 17-year-olds , lamotrigine may be effective in a subset of older adolescents . Clinical trial registration information-Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients ; http:// clinical trials.gov/ ; NCT00723450",
"OBJECTIVE The purpose of the present study was to evaluate the efficacy of divalproex for reducing aggressive behavior among children 6 to 13 years old with attention deficit hyperactivity disorder ( ADHD ) and a disruptive disorder whose chronic aggression was underresponsive to a prospect i ve psychostimulant trial . METHOD Children received open stimulant treatment during a lead-in phase that averaged 5 weeks . Agent and dose were assessed weekly and modified to optimize response . Children whose aggressive behavior persisted at the conclusion of the lead-in phase were r and omly assigned to receive double-blind , flexibly dosed divalproex or a placebo adjunctive to stimulant for 8 weeks . Families received weekly behavioral therapy throughout the trial . The primary outcome measure was the proportion of children whose aggressive behavior remitted , defined by post-trial ratings of negligible or absent aggression . RESULT A significantly higher proportion of children r and omly assigned to divalproex met remission criteria ( eight out of 14 [ 57 % ] ) than those r and omly assigned to placebo ( two out of 13 [ 15 % ] ) . Divalproex was generally well tolerated . CONCLUSIONS Among children with ADHD whose chronic aggressive behavior is refractory to optimized stimulant treatment , the addition of divalproex increases the likelihood that aggression will remit . A larger trial is necessary to specify with greater precision the magnitude of benefit for adjuvant divalproex",
"OBJECTIVE The Treatment of Early Age Mania ( TEAM ) study evaluated lithium , risperidone , and divalproex sodium ( divalproex ) in children with bipolar I disorder who were naive to antimanic medication , or were partial or nonresponders to 1 of 3 study medications . This report evaluates the benefit of either an add-on or a switch of antimanic medications for an 8-week trial period in partial responders and nonresponders , respectively . METHOD TEAM is a r and omized , controlled trial of individuals ( N = 379 ) aged 6 to 15 years ( mean ± SD = 10.2 ± 2.7 years ) with DSM-IV bipolar I disorder ( mixed or manic phase ) . Participants ( n = 154 ) in this report were either nonresponders or partial responders to 1 of the 3 study medications . Nonresponders ( n = 89 ) were r and omly assigned to 1 of the other 2 antimanic medications and cross-tapered . Partial responders ( n = 65 ) were r and omly assigned to 1 of 2 other antimanic medications as an add-on to their initial medication . Adverse event ( AE ) rates are reported only for the add-on group . RESULTS Response rate for children switched to risperidone ( 47.6 % ) was higher than for those switched to either lithium ( 12.8 % ; p = .005 ; number needed to treat [ NNT ] = 3 ; 95 % CI = 1.71 - 9.09 ) or divalproex ( 17.2 % ; p = .03 ; NNT = 3 ; 95 % CI = 1.79 - 20.10 ) ; response rate for partial responders who added risperidone ( 53.3 % ) was higher than for those who added divalproex ( 0 % ; p = .0002 ; NNT = 2 ; 95 % CI = 1.27 - 3.56 ) and trended higher for lithium ( 26.7 % ; p = .07 ; NNT = 4 ) . Reported AEs in the add-on group were largely consistent with the known AE profile for the second medication . Weight gain ( kg ) was observed for all add-on medications : lithium add-on ( n = 29 of 30 ) = 1.66 ± 1.97 ; risperidone add-on ( n = 15 of 15 ) = 2.8 ± 1.34 ; divalproex add-on ( n = 19 of 20 ) = 1.42 ± 1.96 . There was no evidence at the 5 % significance level that the average weight gain was different by study medication for partial responders ( p = .07 , 1-way analysis of variance ) . CONCLUSION Risperidone appears to be more useful than lithium or divalproex for children with bipolar I disorder and other comorbid conditions who are nonresponders or partial responders to an initial antimanic medication trial . Clinical trial registration information- Study of Outcome and Safety of Lithium , Divalproex and Risperidone for Mania in Children and Adolescents ( TEAM ) ; http:// clinical trials.gov/ ; NCT00057681",
"OBJECTIVE To assess critically the short-term efficacy and safety of carbamazepine in the reduction of aggressiveness in children with diagnosed conduct disorder . METHOD Subjects were children aged 5 to 12 years who were hospitalized for treatment-resistant aggressiveness and explosiveness and who had diagnosed conduct disorder . The study was double-blind and placebo-controlled , using a parallel-groups design . Following a 2-week placebo baseline period , children who met the aggression criteria were r and omly assigned to treatments for 6 weeks ; the study ended with a 1-week posttreatment placebo period . Multiple raters rated the children independently , using multiple rating scales under four conditions . The main outcome measures included the Overt Aggression Scale , the Global Clinical Judgments ( Consensus ) Scale , and the Children 's Psychiatric Rating Scale . RESULTS Twenty-two children , aged 5.33 to 11.7 years , completed the study . Carbamazepine was not superior to placebo at optimal daily doses ranging from 400 to 800 mg , mean 683 mg , at serum levels of 4.98 to 9.1 micrograms/mL. Untoward effects associated with administration of carbamazepine were common . CONCLUSIONS In this modest sample of children , the superiority of carbamazepine over placebo in reducing aggressive behavior was not demonstrated",
"Sulthiame was investigated as a tranquillizer in a double-blind trial on 34 severely subnormal patients with disturbed behaviour . A special rating scale was used by nurses for the assessment of behavioural changes in hyperactivity , aggressiveness , destructiveness and anti-sociability . The results showed that sulthiame was significantly effective in reducing disturbed behaviour in general , and aggressiveness and hyperactivity in particular . Only one case of hyperpnoea was observed , in an epileptic patient",
"Forty-two severely subnormal , hospitalized patients with marked and apparently intractable behaviour abnormalities took part in a doubleblind , cross-over trial of sulthiame , which was investigated as a tranquillizer rather than as an anticonvulsant . Detailed assessment s of behavioural changes were made , with the use of rating scales , by nursing observers . The findings were as follows : 1 . Sulthiame was significantly effective in reducing the incidence of disturbed behaviour . 2 . There was insufficient evidence to suggest that it affected the variety of disturbed behaviour . 3 . Most of the patients had taken part in an earlier trial with pericyazine and chlorpromazine and had shown no improvement ; this suggests that sulthiame may well be effective in cases where other tranquillizers have failed . 4 . The so-called ` placebo effect ' did not material ize . 5 . There were no observable side effects during the trial . 6 . The addition of sulthiame to st and ard anticonvulsant therapy brought about a decrease in seizure frequency in only one of 25 epileptic patients",
"OBJECTIVE To determine the relative effects of risperidone and divalproex in pediatric mania . METHODS This is a double-blind , r and omized , outpatient clinical trial with 66 children and adolescents ( mean age= 10.9 ± 3.3 years ; age range= 8 - 18 years ) with mania who were r and omly assigned to either risperidone ( 0.5 - 2 mg/day , n= 33 ) or divalproex ( 60 - 120 μg/mL , n= 33 ) for a six-week period . Measures included the Young Mania Rating Scale ( YMRS ) and Child Depression Rating Scale-Revised ( CDRS-R ) . RESULTS Mixed-effects regression models , with interaction between time and the active drug as predictors , found that the risperidone group had more rapid improvement than the divalproex group ( p The response rate on YMRS was 78.1 % for risperidone and 45.5 % for divalproex ( p . The remission rate for risperidone was 62.5 % , compared with 33.3 % for divalproex ( p 0.05 ) . Improvement on the CDRS-R was significantly higher for the risperidone group relative to the divalproex group ( p in safety , but subject retention was significantly higher at study endpoint in the risperidone group ( p 0.01 ) . Dropout rate was 24 % in the risperidone group and 48 % in the divalproex group , with increased irritability being the most common reason for dropout in the latter . There was no significant weight gain in either group . CONCLUSION Results suggest that risperidone was associated with more rapid improvement and greater reduction in manic symptoms compared to divalproex . Although the results suggest that both drugs are safe , risperidone 's lower attrition rate and lower rate of adverse events may suggest better toleration . Clinical trials with larger sample s are required to confirm these preliminary findings",
"OBJECTIVE To determine if divalproex sodium was superior to placebo in the treatment of symptomatic youths who suffer from a bipolar spectrum disorder and who also have a parent with a diagnosis of a bipolar illness . METHOD Youths , ages 5 to 17 years , meeting DSM-IV criteria for bipolar disorder not otherwise specified ( NOS ) or cyclothymia who also had at least 1 biological parent with bipolar illness were r and omly assigned in a double-blind fashion to receive treatment with either dival-proex sodium or placebo for up to 5 years . Study participation ended if the subject required additional clinical intervention , if the patient developed treatment-related adverse events , or if the participant was not adherent with study procedures . The primary outcome measure was time to study discontinuation for any reason . The study was conducted from August 1997 to April 2003 . RESULTS Fifty-six youths with a mean ( SD ) age of 10.7 ( 3.1 ) years were r and omly assigned and received either divalproex sodium ( N = 29 ) or placebo ( N = 27 ) . In spite of statistical power of 80 % to detect hazard ratios of 2.2 or larger , the treatment groups did not significantly differ in survival time for discontinuation for any reason ( p = .93 ) or discontinuation due to a mood event ( p = .55 ) . Changes in mood symptom ratings and psychosocial functioning from baseline to study discontinuation did not differ between groups ( most significant p > .14 ) . However , both groups did show improvements in mood symptoms and psychosocial functioning over time ( all p values divalproex sodium does not produce clinical ly meaningful improvements in the treatment of symptomatic youths suffering from either bipolar NOS or cyclothymia who are at genetic risk for developing bipolar disorder",
"BACKGROUND Attention deficit hyperactivity disorder ( ADHD ) is one of the most common childhood psychiatric disorder with a prevalence of 8 - 12 % . Even though psychostimulants remain the treatment of choice , its cost and availability in developing countries limits the usage of the drug . In view of free availability and low cost , a R and omized controlled study was carried out using two second line drugs ( clonidine and carbamazepine ) in a tertiary care hospital , Pondicherry , South India . OBJECTIVE To compare the efficacy of clonidine and carbamazepine in children with ADHD . METHOD With approval of ethics committee , a prospect i ve , Double-blind , R and omized controlled study of clonidine and carbamazepine was conducted with 50 children with ADHD ( age group 4 - 12 years ) , over a period of 2 years ( 2005 - 07 ) in a tertiary care hospital , Pondicherry , South India . RESULTS Clonidine was effective in improving the hyperactivity and impulsivity symptoms in children with ADHD as compared to carbamazepine . Statistical significant improvement was not noted with respect to inattention symptoms and other comorbid conditions . CONCLUSION Clonidine can be a safer and cheaper alternative in treatment of children with ADHD , with a predominant effect on their hyperactivity and impulsivity symptoms",
"OBJECTIVE This study evaluated the safety and effectiveness of divalproex sodium ( Depakote ) in the treatment of youths with bipolar disorder . METHOD Forty bipolar disorder patients aged 7 to 19 years , with a manic , hypomanic , or mixed episode , enrolled in an open-label study of divalproex ( 2 - 8 weeks ) , followed by a double-blind , placebo-controlled period ( 8 weeks ) . RESULTS Twenty-two subjects ( 61 % ) showed > or = 50 % improvement in Mania Rating Scale ( MRS ) scores during the open-label period . Significant ( all efficacy measures , including the MRS , Manic Syndrome Scale , Behavior and Ideation Scale , Brief Psychiatric Rating Scale , Clinical Global Impressions Severity scale , and Hamilton Rating Scale for Depression . Of the 23 subjects who discontinued the study during the open-label period , 6 ( 15 % ) discontinued for ineffectiveness , 6 ( 15 % ) for intolerance , 6 ( 15 % ) for noncompliance , and 6 ( 15 % ) for other reasons . Adverse events were generally mild or moderate in severity , with the most common being headache , nausea , vomiting , diarrhea , and somnolence . Laboratory data results were unremarkable . Too few subjects participated in the double-blind period for statistical analysis . CONCLUSION This study provides preliminary support for the safety and effectiveness of divalproex in the treatment of bipolar disorder in youths"
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4116faec-06ff-11f0-808a-c43d1ab1c353
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Objectives The aims of this study were to conduct a systematic review of the microtensile bond strength ( µTBS ) of multi-mode adhesives to dentin and to perform a meta- analysis to assess the significance of differences in the µTBS of one of the most commonly used universal adhesives ( Scotchbond Universal , 3 M ESPE ) depending on whether the etch- and -rinse or self-etch mode was used . Material s and Methods An electronic search was performed of MEDLINE / PubMed , ScienceDirect , and EBSCOhost . Laboratory studies that evaluated the µTBS of multi-mode adhesives to dentin using either the etch- and -rinse or self-etch mode were selected . A meta- analysis was conducted of the review ed studies to quantify the differences in the µTBS of Scotchbond Universal adhesive . Results Only 10 studies fulfilled the inclusion criteria for the systematic review . Extensive variation was found in the restorative material s , testing method ologies , and failure mode in the review ed articles . Furthermore , variation was also observed in the dimensions of the microtensile testing beams . The meta- analysis showed no statistically significant difference between the etch- and -rinse and self-etch modes for Scotchbond Universal adhesive ( p > 0.05 ) . Conclusions Multi-mode ' universal ' adhesives can achieve substantial bonding to dentin , regardless of the used modes ( either etch- and -rinse or self-etch )
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[
"PURPOSE This study evaluated the adhesion of 10-MDP containing self-etch and self-adhesive resin cements to dentin with and without the use of etch- and -rinse technique . MATERIAL S AND METHODS Human third molars ( N=180 ) were r and omly divided into 6 groups ( n=30 per group ) . Conventional ( Panavia F2.0 , Kuraray-PAN ) and self-adhesive resin cements ( Clearfil SA , Kuraray-CSA ) were bonded to dentin surfaces either after application of 3-step etch- and -rinse ( 35 % H3PO4 + ED Primer ) or two-step self-etch adhesive resin ( Clearfil SE Bond ) . Specimens were subjected to shear bond strength test using the universal testing machine ( 0.5 mm/min ) . The failure types were analyzed using a stereomicroscope and quality of hybrid layer was observed under a scanning electron microscope . The data ( MPa ) were analyzed using two-way ANOVA and Tukey 's tests ( α=.05 ) . RESULTS Overall , PAN adhesive cement showed significantly higher mean bond strength ( 12.5 ± 2.3 - 14.1 ± 2.4 MPa ) than CSA cement ( 9.3 ± 1.4 - 13.9 ± 1.9 MPa ) ( P were more frequent in CSA cement groups when used in conjunction with two-step self-adhesive ( 68 % ) or no adhesive at all ( 66 % ) . Hybrid layer quality was inferior in CSA compared to PAN cement in all conditions . CONCLUSION In clinical situations where bonding to dentin substrate is crucial , both conventional and self-adhesive resin cements based on 10-MDP can benefit from etch- and -rinse technique to achieve better quality of adhesion in the early clinical period",
"OBJECTIVE To evaluate the microtensile bond strengths ( μTBS ) and nanoleakage ( NL ) of three universal or multi-mode adhesives , applied with increasing solvent evaporation times . METHODS One-hundred and forty caries-free extracted third molars were divided into 20 groups for bond strength testing , according to three factors : ( 1 ) Adhesive - All-Bond Universal ( ABU , Bisco , Inc. ) , Prime&Bond Elect ( PBE , Dentsply ) , and Scotchbond Universal Adhesive ( SBU , 3 M ESPE ) ; ( 2 ) Bonding strategy - self-etch ( SE ) or etch- and -rinse ( ER ) ; and ( 3 ) Adhesive solvent evaporation time - 5s , 15s , and 25s . Two extra groups were prepared with ABU because the respective manufacturer recommends a solvent evaporation time of 10s . After restorations were constructed , specimens were stored in water ( 37 ° C/24h ) . Resin-dentin beams ( 0.8mm(2 ) ) were tested at 0.5mm/min ( μTBS ) . For NL , forty extracted molars were r and omly assigned to each of the 20 groups . Dentin disks were restored , immersed in ammoniacal silver nitrate , sectioned and processed for evaluation under a FESEM in backscattered mode . Data from μTBS were analyzed using two-way ANOVA ( adhesive vs. drying time ) for each strategy , and Tukey 's test ( α=0.05 ) . NL data were computed with non-parametric tests ( Kruskal-Wallis and Mann-Whitney tests , α=0.05 ) . RESULTS Increasing solvent evaporation time from 5s to 25s result ed in statistically higher mean μTBS for all adhesives when used in ER mode . Regarding NL , ER result ed in greater NL than SE for each of the evaporation times regardless of the adhesive used . A solvent evaporation time of 25s result ed in the lowest NL for SBU-ER . SIGNIFICANCE Residual water and /or solvent may compromise the performance of universal adhesives , which may be improved with extended evaporation times",
"BACKGROUND The durability of restorations bonded with one-step self-etching ( OSSE ) adhesive systems is inferior compared with that of restorations bonded with conventional adhesives . The authors conducted an 18-month r and omized clinical study to evaluate the clinical performance of two OSSE systems in noncarious cervical lesions applied as recommended or with an extra layer of hydrophobic adhesive layer after 18 months of clinical service . METHODS Thirty participants , each of whom had at least two pairs of similar-sized noncarious cervical lesions , took part in this study . The authors placed 120 restorations , 30 in each of four groups : Clearfil S3 Bond ( Kuraray , Osaka , Japan ) ( CS ) and iBond Gluma inside ( Heraeus Kulzer , Hanau , Germany ) ( IB ) , and Clearfil S3 Bond ( CSB ) and iBond Gluma inside ( IBB ) with an extra layer of hydrophobic adhesive applied on top of them . They placed the restorations incrementally , using a resin-based composite . The authors evaluated the restorations at baseline and at 18 months following modified U.S. Public Health Service criteria . RESULTS At 18 months , the retention rate for the IB group was statistically lower than those for the CS , IBB and CSB groups . Marginal discoloration occurred in all groups and was statistically worse in the IB group . CONCLUSIONS The conversion of the iBond Gluma inside and Clearfil S3 Bond adhesive systems into two-step systems by means of applying an extra hydrophobic adhesive layer improved the clinical performance of these material s after 18 months of clinical service . CLINICAL IMPLICATION S The application of an extra hydrophobic adhesive layer over OSSE adhesive systems , layers improved the OSSE systems clinical performance , mainly in terms of retention rate",
"Abstract Objective . The aim of this study was to evaluate the efficacy of the microtensile , microshear and shear bond strength test methods to assess the bond strength of two self-etch adhesives and one etch&rinse adhesive on dentin . Material s and methods : Seventy-five extracted human molars were ground to expose their flat dentin surfaces and r and omly assigned to one of three groups according to the type of test method ( 15 for microtensile , 15 for microshear , 45 for shear ) . Each of these groups was then assigned to three sub-groups according to the bonding systems ( Clearfil SE Bond , Kuraray ; G Bond , GC ; Prime&Bond NT , Dentsply ) used . Then , 15 specimens were prepared for each sub-group according to the test method employed ( n = 15 ) . After being stored in distilled water at 37 ° C for 24 h , the specimens were placed in a universal testing machine for three test methods and stressed at a crosshead speed of 0.5 mm/min . Mean bond strengths were analyzed using Kruskall-Wallis and Mann-Whitney U-tests at a significance level of p highest bond strength ( p = 0.046 ) . Clearfil SE Bond and Prime&Bond NT produced significantly higher values than the G Bond in the microtensile bond test ( p microshear bond test ( p > 0.05 ) . For the shear test , Clearfil SE Bond showed higher bond strength than Prime&Bond NT and G Bond ( p < 0.05 ) . Conclusion : Bond strength to dentin depends on the material and the test method used",
"OBJECTIVE The objective of this r and omized controlled clinical trial was to evaluate the 13-year clinical performance of a mild two-step self-etch adhesive in non-carious cervical lesions with and without prior selective phosphoric acid-etching of the enamel cavity margins . METHODS A total of 100 non-carious cervical lesions in 29 patients were restored with Clearfil AP-X ( Kuraray Noritake ) . The composite restorations were bonded following two different approaches : ( 1 ) application of Clearfil SE Bond ( Kuraray Noritake ) following a self-etch approach ( CSE-NE ) ; ( 2 ) selective phosphoric acid-etching of enamel cavity margins before application of Clearfil SE Bond ( CSE-E ) . The restorations were evaluated after 6 months , 1 , 2 , 3 , 5 , 8 and 13 years of clinical service regarding retention , marginal integrity and discoloration , caries occurrence , preservation of tooth vitality and post-operative sensitivity . RESULTS The patient recall rate at 13 years was 62 % . Six restorations , 4 of the CSE-NE group and 2 of the CSE-E group , were clinical ly unacceptable due to loss of retention ( 1 CSE-NE , 1 CSE-E ) , a severe marginal defect ( 2 CSE-NE , 1 CSE-E ) and caries occurrence in combination with a severe marginal defect ( 1 CSE-NE ) leading to a clinical success rate of 86 % ( CSE-NE ) and 93 % ( CSE-E ) . Ageing of the restorations was characterized by a further increase in the percentage of restorations with a clinical ly acceptable small marginal defect ( CSE-NE : 87 % ; CSE-E : 83 % ) and /or superficial marginal discoloration ( CSE-NE : 53 % ; CSE-E : 56 % ) . The presence of small marginal defects ( CSE-NE : 86 % ; CSE-E : 68 % ) and superficial marginal discoloration ( CSE-NE : 41 % ; CSE-E : 20 % ) at the incisal enamel side was more frequently noticed in the CSE-NE group than in the CSE-E group . The difference , however , was not statistically significant ( McNemar , p>0.05 ) . SIGNIFICANCE After 13 years , the clinical effectiveness of Clearfil SE Bond in non-carious Class-V lesions remained excellent , with selective acid-etching of the enamel cavity margins only having some minor positive effect on marginal integrity and absence of marginal discoloration "
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4116fb46-06ff-11f0-808a-c43d1ab1c353
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Purpose The purpose of this analysis was to evaluate the efficacy and safety of desmopressin for the treatment of nocturia . Methods Data bases including MEDLINE , EMBASE , ISI web of knowledge , the Cochrane Controlled Trial Register of Controlled Trials and Chinese Biological Medical Data base were search ed to identify r and omized controlled trials ( RCTs ) that referred to the efficacy and safety of desmopressin for the treatment of nocturia . A systematic review and meta- analysis were conducted . Results Five studies involving 619 participants were included for the meta- analysis , and 8 RCTs of cross-over design were also identified for the systematic review . The analysis revealed that desmopressin might significantly decrease the frequency of nocturnal voids , nocturnal urine volume and nocturnal diuresis , potentially result ing in an extended duration of the first sleep period and improved sleep quality . The adverse effects of desmopressin were similar to those observed in the placebo group . Conclusions Administered desmopressin was an effective and well-tolerated treatment for nocturia
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"OBJECTIVES To assess whether the synthetic vasopressin analogue desmopressin [ 1-desamino 8-D-arginine vasopressin ] is efficacious and safe in the management of nocturia + /- enuresis in patients with multiple sclerosis . PATIENTS AND METHODS Twenty-two women and 11 men , under 65 years of age , with clinical ly definite multiple sclerosis and nocturnal frequency + /- enuresis were entered into the study . A two week placebo run-in , to establish normal voiding patterns , followed by a double-blind , placebo-controlled , cross-over study of 20 micrograms intranasal desmopressin at night-time was carried out . RESULTS Desmopressin caused a significant decrease in nocturnal urinary frequency , nocturnal urinary volume and the percentage of total daily urine passed at night . There was no significant fall in plasma sodium with desmopressin although there were two cases of asymptomatic hyponatraemia . CONCLUSION Desmopressin is an efficacious and safe treatment for nocturia + /- enuresis in patients with multiple sclerosis",
"To assess whether desmopressin ( 1‐desamino 8‐d‐arginine vasopressin ) is safe and effective in the treatment of nocturnal polyuria in elderly men",
"OBJECTIVE The purpose of this study was to investigate the efficacy and safety of oral desmopressin in the treatment of nocturia in women . STUDY DESIGN Women aged 18 years or older with nocturia ( > or=2 voids per night with a nocturia index score > 1 ) received desmopressin ( 0.1 mg , 0.2 mg , or 0.4 mg ) during a 3-week dose-titration period . After a 1-week washout period , patients who responded in this period received desmopressin or placebo in a double-blind fashion for 3 weeks . RESULTS In double-blind phase , 144 patients were r and omly assigned to groups ( desmopressin , n=72 ; placebo , n=72 ) . For desmopressin , 33 ( 46 % ) patients had a 50 % or greater reduction in nocturnal voids against baseline levels compared with 5 ( 7 % ) patients receiving placebo ( P mean number of nocturnal voids , duration of sleep until the first nocturnal void , nocturnal diuresis , and ratios of nocturnal per 24 hours and nocturnal per daytime urine volumes changed significantly in favor of desmopressin versus placebo ( P headache ( 22 % ) , nausea ( 8 % ) , and hyponatremia ( 6 % ) were reported . Two deaths occurred , although neither could be directly associated with the study drug . CONCLUSION Oral desmopressin is an effective and well-tolerated treatment for nocturia in women",
"To evaluate the decrease in nocturnal diuresis , nocturnal polyuria and the safety of oral desmopressin in elderly subjects with nocturia",
"To investigate the pharmacokinetic profile of oral desmopressin in elderly patients with nocturia , and to analyse any possible correlation between the absorption and clinical effect",
"PURPOSE We evaluated the long-term efficacy and safety of low dose oral desmopressin in elderly patients with benign prostatic hyperplasia with more than nocturnal voids and nocturnal polyuria more than 30 % of total daily urine volume . MATERIAL S AND METHODS Eligible patients with benign prostatic hyperplasia older than 65 years with nocturia , nocturnal polyuria and International Prostate Symptom Score 14 or greater were included in the study . All patients received placebo or 0.1 mg desmopressin orally at bedtime . Patients were required to visit the outpatient clinic from the first visit , and after 1 , 3 , 6 and 12 months of treatment . Patients maintained flow volume charts and used diaries to record voiding data throughout the study . During followup urinalysis , urine sodium , urine osmolality , serum electrolytes , prostate specific antigen , International Prostate Symptom Score , quality of life , transrectal ultrasonography of prostate , uroflowmetry and post-void residual urine volume were performed at each visit . RESULTS A total of 115 patients were enrolled in the study and r and omized as 58 in the placebo group and 57 in the desmopressin group . Desmopressin significantly decreased nocturnal urine output and the number of nocturia episodes , and prolonged the first sleep period ( p desmopressin gradually decreased serum sodium and induced statistically but not clinical ly significant hyponatremia after 12 months of treatment . No serious systemic complications were found during medication . CONCLUSIONS Low dose oral desmopressin is an effective and well tolerated treatment for nocturnal polyuria in the lower urinary tract symptoms of patients with benign prostatic hyperplasia . Long-term desmopressin therapy gradually decreases serum sodium and it might induce hyponatremia even in patients without initial hyponatremia . For long-term desmopressin administration serum sodium should be assessed carefully , at least at 1 week after treatment",
"Objective To investigate the efficacy and safety of oral desmopressin in the treatment of nocturia in men",
"OBJECTIVES To examine the safety and efficacy of desmopressin in three doses given to women with multiple sclerosis to treat nocturia with or without enuresis . PATIENTS AND METHODS Eight women with clinical ly confirmed multiple sclerosis and nocturia with or without enuresis were entered as in- patients into an open , nonr and omized , placebo-controlled study of incremental doses of 20 , 40 and 60 micrograms desmopressin . Urinary and serum sodium , plasma arginine vasopressin and urine osmolality were monitored every 4 h for 24 h. A single dose of placebo or desmopressin was given during each of four 24-h periods . RESULTS There was a significant decrease in nocturnal urinary volumes and a significant increase in nocturnal urinary osmolalities in patients taking desmopressin when compared with those taking a placebo , but there was no difference among the desmopressin doses . There was no significant difference in serum sodium level between the desmopressin doses . However , at the end of the 24-h period with the 60 micrograms dose , serum sodium was decreased significantly . CONCLUSIONS Neither a significant decrease in nocturnal urinary volumes nor an increase in urinary osmolality was achieved by doses of desmopressin > 20 micrograms . A dose of 60 g was associated with a decreased serum sodium level at the end of the 24-h period but there was no biochemical hyponatraemia . Because there were no benefits and a possibility of clinical hyponatraemia with higher doses , doses of > 20 micrograms desmopressin can not be recommended",
"OBJECTIVES To investigate efficacy , safety , and impact on quality of sleep of desmopressin in the treatment of nocturia . METHODS Adults aged > or = 18 yr with nocturia ( > or = 2 voids/night ) received desmopressin tablets ( 0.1 , 0.2 , or 0.4 mg ) during a 3-wk dose-titration period . Patients should show sufficient response during the dose-titration period ( > or = 20 % reduction in nocturnal diuresis ) and a return of nocturnal diuresis to > or = 80 % of baseline levels during washout . Eligible patients then entered a 3-wk double-blind treatment period and received either desmopressin or placebo . RESULTS 127 patients were r and omised to either desmopressin ( n=61 ) or placebo ( n=66 ) . Twenty ( 33 % ) desmopressin-treated patients compared with seven ( 11 % ) placebo-treated patients showed a clinical response , defined as a > or = 50 % reduction in the number of nocturnal voids compared with baseline ( p=0.0014 ) . Compared with placebo , desmopressin result ed in a significant reduction in the mean number of nocturnal voids ( 39 % reduction with desmopressin vs. 15 % with placebo ; absolute difference -0.84 , p duration of the first sleep period ( prolonged by 108 min with desmopressin vs. 41 min with placebo ; p Quality of sleep was also improved with desmopressin versus placebo ( statistically significant for one of the two parameters evaluated ) . Adverse events were mainly mild . CONCLUSIONS Oral desmopressin tablets provide an effective and well-tolerated treatment for nocturia . Compared with placebo , nocturnal voiding frequency is reduced , duration of the first sleep period is increased , and sleep quality may be improved",
"BACKGROUND Neurogenic bladder affects up to 80 % of patients with multiple sclerosis ( MS ) and , in 50 % of these patients , it is a significant cause of disability . The current management of neurogenic bladder , based on fluid restriction , anticholinergic agents , intermittent self-catheterization , and , in some cases , surgical intervention , often fails to relieve all symptoms . Furthermore , anticholinergic drugs have significant adverse effects and may be medically contraindicated . Nocturia is a particularly disabling symptom of neurogenic bladder ; by disrupting sleep patterns , it aggravates the chronic fatigue of MS , imposes serious dem and s on caregivers , and can lead to institutionalization . To evaluate a novel approach to the symptomatic management of nocturia in patients with MS , we have conducted a trial of desmopressin acetate ( 1-desamino-8-D-arginine vasopressin ) , a synthetic analogue of antidiuretic hormone . OBJECTIVE To evaluate the efficacy and short-term safety of desmopressin therapy in the symptomatic treatment of nocturia in patients with MS . METHODS Seventeen patients were enrolled in a double-blind , crossover trial of desmopressin administered at bedtime . Patients with both relapsing-remitting and chronic-progressive forms of MS were admitted . Night time voiding diaries were maintained for the 6 weeks of the trial ; similarly , serum electrolyte levels and plasma osmolality were measured twice weekly and urinalyses and urine cultures were performed weekly during the trial . RESULTS Desmopressin reduced the percentage of nights with nocturia in patients from 97 % to 66 % . The average number of episodes of nocturia per night in patients decreased from 2.35 to 1.09 and the maximum hours of sleep uninterrupted by nocturia increased from 3.74 to 5.77 . These results were highly significant . Four of the 17 patients discontinued participation in the study after developing asymptomatic or minimally symptomatic hyponatremia . CONCLUSIONS Desmopressin was found effective ; no tolerance and only minimal adverse effects have been observed . Our results suggest that desmopressin , either alone or in combination with other therapeutic modalities , is effective in the symptomatic management of nocturia in patients with MS . The only adverse effect attributed to desmopressin was hyponatremia , which occurred in 4 of 17 patients and appeared to be dose related",
"OBJECTIVES To identify whether oral desmopressin ( ddAVP ) reduced nocturnal urine volume ( NUV ) in older men with nocturia without obvious bladder outlet obstruction and to determine whether deficiencies in arginine vasopressin ( AVP ) release and action demonstrated using water deprivation testing predicted responsiveness to ddAVP . DESIGN Participants had a 2-day Clinical Research Center ( CRC ) evaluation followed by a double-blinded , placebo-controlled , crossover trial of individually titrated oral ddAVP . SETTING Participants were from a single Department of Veterans Affairs Medical Center . MEASUREMENTS Maximum urine osmolality and percentage increase in osmolality were measured after subjects received aqueous vasopressin as part of the overnight water deprivation study ; these data were used to categorize participants as normal , having partial central AVP deficiency , or having impaired renal responsiveness to AVP . Response to ddAVP was assessed using data from frequency-volume records . RESULTS Fourteen participants completed the CRC stay and ddAVP trial . Subjects given ddAVP reduced NUV significantly from baseline ( P=.02 ) and had significantly lower NUV than when on placebo ( P=.01 ) . The mean net reduction in NUV from ddAVP compared to placebo was 14+/-18 % . Using water deprivation testing to categorize participants , 10 were normal , two had partial central AVP deficiency , and two had impaired renal responsiveness . The mean net reduction in NUV for those with abnormal water deprivation tests was 11+/-25 % , versus 15+/-16 % for those with normal water deprivation testing ( P=.70 ) . CONCLUSION In this small r and omized , controlled trial in older men with nocturia , ddAVP reduced NUV . Counter to expectations , participants deemed normal according to water deprivation tests had approximately equivalent responsiveness to ddAVP . Although this study can not offer definitive conclusions on the lack of prediction of water deprivation testing for ddAVP benefit , these data offer additional information that may help clarify the pathophysiology and optimal treatment of nocturia in older men",
"AIMS The purpose of this study was to investigate efficacy , safety , and impact on quality of sleep of staggered furosemide and desmopressin in the treatment of nocturia in the elderly . METHODS Patients aged > 60 years with nocturia at least two voids per night were screened for enrollment into the study . A 3-week dose-titration phase established the optimum desmopressin dose ( 0.1 , 0.2 , or 0.4 mg ) . After a 1-week \" washout \" period , patients who showed sufficient response during the dose-titration period were r and omized to receive staggered furosemide and the optimal dose of desmopressin or placebo in a double-blind design for 3 weeks . Voiding diaries were assessed before and after the treatment . RESULTS In all , 82 patients were r and omized to either staggered furosemide and desmopressin ( n=41 ) or placebo ( n=41 ) . In the study group , most patients reported a good response with both reduced nocturnal voids ( 3.5 vs. 2.0 , P urine volume ( 919.6 ml vs. 584.2 ml , P mean duration of the first sleep period was improved by 70 min ( 133.6 vs. 203.2 , P mean number of nocturnal voids ( 43 % vs. 9 % ; P nocturnal urine volume ( 37 % vs. 5 % ; P mean duration of the first sleep period ( 52 % vs. 19 % , P Adverse events were mild . CONCLUSIONS Staggered furosemide and desmopressin provide an effective and well-tolerated treatment for nocturia in the elderly",
" Twenty two patients with multiple sclerosis , complaining of frequency of day time micturition , completed a double blind crossover trial of desmopressin ( DDAVP nasal spray ) versus placebo . There was a significant decrease in micturition frequency in the 6 hour post-treatment period from 3.1 voids after placebo to 2.4 voids and a significant reduction in urinary volume after desmopressin . Eighty per cent of patients preferred the active treatment phase . Mean 24 hour urinary volume did not differ between active and placebo treatments and patients did not complain of increased night time frequency . Transient symptoms of hyponatraemia occurred in one patient but these resolved within 48 hours of stopping desmopressin . There were otherwise no side effects and mean serum sodium concentrations of the group remained unchanged throughout the study . The clinical indications for prescribing daytime desmopressin are discussed and the importance of patient compliance stressed",
"BACKGROUND Female urinary incontinence ( UI ) , overactive bladder ( OAB ) , and other lower urinary tract symptoms ( LUTS ) are highly prevalent conditions with a profound influence on well-being and quality of life . There are a few studies describing progression as well as remission , in the short term , of UI in the general population as well as in selected groups ; at present , there are very few population -based studies describing the natural course of other LUTS in the same women , and there are no long-term longitudinal studies . OBJECTIVE To describe the prevalence of UI , OAB , and other LUTS in the same women studied prospect ively over time and , thus , to assess possible progression or regression . DESIGN , SETTING , AND PARTICIPANTS A longitudinal population -based study was performed in one primary health care district in the city of Gothenburg , Sweden . The participants were a sample of women aged > or = 20 yr who were r and omly selected from the Swedish National Population Register , assessed in 1991 ( n=2911 ) , and available for re assessment in 2007 ( n=1408 ) . METHODS A self-administered postal question naire regarding UI , OAB , and other LUTS was returned by 77 % of the contacted women in 1991 . The same women who responded in 1991 and who were still alive and available in the Swedish National Population Register 16 yr later were reassessed using a similar self-administered postal question naire . RESULTS AND LIMITATIONS In 2007 , 1081 of the available 1408 women responded to the question naire ( 77 % ) . The overall prevalence of UI , OAB , nocturia , and daytime micturition frequency of eight or more times per day increased by 13 % , 9 % , 20 % ( p incidence of UI and OAB were 21 % and 20 % , respectively , and the corresponding remission rates were 34 % and 43 % , respectively . Women with OAB symptoms were classified as OAB dry or OAB wet , depending on the presence or absence of concomitant UI . The prevalence of OAB dry did not differ between the two assessment occasions ( 11 % and 10 % , respectively ) , but the prevalence of OAB wet increased from 6 % to 16 % ( p UI , OAB , and nocturia in the same women from 1991 to 2007 . Both incidence and remission of most symptoms were considerable"
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OBJECTIVES The aim of this review was to evaluate the epidemiologic evidence for ( i ) a causal effect of occupational mechanical exposures on incidence of inguinal hernia , and ( ii ) a prognostic effect of such exposures on hernia recurrence and persistent pain after inguinal hernia repair . METHODS We performed a literature search in Medline , Embase , and Web of Science up to 3 November 2011 . Central information was extracted from included studies , and strengths and limitations were discussed . RESULTS All 23 included studies focused on effects of ( work ) activities that hardly reflected specific occupational risk factors . Eight studies provided information on risk by occupation or occupational activities . Increased risk was reported in six studies , but inflationary bias was likely . The negative findings in two studies might well be explained by bias towards the None due to crude exposure and /or outcome assessment . Three studies on single strenuous events primarily reflected patients ` beliefs regarding risk factors . Information on prognosis with respect to recurrence was found in seven studies . The studies used crude exposure assessment , and two were also underpowered . Four suggested an increased risk . Six studies on prognosis with respect to persistent pain ( one of which also concerned recurrence ) were practically non-informative for the purpose of this review . CONCLUSIONS There is insufficient epidemiologic evidence to draw meaningful conclusions about ( i ) the existence of causal associations between specific occupational mechanical exposures and the development of inguinal hernia , and ( ii ) the influence of these exposures on prognosis after inguinal hernia repair with respect to hernia recurrence and persistent pain
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"The European Hernia Society ( EHS ) is proud to present the EHS Guidelines for the Treatment of Inguinal Hernia in Adult Patients . The Guidelines contain recommendations for the treatment of inguinal hernia from diagnosis till aftercare . They have been developed by a Working Group consisting of expert surgeons with representatives of 14 country members of the EHS . They are evidence -based and , when necessary , a consensus was reached among all members . The Guidelines have been review ed by a Steering Committee . Before finalisation , feedback from different national hernia societies was obtained . The Appraisal of Guidelines for REsearch and Evaluation ( AGREE ) instrument was used by the Cochrane Association to vali date the Guidelines . The Guidelines can be used to adjust local protocol s , for training purpose s and quality control . They will be revised in 2012 in order to keep them up date d. In between revisions , it is the intention of the Working Group to provide every year , during the EHS annual congress , a short up date of new high-level evidence ( r and omised controlled trials [ RCTs ] and meta-analyses ) . Developing guidelines leads to questions that remain to be answered by specific research . Therefore , we provide recommendations for further research that can be performed to raise the level of evidence concerning certain aspects of inguinal hernia treatment . In addition , a short summary , specifically for the general practitioner , is given . In order to increase the practical use of the Guidelines by consultants and residents , more details on the most important surgical techniques , local infiltration anaesthesia and a patient information sheet is provided . The most important challenge now will be the implementation of the Guidelines in daily surgical practice . This remains an important task for the EHS . The establishment of an EHS school for teaching inguinal hernia repair surgical techniques , including tips and tricks from experts to overcome the learning curve ( especially in endoscopic repair ) , will be the next step . Working together on this project was a great learning experience , and it was worthwhile and fun . Cultural differences between members were easily overcome by educating each other , respecting different views and always coming back to the principles of evidence -based medicine . The members of the Working Group would like to thank the EHS board for their support and especially Ethicon for sponsoring the many meetings that were needed to finalise such an ambitious project",
"Background In recent years long-term discomfort after inguinal hernia surgery has become an issue of great concern to hernia surgeons . Long-term results on discomfort from large r and omised studies are sparse . Methods One-thous and one-hundred and eighty-three patients were r and omised in a multicentre trial with the primary aim of comparing recurrence rates after laparoscopic TAPP and Shouldice repair . Evaluating late discomfort and its possible risk factors were secondary objectives , and are reported here . The patients were clinical ly examined after 1 and 5 years , and answered question naires 2 and 3 years postoperation . Results Of 1,068 operated patients , 867 were eligible for analysis after 5 years ( 81.2 % ) . The percentage of patients experiencing discomfort of any kind were 8.5 % in the TAPP group and 11.4 % ( p = 0.156 ) in the Shouldice group . Although discomfort was usually mild it was severe for 0.2 and 0.7 % , respectively . Severe pain the first postoperative week was a risk factor for late discomfort in the Shouldice group ( OR 2.25 , P = 0.022 ) but not in the TAPP group . No other risk factor for late discomfort was found . Conclusion There was no difference between late discomfort at five-year follow-up after laparoscopic TAPP and Shouldice repair . Discomfort was mostly mild and pain during the first postoperative week was a prognostic variable for late discomfort in Shouldice patients",
" Since January , 1976 , male patients undergoing elective unilateral inguinal herniorrhaphy have been included in a trial to see whether early return to normal activity is associated with an increased recurrence rate and to investigate economic consequences . By June , 1981 , 500 patients had been review ed at one year . 2 patients had defaulted . The first 200 patients had been examined at one year and three years . Recurrence was assessed independently , and recurrences were found of which the patient was unaware . The acceptable definition of recurrence was need for reoperation or a truss . The overall recurrence rate at one year was 3.9 % . At three years no further recurrences were detected in the first 200 patients . There was no difference in the recurrence rate for those in the \" early \" group with 8 recurrences in a total of 246 patients and 10 recurrences in 245 patients in the control group . the median inactivity period in the \" early \" group was 48 days , compared with 65 days in the control . This differences of 17 days is significant ( p=0.001 ) . The self-employed \" early \" group returned to work in a median of 31 days . One-third of workers were losing a median of pounds 31 per week ( range pounds 3- pounds 200 ) . Patients can return to normal activity sooner after inguinal herniorrhaphy than has been advised without increasing the recurrence rate at one year and three years and with considerable monetary benefit to one-third of workers",
"BACKGROUND We sought to determine perioperative variables predictive of complications or recurrence for patients undergoing surgical repair of inguinal hernias . PATIENTS AND METHODS Using data from the Veterans Affairs trial , regression analyses were utilized to identify perioperative factors significantly associated with complications ( overall , short-term and long-term ) , long-term pain , and to develop a risk model for recurrence . RESULTS Recurrent and scrotal hernias were predictors for short term and overall complications , regardless of technique . Older age and higher Mental Component Score of the SF-36 were associated with higher risk of long term complications in the open group while prostatism and increased body mass index were the significant predictors in the laparoscopic group . Long-term pain complaints decreased as patient age increased in both groups . Patient and surgeon factors were predictive of recurrence but varied greatly depending on surgical technique . CONCLUSIONS Regardless of technique , scrotal and recurrent hernias were associated with a greater risk of complications and younger patients had more long-term pain . Predictors of recurrence vary based on surgical technique",
"BACKGROUND Groin hernia repair is one of the most frequent operations , but there is no consensus about surgical or anaesthetic technique . Furthermore , no nationwide studies have been done . Our aim was to investigate outcome results of groin hernia surgery to improve quality of treatment . METHODS We prospect ively recorded 26304 groin hernia repairs done in Denmark from Jan 1 , 1998 , to June 30 , 2000 , in a nationwide Danish hernia data base . FINDINGS 93 % of all groin herniorrhaphies done in Denmark in the 30 months of the study were recorded in the data base . Kaplan-Meier estimates of reoperation rates 30 months after anterior mesh repair and laparoscopic repair were significantly lower than after sutured posterior wall repairs in primary inguinal hernia ( 2.2 % and 2.6 % vs 4.4 % ; p Reoperation rates were also lower with anterior mesh repair ( 6.1 % ; p laparoscopic repair ( 3.4 % ; p sutured posterior wall repair ( 10.6 % ) after recurrent hernia . Use of Lichtenstein mesh repair increased from 33 % in January , 1998 , to 62 % in June , 2000 , whereas use of laparoscopic repair remained constant at about 5 % . Kaplan-Meier estimates of reoperation rates were 2.8 % in the first 15 months and 1.6 % in the second ( p=0.03 ) . For elective repairs , only 59 % of patients were treated on an outpatient basis , and only 18 % had local anaesthesia . INTERPRETATION Mesh repairs have a lower reoperation rate than conventional open repairs . Systematic prospect i ve recording of treatment and outcome variables in a national clinical data base improved the overall quality of surgical care . However , there is a large potential for cost savings and more efficient patient care with extended use of mesh techniques , outpatient surgery , and local anaesthesia",
"OBJECTIVE To establish a register of inguinal hernia surgery that allows audit and analyses of data from several centres . DESIGN Prospect i ve recording of data on a common protocol . SETTING Eight Swedish hospitals . SUBJECTS All groin hernia operations done for patients over 15 years old from January 1992 to December 1994 . MAIN OUTCOME MEASURES Methods of repair , postoperative complications including mortality , day surgery rate , and reoperations for recurrence . RESULTS During the three years studied 4879 hernia operations were undertaken in 4474 patients . Postoperative mortality within 30 days of operation for emergency and elective hernia repairs was 3.5 % and 0.07 % , respectively . Of all herniorrhaphies 798 ( 16 % ) were done for recurrences , 142 of these after operations between 1992 and 1994 . At 24 months 4 % of all operations had been redone because of recurrences with highly significant variations among hospitals ranging from 1.5 % to 6.7 % . Postoperative complications within 30 days after operation , direct hernia , recurrent hernia , and the use of absorbable sutures were associated with an increased risk of reoperation . CONCLUSIONS A quality register recorded voluntarily can identify significant interhospital differences in outcome as well as variables associated with an increased risk of reoperation , thereby raising quality awareness and facilitating the process of improvement",
"Objective : Inguinal hernias are very common disorders , especially in men , with inguinal herniorrhaphy being one of the most frequently performed general surgical procedures in men . Theoretically , obesity might increase the risk of groin hernia by increasing intra-abdominal pressure . The objective of the present study was to investigate whether overweight and obesity in middle age could significantly predict future groin hernia in men . Summary Background Data : Design : Prospect i ve cohort study ; Setting : General population of men living in Gothenburg , Sweden ; Participants : A community-based sample of 7483 men aged 47 to 55 years were followed-up from baseline ( 1970–1973 ) for a maximum of 34 years . Main Outcome Measures : A diagnosis of groin hernia according to the Swedish hospital discharge register . Results : A total of 1017 men ( 13.6 % ) were diagnosed with groin hernia . An inverse relationship was found between body mass index ( BMI ) and risk of groin hernia . With each BMI unit ( 3–4 kg ) , the relative risk for groin hernia decreased by 4 % ( P men of normal weight , obese men had a 43 % lower risk ( P = 0.0008 , 95 % confidence interval 21%–59 % ) . Heavy smokers demonstrated a 26 % lower risk for groin hernia ( P = 0.003 , 95 % confidence interval 10%–39 % ) . Diabetes , high physical activity , and blood pressure were not associated with groin hernia . Entering other variables potentially associated with groin hernia , as age , BMI , smoking , and serum cholesterol , in a multivariable analysis left the risk estimates for BMI and smoking virtually unchanged . Conclusions : In a large community-based sample of middle-aged men overweight and obesity were associated with a lower risk for groin hernia during an extended follow-up . Obesity , in comparison with normal weight , reduced the risk of groin hernia by 43 % . A reduced risk of groin hernia was also noted in heavy smokers . Obviously , hernia may be more easily detected in lean men but a true protective effect can not be excluded",
"Abstract . The aim of this study was to investigate in humans the effect of maintained spinal load on the intra-abdominal pressure ( IAP ) , low back kinematics and trunk muscle activity . This study consisted of two endurance tests for the low back muscles performed 3 weeks apart . Nine healthy subjects participated in the study . In the first test ( upright-test ) , the subject had to pull with the back muscles at a constant force in an upright position , and in the second test ( incline-test ) , the subject had to resist a constant forward pulling force while st and ing with a 45 ° inclination of the back in relation to vertical . The IAP , rate of perceived exertion and electromyogram ( EMG ) from the erector spinae , iliocostalis lumborum , rectus abdominus and the external and internal oblique muscles were measured using surface electrodes . There was no significant difference in endurance time between the two tests . Both tests showed a significant increase in EMG amplitude with time for all muscles except the erector spinae muscle . A decrease in the median frequency for the erector spinae muscle was found indicating fatigue , and since no increase in EMG amplitude was found a decrease in force output from the muscle must be assumed . The IAP increased significantly during both tests . There was a considerable variation between the subjects in the size of this development , but the pattern was the same for all subjects . In conclusion it was found that trunk extension until exhaustion initiates an increase in the activity of the abdominal muscles and an increase in the IAP as the low back muscles become fatigued",
"A significant proportion of patients experience chronic post-surgical pain ( CPSP ) following inguinal hernia surgery . Psychological models are useful in predicting acute pain after surgery , and in predicting the transition from acute to chronic pain in non-surgical context s. This is a prospect i ve cohort study to investigate psychological ( cognitive and emotional ) risk factors for CPSP after inguinal hernia surgery . Participants were asked to complete question naires before surgery and 1 week and 4 months after surgery . Data collected before surgery and 1 week after surgery were used to predict pain at 4 months . Psychological risk factors assessed included anxiety , depression , fear-avoidance , activity avoidance , catastrophizing , worry about the operation , activity expectations , perceived pain control and optimism . The study included 135 participants ; follow-up question naires were returned by 119 ( 88.1 % ) and 115 ( 85.2 % ) participants at 1 week and 4 months after surgery respectively . The incidence of CPSP ( pain at 4 months ) was 39.5 % . After controlling for age , body mass index and surgical variables ( e.g. anaesthetic , type of surgery and mesh type used ) , lower pre-operative optimism was an independent risk factor for CPSP at 4 months ; lower pre-operative optimism and lower perceived control over pain at 1 week after surgery predicted higher pain intensity at 4 months . No emotional variables were independently predictive of CPSP . Further research should target these cognitive variables in pre-operative psychological preparation for surgery",
"Introduction : This prospect i ve cohort study involved 781 elective primary inguinal hernia operations performed on 736 patients at the Hernia Centre of Reinbek Hospital from April 2000 to April 2002 . Material and Methods : Small hernias were fixed by the Shouldice repair , and large defects by the Lichtenstein repair with conventional polypropylene mesh . Pain was assessed before the operation , on day 0 , 1 , 2 , 7 , 6 months and 5 years after the operation by the visual analogue scale ( VAS ) . The follow-up was 90.1 % after 6 months and 82.6 % after 5 years . Chronic pain ( CP ) was assessed in relation to preoperative pain , nerve anatomy and intraoperative nerve management . The anatomy of the iliohypogastric nerve ( IHN ) , ilioinguinal nerve ( IIN ) , and genital branch of the genitofemoral nerve ( GB ) before and after surgery was recorded in every operation . Results : The preoperative pain rate was 41.0 % . The CP and sensory disorder rate after 6 months were 16.4 % and 15.9 , respectively . The only independent significant parameters for CP after 6 months were preoperative pain ( P sensory disorder of the groin after 6 months ( P pain and 20.3 % sensory disorder of the groin . Independent significant predictors of CP were : Preoperative pain ( P IIN neurolysis in Lichtenstein repair ( = IIN mobilization from its natural bed and nerve preservation ; P CP after 6 months ( P sensory disorder after 5 years ( P 3 ) after 5 years had had a Lichtenstein repair with IIN neurolysis . The CP population of preoperative pain free patients changed with time : 65 % of the patients with CP after 6 months were pain free after 5 years , and 69 % of the patients with CP after 5 years were asymptomatic after 6 months . Conclusion : Mesh contact with a nerve removed from its natural bed may cause chronic long-term pain . The combination of IIN neurolysis and the Lichtenstein repair should be avoided",
"Most surgeons favour the use of a mesh for open inguinal hernia repair as it has a low recurrence rate . Procedures used most frequently are the Lichtenstein method , mesh plug repair and the Prolene ® Hernia System . The choice of technique may be influenced by the effects on postoperative pain and quality of life",
"OBJECTIVE To provide a detailed description of post-herniorrhaphy convalescence . DESIGN Prospect i ve , descriptive , consecutive question naire case series . SETTING Public university hospital , Denmark . PATIENTS 100 consecutive patients treated for inguinal hernia . INTERVENTION Elective open inguinal herniorrhaphy under local anaesthesia . One day convalescence for light/moderate and three weeks for strenuous physical activity was recommended . MAIN OUTCOME MEASURE Duration of absence from work or main recreational activity . RESULTS Overall median absence ( including the day of operation ) was 6 days ( interquartile range 1 - 16 ) . For unemployed patients it was 1 day ( 0 - 7 ) , for patients with a light or moderate workload 6 days ( 3 - 12 ) , and for those with a heavy workload 25 days ( 21 - 37 ) . Among the 64 patients , who did not follow the recommendations , pain was contributory in 33 and advice from the general practitioner in 12 . Pain was the main cause of impairment of activities of daily living . CONCLUSION Well-defined recommendations for convalescence may , together with improved management of postoperative pain , shorten convalescence ; they are essential in the evaluation of effects of different surgical techniques of herniorrhaphy on convalescence",
" The Shouldice technique is the ‘ gold st and ard ’ of open non‐mesh hernia repair . The aim of this study was to compare 5‐year recurrence rates after Shouldice and laparoscopic transabdominal preperitoneal patch ( TAPP ) repair for primary inguinal hernia",
" Ninety‐seven Royal Naval and Royal Marine officers and ratings undergoing repair of a unilateral inguinal hernia were r and omized postoperatively into two groups : A , those who returned to full working duties 21 days after operation ; B , those who returned to light duties 21 days after operation and to full duties at 3 months . Patients were review ed at 3 and 12 months . One patient was withdrawn because of the development of late sepsis . Two patients in group B developed a recurrence of hernia within 1 year . No patient who returned to full duties at 21 days was unable to do any duty assigned to him . In a concurrent trial 119 male civilian patients were treated in the same hospital under identical conditions . All patients were review ed 21 days after operation and were r and omized into two groups : C , those advised to return to work immediately ; D , those given no advice . Patients in group C returned to work in a mean of 38 days ( range 14–96 days ) , whereas those in group D returned in a mean of 71 days ( range 14–280 days ) . There was no recurrence of hernia in either group within the review period . It is concluded that there is no contraindication to resuming physical work 3 weeks after the uncomplicated repair of a unilateral inguinal hernia , and that active encouragement shortens the interval before return to work"
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To up date a comparative effectiveness review ( 1980–2011 ) of treatments for adolescents whose depressive episode or disorder ( MDE/MDD ) did not respond to one or more trials of SSRI antidepressants . MEDLINE , Cochrane Central , PsychINFO , Cochrane Data base of Systematic Review s , EMBASE , CINAHL , and AMED were search ed in addition to the grey literature . We spanned May 2011 to September 1 , 2017 and included only articles in English . 11 new studies were review ed based on the criteria of having tested a comparative treatment in adolescents with MDD or MDE who were confirmed to have failed one or more SSRI trials . Data were extracted using st and ardized forms and a reference guide in DistillerSR ; a second review er verified the accuracy of the data fields and discrepancies were resolved by consensus . One trial ( N = 29 ) found a small benefit of escalating doses of fluoxetine and the treatment of adolescent depression study ( TORDIA , N = 334 ) found significant benefits of combined SSRI or venlafaxine treatment with CBT for most outcomes . No new studies were identified since the previous review ( 2012 ) . One trial is currently registered that will be a cross over trial of rTMS ; other registered trials are open label . Multiple secondary data analyses of TORDIA have identified important predictors of treatment response and relapse . No new comparative studies were identified since the original review . Trials are desperately needed to identify new treatments for youth with SSRI resistant MDD . These youth should not be deemed as treatment resistant until completing one or two failed trials of SSRI combined with evidence -based psychotherapy
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"OBJECTIVE We examined whether a shortened form of dialectical behavior therapy , dialectical behavior therapy for adolescents ( DBT-A ) is more effective than enhanced usual care ( EUC ) to reduce self-harm in adolescents . METHOD This was a r and omized study of 77 adolescents with recent and repetitive self-harm treated at community child and adolescent psychiatric outpatient clinics who were r and omly allocated to either DBT-A or EUC . Assessment s of self-harm , suicidal ideation , depression , hopelessness , and symptoms of borderline personality disorder were made at baseline and after 9 , 15 , and 19 weeks ( end of trial period ) , and frequency of hospitalizations and emergency department visits over the trial period were recorded . RESULTS Treatment retention was generally good in both treatment conditions , and the use of emergency services was low . DBT-A was superior to EUC in reducing self-harm , suicidal ideation , and depressive symptoms . Effect sizes were large for treatment outcomes in patients who received DBT-A , whereas effect sizes were small for outcomes in patients receiving EUC . Total number of treatment contacts was found to be a partial mediator of the association between treatment and changes in the severity of suicidal ideation , whereas no mediation effects were found on the other outcomes or for total treatment time . CONCLUSION DBT-A may be an effective intervention to reduce self-harm , suicidal ideation , and depression in adolescents with repetitive self-harming behavior . Clinical trial registration information-Treatment for Adolescents With Deliberate Self Harm ; http:// Clinical Trials.gov/ ; NCT00675129",
"OBJECTIVE We previously reported that a history of abuse was associated with a poorer response to combination treatment in the Treatment of Resistant Depression in Adolescents study ( TORDIA ) . We now report on the nature and correlates of abuse that might explain these findings . METHOD Youth who did not benefit from an adequate selective serotonin re-uptake inhibitor ( SSRI ) trial ( N = 334 ) were r and omized to one of the following : an alternative SSRI ; an alternative SSRI plus cognitive behavior therapy ( CBT ) ; venlafaxine ; or venlafaxine plus CBT . Analyses examined the effect of history of abuse on response to the pharmacotherapy and combination therapy . RESULTS Those without a history of physical abuse ( PA ) or sexual abuse ( SA ) had a higher 12-week response rate to combination therapy compared with medication mono-therapy ( 62.8 % versus 37.6 % ; odds ratio [ OR ] = 2.8 , 95 % confidence interval [ CI ] = 1.6 - 4.7 , p response rates to combination versus medication monotherapy ( 48.3 % versus 42.3 % ; OR = 1.3 , 95 % CI = 0.4 - 3.7 ; p = .66 ) , whereas those with history of PA had a much lower rate of response to combination therapy ( 18.4 % versus 52.4 % , OR = 0.1 ; 95 % CI = 0.02 - 0.43 ) . Even after adjusting for other clinical predictors , a history of PA moderated treatment outcome . CONCLUSION These results should be considered within the limitations of a post hoc analysis , lack of detailed assessment of abuse and other forms of trauma , and neuropsychological status . Depressed patients with history of abuse , especially PA may require specialized clinical approaches . Further work is needed to underst and by what mechanisms a history of abuse affects treatment response",
"OBJECTIVE In the Treatment of Resistant Depression in Adolescents , study participants who received medication for sleep had a lower response rate . This report sought to clarify this finding . METHOD Depressed adolescents who had not responded to a previous adequate serotonin-selective reuptake inhibitor ( SSRI ) trial were r and omly assigned to another SSRI , venlafaxine , another SSRI+cognitive behavior therapy ( CBT ) , or venlafaxine+CBT . Augmentation with sleep medication was permitted as clinical ly indicated . RESULTS Youth who received trazodone were six times less likely to respond than those with no sleep medication ( adjusted odds ratio [OR]=0.16 , 95 % confidence interval [ CI ] : 0.05 - 0.50 , p=0.001 ) and were three times more likely to experience self-harm ( OR=3.0 , 95 % CI : 1.1 - 7.9 , p=0.03 ) , even after adjusting for baseline differences associated with trazodone use . None ( 0/13 ) of those cotreated with trazodone and either paroxetine or fluoxetine responded . In contrast , those treated with other sleep medications had similar rates of response ( 60.0 % vs. 50.4 % , χ(2)=0.85 , p=0.36 ) and of self-harm events ( OR=0.5 , 95 % CI : 0.1 - 2.6 , p=0.53 ) as those who received no sleep medication . CONCLUSIONS These findings should be interpreted cautiously because these sleep agents were not assigned r and omly , but at clinician discretion . Nevertheless , they suggest that the use of trazodone for the management of sleep difficulties in adolescent depression should be re-evaluated and that future research on the management of sleep disturbance in adolescent depression is needed . The very low response rate of participants cotreated with trazodone and either fluoxetine or paroxetine could be due to inhibition of CYP 2D6 by these antidepressants",
"OBJECTIVE To advance knowledge regarding strategies for treating selective serotonin reuptake inhibitor (SSRI)-resistant depression in adolescents , we conducted a r and omized controlled trial evaluating alternative treatment strategies . In primary analyses , cognitive-behavioral therapy ( CBT ) combined with medication change was associated with higher rates of positive response to short-term ( 12-week ) treatment than medication alone . This study examines predictors and moderators of treatment response , with the goal of informing efforts to match youths to optimal treatment strategies . METHOD Youths who had not improved during an adequate SSRI trial ( N = 334 ) were r and omized to an alternative SSRI , an alternative SSRI plus CBT , venlafaxine , or venlafaxine plus CBT . Analyses examined predictors and moderators of treatment response . RESULTS Less severe depression , less family conflict , and absence of nonsuicidal self-injurious behavior predicted better treatment response status . Significant moderators of response to CBT + medication ( combined ) treatment were number of comorbid disorders and abuse history ; hopelessness was marginally significant . The CBT/combined treatment superiority over medication alone was more evident among youths who had more comorbid disorders ( particularly attention-deficit/hyperactivity disorder and anxiety disorders ) , no abuse history , and lower hopelessness . Further analyses revealed a stronger effect of combined CBT + medication treatment among youths who were older and white and had no nonsuicidal self-injurious behavior and longer pre study pharmacotherapy . CONCLUSIONS Combined treatment with CBT and antidepressant medication may be more advantageous for adolescents whose depression is comorbid with other disorders . Given the additional costs of adding CBT to medication , consideration of moderators in clinical decision making can contribute to a more personalized and effective approach to treatment",
"Background Many young people with major depression fail first-line treatments . Treatment-resistant depression has various definitions in the literature but typically assumes nonresponse to medication . In young people , cognitive behavioral therapy ( CBT ) is the recommended first-line intervention , thus the definition of treatment resistance should be exp and ed . Therefore , our aim was to synthesize the existing evidence of any interventions for treatment-resistant depression , broadly defined , in children and adolescents and to investigate the effectiveness of CBT in this context . Methods We used Cochrane Collaboration methodology , with electronic search es of Medline , PsycINFO , Embase , and the Cochrane Depression Anxiety and Neurosis Group trials registers . Only r and omized controlled trials were included , and were assessed for risk of bias . Meta- analysis was undertaken where possible and appropriate . Results Of 953 articles retrieved , four trials were eligible for inclusion . For one study , only the trial registration document was available , because the study was never completed . All other studies were well conducted with a low risk of bias , although one study had a high dropout rate . Two studies assessed the effect of adding CBT to medication . While an assertive trial of antidepressants does appear to lead to benefit , when compared with placebo , there was no significant advantage , in either study , or in a meta- analysis of data from these trials , that clearly demonstrated an additional benefit of CBT . The third trial showed little advantage of a tricyclic antidepressant over placebo in the context of an inpatient admission . Conclusion Few r and omized controlled trials have investigated interventions for treatment-resistant depression in young people , and results from these show modest benefit from antidepressants with no additional benefit over medication from CBT . Overall , there is a lack of evidence about effective interventions to treat young people who have failed to respond to evidence -based interventions for depression . Research in this area is urgently required",
"OBJECTIVE The purpose of this study was to report on the outcome of participants in the Treatment of Resistant Depression in Adolescents ( TORDIA ) trial after 24 weeks of treatment , including remission and relapse rates and predictors of treatment outcome . METHOD Adolescents ( ages 12 - 18 years ) with selective serotonin reuptake inhibitor (SSRI)-resistant depression were r and omly assigned to either a medication switch alone ( alternate SSRI or venlafaxine ) or a medication switch plus cognitive-behavioral therapy ( CBT ) . At week 12 , responders could continue in their assigned treatment arm and nonresponders received open treatment ( medication and /or CBT ) for 12 more weeks ( 24 weeks total ) . The primary outcomes were remission and relapse , defined by the Adolescent Longitudinal Interval Follow-Up Evaluation as rated by an independent evaluator . RESULTS Of 334 adolescents enrolled in the study , 38.9 % achieved remission by 24 weeks , and initial treatment assignment did not affect rates of remission . Likelihood of remission was much higher ( 61.6 % versus 18.3 % ) and time to remission was much faster among those who had already demonstrated clinical response by week 12 . Remission was also higher among those with lower baseline depression , hopelessness , and self-reported anxiety . At week 12 , lower depression , hopelessness , anxiety , suicidal ideation , family conflict , and absence of comorbid dysthymia , anxiety , and drug/alcohol use and impairment also predicted remission . Of those who responded by week 12 , 19.6 % had a relapse of depression by week 24 . CONCLUSIONS Continued treatment for depression among treatment-resistant adolescents results in remission in approximately one-third of patients , similar to adults . Eventual remission is evident within the first 6 weeks in many , suggesting that earlier intervention among nonresponders could be important",
"Acceptance and commitment therapy ( ACT ) has a small but growing data base of support . One hundred and one heterogeneous out patients reporting moderate to severe levels of anxiety or depression were r and omly assigned to traditional cognitive therapy ( CT ) or to ACT . To maximize external validity , the authors utilized very minimal exclusion criteria . Participants receiving CT and ACT evidence d large , equivalent improvements in depression , anxiety , functioning difficulties , quality of life , life satisfaction , and clinician-rated functioning . Whereas improvements were equivalent across the two groups , the mechanisms of action appeared to differ . Changes in “ observing ” and “ describing ” one 's experiences appeared to mediate outcomes for the CT group relative to the ACT group , whereas “ experiential avoidance , ” “ acting with awareness , ” and “ acceptance ” mediated outcomes for the ACT group . Overall , the results suggest that ACT is a viable and disseminable treatment , the effectiveness of which appears equivalent to that of CT , even as its mechanisms appear to be distinct",
"OBJECTIVE The authors sought to assess the relationship between c and i date genes and two clinical outcomes , namely , symptomatic improvement and the occurrence of suicidal events , in a sample of treatment-resistant depressed adolescents . METHOD A sub sample of depressed adolescents participating in the Treatment of SSRI-Resistant Depression in Adolescents ( TORDIA ) trial , 155 of whom were of European origin , were genotyped with respect to 21 polymorphisms on 12 genes that have a reported association with depression , treatment response , or suicidal events . Participants had not responded to a previous adequate trial with an antidepressant and were r and omized to receive either another selective serotonin reuptake inhibitor or venlafaxine , with or without cognitive-behavioral therapy ( CBT ) . Single-nucleotide polymorphism ( SNP ) analyses were conducted using PLINK with permutation procedures . RESULTS No relationship was observed between any polymorphism and response to treatment . The FKBP5 ( which codes for a protein causing subsensitivity of the glucocorticoid receptor ) rs1360780TT and rs3800373GG genotypes were associated with suicidal events ( N=18 ) , even after controlling for treatment effects and relevant covariates . These two SNPs were in significant linkage disequilibrium ( r=0.91 ) . CONCLUSIONS The FKBP5 genotypes associated with suicidal events in this study have been reported by others to cause the greatest degree of glucocorticoid receptor subsensitivity . These results are consistent with those of other studies linking alterations in the hypothalamic-pituitary-adrenal axis with suicidal behavior . The small number of events and lack of a placebo condition make these results preliminary . Replication with a larger sample and a placebo condition is needed to assess whether these events are related to treatment",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"OBJECTIVE The aim of this study was to compare fluoxetine dosage titration to 40 - 60 mg/day with fixed fluoxetine 20-mg/day treatment for an additional 10 weeks in pediatric out patients with major depressive disorder ( MDD ) who had not met protocol -defined response criteria after 9-week acute fluoxetine treatment . METHODS Patients unresponsive ( less than or equal to 30 % decrease in Children 's Depression Rating Scale-Revised [ CDRS-R ] score ) after 9-week fluoxetine treatment were r and omly reassigned to continue at 20 mg/day or to increase to 40 mg/day . After 4 weeks , patients unresponsive to 40 mg/day could receive 60 mg/day . RESULTS Twenty-nine ( 29 ) patients , 9 - 17 years of age , received fluoxetine 40 - 60 mg/day ( n = 14 ) or 20 mg/day ( n = 15 ) . At the conclusion of this study phase , 10 patients ( 71 % ) on 40 - 60 mg/day met the response criteria , versus 5 patients ( 36 % ) on 20 mg/day ( p = 0.128 ) . Mean CDRS-R scores improved in both treatment groups ( fluoxetine 40 - 60 mg/day , -9.4 ; fluoxetine 20 mg/day , -1.5 ; p = 0.099 ) . Adverse events were similar in both groups . However , this study phase was statistically underpowered for detecting differences between treatment groups . CONCLUSION More than two thirds of patients whose dosage was increased responded within 10 weeks , suggesting dose escalation may benefit some patients . Approximately one third of patients unresponsive to initial treatment with fluoxetine 20 mg responded to this fixed dosage within another 10 weeks . Fluoxetine 20 - 60 mg/day was well tolerated",
"BACKGROUND We examined the long-term outcome of participants in the Treatment of SSRI-Resistant Depression in Adolescents ( TORDIA ) study , a r and omized trial of 334 adolescents ( aged 12 - 18 years ) with DSM-IV-defined major depressive disorder initially resistant to selective serotonin reuptake inhibitor ( SSRI ) treatment who were subsequently treated for 12 weeks with another SSRI , venlafaxine , another SSRI + cognitive-behavioral therapy ( CBT ) , or venlafaxine + CBT . Responders then continued with the same treatment through week 24 , while nonresponders were given open treatment . METHOD For the current study , patients were reassessed 48 ( n = 116 ) and 72 ( n = 130 ) weeks from intake . Data were gathered from February 2001 to February 2007 . St and ardized diagnostic interviews and measures of depression , suicidal ideation , related psychopathology , and level of functioning were periodically administered . Remission was defined as ≥ 3 weeks with ≤ 1 clinical ly significant symptom and no associated functional impairment ( score of 1 on the adolescent version of the Longitudinal Interval Follow-Up Evaluation [ A-LIFE ] ) , and relapse , as ≥ 2 weeks with probable or definite depressive disorder ( score of 3 or 4 on the A-LIFE ) . Mixed-effects regression models were applied to estimate remission , relapse , and functional recovery . RESULTS By 72 weeks , an estimated 61.1 % of the r and omized youths had reached remission . R and omly assigned treatment ( first 12 weeks ) did not influence remission rate or time to remission , but the group assigned to SSRIs had a more rapid decline in self-reported depressive symptoms and suicidal ideation than those assigned to venlafaxine ( P severe depression , greater dysfunction , and alcohol or drug use at baseline were less likely to remit . The depressive symptom trajectory of the remitters diverged from that of nonremitters by the first 6 weeks of treatment ( P 130 participants in remission at week 24 , 25.4 % relapsed in the subsequent year . CONCLUSIONS While most adolescents achieved remission , more than one-third did not , and one-fourth of remitted patients experienced a relapse . More effective interventions are needed for patients who do not show robust improvement early in treatment . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00018902",
"This paper examines the relationship between plasma concentration of antidepressant and both clinical response and adverse effects in treatment-resistant depressed adolescents . Adolescents ( n = 334 ) with major depression who had not responded to a selective serotonin reuptake inhibitor ( SSRI ) were r and omized to 1 of 4 treatments : switch to another SSRI ( fluoxetine , citalopram , or paroxetine ) , switch to venlafaxine , switch to SSRI plus cognitive behavior therapy , or switch to venlafaxine plus cognitive behavior therapy . Adolescents who did not improve by 6 weeks had their dose increased . Plasma concentrations of medication and metabolites were measured at 6 weeks in 244 participants and at 12 weeks in 204 participants . Adolescents treated with citalopram whose plasma concentration was equal to or greater than the geometric mean ( GM ) showed a higher response rate compared to those with less than the GM , with parallel but nonsignificant findings for fluoxetine . A dose increase of citalopram or fluoxetine at week 6 was most likely to result in response when it led to a change in concentration from less than the GM at 6 weeks to the GM or greater at week 12 . Plasma levels of paroxetine , venlafaxine , or O-desmethylvenlafaxine were not related to clinical response . Exposure was associated with more cardiovascular and dermatologic side effects in those receiving venlafaxine . Antidepressant concentration may be useful in optimizing treatment for depressed adolescents receiving fluoxetine or citalopram",
"OBJECTIVE To examine the bidirectional relationship between parent-child discord and treatment outcome for adolescent treatment-resistant depression . METHOD Depressed youth who had not responded to an adequate course of a selective serotonin reuptake inhibitor ( SSRI ) were r and omized to either a switch to another SSRI or venlafaxine , with or without the addition of cognitive behavior therapy ( CBT ) in the Treatment of SSRI-Resistant Depression in Adolescents ( TORDIA ) study . The Conflict Behavior Question naire was used to assess adolescent ( CBQ-A ) and parent-reported ( CBQ-P ) parent-child discord . The impact of remission on parent-child conflict , and the differential impact of medication and CBT on the CBQ-A and CBQ-P , were assessed using generalized linear models . RESULTS Although there were no differential treatment effects on parent or adolescent-report of conflict , remission was associated with improvement in the CBQ-P. In general , intake family conflict did not predict remission , except in the sub-group of participants whose parents reported clinical ly significant parent-child conflict at intake , for whom high levels of parent-reported conflict predicted a lower likelihood of remission . Conflict also did not moderate treatment response . CONCLUSIONS Remission of depression may be sufficient to reduce parent-reported parent-child conflict . However , higher parent-reported conflict , in the clinical ly significant range , predicts a lower likelihood of remission from depression . Clinical trial registration information-Treatment of SSRI-Resistant Depression in Adolescents ( TORDIA ) ; http:// clinical trials.gov/ ; NCT00018902",
"OBJECTIVE To identify symptom dimensions of depression that predict recovery among selective serotonin reuptake inhibitor ( SSRI ) treatment-resistant adolescents undergoing second-step treatment . METHOD The Treatment of Resistant Depression in Adolescents ( TORDIA ) trial included 334 SSRI treatment-resistant youth r and omized to a medication switch , or a medication switch plus CBT . This study examined five established symptom dimensions ( Child Depression Rating Scale-Revised ) at baseline as they predicted recovery over 24 weeks of acute and continuation treatment . The two indices of recovery that were evaluated were time to remission and number of depression-free days . RESULTS Multivariate analyses examining all five depression symptom dimensions simultaneously indicated that anhedonia was the only dimension to predict a longer time to remission , and also the only dimension to predict fewer depression-free days . In addition , when anhedonia and CDRS-total score were evaluated simultaneously , anhedonia continued to uniquely predict longer time to remission and fewer depression-free days . CONCLUSIONS Anhedonia may represent an important negative prognostic indicator among treatment-resistant depressed adolescents . Further research is needed to eluci date neurobehavioral underpinnings of anhedonia , and to test treatments that target anhedonia in the context of overall treatment of depression",
"BACKGROUND Depression is a major cause of morbidity and mortality in children and adolescents . To date , r and omized , controlled , double-blind trials of antidepressants ( largely tricyclic agents ) have yet to reveal that any antidepressant is more effective than placebo . This article is of a r and omized , double-blind , placebo-controlled trial of fluoxetine in children and adolescents with depression . METHODS Ninety-six child and adolescent out patients ( aged 7 - 17 years ) with nonpsychotic major depressive disorder were r and omized ( stratified for age and sex ) to 20 mg of fluoxetine or placebo and seen weekly for 8 consecutive weeks . R and omization was preceded by 3 evaluation visits that included structured diagnostic interviews during 2 weeks , followed 1 week later by a 1-week , single-blind placebo run-in . Primary outcome measurements were the global improvement of the Clinical Global Impressions scale and the Children 's Depression Rating Scale -- Revised , a measure of the severity depressive symptoms . RESULTS Of the 96 patients , 48 were r and omized to fluoxetine treatment and 48 to placebo . Using the intent to treat sample , 27 ( 56 % ) of those receiving fluoxetine and 16 ( 33 % ) receiving placebo were rated \" much \" or \" very much \" improved on the Clinical Global Impressions scale at study exit ( chi 2 = 5.1 , df = 1 , P = .02 ) . Significant differences were also noted in weekly ratings of the Children 's Depression Rating Scale -- Revised after 5 weeks of treatment ( using last observation carried forward ) . Equivalent response rates were found for patients aged 12 years and younger ( n = 48 ) and those aged 13 years and older ( n = 48 ) . However , complete symptom remission ( Children 's Depression Rating Scale -- Revised fluoxetine-treated patients and 23 % of the placebo patients . CONCLUSION Fluoxetine was superior to placebo in the acute phase treatment of major depressive disorder in child and adolescent out patients with severe , persistent depression . Complete remission of symptoms was rare",
"CONTEXT Many youth with depression do not respond to initial treatment with selective serotonin reuptake inhibitors ( SSRIs ) , and this is associated with higher costs . More effective treatment for these youth may be cost-effective . OBJECTIVE To evaluate the incremental cost-effectiveness over 24 weeks of combined cognitive behavior therapy plus switch to a different antidepressant medication vs medication switch only in adolescents who continued to have depression despite adequate initial treatment with an SSRI . DESIGN R and omized controlled trial . SETTING Six US academic and community clinics . PATIENTS Three hundred thirty-four patients aged 12 to 18 years with SSRI-resistant depression . INTERVENTION Participants were r and omly assigned to ( 1 ) switch to a different medication only or ( 2 ) switch to a different medication plus cognitive behavior therapy . MAIN OUTCOME MEASURES Clinical outcomes were depression-free days ( DFDs ) , depression-improvement days ( DIDs ) , and quality -adjusted life-years based on DFDs ( DFD-QALYs ) . Costs of intervention , non protocol services , and families were included . RESULTS Combined treatment achieved 8.3 additional DFDs ( P = .03 ) , 0.020 more DFD-QALYs ( P = .03 ) , and 11.0 more DIDs ( P = .04 ) . Combined therapy cost $ 1633 more ( P = .01 ) . Cost per DFD was $ 188 ( incremental cost-effectiveness ratio [ ICER ] = $ 188 ; 95 % confidence interval [ CI ] , -$22 to $ 1613 ) , $ 142 per DID ( ICER = $ 142 ; 95 % CI , -$14 to $ 2529 ) , and $ 78,948 per DFD-QALY ( ICER = $ 78,948 ; 95 % CI , -$9261 to $ 677,448 ) . Cost-effectiveness acceptability curve analyses suggest a 61 % probability that combined treatment is more cost-effective at a willingness to pay $ 100,000 per QALY . Combined treatment had a higher net benefit for subgroups of youth without a history of abuse , with lower levels of hopelessness , and with comorbid conditions . CONCLUSIONS For youth with SSRI-resistant depression , combined treatment decreases the number of days with depression and is more costly . Depending on a decision maker 's willingness to pay , combined therapy may be cost-effective , particularly for some subgroups . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00018902",
"OBJECTIVE To assess the relative efficacy of antidepressant medication , alone and in combination with cognitive behavioral therapy ( CBT ) , on comorbid symptoms of anxiety , attention , and disruptive behavior disorders in participants in the Treatment of Resistant Depression in Adolescents ( TORDIA ) trial . METHOD Adolescents with selective serotonin reuptake inhibitor (SSRI)-resistant depression ( N = 334 ) were r and omly assigned to a medication switch alone ( to another SSRI or to venlafaxine ) or to a medication switch plus CBT . Anxiety , attention-deficit/hyperactivity disorder ( ADHD ) , and disruptive behavior disorder ( DBD ) symptoms were assessed by psychiatric interview and self-report at regular intervals between baseline and 24 weeks . The differential effects of medication and of CBT , and the impact of remission on the course of comorbid symptoms and diagnoses , were assessed using generalized linear mixed models . RESULTS Remission was associated with a greater reduction in scalar measures of anxiety , ADHD , and DBDs , and a greater decrease in the rate of diagnosed anxiety disorders . The correlations between the changes in symptoms of depression on the CDRS-R and anxiety , ADHD , and oppositional symptoms were modest , ranging from r = 0.12 to r = 0.28 . There were no significant differential treatment effects on diagnoses , or corresponding symptoms . CONCLUSION The achievement of remission had a beneficial effect on anxiety , ADHD , and DBD symptoms , regardless of the type of treatment received . There were no differential effects of medication or CBT on outcome , except for a nonsignificant trend that those adolescents treated with SSRIs showed a greater decrease in rates of comorbid DBDs relative to those treated with venlafaxine . Clinical trial registration information-Treatment of SSRI-Resistant Depression In Adolescents ( TORDIA ) ; http:// clinical trials.gov/ ; NCT00018902",
"CONTEXT Only about 60 % of adolescents with depression will show an adequate clinical response to an initial treatment trial with a selective serotonin reuptake inhibitor ( SSRI ) . There are no data to guide clinicians on subsequent treatment strategy . OBJECTIVE To evaluate the relative efficacy of 4 treatment strategies in adolescents who continued to have depression despite adequate initial treatment with an SSRI . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial of a clinical sample of 334 patients aged 12 to 18 years with a primary diagnosis of major depressive disorder that had not responded to a 2-month initial treatment with an SSRI , conducted at 6 US academic and community clinics from 2000 - 2006 . INTERVENTIONS Twelve weeks of : ( 1 ) switch to a second , different SSRI ( paroxetine , citalopram , or fluoxetine , 20 - 40 mg ) ; ( 2 ) switch to a different SSRI plus cognitive behavioral therapy ; ( 3 ) switch to venlafaxine ( 150 - 225 mg ) ; or ( 4 ) switch to venlafaxine plus cognitive behavioral therapy . MAIN OUTCOME MEASURES Clinical Global Impressions-Improvement score of 2 or less ( much or very much improved ) and a decrease of at least 50 % in the Children 's Depression Rating Scale-Revised ( CDRS-R ) ; and change in CDRS-R over time . RESULTS Cognitive behavioral therapy plus a switch to either medication regimen showed a higher response rate ( 54.8 % ; 95 % confidence interval [ CI ] , 47%-62 % ) than a medication switch alone ( 40.5 % ; 95 % CI , 33%-48 % ; P = .009 ) , but there was no difference in response rate between venlafaxine and a second SSRI ( 48.2 % ; 95 % CI , 41%-56 % vs 47.0 % ; 95 % CI , 40%-55 % ; P = .83 ) . There were no differential treatment effects on change in the CDRS-R , self-rated depressive symptoms , suicidal ideation , or on the rate of harm-related or any other adverse events . There was a greater increase in diastolic blood pressure and pulse and more frequent occurrence of skin problems during venlafaxine than SSRI treatment . CONCLUSIONS For adolescents with depression not responding to an adequate initial treatment with an SSRI , the combination of cognitive behavioral therapy and a switch to another antidepressant result ed in a higher rate of clinical response than did a medication switch alone . However , a switch to another SSRI was just as efficacious as a switch to venlafaxine and result ed in fewer adverse effects . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00018902",
"OBJECTIVE To identify the predictors of suicidal events and attempts in adolescent suicide attempters with depression treated in an open treatment trial . METHOD Adolescents who had made a recent suicide attempt and had unipolar depression ( n = 124 ) were either r and omized ( n = 22 ) or given a choice ( n = 102 ) among three conditions . Two participants withdrew before treatment assignment . The remaining 124 youths received a specialized psychotherapy for suicide attempting adolescents ( n = 17 ) , a medication algorithm ( n = 14 ) , or the combination ( n = 93 ) . The participants were followed up 6 months after intake with respect to rate , timing , and predictors of a suicidal event ( attempt or acute suicidal ideation necessitating emergency referral ) . RESULTS The morbid risks of suicidal events and attempts on 6-month follow-up were 0.19 and 0.12 , respectively , with a median time to event of 44 days . Higher self-rated depression , suicidal ideation , family income , greater number of previous suicide attempts , lower maximum lethality of previous attempt , history of sexual abuse , and lower family cohesion predicted the occurrence , and earlier time to event , with similar findings for the outcome of attempts . A slower decline in suicidal ideation was associated with the occurrence of a suicidal event . CONCLUSIONS In this open trial , the 6-month morbid risks for suicidal events and for reattempts were lower than those in other comparable sample s , suggesting that this intervention should be studied further . Important treatment targets include suicidal ideation , family cohesion , and sequelae of previous abuse . Because 40 % of events occurred with 4 weeks of intake , an emphasis on safety planning and increased therapeutic contact early in treatment may be warranted",
"OBJECTIVE To identify predictors and moderators of response to acute treatments among depressed adolescents ( N = 439 ) r and omly assigned to fluoxetine , cognitive-behavioral therapy ( CBT ) , both fluoxetine and CBT , or clinical management with pill placebo in the Treatment for Adolescents With Depression Study ( TADS ) . METHOD Potential baseline predictors and moderators were identified by a literature review . The outcome measure was a week 12 predicted score derived from the Children 's Depression Rating Scale-Revised ( CDRS-R ) . For each c and i date moderator or predictor , a general linear model was conducted to examine main and interactive effects of treatment and the c and i date variable on the CDRS-R predicted scores . RESULTS Adolescents who were younger , less chronically depressed , higher functioning , and less hopeless with less suicidal ideation , fewer melancholic features or comorbid diagnoses , and greater expectations for improvement were more likely to benefit acutely than their counterparts . Combined treatment , under no condition less effective than monotherapy , was more effective than fluoxetine for mild to moderate depression and for depression with high levels of cognitive distortion , but not for severe depression or depression with low levels of cognitive distortion . Adolescents from high-income families were as likely to benefit from CBT alone as from combined treatment . CONCLUSIONS Younger and less severely impaired adolescents are likely to respond better to acute treatment than older , more impaired , or multiply comorbid adolescents . Family income level , cognitive distortions , and severity of depression may help clinicians to choose among acute interventions , but combined treatment proved robust in the presence of moderators",
"OBJECTIVES To determine if , in the short term , depressed adolescents attending routine NHS Child and Adolescent Mental Health Services ( CAMHS ) , and receiving ongoing active clinical care , treatment with selective serotonin reuptake inhibitors ( SSRIs ) plus cognitive behaviour therapy ( CBT ) compared with SSRI alone , results in better healthcare outcomes . DESIGN A pragmatic r and omised controlled trial ( RCT ) was conducted on depressed adolescents attending CAMHS who had not responded to a psychosocial brief initial intervention ( BII ) prior to r and omisation . SETTING Six English CAMHS participated in the study . PARTICIPANTS A total of 208 patients aged between 11 and 17 years were recruited and r and omised . INTERVENTIONS All participants received active routine clinical care in a CAMHS outpatient setting and an SSRI and half were offered CBT . MAIN OUTCOME MEASURES The duration of the trial was a 12-week treatment phase , followed by a 16-week maintenance phase . Follow-up assessment s were at 6 , 12 and 28 weeks . The primary outcome measure was the Health of the Nation Outcome Scales for Children and Adolescents ( HoNOSCA ) . Secondary outcome measures were self-report depressive symptoms , interviewer-rated depressive signs and symptoms , interviewer-rated psychosocial impairment and clinical global impression of response to treatment . Information on re source use was collected in interview at baseline and at the 12- and 28-week follow-up assessment s using the Child and Adolescent Service Use Schedule ( CA-SUS ) . RESULTS Of the 208 patients r and omised , 200 ( 96 % ) completed the trial to the primary end-point at 12 weeks . By the 28-week follow-up , 174 ( 84 % ) participants were re-evaluated . Overall , 193 ( 93 % ) participants had been assessed at one or more time points . Clinical characteristics indicated that the trial was conducted on a severely depressed group . There was significant recovery at all time points in both arms . The findings demonstrated no difference in treatment effectiveness for SSRI + CBT over SSRI only for the primary or secondary outcome measures at any time point . This lack of difference held when baseline and treatment characteristics where taken into account ( age , sex , severity , co-morbid characteristics , quality and quantity of CBT treatment , number of clinic attendances ) . The SSRI + CBT group was somewhat more expensive over the 28 weeks than the SSRI-only group ( p=0.057 ) and no more cost-effective . Over the trial period there was on average a decrease in suicidal thoughts and self-harm compared with levels recorded at baseline . There was no significant increase in disinhibition , irritability and violence compared with levels at baseline . Around 20 % ( n=40 ) of patients in the trial were non-responders . Of these , 17 ( 43 % ) showed no improvement by 28 weeks and 23 ( 57 % ) were considered minimally ( n=10 ) or moderately to severely worse ( n=13 ) . CONCLUSIONS For moderately to severely depressed adolescents who are non-responsive to a BII , the addition of CBT to fluoxetine plus routine clinical care does not improve outcome or confer protective effects against adverse events and is not cost-effective . SSRIs ( mostly fluoxetine ) are not likely to result in harmful adverse effects . The findings are broadly consistent with existing guidelines on the treatment of moderate to severe depression . Modification is advised for those presenting with moderate ( 6 - 8 symptoms ) to severe depressions ( > 8 symptoms ) and in those with either overt suicidal risk and /or high levels of personal impairment . In such cases , the time allowed for response to psychosocial interventions should be no more than 2 - 4 weeks , after which fluoxetine should be prescribed . Further research should focus on evaluating the efficacy of specific psychological treatments against brief psychological intervention , determining the characteristics of patients with severe depression who are non-responsive to fluoxetine , relapse prevention in severe depression and improving tools for determining treatment responders and non-responders",
"OBJECTIVE Nonadherence to antidepressant treatment may contribute to poor outcome and to suicidal adverse events in adolescent depression . We examine the relationship between adherence and both clinical response and suicidal events in participants in the Treatment of Resistant Depression in Adolescents ( TORDIA ) study . METHOD The relationship between adherence to medication and clinical outcome was assessed in 190 treatment-resistant depressed adolescents who were r and omized to one of four cells : switch to another selective serotonin reuptake inhibitor ( SSRI ) , switch to venlafaxine , or either of these two medication switches plus cognitive behavioral therapy . Plasma levels of antidepressant drug and metabolites were determined after 6 and 12 weeks of treatment . A twofold or greater variation in the dose-adjusted concentration of drug plus metabolites ( level/dose ratio [ LDR ] ) was defined as nonadherence . Nonadherence was also determined by clinician pill counts ( CPC ) of the proportion of prescribed pills that were unused and was defined as having greater than 30 % of the prescribed pills remaining . RESULTS LDR and CPC showed low concordance . LDR was unrelated to clinical response . CPC adherence was related to a higher response rate overall ( adherent , 63.0 % versus nonadherent , 47.2 % , p = .03 ) . Approximately half ( 50.8 % ) of the sample surveyed showed evidence of nonadherence by CPC . Neither measure of adherence was related to the occurrence of suicidal events or to the pace of decline in suicidal ideation . CONCLUSIONS Clinician pill counts may be a relevant measure of adherence that is related to outcome under formal clinical trial conditions in depressed adolescents . Nonadherence appears to be a common and significant source of treatment nonresponse . Clinical Trial Registration Information-Treatment of SSRI-Resistant Depression in Adolescents ( TORDIA ) ; http://www . clinical trials.gov ; NCT00018902",
"Importance Suicide is a leading cause of death among 10- to 24-year-old individuals in the United States ; evidence on effective treatment for adolescents who engage in suicidal and self-harm behaviors is limited . Objective To evaluate the efficacy of dialectical behavior therapy ( DBT ) compared with individual and group supportive therapy ( IGST ) for reducing suicide attempts , nonsuicidal self-injury , and overall self-harm among high-risk youths . Design , Setting , and Participants This r and omized clinical trial was conducted from January 1 , 2012 , through August 31 , 2014 , at 4 academic medical centers . A total of 173 participants ( pool of 195 ; 22 withdrew or were excluded ) 12 to 18 years of age with a prior lifetime suicide attempt ( ≥3 prior self-harm episodes , suicidal ideation , or emotional dysregulation ) were studied . Adaptive r and omization balanced participants across conditions within sites based on age , number of prior suicide attempts , and psychotropic medication use . Participants were followed up for 1 year . Interventions Study participants were r and omly assigned to DBT or IGST . Treatment duration was 6 months . Both groups had weekly individual and group psychotherapy , therapist consultation meetings , and parent contact as needed . Main Outcomes and Measures A priori planned outcomes were suicide attempts , nonsuicidal self-injury , and total self-harm assessed using the Suicide Attempt Self-Injury Interview . Results A total of 173 adolescents ( 163 [ 94.8 % ] female and 97 [ 56.4 % ] white ; mean [ SD ] age , 14.89 [ 1.47 ] years ) were studied . Significant advantages were found for DBT on all primary outcomes after treatment : suicide attempts ( 65 [ 90.3 % ] of 72 receiving DBT vs 51 [ 78.9 % ] of 65 receiving IGST with no suicide attempts ; odds ratio [ OR ] , 0.30 ; 95 % CI , 0.10 - 0.91 ) , nonsuicidal self-injury ( 41 [ 56.9 % ] of 72 receiving DBT vs 26 [ 40.0 % ] of 65 receiving IGST with no self-injury ; OR , 0.32 ; 95 % CI , 0.13 - 0.70 ) , and self-harm ( 39 [ 54.2 % ] of 72 receiving DBT vs 24 [ 36.9 % ] of 65 receiving IGST with no self-harm ; OR , 0.33 ; 95 % CI , 0.14 - 0.78 ) . Rates of self-harm decreased through 1-year follow-up . The advantage of DBT decreased , with no statistically significant between-group differences from 6 to 12 months ( OR , 0.65 ; 95 % CI , 0.12 - 3.36 ; P = .61 ) . Treatment completion rates were higher for DBT ( 75.6 % ) than for IGST ( 55.2 % ) , but pattern-mixture models indicated that this difference did not informatively affect outcomes . Conclusions and Relevance The results of this trial support the efficacy of DBT for reducing self-harm and suicide attempts in highly suicidal self-harming adolescents . On the basis of the criteria of 2 independent trials supporting efficacy , results support DBT as the first well-established , empirically supported treatment for decreasing repeated suicide attempts and self-harm in youths . Trial Registration Clinical Trials.gov Identifier : NCT01528020",
"BACKGROUND To identify distinct depressive symptom trajectories in the TORDIA study and determine their correlates . METHODS Latent Class Growth Analysis ( LCGA ) using the Children 's Depression Rating Scale-Revised ( CDRS-R ) through 72 weeks from intake . RESULTS 3 classes were identified : ( 1 ) little change in symptomatic status ( \" NO \" ) , comprising 24.9 % of participants , with a 72-week remission rate of 25.3 % ; ( 2 ) slow , steady improvement ( \" SLOW \" ) , comprising 47.9 % of participants , with a remission rate of 60.0 % , and ( 3 ) rapid symptom response ( \" GO \" ) , comprising 27.2 % of participants , with a remission rate of 85.7 % . Higher baseline CDRS-R ( p poorer functioning ( p=0.03 ) were the strongest discriminators between NO and GO . Higher baseline CDRS ( p scores on the Mania Rating Scale ( MRS ) ( p=0.01 ) were the strongest discriminators between SLOW and GO . Other variables differentiating GO from both NO and from SLOW , were better baseline functioning , lower hopelessness , and lower family conflict . Both NO and SLOW showed increases on the MRS over time compared to GO ( ps ≤ 0.04 ) , and increasing MRS was strongly associated with lack of remission by 72 weeks ( p=0.02 ) . LIMITATIONS High rate of open treatment by the end of the follow-up period creates difficulty in drawing clear inferences about the long-term impact of initial r and omization . CONCLUSION Along with depressive severity , sub-syndromal manic symptoms , at baseline , and over time emerged as important predictors and correlates of poor outcome in this sample . Further research is needed on the treatment of severe depression , and on the assessment and management of sub-syndromal manic symptoms in treatment resistant depression",
"The present study represents one of the first comparisons of the long-term effectiveness of traditional cognitive behavior therapy ( i.e. , Beckian cognitive therapy ; CT ) and acceptance and commitment therapy ( ACT ) . One hundred thirty-two anxious or depressed out patients were r and omly assigned to receive either CT or ACT , and were assessed at posttreatment ( n=90 ) and at 1.5-year ( n=91 ) follow-up . As previously reported , the two treatments were equivalently effective at posttreatment according to measures of depression , anxiety , overall ( social/occupational/symptom-related ) functioning , and quality of life . However , current results suggest that treatment gains were better maintained at follow-up in the CT condition . Clinical significance analyses revealed that , at follow-up , one-third more CT patients were in the clinical ly normative range in terms of depressive symptoms and more than twice as many CT patients were in the normative range in terms of functioning levels . The possible long-term advantage of CT relative to ACT in this population is discussed"
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The following aims were set for this systematic literature review : ( a ) to make an inventory of existing methods to achieve bondable surfaces on oxide ceramics and ( b ) to evaluate which methods might provide sufficient bond strength . Current literature of in vitro studies regarding bond strength achieved using different surface treatments on oxide ceramics in combination with adhesive cement systems was selected from PubMed and systematic ally analyzed and completed with reference tracking . The total number of publications included for aim a was 127 studies , 23 of which were used for aim b. The surface treatments are divided into seven main groups : as-produced , grinding/polishing , airborne particle abrasion , surface coating , laser treatment , acid treatment , and primer treatment . There are large variations , making comparison of the studies difficult . An as-produced surface of oxide ceramic needs to be surface treated to achieve durable bond strength . Abrasive surface treatment and /or silica-coating treatment with the use of primer treatment can provide sufficient bond strength for bonding oxide ceramics . This conclusion , however , needs to be confirmed by clinical studies . There is no universal surface treatment . Consideration should be given to the specific material s to be cemented and to the adhesive cement system to be used
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"OBJECTIVE this study evaluated the effect of surface treatments ( Nd : YAG laser , CO2 laser , Al203 airborne-particle abrasion , and silica-coating ) on the zirconia-to-resin shear bond strength ( SBS ) . METHOD AND MATERIAL S eighty-one Lava ( 3 M ESPE ) blocks ( 13 x 4 x 2 mm ) were embedded in acrylic resin , polished , and r and omly divided into three groups , which received the following surface treatments : no abrasion , Al203 airborne-particle abrasion ( 50 Μm ) , or silica-coating ( Cojet , 3 M ESPE ) . Each group was divided into three subgroups that were treated with Nd : YAG laser , CO2 laser , or no laser irradiation . Following application of a monomer phosphate-containing primer , cylinders of resin cement ( Panavia F , Kuraray ) ( n = 18 ) were built on the surface . SBS testing was carried out after 24 hours of storage in water . Surface roughness and topography ( SEM ) after treatments were evaluated . RESULTS according to ANOVA and Tukey test ( α = 0.05 ) , mean SBS after Nd : YAG laser treatment ranged from 14.09 to 16.20 MPa and was statistically higher than CO2 laser ( 6.24 to 10.51 MPa ) and no laser treatment ( 4.65 to 8.79 MPa ) . The Nd : YAG laser created more roughness on zirconia when compared to the CO2 laser and abrasion treatments . Silica-coating increased the SBS of lased and nonlased zirconia . Significant microcracks were found on specimens treated with CO2 . CONCLUSION Nd : YAG laser pretreatment , whether associated with abrasion methods or not , created consistent roughness on the zirconia surface and significantly increased zirconia SBS to Panavia F. Silica-coating could potentially increase the SBS of lased and nonlased zirconia . Significant microcracks were found on specimens treated with the CO2 laser ",
"PURPOSE To investigate the influence of cyclic impact load and the number of load cycles on compressive shear bond strength under the three different cements . MATERIAL S AND METHODS The following material s were used : Super Bond C&B ( SB ) and Panavia Fluoro Cement ( PF ) as adhesive resin cements , Fuji Luting ( FL ) as a resin-modified glass-ionomer cement , and zirconium dioxide ceramics as adherend . Before the shear bond test , three different impact loading conditions ( compressive direction , shear direction , and no impact ) and the number of load cycles ( 1 to 106 cycles ) , were performed . A total of 189 specimens ( n = 3/group ) were r and omly assigned to groups and tested . A cyclic impact test was performed by applying a load of 98N at a distance of 40 mm and a loading cycle frequency of 1 Hz . All results were statistically analyzed with two-way ANOVA and Tukey 's multiple comparison test . RESULTS Shear bond strengths of SB , PF , and FL subjected to no cyclic impact load were 21.6 to 53.8 MPa in SB , 27.0 to 63.6 MPa in PF , and 20.0 to 35.9 MPa in FL . The shear bond strength of SB and PF increased to a certain degree from one to 105 cycles , while FL did likewise from one to 104 cycles . CONCLUSION The shear bond strengths of SB , PF , and FL were greatest without cyclic impact , followed by compressive and then shear cyclic impact",
"OBJECTIVE To evaluate the effect of five experimental silane monomer primers in vitro on the shear bond strength of a phosphate ester resin-composite cement bonded to a silicatized zirconia framework . METHODS A total of 144 planar zirconia ( Procera AllZircon ) specimens were subjected to tribochemical silica treatment , r and omly divided into 12 sub-groups ( n=12 ) , and silanized with 1.0%(v/v ) activated solutions of 3-acryloxypropyltrimethoxysilane , 3 glycidoxypropyltrimethoxysilane , 3-methacryloxypropyltrimethoxysilane , styrylethyltrimethoxysilane , and 3-isocyanatopropyltriethoxysilane , which had been prepared in 95 % ethanol ( pH 4.5 ) . A ready-to-use 3-methacryloxypropyltrimethoxysilane ( RelyX ™ Ceramic Primer ) was used as the control . One resincomposite cement ( RelyX ™ Unicem ) stub was bonded to each silicatized and silanized zirconia specimen . Half of the specimen groups were dry-tested and half were thermo-cycled at 6000 cycles between 5 ° C and 55 ° C , with a constant dwelling time of 30s . The shear bond strengths of the cement stubs bonded to zirconia were measured using a universal testing machine using a constant cross-head speed of 1mm/min . The silane primer activation was evaluated using Fourier-transform infrared spectroscopy . RESULTS The highest shear bond strength was obtained for 3-acryloxypropyltrimethoxysilane in dry storage , 11.7 MPa ( SD , 2.3 MPa ) and after thermo-cycling 17.6 ( 4.1 ) MPa for glycidoxypropyltrimethoxysilane . The lowest shear bond strength values were obtained with control silane : in dry storage , 4.5 ( 1.3 ) MPa , after thermo-cycling 6.5 ( 2.6 ) MPa . Thermo-cycling increased the bond strengths significantly ( ANOVA , p experimental silane primers in vitro produced significantly greater shear bond strengths than the ready-to-use control silane",
"The purpose of the study was to evaluate the shear bond strengths ( SBS ) of two resin cements to intaglio surfaces of zirconia from two manufacturers after three surface treatment methods . Forty zirconia specimens from one manufacturer ( Lava , 3 M ESPE ) and 40 zirconia specimens from another manufacturer ( Cercon , Dentsply ) , each with system-specific intaglio surfaces , were r and omly divided into four treatment groups ( 20 sample s per group , 10 for each manufacturer ) : no treatment ( No_T ) , s and blasting with 50microm Al2O3 ( S_50 ) , s and blasting with 110 microm al2O3 ( S_110 ) , and Rocatec silica coating and silanization ( ESPE-Sil , 3 M ESPE ) ( Roc ) . A 5-mm metal ring was fixed upon the zirconia and was filled with one of two different resin composite cements ( RelyX Unicem , 3 M ESPE and Panavia F 2.0 , Kuraray ) . Sample s were stored in distilled water at 37 degrees C for 7 days ; SBS was evaluated using a universal testing machine . Values were calculated in MPa and the data were analyzed by ANOVA and Tukey HSD test ( P bond strength of Panavia compared to the control group ( P = .195 ) ; using RelyX Unicem , S_50 and Roc , mean SBS values were significantly higher than values for No_T ( S50 P = .0048 ; Roc P bond strength of RelyX Unicem resin cement to both zirconia substrates . No statistically significant changes were found using Panavia on Lava . S and blasting with 110 microm Al2O3 provided the highest bond strength for Panavia on Cercon",
"The present study evaluated the durability of bond strength between zirconia and 3 different resin cements . Thirty stabilized tetragonal zirconium-dioxide blocks were duplicated in dual-curing resin core build-up material specimens . Resin blocks were r and omly luted to zirconium surfaces using 1 ) Clearfil Esthetic Cement ( CLF ) , 2 ) RelyX Unicem Aplicap ( RELX ) , or 3 ) Multilink Automix ( MLA ) . After 24 h , half of the specimens from each of the 3 groups were loaded in tension until fracture ( 0.5 mm/min ) . The remaining half were tested after 6,000 thermal cycles ( 5 to 55 ° C ) . Data were analyzed using 2-way ANOVA and the Tukey test ( α = 0.05 ) . Fractographic analysis was performed using a stereomicroscope . Tensile bond strength values were significantly affected by the luting agent system employed and by thermal aging ( P highest tensile bond strength values in non-thermal-aged groups were observed for specimens from the RELX and CLF groups . In contrast , in the thermal-aged groups , the highest tensile bond strength values were for the MLA and RELX groups . Moreover , while thermocycling significantly affected bond strengths in the RELX and CLF groups , the mean strength of the MLA group did not significantly change after aging . There was little difference in the distribution of failure modes in any group",
"PURPOSE This study evaluated the adhesive quality of simplified self-adhesive and conventional resin cements to Y-TZP in dry and aged conditions . METHODS Y-TZP ceramic blocks ( N = 192 ) ( 5 x 5 x 2 mm ) were embedded in acrylic resin and r and omly divided into two groups , based on surface conditioning : 96 % isopropanol or chairside tribochemical silica coating and silanization . Conditioned ceramics were divided into four groups to receive the resin cements ( Panavia F 2.0 , Variolink II , RelyX U100 and Maxcem ) . After 24 hours , half of the specimens ( n = 12 ) from each group were su bmi tted to shear bond strength testing ( 0.5 mm/minute ) . The remaining specimens were tested after 90 days of water storage at 37 degrees C and thermocycling ( 12,000x , 5 degrees C-55 degrees C ) . Failure types were then assessed . The data were analyzed using three-way ANOVA and the Tukey 's test ( alpha = 0.05 ) . RESULTS Significant effects of ceramic conditioning , cement type and storage conditions were observed ( p low bond strength values in dry conditions and the bond strength was reduced dramatically after aging . Groups conditioned using silica coating and silanization showed higher bond strengths both in dry and aged conditions . A high number of specimens failed prematurely prior to testing when they were cleaned using 96 % isopropanol . CONCLUSION Overall , silica coating and silanization showed higher , stable bond strengths with and without aging . The durability of resin-ceramic adhesion varied , depending on the adhesive cement type",
"Abstract Objective . The purpose of this in vitro study was to evaluate the influence of different power outputs of a carbon dioxide ( CO2 ) laser on shear bond strength of resin cement to zirconium dioxide-based ceramic . Material s and methods . Fifty zirconium dioxide core specimens ( 10 mm diameter and 2 mm thickness ) were produced and they were embedded in the centers of auto-polymerizing acrylic resin blocks . Ten specimens served as control and no surface treatment was applied . Subsequently specimens were r and omly divided into four groups , each containing 10 specimens for surface treatment with CO2 laser with different output power ; laser treated with 2 W ( Group 2 W ) , 3 W ( Group 3 W ) , 4 W ( Group 4 W ) and finally 5 W ( Group 5 W ) . Fifty composite resin discs were fabricated and cemented with adhesive resin cement to the specimen surfaces . A universal test machine was used for shear bond strength test at a crosshead speed 1 mm/min . Data were statistically analyzed by one-way analyses of variance ( ANOVA ) with Post-Hoc Tukey tests ( α = 0.05 ) . Results . It was found that the shear bond strength values were affected by power outputs of laser ( p Highest shear bond strength values were obtained with group 2 W ( 21.0 ± 2.7 ) . Lowest values were obtained with group 5 W ( 14.4 ± 1.6 ) . Conclusion . The current study revealed that there was a relationship between laser output power and shear bond strength for zirconium dioxide ceramics . However , output power of the laser and the energy level is a critical factor on micromechanical retention",
"This study evaluated the influence of surface treatments and metal primers on the bond strength of resin cements to a yttrium-stabilized tetragonal zirconia ( Y-TZP ) ceramic . Two-hundred and forty plates of Y-TZP ceramic were r and omly assigned to 24 groups ( n = 10 ) according to the combination of surface treatment ( none , air abrasion with Al2O3 particles , Er : YAG laser irradiation ) , metal primer ( none , Alloy Primer , Metal Primer II or Metaltite ) and resin cement ( Calibra [ Bis-GMA-based ] or Panavia F2.0 [ MDP-based ] ) . Fragments of dentin with a cylindrical edge ( 0.8 mm in diameter ) were fixed to ceramic surfaces with the resin cements . The micro-shear bond test was carried out at a 1 mm/minute speed until failure , and the ceramic surfaces were examined after debonding . Bond strengths were analyzed through three-way ANOVA/Tukey test with a 5 % significance level . Changes in topography after surface treatments were evaluated with scanning electron microscopy . Surface treatments significantly modified the topography of the Y-TZP ceramic . Air abrasion result ed in increased bond strength for both resin cements . However , air abraded and laser irradiated specimens presented higher bond strength with the Bis-GMA-based resin cement than with the MDP-based cement . Both cements presented similar behavior on untreated surfaces . The three metal primers yielded a significant increase in bond strength , regardless of the surface treatment and resin cement . Adhesive failures were the most prevalent . Air abrasion with Al2O3 particles and the application of metal primers increased bond strength to Y-TZP surfaces for both resin cements",
"OBJECTIVE To evaluate short- and long-term shear bond strengths of 4 luting agents to zirconia following different surface treatments . METHOD AND MATERIAL S A total of 320 ceramic specimens fabricated from a commercial zirconium oxide ceramic ( Lava ) were r and omly divided into 4 groups : left untreated ( NOT ) , airborne-particle abraded ( SND ) , Rocatec tribochemical silica/silane coated ( ROC ) , or ground and polished ( GRD ) . Resin composite cylinders were bonded to the zirconia specimens with resin composite luting agent RelyX ARC ( ARC ) , universal adhesive resin composite RelyX Unicem ( UNI ) , adhesive-phosphate-monomer-containing resin composite Panavia F ( PAN ) , or the hybrid glass-ionomer cement RelyX Luting ( LUT ) . Subgroups of 10 specimens were stored in distilled water ( 37 degrees C ) for 3 days ( ST ) or stored for 180 days and thermocycled for 12,000 cycles ( LT/TC ) before shear bond strength was tested . Statistical analyses included Kruskal-Wallis and Wilcoxon 2- sample rank sum test ( alpha = .01 ) . RESULTS Short-term shear bond strengths were higher with ROC than with SND , which were both greater than GRD or NOT . UNI revealed higher shear bond strengths than PAN , ARC , and LUT . LT/TC significantly decreased shear bond strength values . GRD and NOT produced the lowest shear bond strengths . SND and ROC significantly increased bond strength . ROC generally yielded the highest long-term shear bond strength , especially with UNI , PAN , or ARC . These were similar to SND and PAN , which revealed the highest long-term shear bond strengths . CONCLUSIONS Surface treatment , luting agent , and storage conditions significantly influence shear bond strengths to zirconia . Artificial aging significantly reduces shear bond strengths . Airborne-particle abrasion combined with a resin composite containing adhesive phosphate monomers or tribochemical silica/silane coating combined with any of the tested resin composite luting agents provides superior long-term shear bond strength values",
"OBJECTIVE The increased popularity of alumina-based restorations has result ed in an interest in proper adhesive techniques to assure a strong and predictable bond to these restorations . This study investigated the early bond strength of three different resin-cement systems to densely sintered alumina ( aluminum-oxide ceramic ) with and without the use of their corresponding silane coupling agent ( silanization ) . METHOD AND MATERIAL S Ninety sample s of densely sintered high-purity aluminum-oxide ceramic were r and omly divided into three groups . Composite cylinders were bonded to the ceramic sample s with three resin-cement/bonding-agent systems : Noribond DC ( NOR ) , Panavia 21 EX ( PAN ) , and Variolink II ( VAR ) . Each resin-cement/bonding-agent system was used with and without their corresponding silane ( SIL ) coupling agent ( n = 15 ) . After fabrication , the specimens were stored in distilled water for 3 days at room temperature , and shear bond strength was tested . RESULTS Application of the silane-coupling agent on s and blasted densely sintered alumina did not significantly influence bond strengths with PAN . Silanization significantly improved shear bond strengths with NOR and VAR . NOR-SIL and VAR-SIL revealed the statistically highest values , with NOR-SIL showing the highest mean bond strength of all groups . CONCLUSIONS Silanization of s and blasted densely sintered alumina had mixed effects on the applied resin cements : It had no effect on the performance of the phosphate-modified resin cement PAN , but significantly improved shear bond strength of the Bis-GMA composite resin cements VAR and NOR . NOR-SIL revealed the highest overall mean bond strength",
"The objectives of this study were ( 1 ) to evaluate the bond strength of four resin material s with various chemical compositions following the manufacturers ’ instructions only and ( 2 ) to test their durability in dry and thermal aged conditions when they were bonded to zirconia ceramic . Four types of resin material s namely , Panavia F 2.0 , Multilink , SuperBond and Quadrant Posterior Dense , were attached to the disc-shaped zirconia ceramics ( LAVA , 3 M ESPE ) using polyethylene molds and polymerized accordingly after the ceramics were wet ground finished and ultrasonically cleaned . The specimens were r and omly divided into two groups for ageing conditions . While the dry groups were tested immediately after attachment of the resin cement , the other specimens were subjected to thermocycling ( ×6,000 , 5–55 ° C ) . Bond strength results were significantly affected by the storage condition ( p highest bond strength results under dry conditions ( 9.6 ± 4.1 MPa ) . When manufacturers ’ instructions of the resin cements were followed , no adhesion ( 0 MPa ) was achieved on the zirconia after 6,000 thermal cyclings including Panavia F 2.0",
"OBJECTIVES The aim of this study was to functionalize the surface of yttria partially stabilized tetragonal zirconia ceramics ( Y-TZP ) with a nano-structured alumina coating to improve resin bonding . MATERIAL S AND METHODS A total of 120 densely sintered disc-shaped specimens ( 15.5+/-0.03 mm in diameter and 2.6+/-0.03 mm thick ) were produced from biomedical- grade TZ-3YB-E zirconia powder ( Tosoh , Tokyo , Japan ) , r and omly divided into three groups of 40 and subjected to the following surface treatments : AS - as-sintered ; APA - airborne-particle abraded ; POL - polished . Half of the discs in each group received an alumina coating that was fabricated by exploiting the hydrolysis of aluminium nitride ( AlN ) powder ( groups AS-C , APA-C , POL-C ) . The coating was characterized using scanning electron microscopy ( SEM ) , atomic force microscopy ( AFM ) , and transmission electron microscopy ( TEM ) . The shear-bond strength of the self-etching composite resin ( RelyX Unicem , 3 M ESPE , USA ) was then studied for the coated and uncoated surfaces of the as-sintered , polished and airborne-particle abraded specimens before and after thermocycling ( TC ) . RESULTS The SEM/TEM analyses revealed that the application of an alumina coating to Y-TZP ceramics created a highly retentive surface for resin penetration . The coating showed good surface coverage and a uniform thickness of 240 nm . The resin-bond strength to the groups AS-C , APA-C , POL-C was significantly higher than to the groups AS , APA and POL , both before and after TC ( p debonded spontaneously . In contrast , the TC did not affect the bond strength of the AS-C , POL-C and APA-C groups . SIGNIFICANCE A non-invasive method has been developed that significantly improves resin-bond strength to Y-TZP ceramics . After surface functionalization the bond survives thermocycling without reduction in strength . The method is relatively simple and has the potential to become an effective conditioning method for zirconia ceramics",
"This study evaluated the effect of chairside and laboratory types of surface conditioning methods on the adhesion of dual-cure resin cement with MDP functional monomer to zirconia ceramic after thermocycling . Disk-shaped ( diameter : 10 mm , thickness : 2 mm ) Y-TZP ceramics ( Lava , 3 M ESPE ) were used ( N=40 ) and finished with wet 1200-grit silicon carbide abrasive paper . Specimens were r and omly divided into four experimental groups according to the following surface conditioning methods ( n=10 per group ) : Group 1 - -Chairside airborne particle abrasion with 50-microm Al2O2 + Alloy Primer ( Kuraray ) ; Group 2 - -Airborne particle abrasion with 50-microm Al2O3 + Cesead II Opaque Primer ( Kuraray ) ; Group 3 - -Airborne particle abrasion with 50-microm A12O3 + Silano-Pen + silane coupling agent ( Bredent ) ; Group 4 - -Laboratory tribochemical silica coating ( 110-microm Al2O3 + 110-microm SiOx ) ( Rocatec ) + silane coupling agent ( ESPE-Sil ) . Adhesive cement , Panavia F 2.0 ( Kuraray ) , was bonded incrementally to the ceramic surfaces using polyethylene molds ( diameter : 3.6 mm , height : 5 mm ) . All specimens were thermocycled ( 5 and 55 degrees C , 6,000 cycles ) and subjected to shear bond strength test ( 1 mm/min ) . Data were statistically analyzed ( one-way ANOVA , alpha=0.05 ) , whereby no significant differences were found among the four groups ( 8.43+/-1.3 , 8.98+/-3.6 , 12.02+/-6.7 , and 8.23+/-3.8 MPa ) ( p=0.1357 ) . Therefore , the performance of chairside conditioning methods used for zirconia was on par with the laboratory alternative tested",
"PURPOSE To evaluate the influence of four surface treatments on the bond strength of a self-adhesive resin cement to an yttria-stabilized zirconia ( Y-TZP ) ceramic material ( Lava Frame zirconia ) . MATERIAL S AND METHODS Forty plates ( 8 x 6 x 1 mm ) of a Y-TZP ceramic restorative material were r and omly assigned to four groups ( n = 10 ) according to the surface treatments : control , no treatment ; airborne-particle abrasion with 50-μm Al2O3 ; coating with an MDP-based primer ; conditioning with Rocatec System . The ceramic plates treated with each of the four methods were further divided into 2 subgroups according to the resin cement tested : RelyXTM ARC ( ARC , conventional ) and RelyXTM Unicem ( Ucem , self-adhesive ) . The resin cements were put into PVC tubes ( diameter 0.75 mm , 0.5 mm height ) placed on the ceramic plate surfaces . After water storage at 37 ° C for 24 h , the specimens were su bmi tted to a microshear bond strength ( μSBS ) test at a crosshead speed of 1.0 mm/min . RESULTS The surface treatments significantly influenced the μSBS ( p significantly higher μSBS than ARC ( p : ARC 15.9 ± 5.0 MPa and UCem 36.2 ± 2.1 MPa . The highest μSBS values were presented by UCem on ceramic plates treated with the MDP-based primer ( 36.2 ± 2.1 MPa ) and Rocatec system ( 37.4 ± 2.3 MPa ) . CONCLUSION Irrespective of the surface treatment , the self-adhesive resin cement performed better in terms of bond strength to yttria-stabilized zirconia ceramic than did conventional resin cement",
"OBJECTIVE Various chemical interactions can be used to develop ceramic-resin bonding and specific approaches are available for zirconia ceramics . This study evaluated the effect of a new experimental primer , a mixture of organophosphate and carboxylic acid monomers , on the zirconia-to-resin shear bond strength ( SBS ) . METHODS Forty Y-TZP blocks ( 15x4x2 mm ) were embedded in an acrylic resin base , polished , Al(2)O(3)-s and blasted and r and omly divided into eight groups . Three different resin-based luting agents ( BisCem , Duo-Link , Panavia F ) were used to build 2.4mm-diameter cylinders ( n=15 ) onto the zirconia surface with and without the new experimental zirconia primer . The new primer was also tested with Z100 restorative composite resin cylinders . In addition , Panavia was used with its own primer ( Clearfil Ceramic Primer ) . SBS testing was carried out after 24h of storage in water . Scanning electron microscopy ( SEM ) was used to evaluate the zirconia surface topography and failure mode . RESULTS According to ANOVA and Tukey test ( alpha=0.05 ) , the association of the experimental primer with the restorative composite resin Z100 yielded the highest SBS ( 29.35MPa ) followed by DuoLink with the new primer ( 26.68MPa ) . The groups that did not receive the experimental primer presented the lowest SBS values ( from 5.95 to 9.79MPa ) . The failure mode was adhesive for the non-primed specimens and predominantly mixed in the primed groups . SIGNIFICANCE The use of the new zirconia experimental primer based on organophosphate/carboxylic acid monomers increased the bond strength of different resin-based luting agents including Z100 restorative material",
"OBJECTIVES This study investigated the influence of a silica-coating method on the resin bond of two different resin composite cements to the intaglio surface of Procera AllCeram densely sintered , high-purity , alumina ceramic restorations after long-term storage and thermocycling . METHOD AND MATERIAL S Densely sintered alumina ceramic specimens were fabricated with the intaglio surface of the Procera AlICeram coping and r and omly divided into five adhesive groups ( 100 total specimens ) . Resin composite cylinders were bonded either to the untreated or to the tribochemical silica/silane-coated ceramic surface with either a conventional Bis-GMA resin cement or a resin composite containing an adhesive phosphate monomer ( Panavia 21 ) in combination with their corresponding bonding/silane coupling agents . Panavia was also used without silanization to the untreated ceramic surface ( control ) . Subgroups of 10 specimens were stored in distilled water for either 3 ( baseline ) or 180 days prior to shear bond strength testing . The 180-day sample s were subjected to repeated thermocycling for a total of 12,000 cycles . Data were analyzed with one-way analysis of variance and Tukey 's multiple comparison . RESULTS Silica coating significantly increased overall bond strength to Procera AllCeram . RelyX ARC and silica coating revealed the highest bond strength at baseline . Long-term storage and thermocycling significantly decreased overall bond strength . Two groups revealed the significantly highest bond strength values after artificial aging : Panavia 21 with its silane/bonding agent to the original ceramic surface and Panavia 21 to the silica-coated ceramic surface . CONCLUSION The use of a resin composite containing an adhesive phosphate monomer either in combination with a silane coupling/bonding agent or after tribochemical silica/silane coating revealed the highest long-term shear bond strength to the intaglio surface of Procera AllCeram restorations",
"The aim of this study was to evaluate the influence of silica coating and 10-methacryloyloxydecyl dihydrogen phosphate (MDP)-based primer applications upon the bonding durability of a MDP-based resin cement to a yttrium stabilized tetragonal zirconia ( Y-TZP ) ceramic . Ninety-six Y-TZP tabs were embedded in an acrylic resin ( free surface for adhesion : 5 × 5 mm(2 ) ) , ground finished and r and omly divided into four groups ( N = 24 ) according to the ceramic surface conditioning : ( 1 ) cleaning with isopropanol ( ALC ) ; ( 2 ) ALC + phosphoric acid etching + MDP-based primer application ( MDP-primer ) ; ( 3 ) silica coating + 3-methacryloyloxypropyl trimethoxysilane (MPS)-based coupling agent application ( SiO2 + MPS-Sil ) ; and ( 4 ) SiO2 + MDP-primer . The MDP-based resin cement was applied on the treated surface using a cylindrical mold ( diameter= 3 mm ) . Half of the specimens from each surface conditioning were stored in distilled water ( 37 ° C , 24 h ) before testing . Another half of the specimens were stored ( 90 days ) and thermo-cycled ( 12,000 x ) during this period ( 90 d/TC ) before testing . A shear bond strength ( SBS ) test was performed at a crosshead speed of 0.5 mm/min . Two factors composed the experimental design : ceramic conditioning strategy ( in four levels ) and storage condition ( in two levels ) , totaling eight groups . After 90 d/TC ( Tukey ; p SiO2 + MDP-primer ( 24.40 MPa ) promoted the highest SBS . The ALC and MDP-primer groups debonded spontaneously during 90 d/TC . Bonding values were higher and more stable in the SiO2 groups . The use of MDP-primer after silica coating increased the bond strength ",
"OBJECTIVE The current study evaluated the micro-shear bond strength between a resin luting agent and four strengthened all-ceramic systems under different surface treatments . METHODS Rectangular specimens of IPS Empress 2 ( Ivoclar-Vivadent ) , Cergogold ( DeguDent ) , In Ceram Alumina ( Vita ) and Cercon ( DeguDent ) ceramics were fabricated and r and omly divided into three groups : 1-no treatment ; 2-etched with 9.5 % hydrofluoric acid and 3-airborne-particle abraded with 50 microm aluminum oxide particles . The ceramic surfaces of the specimens were coated with a silane agent ( Clearfil Porcelain Bond , Kuraray ) , then bonded with a resin-luting agent ( Panavia F , Kuraray ) . A micro-shear bond test was carried out to measure the bond strength . Moreover , each ceramic surface was observed morphologically by scanning electron microscopy . The results were su bmi tted to analysis of variance and Tukey 's post-hoc analysis ( p bond strength of all ceramic systems evaluated was affected by the surface treatments ( p bond strength of IPS Empress 2 were found when the surface treatment used was hydrofluoric acid etching , followed by airborne particle abrasion treatment . On the other h and , airborne particle abrasion treatment and acid etching were not different for Cergogold and In Ceram Alumina ceramics , but they were higher when compared to the control ( p bond strength to Cercon was found when it was treated with airborne particle abrasion with aluminum oxide . The SEM photographs showed that the hydrofluoric acid etching treatment affected the surface of IPS Empress 2 and Cergogold ; however , Cercon and In Ceram surface morphology were not changed by the hydrofluoric acid etching . The airborne particle abrasion treatment altered the Cercon ceramic morphology but it did not change the other ceramic 's surface",
"The traditional zinc phosphate cementation technique for crowns and fixed partial dentures ( FPDs ) is based on mechanical retention where the geometry of the prepared tooth provides retention for the restoration . In clinical situations where mechanical retention is compromised or regarded insufficient , a bonding system can be used to provide retention . This study investigates whether bond strengths of different bonding systems to densely sintered high-strength alumina ceramics are sufficient . One hundred twenty pairs of industrially manufactured specimens -- one block and one cylinder-shaped disc of densely sintered alumina -- were used . The cementation surfaces of the blocks were s and blasted with 110-microm aluminium oxide while the cementation surfaces of the discs were left untreated , as produced . The pairs were then bonded with one of six different bonding systems . Each bonding group of 20 sample s was r and omly divided into thermocycled and non-thermocycled subgroups ( n=10 ) . Both subgroups were stored 1 week in distilled water ( 37 degrees C ) . During this week , the thermocycled subgroup underwent 5000 thermocycles ( 5 degrees C-55 degrees C ) . Following pre-treatment , the specimens were loaded until fracture in a universal testing machine to determine shear bond strength . Data were analysed using student 's t-test and a one-way ANOVA . Fractured interfaces were examined under a light microscope to classify the failure mode of the debonded area as adhesive , cohesive , or a combination of the two . The highest bond strengths , achieved with two of the bonding systems , were significantly higher than the remaining bonding systems , irrespective of pretreatment--(p>0.001 ) . The predominant failure mode for both treated and untreated surfaces was adhesive . Two of the six tested bonding systems achieved sufficient shear bond strength to densely sintered alumina . Furthermore , recommendations on whether to use surface-treated or as produced densely sintered alumina must be based on which bonding system is being used",
"Abstract Objective . The purpose of this in-vitro study was to evaluate and compare the effects of different surface treatments and laser irradiation on the shear bond strength of resin cement to zirconia-based ceramic . Material and methods . Forty zirconia core specimens ( 10-mm diameter , 2-mm thickness ) were produced and embedded in the centers of autopolymerizing acrylic resin blocks . Subsequently , specimens were r and omly divided into four groups , each containing 10 specimens , for different surface treatment methods . The details of the groups are as follows : Group C , no treatment applied ( control ) ; Group SB , bonding surfaces of ceramic disks were airborne particle-abraded with 110-μm alumina oxide particles ; Group HF , bonding surfaces of ceramic disks were etched with 9.6 % hydrofluoric acid ; and Group L , bonding surfaces of ceramic disks were irradiated by a CO2 laser . A total of 40 composite resin disks were fabricated and cemented with an adhesive resin cement to the specimen surfaces . A universal test machine was used for the shear bond strength test at a crosshead speed of 1 mm/min . Results . The highest shear bond strength values were obtained with Group L ( 20.99 ± 3.77 MPa ) and the lowest values with Group C ( 13.39 ± 3.10 MPa ) . Although there was no significant difference between Groups C , HF and SB ( P > 0.05 ) , Group L showed a significant difference from all other groups ( p CO2 laser etching may represent an effective method for conditioning zirconia surfaces , enhancing micromechanical retention and improving the bond strength of resin cement on zirconia ceramic",
"OBJECTIVE The aim of this study was to evaluate the effect of different surface treatments ; s and blasting , Er : YAG , Nd : YAG , or CO(2 ) laser irradiation on the shear bond strength ( SBS ) of zirconia ceramic to dentin . BACKGROUND DATA Zirconia is not properly luted with resin cements . Various surface treatment methods have been suggested for zirconia to obtain high bond strength to resin cements . There is no study that compared the effect of different laser types ( Er : YAG , Nd : YAG , CO(2 ) ) with s and blasting on SBS between zirconia and dentin . METHODS One hundred and twenty human maxillary third molar teeth were sectioned 3 mm below the occlusal surfaces , embedded in a metal ring with autopolymerizing acrylic resin , and stored in distilled water at 37(0)C. One hundred and twenty disc-shaped zirconia specimens were fabricated ( 6 mm in diameter and 4 mm in thickness ) , and r and omly assigned to six groups ( n=20 ) : Group 1 , untreated ( control ) ; Group 2 , s and blasted ; Group 3 , Er : YAG laser irradiated ; Group 4 , Nd : YAG laser irradiated with contact ; Group 5 , Nd : YAG laser irradiated with non-contact ; Group 6 , CO(2 ) laser irradiated . They were cemented onto the dentin with dual-cured resin cement ( Variolink ( ® ) ) . After they were stored in distilled water at 37(0)C for 24 h , the SBS test was performed at a crosshead speed of 1 mm/min . The fractured specimens were examined under a stereomicroscope to evaluate the fracture pattern . RESULTS Results of this study did not show statistically significant differences between Groups 1 and 2 , or among Groups 3 , 4 and 5 . The lowest SBS was recorded in Group 6 ( CO(2 ) laser ) , and the highest SBS was recorded in Group 4 ( Nd : YAG laser with contact ) , followed by Group 3 ( Er : YAG laser ) . The adhesive failure mode was predominantly observed in Groups 2 , 3 , 5 , and 6 . Group 1 showed 45 % mixed failure and Group 4 showed 50 % mixed failure . CONCLUSIONS This study shows that Er : YAG and Nd : YAG laser treatment increased the bond strength of zirconia compared to s and basting and CO(2 ) laser treatment",
"STATEMENT OF PROBLEM Ceramic surface treatment is crucial for bonding to resin . High crystalline ceramics are poorly conditioned using traditional procedures . PURPOSE The purpose of this study was to evaluate the effect of silica coating on a densely sintered alumina ceramic relative to its bond strength to composite , using a resin luting agent . Material and methods Blocks ( 6 x 6 x 5 mm ) of ceramic and composite were made . The ceramic ( Procera AllCeram ) surfaces were polished , and the blocks were divided into 3 groups ( n = 5 ) : SB , airborne-particle abrasion with 110-microm Al 2 O 3 ; RS , silica coating using Rocatec System ; and CS , silica coating using CoJet System . The treated ceramic blocks were luted to the composite ( W3D Master ) blocks using a resin luting agent ( Panavia F ) . Specimens were stored in distilled water at 37 degrees C for 7 days and then cut in 2 axes , x and y , to obtain specimens with a bonding area of approximately 0.6 mm 2 ( n = 30 ) . The specimens were loaded to failure in tension in a universal testing machine , and data were statistically analyzed using a r and omized complete block design analysis of variance and Tukey 's test ( alpha=.05 ) . Fractured surfaces were examined using light microscopy and scanning electron microscopy to determine the type of failure . Energy-dispersive spectroscopy was used for surface compositional analysis . RESULTS Mean bond strength values ( MPa ) of Groups RS ( 17.1 + /- 3.9 ) ( P = .00015 ) and CS ( 18.5 + /- 4.7 ) ( P = .00012 ) were significantly higher than the values of Group SB ( 12.7 + /- 2.6 ) . There was no statistical difference between Groups RS and CS . All failures occurred at the adhesive zone . CONCLUSION Tribochemical silica coating systems increased the tensile bond strength values between Panavia F and Procera AllCeram ceramic",
"OBJECTIVE To evaluate the influence of different surface treatments on the microtensile bond strength of resin cement to zirconia ceramic . MATERIAL S AND METHODS Twelve cylinder-shaped ( ∅ 12 × 5.25 mm high ) blocks of a commercial zirconium-oxide ceramic ( Cercon ® Zirconia , DENTSPLY ) were r and omly divided into 4 groups ( n=3 ) , based on the surface treatment to be performed : ( 1 ) airborne particle abrasion with 125 μm Al₂O₃ particles ( S ) ; ( 2 ) selective infiltration etching ( SIE ) ; ( 3 ) experimental hot etching solution applied for 30 min ( ST ) and ( 4 ) no treatment ( C ) . Paradigm MZ100 blocks ( 3 M ESPE ) were cut into twelve cylinders of 4 mm in thickness . Composite cylinders were bonded to conditioned ceramics using a resin cement ( Calibra ® , DENTSPLY ) , in combination with the proprietary adhesive system . After 24h bonded specimens were cut into microtensile sticks and loaded in tension until failure . Bond strength data were analyzed with Kruskall-Wallis and Dunn 's Multiple Range test for multiple comparisons ( p was recorded and the interfacial morphology of debonded specimens was analyzed using a scanning electron microscope ( SEM ) . RESULTS Bond strength values achieved after SIE and ST treatment were significantly higher than after S treatment and without any treatment ( p were mostly recorded in the S group . SIGNIFICANCE Conditioning the high-strength ceramic surface with SIE and ST treatments yielded higher bond strengths of the resin cement than when zirconia ceramic was treated with airborne particle abrasion or left untreated",
"Objective . In this study , we evaluated the effect of two silane coupling agents and their blends with a cross-linker silane on the bond strength of a dimethacrylate-based resin composite cement to surface-conditioned zirconia . Material and Methods . A total of 40 planar zirconia specimens were used for 8 test groups . After alumina particle abrasion , followed by tribochemical silica-coating , the specimens were r and omly assigned to four silanizations : with 1.0 vol% 3-methacryloyloxypropyltrimethoxysilane or 1.0 vol% 3-mercaptopropyltrimethoxysilane or their blends with 1.0 vol% 1,2-bis-(triethoxysilyl)ethane ( all in ethanol/water ) . The resin composite ( RelyX ™ ARC , 3 M ESPE ) stubs ( n=10/group ) were light-polymerized onto zirconia specimens . Four test groups were tested without water storage and 4 thermo-cycled at 6000 cycles ( 5±1 ° C to 55±1 ° C ) , with a dwelling time of 30 s. The shear bond strength of the cement stubs to zirconia was measured using a universal testing machine at a constant cross-head speed of 1 mm/min . Scanning electron microscopy was employed for imaging the zirconia surface after conditioning and testing . Failure mode was evaluated visually . A surface chemical analysis was carried out with the EDXA system . Results . The highest shear bond strength was 21.9±8.7 MPa , obtained with a blend of 3-mercaptopropyltrimethoxysilane and 1,2-bis-(triethoxysilyl)ethane ( dry storage ) , and 16.0±1.5 MPa , with 3-methacryloyloxypropyltrimethoxysilane ( thermo-cycled ) . Thermo-cycling decreased the bond strengths significantly ( ANOVA , p from spontaneous debonding during thermo-cycling . Conclusions . The luting cement adhesion might be promoted to silica-coated zirconia with 1.0 vol% 3-methacryloyloxypropyltrimethoxysilane and with a blend of 1.0 vol% 3-mercaptopropyltrimethoxysilane and 1.0 vol% 1,2-bis-(triethoxysilyl)ethane",
"The current study evaluated the effects of various pretreatments and aging in water on the bond strength to hot isostatic pressed yttrium-oxide partially stabilized zirconia . Sixty zirconia ceramic specimens ( Denzir ) were r and omly divided into three groups of 20 . One group of specimens ( n=10 ) was then bonded to each other using a resin composite cement ( RelyX Unicem ) , the second group ( n=10 ) was bonded with RelyX Unicem and a metal primer ( Metal Primer II ) , while the third group ( n=10 ) was bonded with RelyX Unicem and a ceramic primer ( Ceramic Primer ) . The specimens were then subjected to shear force before and after s and blasting and before and after aging in water for 180 days . Before aging , no significant differences ( p > 0.05 ) were seen within the different groups , either before or after s and blasting . S and blasting and pretreatment with the metal ( p ceramic ( p bond strength compared to that of the non-treated specimens . After aging , the bond strength of the s and blasted specimens with metal primer was significantly higher than that of the s and -blasted specimens with ceramic primer ( p metal primer , the bond strength was not significantly affected after aging ( p > 0.05 ) , whereas , for those specimens with the ceramic primer ( p no primer ( p bond strength significantly decreased . Thus , air abrasion and pretreatment with a metal primer seems to be an appropriate method for improving bond strength"
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Background The aim of this study was to determine which programme characteristics influence the effectiveness of secondary prevention programmes for Coronary Heart Disease . Design The study follows a meta-regression design . Methods We conducted a meta-regression within a systematic review of r and omized trials comparing secondary prevention programmes versus usual care . The primary outcome was all-cause mortality . Studies were identified by search ing multiple electronic data bases , bibliographies of published studies , contact with experts , and references provided by the United States Centers for Medicare and Medicaid Services . Primary authors of all relevant trials were surveyed for detailed information on programme characteristics . Forty-six unique trials were identified ( 18 821 patients ) . The pooled all-cause mortality risk ratio ( RR ) for programmes was 0.87 [ 95 % confidence interval ( CI ) 0.79 - 0.97 ] . Programmes containing less than 10 h of patient contact with health professionals reduced all-cause mortality ( RR 0.80 , 95 % CI 0.68 - 0.95 ) as effectively as programmes with more contact time . Programmes provided in general practice setting s were effective at reducing all-cause mortality ( RR 0.76 , 95 % CI 0.63 - 0.92 ) and compared favourably with the effectiveness of hospital-based programmes . Other characteristics , including specialist versus generalist provision , did not appreciably impact programme effectiveness . Conclusions Shorter secondary prevention programmes , those based in general practice , and those staffed by generalists are at least as effective in reducing all cause mortality in patients with coronary heart disease as longer programmes , hospital-based programmes , and programmes staffed by specialists
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"Of 22 r and omized trials of rehabilitation with exercise after myocardial infa rct ion ( MI ) , one trial had results that achieved conventional statistical significance . To determine whether or not these studies , in the aggregate , show a significant benefit of rehabilitation after myocardial infa rct ion , we performed an overview of all r and omized trials , involving 4,554 patients ; we evaluated total and cardiovascular mortality , sudden death , and fatal and nonfatal reinfa rct ion . For each endpoint , we calculated an odds ratio ( OR ) and 95 % confidence interval ( 95 % CI ) for the trials combined . After an average of 3 years of follow-up , the ORs were significantly lower in the rehabilitation than in the comparison group : specifically , total mortality ( OR = 0.80 [ 0.66 , 0.96 ] ) , cardiovascular mortality ( OR = 0.78 [ 0.63 , 0.96 ] ) , and fatal reinfa rct ion ( OR = 0.75 [ 0.59 , 0.95 ] ) . The OR for sudden death was significantly lower in the rehabilitation than in the comparison group at 1 year ( OR = 0.63 [ 0.41 , 0.97 ] ) . The data were compatible with a benefit at 2 ( OR = 0.76 [ 0.54 , 1.06 ] ) and 3 years ( OR = 0.92 [ 0.69 , 1.23 ] ) , but these findings were not statistically significant . For nonfatal reinfa rct ion , there were no significant differences between the two groups after 1 ( OR = 1.09 [ 0.76 , 1.57 ] ) , 2 ( OR = 1.10 [ 0.82 , 1.47 ] ) , or 3 years ( OR = 1.09 [ 0.88 , 1.34 ] ) of follow-up . The observed 20 % reduction in overall mortality reflects a decreased risk of cardiovascular mortality and fatal reinfa rct ion throughout at least 3 years and a reduction in sudden death during the 1st year after infa rct ion and possibly for 2 - 3 years . With respect to the independent effects of the physical exercise component of cardiac rehabilitation , the relatively small number of \" exercise only \" trials , combined with the possibility that they may have had a formal or informal nonexercise component precludes the possibility of reaching any definitive conclusion . To do so would require a r and omized trial of sufficient size to distinguish between no effect and the most plausible effect based on the results of this overview",
"BACKGROUND Recent clinical trials have shown that modification of plasma lipoprotein concentrations can favorably alter progression of coronary atherosclerosis , but no data exist on the effects of a comprehensive program of risk reduction involving both changes in lifestyle and medications . This study tested the hypothesis that intensive multiple risk factor reduction over 4 years would significantly reduce the rate of progression of atherosclerosis in the coronary arteries of men and women compared with subjects r and omly assigned to the usual care of their physician . METHODS AND RESULTS Three hundred men ( n = 259 ) and women ( n = 41 ) ( mean age , 56 + /- 7.4 years ) with angiographically defined coronary atherosclerosis were r and omly assigned to usual care ( n = 155 ) or multifactor risk reduction ( n = 145 ) . Patients assigned to risk reduction were provided individualized programs involving a low-fat and -cholesterol diet , exercise , weight loss , smoking cessation , and medications to favorably alter lipoprotein profiles . Computer-assisted quantitative coronary arteriography was performed at baseline and after 4 years . The main angiographic outcome was the rate of change in the minimal diameter of diseased segments . All subjects underwent medical and risk factor evaluations at baseline and yearly for 4 years , and reasons for all hospitalizations and deaths were documented . Of the 300 subjects r and omized , 274 ( 91.3 % ) completed a follow-up arteriogram , and 246 ( 82 % ) had comparative measurements of segments with visible disease at baseline and follow-up . Intensive risk reduction result ed in highly significant improvements in various risk factors , including low-density lipoprotein cholesterol and apolipoprotein B ( both , 22 % ) , high-density lipoprotein cholesterol ( + 12 % ) , plasma triglycerides ( -20 % ) , body weight ( -4 % ) , exercise capacity ( + 20 % ) , and intake of dietary fat ( -24 % ) and cholesterol ( -40 % ) compared with relatively small changes in the usual-care group . No change was observed in lipoprotein(a ) in either group . The risk-reduction group showed a rate of narrowing of diseased coronary artery segments that was 47 % less than that for subjects in the usual-care group ( change in minimal diameter , -0.024 + /- 0.066 mm/y versus -0.045 + /- 0.073 mm/y ; P deaths occurred in each group . There were 25 hospitalizations in the risk-reduction group initiated by clinical cardiac events compared with 44 in the usual-care group ( rate ratio , 0.61 ; P = .05 ; 95 % confidence interval , 0.4 to 0.9 ) . CONCLUSIONS Intensive multifactor risk reduction conducted over 4 years favorably altered the rate of luminal narrowing in coronary arteries of men and women with coronary artery disease and decreased hospitalizations for clinical cardiac events",
"Background Significant regression of coronary and femoral atherosclerotic lesions has been documented by angiographic studies using aggressive lipid-lowering treatment . This study tested the applicability and effects of intensive physical exercise and low-fat diet on coronary morphology and myocardial perfusion in nonselected patients with stable angina pectoris . Methods and Results Patients were recruited after routine coronary angiography for stable angina pectoris ; they were r and omized to an intervention group ( n = 56 ) and a control group on “ usual care ” ( n = 57 ) . Treatment comprised intensive physical exercise in group training sessions ( minimum , 2 hr/wk ) , daily home exercise periods ( 20 min/d ) , and low-fat , low-cholesterol diet ( American Heart Association recommendation , phase 3 ) . No lipid-lowering agents were prescribed . After 12 months of participation , repeat coronary angiography was performed ; relative and minimal diameter reductions of coronary lesions were measured by digital image processing . Change in myocardial perfusion was assessed by 201TI scintigraphy . In patients participating in the intervention group , body weight decreased by 5 % ( p total cholesterol by 10 % ( p triglycerides by 24 % ( p high density lipoproteins increased by 3 % ( p = NS ) . Physical work capacity improved by 23 % ( p myocardial oxygen consumption , as estimated from maximal rate-pressure product , by 10 % , ( p Stress-induced myocardial ischemia decreased concurrently , indicating improvement of myocardial perfusion . Based on minimal lesion diameter , progression of coronary lesions was noted in nine patients ( 23 % ) , no change in 18 patients ( 45 % ) , and regression in 13 patients ( 32 % ) . In the control group , metabolic and hemodynamic variables remained essentially unchanged , whereas progression of coronary lesions was noted in 25 patients ( 48 % ) , no change in 18 patients ( 35 % ) , and regression in nine patients ( 17 % ) . These changes were significantly different from the intervention group ( p physical exercise and low-fat diet , coronary artery disease progresses at a slower pace compared with a control group on usual care",
"Background —Whether cardiac rehabilitation ( CR ) is effective in patients older than 75 years , who have been excluded from most trials , remains unclear . We enrolled patients 46 to 86 years old in a r and omized trial and assessed the effects of 2 months of post-myocardial infa rct ion ( MI ) CR on total work capacity ( TWC , in kilograms per meter ) and health-related quality of life ( HRQL ) . Methods and Results —Of 773 screened patients , 270 without cardiac failure , dementia , disability , or contraindications to exercise were r and omized to outpatient , hospital-based CR ( Hosp-CR ) , home-based CR ( Home-CR ) , or no CR within 3 predefined age groups ( middle-aged , 45 to 65 years ; old , 66 to 75 years ; and very old , > 75 years ) of 90 patients each . TWC and HRQL were determined with cycle ergometry and Sickness Impact Profile at baseline , after CR , and 6 and 12 months later . Within each age group , TWC improved with Hosp-CR and Home-CR and was unchanged with no CR . The improvement was similar in middle-aged and old persons but smaller , although still significant , in very old patients . TWC reverted toward baseline by 12 months with Hosp-CR but not with Home-CR . HRQL improved in middle-aged and old CR and control patients but only with CR in very old patients . Complications were similar across treatment and age groups . Costs were lower for Home-CR than for Hosp-CR . Conclusions —Post-MI Hosp-CR and Home-CR are similarly effective in the short term and improve TWC and HRQL in each age group . However , with lower costs and more prolonged positive effects , Home-CR may be the treatment of choice in low-risk older patients",
"BACKGROUND Increases in life stress have been linked to poor prognosis , after myocardial infa rct ion ( MI ) . Previous research suggested that a programme of monthly screening for psychological distress , combined with supportive and educational home nursing interventions for distressed patients , may improve post-MI survival among men . Our study assessed this approach for both men and women . We aim ed to find out whether the programme would reduce 1-year cardiac mortality for women and men . METHODS We carried out a r and omised , controlled trial of 1376 post-MI patients ( 903 men , 473 women ) assigned to the intervention programme ( n = 692 ) or usual care ( n = 684 ) for 1 year . All patients completed a baseline interview that included assessment of depression and anxiety . Survivors were also interviewed at 1 year . FINDINGS The programme had no overall survival impact . Preplanned analyses showed higher cardiac ( 9.4 vs 5.0 % , p = 0.064 ) and all-cause mortality ( 10.3 vs 5.4 % , p = 0.051 ) among women in the intervention group . There was no evidence of either benefit or harm among men ( cardiac mortality 2.4 vs 2.5 % , p = 0.94 ; all-cause mortality 3.1 vs 3.1 % , p = 0.93 ) . The programme 's impact on depression and anxiety among survivors was small . INTERPRETATION Our results do not warrant the routine implementation of programmes that involve psychological-distress screening and home nursing intervention for patients recovering from MI . The poorer overall outcome for women , and the possible harmful impact of the intervention on women , underline the need for further research and the inclusion of adequate numbers of women in future post-MI trials",
"Abstract Objective : To evaluate the effects of secondary prevention clinics run by nurses in general practice on the health of patients with coronary heart disease . Design : R and omised controlled trial of clinics over one year with assessment by self completed postal question naires and audit of medical records at the start and end of the trial . Setting : R and om sample of 19 general practice s in northeast Scotl and . Subjects : 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease who did not have terminal illness or dementia and were not housebound . Intervention : Clinic staff promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures : Health status measured by the SF-36 question naire , chest pain by the angina type specification , and anxiety and depression by the hospital anxiety and depression scale . Use of health services before and during the study . Results : There were significant improvements in six of eight health status domains ( all functioning scales , pain , and general health ) among patients attending the clinic . Role limitations attributed to physical problems improved most ( adjusted difference 8.52 , 95 % confidence interval 4.16 to 12.9 ) . Fewer patients reported worsening chest pain ( odds ratio 0.59 , 95 % confidence interval 0.37 to 0.94 ) . There were no significant effects on anxiety or depression . Fewer intervention group patients required hospital admissions ( 0.64 , 0.48 to 0.86 ) , but general practitioner consultation rates did not alter . Conclusions : Within their first year secondary prevention clinics improved patients ' health and reduced hospital admissions . Key messages Nurse led clinics in general practice were used to promote secondary prevention to patients with coronary heart disease Within the first year the health of patients invited to the clinics improved Most benefit was in functional status , but chest pain improved too There was no effects on anxiety or depression There were significant reductions in hospital admissions in the first",
"The Women ’s Lifestyle Heart Trial was a small ( N=28 ) r and omized controlled trial to evaluate the effects of a comprehensive lifestyle self-management program ( very low-fat vegetarian diet , stress-management training , exercise , group support , and smoking cessation ) on reduction of cardiovascular risk factors in postmenopausal women with coronary heart disease ( CHD ) . Women assigned to the treatment condition ( Prime Time ) participated in a week-long retreat followed by twice-weekly 4-hour meetings . Endpoints were program adherence ; changes in lipid profiles , body mass , blood pressure , hypolipidemic and antihypertensive medications ; and quality of life . Risk factor and psychosocial evaluations were conducted at baseline and at 4 , 12 , and 24 months . Repeated measures analyses of covariance revealed that the dietary , stress management , and physical activity changes made by intervention women were dramatic and lasting . There were significantly greater improvements in the Prime Time condition compared to the usual care control group on body mass , angina symptoms , and quality of life , and a tendency for a greater reduction in blood pressure-lowering medications . Similar patterns were seen in lipids , blood pressure , and lipid-lowering medications , but did not reach significance . These results demonstrate that postmenopausal CHD women can make lasting lifestyle changes , and that these changes may reduce the need for cardiac medications and improve CHD risk factors and quality of life",
"In a prospect i ve , r and omised , controlled trial to determine whether comprehensive lifestyle changes affect coronary atherosclerosis after 1 year , 28 patients were assigned to an experimental group ( low-fat vegetarian diet , stopping smoking , stress management training , and moderate exercise ) and 20 to a usual-care control group . 195 coronary artery lesions were analysed by quantitative coronary angiography . The average percentage diameter stenosis regressed from 40.0 ( SD 16.9)% to 37.8 (16.5)% in the experimental group yet progressed from 42.7 (15.5)% to 46.1 (18.5)% in the control group . When only lesions greater than 50 % stenosed were analysed , the average percentage diameter stenosis regressed from 61.1 (8.8)% to 55.8 (11.0)% in the experimental group and progressed from 61.7 (9.5)% to 64.4 (16.3)% in the control group . Overall , 82 % of experimental-group patients had an average change towards regression . Comprehensive lifestyle changes may be able to bring about regression of even severe coronary atherosclerosis after only 1 year , without use of lipid-lowering drugs",
"Objective To evaluate whether nurse run clinics in general practice improve secondary prevention in patients with coronary heart disease . Design R and omised controlled trial . Setting A r and om sample of 19 general practice s in northeast Scotl and . Patients 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease , but without terminal illness or dementia and not housebound . Intervention Nurse run clinics promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures Components of secondary prevention assessed at baseline and one year were : aspirin use ; blood pressure management ; lipid management ; physical activity ; dietary fat ; and smoking status . A cumulative score was generated by counting the number of appropriate components of secondary prevention for each patient . Results There were significant improvements in aspirin management ( odds ratio 3.22 , 95 % confidence interval 2.15 to 4.80 ) , blood pressure management ( 5.32 , 3.01 to 9.41 ) , lipid management ( 3.19 , 2.39 to 4.26 ) , physical activity ( 1.67 , 1.23 to 2.26 ) and diet ( 1.47 , 1.10 to 1.96 ) . There was no effect on smoking cessation ( 0.78 , 0.47 to 1.28 ) . Of six possible components of secondary prevention , the baseline mean was 3.27 . The adjusted mean improvement attributable to intervention was 0.55 of a component ( 0.44 to 0.67 ) . Improvement was found regardless of practice baseline performance . Conclusions Nurse run clinics proved practical to implement in general practice and effectively increased secondary prevention in coronary heart disease . Most patients gained at least one effective component of secondary prevention and , for them , future cardiovascular events and mortality could be reduced by up to a third",
"The effects of an exercise program started early after myocardial infraction and the added effects of an outpatient teaching-counseling program were studied . At r and om , 84 patients were allocated to a control group ( A ) , 88 patients to an exercise group ( B1 ) and 86 patients to an exercise and teaching-counseling group ( B2 ) . The same exercise program was prescribed for patients in groups B1 and B2 and was started about 4.5 days after myocardial infa rct ion and continued for 3 months . The outpatient teaching-counseling program consisted of eight group sessions pertaining to risk factor reduction and psychosocial adjustment to myocardial infraction . A low-level treadmill test and an exercise test were performed at 3 months and the exercise test was repeated at 6 months . The clinical , hemodynamic and electrocardiographic responses to these tests were not different among the three groups . However , by the end of 3 months , patients in group B1 and B2 reported walking greater distances than patients in group A. The incidence of morbidity and mortality was not different between the groups . No deleterious or beneficial physiologic effects of an exercise program either by itself or combined with a teaching-counseling program were demonstrated . Routine medical care and our interventions were equally effective in permitting the spontaneous hemodynamics improvements after myocardial infraction . More than 3 months after myocardial infa rct ion , the group as a whole manifested spontaneous recovery in the form of a significant decrease in resting heart rate ( p less than 0.001 ) and a significant increase in systolic and diastolic blood pressure at rest and with submaximal exercise ( p less than 0.001 ) . No further improvements were observed between 3 and 6 months",
"BACKGROUND It was the aim of this study to assess the long-term effects of physical exercise and low-fat diet on the progression of coronary artery disease . At the beginning of the study , 113 male patients with coronary artery disease were r and omized to an intervention group ( n=56 ) or a control group ( n=57 ) ; 90 patients ( 80 % ) could be reevaluated after 6 years . METHODS AND RESULTS Patients in the intervention group ( n=40 ) showed a reduction in total serum cholesterol ( 6.03+/-1.03 versus 5.67+/-1.01 mmol/L ; P triglyceride levels ( 1.94+/-0.8 versus 1.6+/-0.89 mmol/L ; P body mass index ( 26+/-2 versus 27+/-2 kg/m2 ; P = NS ) , but results were not statistically different from the control group ( n=50 ) ( total serum cholesterol , 6.05+/-1.02 versus 5.79+/-0.88 mmol/L ; triglycerides , 2.25+/-1.28 versus 1.85+/-0.96 mmol/L [ both P = NS ] ; body mass index , 26+/-2 versus 28+/-3 kg/m2 [ P physical work capacity ( 166+/-59 versus 212+/-89 W ; P stenoses progressed at a significantly slower rate than in the control group ( P Energy expenditure during exercise was assessed in a subgroup ; patients with regression of coronary stenoses spent an average of 1784+/-384 kcal/wk ( approximately 4 hours of moderate aerobic exercise per week ) . Multivariate regression analysis identified only physical work capacity as independently contributing to angiographic changes . CONCLUSIONS After 6 years of multifactorial risk intervention , there is significant and persistent improvement in lipoprotein levels and physical work capacity , which results in a significant retardation of disease progression . These beneficial effects appear to be largely due to chronic physical exercise",
"Coronary artery diseases ( CAD ) are main causes of morbidity and hospitalisation in western countries and CAD patients are at considerable risk of suffering further cardiac events . The development and evaluation of secondary prevention programmes therefore an important task . This thesis includes investigations on CAD patients admitted to a secondary prevention programme at Malmö University Hospital , Malmö , Sweden . Four weeks after discharge from the hospital , consecutive male and female patients aged 50 - 70 years with acute myocardial infa rct ion ( AMI ) or treated with coronary artery bypass grafting ( CABG ) surgery were r and omised to a hospital organised preventive intervention or to usual follow-up at their general practitioners . In the three studies using this r and omised design , 87 ( study II ) , 90 ( study IV ) , and 106 ( study V ) intervention patients were available for evaluation . In addition , without r and omisation , lipid levels at four weeks after the event was compared with levels estimated within 24 hours after onset of symptoms in 141 AMI patients ( study I ) , and quality of life ( QL ) were estimated by question naire at one month and at one year after the event in 266 AMI , 94 CABG , and 16 percutaneous transluminal coronary angioplasty ( PTCA ) patients ( study III ) . The prevention programme was effective in improving food habits but showed no impact on smoking habits or physical exercise in AMI patients ( study II ) . The intervention also did not show any significant improvement in working capacity in AMI and CABG patients . However , working capacity improved in both intervention and reference CABG patients , most probably due to improved coronary circulation from the surgery ( study IV ) . Cholesterol levels decreased significantly in AMI and CABG intervention patients as compared to the corresponding reference patients . This difference most likely was due to a higher frequency of lipid lowering drugs used in the intervention patients ( study V ) . The prevention programme also decreased body mass index significantly in AMI but not in CABG patients ( study V ) . In AMI patients receiving thrombolysis , cholesterol levels estimated within 24 hours after onset of symptoms and at four weeks after the event were virtually equal . In AMI patients not receiving thrombolysis , the lipid estimates from four weeks after the event were slightly , but significantly , above the within 24 hours from onset of symptoms estimates ( study I ) . One month after the event , both somatic and psychological aspects of QL were negatively affected in AMI and CABG patients compared to population controls . One year after the event , patients differed from controls mainly in somatic symptoms ( study III ) . Thus , the intervention programme was most successful in affecting lipid levels and food habits in AMI patients . QL was considerably affected in patients following an cardiac event , especially during the initial recovery phase . In addition , in patients receiving thrombolysis , cholesterol levels estimated four weeks after an AMI are reasonably valid estimates of baseline values and may be used to decide about lipid lowering interventions",
"BACKGROUND Disease management programs ( DMPs ) that use multidisciplinary teams and specialized clinics reduce hospital admissions and improve quality of life and functional status . Evaluations of cardiac DMPs delivered by home health nurses are required . METHODS Between August 1999 and August 2000 we identified consecutive patients admitted to hospital with elevated cardiac enzymes . Patients who agreed were r and omly assigned to participate in a DMP or to receive usual care . The DMP included 6 home visits by a cardiac-trained nurse , a st and ardized nurses ' checklist , referral criteria for specialty care , communication with the family physician and patient education . We measured readmission days per 1000 follow-up days for angina , congestive heart failure ( CHF ) and chronic obstructive pulmonary disease ( COPD ) ; all-cause readmission days ; and provincial cl aims for emergency department visits , physician visits , diagnostic or therapeutic services and laboratory services . RESULTS We screened 715 consecutive patients admitted with elevated cardiac markers between August 1999 and August 2000 . Of those screened 71 DMP and 75 usual care patients met the diagnostic criteria for myocardial infa rct ion , were eligible for visits from a home health nurse and consented to participate in the study . Readmission days for angina , CHF and COPD per 1000 follow-up days were significantly higher for usual care patients than for DMP patients ( incidence density ratio [ IDR ] = 1.59 , 95 % confidence interval [ CI ] 1.27 - 2.00 , p All-cause readmission days per 1000 follow-up days were significantly higher for usual care patients than for DMP patients ( IDR = 1.53 , 95 % CI 1.37 - 1.71 , p difference in emergency department encounters per 1000 follow-up days was significant ( IDR = 2.08 , 95 % CI 1.56 - 2.77 , p DMP patients than for usual care patients for emergency department visits ( p = 0.007 ) , diagnostic or therapeutic services ( p = 0.012 ) and laboratory services ( p = 0.007 ) . INTERPRETATION The results provide evidence that an appropriately developed and implemented community-based inner-city DMP delivered by home health nurses has a positive impact on patient outcomes",
"Prognosis during 5 years of follow-up after first myocardial infa rct ion ( MI ) in a group of men ( aged 40 to 55 years ) was related to risk factors determined at the time of MI . Progression of coronary artery disease ( CAD ) was measured by the occurrence of severe angina pectoris , recurrent myocardial infa rct ion , and cardiac death . Only smoking and serum cholesterol level influenced prognosis . It was possible to identify a subgroup ( patients smoking less than 20 cigarettes/day and having a cholesterol level of less than 7.0 mmoles/L ) with low risk for progression of CAD . A r and omly applied 6-week rehabilitation program shortly after MI was associated with a 50 % decrease in progressive CAD when compared to the control group . Since only a slight decrease in cholesterol levels was found in the rehabilitation group , a direct effect of the rehabilitation program could thus not be excluded because the second important risk factor , smoking , did not show differences between the two groups . The smoking habits at the time of MI determined the continuation of cigarette smoking and rehabilitation did not influence smoking habits ",
"This prospect i ve study evaluated the effect of an individualized , comprehensive , home-based cardiac rehabilitation program combining exercise training with risk factor modification and psychosocial counseling on risk factors , psychological well-being , functional capacity , and work resumption in 99 post-percutaneous coronary interventions ( PCI ) patients r and omized to control ( st and ard care plus telephone follow-up , n=49 ) or intervention ( individualized , comprehensive , home-based cardiac rehabilitation , n=50 ) groups . Data were collected at time 1 ( T(1 ) ) during hospital admission , time 2 ( T(2 ) ) approximately 2 months post-PCI , and time 3 ( T(3 ) ) approximately 12 months post-PCI . Results suggest that the allocation to an individualized , comprehensive , home-based cardiac rehabilitation program provided more advantageous outcomes . At both follow-ups , the intervention group showed within-group improvement in serum cholesterol levels ( P exercise participation ( P body mass index ( BMI ) ( P psychological well-being ( P functional capacity ( P returned to work at T(2 ) ( P risk factor profiles and work resumption patterns for patients following PCI",
"OBJECTIVES This study evaluated the effectiveness of cardiac counseling and rehabilitation programs led by a nurse counselor , compared with normal care on outcomes for myocardial infa rct ion ( MI ) patients and their partners . METHODS A r and omized controlled trial with follow-up to 1 year was conducted with 100 patients recruited within 72 hours of a first MI and their partners : a Control group received normal care ; an Inpatient group received cardiac rehabilitation from a nurse counselor while in hospital ; and an Extended group received the same cardiac rehabilitation as the Inpatient group , but with additional sessions continuing up to 6 weeks after discharge from hospital . The scales for main outcome measures were 1 ) knowledge of heart disease and treatment ( correct , misconceptions , and uncertainty ) ; 2 ) mood ( Hospital Anxiety and Depression Scale ) ; 3 ) satisfaction ; 4 ) disability ( Functional Limitations Profile ) . RESULTS Inpatient cardiac counseling and rehabilitation result ed in more knowledge , less anxiety , less depression , and greater satisfaction with care in both patients and partners and in less disability in patients , with effects enduring to 1 year . There was some evidence of additional benefit from the Extended program . Both nurse counselors achieved benefits on all outcome variables . CONCLUSIONS This Inpatient cardiac counseling and rehabilitation program result ed in significant and enduring benefits of clinical value . It is likely that it would be acceptable to most post-MI patients , many of whom are not offered or are unable to accept outpatient cardiac rehabilitation",
"This study was a secondary analysis of data collected on 202 patients hospitalized with common medical or surgical cardiac conditions who completed a 24-week postdischarge follow-up program as part of a large-scale r and omized clinical trial . Subjects were age 65 years or older , admitted from their homes with one of the following diagnosis-related groups : heart failure , angina , myocardial infa rct ion , coronary artery bypass graft surgery , or cardiac valve replacement . The intervention consisted of comprehensive discharge planning and home follow-up by an advanced practice nurse ( APN ) for 4 weeks after discharge . Control subjects received usual care . Findings indicated that medical patients in the intervention group had fewer multiple readmissions during the 24 weeks of follow-up and a reduced total number of days of rehospitalization . There were fewer hospital readmissions in the surgical group when measured from discharge to 6 weeks . There were no differences in functional status between intervention and control groups for either population . The findings of this study suggest that high-risk elders with significant cardiac problems may benefit from a care program that emphasizes collaborative , coordinated discharge planning and home follow-up that includes telephone and home visits by APNs",
"The aim of this study was to compare the effects of residential multifactorial cardiac rehabilitation , outpatient multifactorial rehabilitation , stress management , and st and ard coronary rehabilitation , on cardiac risk reduction . Out of 144 eligible male patients recently treated with percantaneous transluminal coronary angiography ( PTCA ) , coronary artery bypass graft ( CABG ) , or acute myocardial infa rct ion ( AMI ) , 132 were r and omized into this study . All interventions covered a 12-month active intervention , intense during the first months and subsequently leveled out . Main assessment s were performed before r and omization and after the intervention . Patients offered behavioral rehabilitation showed improved selfreported healthy diet habits and exercise frequency , and higher internal locus of control . Although blood lipids , exercise capacity , body mass , anxiety , depression , and Type A scores were changed in the expected direction , no significant difference emerged between active intervention and the st and ard care condition . St and ard care of today appears to have great potential in particular if supplemented with some kind of stress management",
"Abstract Objective : To assess the value of health education for patients with angina in reducing risk factors for cardiovascular disease and lessening the effect of angina on everyday activities . Design : R and omised controlled trial of personal health education given every four months . Setting : 18 general practice s in the greater Belfast area . Subjects : 688 patients aged less than 75 years and known to have had angina for at least six months ; 342 r and omised to receive education and 346 to no education . Main outcome measures : Restriction of everyday activities , dietary habit , smoking habit , frequency of physical exercise ; blood pressure , body mass index , and serum total cholesterol concentration at entry to trial and after two years . Results : 317 in the intervention group and 300 in the control group completed the trial . At the two year review more of the intervention group ( 140 , 44 % ) reported taking daily physical exercise than the control group ( 70 , 24 % ) . The intervention group also reported eating a healthier diet than the control group and less restriction by angina in any everyday activity . No significant differences were found between the groups in smoking habit , systolic or diastolic blood pressure , cholesterol concentration , or body mass index . Conclusion : Despite having no significant effect on objective cardiovascular risk factors , personal health education of patients with angina seems to increase exercise and improve dietary habits and is effective in lessening the restriction of everyday activities",
"CONTEXT The Lifestyle Heart Trial demonstrated that intensive lifestyle changes may lead to regression of coronary atherosclerosis after 1 year . OBJECTIVES To determine the feasibility of patients to sustain intensive lifestyle changes for a total of 5 years and the effects of these lifestyle changes ( without lipid-lowering drugs ) on coronary heart disease . DESIGN R and omized controlled trial conducted from 1986 to 1992 using a r and omized invitational design . PATIENTS Forty-eight patients with moderate to severe coronary heart disease were r and omized to an intensive lifestyle change group or to a usual-care control group , and 35 completed the 5-year follow-up quantitative coronary arteriography . SETTING Two tertiary care university medical centers . INTERVENTION Intensive lifestyle changes ( 10 % fat whole foods vegetarian diet , aerobic exercise , stress management training , smoking cessation , group psychosocial support ) for 5 years . MAIN OUTCOME MEASURES Adherence to intensive lifestyle changes , changes in coronary artery percent diameter stenosis , and cardiac events . RESULTS Experimental group patients ( 20 [ 71 % ] of 28 patients completed 5-year follow-up ) made and maintained comprehensive lifestyle changes for 5 years , whereas control group patients ( 15 [ 75 % ] of 20 patients completed 5-year follow-up ) made more moderate changes . In the experimental group , the average percent diameter stenosis at baseline decreased 1.75 absolute percentage points after 1 year ( a 4.5 % relative improvement ) and by 3.1 absolute percentage points after 5 years ( a 7.9 % relative improvement ) . In contrast , the average percent diameter stenosis in the control group increased by 2.3 percentage points after 1 year ( a 5.4 % relative worsening ) and by 11.8 percentage points after 5 years ( a 27.7 % relative worsening ) ( P=.001 between groups . Twenty-five cardiac events occurred in 28 experimental group patients vs 45 events in 20 control group patients during the 5-year follow-up ( risk ratio for any event for the control group , 2.47 [ 95 % confidence interval , 1.48 - 4.20 ] ) . CONCLUSIONS More regression of coronary atherosclerosis occurred after 5 years than after 1 year in the experimental group . In contrast , in the control group , coronary atherosclerosis continued to progress and more than twice as many cardiac events occurred",
"Abstract Objective : To evaluate rehabilitation after myocardial infa rct ion . Design : R and omised controlled trial of rehabilitation in unselected myocardial infa rct ion patients in six centres , baseline data being collected on admission and by structured interview ( of patients and spouses ) shortly after discharge and outcome being assessed by structured interview at six months and clinical examination at 12 months . Setting : Six district general hospitals . Subjects : All 2328 eligible patients admitted over two years with confirmed myocardial infa rct ion and discharged home within 28 days . Interventions : Rehabilitation programmes comprising psychological therapy , counselling , relaxation training , and stress management training over seven weekly group outpatient sessions for patients and spouses . Main outcome measures : Anxiety , depression , quality of life , morbidity , use of medication , and mortality . Results : At six months there were no significant differences between rehabilitation patients and controls in reported anxiety ( prevalence 33 % ) or depression ( 19 % ) . Rehabilitation patients reported a lower frequency of angina ( median three versus four episodes a week ) , medication , and physical activity . At 12 months there were no differences in clinical complications , clinical sequelae , or mortality . Conclusions : Rehabilitation programmes based on psychological therapy , counselling , relaxation training , and stress management seem to offer little objective benefit to patients who have experienced myocardial infa rct ion compared with previous reports of smaller trials . Key messages In this series there were no important differences by age , sex , hospital , or baseline anxiety or depression At six months the prevalence rates of clinical anxiety and depression remained high ( 33 % and 19 % respectively ) Patients and spouses rated programmes highly , which suggests a “ quality of care ” role for",
"Community studies have demonstrated suboptimal achievement of lipid targets in the management of patients with coronary heart disease ( CHD ) . An effective strategy is required for the application of evidence -based prevention therapy for CHD . The objective of this study was to test coaching as a technique to assist patients in achieving the target cholesterol level of coronary intervention ) to receive either the coaching intervention ( n = 121 ) or usual medical care ( n = 124 ) . The primary outcome measure was fasting serum total cholesterol ( TC ) , serum triglyceride ( TG ) , high-density lipoprotein cholesterol ( HDL-C ) , and calculated low-density lipoprotein cholesterol ( LDL-C ) level , measured at 6 months post-r and omization . At 6 months , the serum TC and LDL-C levels were significantly lower in the coaching intervention group ( n = 107 ) than the usual care group ( n = 112 ) : mean TC ( 95%CI ) 5.00 ( 4.82 - 5.17 ) mmol/L versus 5.54 ( 5.36 - 5.72 ) mmol/L ( P LDL-C ( 95%CI ) 3.11 ( 2.94 - 3.29 ) mmol/L versus 3.57 ( 3.39 - 3.75 ) mmol/L ( P Coaching had no impact on TG or on HDL-C levels . Multivariate analysis showed that being coached ( P coaching intervention is best explained by both adherence to drug therapy and to dietary advice given . Coaching may be an appropriate method to reduce the treatment gap in applying evidence -based medicine to the \" real world .",
"A group of 93 coronary patients recently treated with percutaneous transluminal coronary angioplasty ( PTCA ) were r and omly assigned to either an intervention or a control group . Subjects in the intervention group participated in a comprehensive behaviorally oriented program aim ed at achieving significant long-term changes in risk factor-related lifestyle behavior . Assessment s of lifestyle behaviors , psychological factors , biological risk factors , and rehabilitation as well as secondary prevention endpoints were carried out , at inclusion and after 12 months . Results showed that the intervention patients , as compared with controls , improved significantly on measures assessing smoking , exercise , and diet habits . These self-rated changes were confirmed by weight reductions and improved exercise capacity , as well as by between-group differences in sub clinical chest pain during an exercise test . However , few effects were found on the different psychological variables , as well as on morbidity or return to work",
"OBJECTIVE : To examine the ability of a secondary prevention programme to improve the lifestyle in myocardial infa rct ion patients aged 50 - 70 years . DESIGN : Habitual physical activity , food habits , and smoking habits were assessed from question naires at admission to hospital and at the one year follow up . Initially , all patients were invited to join an exercise programme and were informed about cardiovascular risk factors . Four weeks after discharge from the hospital , 87 patients were r and omised to follow up at the coronary prevention unit by a special trained nurse ( the intervention group ) , and 81 to follow up by their general practitioners ( the usual care group ) . After r and omisation , the intervention group was educated about the effects of smoking cessation , dietary management , and regular physical activity . The intervention group also participated in a physical training programme two to three times weekly for 10 - 12 weeks . MAIN RESULTS : 89 % of the patients referred to the intervention group improved their food habits compared with 62 % of the patients referred to the usual care group ( P = 0.008 ) . Furthermore , 50 % of the smokers referred to the intervention group stopped smoking compared to 29 % in the usual care group ( P = 0.09 ) . Changes in physical activity did not differ between the groups . CONCLUSIONS : This secondary prevention programme based on a nurse rehabilitator was successful in improving food habits in patients with acute myocardial infa rct ion . Initiating the smoking cessation programme during the hospital stay followed by repeated counselling during follow up might have improved the results . The exercise programme had no advantage in supporting physical activity compared to usual care",
"The purpose of this prospect i ve r and omized controlled trial was to assess the impact of phase III comprehensive cardiac rehabilitation ( CR ) on health-related quality of life ( HRQOL ) in elderly patients with coronary artery disease ( CAD ) . Thirty-eight elderly males ( mean age , 70 years ) with CAD were stratified as the intervention group ( n=20 ) and the control group ( n=18 ) . In the intervention group , patients participated in CR for 6 months , whereas in the control group , they received st and ard care . Vali date d question naires were obtained to evaluate HRQOL using the Medical Outcome Study Short-Form 36 Health Status Survey ( SF-36 ) , State-trait anxiety inventory question naire ( STAI ) and Self-rating Depression Scale ( SDS ) at baseline and after 6 months . At baseline , scores of SF-36 except for general health , STAI and SDS were not different in either group . After 6 months , in the intervention group , scores of bodily pain , general health , vitality and mental health of SF-36 improved significantly compared with baseline . State anxiety scores also improved significantly ( p SDS depression scores were not improved . In the control group , none of the parameters significantly changed . These results indicate that elderly patients with CAD should be vigorously encouraged to pursue CR even in chronic phase III",
"This study examined whether nurses could manage coronary risk factors in patients with unstable angina more effectively than physicians practicing usual care . Three hundred twenty-six patients were r and omized in the emergency room to a 6-month program of risk factor management by a registered nurse versus participation in usual care . The nurse intervention consisted of a 30-minute counseling visit at 6 to 10 days after the chest pain episode and a second 30-minute session 1 month later . Multiple risk factors were assessed and addressed : smoking , blood lipids , blood pressure , blood glucose , physical inactivity , weight , psychological stress , and social isolation . Compared with usual care , nurse intervention patients significantly reduced both triglycerides ( -29 + /- 8 vs 5 + /- 6 mg/dl ; p weight ( -0.9 + /- 3.3 vs + 0.1 + /- 2.1 kg ; p = 0.0071 ) , and had corresponding improvements in self-reported diet compliance and exercise ( + 34 + /- 106 vs + 9 + /- 98 minutes , p = 0.0491 ) . No significant differences between groups were observed in terms of 6-month changes in total , high-density lipoprotein , or low-density lipoprotein cholesterol , blood pressure , fasting blood glucose , percent body fat or waist-hip ratio , or psychological distress scores . The 6-month rate of recurrent events ( cardiac death , out-of-hospital cardiac arrest , myocardial infa rct ion ) and /or revascularizations ( coronary artery bypass surgery or coronary angioplasty ) was lower in the nurse intervention group ( 1 % vs 9 % ; p = 0.002 ) . We conclude that a nurse-delivered risk factor intervention program for patients with chest pain is feasible and more effective than usual care in terms of fostering lifestyle changes that may lower coronary risk",
" One hundred six postmyocardial infa rct ion subjects who either achieved a mean work load of less than seven mets on treadmill testing , who were rated as anxious and /or depressed , or who met both criteria , participated in a controlled study comparing the rehabilitation effectiveness of exercise therapy and group counseling . Each intervention lasted 12 weeks . Follow-up evaluations were scheduled at three months , six months and one year . Exercise substantially increased mean work capacity , decreased fatigue , lessened anxiety and depression , and promoted independence and sociability . Counseling substantially reduced depression and promoted a sense of friendliness , and decreased interpersonal friction as well as greater independence and sociability . The control group reported no substantial change on any measured factor . Neither counseling nor exercise had an effect on mortality though subjects in the exercise group reported fewer major cardiovascular sequelae",
"The effects of a rehabilitation programme one year after myocardial infa rct ion ( MI ) were investigated in 171 patients under 65 years of age . These patients were allocated at r and om to rehabilitation and control groups before discharge from hospital . The groups were comparable with regard to age , sex and clinical data . The programme included physical exercise , counselling of patients and relatives , and social measures over a 3-month period during the convalescent stage . One year after MI patients in the rehabilitation group showed lower systolic blood pressure at rest and lower diastolic pressure on submaximal exercise than controls . No differences were found with regard to mean work capacity , days off work , return to work , psychological status , and underst and ing of the illness . At 12 months all patients were less physically and socially active than before MI , they were more dependent on their relatives than before , and they had poor underst and ing of their illness",
"R and omized clinical trials of cardiac rehabilitation following myocardial infa rct ion have typically demonstrated a lower mortality in treated patients , but with a statistically significant reduction in only one trial . To overcome the problem of not being able to detect small but clinical ly important benefits in mortality in r and omized clinical trials of exercise and risk factor rehabilitation after myocardial infa rct ion with small numbers of patients , we carried out a meta- analysis on the combined results of ten r and omized clinical trials that included 4347 patients ( control , 2145 patients ; rehabilitation , 2202 patients ) . The pooled odds ratios of 0.76 ( 95 % confidence intervals , 0.63 to 0.92 ) for all-cause death and of 0.75 ( 95 % confidence intervals , 0.62 to 0.93 ) for cardiovascular death were significantly lower in the rehabilitation group than in the control group , with no significant difference for nonfatal recurrent myocardial infa rct ion . These results suggest that , for appropriately selected patients , comprehensive cardiac rehabilitation has a beneficial effect on mortality but not on nonfatal recurrent myocardial infa rct ion",
"Background The study was design ed to determine whether a 1-year hospital-based secondary prevention programme would have any long-term effects on serum lipid levels and the use of lipid-lowering drugs in patients with coronary artery disease 4 years after referral to primary care facilities for follow-up . Design / methods After acute myocardial infa rct ion or coronary bypass surgery , 241 consecutive patients were r and omly assigned to conventional care ( CC ) by the primary health care facilities or to a 1-year hospital-based secondary prevention programme ( SPP ) with target levels for serum cholesterol ( serum cholesterol , LDL-cholesterol and triglyceride levels in the SPP group but no change in the CC group , and lipid-lowering drugs were used more frequently in the SPP group . These changes were maintained after 5 years . The proportion of patients achieving target serum cholesterol and triglyceride levels were larger in the SPP group . Conclusions Initiatives regarding cholesterol lowering and drug treatment taken by specialists within a structured hospital-based SPP have long-term impact . Accordingly , drug treatment should be initiated and adjusted to adequate doses before patients are referred to primary care for follow-up",
"BACKGROUND Acute hospitalizations represent substantial financial liability to closed health care systems . Among hospitalized patients , those with repeated admissions are high-cost users . Most managed care plans employ case management to control hospital use . This technique attempts to detect and fulfill unmet medical and social needs , intensify postdischarge care , identify and mobilize effective community services , and enhance primary care access . Despite the popularity of case management to control hospital use , few trials have examined its efficacy . METHODS We conducted a r and omized controlled trial of an intervention of case managers at a university-affiliated Veterans Affairs medical center . Six hundred sixty-eight patients aged 45 years or older who were discharged from the general medicine inpatient service , who had access to a telephone , and who received primary care at the hospital 's clinics were r and omized to the intervention ( N = 333 ) and control ( N = 335 ) groups . Within 24 hours of discharge , case managers mailed educational material s and access information to intervention patients , and within 5 days they called to review and resolve unmet needs , early warning signs , barriers to keeping appointments , and any readmissions . Case managers contacted intervention patients if they made no visits for 30 days . This result ed in a total of 6260 patient-case manager contacts . Control and intervention patients were followed up for 12 months . RESULTS Intervention patients had more frequent visits per patient per month to the general medicine clinic ( 0.30 + /- 0.23 vs 0.26 + /- 0.22 , P = .008 ) , but we detected no significant differences between groups in nonelective readmissions , readmission days , or total readmissions . CONCLUSIONS Frequent contacts for education , care , and accessibility by case managers using protocol s were ineffective in reducing nonelective readmissions",
"Health promotion programmes for patients with coronary heart disease are valuable,1 2 but there is little evidence on their lasting effect.3 A r and omised controlled trial in which patients who received personalised health promotion for two years showed significant benefits in lifestyle and quality of life.2 4 We investigated whether the differences in lifestyle , quality of life , and risk factors persisted between the two groups five years after enrolment . Patients aged under 75 who had had angina ( all grade s included ) for at least six months and no other concurrent serious illness were identified by 18 general practice s in Belfast . Their diagnosis was confirmed at interview , and they were r and omly allocated to receive either usual NHS care and personal health promotion from a trained nurse every four months for two years or usual NHS care alone . Sealed envelopes opened at interview showed group allocations . Both groups were review ed",
"The aim of the study was to evaluate a multifactorial rehabilitation programme based on interdisciplinary caring efforts for myocardial infa rct ion ( MI ) patients . R and omly chosen MI- patients participated , either in a six-month rehabilitation programme ( intervention group = 53 ) or in routine cardiac follow-ups ( control group = 63 ) . Subjective and objective instruments were used for measuring their health recovery . Biophysical improvements were showed as an increased physical capacity ( p less than 0.001 ) using a submaximal exercise test six months after MI , and less reinfa rct ions ( p less than 0.024 ) twelve months after MI , to the intervention patients ' advantage . Psychological improvements were demonstrated in a higher life satisfaction ( p less than 0.001 ) six months and ( 0.1 greater than p greater than 0.05 ) twelve months after MI to the intervention patients ' advantage . Social improvements were indicated as a better leisure situation ( p less than 0.004 ) six months after MI , and as a better partner situation ( p less than 0.010 ) , including a less influenced sex life ( p less than 0.017 ) , twelve months after MI to the intervention patients ' advantage . As to the overall view , the caring rehabilitation programme appeared to be required for the MI- patients ' health recovery . In order to be able to reach an optimal state of human health , an even more individualised programme seems to be necessary",
"OBJECTIVE To evaluate the effectiveness of a nurse led shared care programme to improve coronary heart disease risk factor levels and general health status and to reduce anxiety and depression in patients awaiting coronary artery bypass grafting ( CABG ) . DESIGN R and omised controlled trial . SETTING Community , January 1997 to March 1998 . STUDY GROUPS 98 ( 75 male ) consecutive patients were recruited to the study within one month of joining the waiting list for elective CABG at Glasgow Royal Infirmary University NHS Trust . Patients were r and omly assigned to usual care ( control ; n = 49 ) or a nurse led intervention programme ( n = 49 ) . INTERVENTION A shared care programme consisting of health education and motivational interviews , according to individual need , was carried out monthly . Care was provided in the patients ' own homes by the community based cardiac liaison nurse alternating with the general practice nurse at the practice clinic . OUTCOME MEASURES Smoking status , obesity , physical activity , anxiety and depression , general health status , and proportion of patients exceeding target values for blood pressure , plasma cholesterol , and alcohol intake . RESULTS Compared with patients who received usual care , those participating in the nurse led programme were more likely to stop smoking ( 25 % v 2 % , p = 0.001 ) and to reduce obesity ( body mass index > 30 kg/m2 ) ( 16.3 % v 8.1 % , p = 0.01 ) . Target systolic blood pressure improved by 19.8 % compared with a 10.7 % decrease in the control group ( p = 0.001 ) and target diastolic blood pressure improved by 21.5 % compared with 10.2 % in the control group ( p = 0.000 ) . However , there was no significant difference between groups in the proportion of patients with cholesterol concentrations exceeding target values . There was a significant improvement in general health status scores across all eight domains of the 36 item short form health survey with changes in difference in mean scores between the groups ranging from 8.1 ( p = 0.005 ) to 36.1 ( p Levels of anxiety and depression improved ( p time spent being physically active ( p nurse led shared care intervention was shown to be effective for improving care for patients on the waiting list for CABG",
"BACKGROUND Despite the large body of evidence confirming the effectiveness of lipid lowering for the secondary prevention of coronary heart disease ( CHD ) events , undertreatment of hyperlipidemia is common . This study tested the effectiveness of a nurse case management program to lower blood lipids in patients with CHD . METHODS A total of 228 consecutive , eligible adults with hypercholesterolemia and CHD were recruited during hospitalization after coronary revascularization . Patients were r and omized to receive lipid management , including individualized lifestyle modification and pharmacologic intervention , from a nurse practitioner for 1 year after discharge in addition to their usual care ( NURS ) , or to usual care enhanced with feedback on lipids to their primary provider and /or cardiologist ( EUC ) . RESULTS Significantly more patients in the NURS group than in the EUC group achieved low-density lipoprotein cholesterol ( LDL-C ) levels changes in lipids and lipoproteins were accompanied by significant improvements in dietary and exercise patterns in the NURS group . In a multivariate analysis adjusting for other covariates , being assigned to the NURS group ( P = .0001 ) and being on a lipid-lowering medication ( P = .001 ) were significant independent predictors of LDL-C level . CONCLUSIONS Control of hypercholesterolemia in patients who have undergone coronary revascularization can be improved by a nurse case-management program . Because the National Cholesterol Education Program Adult Treatment Panel III guidelines have broadened the definition of high-risk population s that warrant aggressive treatment , nurse case-management programs may offer key opportunities to enhance appropriate application of new treatment paradigms",
"BACKGROUND Rehabilitation is an important part of the treatment of patients with ischemic heart disease . Therefore , many patients undergoing coronary artery bypass surgery ( CABS ) also participate in cardiac rehabilitation programs . This study was conducted to investigate whether rehabilitation influences quality of life and work status after CABS . METHODS Consecutive patients undergoing elective CABS were r and omly assigned to a rehabilitation group ( R , N = 119 ) and a hospital-treatment group ( H N = 109 ) . All patients received usual medical care . Group R participated in a rehabilitation program based on exercise and counseling . The follow-up time was 5 years . The measured domains of health-related quality of life were heart symptoms , functional class , exercise capacity , use of medication , depression , the patients ' perception of health , and overall life situation . The Nottingham Health Profile as a measure of perceived distress was used . RESULTS Symptoms , use of medication , exercise capacity , and depression scores did not differ between groups R and H. Five years after the CABS , the patients in group R reported less restriction in physical mobility on the Nottingham Health Profile than patients in group H ( P = 0.005 ) , and more patients in group R than in group H perceived their health ( P = 0.03 ) and overall life situation ( P = 0.02 ) as good . The increase in the proportion of subjects working was higher in group R than group H at 3 years after the CABS ( P = 0.02 ) , but not at other follow-up times . CONCLUSION A cardiac rehabilitation program in conjunction with usual medical care after CABS may induce a perception of improved health . The influence on return to work is limited",
"BACKGROUND We evaluated the effectiveness of a low-cost group visit intervention for changing the dietary intake and lipid levels of patients with known coronary artery disease ( CAD ) . METHODS We performed a controlled r and om group assignment trial in 4 community outpatient clinics . The Dietary Intervention and Evaluation Trial r and omized 97 patients with CAD to either a control group that followed the National Cholesterol Education Program 's Step II-III diet plan ( n=48 ) or an experimental group that received meal plans , recipes , and nutritional information during monthly group office sessions ( n=49 ) . Both groups received lipid-lowering medications and were followed-up over 12 months . We assessed dietary intake , fasting lipid profiles , hemoglobin A1C levels , and per member per month ( PMPM ) expense data . RESULTS Food frequency data showed that eating fruits and vegetables and cooking with monounsaturated fat increased significantly in the experimental group compared with the control group at 1 year ( P=.0072 ; P=.0001 ; P=.0004 ) . The total PMPM expenses decreased for both groups ( 38 % for the experimental group and 10 % for the control group ) , but the cost difference was statistically nonsignificant ( P=.2975 ) . Both groups noted low-density lipoprotein reductions , significant only in the experimental group ( P=.0035 ) . CONCLUSIONS Our study suggests that using group office visits for patients with CAD was an effective method for helping subjects make dietary changes and for improving lipid levels . Patients with known CAD and elevated lipid levels were willing to make significant lifestyle changes when offered a program that emphasizes healthy foods in a group visit format",
"OBJECTIVE To determine how frequently the National Cholesterol Education Program ( NCEP ) goal of a low-density lipoprotein ( LDL ) cholesterol level of 100 mg/dL or less is achieved in clinical practice in patients with coronary artery disease and what fraction of patients can achieve this goal without drug therapy . DESIGN We examined the results of lipid management in 152 consecutive patients who had completed cardiac rehabilitation after an acute coronary event . Patients were r and omized to follow-up by specially trained nurses or by preventive cardiologists , and they were not receiving lipid-lowering drugs at the start of the study . MATERIAL AND METHODS Patients were given aggressive diet and exercise recommendations and lipid-lowering drugs in accordance with NCEP guidelines . Follow-up was continued for a mean of 526 days after the first lipid assessment subsequent to the coronary event . Multiple logistic regression analysis was used to identify independent predictors of a final LDL cholesterol level of 100 mg/dL or less . RESULTS Of the study group , 39 % achieved the NCEP goal LDL cholesterol level of 100 mg/dL or less . Characteristics of the patients with LDL cholesterol levels of 100 mg/dL or less in comparison with those with LDL cholesterol levels of more than 100 mg/dL included a greater frequency of drug therapy ( 65 % versus 38 % ) , more rigorous dietary compliance , longer follow-up ( 586 + /- 317 days versus 493 + /- 264 days ) , more favorable weight change ( -0.3 + /- 4.9 kg versus + 1.7 + /- 5.0 kg ) , and more extensive weekly exercise ( 183 + /- 118 minutes versus 127 + /- 107 minutes ) . CONCLUSION The registered nurses managed the lipids of these patients as effectively as did the preventive cardiologists . Appropriate drug therapy was the most important factor in achieving an LDL cholesterol level of 100 mg/dL or less , but 35 % of patients attaining this NCEP goal were not receiving drug therapy . Exercise , dietary compliance , and weight loss were also important factors",
"To evaluate the short-term effects of an intervention that consists of stress management training and dietary changes in patients with ischemic heart disease ( IHD ) , we compared the cardiovascular status of 23 patients who received this intervention with a r and omized control group of 23 patient who did not . After 24 days , patients in the experimental group demonstrated a 44 % mean increase in duration of exercise , a 55 % mean increase in total work performed , somewhat improved left ventricular regional wall motion during peak exercise , and a net change in the left ventricular ejection fraction from rest to maximum exercise of + 6.4 % . Also , we measured a 20.5 % mean decrease in plasma cholesterol levels and a 91.0 % mean reduction in frequency of anginal episodes . In this selected sample , short-term improvements in cardiovascular status seem to result from these adjuncts to conventional treatments of IHD"
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4116fd3a-06ff-11f0-808a-c43d1ab1c353
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The management of oral submucous fibrosis ( OSF ) is quite challenging , and as yet , no effective therapy is available for its management . The present systematic review and meta- analysis sought to assess the effectiveness of aloe vera in alleviating pain and clinical signs of OSF . A comprehensive search in PubMed / Medline , Scopus , and Web of Science data bases was conducted to identify the relevant r and omized clinical trials . RevMan 5.3 software was used for data analysis . Six r and omized controlled trials fulfilled the inclusion criteria . The results of meta- analysis showed statistically significant differences between aloe vera and control groups in alleviating pain/burning sensation at the end of the first and second month , in favor of aloe vera , but no significant differences were found at the end of the third month . With regard to objective clinical outcomes , no statistically significant differences were found between the groups . Aloe vera has a promising effect in reducing pain/burning sensation and clinical improvement in patients with OSF . However , owing to the marked heterogeneity of the included studies , conducting well- design ed trials with long follow-up periods , st and ardized outcome measures and adequate sample sizes are warranted
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"BACKGROUND Oral submucous fibrosis ( OSMF ) is a well-established precancerous condition affecting the oral mucosa . It is a disease that causes significant morbidity ( in terms of loss of mouth function as tissues become rigid and mouth opening becomes difficult ) and mortality ( when transformation into squamous cell carcinoma occurs ) . AIM The aim of the study is to compare the efficacy of Aloe vera with antioxidant when given along with physiotherapy in the management of OSMF . MATERIAL S AND METHODS Forty patients presenting with clinical signs and symptoms of OSMF were included for the study after informed consent . Group A included 20 patients who received Aloe vera gel ( forever living gel ) along with physiotherapy . Group B included 20 patients who received antioxidant capsules twice daily for 3 months along with physiotherapy exercises four times in a day . The following parameters , that is , burning sensation , mouth opening , tongue protrusion and cheek flexibility were recorded at each visit . RESULTS Majority of the participant enrolled were in the age range of 30 to 35 years . Improvement in all the parameters was seen with the individuals receiving Aloe vera gel in comparison to antioxidants . CONCLUSION So , Aloe vera being a soothing , simple and safe mode of treatment along with proper habit restriction can be considered to be an effectual protocol in the management of OSMF . The analgesic effects of Aloe vera with the physiotherapy exercises provide better results in reducing burning sensation and improving mouth opening , tongue protrusion and cheek flexibility in comparison to antioxidants",
"BACKGROUND Oral submucous fibrosis is a chronic disease , treatment of which has largely been symptomatic . Aloe vera has immunomodulatory , anti-inflammatory , wound healing , antioxidant , and antineoplastic activities . All such properties of aloe vera suggest the possibility of its use in the management of oral submucous fibrosis . METHODS Seventy-four patients of oral submucous fibrosis were r and omly divided into 2 groups . Group A patients were treated with systemic ( juice ) and topical aloe vera ( gel ) for 3 months . Group B patients were treated with intralesional injection of hydrocortisone and hyaluronidase for 6 weeks with antioxidant supplements for 3 months . Patients were assessed for reduction in burning sensation and increase in mouth opening , cheek flexibility , and tongue protrusion at an interval of 1 , 2 , and 3 months . RESULTS Both the groups showed statistically significant improvements in all the study parameters at the end of study period ( P response to aloe vera was comparable to that of intralesional injections of hydrocortisone and hyaluronidase with antioxidant supplementation . CONCLUSION The study concludes that aloe vera can be an alternative , safe , and effective treatment regime in the management of oral submucous fibrosis . Long-term follow-up studies with larger sample size are recommended",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"OBJECTIVE To investigate the effectiveness of turmeric with black pepper and nigella sativa in oral submucous fibrosis ( OSMF ) . STUDY DESIGN Forty OSMF patients were r and omly divided into two groups . The study was performed under a double-blind , r and omized design . Group A received turmeric with black pepper and group B received nigella sativa for 3 months . Clinical evaluation was done every 15 days . Patients ' serum superoxide dismutase ( SOD ) levels were assessed before and after treatment and also compared with healthy controls . The response to treatment was analyzed using analysis of variance , paired t test , and unpaired t test . RESULTS After the treatment , groups A and B showed 3.85 ± 0.22 mm and 3.6 ± 0.07 mm improvement in mouth opening , respectively ( P reduction in burning sensation , respectively ( P improvement in serum SOD levels , respectively ( P maximum mouth opening achieved was 8 mm in group A and 7 mm in group B. The mean pretreatment SOD level for controls and patients was 3.61 ± 0.24 U/mL in group A and 2.63 ± 0.18 U/mL in group B. CONCLUSION Turmeric with black pepper and nigella sativa improved mouth opening , burning sensation , and SOD levels in the present OSMF study patients ; however , further investigations are needed",
"OBJECTIVE Definitive therapy is not defined for the management of oral submucous fibrosis ( OSMF ) . This study evaluated the efficacy of aloe vera gel as an adjuvant treatment of OSMF . STUDY DESIGN A double-blind , placebo-controlled , parallel-group r and omized controlled trial was conducted on 60 subjects with OSMF divided into medicinal treatment ( submucosal injection of hyaluronidase and dexamethasone , n = 30 ) and surgical treatment ( n = 30 ) categories . Each category was r and omly divided into groups A ( with aloe vera , n = 15 per category ) and B ( without aloe vera , n = 15 per category ) . Follow-up assessment for various symptoms was performed , and results were analyzed using paired and unpaired Student t tests . RESULTS The group receiving aloe vera had a significant improvement in most symptoms of OSMF ( P effective as an adjuvant in treatment of OSMF",
"OBJECTIVES To evaluate and compare the therapeutic response of lycopene and curcumin with placebo in patients suffering from oral submucous fibrosis ( OSMF ) and to correlate the habit variables of smoked and smokeless tobacco products in OSMF . METHODS A r and omized placebo-controlled parallel clinical study was conducted on ninety OSMF patients , who were divided into three treatment groups using computer-generated r and omization . Group A patients ( n = 30 ) were given curcumin tablet ( 300 mg ) twice daily , Group B patients ( n = 30 ) received lycopene capsules ( 8 mg ) twice daily , and for Group C ( n = 30 ) , placebo capsules were given once daily for a period of six months . Both the participant and outcome assessor were blinded . Pre- and post-treatment comparison of mouth opening , burning sensation , tongue protrusion , and cheek flexibility was analyzed at periodic follow-up of 9 months . RESULTS The overall improvement in mouth opening , burning sensation , tongue protrusion , and cheek flexibility was 3.9 ± 4.9 mm , 4.8 ± 2.6 , 5.0 ± 7.2 mm , & 0.36 ± 0.71 mm , respectively , for curcumin and 4.1 ± 4.2 mm , 5.0 ± 2.3 , 2.4 ± 3.5 mm , & 0.66 ± 0.80 mm , respectively , for lycopene with the p value both curcumin and lycopene treatment groups in comparison with placebo . However , the therapeutic efficacy of curcumin and lycopene was found to be almost equal in OSMF patients"
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4116fd94-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Cholecystectomy is the removal of gallbladder and is performed mainly for symptomatic gallstones . Although laparoscopic cholecystectomy is currently preferred over open cholecystectomy for elective cholecystectomy , reports of r and omised clinical trials comparing the choice of cholecystectomy ( open or laparoscopic ) in acute cholecystitis are still being conducted . Drainage in open cholecystectomy is a matter of considerable debate . Surgeons use drains primarily to prevent subhepatic abscess or bile peritonitis from an undrained bile leak . Critics of drain condemn drain use as it increases wound and chest infection . OBJECTIVES To assess the benefits and harms of routine abdominal drainage in uncomplicated open cholecystectomy . SEARCH STRATEGY We search ed The Cochrane Hepato-Biliary Group Controlled Trials Register , the Cochrane Central Register of Controlled Trials ( CENTRAL ) in The Cochrane Library , MEDLINE , EMBASE , and Science Citation Index Exp and ed until April 2006 . SELECTION CRITERIA We included r and omised clinical trials comparing ' no drain ' versus ' drain ' in patients who had undergone uncomplicated open cholecystectomy ( irrespective of language , publication status , and the type of drain ) . R and omised clinical trials comparing one drain with another were also included . DATA COLLECTION AND ANALYSIS We collected the data on the characteristics and method ological quality of each trial , number of abdominal collection s requiring different treatments , bile peritonitis , wound infection , chest complications , and hospital stay from each trial . We analysed the data with both the fixed-effect and the r and om-effects models using RevMan Analysis . For each outcome , we calculated the odds ratio ( OR ) with 95 % confidence intervals ( CI ) based on intention-to-treat analysis . MAIN RESULTS Twenty eight trials involving 3659 patients were included . There were 20 comparisons of ' no drain ' versus ' drain ' and 12 comparisons of one drain with another . There was no statistically significant difference in mortality , bile peritonitis , total abdominal collection s , abdominal collection s requiring different treatments , or infected abdominal collection s. ' No drain ' group had statistically significant lower wound infection ( OR 0.61 , 95 % CI 0.43 to 0.87 ) and statistically significant lower chest infection ( OR 0.59 , 95 % CI 0.42 to 0.84 ) than drain group . We found no significant differences between different types of drains . AUTHORS ' CONCLUSIONS Drains increase the harms to the patient without providing any additional benefit for patients undergoing open cholecystectomy and should be avoided in open cholecystectomy
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"The benefits of some ancillary techniques of cholecystectomy are exaggerated by retrospective study of selected patients . Therefore , the authors performed a prospect i ve , r and omized study of 100 consecutive patients who underwent simple elective cholecystectomy for chronic cholecystitis and cholelithiasis . No patient was excluded because of incomplete hemostasis or fear of bile leakage . The frequency of pulmonary complications and wound infections was independent of the type of incision -- vertical or subcostal . Peritoneal drainage was found to be unnecessary . Short-term drainage may increase the frequency of postoperative fever , but did not increase pulmonary complications or wound infections . In these patients , intra-abdominal sepsis is rare ; wound infections were uncommon and the gallbladder bile was usually sterile and not the cause of postoperative infection",
"Abstract During the 24-month period commencing January 1975 , 200 patients underwent elective cholecystectomy for chronic cholecystitis . According to a prospect i ve r and omized protocol , 100 patients were drained and an identical number were not drained . The two groups were similar with respect to age , weight , diabetic history , and all other measured clinical parameters . Patients who were not drained had less postoperative fever in terms of actual temperature elevation and duration of fever and were discharged from the hospital earlier . There was no difference in the incidence of wound infection or other complications between the two groups . This study confirms that elective cholecystectomy without drainage of the subhepatic space can be done safely and that less postoperative fever and shorter hospitalization can be expected",
"Closed-suction drainage was compared prospect ively to open , passive drainage ( Penrose drains ) in 128 patients undergoing cholecystectomy . Patients were r and omized at the time of operation to receive either closed-suction drains ( Group I , 67 patients ) or Penrose drains ( Group II , 61 patients ) . The preoperative clinical parameters of the two groups were similar . The patients in Group I when compared with those in Group II had a shorter duration of drainage ( 3.3 days and 4.1 days , respectively , p less than 0.01 ) , a lesser volume of drainage in the first 48 hours postoperatively ( 78 ml and 132 ml , respectively , p less than 0.001 ) , a decreased incidence of fever on the night of operation ( 24 of 67 patients and 39 of 61 patients , respectively , p less than 0.05 ) and on the first postoperative day ( 26 of 67 patients and 32 of 61 patients , respectively , p less than 0.05 ) , and a lower leukocyte count on the first postoperative day ( 12,000 cells/mm3 and 14,100 cells/mm3 , respectively , 0.05 less than p less than 0.1 ) . Patients in Group I tended to have a lower rate of wound infection ( 1 of 67 patients versus 5 of 61 patients in Group II , 0.05 less than p less than 0.1 ) and had a much lower incidence of drain site tenderness ( 8 of 67 patients in Group I versus 24 of 61 patients in Group II , p less than 0.05 ) . This study demonstrates the superiority of closed-suction drains over open , passive drains after cholecystectomy",
"Consecutive patients undergoing emergency appendectomy ( 283 ) or urgent cholecystectomy ( 51 ) were prospect ively studied for the development of postoperative incisional or peritoneal sepsis . Severity of the original peritoneal infection was carefully recorded , while use of a Penrose dam to drain the peritoneum was r and omized according to pre-assigned hospital number . Both aerobic and anaerobic cultures were taken from the abdomen at the time of operation as well as from all postoperative infectious foci . Results demonstrated no essential differences in incidence of wound and peritoneal infection following appendectomy for simple or suppurative appendicitis ( 187 ) or following cholecystectomy for acute cholecystitis ( 51 ) . However , with gangrenous or perforative appendicitis ( 94 ) , incisional and intra-abdominal infection rates were 43 % and 45 % , respectively , when a drain was used ; yet only 29 and 13 % , respectively , without a drain . These latter differences were significant ( p intra-abdominal abscesses were three times as likely to drain through the incision than along any tract provided by the rubber conduit . Cultures revealed that hospital pathogens accounted for a greater proportion of wound and peritoneal sepsis after cholecystectomy and appendectomy for simple or suppurative appendicitis if a drain had been inserted than if managed otherwise . By contrast , a mixed bacterial flora was responsible for most infections following appendectomy for gangrenous or perforated appendicitis , irrespective as to use of a drain",
"Some surgeons drain the gallbladder bed routinely , some selectively and some not at all . We aim ed to clarify this confusion by entering 155 consecutive patients undergoing emergency and elective cholecystectomy without exploration of the common bile duct into a r and om control clinical trial . In 78 patients a 3 mm suction drain was left in the gallbladder bed and in 77 the abdomen was closed without drainage . There were no withdrawals , one death ( in the drainage group ) from myocardial infa rct ion and one intraperitoneal abscess complicating postoperative pancreatitis ( in the no‐drainage group ) . Other events studied were postoperative pyrexia , wound infection , respiratory tract infection and duration of hospital stay . In none of these did the two groups differ either clinical ly or statistically . We conclude that drainage or non‐drainage of the gallbladder bed must remain a matter of individual preference",
"Although laparoscopic cholecystectomy has rapidly developed in the treatment of gall bladder disease in the absence of controlled clinical trial data its outcome parameters compared with open cholecystectomy remain unclear . A prospect i ve audit of the introduction of laparoscopic cholecystectomy in the west of Scotl and over a two year period was carried out to attempt to assess this new procedure . A total of 45 surgeons in 19 hospitals performing laparoscopic cholecystectomy su bmi tted prospect i ve data from September 1990 - 1992 . A total of 2285 cholecystectomies were audited ( a completed data collection rate of 99 % ) . Laparoscopic cholecystectomy was attempted in 1683 ( 74 % ) patients and completed in 1448 patients ( median conversion rate to the open procedure 17 % ) . The median operation time in the completed laparoscopic cholecystectomy patients was 100 minutes ( range 30 - 330 ) and overall hospital stay three days ( 1 - 33 ) . There were nine deaths ( 0.5 % ) after laparoscopic cholecystectomy although only two were directly attributable to the laparoscopic procedure . In the laparoscopic cholecystectomy group there were 99 complications ( 5.9 % ) , 53 ( 3 % ) of these were major requiring further invasive intervention . Forty patients ( 2.4 % ) required early or delayed laparotomy for major complications such as bleeding or bile duct injuries . There were 11 ( 0.7 % ) bile duct injuries in the laparoscopic cholecystectomy series , five were noted during the initial procedure and six were recognised later result ing from jaundice or bile leaks . Ductal injuries occurred after a median of 20 laparoscopic cholecystectomies . In conclusion laparoscopic cholecystectomy has rapidly replaced open cholecystectomy in the treatment of gall bladder disease . Although the overall death and complication rate associated with laparoscopic cholecystectomy is similar to open cholecystectomy , the bile duct injury rate is higher",
"The subhepatic placement of prophylactic drains following cholecystectomy remains a common practice despite studies demonstrating the safety of omitting such drains . The accumulation and fate of subhepatic fluid constitute the chief concern . In a prospect i ve comparative study , 76 patients were r and omized into drained and non-drained groups . Postoperative ultrasonographic studies showed no localized fluid accumulations in the majority of instances . Small accumulations of fluid in the gallbladder bed were demonstrated on the initial postoperative sonograms in nine patients in the two groups . Long-term patient follow-up confirmed such fluid , which remained stable or decreased in size , to be clinical ly insignificant",
"In this prospect i ve r and omized study , the influence of an intraperitoneal drain on the incidence and clinical significance of subhepatic collection s occurring in patients after acute or elective cholecystectomy was assessed by ultrasound examination . A total of 112 patients entered the study , of whom 54 received a drain . There was no significant difference between the drainage and the non‐drainage groups with respect to mean age or sex distribution , the number of patients in whom the gallbladder bed was formally closed ( 27 versus 21 ) nor in the number of acute cholecystectomies performed in either group ( 12 versus 13 ) . Ultrasound detected 10 ( 18 per cent ) collection s in the drainage group and only one ( 1·8 per cent ) in the non‐drainage group ( P None of the collection s required any further treatment and no morbidity occurred that was directly attributable to the presence of the retained fluid . These results suggest that rather than preventing fluid collection s , suction drains may predispose to the development of subhepatic collection s after cholecystectomy",
"Daily ultrasonography of the gallbladder bed was performed in patients with suction or passive tube drains after elective cholecystectomy . A total of 19 patients was r and omized to suction drainage and 17 to passive tube drainage . A policy of early drain removal was followed . No significant difference was found between the volume drained and the size of collection detected in either group . Significant bile leaks were detected and were adequately drained by suction and passive tube drains . There were no complications from drains . In view of these findings , we advocate short-term drainage of the gallbladder bed after both open and laparoscopic cholecystectomy using the drain of the surgeon 's choice",
"The efficacy of low pressure , high pressure and passive drainage systems have been compared after cholecystectomy . Symptoms of pain , discomfort and nausea were compared using linear analogue scales and spirometry was used to examine pre-operative and postoperative respiratory function . The low pressure suction drain removed an intraperitoneal marker , gentamicin , more effectively than the high pressure suction drain , but not more effectively than the passive drain . There were no differences in postoperative respiratory function nor in the amount of pain or discomfort between the groups . The passive drain group reported less nausea than the suction drain groups . If a negative pressure drainage system is to be used , a low pressure suction drain should be used in preference to a high pressure system",
"One hundred eighty-four patients who underwent biliary surgery were r and omly allocated to four groups arranaed in a 2 by 2 design . In 92 patients the drain was brought out through the wound and in the other 92 through a stab incision . In half of the patients in each group the drain was connected to a suction system and in the other half to a sterile bag . Suction was found to impair rather than enhance intraperitoneal drainage . In patients who underwent elective cholecystectomy and early operation for acute cholecystitis , the amount of discharge was more than twice as large when suction was omitted than when it was applied . After common duct operations the amount of discharge was very large and there was little difference in cases with and without suction . Prolonged drainage , static or suction , result ed in an increase in the serum haptoglobin level . Analysis of out data suggested that after a few days the drain starts to act as a traumatic stimulus . No difference was found between cases with the drain brought out through a stab incision and those with the drain brought out through the main wound . A number of studies have ascertained the superiority of closed to open drainage . The results of the present trial lead us to recommend that after biliary surgery the closed us to recommend that after biliary surgery the closed drain should not be connected to a suction apparatus and that after elective cholecystectomy the drain should preferably be removed after a few days",
"OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases were Cochrane Controlled Trials Register = 78.5 % , MEDLINE = 68.8 % , Embase = 65.0 % , and Science/Social Sciences Citation Index = 60.7 % . Search ing another twenty-six data bases after Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , and Embase only found 2.4 % additional trials . There was no significant difference between trials found in the CCTR , MEDLINE , and Embase compared with other trials , with respect to adequate allocation concealment or sample size . CONCLUSIONS There was a large variation between review s in the exhaustiveness of the literature search es . CCTR was the single best source of RCTs . Additional data base search ing retrieved only a small percentage of extra trials . Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials",
"This r and omized , prospect i ve study evaluates drainage of the subhepatic space in patients undergoing simple , uncomplicated cholecystectomy . One hundred twenty-two patients were divided into open ( Penrose ) drainage , closed sump drainage and no drainage groups . Open drainage result ed in increased morbidity and a longer postoperative hospital stay . The best results were in patients without drains . Subhepatic drainage is unnecessary in simple , uncomplicated cholecystectomy",
"The aim of this prospect i ve trial was to determine whether surgical approach ( open versus laparoscopic ) had an impact on morbidity and postoperative recovery after cholecystectomy for acute cholecystitis",
"Methods for combining data from several studies exist and appear to be quite useful . None satisfactorily addresses the question of what studies should be combined . This issue is the most serious method ological limitation . Even studies with statistically significant interaction might still be combined if the effect were in the same direction . Thus , substantial scientific input is required as to what criteria must be met by each potential study . Much can be learned from combining or pooling data but it must be done cautiously . Pooling exercises do not replace well design ed prospect i ve clinical trials . Efforts for establishing basic design criteria to allow for multicentre and multicountry trials to be more easily combined might be useful .",
"A prospect i ve r and omized and controlled study of prophylactic drainage after simple , elective cholecystectomy was carried out . From March 1988 to June 1991 80 patients received an Easy-Flow drain and 80 did not . Operation and perioperative management were st and ardized . The endpoint of the study was postoperative morbidity , especially postoperative pyrexia and subhepatic fluid collection . The latter was identified by ultrasonography performed daily on postoperative day 1 - 4 . No patient died . The morbidity including postoperative pyrexia revealed no difference between drained and undrained patients . In 19 of the patients with ( 23.8 % ) and in 25 of the patients without drainage ( 31.3 % ) a subhepatic fluid collection could be demonstrated by ultrasonography . This difference was not statistically significant either . We conclude that prophylactic drainage after elective , simple cholecystectomy is of no use for the patient . As subhepatic fluid collection s can be seen in drained as well as in undrained patients it has to be accepted that drainage does not guarantee the removal of subhepatic fluid . Therefore its indicatory function ( bleeding ) and the ability to prevent the patient having biliary peritonitis or local abscess has to be put in doubt",
"Eighty patients undergoing cholecystectomy were either assigned deliberately ( n=30 ) or r and omized ( n=50 ) to drainage ( n=38 ) or nondrainage ( n=42 ) . Subhepatic collection s were seen on ultrasonography ( US ) after 48 to 72 hours in 12 of 35 patients with drainage and 24 of 42 patients without drainage ( p symptomatic , and none required treatment . Postoperative infective complications were seen in 13 of 38 patients with drainage and 4 of 42 without drainage ( p postoperative infective complications ( p Cholecystectomy was then performed in 100 patients without using a drain . BULIDA radioisotope scans revealed a bile leak in only 4 of 34 patients studied . Subhepatic collection s were seen on US after 48 to 72 hours in 42 patients . The collection resolved in 22 patients and was smaller in 6 on repeat US . None of the patients with collection was symptomatic , and none required treatment . Postoperative infective complications were seen in 7 of 42 patients with a collection and 5 of 58 patients without a collection ( not significant ) . We conclude that ( 1 ) cholecystectomy with drainage is associated with more infective complications than when a drain is not used ; ( 2 ) cholecystectomy without drainage is safe ; and ( 3 ) asymptomatic nonbilious subhepatic collection s are common after cholecystectomy without drainage but do not require treatment , resolving spontaneously . RésuméQuatre-vingt patients ( 50 par r and omisation ) ont eu un drainage ( n=38 ) ou non ( n=42 ) après cholécystectomie traditionnelle . Une collection soushépatique a été mise en évidence par échographie dans les 48–72 heures postopératoires chez 12/35 patients avec drainage et chez 24/42 patients sans drainage ( p complications postopératoires infectieuses ont été observées chez 13/38 patients ayant eu un drainage comparées à 4/42 des patients sans drainage ( p infection postopératoire comparés à aucun des 18 patients sans drainage ni collection ( p cholécystectomies sans drainage . Une scintigraphie au technétium a mis en évidence une fuite biliaire chez 4 des 34 patients étudiés . Une collection soushépatique a été mise en évidence par échographie chez 42 patients . Lors de la surveillance échographique , la collection s'est résorbée spontanément chez 22 patients et a diminué d ' importance chez 6 . Aucune de ces collection s n'étaient symptomatiques et aucune n'a nécessité de geste thérapeutique . Des complications postopératoires ont été observés chez 7/42 patients avec une collection comparés à 5/58 patients sans collection ( différence non significative ) . Nous concluons que : ( 1 ) il y a plus d'infection lorsque l'on draine l'abdomen après une cholécystectomie que lorsque l'intervention se termine sans drainage ; ( 2 ) la cholécystectomie sans drainage est sans danger ; et ( 3 ) des collection s bilieuses asymptomatiques sont fréquentes après cholécystectomie sans drainage , mais elles se résorbent habituellement sans nécessiter d'intervention . ResumenOchenta pacientes sometidos a colecistectomía fueron r and omizados a drenaje ( 38 ) o no drenaje ( 42 ) . Se observaron colecciones subhepáticas en ultrasonografía practicada a las 48–72 horas en 12/35 pacientes con drenaje y en 24/42 pacientes sin drenaje ( p Complicaciones sépticas postoperatorias fueron registradas en 13/38 pacientes con drenaje y en 4/42 sin drenaje ( p subhepática , y ninguno de 18 sin drenaje y sin colección presentaron complicaciones sépticas postoperatorias ( p colecistectomías sin drenaje . La escanografía con radioisótopos , BULIDA , reveló escape biliar en sólo 4 de 34 pacientes estudiados ; se visualizaron colecciones subhepáticas por US a las 48–72 horas en 42 pacientes . La colección se resolvió en 22 y apareció menor en 6 casos en que se repitió la US . Ninguna de estas colecciones fue sintomática y ninguna requirió tratamiento alguno . Se registraron complicaciones sépticas en 7/42 pacientes con colección y en 5/58 sin colección ( ns ) . Nuestra conclusión es que la colecistectomía con drenaje se asocia con un numéro mayor de complicaciones sépticas . La colecistectomía libre de drenaje es un procedimiento seguro ; las colecciones no biliares subhepáticas asintomáticas son frecuentes después de la colecistectomía sin drenaje pero no requieren tratamiento y se resuelven espontáneamente",
"Drainage after cholecystectomy remains routine despite the lack of scientific supportive data . Numerous clinical studies in the past have attempted to address this controversy but have failed to resolve the issue for different reasons . These include retrospective design , inclusion of only selected cases , and r and omization before surgery . In this study 479 patients undergoing cholecystectomy were r and omly allocated to a drainage group ( a high-pressure suction drain in Morison 's pouch for 48 hours ) or a nondrainage group . R and omization was performed at the time of peritoneal closure . All patients undergoing cholecystectomy , both elective and urgent , were included and the operations were performed by all grade s of surgeons . There were two deaths from cardiopulmonary causes , both in the drainage group . No patient required reoperation in either group . The incidence of both wound infections ( 15 vs 5 ; p less than 0.05 ) and chest infections ( 56 vs 19 , p less than 0.02 ) was significantly higher in the drainage group . Three hundred fifty-six patients underwent abdominal ultrasonography 72 hours after surgery . The number of subhepatic fluid collection s thus detected was significantly higher in the patients who received a drain ( 17 vs 6 , p less than 0.05 ) . None of these collection s was clinical ly significant . The postoperative hospital stay was longer in the patients with drains ( 10.3 vs 9.1 days ) , but this difference failed to reach statistical significance . We conclude from this study that the use of a drain after cholecystectomy serves no useful purpose and is potentially harmful . This practice should be ab and oned",
"A consecutive series of 50 patients undergoing elective cholecystectomy without prophylactic antibiotics entered a prospect i ve r and omized trial to compare the post-operative clinical course whether the subhepatic space was drained or not . 26 patients ( mean age 58 yrs ) were drained and 24 patients ( mean age 59 yrs ) were not . The incidence of positive gallbladder bile cultures were respectively 8 and 19 % ( N.S. ) in the drained and undrained groups . The incidence of post-operative mortality , thrombo-phlebitis and intra-abdominal sepsis was zero in both groups . In the drained or undrained series , the incidence of wound infection was respectively 4 % and 0 % ( N.S. ) , that of urinary infection was 8 % and 13 % ( N.S. ) and that of pulmonary atelectasis was 15 and 17 % ( N.S. ) . A further consecutive series of 100 undrained elective cholecystectomies ( 18 % positive bile cultures ) without prophylactic antibiotics was then performed with the same uneventful postoperative course . This study therefore indicates that even in the presence of bacterobilia elective cholecystectomy can be safely performed without subhepatic space drainage and without prophylactic antibiotics",
"Sump drainage was compared with closed static drainage in a r and omized trial using a restricted sequential plan . Sump drains were converted into static drains by closing the air-vent tubes and by omitting suction . Sump drains so converted evacuated more intraperitoneal fluid during the first 24 hours after cholecystectomy than did drains in which the sump was functioning . For drainage after cholecystectomy , the sump drain is inferior to the passive drain in a closed circuit",
"Based on the data of 56 patients undergoing elective cholecystectomy the value of subhepatic drainage is evaluated in a r and omized controlled clinical trial . The design of the study and the perioperative management of the patients are described in detail and the results analyzed according to clinical course , blood tests and abdominal ultrasound",
"A prospect i ve trial to assess the effect of suction in an abdominal drain following cholecystectomy was carried out . Three types of closed drainage system were compared : a simple tube drain , a low negative pressure drain , and a high negative pressure drain : 120 consecutive patients undergoing cholecystectomy were r and omly allocated to one of the three drainage groups . There was no significant difference in postoperative pyrexia , wound infection , chest infection , or hospital stay . This study failed to demonstrate any clinical ly useful difference between high negative pressure , low negative pressure , and static drainage system were compared : a simple tube drain , a low negative used , suction is not necessary and a simple tube drain ( greater than 6 mm internal diameter ) is the most effective form of drainage",
"200 patients undergoing elective cholecystectomy were studied in a prospect i ve r and omized manner . This study suggests that the nasogastric tube and postoperative iv-infusions are unnecessary . We continue to use a subhepatic drain . Exception : the senior surgeon in a straightforward case",
"A prospect i ve controlled trial of drainage after cholecystectomy has been carried out . In a consecutive series of 143 patients undergoing cholecystectomy , 50 patients were r and omly allocated to a drainage group and a further 50 patients to a non‐drainage group . The remaining 43 patients were drained electively because the common bile duct was explored or because of infection or incomplete haemostasis ",
"Following cholecystectomy , 50 patients were r and omly allocated for suction drainage by small ( 2.5 mm ) Redivac or large calibre ( 6 mm ) Redivac drains . There were 25 patients in each group . Subhepatic collection was detected by ultrasonic examination in 5 patients on the seventh postoperative day . The smaller drain was used in all of these patients . Of these 5 patients , one developed pulmonary infection , a second had internal bleeding requiring laparotomy , while the remaining 3 were asymptomatic . Subhepatic fluid was not detected in any patient who had the larger drain",
"383 patients undergoing cholecystectomy for non-acute gallbladder pathology were r and omized with regard to the use of an intraperitoneal drain . 187 patients were drained , 196 patients were not drained . The postoperative course of temperature and liver laboratory tests , the duration of hospital stay and the postoperative morbidity were studied . There were no obviously significant differences between drained and undrained patients . Thus drainage of the subhepatic space after cholecystectomy as performed in this study , could not be associated with any disadvantages for the patient . The advantage of the intraperitoneal drain , could , because of a failing r and omization in 13 % of the patients not be completely evaluated . The preventive effect of the drain with regard to the incidence of postoperative complications however appeared to be very limited . The use of a prophylactic intraperitoneal drain after cholecystectomy could therefore safely be limited to appropriate patients as judged by the operating surgeon",
"A r and omized , prospect i ve study of 300 cholecystectomies was undertaken to evaluate the merits of drainage through a st and ard Penrose or Chaffin-Pratt sump tube matched against no drainage at all . There was no difference in mortality or length of hospital stay . There was , however , a significantly higher incidence of postoperative pyrexia due to atelectasis and wound infection in the drainage groups . Neither drain fulfilled its objective of providing outflow for a subhepatic collection , thus avoiding bile peritonitis . This study suggests that surgical drainage after every uncomplicated cholecystectomy is unnecessary and unwise",
"One hundred twenty-three patients undergoing elective cholecystectomy at USAF Medical Center Keesler were studied in a prospect i ve r and omized manner to determine the differences in morbidity and mortality following drained and undrained cholecystectomies . The groups were compared for differences in mortality , wound infection , postoperative fever , and length of hospitalization . One death occurred due to an unrelated cause in an undrained patient . Three per cent of the undrained group developed wound infections as compared to five per cent in the drained group . This was not statistically significant . A significant difference occurred in postoperative fever between the drained ( 58 % ) and undrained ( 30 % ) groups . Postoperative hospitalization was also significantly shorter in the undrained group . This study suggests that drainage following elective cholecystectomy is not only unnecessary , but may add to postoperative morbidity and length of hospitalization",
"This prospect i ve clinical study was done to assess the efficacy of postcholecystectomy drainage . A total of 173 cholecystectomized patients were r and omized into two groups ; group A ( 86 patients ) without drainage and group B ( 87 patients ) with drainage . Group B included two types of patients ; B1 ( 52 patients ) with suction drain and B2 ( 35 patients ) with gravity drain . Evidence of wound infection , chest complications , and duration of hospital stay were recorded in every case . Ninety five patients were assessed for chest complications and subhepatic collection by chest x-ray and abdominal ultrasonography . In group B patients the total amount of fluid drained was measured . The results were analysed by appropriate statistical methods . There was no significant difference in the rate of wound infection or atelectasis in either group , although there was apparent increase of lung complications and subhepatic collection s in Group B1 . The average postoperative hospital stay was significantly increased in group B patients . Considering all the parameters of this study , it was found that drainage with gravity was attended with the least morbidity",
"Abstract The effects of intraperitoneal drains and nasogastric tubes were studied in 100 consecutive patients undergoing elective cholecystectomy without exploration of the common duct . The study was performed as a r and omized trial . Concurrent assessment of the effect of both the drain and the gastric tube was achieved with a 2 by 2 design . A large number of serum tests were systematic ally checked postoperatively . There was one death in a patient treated without either a drain or gastric tube . Apart from that , there were few complications . In accordance with the results of an earlier r and omized trial , no difference in postoperative pyrexia and hospital stay was found between patients with and those without intraperitoneal drains . The concept of drainage fever is therefore refuted . An abnormal increase in the serum bilirubin level was found significantly more often after operations without an intraperitoneal drain . This transient rise is explained as being due to resorption of bile that would otherwise have been discharged via the drain . An abnormal rise in the haptoglobin level also occurred significantly more often in patients in whom intraperitoneal drains were not used . The suggested explanation is that omission of the drain adds to the operation 's traumatic effect . Vomiting occurred significantly more often in patients without nasogastric tubes . The use of intraperitoneal drains and nasogastric tubes is recommended",
"A prospect i ve trial is described in which simple tube drainage was compared with suction drainage after cholecystectomy . Postoperative chest infection and infected or painful drain wounds were both significantly more common with simple tube drains . Postoperative discomfort was more frequent with tube drains in situ and wound infection more common in the suction group , but neither of these differences was statistically significant . The mean volume of fluid drained and duration of hospital stay did not differ between methods . It is concluded that both methods are satisfactory , but suction drainage is recommended",
"One hundred and fifty patients were prospect ively r and omised into 3 groups ( 50 in each group ) ; to receive a passive drain , closed suction drain or no drain after elective cholecystectomy . The drain was removed within 24 hours in 84 % of patients and was continued longer only if the amount of drainage was excessive or bilious . On the 3rd post-operative day , an ultrasound examination was performed in all patients for detection of subhepatic/subphrenic collection . Collection s were more frequently encountered in the patients without any drain ( 42 % ) followed by passive drain ( 26 % ) and suction drain group ( 20 % ) . Chest complications were frequently noted ( passive drain ; 6 % suction drain , 12 % , and no drain , 8 % ) , however , occurrence of this complication in various groups was similar ( p > 0.1 ) . Two patients ( 4 % ) without drain required ultrasound guided aspiration of subhepatic collection . Mean post-operative hospital stay was nearly equal for all the groups ( passive drain : 4.22 + /- 1 days , suction drain : 4.26 + /- 1.4 days and no drain : 4.62 + /- 2.3 days ) . Drainage reduced the incidence of post-cholecystectomy collection s and need for invasive intervention for collection related complications . However , the type of drainage ( active or passive ) did not influence the incidence of collection , frequency of complications and duration of post-operative hospital stay"
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OBJECTIVE the positive effect of physical training in healthy elderly people is well documented . The aim of this systematic review was to describe the effect of physical training on physical performance in institutionalised elderly patients with multiple diagnoses . DESIGN systematic literature review of r and omised controlled trials regarding effects of physical training of elderly ( 70 + ) subjects . METHODS the r and omised controlled trials were evaluated using a modified version of an evaluation form originally developed by the Cochrane Collaboration . It is based on a weighted scale of 0 - 100 points , and ranks the studies as high , moderate or low method ological quality . A total of 16 r and omised controlled trials were included in the review . RESULTS six studies scored as high quality , eight as moderate and two as low . There was a large heterogeneity in the studies concerning sample size , types of interventions and types of assessment s. There is strong evidence for a positive effect of physical training on muscle strength and mobility ; moderate evidence for an effect on range of motion ; and contradictory evidence regarding gait , activities of daily living , balance and endurance . CONCLUSION more studies are required , with larger sample sizes , higher specificity as to the types of interventions and assessment s , greater focus on clinical ly relevant outcomes such as endurance and activities of daily living , and also , for example , quality of life and mortality
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"BACKGROUND The purpose of this study was to evaluate how weight training or nursing-based rehabilitative care programs in nursing homes impact on resident performance of Activities of Daily Living ( ADL ) and objectives tests of physical performance . METHODS This study involved a quasi-experimental control , longitudinal comparison of functional status over a 10-month period , where baseline status was adjusted through a weighting procedure based on functional status , cognitive status , and age . All residents from six residential care nursing home facilities were eligible except those with a terminal prognosis , a projected stay of less than 90 days , or with health complications that prohibited contact . Homes were placed into matched triplets based on patient characteristics : two members of each triplet were r and omly design ated to be experimental sites , the third became the control site . Baseline data were available for 468 subjects , follow-up for 392 . ADL self-performance measures derived from the Minimum Data Set , including indicators of early loss ADL , locomotion , and late loss ADL ; a number of objective functional tests ( including measures of balance , power , and endurance ) ; and mood state as measured by the Geriatric Depression Scale . RESULTS Mean ADL values in the two experimental groups declined at a significantly lower rate than did rates for the controls . Functional decline was also lower in more specific measures : locomotion , early loss ADL , and late loss ADL . CONCLUSIONS With both interventions , facilities were able to implement a broad-based intervention that result ed in a significant reduction in ADL decline rates . A facility-wide nursing rehabilitation program can play a useful role in reversing functional decline , helping residents to maintain their involvement in a broad spectrum of ADL activities",
"BACKGROUND Physical activity programs in nursing homes typically consist of seated , range of motion ( ROM ) exercises , regardless of resident abilities . The Functional Fitness for Long-Term Care ( FFLTC ) Program was design ed not only to maintain ROM , but also to improve strength , balance , flexibility , mobility , and function . In addition , it was tailored to meet the needs of both high and low mobility residents . METHODS The feasibility and efficacy of the FFLTC Program were evaluated with 68 residents ( mean age 80 ) from five institutions . Persons were classified as low or high mobility and r and omized into either the FFLTC program or a seated ROM program . Classes were conducted in groups of 4 to 10 residents by trained facility staff for 45 minutes , three times per week . Assessment s at baseline and 4 months consisted of mobility , balance , gait , flexibility , functional capacity , and several upper and lower extremity strength measures . RESULTS Attendance averaged 86 % for the FFLTC and 79 % for the ROM classes . Four months of exercise led to significant improvements in mobility ( 16 % ) , balance ( 9 % ) , flexibility ( 36 % ) , knee ( 55 % ) , and hip ( 12 % ) strength for the FFLTC group . Shoulder strength was the only improvement found for the ROM group . The ROM group significantly deteriorated in some areas , particularly hip strength , mobility , and functional ability . CONCLUSIONS Institutionalized seniors , even those who are physically frail , incontinent and /or have mild dementia , can respond positively to a challenging exercise program . The FFLTC program demonstrated clear benefits over typical , seated ROM exercises . Moreover , with minimal training , the program can be safely delivered at low cost by institutional staff and volunteers",
"OBJECTIVE The purpose of this study was to determine if 1.0 Full-time Equivalent ( FTE ) physical therapy ( PT ) and 1.0 FTE occupational therapy ( OT ) per 50 beds result ed in differences in functional status for nursing home residents when compared to 1.0 FTE PT and 1.0 FTE OT per 200 beds . DESIGN R and omized control program evaluation , cost analysis . SETTING Nursing home in the province of Alberta , Canada . PATIENTS 115 residents assigned to 1 PT and 1 OT per 50 beds ( enhanced group ) versus 1 PT and 1 OT per 200 beds ( control group ) using stratified r and om allocation by severity of condition . INTERVENTIONS Both groups received ongoing treatment , follow-up , and restorative interventions , but enhanced group received more hours of service . OUTCOME MEASURES Functional Independence Measure ( FIM ) , Functional Assessment Measures ( FAM ) , and Clinical Outcome Variables Scale ( COVS ) recorded at 6-month intervals over a 2-year period . RESULTS Mean score differences favored the enhanced group for the tests over the 2 years . Significance was observed on FIM Total at 6 and 12 months , FIM Self Care at 6 months , FIM Communication at 24 months , and FIM Psychosocial at 6 , 12 , 18 , and 24 months ; FAM Total at 6 , 12 , 18 , and 24 months , FAM Self Care at 6 months , FAM Mobility at 12 months , FAM Communication at 6 and 24 months , FAM Psychosocial at 6 , 12 , 18 , and 24 months , and FAM Cognition at 6 and 12 months ; and COVS at 6 , 12 , 18 , and 24 months . A cost analysis demonstrated that PT/OT offered at the 1:50 ratio would result in a cost savings in terms of nursing staff dollars for 30 long-term-care beds of $ 16,973 over the 2 years of the study compared to the 1:200 ratio . This equates to an annual cost savings of $ 283 per bed . CONCLUSIONS Increasing the amount of PT/OT can have a positive effect on the functional status and cost of care of long-term care residents",
"All persons aged 70 through 75 years ( N = 457 ) in a Swedish community were invited to participate in a 9 week balance training study . Out of 55 interested subjects , 15 were chosen at r and om for a study group ; 15 matched controls were also selected . Before and after the investigation period the balance function was assessed by clinical balance tests and dynamic posturography . In the clinical balance tests , the training group significantly improved their balance st and ing on one leg with eyes closed as well as st and ing on one leg while shaking the head ; they also walked 15 m back and forth faster . In the dynamic posturography the training group significantly improved their equilibrium scores in the 3 most difficult test conditions . The results of the control group were unchanged except for one test condition in the dynamic posturography . The differences in one-leg st and ing with head shaking , walking 2 x 15 m , and the equilibrium score using sway-referenced platform in dynamic posturography were proved to be attributable to the training . The first investigation in all 29 subjects formed normative dynamic posturography data for the age group 70 through 75 years . The normative posturographic data of this age group differed from previously obtained data in the age groups 20 through 59 and 60 through 69 years . It is concluded that elderly may improve their balance by regular balance training exercises for as short a period as 9 weeks . This might prove to be of great value in improving balance and thereby preventing accidental falls and subsequent fractures in elderly",
"BACKGROUND Past studies suggest multidisciplinary interventions that include physical therapy ( PT ) can improve function of nursing home residents . This trial specifically evaluates effects of PT for frail long-stay nursing home residents . DESIGN R and omized , controlled trial . SETTING One academic nursing home and eight community nursing homes . PATIENTS A total of 194 elderly nursing home residents dependent in at least two activities of daily living residing in the nursing home for at least 3 months . INTERVENTIONS Patients were r and omized to individually tailored one-on-one PT sessions or friendly visits ( FVs ) three times a week for 4 months . Physical therapy included range-of-motion , strength , balance , transfer , and mobility exercises . MAIN OUTCOME MEASURES Performance-based physical function assessed by the Physical Disability Index ; self-perceived health status assessed with the Sickness Impact Profile ; observer-reported activities of daily living ; and falls . RESULTS Eighty-nine percent and 92 % of PT and FV sessions , respectively , were attended ; 5 % and 9 % of subjects dropped out in the PT group and FV group , respectively . Compared with the FV group , the PT group experienced no significant improvements in overall Physical Disability Index , Sickness Impact Profile , or activities of daily living scores . A 15.5 % improvement in the mobility subscale of the Physical Disability Index was seen ( 95 % confidence interval [ CI ] , 6.4 % to 24.7 % ) ; no benefits in range-of-motion , strength , or balance subscales were found . Compared with the FV group , the PT group used assistive devices for bed mobility tasks less often ( P = .06 ) and were less likely to use assistive devices and wheelchairs for locomotion ( P group vs 60 falls in the FV group ( P = .11 ) . Charge for the 4-month PT program was $ 1220 per subject ( 95 % CI , $ 412 to $ 1832 ) . CONCLUSION This st and ardized physical therapy program provided modest mobility benefits for very frail long-stay nursing home residents with physical disability due to multiple comorbid conditions",
"BACKGROUND Identification of the physiologic factors most relevant to functional independence in the elderly population is critical for the design of effective interventions . It has been suggested that muscle power may be more directly related to impaired physical performance than muscle strength in elderly persons . We tested the hypothesis that peak muscle power is closely associated with self-reported functional status in sedentary elderly community-dwelling women . METHODS We used baseline data that were collected as part of a 1-year r and omized controlled clinical trial of a combined program of strength , power , and endurance training in 80 elderly women ( mean age 74.8 + /- 5.0 years ) with 3.2 + /- 1.9 chronic diseases , selected for baseline functional impairment and /or falls . RESULTS Functional status at baseline was related in univariate analyses to physiologic capacity , habitual physical activity level , neuropsychological status , and medical diagnoses . Leg power had the strongest univariate correlation to self-reported functional status ( r = -.47 , p leg press power and habitual physical activity level were the only two factors that contributed independently to functional status ( r = .64 , p Leg power is a strong predictor of self-reported functional status in elderly women",
"Regular exercise is widely advocated for the young and middle-aged , but less is heard about its relevance to elderly people . This study reports the findings of a controlled trial of seated exercise in residents of local authority homes for the elderly . Forty-nine residents aged 64 - 91 years volunteered for the 7-month project , and participated in either twice-weekly exercise or reminiscence sessions . Primary outcome measures were postural sway , flexibility of the spine and knees , h and -grip strength and functional capacity . The average ( range of ) attendance at the exercise sessions was 91 % ( 64 - 100 % ) , and at the reminiscence sessions was 86 % ( 46 - 100 % ) . By the end of the project , the change observed in the exercise group was significantly different from that of the reminiscence group in terms of grip strength ( p spinal flexion ( p chair-to-st and time ( p activities of daily living ( p self-rating of depression ( p very elderly residents of old peoples homes can benefit from participation in regular seated exercise and improve their functional capacity",
"The purpose of this study was to determine whether a moderate to high intensity strengthening and aerobic exercise program can improve the strength , exercise capacity , gait and balance of deconditioned male nursing home residents . Ambulatory subjects who scored 30 or less on the modified Tinetti gait and balance assessment scale , who demonstrated less than 80 % of age-matched lower extremity strength on isokinetic muscle testing and who gave informed consent were enrolled . Subjects were r and omized to either an exercise ( n = 8) or a control ( n = 6 ) group . All participants underwent an exercise test to determine maximal oxygen uptake ( Vo2max ) and received quantitative gait and balance measurements . The subjects assigned to the exercise group then completed a 12-wk program of weight training for the lower extremities and stationary cycling . Both the exercise and control groups were then retested . Ten outcome variables were assessed : Tinetti mobility scores , Vo2max , isokinetic-tested lower extremity strength and endurance , stride length , gait velocity , stance time , gait duration , cadence and balance . The exercise group , after completion of the program , demonstrated significant improvements in Tinetti mobility scores ( P combined right and left quadricep muscle strength ( P right and left lower extremity muscular endurance ( P left stride length and gait velocity ( P control group revealed no changes of significance with the exception of improvement of the combined right and left hamstring muscle strength ( P < 0.05 ) . Nevertheless , for those outcome variables that had improved significantly in the exercise group , the changes amounted to only a 5 to 10 % increase over the baseline measurements . These findings showed that an appropriately design ed high intensity exercise program can result in significant although limited improvements for clinical mobility scores , strength , muscular endurance and certain gait parameters",
"The quadriceps strength of a group of residents homes for the elderly ( mean age 83 years ) was assessed in a r and omized controlled trial of seated group exercise versus group reminiscence therapy . Fifty-five of 65 volunteers completed the 6-month study , with 4 dropouts from the exercise group , and 6 dropouts from the reminiscence group . There were no adverse effects . Average of attendance at the exercise sessions was 72 % ( range , 18 % to 98 % ) and 62 % ( range , 29 % to 100 % ) at the reminiscence sessions . The reminiscence sessions comprised group interaction and discussion prompted by the use of reminiscence aids . By the end of the study , the change observed in the exercise group was significantly different from the reminiscence group in terms of quadriceps strength ( p ability to climb up steps , but neither cognitive function ( Mini-Mental State Examination ) nor reaction time altered significantly ",
"The purpose of this research was to explore the role of exercise in preventing falls , specifically assessing the effectiveness of an ankle strengthening and walking program to improve balance , ankle strength , walking speed , and falls efficacy and to decrease falls and subjects ' fear of falling . Sixteen individuals participated in the study which was conducted at two nursing homes . Subjects were assigned r and omly to an intervention or control group . The participants in the intervention group completed a 3-month supervised program of ankle strengthening exercises and walking . Descriptive statistics were used to characterize the sample , and differences in the least square means were used to assess the outcome variables ( i.e. , balance , ankle strength , walking speed , falls , fear of falling , falls efficacy ) before the exercise program , and again at 3 months and 6 months after the program for the intervention and control subjects . Findings for the intervention group from pretest to 3-month posttest were , for the most part , maintained or in the predicted direction , suggesting that regular exercise shows promise for preventing deterioration and improving fall-related outcomes for elderly nursing home residents",
"OBJECTIVE Resistance and endurance training result in gains in fitness in the aged . It is unclear whether the debilitated elderly can perform moderate-intensity training and whether such training results in short-term improvements in strength , endurance , and function in this population . DESIGN R and omized , controlled trial . SETTING S AND PATIENTS Subjects were from a Veterans Affairs nursing home and rehabilitation unit and a community nursing home . They were older than 60 yrs with impairment in at least one physical activity of daily living . Seventy-eight subjects volunteered and 58 ( mean age , 75 yrs ; 9 women , 49 men ) completed the intervention and initial posttest . Only one subject withdrew because of injury or disinterest . INTERVENTION Thrice-weekly resistance training ( using an isokinetic dynamometer ) and twice-weekly endurance training for 4 to 8 weeks . MAIN OUTCOMES Isometric strength in dominant arm and leg , heart rate response to timed endurance test , and activities of daily living score . RESULTS The mean change in isometric strength across the muscle movements tested was 32.8 % in the training group and 10.2 % in the control group ( difference , 22.6 % ; 95 % confidence interval , 6.2 % to 39.0 % ) . No change in heart rate during exercise was seen in the training group . Trained subjects tended to have a greater improvement in functional activity than control subjects , which was statistically significant ( p = .04 ) for those subjects who at enrollment were most dysfunctional ( i.e. , activities of daily living score less than 13 [ maximum score 26 ] ) . CONCLUSION This group of debilitated elderly patients effectively performed resistance training and increased their strength , with the most impaired gaining the most function . Few in the group could effectively perform endurance training",
"Endurance training in nursing home patients was evaluated by selecting 15 of 150 patients for a conditioning program eliminating those patients with dementia and /or significant cardiac disease . After a medical and laboratory screen , all had a symptom-limited exercise test ( SLXT ) using arm and leg ergometry . Only two patients were able to use the treadmill and many had difficulty with leg cycling . Exercise capacities averaged 2 - 3METs in most patients . The exercise ( E ) group included eight r and omly selected subjects who participated in a three times weekly upper and lower conditioning program using target heart rates based on the SLXT . The control ( C ) group continued in the daily nursing home routine . The SLXT was repeated at the end of one year . Two patients in each group expired from unassociated medical problems . Three patients in group E were hospitalized for brief periods . In group E there was a small but significant training effect in the arms ( p = 0.05 ) but not in the legs . It would appear that a small training effect can occur in elderly nursing home patients with a conditioning program . The magnitude is limited by the low intensity of the program as well as the detraining effect of intercurrent illness . Functional limitations of the legs may be responsible for the lack of a training effect in these muscle groups",
"OBJECTIVE To evaluate an exercise protocol design ed to improve strength and mobility , and to decrease injury risk factors in physically restrained nursing home residents . DESIGN A r and omized controlled trial . PARTICIPANTS Ninety-seven residents were r and omized into either exercise or control groups . Thirty-five exercise and 37 control group residents completed all post- assessment s after a 9-week trial . INTERVENTION Walking or wheelchair movement training was supplemented by rowing exercise three times per week . Practice in behaviors related to safe movement was provided incidental to the exercise . MEASUREMENT Endurance , speed , and injury risk measures relevant to walking , wheelchair propulsion , and st and ing were assessed by st and ardized protocol s. Rowing endurance , rowing range of motion , and h and grip strength measures were collected to assess the effect of the rowing component of the exercise protocol . RESULTS Fifty-four percent of the subjects who provided consent did not complete the protocol because of health status changes , lack of cooperation , or physical limitations that precluded exercise . The subjects who completed the exercise program showed significant improvement on injury risk and measures related to upper body strength ( h and grip strength , rowing endurance , wheelchair endurance , and speed ) . Measures related to lower body strength did not significantly improve . CONCLUSION Physically restrained residents are very frail , and it is difficult to implement a long-term exercise program with many residents because of the frailty . However , a substantial proportion of residents did cooperate well with the exercise program and showed improvement on measures correlated with decreased injury risk . The exercise program could be easily modified to include more lower body exercise , and the result ant protocol would be an important adjunct to restraint reduction programs",
"OBJECTIVE To determine if an exercise intervention , Functional Incidental Training ( FIT ) , results in improvements in mobility endurance and physical activity when compared with prompted voiding ( PV ) among cognitively and mobility impaired nursing home residents . DESIGN Residents from four nursing homes were r and omized into either a PV only ( PV ) or a PV plus FIT ( FIT ) intervention group for 8 weeks . Research staff implemented all intervention and measurement protocol s. PARTICIPANTS Seventy-six incontinent nursing home residents completed all phases of the trial . MEASURES The st and ing , walking , and wheelchair endurance , physical activity , and frequency of agitation of all residents were assessed before , during , and after the 8-week intervention . RESULTS The average length of time that subjects could walk or wheel was 2.6 and 4.6 minutes , respectively , at baseline . There was a significant group x time interaction after intervention , with only the FIT group showing improvements in walking , wheelchair , and st and ing endurance ( Manova F = 4.56 , 2.62 , and 5.98 , respectively ; P frequency with which agitation was observed showed a significant drop over time in both groups ( F = 14.3 , P The FIT intervention , which requires 6 minutes more nurses ' aide time than does PV , increases both physical activity and mobility endurance in extremely frail and deconditioned nursing home residents . The increased cost of this intervention must be evaluated both in terms of clinical outcomes and by the reality that the target group for this intervention is very frail and will continue to require nursing home care , even assuming an excellent response to the intervention",
"BACKGROUND Although disuse of skeletal muscle and undernutrition are often cited as potentially reversible causes of frailty in elderly people , the efficacy of interventions targeted specifically at these deficits has not been carefully studied . METHODS We conducted a r and omized , placebo-controlled trial comparing progressive resistance exercise training , multinutrient supplementation , both interventions , and neither in 100 frail nursing home residents over a 10-week period . RESULTS The mean ( + /- SE ) age of the 63 women and 37 men enrolled in the study was 87.1 + /- 0.6 years ( range , 72 to 98 ) ; 94 percent of the subjects completed the study . Muscle strength increased by 113 + /- 8 percent in the subjects who underwent exercise training , as compared with 3 + /- 9 percent in the nonexercising subjects ( P Gait velocity increased by 11.8 + /- 3.8 percent in the exercisers but declined by 1.0 + /- 3.8 percent in the nonexercisers ( P = 0.02 ) . Stair-climbing power also improved in the exercisers as compared with the nonexercisers ( by 28.4 + /- 6.6 percent vs. 3.6 + /- 6.7 percent , P = 0.01 ) , as did the level of spontaneous physical activity . Cross-sectional thigh-muscle area increased by 2.7 + /- 1.8 percent in the exercisers but declined by 1.8 + /- 2.0 percent in the nonexercisers ( P = 0.11 ) . The nutritional supplement had no effect on any primary outcome measure . Total energy intake was significantly increased only in the exercising subjects who also received nutritional supplementation . CONCLUSIONS High-intensity resistance exercise training is a feasible and effective means of counteracting muscle weakness and physical frailty in very elderly people . In contrast , multi-nutrient supplementation without concomitant exercise does not reduce muscle weakness or physical frailty",
"Fifty female subjects , aged 72 - 92 ( mean 82 ) years , were enrolled in a 12-week ( 36 classes ) exercise program aim ed at increasing postural stability . Subjects were residents of sheltered apartments , rest homes or nursing homes , well enough and mobile enough to participate in the classes . The subjects were r and omized into an exercise or a control group . Their postural sway , st and ing at rest on a force platform , was measured with eyes open and eyes closed . The groups were well matched in all respects . The results showed no improvement in the postural sway as a result of the exercise program . We hypothesize that increasing postural sway in the elderly represents a deterioration in , for the most part , the nervous system and may at this extreme of life indicate an irreversible loss of function . For this reason no improvement in postural sway may be possible"
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4116fe52-06ff-11f0-808a-c43d1ab1c353
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Amphetamine-type substances are frequently detected among drivers injured or killed due to road-trauma . However , the role of this substance in crash causation remains equivocal . We performed a systematic review to evaluate existing evidence regarding the association between amphetamine use and the risk of injury or death due to road traffic accidents . A bibliographical search of PubMed , SafetyLit , Scopus , and Science Direct literature data bases from 01 January 1980 until May 2015 was performed . The quality of included studies was assessed using the Newcastle-Ottowa Scale ( NOS ) ( cut-off of ≥7 indicated high quality ) . Inter-rater reliability between three independent review ers for the NOS was calculated using Cohens kappa ( κ ) statistic , and best- evidence synthesis was performed . A total of 182 articles were found . Nine studies met eligibility criteria for inclusion for review , and seven studies were included for best- evidence synthesis . Best- evidence synthesis demonstrated a conflicting level of evidence for associations between the use of-amphetamine-type substances and the risk of sustaining an injury , and a moderate level of evidence between amphetamine use and the risk of death due to road trauma . This is the first review to synthesis e evidence regarding the association between amphetamine-type substance use and the risk of injury or death due to a road traffic accident . More conclusive evidence of death due to road trauma among amphetamine users may reflect significant and global deficits in functioning associated with effective vehicular control under the influence of this substance . Additional high quality , sufficiently powered studies are required to eluci date the magnitude of these associations
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"The driving performance is easily impaired as a consequence of the use of alcohol and /or licit and illicit drugs . However , the role of drugs other than alcohol in motor vehicle accidents has not been well established . The objective of this study was to estimate the association between psychoactive drug use and motor vehicle accidents requiring hospitalisation . A prospect i ve observational case-control study was conducted in the Tilburg region of The Netherl and s from May 2000 to August 2001 . Cases were car or van drivers involved in road crashes needing hospitalisation . Demographic and trauma related data was collected from hospital and ambulance records . Urine and /or blood sample s were collected on admission . Controls were drivers recruited at r and om while driving on public roads . Sampling was conducted by research ers , in close collaboration with the Tilburg police , covering different days of the week and times of the day . Respondents were interviewed and asked for a urine sample . If no urine sample could be collected , a blood sample was requested . All blood and urine sample s were tested for alcohol and a number of licit and illicit drugs . The main outcome measures were odds ratios ( OR ) for injury crash associated with single or multiple use of several drugs by drivers . The risk for road trauma was increased for single use of benzodiazepines ( adjusted OR 5.1 ( 95 % Cl : 1.8 - 14.0 ) ) and alcohol ( blood alcohol concentrations of 0.50 - 0.79 g/l , adjusted OR 5.5 ( 95 % Cl : 1.3 - 23.2 ) and > or=0.8 g/l , adjusted OR 15.5 ( 95 % Cl : 7.1 - 33.9 ) ) . High relative risks were estimated for drivers using combinations of drugs ( adjusted OR 6.1 ( 95 % Cl : 2.6 - 14.1 ) ) and those using a combination of drugs and alcohol ( OR 112.2 ( 95 % Cl : 14.1 - 892 ) ) . Increased risks , although not statistically significantly , were assessed for drivers using amphetamines , cocaine , or opiates . No increased risk for road trauma was found for drivers exposed to cannabis . The study concludes that drug use , especially alcohol , benzodiazepines and multiple drug use and drug-alcohol combinations , among vehicle drivers increases the risk for a road trauma accident requiring hospitalisation ",
"Rationale The number of road fatalities related to the presence of amphetamines in drivers has been relatively constant over the past 10 years . However , there remains uncertainty as to the extent that these drugs induce driving impairment , and whether any such impairments translate to an increase in road fatalities . Objectives To examine the acute effects of 0.42 mg/kg dexamphetamine on simulated driving performance , and to establish which , if any , simulated driving abilities become impaired following dexamphetamine administration . Methods A repeated- measures , counter-balanced , double-blind , placebo-controlled design was employed . Twenty healthy volunteers completed two treatment conditions—0.42 mg/kg dexamphetamine and placebo . Performance was assessed using a driving simulator task . Blood and saliva sample s were obtained prior to the driving tasks and immediately after task completion ( 120 min and 170 min post-drug administration , respectively ) . Results Mean dexamphetamine blood concentrations were 83 ng/ml and 98 ng/ml at 120 min and 170 min , respectively . Results indicated a decrease in overall simulated driving ability following dexamphetamine administration during the day-time but not the night-time scenario tasks . Contributing to this performance reduction , “ incorrect signalling ” , “ failing to stop at a red traffic light ” and “ slow reaction times ” were the behaviours most strongly affected by dexamphetamine . Conclusions The decrease in simulated driving ability observed during the day-time driving tasks are consistent with the perceptual narrowing or tunnel vision that is associated with dexamphetamine consumption",
"dl-3,4-methylenedioxymethamphetamine ( MDMA ) and methamphetamine are commonly used illicit drugs that are thought to impair driving ability . The St and ardized Field Sobriety Tests ( SFSTs ) are utilized widely to detect impairment associated with drugs other than alcohol in drivers , although limited evidence concerning MDMA and methamphetamine consumption on SFST performance exists . The aim of this study was to evaluate whether the SFSTs were a sensitive measure for identifying the presence of the specific isomer d-methamphetamine and MDMA . In a double-blind , within-subject , counter-balanced and placebo-controlled study , 58 healthy and abstinent recreational drugs users were administered three treatments : 100 mg of MDMA , 0.42 mg/kg d-methamphetamine , and placebo . For each condition the SFSTs were administered at 4 and 25 h post treatment . d-methamphetamine was not found to significantly impair SFST performance unlike MDMA , which significantly impaired SFST performance in comparison to placebo with 22 % of the sample failing the test at the 4h testing time-point . No differences were observed at the 25 h testing time-point for any of the conditions . It was concluded that the SFSTs are not efficient in identifying the presence of low level d-methamphetamine , and are significantly better at detecting the presence of MDMA at the levels assessed",
"OBJECTIVES Methamphetamine is considered to be one of the most popularly abused drugs by drivers ; however , its exact effect on driving and driving behaviour has yet to be thoroughly investigated . This being despite methamphetamine 's increased prevalence in injured and deceased drivers . METHODS Twenty healthy recreational illicit stimulant users ( 10 male and 10 female ) , aged between 21 and 32 years ( mean = 25.4 years , SD = 3.3 years ) attended two testing sessions involving oral consumption of 0.42 mg/kg d-methamphetamine or a matching placebo . The drug administration was counter-balanced , double-blind , and medically supervised . At each session driving , performance was assessed 2.5 h post drug administration . RESULTS d-methamphetamine ( 0.42 mg/kg ) did not significantly impair overall simulated driving performance 2.5 h post drug administration . At the individual driving variable level , participants in the d-methamphetamine condition were observed to be driving slower when an emergency situation occurred ( T = 44 , p average speeds in excess of the speed limit ( 100 km/h ) when the emergency situations occurred . The d-methamphetamine condition did also produce four times more infringements where participants did not stop at red traffic light in comparison to the placebo , but this effect was only evident at a trend level ( T = 7 , p = 0.11 ) . CONCLUSIONS The findings presented herein suggest that d-methamphetamine administered at the levels supplied did not impair driving performance in a manner consistent with epidemiological evidence . Further research is certainly required to eluci date the effects of various doses of methamphetamine , alone and in combination with other legal and illicit substances"
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4116feb6-06ff-11f0-808a-c43d1ab1c353
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Background The use of financial incentives or pay-for-performance programs for health care providers has triggered emerging interest in the use of financial incentives for encouraging health behaviour change . Purpose This paper aims to identify key conditions under which the use of financial incentives for improvements in public health outcomes is most likely to be effective and appropriate . Methods We review recent systematic review s on their effectiveness in changing health behaviour and identify existing moral concerns concerning personal financial incentives . Results Current evidence indicates that incentives can be effective in driving health behaviour change under certain provisos , while a number of misgivings continue to be deliberated on . We outline a number of key principles for consideration in decisions about the potential use of incentives in leading to public health improvements . Conclusion These key principles can assist policy makers in making decisions on the use of financial incentives directed at achieving improvements in public health
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"Although treatment outcome in prize-based contingency management has been shown to depend on reinforcement schedule , the optimal schedule is still unknown . Therefore , we conducted a retrospective analysis of data from a r and omized clinical trial ( Ghitza et al. , 2007 ) to determine the effects of the probability of winning a prize ( low vs. high ) and the size of the prize won ( small , large , or jumbo ) on likelihood of abstinence until the next urine- collection day for heroin and cocaine users ( N=116 ) in methadone maintenance . Higher probability of winning , but not the size of individual prizes , was associated with a greater percentage of cocaine-negative , but not opiate-negative , urines",
"BACKGROUND Smoking is the leading preventable cause of premature death in the United States . Previous studies of financial incentives for smoking cessation in work setting s have not shown that such incentives have significant effects on cessation rates , but these studies have had limited power , and the incentives used may have been insufficient . METHODS We r and omly assigned 878 employees of a multinational company based in the United States to receive information about smoking-cessation programs ( 442 employees ) or to receive information about programs plus financial incentives ( 436 employees ) . The financial incentives were $ 100 for completion of a smoking-cessation program , $ 250 for cessation of smoking within 6 months after study enrollment , as confirmed by a biochemical test , and $ 400 for abstinence for an additional 6 months after the initial cessation , as confirmed by a biochemical test . Individual participants were stratified according to work site , heavy or nonheavy smoking , and income . The primary end point was smoking cessation 9 or 12 months after enrollment , depending on whether initial cessation was reported at 3 or 6 months . Secondary end points were smoking cessation within the first 6 months after enrollment and rates of participation in and completion of smoking-cessation programs . RESULTS The incentive group had significantly higher rates of smoking cessation than did the information-only group 9 or 12 months after enrollment ( 14.7 % vs. 5.0 % , P Incentive-group participants also had significantly higher rates of enrollment in a smoking-cessation program ( 15.4 % vs. 5.4 % , P completion of a smoking-cessation program ( 10.8 % vs. 2.5 % , P smoking cessation within the first 6 months after enrollment ( 20.9 % vs. 11.8 % , P financial incentives for smoking cessation significantly increased the rates of smoking cessation . ( Clinical Trials.gov number , NCT00128375 .",
"AIMS This study examined whether voucher-based reinforcement therapy ( VBRT ) contingent upon smoking abstinence during pregnancy is an effective method for decreasing maternal smoking during pregnancy and improving fetal growth . DESIGN , SETTING AND PARTICIPANTS A two-condition , parallel-groups , r and omized controlled trial was conducted in a university-based research clinic . A total of 82 smokers entering prenatal care participated in the trial . INTERVENTION Participants were assigned r and omly to either contingent or non-contingent voucher conditions . Vouchers exchangeable for retail items were available during pregnancy and for 12 weeks postpartum . In the contingent condition , vouchers were earned for biochemically verified smoking abstinence ; in the non-contingent condition , vouchers were earned independent of smoking status . MEASUREMENTS Smoking outcomes were evaluated using urine-toxicology testing and self-report . Fetal growth outcomes were evaluated using serial ultrasound examinations performed during the third trimester . FINDINGS Contingent vouchers significantly increased point-prevalence abstinence at the end-of-pregnancy ( 41 % versus 10 % ) and at the 12-week postpartum assessment ( 24 % versus 3 % ) . Serial ultrasound examinations indicated significantly greater growth in terms of estimated fetal weight , femur length and abdominal circumference in the contingent compared to the non-contingent conditions . CONCLUSIONS These results provide further evidence that VBRT has a substantive contribution to make to efforts to decrease maternal smoking during pregnancy and provide new evidence of positive effects on fetal health",
"BACKGROUND Many governments have implemented conditional cash transfer ( CCT ) programmes with the goal of improving options for poor families through interventions in health , nutrition , and education . Families enrolled in CCT programmes receive cash in exchange for complying with certain conditions : preventive health requirements and nutrition supplementation , education , and monitoring design ed to improve health outcomes and promote positive behaviour change . Our aim was to disaggregate the effects of cash transfer from those of other programme components . METHODS In an intervention that began in 1998 in Mexico , low-income communities ( n=506 ) were r and omly assigned to be enrolled in a CCT programme ( Oportunidades , formerly Progresa ) immediately or 18 months later . In 2003 , children ( n=2449 ) aged 24 - 68 months who had been enrolled in the programme their entire lives were assessed for a wide variety of outcomes . We used linear and logistic regression to determine the effect size for each outcome that is associated with a doubling of cash transfers while controlling for a wide range of covariates , including measures of household socioeconomic status . FINDINGS A doubling of cash transfers was associated with higher height-for-age Z score ( beta 0.20 , 95 % CI 0.09 - 0.30 ; p lower prevalence of stunting ( -0.10 , -0.16 to -0.05 ; p lower body-mass index for age percentile ( -2.85 , -5.54 to -0.15 ; p=0.04 ) , and lower prevalence of being overweight ( -0.08 , -0.13 to -0.03 ; p=0.001 ) . A doubling of cash transfers was also associated with children doing better on a scale of motor development , three scales of cognitive development , and with receptive language . INTERPRETATION Our results suggest that the cash transfer component of Oportunidades is associated with better outcomes in child health , growth , and development",
"BACKGROUND Relapse to drug use is often seen when contingencies design ed to reduce drug use are discontinued . This paper reports on a stepdown maintenance contingency and 1-year follow-up in 110 patients who were maintained on methadone ( 50 or 70 mg/day ) and who had completed a contingency management trial targeted to decreasing their opiate use . In the prior study ( induction phase , 8 weeks ) participants received vouchers for each opiate-negative urine screen or noncontingently . METHODS In this study ( maintenance phase , 12 weeks ) , participants were rer and omized to receive vouchers and take-home methadone doses contingent on providing opiate-negative urine specimens ( N=55 ) or noncontingently ( N=55 ) . Since participants had been rer and omized from induction-phase contingencies , most study data were analyzed as if from a 2 x 2 ( inductionxmaintenance ) design . Follow-up interviews were conducted at 3 , 6 , and 12 months after study participation . RESULTS Patients who received the maintenance contingency following an 8-week induction contingency had better outcomes than those who received noncontingent incentives in either the maintenance or induction phases of the trial . Good outcome at follow-up was predicted by enrollment in methadone maintenance after the study . Significantly more participants in the maintenance contingency group transferred directly to another methadone program . CONCLUSION These findings support the therapeutic value of extending the duration of contingency management and long-term methadone maintenance",
"This study 's goals were to characterize the relationship between early and longer term cocaine abstinence and assess whether increasing early abstinence increases longer term abstinence . Results from 190 cocaine-dependent out patients were analyzed . Participants were divided into 2 conditions : ( a ) those treated with community reinforcement approach ( CRA ) plus contingent vouchers ( n = 125 ) and ( b ) those treated with control treatments ( n = 65 ) . A period of sustained abstinence during treatment was associated with significantly greater odds of posttreatment abstinence , with no evidence of differences between the 2 treatment conditions in that regard . Treatment conditions differed in that CRA plus contingent vouchers increased the proportion of participants who sustained a period of during-treatment abstinence and increased abstinence during 6-month posttreatment follow-up . Devising interventions that increase the proportion of individuals who achieve an early period of sustained abstinence may be key to increasing longer term cocaine abstinence",
"We report results from a pilot study examining the use of vouchers redeemable for retail items as incentives for smoking cessation during pregnancy and postpartum . Of 100 study -eligible women who were still smoking upon entering prenatal care , 58 were recruited from university-based and community obstetric practice s to participate in a smoking cessation study . Participants were assigned to either contingent or noncontingent voucher conditions . Vouchers were available during pregnancy and for 12 weeks postpartum . In the contingent condition , vouchers were earned for biochemically verified smoking abstinence . In the noncontingent condition , vouchers were earned independent of smoking status . Abstinence monitoring and associated voucher delivery was conducted daily during the initial 5 days of the cessation effort , gradually decreased to every other week antepartum , increased to once weekly during the initial 4 weeks postpartum , and then decreased again to every other week for the remaining 8 weeks of the postpartum intervention period . Contingent vouchers increased 7-day point-prevalence abstinence at the end-of-pregnancy ( 37 % vs. 9 % ) and 12-week postpartum ( 33 % vs. 0 % ) assessment s. That effect was sustained through the 24-week postpartum assessment ( 27 % vs. 0 % ) , which was 12 weeks after discontinuation of the voucher program . Total mean voucher earnings across antepartum and postpartum were 397 US dollars ( SD=414 US dollars ) and 313 US dollars ( SD=142 dollars ) in the contingent and noncontingent conditions , respectively . The magnitude of these treatment effects exceed levels typically observed with pregnant and recently postpartum smokers , and the maintenance of effects through 24 weeks postpartum extends the duration beyond those reported previously",
"OBJECTIVES This study assessed the independent and combined effects of different levels of monetary incentives and a theory-based educational intervention on return for tuberculosis ( TB ) skin test reading in a sample of active injection drug and crack cocaine users . Prevalence of TB infection in this sample was also determined . METHODS Active or recent drug users ( n = 1004 ) , recruited via street outreach techniques , were skin tested for TB . They were r and omly assigned to 1 of 2 levels of monetary incentive ( $ 5 and $ 10 ) provided at return for skin test reading , alone or in combination with a brief motivational education session . RESULTS More than 90 % of those who received $ 10 returned for skin test reading , in comparison with 85 % of those who received $ 5 and 33 % of those who received no monetary incentive . The education session had no impact on return for skin test reading . The prevalence of a positive tuberculin test was 18.3 % . CONCLUSIONS Monetary incentives dramatically increase the return rate for TB skin test reading among drug users who are at high risk of TB infection ",
"CONTEXT Identifying effective obesity treatment is both a clinical challenge and a public health priority due to the health consequences of obesity . OBJECTIVE To determine whether common decision errors identified by behavioral economists such as prospect theory , loss aversion , and regret could be used to design an effective weight loss intervention . DESIGN , SETTING , AND PARTICIPANTS Fifty-seven healthy participants aged 30 - 70 years with a body mass index of 30 - 40 were r and omized to 3 weight loss plans : monthly weigh-ins , a lottery incentive program , or a deposit contract that allowed for participant matching , with a weight loss goal of 1 lb ( 0.45 kg ) a week for 16 weeks . Participants were recruited May-August 2007 at the Philadelphia VA Medical Center in Pennsylvania and were followed up through June 2008 . MAIN OUTCOME MEASURES Weight loss after 16 weeks . RESULTS The incentive groups lost significantly more weight than the control group ( mean , 3.9 lb ) . Compared with the control group , the lottery group lost a mean of 13.1 lb ( 95 % confidence interval [ CI ] of the difference in means , 1.95 - 16.40 ; P = .02 ) and the deposit contract group lost a mean of 14.0 lb ( 95 % CI of the difference in means , 3.69 - 16.43 ; P = .006 ) . About half of those in both incentive groups met the 16-lb target weight loss : 47.4 % ( 95 % CI , 24.5%-71.1 % ) in the deposit contract group and 52.6 % ( 95 % CI , 28.9%-75.6 % ) in the lottery group , whereas 10.5 % ( 95 % CI , 1.3%-33.1 % ; P = .01 ) in the control group met the 16-lb target . Although the net weight loss between enrollment in the study and at the end of 7 months was larger in the incentive groups ( 9.2 lb ; t = 1.21 ; 95 % CI , -3.20 to 12.66 ; P = .23 , in the lottery group and 6.2 lb ; t = 0.52 ; 95 % CI , -5.17 to 8.75 ; P = .61 in the deposit contract group ) than in the control group ( 4.4 lb ) , these differences were not statistically significant . However , incentive participants weighed significantly less at 7 months than at the study start ( P = .01 for the lottery group ; P = .03 for the deposit contract group ) whereas controls did not . CONCLUSIONS The use of economic incentives produced significant weight loss during the 16 weeks of intervention that was not fully sustained . The longer-term use of incentives should be evaluated . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00520611"
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Purpose The gut – liver interaction suggests that modification of gut bacterial flora using probiotics and synbiotics may improve liver function . This systematic review and meta- analysis aim ed to clarify the effect of probiotics and synbiotics consumption on the serum concentration of liver function enzymes . Methods PubMed ( MEDLINE ) , Cumulative Index to Nursing and Allied Health Literature , and Cochrane Library ( Central ) were search ed from 1980 to August 2017 for studies where adults consumed probiotics and /or synbiotics in controlled trials and changes in liver function enzymes were examined . Results A total of 17 studies ( 19 trials ) were included in the meta- analysis . R and om effects meta-analyses were applied . Probiotics and synbiotics significantly reduced serum alanine aminotransferase [ − 8.05 IU/L , 95 % confidence interval ( CI ) − 13.07 to − 3.04 ; p = 0.002 ] ; aspartate aminotransferase ( − 7.79 IU/L , 95 % CI : − 13.93 to − 1.65 ; p = 0.02 ) and gamma-glutamyl transpeptidase ( − 8.40 IU/L , 95 % CI − 12.61 to − 4.20 ; p 0.001 ) . Changes in the serum concentration of alkaline phosphatase and albumin did not reach a statistically significant level . Changes to bilirubin levels were in favour of the control group ( 0.95 μmol/L , 95 % CI 0.48–1.42 ; p liver disease at baseline , synbiotics supplementation and duration of supplementation ≥ 8 weeks result ed in more pronounced improvement in liver function enzymes than their counterparts . Conclusions Probiotics and synbiotics may be suggested as supplements to improve serum concentration of liver enzymes , especially when synbiotics administered for a period ≥ 8 weeks and in individuals with liver disease
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"Background Increased exposure to intestinal bacterial products may contribute to the pathogenesis of non alcoholic steatohepatitis ( NASH ) . Bifidobacteria are predominant bacterial species in the human gut microbiota and have been considered to exert a beneficial effect on human health by maintaining the equilibrium of the resident microbiota . Aims To evaluate the effects of Bifidobacterium longum with fructo-oligosaccharides ( Fos ) in the treatment of NASH . Methods A total of 66 patients were r and omly and equally divided into two groups receiving Bifidobacterium longum with Fos and lifestyle modification ( i.e. , diet and exercise ) versus lifestyle modification alone . The following variables were assessed at −4 ( beginning of the dietary lead-in period ) , 0 ( r and omization ) , 6 , 12 , 18 , and 24 weeks : aspartate transaminase ( AST ) , alanine transaminase ( ALT ) , bilirubin , albumin , total cholesterol , high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein ( LDL ) cholesterol , triglycerides , fasting plasma glucose , insulin , C-peptide , C-reactive protein ( CRP ) , tumor necrosis factor (TNF)-α , homeostasis model assessment of insulin resistance ( HOMA-IR ) , and serum endotoxins . Liver biopsies were performed at entry and repeated after 24 weeks of treatment . Results At the end of study period , we observed that the Bifidobacterium longum with Fos and lifestyle modification group versus the lifestyle modification alone group showed significant differences in the AST −69.6 versus −45.9 IU/mL ( P LDL cholesterol −0.84 versus −0.18 mmol/L ( P ) , HOMA-IR −1.1 versus −0.6 ( P serum endotoxin −45.2 versus −30.6 pg/mL ( P steatosis ( P , and the NASH activity index ( P 0.05 ) . Conclusions Bifidobacterium longum with Fos and lifestyle modification , when compared to lifestyle modification alone , significantly reduces TNF-α , CRP , serum AST levels , HOMA-IR , serum endotoxin , steatosis , and the NASH activity index ",
"Background The beneficial effect of probiotics on renal profile and liver function has been reported among patients with chronic kidney disease and fatty liver respectively . However , its effect on renal profile and liver function among type 2 diabetic individuals has not been fully understood . To investigate the effect of microbial cell preparation on renal profile and liver function tests among type 2 diabetic individuals . Methods A r and omized , double-blind , parallel-group , controlled clinical trial was conducted on a total of 136 type 2 diabetics age 30 - 70 years old in a teaching hospital in Kuala Lumpur , Malaysia . Subjects were r and omly assigned to receive microbial cell preparation ( N = 68 ) or a placebo ( N = 68 ) for 12 weeks . The outcomes measured at baseline , week 6 , and week 12 and included changes in renal profile ( Sodium , Potassium , Urea , Creatinine , Glomerular Filtration Rate ) , and liver function tests ( Albumin , Total Protein , Alkaline Phosphatase , Alanine Aminotransferase , Aspartate Aminotransferase ) . Intention to treat ( ITT ) analysis was performed on all the recruited subjects , while per protocol ( PP ) analysis was conducted on those who completed the trial with good compliance . Result The urea levels significantly declined in the probiotic group . Serum urea levels reduced from 4.26 mmol/L to 4.04 mmol/L in Probiotic Group while it increased in Placebo Group from 4.03 mmol/L to 4.24 mmol/L. These changes were significant between groups in ITT analysis ( p = 0.018 ) . Other parameters did not change significantly between groups . Conclusion 12 weeks supplementation with daily dosage of 6 × 1010 Colony Forming Units of multi-strain microbial cell preparation significantly improved urea levels . Trial registration ( Clinical trials : # NCT01752803",
"BACKGROUND Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in the world . Oral administration of synbiotic has been proposed as an effective treatment of NAFLD because of its modulating effect on the gut flora , which can influence the gut-liver axis . OBJECTIVE The objective was to evaluate the effects of supplementation with synbiotic on hepatic fibrosis , liver enzymes , and inflammatory markers in patients with NAFLD . DESIGN In a r and omized , double-blind , placebo-controlled clinical trial conducted as a pilot study , 52 patients with NAFLD were supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule . Both groups were advised to follow an energy-balanced diet and physical activity recommendations . RESULTS At the end of the study , the alanine aminotransferase ( ALT ) concentration decreased in both groups ; this reduction was significantly greater in the synbiotic group . At the end of the study , the following significant differences [ means ( 95 % CIs ) ] were seen between the synbiotic and placebo groups , respectively : ALT [ -25.1 ( -26.2 , -24 ) compared with -7.29 ( -9.5 , -5.1 ) IU/L ; P 0.001 ] , aspartate aminotransferase [ -31.33 ( -32.1 , -30.5 ) compared with -7.94 ( -11.1 , -4.8 ) IU/L ; P ] , γ-glutamyltransferase [ -15.08 ( -15.5 , -14.7 ) compared with -5.21 ( -6.6 , -3.9 ) IU/L ; P protein [ -2.3 ( -3 , -1.5 ) compared with -1.04 ( -1.5 , -0.6 ) mmol/L ; P 0.05 ] , tumor necrosis factor-α [ -1.4 ( -1.7 , -1.1 ) compared with -0.59 ( -0.8 , -0.3 ) mmol/L ; P p65 [ -0.016 ( -0.022 , -0.011 ) compared with 0.001 ( -0.004 , -0.007 ) mmol/L ; P score as determined by transient elastography [ - 2.98 ( -3.6 , -2.37 ) compared with -0.77 ( -1.32 , -0.22 ) kPa ; P CONCLUSIONS Synbiotic supplementation in addition to lifestyle modification is superior to lifestyle modification alone for the treatment of NAFLD , at least partially through attenuation of inflammatory markers in the body . Whether these effects will be sustained with longer treatment duration s remains to be determined",
"BACKGROUND Gut flora is related to the major complications of liver cirrhosis including hepatic encephalopathy , spontaneous bacterial peritonitis , and variceal bleeding . Prior studies have reported a beneficial effect of gut flora modification with probiotic bacteria in patients with minimal hepatic encephalopathy . We aim ed to study the effect of probiotics on clinical and laboratory parameters of patients with compensated cirrhosis . METHODS A double-blind placebo-controlled study that included patients with liver cirrhosis and at least one major complication of cirrhosis in the past , clinical evidence of portal hypertension , or decreased hepatic synthetic function . Participants were r and omly assigned to receive probiotic capsules containing Lactobacillus acidophilus , Lactobacillus bulgaricus , Bifidobacterium lactis , and Streptococcus thermophiles or placebo for a period of 6 mo . RESULTS A total of 36 patients were available for final analysis ( distributed equally between the probiotic and placebo groups ) . The administration of probiotics was not associated with significant differences in either clinical or laboratory parameters between the two groups . Because the lack of a beneficial effect may be related to the compensated liver disease of patients , we conducted a sub analysis of patients with baseline ammonia levels > 50 mmol/L. In this subgroup , the administration of probiotics appeared to significantly reduce the ammonia levels starting after 1 mo of treatment . However , this effect diminished and lost its significance following comparison to the placebo group . CONCLUSIONS Our study did not show a significant beneficial effect of probiotic supplementation in patients with compensated liver cirrhosis . Nevertheless , it points toward a possible positive effect of probiotics in patients with above normal baseline ammonia levels . This issue requires further investigation in larger cohorts",
"Abstract Bacillus subtilis CU1 is a recently described probiotic strain with beneficial effects on immune health in elderly subjects . The following work describes a series of studies supporting the safety of the strain for use as an ingredient in food and supplement preparations . Using a combination of 16S rDNA and gyrB nucleotide analyses , the species was identified as a member of the Bacillus subtilis complex ( B. subtilis subsp . spizizenii ) . Further characterization of the organism at the strain level was achieved using r and om amplified polymorphic DNA polymerase chain reaction ( RAPD PCR ) and pulsed field gel electrophoresis ( PFGE ) analyses . B. subtilis CU1 did not demonstrate antibiotic resistance greater than existing regulatory cutoffs against clinical ly important antibiotics , did not induce hemolysis or produce surfactant factors , and was absent of toxigenic activity in vitro . Use of B. subtilis CU1 as a probiotic has recently been evaluated in a 16‐week r and omized , double‐blind , placebo‐controlled , parallel‐arm study , in which 2 × 109 spores per day of B. subtilis CU1 were administered for a total 40 days to healthy elderly subjects ( 4 consumption periods of 10 days separated by 18‐day washouts ) . This work describes safety related endpoints not previously reported . B. subtilis CU1 was safe and well‐tolerated in the clinical subjects without undesirable physiological effects on markers of liver and kidney function , complete blood counts , hemodynamic parameters , and vital signs . HighlightsA safety assessment of the probiotic Bacillus subtilis CU1 was conducted . Genomic analyses identified the species as a member of the B. subtilis complex . Antibiotic resistance was not observed at levels exceeding regulatory cut‐offs . B. subtilis CU1 was absent of toxigenic activity in vitro . B. subtilis CU1 was safely consumed ( 2 × 109 spores/day ) by all clinical subjects",
"Probiotic supplementation may provide health benefits , especially for individuals with an underlying disease state that makes them more susceptible to infections . The purpose of this experiment was to evaluate the safety and tolerance of Lactobacillus reuteri ingestion by subjects infected with the human immunodeficiency virus ( HIV ) . Thirty-nine subjects consumed a freeze-dried preparation of L. reuteri or a placebo for 21 days in a double-masked , parallel design experiment . Serum chemistry , haematology , immune profile , urinalysis , physical examination , gastrointestinal tolerance and faecal microbiota data were collected . No clinical ly significant changes were noted in any of the safety parameters measured . Overall , tolerance was good in both groups . Consumption of L. reuteri tended to increase faecal levels of L. reuteri on days 7 , 14 and 21 of treatment feeding ( P faecal levels of L. reuteri and total Lactobacillus species were lower than levels previously observed in healthy male adults . Overall , this study documents that L. reuteri may be fed to HIV-positive individuals at 1 x 10(10 ) colony forming units/day without any clinical ly significant safety or tolerance problems",
"OBJECTIVE To evaluate the efficacy of low carbohydrate diet ( LCD ) as compared with low fat diet ( LFD ) to decrease aminotransferase levels in obese women with nonalcoholic fatty liver disease . MATERIAL AND METHODS A total of 59 women were r and omly enrolled in a non-controlled clinical intervention study to receive either LCD or LFD during six months . Apparently healthy non-pregnant obese women aged 20 to 65 years were eligible to participate . Previous diagnosis of hepatic disease , serum creatinine level ≥ 1.5 mg/dL , severe life-limiting medical illness , pregnancy , active participation in other dietary program , use of weight loss drugs , or alcohol consumption ≥ 30 g per day were exclusion criteria . RESULTS A total of 31 obese women who received LCD were compared with 28 women allocated in the LFD group . There were 3 ( LCD group ) and 2 ( LFD group ) women with lost of follow-up . No differences in the proportion of type 2 diabetes , hypertension and hyperlipidemia were noted between women in the LCD and LFD groups . At end of follow-up , there were not significant statistical differences in the anthropometric and biochemical characteristics between women in both groups . The weight loss was 5.7 and 5.5 % for women in the LCD LFD groups . Although the decrease of AST ( 31.7 and 22.4 % ) and ALT ( 41 and 33.3 % ) levels was more elevated in the women of LCD group , as compared with the LFD group , there were not significant statistical differences . CONCLUSIONS Our results show that weight loss , irrespective of the type of diet , reduces aminotransferase levels in obese women with NAFLD",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"BACKGROUND & AIMS To examine the effect of supplementation with probiotics on respiratory and gastrointestinal illness in healthy active men and women . METHODS A r and omised double-blind placebo-controlled trial was conducted . Four hundred and sixty five participants ( 241 males ; age 35 ± 12 y ( mean ± SD ) and 224 females ; age 36 ± 12 y ) were assigned to one of three groups : Group 1 - Bifidobacterium animalis subsp . lactis Bl-04 ( Bl-04 ) 2.0 × 10(9)colony forming units per day , CFU per day , Group 2 - Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp . lactis Bi-07 ( NCFM & Bi-07 ) 5 × 10(9 ) CFU each per day ) or Group 3 - placebo mixed in a drink . RESULTS The risk of an upper respiratory illness episode was significantly lower in the Bl-04 group ( hazard ratio 0.73 ; 95 % confidence interval 0.55 - 0.95 ; P = 0.022 ) compared to placebo . There was no significant difference in illness risk between the NCFM & Bi-07 group ( hazard ratio 0.81 ; 0.62 - 1.08 ; P = 0.15 ) and the placebo group . There was a 0.7 and 0.9 month delay in the median time to an illness episode in the Bl-04 and NCFM & Bi-07 groups respectively compared to placebo ( placebo 2.5 months ; Bl-04 3.2 months ; NCFM & Bi-07 3.4 months ) . There were insufficient GI illness episodes for analysis . The NCFM & Bi-07 group but not the Bl-04 group undertook significantly more physical activity ( 8.5 % ; 6.7%-10 % ; P healthy physically-active adults . TRIAL REGISTRATION Australia New Zeal and Clinical Trials Registry : Number ACTRN12611000130965",
"Background Probiotics might reduce gut-derived microbial lipopolysaccharide ( LPS ) by restoring bowel flora in patients with alcoholic hepatitis ( AH ) . We evaluated the therapeutic effects of probiotics in patients with AH . Patients and methods Between September 2010 and April 2012 , 117 patients ( probiotics 60 and placebo 57 ) were prospect ively r and omized to receive the 7 days of cultured Lactobacillus subtilis/Streptococcus faecium ( 1500 mg/day ) or placebo . All patients were hospitalized and were not permitted to consume alcohol for the 7 days of the study . Liver function test , proinflammatory cytokines , LPS , and colony-forming units by stool culture were examined and compared after therapy . Results In both groups , the mean levels of aspartate aminotransferase/alanine aminotransferase , alkaline phosphatase , & ggr;-glutamyl transpeptidase , bilirubin , and prothrombin time were significantly improved after 7 days of abstinence . In the probiotics group ( baseline and after ) , albumin ( 3.5±0.7 and 3.7±0.6 g/dl , P=0.038 ) and tumor necrosis factor-&agr ; ( 121±244 and 71±123 pg/ml , P=0.047 ) showed differences . In addition , the number of colony-forming units of Escherichia coli was significantly reduced ( 435±287 and 168±210 , P=0.002 ) . In the placebo group , the level of LPS ( 1.7±2.8 and 2.0±2.7 EU/ml ) was significantly increased . In the intergroup comparison , significant differences in the levels of tumor necrosis factor-&agr ; ( P=0.042 ) and LPS ( P=0.028 ) were observed between the groups . Conclusion Immediate abstinence is the most important treatment for patients with AH . In addition , 7 days of oral supplementation with cultured L. subtilis/S. faecium was associated with restoration of bowel flora and improvement of LPS in patients with AH",
"Background Bacillus probiotics health benefits have been until now quite poorly studied in the elderly population . This study aim ed to assess the effects of Bacillus subtilis CU1 consumption on immune stimulation and resistance to common infectious disease ( CID ) episodes in healthy free-living seniors . Results One hundred subjects aged 60–74 were included in this r and omized , double-blind , placebo-controlled , parallel-arms study . Subjects consumed either the placebo or the probiotic ( 2.109B . subtilis CU1 spores daily ) by short periodical courses of 10 days intermittently , alternating 18-day course of break . This scheme was repeated 4 times during the study . Symptoms of gastrointestinal and upper/lower respiratory tract infections were recorded daily by the subjects throughout the study ( 4 months ) . Blood , saliva and stool sample s were collected in a predefined subset of the first forty-four subjects enrolled in the study . B. subtilis CU1 supplementation did not statistically significantly decrease the mean number of days of reported CID symptoms over the 4-month of study ( probiotic group : 5.1 ( 7.0 ) d , placebo group : 6.6 ( 7.3 ) d , P = 0.2015 ) . However , in the subset of forty-four r and omized subjects providing biological sample s , we showed that consumption of B. subtilis CU1 significantly increased fecal and salivary secretory IgA concentrations compared to the placebo . A post-hoc analysis on this subset showed a decreased frequency of respiratory infections in the probiotc group compared to the placebo group . Conclusion Taken together , our study provides evidence that B. subtilis CU1 supplementation during the winter period may be a safe effective way to stimulate immune responses in elderly subjects",
"BACKGROUND Probiotics have profound effect on nonalcoholic steatohepatitis ( NASH ) in animal models . We aim ed to test the hypothesis that probiotics treatment was superior to usual care in reducing liver fat in NASH patients . MATERIAL AND METHODS Patients with histology-proven NASH were r and omized to receive probiotics ( n = 10 ) or usual care ( n = 10 ) for 6 months . The Lepicol probiotic formula contained Lactobacillus plantarum , Lactobacillus deslbrueckii , Lactobacillus acidophilus , Lactobacillus rhamnosus and Bifidobacterium bifidum . The primary endpoint was change in intrahepatic triglyceride content ( IHTG ) , as measured by proton-magnetic resonance spectroscopy , from baseline to month 6 . Secondary endpoints included changes in liver biochemistry and metabolic profile . RESULTS IHTG decreased from 22.6 ± 8.2 % to 14.9 ± 7.0 % in the probiotic group ( P = 0.034 ) but remained static in the usual care group ( 16.9 ± 6.1 % to 16.0 ± 6.6 % ; P = 0.55 ) . Six subjects in the probiotic group had IHTG reduced by more than 30 % from baseline , compared to 2 subjects in the usual care group ( P = 0.17 ) . The probiotic group also had greater reduction in serum aspartate aminotransferase level ( P = 0.008 ) . On the other h and , the use of probiotics was not associated with changes in body mass index , waist circumference , glucose and lipid levels . CONCLUSIONS Probiotics treatment may reduce liver fat and AST level in NASH patients . The therapeutic potential of probiotics in NASH should be tested in larger studies",
"Minimal hepatic encephalopathy ( MHE ) is an important disorder that may seriously impair daily functioning and quality of life in patients with cirrhosis . Treatment with lactulose is of benefit . The possible role of synbiotics ( probiotics and fermentable fiber ) has not been assessed . We screened 97 consecutive cirrhotic patients without overt hepatic encephalopathy for MHE using the number connection test and measurement of brainstem auditory evoked potentials . MHE , defined by abnormality on at least one test modality , was present in 58 ( 60 % ) patients . Fifty-five of these patients with MHE were r and omized to receive a synbiotic preparation ( n = 20 ) , fermentable fiber alone ( n = 20 ) , or placebo ( n = 15 ) for 30 days . Cirrhotic patients with MHE were found to have substantial derangements in the gut microecology , with significant fecal overgrowth of potentially pathogenic Escherichia coli and Staphylococcal species . Synbiotic treatment significantly increased the fecal content of non-urease-producing Lactobacillus species at the expense of these other bacterial species . Such modulation of the gut flora was associated with a significant reduction in blood ammonia levels and reversal of MHE in 50 % of patients . Synbiotic treatment was also associated with a significant reduction in endotoxemia . The Child-Turcotte-Pugh functional class improved in nearly 50 % of cases . Treatment with fermentable fiber alone was also of benefit in a substantial proportion of patients . In conclusion , treatment with synbiotics or fermentable fiber is an alternative to lactulose for the management of MHE in patients with cirrhosis",
"Background : Patients with chronic liver disease generally have intestinal flora imbalance that is related to the development and worsening of the disease . Objective : The purpose of this study was to evaluate the effects of probiotic yogurt on intestinal flora of patients with chronic liver disease . Methods : A r and omized controlled trial , pretest-posttest control group design , was used . Patients were r and omized to an experimental group ( 41 patients ) or a control group ( 40 patients ) . Patients in the experimental group were given probiotic yogurt ( one cup each time , three times per day for 14 days ) containing Bacillus bifidus , Lactobacillus acidophilus , Lactobacillus bulgaricus , and Streptococcus thermophilus within 2 hours after meals . Levels of fecal flora , symptoms and signs , and laboratory examination indexes were collected . Results : After intervention , the experimental group had a lower Escherichia coli count and reduced intestinal flora imbalance ( p symptoms and signs , including significant improvement in debilitation , food intake , appetite , abdominal distension , and ascitic fluid ( p Probiotic yogurt reduces the levels of intestinal flora imbalance and has an additional therapeutic effect on patients with chronic liver disease",
"The effects of chronic alcohol consumption on the bowel flora and the potential therapeutic role of probiotics in alcohol-induced liver injury have not previously been evaluated . In this study , 66 adult Russian males admitted to a psychiatric hospital with a diagnosis of alcoholic psychosis were enrolled in a prospect i ve , r and omized , clinical trial to study the effects of alcohol and probiotics on the bowel flora and alcohol-induced liver injury . Patients were r and omized to receive 5 days of Bifidobacterium bifidum and Lactobacillus plantarum 8PA3 versus st and ard therapy alone ( abstinence plus vitamins ) . Stool cultures and liver enzymes were performed at baseline and again after therapy . Results were compared between groups and with 24 healthy , matched controls who did not consume alcohol . Compared to healthy controls , alcoholic patients had significantly reduced numbers of bifidobacteria ( 6.3 vs. 7.5 log colony-forming unit [CFU]/g ) , lactobacilli ( 3.15 vs. 4.59 log CFU/g ) , and enterococci ( 4.43 vs. 5.5 log CFU/g ) . The mean baseline alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) , and gamma-glutamyl transpeptidase ( GGT ) activities were significantly elevated in the alcoholic group compared to the healthy control group ( AST : 104.1 vs. 29.15 U/L ; ALT : 50.49 vs. 22.96 U/L ; GGT 161.5 vs. 51.88 U/L ) , indicating that these patients did have mild alcohol-induced liver injury . After 5 days of probiotic therapy , alcoholic patients had significantly increased numbers of both bifidobacteria ( 7.9 vs. 6.81 log CFU/g ) and lactobacilli ( 4.2 vs. 3.2 log CFU/g ) compared to the st and ard therapy arm . Despite similar values at study initiation , patients treated with probiotics had significantly lower AST and ALT activity at the end of treatment than those treated with st and ard therapy alone ( AST : 54.67 vs. 76.43 U/L ; ALT 36.69 vs. 51.26 U/L ) . In a subgroup of 26 subjects with well-characterized mild alcoholic hepatitis ( defined as AST and ALT greater than 30 U/L with AST-to-ALT ratio greater than one ) , probiotic therapy was associated with a significant end of treatment reduction in ALT , AST , GGT , lactate dehydrogenase , and total bilirubin . In this subgroup , there was a significant end of treatment mean ALT reduction in the probiotic arm versus the st and ard therapy arm . In conclusion , patients with alcohol-induced liver injury have altered bowel flora compared to healthy controls . Short-term oral supplementation with B. bifidum and L. plantarum 8PA3 was associated with restoration of the bowel flora and greater improvement in alcohol-induced liver injury than st and ard therapy alone",
"Background and aim Minimal hepatic encephalopathy ( MHE ) is associated with poor quality of life and increased work disability . Treatment with lactulose and probiotics has shown some benefit . We compared lactulose with probiotics and a combination of lactulose plus probiotics in the treatment of MHE . Patients and methods One hundred and ninety cirrhotic patients without overt encephalopathy [ Child 's A grade 71 patients ( 37.4 % ) , Child 's B grade 72 patients ( 37.9 % ) , Child 's C grade 47 patients ( 24.7 % ) ] were evaluated by psychometry ( number connection tests A and B or figure connection tests A and B ) and P300 auditory event-related potential ( P300ERP ) . MHE was diagnosed by abnormal psychometry and /or P300ERP . Patients were r and omized to receive lactulose [ group A ( n=35 ) : dose 30–60 ml/day ] , probiotics [ group B ( n=35 ) : dose 1 capsule three times/day , each capsule contained Streptococcus faecalis 60 million , Clostridium butyricum 4 million , Bacillus mesentricus 2 million , lactic acid bacillus 100 million ] and lactulose plus probiotics [ group C ( n=35 ) ] for 1 month . Response was defined by normalization of the abnormal test parameters . Results MHE was diagnosed in 105 ( 55.2 % ) patients . Of the 105 patients , 75 ( 71 % ) had both abnormal psychometry and P300ERP , whereas 90 ( 86 % ) had abnormal psychometry alone , and 89 patients ( 85 % ) had abnormal P300ERP alone . Significant improvement was seen in abnormal psychometry tests ( group A : n=31 vs. n=12 , group B : n=29 vs. n=14 , group C : n=30 vs. n=10 ) , P300ERP ( group A : 376.8±22.3 vs. 344.3±30.6 ms , group B : 385.4±28.5 vs. 355.5±27.9 ms , group C : 387.7±27.5 vs. 347.7±31.5 ms ) and venous ammonia levels ( group A : 102.3±63.1 vs. 69.3±33.3 μmol/l , group B : 108.2±37.5 vs. 75.7±33.0 μmol/l , group C : 96.3±27.7 vs. 68.7±28.4 μmol/l ) in lactulose , probiotics and a combination of lactulose plus probiotics groups after treatment . Normalization of abnormal psychometry and P300ERP was seen in 54.8 , 51.6 and 56.6 % of patients treated with lactulose , probiotics and lactulose plus probiotics groups , respectively . Conclusion A total of 55 % of the patients with cirrhosis had MHE . Lactulose or probiotics or combinations of both are equally effective in the treatment of MHE ",
"OBJECTIVE The present pilot trial was carried out to evaluate the effects of an acute treatment with a mixture containing 500 million of Lactobacillus bulgaricus and Streptococcus thermophilus per day in patients with non alcoholic fatty liver disease ( NAFLD ) . RESEARCH METHODS A sample of 30 patients with NAFLD ( diagnosed by liver biopsy ) was enrolled and 28 patients were analyzed in a double blind r and omized clinical trial . Patients were r and omized to one of the following treatments during 3 months : group I , treated with one tablet per day with 500 million of Lactobacillus bulgaricus and Streptococcus thermophilus and group II , treated with one placebo tablet ( 120 mg of starch ) . RESULTS In group I , alanine amino transferase ( ALT : 67.7 + /- 25.1 vs. 60.4 + /- 30.4 UI/L ; p aspartate aminotransferase activity ( AST : 41.3 + /- 15.5 vs. 35.6 + /- 10.4 UI/L ; p gammaglutamine transferase levels ( gammaGT : 118.2 + /- 63.1 vs. 107.7 + /- 60.8 UI/L ; p liver function parameters remained unchanged ( ALT : 60.7 + /- 32.1 vs. 64.8 + /- 35.5 UI/L ; p aspartate aminotransferase activity ( AST : 31.7 + /- 13.1 vs. 36.4 + /- 13.8 UI/L ; ns ) and gammaglutamine transferase levels ( gammaGT : 82.1 + /- 55.1 vs. 83.6 + /- 65.3 UI/L ; ns ) . Anthropometric parameters and cardiovascular risk factors remained unchanged after treatment in both groups . CONCLUSION A tablet of 500 million of Lactobacillus bulgaricus and Streptococcus thermophilus , with a r and omized clinical design , improved liver aminotransferases levels in patients with NAFLD",
"Aim : Although numerous animal studies suggest that probiotic therapy has beneficial effects in various liver diseases , the evidence for beneficial effects in human liver disease is controversial . This study was carried out to investigate the efficacy of probiotic therapy in alleviating small intestinal bacterial overgrowth ( SIBO ) and permeability in chronic liver disease . Methods : Fifty-three patients with chronic liver disease were r and omized to either probiotic therapy or placebo . Six bacterial species were used : Bifidobacterium bifidum , Bifidobacterium lactis , Bifidobacterium longum , Lactobacillus acidophilus , Lactobacillus rhamnosus , and Streptococcus thermophilus . After 4 weeks , changes in the composition of fecal bacteria , SIBO , intestinal permeability , and clinical symptoms were examined . Results : Three of the six probiotic species , B. lactis , L. rhamnosus , and L. acidophilus , increased in the feces of the probiotic therapy group ( P SIBO disappeared in many individuals of the probiotic therapy group , but none in the placebo ( 24 vs. 0 % , P General gastrointestinal symptoms also improved more in the probiotic group and improvement in intestinal permeability was slightly but not significantly more frequent in the probiotic arm than the placebo arm ( 50 vs. 31.3 % , P=0.248 ) . Numbers of lactobacilli in stool were correlated negatively with intestinal permeability ( P for trend Liver chemistry did not improve significantly in either group . Conclusions : We conclude that short-term probiotic administration in chronic liver disease is effective in alleviating SIBO and clinical symptoms , but ineffective in improving intestinal permeability and liver function"
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OBJECTIVE To examine the effectiveness of group circuit class therapy for improving the mobility of adults after stroke . DESIGN Cochrane systematic review . METHODS A comprehensive search strategy was used to find r and omized and quasi-r and omized controlled trials of adults post-stroke receiving circuit class therapy . Two authors independently selected trials for inclusion , assessed the method ological rigor and extracted data . RESULTS Six trials were included , involving 292 participants ; most were community-dwelling survivors who were able to walk independently . Circuit class therapy was effective in improving walking ability ( 6-minute walk test mean difference , 76.6 m , 95 % confidence interval 38.4 - 114.7 , walking speed mean difference 0.12 m/s , 95 % confidence interval 0 - 0.24 ) and balance ( step test mean difference 3.0 steps , 95 % confidence interval 0.08 - 5.9 , activities specific balance confidence mean difference 7.76 points , 95 % confidence interval 0.66 - 14.9 ) . Other balance measures did not show a difference in effect . Results from two studies suggest that circuit class therapy can reduce length of hospital stay ( mean difference -19.7 days , 95 % confidence interval -35.4 to -4.0 ) . Two studies measured adverse events ( falls ) ; all were minor . CONCLUSION Circuit class therapy is safe and effective in improving mobility in people after stroke and , when provided as part of hospital-based rehabilitation , may reduce length of stay
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"Background and Purpose — This study compared the psychometric properties of 3 clinical balance measures , the Berg Balance Scale ( BBS ) , the Balance subscale of the Fugl-Meyer test ( FM-B ) , and the Postural Assessment Scale for Stroke Patients ( PASS ) , in stroke patients with a broad range of neurological and functional impairment from the acute stage up to 180 days after onset . Methods — One hundred twenty-three stroke patients were followed up prospect ively with the 3 balance measures 14 , 30 , 90 , and 180 days after stroke onset ( DAS ) . Reliability ( interrater reliability and internal consistency ) and validity ( concurrent validity , convergent validity , and predictive validity ) of each measure were examined . A comparison of the responsiveness of each of the 3 measures was made on the basis of the entire group of patients and 3 separate groups classified by degree of neurological severity . Results — The FM-B and BBS showed a significant floor or ceiling effect at some DAS points , whereas the PASS did not show these effects . The BBS , FM-B , and PASS all had good reliability and validity for patients at different recovery stages after stroke . The results of effect size demonstrated fair to good responsiveness of all 3 measures within the first 90 DAS but , as expected , only a low level of responsiveness at 90 to 180 DAS . The PASS was more responsive to changes in severe stroke patients at the earliest period after stroke onset , 14 to 30 DAS . Conclusions — All 3 measures tested showed very acceptable levels of reliability , validity , and responsiveness for both clinicians and research ers . The PASS showed slightly better psychometric characteristics than the other 2 measures",
"Background and Purpose Comparison of incidence and case-fatality rates for stroke in different countries may increase our underst and ing of the etiology of the disease , its natural history , and management . Within the context of an aging population and the trend for governments to set targets to reduce stroke risk and death from stroke , prospect i ve comparison of such data across countries may identify what drives the variation in risk and outcome . Methods Population -based stroke registers , using multiple sources of notification , ascertained cases of first in a lifetime stroke between 1995 and 1997 for all age groups . The study population s were in Erlangen , Germany ; Dijon , France ; and London , UK . Crude incidence rates were age-st and ardized to the European population for comparative purpose s. Case-fatality rates up to 1 year after the stroke were obtained , and logistic regression adjusting for age group , sex , and pathological subtype of stroke was used to compare survival in the 3 communities . Results A total of 2074 strokes were registered over the 3 years . The age-st and ardized rate to the European population was 100.4 ( 95 % CI 91.7 to 109.1 ) per 100 000 in Dijon , 123.9 ( 95 % CI 115.6 to 132.2 ) in London , and 136.4 ( 95 % CI 124.9 to 147.9 ) in Erlangen . Both crude and adjusted rates were lowest in Dijon , France . The incidence rate ratio , with Dijon as the baseline comparison ( 1 ) , was 1.21 ( 95 % CI 1.09 to 1.34 ) in London and 1.37 ( 95 % CI 1.22 to 1.54 ) in Erlangen ( P proportion of the subtypes of stroke between population s , with London having lower rates of cerebral infa rct ion and higher rates of subarachnoid hemorrhage and unclassified stroke ( P Case-fatality rates varied significantly between centers at 1 year , after adjustment for age , sex , and subtype of stroke ( 35 % overall , 34 % Erlangen , 41 % London , and 27 % Dijon;P risk of stroke varies significantly between population s in Europe as does the risk of death . The striking differences in survival require clarification but lend weight to the evidence that stroke management may differ between northern and central Europe and influence outcome",
"Background When people with stroke recover gait speed , they report improved function and reduced disability . However , the minimal amount of change in gait speed that is clinical ly meaningful and associated with an important difference in function for people poststroke has not been determined . Objective The purpose of this study was to determine the minimal clinical ly important difference ( MCID ) for comfortable gait speed ( CGS ) associated with an improvement in the modified Rankin Scale ( mRS ) score for people between 20 to 60 days poststroke . Design This was a prospect i ve , longitudinal , cohort study . Methods The participants in this study were 283 people with first-time stroke prospect ively enrolled in the ongoing Locomotor Experience Applied Post Stroke ( LEAPS ) multi-site r and omized clinical trial . Comfortable gait speed was measured and mRS scores were obtained at 20 and 60 days poststroke . Improvement of ≥1 on the mRS was used to detect meaningful change in disability level . Results Mean ( SD ) CGS was 0.18 ( 0.16 ) m/s at 20 days and 0.39 ( 0.22 ) m/s at 60 days poststroke . Among all participants , 47.3 % experienced an improvement in disability level ≥1 . The MCID was estimated as an improvement in CGS of 0.16 m/s anchored to the mRS . Limitations Because the mRS is not a gait-specific measure of disability , the estimated MCID for CGS was only 73.9 % sensitive and 57.0 % specific for detecting improvement in mRS scores . Conclusions We estimate that the MCID for gait speed among patients with subacute stroke and severe gait speed impairments is 0.16 m/s . Patients with subacute stroke who increase gait speed ≥0.16 m/s are more likely to experience a meaningful improvement in disability level than those who do not . Clinicians can use this reference value to develop goals and interpret progress in patients with subacute stroke ",
"OBJECTIVES To determine the effect of two different community-based group exercise programs on functional balance , mobility , postural reflexes , and falls in older adults with chronic stroke . DESIGN A r and omized , clinical trial . SETTING Community center . PARTICIPANTS Sixty-one community-dwelling older adults with chronic stroke . INTERVENTION Participants were r and omly assigned to an agility ( n=30 ) or stretching/weight-shifting ( n=31 ) exercise group . Both groups exercised three times a week for 10 weeks . MEASUREMENTS Participants were assessed before , immediately after , and 1 month after the intervention for Berg Balance , Timed Up and Go , step reaction time , Activities-specific Balance Confidence , and Nottingham Health Profile . Testing of st and ing postural reflexes and induced falls evoked by a translating platform was also performed . In addition , falls in the community were tracked for 1 year from the start of the interventions . RESULTS Although exercise led to improvements in all clinical outcome measures for both groups , the agility group demonstrated greater improvement in step reaction time and paretic rectus femoris postural reflex onset latency than the stretching/weight-shifting group . In addition , the agility group experienced fewer induced falls on the platform . CONCLUSION Group exercise programs that include agility or stretching/weight shifting exercises improve postural reflexes , functional balance , and mobility and may lead to a reduction of falls in older adults with stroke",
"The purpose of this study was to investigate whether additional practice of either upper limb or mobility tasks improved functional outcome during inpatient stroke rehabilitation . This prospect i ve , r and omised , single blind clinical trial recruited 30 stroke subjects into either an Upper Limb or a Mobility Group . All subjects received their usual rehabilitation and an additional session of task-related practice using a circuit class format . Independent assessors , blinded to group allocation , tested all subjects . Outcome measures used were three items of the Jebsen Taylor H and Function Test ( JTHFT ) , two arm items of the Motor Assessment Scale ( MAS ) , and three mobility measures , the Timed Up and Go Test ( TUGT ) , Step Test , and Six Minute Walk Test ( 6MWT ) . Both groups improved significantly between pre- and post-tests on all of the mobility measures , however only the Upper Limb Group made a significant improvement on the JTHFT and MAS upper arm items . Following four weeks training , the Mobility Group had better locomotor ability than the Upper Limb Group ( between-group differences in the 6MWT of 116.4 m , 95 % CI 31.4 to 201.3 m , Step Test 2.6 repetitions , 95 % CI -1.0 to 6.2 repetitions , and TUGT -7.6 sec , 95 % CI -15.5 to 0.2 sec ) . The JTHFT dexterity scores in the Upper Limb Group were 6.5 sec ( 95 % CI -7.4 to 20.4 sec ) faster than the Mobility Group . Our findings support the use of additional task-related practice during inpatient stroke rehabilitation . The circuit class format was a practical and effective means to provide supervised additional practice that led to significant and meaningful functional gains",
"OBJECTIVE To evaluate the internal and absolute reliability and construct validity of the Activities-Specific Balance Confidence ( ABC ) scale and a new Canadian French version ( ABC-CF ) of it among people with stroke . DESIGN Cross-sectional data from a r and omized controlled trial . SETTING Community . PARTICIPANTS Ninety-one people with a residual walking deficit between 57 and 386 days poststroke . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES The ABC and ABC-CF scales , Berg Balance Scale ( BBS ) , comfortable and maximum gait speeds , Timed Up & Go ( TUG ) test , 6-minute walk test ( 6MWT ) , Barthel Index , physical function scale of the Medical Outcomes Study 36-Item Short-Form Health Survey , Geriatric Depression Scale ( GDS ) , and the EQ-5D visual analog scale ( EQ VAS ) . RESULTS Internal consistency ( Cronbach alpha ) was .94 and .93 and the st and ard error of measurement was 5.05 and 5.13 for the ABC ( n=51 ) and the ABC-CF ( n=35 ) scales , respectively . Spearman rho values ranged from .30 to .60 for the ABC scale and from .45 to .68 on the ABC-CF scale for associations with scores on the BBS , comfortable and maximum gait speeds , TUG , 6MWT , Barthel Index , physical function scale , GDS , and EQ VAS . CONCLUSIONS Evidence of internal and absolute reliability and of construct validity of the ABC and the ABC-CF scales supports their use for cross-sectional measurements of balance self-efficacy among community-dwelling people in the first year poststroke ",
"OBJECTIVE To compare the effectiveness of circuit class therapy and individual physiotherapy ( PT ) sessions in improving walking ability and functional balance for people recovering from stroke . DESIGN Nonr and omized , single-blind controlled trial . SETTING Medical rehabilitation ward of a rehabilitation hospital . PARTICIPANTS Sixty-eight persons receiving inpatient rehabilitation after a stroke . INTERVENTIONS Subjects received group circuit class therapy or individual treatment sessions as the sole method of PT service delivery for the duration of their inpatient stay . MAIN OUTCOME MEASURES Five-meter walk test ( 5MWT ) , two-minute walk test ( 2MWT ) , and the Berg Balance Scale ( BBS ) measured 4 weeks after admission . Secondary outcome measures included the Iowa Level of Assistance Scale , Motor Assessment Scale upper-limb items , and patient satisfaction . Measures were taken on admission and 4 weeks later . RESULTS Subjects in both groups showed significant improvements between admission and week 4 in all primary outcome measures . There were no significant between group differences in the primary outcome measures at week 4 ( 5MWT mean difference , .07 m/s ; 2MWT mean difference , 1.8 m ; BBS mean difference , 3.9 points ) . A significantly higher proportion of subjects in the circuit class therapy group were able to walk independently at discharge ( P=.01 ) and were satisfied with the amount of therapy received ( P=.007 ) . CONCLUSIONS Circuit class therapy appeared as effective as individual PT sessions for this sample of subjects receiving inpatient rehabilitation poststroke . Favorable results for circuit classes in terms of increased walking independence and patient satisfaction suggest this model of service delivery warrants further investigation",
"OBJECTIVE To evaluate the immediate and retention effects of a 4-week training program on the performance of locomotor-related tasks in chronic stroke . DESIGN R and omized , controlled pilot study with 2-month follow-up . SETTING Rehabilitation center . SUBJECTS A convenience sample consisting of 12 chronic stroke subjects was used . Subjects were r and omly assigned to the experimental or the control group . Three subjects withdrew from the study . INTERVENTION Both experimental and control groups participated in exercise classes three times a week for 4 weeks . The exercise class for the experimental group focused on strengthening the affected lower limb and practicing functional tasks involving the lower limbs , while the control group practice d upper-limb tasks . MAIN OUTCOME MEASURES Lower-limb function was evaluated by measuring walking speed and endurance , peak vertical ground reaction force through the affected foot during sit-to-st and , and the step test . RESULTS The experimental group demonstrated significant immediate and retained ( 2-month follow-up ) improvement ( p walking speed and endurance , force production through the affected leg during sit-to-st and , and the number of repetitions of the step test . CONCLUSION The pilot study provides evidence for the efficacy of a task-related circuit class at improving locomotor function in chronic stroke",
"OBJECTIVES To examine the effects of a community-based group exercise program for older individuals with chronic stroke . DESIGN Prospect i ve , single-blind , r and omized , controlled intervention trial . SETTING Intervention was community-based . Data collection was performed in a research laboratory located in a rehabilitation hospital . PARTICIPANTS Sixty-three older individuals ( aged > or = 50 ) with chronic stroke ( poststroke duration > or = 1 year ) who were living in the community . INTERVENTION Participants were r and omized into intervention group ( n=32 ) or control group ( n=31 ) . The intervention group underwent a fitness and mobility exercise ( FAME ) program design ed to improve cardiorespiratory fitness , mobility , leg muscle strength , balance , and hip bone mineral density ( BMD ) ( 1-hour sessions , three sessions/week , for 19 weeks ) . The control group underwent a seated upper extremity program . MEASUREMENTS Cardiorespiratory fitness ( maximal oxygen consumption ) , mobility ( 6-minute walk test ) , leg muscle strength ( isometric knee extension ) , balance ( Berg Balance Scale ) , activity and participation ( Physical Activity Scale for Individuals with Physical Disabilities ) , and femoral neck BMD ( using dual-energy x-ray absorptiometry ) . RESULTS The intervention group had significantly more gains in cardiorespiratory fitness , mobility , and paretic leg muscle strength than controls . Femoral neck BMD of the paretic leg was maintained in the intervention group , whereas a significant decline of the same occurred in controls . There was no significant time-by-group interaction for balance , activity and participation , nonparetic leg muscle strength , or nonparetic femoral neck BMD . CONCLUSION The FAME program is feasible and beneficial for improving some of the secondary complications result ing from physical inactivity in older adults living with stroke . It may serve as a good model of a community-based fitness program for preventing secondary diseases in older adults living with chronic conditions",
"UNLABELLED Mudge S , Barber PA , Stott NS . Circuit-based rehabilitation improves gait endurance but not usual walking activity in chronic stroke : a r and omized controlled trial . OBJECTIVE To determine whether circuit-based rehabilitation would increase the amount and rate that individuals with stroke walk in their usual environments . DESIGN Single-blind r and omized controlled trial . SETTING Rehabilitation clinic . PARTICIPANTS Sixty participants with a residual gait deficit at least 6 months after stroke originally enrolled in the study . Two withdrew in the initial phase , leaving 58 participants ( median age , 71.5y ; range , 39.0 - 89.0y ) who were r and omized to the 2 intervention groups . INTERVENTIONS The exercise group had 12 sessions of clinic-based rehabilitation delivered in a circuit class design ed to improve walking . The control group received a comparable duration of group social and educational classes . MAIN OUTCOME MEASURES Usual walking performance was assessed using the StepWatch Activity Monitor . Clinical tests were gait speed ( timed 10-meter walk ) and endurance ( six-minute walk test [ 6MWT ] ) , confidence ( Activities-Based Confidence Scale ) , self-reported mobility ( Rivermead Mobility Index [ RMI ] ) , and self-reported physical activity ( Physical Activity and Disability Scale ) . RESULTS Intention-to-treat analysis revealed that the exercise group showed a significantly greater distance for the 6MWT than the control group immediately after the intervention ( P=.030 ) but that this effect was not retained 3 months later . There were no changes in the StepWatch measures of usual walking performance for either group . The exercise and control groups had significantly different gait speed ( P=.038 ) and scores on the RMI ( P=.025 ) at the 3-month follow-up . These differences represented a greater decline in the control group compared with the exercise group for both outcome measures . CONCLUSIONS Circuit-based rehabilitation leads to improvements in gait endurance but does not change the amount or rate of walking performance in usual environments . Clinical gains made by the exercise group were lost 3 months later . Future studies should consider whether rehabilitation needs to occur in usual environments to improve walking performance ",
"OBJECTIVES To determine the feasibility and effect of exercise training after stroke . DESIGN R and omized exploratory trial comparing exercise training ( including progressive endurance and resistance training ) with relaxation ( attention control ) . SETTING Interventions were performed in a rehabilitation hospital . PARTICIPANTS Sixty-six independently ambulatory patients ( mean age 72 , 36 men ) without significant dysphasia , confusion , or medical contraindications to exercise training who had completed their usual rehabilitation and had been discharged from hospital . INTERVENTION Both interventions were held three times a week for 12 weeks . Up to seven patients attended each session . MEASUREMENTS The Functional Independence Measure ; Nottingham Extended Activities of Daily Living ; Rivermead Mobility Index ; functional reach ; sit-to-st and ; elderly mobility score ; timed up- and -go ; Medical Outcomes Study 36-Item Short Form Question naire , version 2 ( SF-36 ) ; Hospital Anxiety and Depression Score ; aspects of physical fitness ( comfortable walking speed , walking economy , and explosive leg extensor power ) were measured at baseline , immediately after interventions ( 3 months ) , and 7 months after baseline . RESULTS The median number of intervention sessions attended was 36 ( interquartile range ( IQR ) 30.00 - 36.75 ) for exercise and 36 ( IQR 30.50 - 37.00 ) for relaxation . Adherence to the individual exercises ranged from 94 % to 99 % . At 3 months , role-physical ( an item in SF-36 ) , timed up- and -go , and walking economy were significantly better in the exercise group ( analysis of covariance ) . At 7 months , role-physical was the only significant difference between groups . CONCLUSION Exercise training for ambulatory stroke patients was feasible and led to significantly greater benefits in aspects of physical function and perceived effect of physical health on daily life",
"Objective : To examine the effectiveness of task-oriented progressive resistance strength training on lower extremity strength and functional performance in chronic stroke subjects . Design : Single-blind , r and omized controlled trial . Setting : Medical centre and district hospital . Subjects : Forty-eight subjects at least one year post stroke . Interventions : Participants r and omly allocated to two groups , control ( n-/24 ) and experimental ( n-/24 ) . Subjects in the control group did not receive any rehabilitation training . Subjects in the experimental group were put on a four-week task-oriented progressive resistance strength training . Main measures : Lower extremity muscle strength , gait velocity , cadence , stride length , six-minute walk test , step test , and timed up and go test . Results : Muscle strength significantly improved in the experimental group for strong side muscle groups ( ranged from 23.9 % to 36.5 % ) and paretic side muscle groups ( ranged from 10.1 % to 77.9 % ) . In the control group muscle strength changes ranged from 6.7 % gain to 11.2 % decline . The experimental group showed significant improvement in all selected measures of functional performance except for the step test . In the control group , the number of repetitions of the step test significantly decreased ( -20.3 % ) with no change in other functional tests . There was a significant difference between groups for muscle strength and all functional measures . The strength gain was significantly associated with gain in the functional tests . Conclusions : The task-oriented progressive resistance strength training programme could improve lower extremity muscle strength in individuals with chronic stroke and could carry over into improvement in functional abilities"
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ABSTRACT Objective : We aim to report a systematic review and meta- analysis of r and omized controlled trials ( RCTs ) on effects of olive oil consumption compared with other plant oils on blood lipids . Methods : PubMed , web of science , Scopus , ProQuest , and Embase were systematic ally search ed until September 2017 , with no age , language and design restrictions . Weighed mean difference ( WMD ) and 95 % confidence interval ( CI ) were expressed as effect size . Sensitivity analyses and pre specified subgroup was conducted to evaluate potential heterogeneity . Meta-regression analyses were performed to investigate association between blood lipid-lowering effects of olive oil and duration of treatment . Results : Twenty-seven trials , comprising 1089 participants met the eligibility criteria . Results of this study showed that compared to other plant oils , high-density lipoprotein level increased significantly more for OO ( 1.37 mg/dl : 95 % CI : 0.4 , 2.36 ) . Also OO consumption reduced total cholesterol ( TC ) ( 6.27 mg/dl , 95 % CI : 2.8 , 10.6 ) , Low-density lipoprotein ( LDL-c ) ( 4.2 mg/dl , 95 % CI : 1.4 , 7.01 ) , and triglyceride ( TG ) ( 4.31 mg/dl , 95 % CI : 0.5 , 8.12 ) significantly less than other plant oils . There were no significant effects on Apo lipoprotein A1 and Apo lipoprotein B. Conclusion : This meta- analysis suggested that OO consumption decreased serum TC , LDL-c , and TG less but increased HDL-c more than other plant oils
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"Aim : To evaluate whether the consumption of virgin argan oil ( VAO ) is associated with a change in serum lipids and reduces the risk of cardiovascular disease in healthy Moroccans . Methods : Sixty volunteers consumed butter ( 25 g/day ) during 2 weeks ( stabilization period ) and were r and omly divided into two groups : the treatment group received 25 g/day of VAO during 3 weeks ( intervention period ) , and the control group received 25 g/day of extra virgin olive oil ( EVO ) . Throughout the study , weight , blood pressure , and daily food intake were measured . Serum total cholesterol and low- and high-density lipoprotein cholesterol , triglycerides , and apolipoproteins A-I and B were measured at the end of each diet period . Results : Analysis of food intake showed that the daily diet is isocaloric for the butter regimen ( 2,537 ± 244 kcal/day ) as well as for the VAO and EVO regimens ( 2,561± 246 and 2,560 ± 253 kcal/day , respectively ) . Analysis of the lipid intake showed a reduction in saturated fatty acids with VAO and EVO regimens ( 27 ± 1.4 and 26.4 ± 3.4 % , respectively ) as compared with the stabilization period ( 41.6 ± 2.4 % ) . The analysis of serum lipids showed a significant increase in high-density lipoprotein cholesterol and apolipoprotein A-I in both VAO group ( 8.4 % , p = 0.012 , and 5.2 % , p = 0.027 , respectively ) and EVO group ( 17.3 % , p = 0.001 , and 5.9 % , p = 0.036 , respectively ) . However , low-density lipoprotein cholesterol and apolipoprotein B ( 13.8 % , p = 0.037 , and 7.8 % , p = 0.039 , respectively ) decreased significantly only in EVO group as compared with the stabilization period , while triglycerides decreased significantly by 17.5 % ( p = 0.039 ) only in VAO group . Conclusion : These results confirm the cholesterol-lowering effect of EVO and show for the first time the triglyceride-lowering effect of VAO in men",
"BACKGROUND Low-fat diets increase plasma triacylglycerol and decrease HDL-cholesterol concentrations , thereby potentially adversely affecting cardiovascular disease ( CVD ) risk . High-monounsaturated fatty acid ( MUFA ) , cholesterol-lowering diets do not raise triacylglycerol or lower HDL cholesterol , but little is known about how peanut products , a rich source of MUFAs , affect CVD risk . OBJECTIVE The present study compared the CVD risk profile of an Average American diet ( AAD ) with those of 4 cholesterol-lowering diets : an American Heart Association/National Cholesterol Education Program Step II diet and 3 high-MUFA diets [ olive oil ( OO ) , peanut oil ( PO ) , and peanuts and peanut butter ( PPB ) ] . DESIGN A r and omized , double-blind , 5-period crossover study design ( n = 22 ) was used to examine the effects of the diets on serum lipids and lipoproteins : AAD [ 34 % fat ; 16 % saturated fatty acids ( SFAs ) , 11 % MUFAs ] , Step II ( 25 % fat ; 7 % SFAs , 12 % MUFAs ) , OO ( 34 % fat ; 7 % SFAs , 21 % MUFAs ) , PO ( 34 % fat ; 7 % SFAs , 17 % MUFAs ) , and PPB ( 36 % fat ; 8 % SFAs , 18 % MUFAs ) . RESULTS The high-MUFA diets lowered total cholesterol by 10 % and LDL cholesterol by 14 % . This response was comparable with that observed for the Step II diet . Triacylglycerol concentrations were 13 % lower in subjects consuming the high-MUFA diets and were 11 % higher with the Step II diet than with the AAD . The high-MUFA diets did not lower HDL cholesterol whereas the Step II diet lowered it by 4 % compared with the AAD . The OO , PO , and PPB diets decreased CVD risk by an estimated 25 % , 16 % , and 21 % , respectively , whereas the Step II diet lowered CVD risk by 12 % . CONCLUSION A high-MUFA , cholesterol-lowering diet may be preferable to a low-fat diet because of more favorable effects on the CVD risk profile",
"Twenty-one healthy normocholesterolemic young adults , men and women , completed a r and omized 30-d/30-d crossover comparison of the effect of palmolein and olive oil on plasma lipids . The subjects were free-living volunteers who changed to low-fat diets to which one of the test oils was added ( used as a spread , for baking , or for frying ) in turn . Complete food records were kept throughout : the test oils were compared at 17 % of total dietary energy . Under the conditions of this experiment plasma total and low-density-lipoprotein ( LDL ) cholesterol were almost identical with the two oils , so that when the palmitic acid ( 16:0 ) in palm oil replaced oleic acid ( 18:1 ) in olive oil the expected increase in LDL cholesterol was not seen . These results indicate that 16:0 , though saturated , is not always a plasma cholesterol-raising fatty acid . Palmolein is rich in vitamin E , alpha-tocopherol , and especially tocotrienols , but the latter were barely detectable in plasma",
"BACKGROUND Nutritional therapy is a cornerstone of diabetes management , but no epidemiologic studies have investigated the relation between specific dietary fatty acids and cholesterol and cardiovascular disease ( CVD ) risk among diabetic patients . OBJECTIVE This study assessed the relation between specific dietary fatty acids and cholesterol and CVD risk among women with type 2 diabetes . DESIGN Among 5672 women with type 2 diabetes from the Nurses ' Health Study , diet was assessed prospect ively and up date d periodically . Relative risks of CVD were estimated from Cox proportional hazards analysis after adjustment for potential confounders . RESULTS Between 1980 and 1998 , we identified 619 new cases of CVD ( nonfatal myocardial infa rct ion , fatal coronary heart disease , and stroke ) . The relative risk ( RR ) of CVD for an increase of 200 mg cholesterol/1000 kcal was 1.37 ( 95 % CI : 1.12 , 1.68 ; P = 0.003 ) . Each 5 % of energy intake from saturated fat , as compared with equivalent energy from carbohydrates , was associated with a 29 % greater risk of CVD ( RR : 1.29 ; 95 % CI : 1.02 , 1.63 ; P = 0.04 ) . The ratio of polyunsaturated to saturated fat ( P : S ) was inversely associated with the risk of fatal CVD . We estimated that replacement of 5 % of energy from saturated fat with equivalent energy from carbohydrates or monounsaturated fat was associated with a 22 % or 37 % lower risk of CVD , respectively . CONCLUSIONS A higher intake of cholesterol and saturated fat and a low P : S were related to increased CVD risk among women with type 2 diabetes . Among diabetic persons , replacement of saturated fat with monounsaturated fat may be more effective in lowering CVD risk than is replacement with carbohydrates",
"To evaluate which dietary fat may provide the best response in terms of plasma lipids and lipoproteins and also of platelet aggregability and superoxide formation by white blood cells , 12 type II patients were r and omly allocated to three different diets , which provided polyunsaturated fatty acids ( corn oil ) , monounsaturated fatty acids ( olive oil ) , and a supplementation of ethyl esters of n-3 fatty acids to a prudent diet . Olive oil and , more significantly , n-3 ethyl esters lowered total cholesterol best ( -2.2 % and -5.8 % , respectively ) ; the latter diet , as expected , also significantly lowered triglyceridemia ( -21.4 % ) . The corn-oil diet exerted a small , statistically significant reduction of high-density-lipoprotein cholesterol ( HDL ) ( -4.3 % ) , and it also lowered plasma total apo B concentrations ( -3.8 % ) . n-3 ethyl esters significantly raised both total ( + 3.1 % ) and particularly HDL2 cholesterol ( + 24 % ) . Platelet reactivity was insignificantly reduced by the three regimens , but all three significantly reduced thrombin-stimulated formation of thromboxane B2 . Finally , only the n-3 fatty acid supplementation significantly reduced O2- generation by adherent monocytes . Dietary unsaturated fatty acids are generally effective on the plasma lipid and lipoproteins in type II patients , but significant differences may be found between the three tested regimens",
"The aim of the present study was to determine the effect of long-term optional intake of vegetable oils ( canola , grape seed , corn ) and yogurt butter on the serum , liver and muscle cholesterol status . Twenty-five male Wistar rats were r and omly categorized into five groups ( n=5 ) as follows : control , canola oil , grape seed oil , corn oil and manually prepared yogurt butter . In each group , 24h two bottle choice ( oil and water ) tests were performed for 10 weeks . Serum cholesterol values showed a trend to decrease in grape seed oil , corn oil and yogurt butter groups compared to the control . Optional intake of yogurt butter made a significant increase in HDL-C values ( 42.34+/-9.98 mg/dL ) yet decrease in LDL-C values ( 11.68+/-2.06 mg/dL ) compared to the corresponding control ( 19.07+/-3.51 ; 30.96+/-6.38 mg/dL , respectively ) . Furthermore , such findings were concomitant with a significant decrease in the liver TC levels ( 1.75+/-0.31 mg/g liver ) and an increase in the muscle TC levels ( 1.85+/-0.32 mg/g liver ) compared to the corresponding control ( 2.43+/-0.31 ; 0.94+/-0.14 mg/g liver , respectively ) . Optional intake of manually prepared yogurt butter has more beneficial effects on serum lipoprotein cholesterol values with some alterations in the liver and muscle cholesterol states than the vegetable oils",
"OBJECTIVE To evaluate the effects of a trans fat-free monounsaturated fatty acid-rich vegetable oil ( NuSun sunflower oil , National Sunflower Association , Bismark , ND ) that is a good source of polyunsaturated fatty acids ( PUFA ) and low in saturated fatty acids on lipid and lipoprotein levels and oxidative stress . DESIGN A double-blinded , r and omized , three period crossover , controlled feeding study . SUBJECTS/ SETTING Thirty-one men ( n=12 ) and women ( n=19 ) with moderate hypercholesterolemia who were 25 to 64 years of age . INTERVENTION Experimental diets provided 30 % fat ( olive oil or NuSun sunflower oil contributed one half of the total fat ) , 8.3 % vs 7.9 % saturated fatty acid , 17.2 % vs 14.2 % monounsaturated fatty acid , and 4.3 % vs. 7.7 % PUFA ( olive oil and NuSun sunflower oil , respectively ) , and 294 mg cholesterol . The control diet was an average American diet ( 34 % fat , 11.2 % saturated fatty acid , 14.9 % monounsaturated fatty acid , 7.8 % PUFA ) . Subjects consumed each diet for 4 weeks with a 2-week compliance break before crossing over to another diet . MAIN OUTCOME MEASURES Lipid and lipoprotein levels were measured , and measures of oxidative stress , including lag time , rate of oxidation , total dienes , and lipid hydroperoxides , were assessed . STATISTICAL ANALYSIS The mixed model procedure was used to test for main effects of diet , feeding period , and order of diets . Tukey-Kramer adjusted P values were used to determine diet effects . RESULTS The NuSun sunflower oil diet decreased both total and low-density lipoprotein cholesterol levels compared with the average American diet and the olive oil diet . There was no effect of the olive oil diet compared with the average American diet . Total cholesterol decreased 4.7 % and low-density lipoprotein cholesterol decreased 5.8 % on the NuSun sunflower oil diet vs the average American diet . There was no effect of the experimental diets on triglyceride levels , rate of oxidation , total dienes , lipid hydroperoxides , or alpha-tocopherol . Lag time was the longest following the olive oil diet and shortest following the NuSun sunflower oil diet . CONCLUSIONS The higher PUFA content appeared to account for the greater total and low-density lipoprotein cholesterol lowering and reduction in lag time of the NuSun sunflower oil diet . However , the fact that there were no differences in the result ing oxidation products suggests there were no adverse effects on low-density lipoprotein oxidation . Since PUFAs are important for cholesterol lowering , foods that replace saturated fatty acids should include a balance of unsaturated fatty acids",
"Background : The study on natural substances especially , dietary components such as liquid oils affecting cholesterol can be important for therapeutic propose . Sesame seeds with various biomedical actions can be control the hypercholesterolemia . On the other h and , olive oil has a wide range of therapeutic effect on lipid profile in human . The aim of this study is to evaluate and compare lipid profile changes after olive and sesame oils consumption in hypercholesterolemia . Methods : This study was a clinical r and omized trial that was performed via parallel design on 48 patients . The patients were r and omly allocated in to two groups : A : olive oil and B : sesame oil . After 1 month prescription of Step I National Cholesterol Education Program diet , patients consumed 4 table spoons aprox . 60 g ) of refined olive or sesame oil daily as an exchange of other oils , for 1 month . Lipid profiles The P Out of 48 patients , 24 ( 50 % ) were men . The mean age was 41.7 ± 8.3 years . The mean of total cholesterol , triglyceride ( TG ) , low density lipoprotein ( LDL ) , cholesterol , and high density lipoprotein ( HDL ) cholesterol , before oil consumption was 224.5 ± 22 , 256 ± 132 , 132.6 ± 9 , and 44.5 ± 11 mg/dl . After olive oil consumption cholesterol , TG , LDL-C , weight , waist and BMI were decreased and HDL-C was increased . After sesame oil consumption cholesterol , TG , LDL-C were significantly decreased . Weight , waist were decreased and HDL-C was increased ( P > 0.05 ) . Conclusions : Sesame oil had equivalent effect on lipid profile in comparison olive oil and lipid profile improvement was better in sesame oil in LDL-C and TG",
"BACKGROUND Despite the high content of palmitic acid , palm olein has been shown to have a neutral effect on plasma cholesterol concentrations when compared with olive oil , which is suggested to be attributable to palmitic acid in the sn-1 and sn-3 position . In contrast , palmitic acid is in the sn-2 position in lard . OBJECTIVE The objective was to investigate the effects of a diet rich in palm olein , fractionated palm oil , olive oil , and lard on plasma blood lipids , inflammatory markers , glucose , and insulin . DESIGN A controlled double-blinded , r and omized 3 × 3 wk crossover dietary intervention study included 32 healthy men who daily replaced part of their habitual dietary fat intake with ~ 17 % of energy from palm olein , olive oil , or lard , respectively . RESULTS Compared with intake of olive oil , palm olein and lard increased total cholesterol and LDL cholesterol ( P ) . Palm olein result ed in a lower plasma triacylglycerol concentration than did olive oil ( P in plasma HDL-cholesterol , high-sensitivity C-reactive protein , plasminogen activator-1 , insulin , and glucose concentrations . CONCLUSIONS The current study did not support the previous finding that the effect of palm olein on total plasma cholesterol and LDL cholesterol in healthy individuals with normal plasma cholesterol concentrations is neutral compared with that of olive oil . Thus , sn-positioning was not confirmed to be important with regard to the effect on plasma cholesterol . The relatively lower plasma triacylglycerol concentration after the palm olein diet than after the olive oil diet was unexpected . This trial is registered at clinical trials.gov as NCT00743301",
"OBJECTIVE We investigated the effects of dietary intervention with canola or olive oil in comparison with commonly used refined oil in Asian Indians with nonalcoholic fatty liver disease ( NAFLD ) . SUBJECTS AND METHODS This was a 6-month intervention study including 93 males with NAFLD , matched for age and body mass index ( BMI ) . Subjects were r and omized into three groups to receive olive oil ( n=30 ) , canola oil ( n=33 ) , and commonly used soyabean/safflower oil ( control ; n=30 ) as cooking medium ( not exceeding 20 g/day ) along with counseling for therapeutic lifestyle changes . The BMI , fasting blood glucose ( FBG ) and insulin levels , lipids , homeostasis model of assessment for insulin resistance ( HOMA-IR ) , HOMA denoting β-cell function ( HOMA-βCF ) , and disposition index ( DI ) were measured at pre- and post-intervention . Data were analyzed with one-way analysis of variance ( ANOVA ) and Tukey 's Honestly Significant Difference multiple comparison test procedures . RESULTS Olive oil intervention led to a significant decrease in weight and BMI ( ANOVA , P=0.01 ) compared with the control oil group . In a comparison of olive and canola oil , a significant decrease in fasting insulin level , HOMA-IR , HOMA-βCF , and DI ( P in high-density lipoprotein level ( P=0.004 ) in the olive oil group and a significant decrease in FBG ( P=0.03 ) and triglyceride ( P=0.02 ) levels in the canola oil group . The pre- and post-intervention difference in liver span was significant only in the olive ( 1.14 ± 2 cm ; P and canola ( 0.66 ± 0.33 cm ; P In the olive and canola oil groups , post-intervention grading of fatty liver was reduced significantly ( grade I , from 73.3 % to 23.3 % and from 60.5 % to 20 % , respectively [ P grading of fatty liver , liver span , measures of insulin resistance , and lipids with use of canola and olive oil compared with control oils in Asian Indians with NAFLD",
"We investigated the effect of olive oil , rapeseed oil , and sunflower oil on blood lipids and lipoproteins including number and lipid composition of lipoprotein subclasses . Eighteen young , healthy men participated in a double-blinded r and omized cross-over study ( 3-week intervention period ) with 50 g of oil per 10 MJ incorporated into a constant diet . Plasma cholesterol , triacylglycerol , apolipoprotein B , and very low density lipoprotein ( VLDL ) , intermediate density lipoprotein ( IDL ) , and low density lipoprotein ( LDL ) cholesterol concentrations were 10;-20 % higher after consumption of the olive oil diet compared with the rapeseed oil and sunflower oil diets [ analysis of variance ( ANOVA ) , P size of IDL , VLDL , and LDL subfractions did not differ between the diets , whereas a significantly higher number ( apolipoprotein B concentration ) and lipid content of the larger and medium-sized LDL subfractions were observed after the olive oil diet compared with the rapeseed oil and sunflower oil diets ( ANOVA , P Total HDL cholesterol concentration did not differ significantly , but HDL(2a ) cholesterol was higher after olive oil and rapeseed oil compared with sunflower oil ( ANOVA , P rapeseed oil and sunflower oil had more favorable effects on blood lipids and plasma apolipoproteins as well as on the number and lipid content of LDL subfractions compared with olive oil . Some of the differences may be attributed to differences in the squalene and phytosterol contents of the oils",
"The serum concentration of lipids and composition of fatty acids after overnight fasting were studied in 18 patients with rheumatoid arthritis treated for 12 weeks with either 20 ml of evening primrose oil containing 9 % of gamma-linolenic acid or olive oil . The serum concentrations of oleic acid , eicosapentaenoic acid , and apolipoprotein B decreased and those of linoleic acid , gamma-linolenic acid , dihomo-gamma-linolenic acid , and arachidonic acid increased during treatment with evening primrose oil . During olive oil treatment the serum concentration of eicosapentaenoic acid decreased and those of high density lipoprotein-cholesterol and apolipoprotein A-I increased slightly . The decrease in serum eicosapentaenoic acid and the increase in arachidonic acid concentrations induced by evening primrose oil may not be favourable effects in patients with rheumatoid arthritis in the light of the roles of these fatty acids as precursors of eicosanoids",
"OBJECTIVE The present study was undertaken to examine the effect of a polyunsaturated fat diet compared with an isocaloric Mediterranean-style monounsaturated fat diet . RESEARCH DESIGN AND METHODS This was a r and omized 2-week crossover study on either a high-polyunsaturated or a high-monounsaturated fat diet in 11 well-controlled diabetic men . Blood was taken fasting and for up to 8 h after a high fat meal . Lipoproteins were isolated by sequential ultracentrifugation . Apolipoprotein ( apo ) B48 and apo B100 were separated by PAGE . Fatty acids were analyzed by gas-liquid chromatography RESULTS Fasting blood glucose and insulin levels were significantly higher on the linoleic acid diet compared with the oleic acid diet ( P Plasma cholesterol and LDL cholesterol levels were also significantly higher on the linoleic acid diet ( P fasting chylomicron apo B48 and apo B100 ( P postpr and ial chylomicron and VLDL apo B48 and B100 ( P linoleic acid diet . CONCLUSIONS This study suggests that , in type 2 diabetes , an oleic acid-rich Mediterranean-type diet versus a linoleic acid-enriched diet may reduce the risk of atherosclerosis by decreasing the number of chylomicron remnant particles",
"The effect of rice bran oil , and oil not commonly consumed in the United States , on plasma lipid and apolipoprotein concentrations was studied within the context of a National Cholesterol Education Panel ( NCEP ) Step 2 diet and compared with the effects of canola , corn , and olive oils . The study subjects were 15 middle-aged and elderly subjects ( 8 postmenopausal women and 7 men ; age range , 44 to 78 years ) with elevated low-density lipoprotein ( LDL ) cholesterol ( C ) concentrations ( range , 133 to 219 mg/dL ) . Diets enriched in each of the test oils were consumed by each subject for 32-day periods in a double-blind fashion and were ordered in a Latin square design . All food and drink were provided by the metabolic research unit . Diet components were identical ( 17 % of calories as protein , 53 % as carbohydrate , 30 % as fat [ rice bran , canola , corn , or olive oil . Mean + /- SD plasma total cholesterol concentrations were 192 + /- 19 , 194 + /- 20 , 194 + /- 19 , and 205 + /- 19 mg/dL , and LDL-C concentrations were 109 + /- 30 , 109 + /- 26 , 108 + /- 31 , and 112 + /- 29 mg/dL after consumption of the rice bran , canola , corn , and olive oil-enriched diets , respectively . Plasma cholesterol and LDL-C concentrations were similar and statistically indistinguishable when the subjects consumed the rice bran , canola , and corn oil-enriched diets and lower than when they consumed the olive oil-enriched diet . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Our group has compared plasma lipids in r and omised crossover trials in which approximately half the fat intake of subjects was changed from palmolein to each of three predominantly monounsaturated oils in a series of experiments in free living volunteers . With canola oil total cholesterols were lower than on palmolein ; part of this reduction was due to lower HDL-cholesterol ( HDL-c ) so that total cholesterol/ HDL-c was only 2 % lower . With olive oil mean total cholesterols were the same as on palmolein but HDL-cholesterols were a little lower and LDL-cholesterols a little higher . Plasma lipid fatty acid patterns confirmed the diet change , showing 5 % higher 16 : 0 on palmolein and 11 % higher 18 : 1 on olive oil . To test the possibility that lack of effect of the extra palmitic acid in the palmolein – olive oil comparison was because subjects were young , thin and active , comparison of a third oil , high oleic sunflower oil ( HOSO ) with palmolein was made in both young and middleaged subjects . Plasma total and LDL-cholesterols were 7 % lower in the whole group on HOSO but HDL-c was also 5 % lower so total cholesterol/HDL-c was only 3 % lower than on palmolein . There was no difference in lowering of LDL-c on HOSO between young and older subjects . In comparisons of all three predominantly monounsaturated oils with palmolein a higher HDL-c on palmolein reduced the presumed health benefit of lower total cholesterols on canola and high oleic sunflower oil . The reason for no reduction of total cholesterol on olive oil compared with palmolein was presumably due to the higher linoleic and higher phytosterols in palmolein and higher squalene in the olive oil",
"Objective : The objective of this trial was to compare the effect on the susceptibility of plasma Low Density Lipoprotein ( LDL ) to oxidative modifications of consumption of two oleic rich diets , prepared with two different plant oils , virgin olive oil (OL)1 and refined high monounsaturated fatty acids ( MUFA sunflower oil ( SU ) ) , with the susceptibility of plasma LDL to oxidation after an National Cholesterol Education Program step 1 ( NCEP-I ) phase diet . Design : A r and omized crossover design .Subjects and interventions : Twenty-two healthy normolipidemic young males consumed an NCEP-I diet for a 4-week period . Subjects were then assigned to two diets each of 4-weeks duration . Group one was placed on an olive oil enriched diet ( 40 % fat , 22 % MUFA ) followed by a 4-week period of a MUFA diet enriched in sunflower oil ( 40 % fat , 22 % MUFA ) . In group two , the order of the diets was reversed . Results : Both MUFA diets induced a decrease in saturated ( 14:0 , 16:0 , and 18:0 ) and an increase in monounsaturated and polyunsaturated n-6 ( 18:2 , 20:3 , and 20:5 ) plasma LDL-phospholipid fatty acids , compared to the NCEP-I diet ( P differences in lag times were observed between the olive oil and the NCEP-I diet periods . However there was a greater inhibition time ( P rich sunflower oil diet compared to the NCEP-I diet . These differences were probably related to the relative enrichment of plasma LDL particles in α-tocopherol due to the high vitamin E content of the MUFA-rich sunflower oil . Indeed , the α-tocopherol content was positively correlated with lag time ( r=0.338 ; P susceptibility to oxidation . Sponsorship : This work has been supported by grants from the Investigaciones de la Seguridad Social ( FIS 92/0182 , to Francisco Pérez Jiménez ) ; and from Koype Co , And újar , Jaén , Spain . European Journal of Clinical Nutrition ( 2000 ) 54 ,",
"Background : Corn oil ( CO ) and extra-virgin olive oil ( EVOO ) are rich sources of unsaturated fatty acids ( UFA ) , but UFA profiles differ among oils , which may affect lipoprotein levels . Objectives : The objective of this study was to assess the effects of CO versus EVOO intake on fasting lipoprotein and subfraction cholesterol levels , apolipoprotein ( apo ) A1 , apo B , and low-density lipoprotein particle concentrations in men and women . Subjects/ Methods : As part of a weight maintenance diet , men and women were provided with food items prepared with 54 g per day of CO or EVOO ( 21-day treatment , 21-day washout ) in a r and omized , double-blind , controlled-feeding , crossover trial . Fasting lipoprotein cholesterol and related variables were determined with density gradient ultracentrifugation . Results : Among the 54 completers , CO reduced total cholesterol , low-density lipoprotein cholesterol ( LDL-C ) , very low-density lipoprotein cholesterol ( VLDL-C ) , non-high-density lipoprotein cholesterol ( non-HDL-C ) , apo B and LDL particle concentration to a greater extent compared with EVOO intake . Changes in LDL-C and VLDL-C contributed to the larger reduction in non-HDL-C with CO compared with EVOO intake ( −0.39 mmol/l vs −0.04 mmol/l ; P reduction in LDL-C by CO intake was attributable to changes ( P CO vs EVOO in large LDL1 + 2-C ( −0.22 mmol/l ) and intermediate-density lipoprotein cholesterol ( −0.12 mmol/l ) . HDL-C responses did not differ between treatments , but apo A1 increased more with EVOO compared with CO intake ( 4.6 versus 0.7 mg/dl , respectively , P=0.016 ) . Conclusions : CO intake reduced atherogenic lipoprotein cholesterol and particle concentrations to a larger extent than did EVOO , which may have implication s for cardiovascular disease risk",
"Purpose Lipoprotein associated phospholipase A2 ( Lp-PLA2 ) is a novel inflammatory factor that has been independently associated with stroke and cardiovascular disease ( CVD ) . Omega-3 fats have been implicated in reducing inflammation associated with CVD . The aim of this study was to determine if an 8-week isocaloric diet supplemented with eicosapentaenoic acid ( EPA ) and docosahexaenoic ( DHA ) in the form of fish oil or α-linolenic acid ( ALA ) in the form of flaxseed oil would alter Lp-PLA2 among healthy adults ages 50 years and older . Methods Fifty-nine healthy adults ( ~75 % female , average age 61 years ) were r and omized to one of three groups with equal amounts of total fat intake . All capsules contained ~1 g of fat . The control group ( n = 19 ) consumed olive oil capsules ( ~11 g/day ) ; the ALA group ( n = 20 ) consumed flaxseed oil capsules ( ~11 g/day ) and the EPA/DHA group ( n = 20 ) consumed fish oil capsules ( ~2 g/day + 9 g/day of olive oil ) . Fasting blood sample s were obtained before and after the 8-week intervention for determination of Lp-PLA2 mass and activity as well as lipid values . Results We did not find any significant changes in Lp-PLA2 mass or activity after the intervention in any of the groups ; however , change in oxidized LDL was associated with change in Lp-PLA2 mass ( r = 0.37 , p with omega-3 fatty acids for 8-weeks did not influence Lp-PLA2 activity or mass among older adults ; altering oxidized LDL may be necessary to see changes in Lp-PLA2 levels",
"BACKGROUND & AIMS Hypertension is one of the most important risk factors for coronary heart disease . Recent studies have pointed out the possibility that virgin olive oil ( VOO ) may lower blood pressure in hypertensive ( HT ) subjects . However , until the date there is scarce information regarding elderly people . The present study was design ed to assess the effect of dietary VOO on blood pressure in medically treated hypertensive elderly patients . METHODS 31 medically treated HT elderly patients and 31 normotensive ( NT ) elderly volunteers participated in a r and omized sequential dietary intervention . Subjects consumed diets enriched in sunflower oil ( SO ) or VOO for 4 weeks each with a 4-week washout period between them . RESULTS VOO reduced total and LDL-cholesterol in NT but not in HT ( P levels of tocopherols among the groups studied . Iron-induced oxidation of LDL result ed in a complete loss of monoacylglycerols ( MG ) and diacylglycerols ( DG ) and a reduction in triacylglycerols ( TG ) ( 60 - 80 % ) , which was found to be greater in HT ( P systolic pressure in the HT group ( 136 + /- 10 mmHg ) compared to SO ( 150 + /- 8 mmHg ) . CONCLUSION Dietary VOO proved to be helpful in reducing the systolic pressure of treated HT elderly subjects . However , a greater resistance to the lowering effect of VOO of total and LDL-cholesterol and a greater susceptibility to TG oxidation was detected in these patients",
"BACKGROUND & AIMS The aim of this study was to compare the in vivo effects of a diet rich in virgin olive oil or sunflower oil on the lipid profile and on LDL susceptibility to oxidative modification in free-living Spanish male patients with peripheral vascular disease . METHODS A total of 20 Spanish male subjects diagnosed with peripheral vascular disease were r and omly divided into two groups ( n = 10 ) receiving different supplements , virgin olive oil and sunflower oil for 4 months . RESULTS The adaptation of patients to the experimental supplements was demonstrated since plasma and LDL fatty acids composition reflected dietary fatty acids . No differences in triglycerides , total cholesterol , LDL-cholesterol or HDL-cholesterol concentrations were found between the groups of patients . A significantly higher LDL susceptibility to oxidation was observed after sunflower oil intake in comparison with virgin olive oil , in spite of an increase in LDL alpha-tocopherol concentration in sunflower oil group . CONCLUSIONS The results of the present study provide further evidence that sunflower-oil-enriched diets does not protect LDL against oxidation as virgin olive oil does in patients with peripheral vascular disease",
"Various studies have already shown that the fatty acid composition of dietary fat has different effects on hemostasis and platelet function . However , knowledge on this topic is incomplete . In the present study , fifty-eight healthy students received either a 4-week rapeseed oil [ high content of monounsaturated fatty acids ( MUFA ) and high n-3/n-6 PUFA ratio ] , an olive oil ( high content of MUFA , low n-3/n-6 PUFA ratio ) or a sunflower oil ( low content of MUFA , low n-3/n-6 PUFA ratio ) diet . In each group , effects on hemostatic parameters were compared with a wash-in diet rich in saturated fatty acids with respect to intermediate-time effects on the hemostatic system and platelet function . With the olive oil diet , a reduction of coagulation factors VIIc , XIIc , XIIa , and Xc was found , whereas sunflower oil led to lower values of coagulation factors XIIc , XIIa , and IXc . In all study groups levels of plasmin-alpha2-antiplasmin were lower in week 4 than at baseline . Lower fibrinogen binding on platelets was found after the sunflower oil diet , whereas expression of CD62 and spontaneous platelet aggregation were slightly higher after the olive oil diet . However , given the major differences in the fatty acid compositions of the diets , the differences between the groups with respect to hemostasis tended to be small . Therefore , the clinical significance of the present findings remains to be evaluated",
"The present studies were conducted to evaluate the cholesterolemic effects of whole-food diets high in stearic acid . In study no. 1 , normocholesterolemic young men were fed diets high in stearic acid provided by cocoa butter ( CB ) ; oleic acid provided by olive oil ( OO ) ; linoleic acid provided by soybean oil ( SO ) ; and myristic acid ( and lauric acid ) provided by dairy butter ( B ) . In study no. 2 , different subjects with similar baseline characteristics were fed diets high in stearic acid provided by milk chocolate ( C ) , CB , CB+B ( 4:1 , MIX ) , and myristic ( and lauric ) acid provided by B. Both studies used a r and omized , crossover , double-blind experimental design , and experimental subjects ( n = 18 for study no. 1 and n = 15 for study no. 2 ) in each study consumed every diet for 26 days with a 1-month wash-out period between each experimental period . The diets provided 37 % of calories from fat , of which 81 % was provided by the test fat . Ten ounces ( 280 g ) C was provided daily by the C diet . In study no. 1 , the B diet was hypercholesterolemic , whereas the SO diet was hypocholesterolemic , compared with the other diets . The OO and SO diets were hypocholesterolemic compared with the CB diet . Low-density lipoprotein ( LDL ) cholesterol levels , in general , paralleled the changes in plasma total cholesterol levels . SO significantly decreased apolipoprotein ( apo ) B levels compared with the other diets . Plasma very-low density lipoprotein ( VLDL ) cholesterol , high-density lipoprotein ( HDL ) cholesterol , and apo A-I levels were unaffected by the experimental diets . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE Olive oil ( OO ) is a rich source of monounsaturated fat and bioactive components that exert strong anti-oxidant and anti-inflammatory properties . Flaxseed oil ( FO ) is rich in α-linolenic n-3 fatty acid ( ALA ) , which also exhibits anti-inflammatory effects . This r and omized , cross-over study aim ed at exploring whether diet 's enrichment with FO could beneficially alter inflammatory markers and lipid profile , compared to OO , in a sample of normal weight , apparently healthy young adults . MATERIAL S AND METHODS Participants were supplied with 15 mL/day of either FO or OO . Each intervention and the wash-out period lasted 6 weeks . Dietary , anthropometric and physical activity variables were recorded at the beginning and the end of each intervention . Serum biochemical and inflammatory markers were measured . Compliance to the intervention was evaluated by fatty acid analysis in erythrocytes . Repeated Measures ANOVA was used to assess the effect of the treatment . RESULTS Thirty seven participants completed the study . No difference between the two interventions was observed in adiponectin , TNF-α , high sensitivity-CRP or glucose levels and lipid profile . At the end of the FO period , participants exhibited significant reductions in total ( -5.0 % ) and LDL-cholesterol ( -6.7 % ) levels ( all P period serum adiponectin changes were significantly correlated with changes in erythrocyte % ALA ( rs=0.34 , P=0.007 ) and in erythrocyte % EPA ( r(s)=0.47 , P=0.01 ) , respectively . CONCLUSIONS Daily consumption of FO did not confer any benefit in inflammatory or biochemical markers in normal weight young adults , who traditionally use olive oil as the main edible oil",
"BACKGROUND Postpr and ial lipemia is important in the development of coronary artery disease because of elevated postpr and ial triacylglycerol-rich plasma lipoproteins and suppressed HDL-cholesterol concentrations . We showed in healthy subjects a possible association between postpr and ial lipid metabolism and the responses of the duodenal incretin hormones glucagon-like peptide 1 ( GLP-1 ) and gastric inhibitory polypeptide after meals rich in saturated and monounsaturated fatty acids ( oleic acid ) , respectively . OBJECTIVE The objective was to compare the postpr and ial responses ( 8 h ) of glucose , insulin , fatty acids , triacylglycerol , gastric inhibitory polypeptide , and GLP-1 to saturated- and monounsaturated-rich test meals . DESIGN Twelve overweight patients with type 2 diabetes ingested 3 meals r and omly : an energy-free soup with 50 g carbohydrate ( control meal ) , the control meal plus 100 g butter , and the control meal plus 80 g olive oil . Triacylglycerol responses were measured in total plasma and in a chylomicron-rich and a chylomicron-poor fraction . RESULTS No significant differences in the glucose , insulin , or fatty acid responses to the 2 fat-rich meals were seen . The plasma triacylglycerol and chylomicron triacylglycerol responses were highest after the butter meal . HDL-cholesterol concentrations decreased significantly after the butter meal but did not change significantly after the olive oil meal . GLP-1 responses were highest after the olive oil meal . CONCLUSIONS Olive oil induced lower triacylglycerol concentrations and higher HDL-cholesterol concentrations than did butter , without eliciting significant changes in glucose , insulin , or fatty acids . Furthermore , olive oil induced higher concentrations of GLP-1 , which may indicate a relation between fatty acid composition , incretin responses , and triacylglycerol metabolism postpr and ially in patients with type 2 diabetes",
"Camelina sativa-derived oil ( camelina oil ) is a good source of alpha-linolenic acid . The proportion of alpha-linolenic acid in serum fatty acids is associated with the risk of cardiovascular diseases . We studied the effects of camelina oil on serum lipids and on the fatty acid composition of total lipids in comparison to rapeseed and olive oils in a parallel , double-blind setting . Sixty-eight hypercholesterolemic subjects aged 28 to 65 years were r and omly assigned after a 2-week pretrial period to 1 of 3 oil groups : camelina oil , olive oil , and rapeseed oil . Subjects consumed daily 30 g ( actual intake , approximately 33 mL ) of test oils for 6 weeks . In the camelina group , the proportion of alpha-linolenic acid in fatty acids of serum lipids was significantly higher ( P rapeseed oil group and 4 times higher compared to the olive oil group . Respectively the proportions of 2 metabolites of alpha-linolenic acid ( eicosapentaenoic and docosapentaenoic acids ) increased and differed significantly in the camelina group from those in other groups . During the intervention , the serum low-density lipoprotein ( LDL ) cholesterol concentration decreased significantly by 12.2 % in the camelina oil group , 5.4 % in the rapeseed oil group , and 7.7 % in the olive oil group . In conclusion , camelina oil significantly elevated the proportions of alpha-linolenic acid and its metabolites in serum of mildly or moderately hypercholesterolemic subjects . Camelina oil 's serum cholesterol-lowering effect was comparable to that of rapeseed and olive oils",
"This study examines , for the first time , the effect of hybrid Elaeis oleifera × E. guineensis palm oil supplementation on human plasma lipids related to CVD risk factors . One hundred sixty eligible participants were r and omized and assigned to one of the two treatments : 25 mL hybrid palm oil ( HPO group ) or 25 mL extra virgin olive oil ( EVOO group ) daily for 3 months . Fasting venous sample s were obtained at baseline and after 1 , 2 and 3 months for measurement of plasma lipids ( TC , LDL-C , HDL-C and TAGs ) . Changes in body mass index and waist circumference were also assessed . Although there was an overall reduction in TC ( 7.4 % , p LDL-C ( 15.6 % , p TC ( p = 0.0525 ) , LDL-C ( p = 0.2356 ) , HDL-C ( p = 0.8293 ) or TAGs ( p = 0.3749 ) . Furthermore , HPO consumption had similar effects on plasma lipids to EVOO , thus providing additional support for the concept that hybrid Elaeis oleifera × E. guineensis palm oil can be seen as a \" tropical equivalent of olive oil \""
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Excessive sedentary time is detrimentally linked to obesity , type 2 diabetes , cardiovascular disease and premature mortality . Studies have been investigating the use of activity-permissive workstations to reduce sedentary time in office workers , a highly sedentary target group . This review systematic ally summarizes the evidence for activity-permissive workstations on sedentary time , health-risk biomarkers , work performance and feasibility indicators in office workplaces . In July 2013 , a literature search identified 38 relevant peer- review ed publications . Key findings were independently extracted by two research ers . The average intervention effect on sedentary time was calculated via meta- analysis . In total , 984 participants across 19 field-based trials and 19 laboratory investigations were included , with sample sizes ranging from n = 2 to 66 per study . Sedentary time , health-risk biomarkers and work performance indicators were reported in 13 , 23 and 23 studies , respectively . The pooled effect size from the meta- analysis was -77 min of sedentary time/8-h workday ( 95 % confidence interval = -120 , -35 min ) . Non-significant changes were reported for most health- and work-related outcomes . Studies with acceptability measures reported predominantly positive feedback . Findings suggest that activity-permissive workstations can be effective to reduce occupational sedentary time , without compromising work performance . Larger and longer-term r and omized-controlled trials are needed to underst and the sustainability of the sedentary time reductions and their longer-term impacts on health- and work-related outcomes
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"Background Excessive time spent in sedentary behaviours ( sitting or lying with low energy expenditure ) is associated with an increased risk for type 2 diabetes , cardiovascular disease and some cancers . Desk-based office workers typically accumulate high amounts of daily sitting time , often in prolonged unbroken bouts . The St and Up Victoria study aims to determine whether a 3-month multi-component intervention in the office setting reduces workplace sitting , particularly prolonged , unbroken sitting time , and results in improvements in cardio-metabolic biomarkers and work-related outcomes , compared to usual practice . Methods / Design A two-arm cluster-r and omized controlled trial ( RCT ) , with worksites as the unit of r and omization , will be conducted in 16 worksites located in Victoria , Australia . Work units from one organisation ( Department of Human Services , Australian Government ) will be allocated to either the multi-component intervention ( organisational , environmental [ height-adjustable workstations ] , and individual behavioural strategies ) or to a usual practice control group . The recruitment target is 160 participants ( office-based workers aged 18–65 years and working at least 0.6 full time equivalent ) per arm . At each assessment ( 0- [ baseline ] , 3- [ post intervention ] , and 12-months [ follow-up ] ) , objective measurement via the activPAL3 activity monitor will be used to assess workplace : sitting time ( primary outcome ) ; prolonged sitting time ( sitting time accrued in bouts of ≥30 minutes ) ; st and ing time ; sit-to-st and transitions ; and , moving time . Additional outcomes assessed will include : non-workplace activity ; cardio-metabolic biomarkers and health indicators ( including fasting glucose , lipids and insulin ; anthropometric measures ; blood pressure ; and , musculoskeletal symptoms ) ; and , work-related outcomes ( presenteeism , absenteeism , productivity , work performance ) . Incremental cost-effectiveness and identification of both workplace and individual-level mediators and moderators of change will also be evaluated . Discussion St and Up Victoria will be the first cluster- RCT to evaluate the effectiveness of a multi-component intervention aim ed at reducing prolonged workplace sitting in office workers . Strengths include the objective measurement of activity and assessment of the intervention on markers of cardio-metabolic health . Health- and work-related benefits , as well as the cost-effectiveness of the intervention , will help to inform future occupational practice .Trial registration",
"BACKGROUND A prospect i ve study of computer users was performed to determine the occurrence of and evaluate risk factors for neck or shoulder ( N/S ) and h and or arm ( H/A ) musculoskeletal symptoms ( MSS ) and disorders ( MSD ) . METHODS Individuals ( n = 632 ) newly hired into jobs requiring > or = 15 hr/week of computer use were followed for up to 3 years . At study entry , workstation dimensions and worker postures were measured and medical and psychosocial risk factors were assessed . Daily diaries were used to document work practice s and incident MSS . Those reporting MSS were examined for specific MSD . Incidence rates of MSS and MSD were estimated with survival analysis . Cox regression models were used to evaluate associations between participant characteristics at entry and MSS and MSD . RESULTS The annual incidence of N/S MSS was 58 cases/100 person-years and of N/S MSD was 35 cases/100 person-years . The most common N/S MSD was somatic pain syndrome . The annual incidence of H/A MSS was 39 cases/100 person-years and of H/A MSD was 21 cases/100 person-years . The most common H/A disorder was deQuervain 's tendonitis . Forty-six percent of N/S and 32 % of H/A MSS occurred during the first month of follow-up . Gender , age , ethnicity , and prior history of N/S pain were associated with N/S MSS and MSD . Gender , prior history of H/A pain , prior computer use , and children at home were associated with either H/A MSS or MSD . CONCLUSIONS H/A and N/S MSS and MSD were common among computer users . More than 50 % of computer users reported MSS during the first year after starting a new job",
"Background : Seated working positions are often regarded as a cause for discomfort in the musculoskeletal system . Performing work in different working positions — that is , alternating between sitting and st and ing ( sit-st and workstation paradigm)—could help reduce physical complaints . Objective : The questions were whether performing office work partly in a st and ing position leads to reduced complaints and whether st and ing would change the efficiency of data entry office work . Method : We investigated the effect of a sit-st and workstation paradigmd during experimental data entry office work on physical and psychological complaints and data entry efficiency by conducting a r and omized controlled trial with 60 male participants ages 18 to 35 years . Results : In this experiment , musculoskeletal complaints were reduced by a sit-st and workstation paradigm . A trend could be identified indicating a small but nonsignificant loss of efficiency in data entry while st and ing . Conclusion : A sit-st and workstation paradigm reduces musculoskeletal complaints without considerably affecting data entry efficiency under the presented study conditions ( young male participants , short duration , fixed and controlled sit-st and workstation paradigm , simulated experimental working condition ) . Application : According to the present data , implementing a sit-st and workstation paradigm can be an effective workplace health intervention to reduce musculoskeletal complaints . This experiment encourages further studies on the effectiveness of a sit-st and workstation paradigm . Experimental research and field studies that prove the reduction of complaints when introducing a sit-st and workstation paradigm in the workplace could be the basis for evidence -based recommendations regarding such interventions",
"OBJECTIVE Observational studies show breaking up prolonged sitting has beneficial associations with cardiometabolic risk markers , but intervention studies are required to investigate causality . We examined the acute effects on postpr and ial glucose and insulin levels of uninterrupted sitting compared with sitting interrupted by brief bouts of light- or moderate-intensity walking . RESEARCH DESIGN AND METHODS Overweight/obese adults ( n = 19 ) , aged 45–65 years , were recruited for a r and omized three-period , three-treatment acute crossover trial : 1 ) uninterrupted sitting ; 2 ) seated with 2-min bouts of light-intensity walking every 20 min ; and 3 ) seated with 2-min bouts of moderate-intensity walking every 20 min . A st and ardized test drink was provided after an initial 2-h period of uninterrupted sitting . The positive incremental area under curves ( iAUC ) for glucose and insulin ( mean [ 95 % CI ] ) for the 5 h after the test drink ( 75 g glucose , 50 g fat ) were calculated for the respective treatments . RESULTS The glucose iAUC ( mmol/L ) ⋅ h after both activity-break conditions was reduced ( light : 5.2 [ 4.1–6.6 ] ; moderate : 4.9 [ 3.8–6.1 ] ; both P compared with uninterrupted sitting ( 6.9 [ 5.5–8.7 ] ) . Insulin iAUC ( pmol/L ) ⋅ h was also reduced with both activity-break conditions ( light : 633.6 [ 552.4–727.1 ] ; moderate : 637.6 [ 555.5–731.9 ] , P compared with uninterrupted sitting ( 828.6 [ 722.0–950.9 ] ) . CONCLUSIONS Interrupting sitting time with short bouts of light- or moderate-intensity walking lowers postpr and ial glucose and insulin levels in overweight/obese adults . This may improve glucose metabolism and potentially be an important public health and clinical intervention strategy for reducing cardiovascular risk ",
"Background Occupational sedentary behaviour is an important contributor to overall sedentary risk . There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours . The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time , sustained sedentary time ( bouts > 30 minutes ) , increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity ( MVPA ) during work hours . Methods A r and omised controlled trial ( ANZCTR number : ACTN12612000743864 ) was conducted using clerical , call centre and data processing workers ( n = 62 , aged 25–59 years ) in 3 large government organisations in Perth , Australia . Three groups developed interventions with a participatory approach : ‘ Active office ’ ( n = 19 ) , ‘ Active Workstation ’ and promotion of incidental office activity ; ‘ Traditional physical activity ’ ( n = 14 ) , pedometer challenge to increase activity between productive work time and ‘ Office ergonomics ’ ( n = 29 ) , computer workstation design and breaking up computer tasks . Accelerometer ( ActiGraph GT3X , 7 days ) determined sedentary time , sustained sedentary time , breaks in sedentary time , light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period . Results For all participants there was a significant reduction in sedentary time on work days ( −1.6 % , p = 0.006 ) and during work hours ( −1.7 % , p = 0.014 ) and a significant increase in number of breaks/sedentary hour on work days ( 0.64 , p = 0.005 ) and during work hours ( 0.72 , p = 0.015 ) ; there was a concurrent significant increase in light activity during work hours ( 1.5 % , p = 0.012 ) and MVPA on work days ( 0.6 % , p = 0.012 ) . Conclusions This study explored novel ways to modify work practice s to reduce occupational sedentary behaviour . Participatory workplace interventions can reduce sedentary time , increase the frequency of breaks and improve light activity and MVPA of office workers by using a variety of interventions . Trial Registration Australian New Zeal and Clinical Trials Registry ACTN12612000743864",
"Objectives To test the efficacy of a multicomponent technology intervention for reducing daily sedentary time and improving cardiometabolic disease risk among sedentary , overweight university employees . Design Blinded , r and omised controlled trial . Setting A large south-eastern university in the USA . Participants 49 middle-aged , primarily female , sedentary and overweight adults working in sedentary jobs enrolled in the study . A total of 40 participants completed the study . Interventions Participants were r and omised to either : ( 1 ) an intervention group ( N=23 ; 47.6 + 9.9 years ; 94.1 % female ; 33.2 + 4.5 kg/m2 ) ; ( 2 ) or wait-list control group ( N=17 ; 42.6 + 8.9 years ; 86.9 % female ; 31.7 + 4.9 kg/m2 ) . The intervention group received a theory-based , internet-delivered programme , a portable pedal machine at work and a pedometer for 12 weeks . The wait-list control group maintained their behaviours for 12 weeks . Outcome measures Primary ( sedentary and physical activity behaviour measured objective ly through StepWatch ) and secondary ( heart rate , blood pressure , height , weight , waist circumference , per cent body fat , cardiorespiratory fitness , fasting lipids ) outcomes were measured at baseline and postintervention ( 12 weeks ) . Exploratory outcomes including intervention compliance and process evaluation measures were also assessed postintervention . Results Compared to controls , the intervention group reduced daily sedentary time ( mean change ( 95%CI ) : −58.7 min/day ( −118.4 to 0.99 ; p daily sedentary time among full-time sedentary employees . These findings hold public health significance due to the growing number of sedentary jobs and the potential of these technologies in large-scale worksite programmes . Trial Registration Clinical Trials.gov # NCT01371084",
"Sitting on a therapy ball or st and ing may be a passive means of increasing energy expenditure throughout the workday . The purpose of this study was to determine the energy expenditure and liking of performing clerical work in various postures . Subjects included 24 men and women employed in sedentary clerical occupations . Energy expenditure was measured while word processing in three st and ardized postures ; sitting in an office chair , sitting on a therapy ball , and st and ing . Adults ranked their comfort , fatigue , and liking of each posture and were asked to perform their choice of 20 min of additional clerical work in one of the postures . Energy expenditure was 4.1 kcal/h greater ( p ≤ 0.05 ) while performing clerical work while sitting on a therapy ball and st and ing than while sitting in an office chair . There was no difference in energy expenditure between the therapy ball and st and ing postures ( p ≥ 0.48 ) . Subjects also liked sitting on a therapy ball as much as sitting in an office chair and liked sitting on a therapy ball more than st and ing ( p ≤ 0.05 ) . More subjects chose to perform additional clerical work while seated on a therapy ball than while st and ing ( p = 0.03 ) . In conclusion , sitting on a therapy ball or st and ing rather than sitting in an office chair while performing clerical work increases passive energy expenditure ",
"BACKGROUND Prolonged sitting is prevalent in the workplace and is associated with adverse health markers . PURPOSE Investigate the effects of point-of-choice ( PoC ) prompting software , on the computer used at work ( PC ) , to reduce long uninterrupted sedentary periods and total sedentary time at work . DESIGN Assessor-blinded , parallel group , active-controlled r and omized trial . SETTING / PARTICIPANTS A convenience sample of office workers from Glasgow , United Kingdom . Data were collected April to June 2010 , and analyzed October 2010 to June 2011 . INTERVENTION The education group ( n=14 ) received a brief education session on the importance of reducing long sitting periods at work . The PoC group ( n=14 ) received the same education along with prompting software on their PC for 5 workdays , which reminded them to st and up every 30 minutes . MAIN OUTCOME MEASURES Sitting time was measured objective ly using the activPAL ™ activity monitor for 5 workdays at baseline and 5 workdays during the intervention . The number and time spent sitting in events > 30 minutes ' duration were the main outcome measures . RESULTS At baseline , participants spent 5.7±1.0 hours/day ( 76%±9 % ) of their time at work sitting . Of that time , 3.3±1.3 hours/day was spent sitting in 3.7±1.4 events > 30 minutes . There was a significant difference between the groups in the change ( intervention to baseline ) of both the number ( ANCOVA ; -6.8 % , p=0.014 ) and duration ( -15.5 % , p=0.007 ) of sitting events > 30 minutes . During the intervention , compared with baseline , the PoC group reduced the number ( paired t-test ; -0.11 events/hour , p=0.045 ) and duration ( -12.2 % , p=0.035 ) of sitting events > 30 minutes . However , there was no significant difference in total sitting time between groups ( -4.4 % , p=0.084 ) . CONCLUSIONS Point-of-choice prompting software on work computers recommending taking a break from sitting plus education is superior to education alone in reducing long uninterrupted sedentary periods at work . TRIAL REGISTRATION This trial was registered at Clinical Trials.govNCT01628861",
"Work Related Musculoskeletal Disorders ( WMSDs ) among office workers with intensive computer use is widespread and the prevalence of symptoms is growing . This r and omized controlled trial investigated the effects of an office ergonomics training combined with a sit-st and workstation on musculoskeletal and visual discomfort , behaviors and performance . Participants performed a lab-based customer service job for 8 h per day , over 15 days and were assigned to : Ergonomics Trained ( n = 11 ) or Minimally Trained ( n = 11 ) . The training consisted of : a 1.5-h interactive instruction , a sit/st and practice period , and ergonomic reminders . Ergonomics Trained participants experienced minimal musculoskeletal and visual discomfort across the 15 days , varied their postures , with significantly higher performance compared to the Minimally Trained group who had a significantly higher number of symptoms , suggesting that training plays a critical role . The ability to mitigate symptoms , change behaviors and enhance performance through training combined with a sit-st and workstation has implication s for preventing discomforts in office workers",
"BACKGROUND Desk-based office employees sit for most of their working day . To address excessive sitting as a newly identified health risk , best practice frameworks suggest a multi-component approach . However , these approaches are re source intensive and knowledge about their impact is limited . PURPOSE To compare the efficacy of a multi-component intervention to reduce workplace sitting time , to a height-adjustable workstations-only intervention , and to a comparison group ( usual practice ) . DESIGN Three-arm quasi-r and omized controlled trial in three separate administrative units of the University of Queensl and , Brisbane , Australia . Data were collected between January and June 2012 and analyzed the same year . SETTING / PARTICIPANTS Desk-based office workers aged 20 - 65 ( multi-component intervention , n=16 ; workstations-only , n=14 ; comparison , n=14 ) . INTERVENTION The multi-component intervention comprised installation of height-adjustable workstations and organizational-level ( management consultation , staff education , manager e-mails to staff ) and individual-level ( face-to-face coaching , telephone support ) elements . MAIN OUTCOME MEASURES Workplace sitting time ( minutes/8-hour workday ) assessed objective ly via activPAL3 devices worn for 7 days at baseline and 3 months ( end-of-intervention ) . RESULTS At baseline , the mean proportion of workplace sitting time was approximately 77 % across all groups ( multi-component group 366 minutes/8 hours [ SD=49 ] ; workstations-only group 373 minutes/8 hours [ SD=36 ] , comparison 365 minutes/8 hours [ SD=54 ] ) . Following intervention and relative to the comparison group , workplace sitting time in the multi-component group was reduced by 89 minutes/8-hour workday ( 95 % CI=-130 , -47 minutes ; p A multi-component intervention was successful in reducing workplace sitting . These findings may have important practical and financial implication s for workplaces targeting sitting time reductions . CLINICAL TRIAL REGISTRATION Australian New Zeal and Clinical Trials Registry 00363297",
"The aim of this study was to compare the postural load during VDU work in the following work postures : ( 1 ) Supporting and not supporting the forearms on the table top , ( 2 ) Sitting and st and ing positions , and ( 3 ) Sightline to the centre of the screen at an angle of 15 degrees and 30 degrees below the horizontal . The muscle load from the upper part of musculus trapezius and from the lumbar part of musculus erector spinae ( L3 level ) was measured by electromyography ( EMG ) . Postural angles of head , upper arm and back were measured by inclinometers . The load on m. trapezius when using the keyboard was significantly less in sitting with supported forearms compared to sitting and st and ing without forearm support . Further , the time and number of periods when the trapezius load was below 1 % MVC was significantly greater with support versus no support . The load on the right erector spinae lumbalis was also significantly less and the time when the load was below 1 % MVC was significantly longer in a sitting work position with support versus st and ing without support . In addition , when using a mouse supporting the forearms reduced the static trapezius load in sitting . The results from this study document clearly the importance of giving the operator the possibility of supporting the forearms on the table top",
"OBJECTIVE To investigate the short-term efficacy of a multicomponent intervention to reduce office workers ' sitting time . METHODS Allocation for this non-r and omized controlled trial ( n=43 participants ; 56 % women ; 26 - 62 years ; Melbourne , Australia ) was by office floor , with data collected during July-September 2011 . The 4-week intervention emphasized three key messages : \" St and Up , Sit Less , Move More \" and comprised organizational , environmental , and individual elements . Changes in minutes/day at the workplace spent sitting ( primary outcome ) , in prolonged sitting ( sitting time accumulated in bouts ≥ 30 min ) , st and ing , and moving were objective ly measured ( activPAL3 ) . RESULTS Relative to the controls , the intervention group significantly reduced workplace sitting time ( mean change [ 95%CI ] : -125 [ -161 , -89 ] min/8-h workday ) , with changes primarily driven by a reduction in prolonged sitting time ( -73 [ -108 , -40 ] min/8-h workday ) . Workplace sitting was almost exclusively replaced by st and ing ( + 127 [ + 92 , + 162 ] min/8-h workday ) with non-significant changes to stepping time ( -2 [ -7 , + 4 ] min/8-h workday ) and number of steps ( -70 [ -350 , 210 ] ) . CONCLUSIONS This multicomponent workplace intervention demonstrated that substantial reductions in sitting time are achievable in an office setting . Larger studies with longer timeframes are needed to assess sustainability of these changes , as well as their potential longer-term impacts on health and work-related outcomes",
"PURPOSE This study aim ed to examine whether reductions in sitting time through alternating 30-min bouts of sitting and st and ing can reduce postpr and ial glucose , insulin , and triglyceride responses . METHODS Twenty-three overweight/obese sedentary office workers ( 17 males and six females ; mean ± SD : age , 48.2 ± 7.9 yr ; body mass index , 29.6 ± 4.0 kg · m(-2 ) ) undertook two short-term ( 5 d ) experimental conditions in an equal , r and omized ( 1:1 ) order . In a simulated office environment , participants performed typical occupational tasks for 8 h · d(-1 ) while in a 1 ) seated work posture ( control condition ) or 2 ) interchanging between a seated and st and ing work posture every 30 min using an electric , height-adjustable workstation ( intervention condition ) . Fasting and postpr and ial blood sample s after a mixed test drink were collected hourly for 4 h on days 1 and 5 of each condition to assess serum insulin , plasma glucose , and triglycerides . Dietary intake ( kJ · d(-1 ) ) and physical activity were st and ardized during each condition . The trial was registered with the Australian New Zeal and Clinical Trials Registry ( ACTRN12611000632998 ) . RESULTS After adjustment for time ( days 1 and 5 ) , incremental area under the analyte time curve differed significantly between conditions for plasma glucose ( P = 0.007 ) but not for serum insulin or plasma triglycerides . Adjusted mean glucose incremental area under the analyte time curve was lowered by 11.1 % after the intervention condition ( 6.38 mM · h(-1 ) ( confidence interval , 5.04 - 7.71 ) ) relative to the control condition ( 7.18 mM · h(-1 ) ( confidence interval , 5.85 - 8.52 ) ) . No temporal changes ( days 1 vs 5 ) between conditions were observed . CONCLUSIONS Alternating st and ing and sitting in 30-min bouts results in modest beneficial effects on postpr and ial glucose responses in overweight/obese office workers",
"Objective To evaluate the effectiveness of a draft occupational health practice guideline aim ed at preventing weight gain on employees ' physical activity , sedentary behaviour and dietary behaviour and on body weight-related outcomes . Methods A r and omised controlled trial was performed comparing guideline -based care to usual care among 16 occupational physicians and 523 employees in the Netherl and s between 2009 and 2011 . Occupational physicians in the intervention group followed the draft guideline by providing advice to employers on how to assess and intervene on the obesogenic work environment and conducted five face-to-face behavioural change counselling sessions with employees to improve their lifestyle . Data of employees were collected by question naire and physical measurements at baseline and 6-months follow-up . Linear and logistic regression analyses were performed to determine effects . Results The intervention showed significant effects on sedentary behaviour at work ( β −28 min/day , 95 % CI −2 to −54 ) and on fruit intake ( β 2.1 pieces/week ; 95 % CI 0.6 to 3.6 ) . No significant intervention effects were found for physical activity , sedentary behaviour in leisure time or during weekend days , snack intake and body weight-related outcomes . Conclusion Guideline -based care result ed in a more favourable sedentary behaviour at work and increased fruit intake but did not improve employees ' physical activity , snack intake or body weight-related outcomes . Trial registration number IS RCT N/73545254 and NTR/1190"
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OBJECTIVES To determine if enteral feeding with donor human milk compared with formula milk reduces the incidence of necrotising enterocolitis ( NEC ) in preterm or low birthweight infants . METHODS Systematic review and meta- analysis of r and omised controlled trials . RESULTS Four small trials , all initiated more than 20 years ago , fulfilled the prespecified inclusion criteria . None of the trials individually found any statistically significant difference in the incidence of NEC . However , meta- analysis found that feeding with donor human milk was associated with a significantly reduced relative risk ( RR ) of NEC . Infants who received donor human milk were three times less likely to develop NEC ( RR 0.34 ; 95 % confidence interval ( CI ) 0.12 to 0.99 ) , and four times less likely to have confirmed NEC ( RR 0.25 ; 95 % CI 0.06 to 0.98 ) than infants who received formula milk . CONCLUSIONS It may be appropriate to consider further larger trials to compare growth , development , and the incidence of adverse outcomes , including NEC , in preterm infants who receive donor human milk versus formula milk
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"Poor weight gain observed in preterm infants who were fed expressed breast milk compared with those fed a cows ' milk formular prompted a detailed study of early postnatal growth in preterm infants fed these two milks . 68 infants were divided into two categories by gestational age at birth ( i ) 28 - 32 weeks ( n=28 ) , ( ii ) 33 - 36 weeks ( n=40 ) . They were r and omly allocated to a feed of expressed breast milk or a milk formula ( Ostermilk 1 ) . Rates of weight gain , linear growth , and head circumference growth were evaluated over two periods : birth-1 month , 1 - 2 months . The younger group who were fed breast milk showed slower overall growth rates over the first month than those fed formula . In the second month , and for the older infants over both of the 2-monthly periods , growth rates were similar in the two feeding regimens . It is concluded that expressed breast milk is inadequate for the growth of very immature preterm infants during early postnatal life",
"A large multicentre study on the short and long term clinical and developmental outcome of infants r and omised to different diets is being undertaken . This report represents an interim analysis of the early postnatal growth performance of an unselected population of 194 preterm infants ( gestation , mean ( SD ) 31 . 0 ( 2 . 9 ) weeks ; birthweight , mean ( SD ) 1364 ( 294 ) g ) , both ill and well , examined in two ( of four ) parallel trials . One trial compared banked breast milk with a new preterm formula ( primary trial ) ; the other compared these diets as supplements to maternal milk ( supplement trial ) . A major dietary effect on the number of days taken to regain birthweight and subsequent gains in weight , length , and head circumference was observed in the primary trial . Infants fed banked breast milk and weighing less than 1200 g at birth took a calculated additional three weeks to reach 2000 g compared with those fed on the preterm formula . A significant influence of diet on body proportions was seen in the relation between body weight , head circumference , and length . Similar though smaller differences in growth patterns were seen in the supplement trial . By the time they reach 2000 g , infants of birthweights 1200 to 1849 g fed on banked breast milk and infants below 1200 g fed on either banked breast milk or maternal milk supplemented ( as necessary ) with banked breast milk , fulfilled stringent criteria for failure to thrive ( weight less than 2 SD below the mean for age ) . Only infants fed the preterm formula as their sole diet had maintained their birth centile by discharge from hospital . The misleading nature of comparisons between extrauterine and intrauterine steady state weight gains is emphasised",
"The effect of diet , human milk or formula , on gastric function ( lipase and pepsin activity , pH , and volume ) and intragastric digestion of fat was assessed in 28 appropriate for gestational age preterm infants ( gestational age , 28.9 ± 1.4 , 29.1 ± 0.9 , 29.5 ± 0.6 wk ; birth weight , 1.00 ± 0.14 to 1.18 ± 0.07 kg ) . The infants were fed either human milk ( n = 11 ) , SMA Super Preemie formula ( n = 9 ) , or Similac , Special Care formula ( n = 8) . Fasting and postpr and ial activity of digestive enzymes , pH , and gastric volume ( measured before or during 50 min after gavage feeding ) did not differ as a function of diet among the three groups of infants . Gastric lipase output , 23.1 ± 5.1 , 28.3± 6.6 , and 22.5 ± 6.4 ( U/kg of body weight ) in human milk- , SMA SP- , or Similac SC-fed infants was comparable to the gastric lipase output of healthy adults fed a high fat diet ( 22.6 ± 3.0 ) . Pepsin output was , however , significantly lower ( 597 ± 77 , 743 ± 97 , and 639± 142 U/kg of body weight ) in human milk- , SMA SP- , and Similac SC-fed infants ) than in healthy adults ( 3352 ± 753 U/kg ) . The hydrolysis of dietary fat was 1.7 - 2.5-fold higher ( p human milk-fed infants than in infants fed either formula . We conclude that differences in type of feeding , i.e. different fatty acid profiles(long chain or medium chain triglycerides ) , different emulsions ( natural or artificial ) , and different fat particle sizes do not affect the level of activity of gastric enzymes . However , the triglyceride within milk fat globules appears to be more accessible to gastric lipase than that within formula fat particles . We suggest that the contribution of gastric lipase to overall fat digestion might be greater in the newborn ( a period of pancreatic insufficiency ) than in the adult",
"My colleagues and I compared the biochemical status and rates of growth of three groups of preterm infants : one group was fed milk obtained early from mothers of preterm infants ; one group received milk produced during the mature stage of lactation by mothers of term infants ; and one group received a whey-based infant formula . Sixty healthy preterm infants with birth weights of 1600 g or less were r and omly assigned to one of the three feedings groups . The 20 infants in each group were followed until they reached a weight of 1800 g. The mean ( + /- S.E.M. ) number of days required to regain birth weight was similar for infants receiving the formula ( 10.3 + /- 0.8 ) and those receiving milk from mothers of preterm infants ( 11.4 + /- 0.8 ) ; both were significantly less than the number ( 18.8 + /- 1.7 ) for infants receiving milk from mothers of term infants ( P less than 0.001 ) . Subsequent rates of weight gain were greater for the groups receiving formula ( 27.0 + /- 0.8 g per day ) and milk from mothers of preterm infants ( 23.7 + /- 1.1 ) than for the group receiving milk from mothers of term infants ( 15.8 + /- 0.8 ) ( P less than 0.001 ) . Similarly , the average increments in crown-to-heel length and in the head circumference were significantly greater for the groups given formula and milk from mothers of preterm infants ( P less than 0.005 and P less than 0.001 , respectively ) . These data indicate that feeding with either milk from mothers of preterm infants or a whey-based infant formula results in more appropriate growth in preterm infants than feeding with milk from mothers of term infants",
"ABSTRACT . This paper comprises 261 low birth weight infants who were divided into four groups with different feeding schedules . Group I – expressed human milk for all the feeds ; Group II – human milk for half the feeds and the nursery formula for the rest ; Group III – colostrum , 20 ml three times a day along with the nursery formula ; and Group IV – control – only the nursery formula . The groups were matched by means of a r and omised block design for identifiable factors which could predispose to the occurrence of infection . Infections were found to be significantly less in the groups which received human milk ( p < 0.001 )",
"In a prospect i ve multicentre study on 926 preterm infants formally assigned to their early diet , necrotising enterocolitis developed in 51 ( 5.5 % ) . Mortality was 26 % in stringently confirmed cases . In exclusively formula-fed babies confirmed disease was 6 - 10 times more common than in those fed breast milk alone and 3 times more common than in those who received formula plus breast milk . Pasteurised donor milk seemed to be as protective as raw maternal milk . Among babies born at more than 30 weeks ' gestation confirmed necrotising enterocolitis was rare in those whose diet included breast milk ; it was 20 times more common in those fed formula only . Other risk factors included very low gestational age , respiratory disease , umbilical artery catheterisation , and polycythaemia . In formula-fed but not breast-milk-fed infants , delayed enteral feeding was associated with a lower frequency of necrotising enterocolitis . With the fall in the use of breast milk in British neonatal units , exclusive formula feeding could account for an estimated 500 extra cases of necrotising enterocolitis each year . About 100 of these infants would die",
"A controlled prospect i ve study was undertaken of 62 high-risk low-birth-weight infants to evaluate the effect of expressed human milk on the prevention of infection . One half received EHM and the remaining half were administered the nursery formula . There was no statistically significant difference in the predisposing factors in the two groups . Infections , however , were much fewer in babies who received EHM (",
"Svenningsen , N.W. , Lindroth , M. and Lindquist , B. ( Department of Paediatrics , University of Lund , Sweden ) . A comparative study of varying protein intake in low birthweight infant feeding . Acta Paediatr Sc and . Suppl . 296 : 28 , 1982 . — In a prospect i ve longitudinal study of 48 very low birthweight and preterm infants with mean birthweight 1 385±343 and gestational age 30.8±2.9 w an assessment was made of the impact of varying the protein intake in the postnatal period from the 3rd to 7th week of life . The infants were r and omly allocated to one of three dietary groups with isocaloric energy supply but different protein content — i.e . human milk ( 1.6 g/100 kcal ) , formula 1 ( 2.3 g/100 kcal ) and formula 2 ( 3.0 g/100 kcal ) . In the human milk group 12 of 18 infants were fed their own mother 's breastmilk . During the study period the mean weight gain was slightly higher in the infants fed formula 1 and 2 . There were no group differences in S‐albumin whereas B‐urea‐N and B‐base deficit were significantly increased in the formula fed infants in comparison to infants fed human milk . After the study period until around 15 weeks of age the slope in weight gain remained slightly higher for formula fed infants . However , the gain in body length and head circumference was equal in all three groups . After around 8 months of age there was no difference in any growth parameter . Neurodevelopmental examinations showed no group differences during the follow‐up period to 2 years of age",
"Growth , protein , and energy balances were studied in two groups of very-low-birth-weight premature infants fed pooled pasteurized human milk ( HM ) or a preterm formula ( PF ) . Each infant was studied at 33 and 36 weeks gestational age with a combined technique of nutrient balance and indirect calorimetry measurement . Weight and length gains were higher with PF than with HM , but head circumference growth was similar with both milks . Although the volume of milk given was lower , energy intake was higher with PF than with HM in both studies ( 126 to 130 vs 103 to 109 kcal/kg/day ) . Percentage of energy absorbed was better with PF than with HM ( 94 % vs 84 % ) at 33 weeks , and similar ( 95 % ) with both milks at 36 weeks . Energy expenditure , which had increased from 33 weeks to 36 weeks , was higher with PF than with HM ( 57 to 63 vs 46 to 52 kcal/kg/day ) during both studies . Energy retention accounted for about 50 % of energy absorbed with both milks , but was higher with PF than with HM ( 60 vs 40 to 50 kcal/kg/day ) in both studies , and result ed in fat accretion well above that seen during intrauterine growth for both milks in both studies . Protein intake was higher with PF than with HM ( 3.1 vs 2.4 gm/kg/day ) in both studies , giving a protein accretion similar to the intrauterine accretion with PF ( 2.2 gm/kg/day ) , but lower with HM . Our results suggest that the nutritional value of pooled pasteurized human milk for VLBW infants should be reconsidered , especially because of its low protein content , and that energy density of preterm formulas must be question ed in view of elevated fat deposition"
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41170136-06ff-11f0-808a-c43d1ab1c353
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Although atrial fibrillation ( AF ) is the most common sustained arrhythmia seen during daily cardiovascular physician practice , its management remained a challenge for cardiology physician as there was no single anti-arrhythmic agents proved to be effective in converting atrial fibrillation and kept its effectiveness in maintaining sinus rhythm over long term . Moreover all the anti-arrhythmic agents that are used in treatment of AF were potentially pro-arrhythmic especially in patients with coronary artery disease and structurally abnormal heart . Some of these drugs also have serious non cardiac side effects that limit its long term use in the management of atrial fibrillation . Several new and investigational anti-arrhythmic agents are emerging but data supporting their effectiveness and safety are still limited . In this systematic review we examine the efficacy and safety of these medications supported by the major published r and omized trials , meta-analyses and review articles and conclude with a summary of guidelines recommendations
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"Background Atrial fibrillation ( AF ) shortens the atrial effective refractory period ( ERP ) and predisposes to further episodes of AF . The acute changes in atrial refractoriness may be related to tachycardia-induced intracellular calcium overload . The purpose of this study was to determine whether digoxin , which increases intracellular calcium , potentiates the acute effects of AF on atrial refractoriness in humans . Methods and Results In 38 healthy adults , atrial ERP was measured at basic drive cycle lengths ( BDCLs ) of 350 and 500 ms after autonomic blockade . Nineteen patients had been treated with digoxin for 2 weeks . After a several-minute episode of AF , atrial ERP was measured serially at alternating BDCLs . Compared with pre-AF ERPs , the first post-AF ERPs were significantly shorter in both the digoxin and the control groups ( P The post-AF ERP at a BDCL of 350 ms shortened to a greater degree in the digoxin group ( 37±16 ms ) than in the control group ( 20±13 ms , P During post-AF determinations of the atrial ERP , secondary AF episodes occurred significantly more often in the digoxin group ( 32 % versus 16%;P AF , digoxin augments the shortening that occurs in atrial refractoriness and predisposes to the reinduction of AF . These effects occur in the setting of autonomic blockade and therefore are more likely to be due to the effects of digoxin on intracellular calcium than to its vagotonic effects",
"Background —Postoperative atrial arrhythmias are common and are associated with considerable morbidity . This study was design ed to evaluate the efficacy and safety of vernakalant for the conversion of atrial fibrillation ( AF ) or atrial flutter ( AFL ) after cardiac surgery . Methods and Results —This was a prospect i ve , r and omized , double-blind , placebo-controlled trial of vernakalant for the conversion of AF or AFL after coronary artery bypass graft , valvular surgery , or both . Patients were r and omly assigned 2:1 to receive a 10-minute infusion of 3 mg/kg vernakalant or placebo . If AF or AFL was present after a 15-minute observation period , then a second 10-minute infusion of 2 mg/kg vernakalant or placebo was given . The primary end point was the conversion of postcardiac surgery AF or AFL to sinus rhythm within 90 minutes of dosing . In patients with AF , 47 of 100 ( 47 % ) who received vernakalant converted to SR compared with 7 of 50 ( 14 % ) patients who received placebo ( P converting postoperative AFL to sinus rhythm . Two serious adverse events occurred within 24 hours of vernakalant administration ( hypotension and complete atrioventricular block ) . There were no cases of torsades de pointes , sustained ventricular tachycardia , or ventricular fibrillation . There were no deaths . Conclusions —Vernakalant was safe and effective in the rapid conversion of AF to sinus rhythm in patients who had AF after cardiac surgery . Clinical Trial Registration — clinical trials.gov . Identifier : NCT00125320",
"BACKGROUND Patients with rheumatic heart disease and atrial fibrillation incur significant morbidity and mortality . It is not known which approach , rate control or maintenance of sinus rhythm might be most appropriate . The present study was undertaken to compare the strategy of ventricular rate control versus maintenance of sinus rhythm in rheumatic atrial fibrillation , and to evaluate the role of amiodarone in this patient population . METHODS AND RESULTS We prospect ively studied 144 patients with chronic rheumatic atrial fibrillation in a double-blind protocol -rhythm control ( group I : 48 patients each with amiodarone -group Ia ; and placebo -group Ib ) and compared the effects with the ventricular rate control ( group II ) by diltiazem ( n=48 , open-label ) . Direct current cardioversion was attempted in group I. The mean age of the study population was 38.6+/-10.3 years , left atrial size was 4.7+/-0.6 cm , atrial fibrillation duration was 6.1+/-5.4 years , and 72.9 % patients had undergone valvular interventions . At 1 year , 45 patients with sinus rhythm in group I compared to 48 patients in group II demonstrated significant increase in exercise to sinus rhythm time , had improvement in functional class and quality of life score . There was no difference in hospitalization rates , systemic bleeds or incidence of thromboembolism . Five patients died in group II but none in group I ( p=0.02 ) . In group I , 73/87 ( 83.9 % ) patients converted , and 45/86 ( 52.3 % ) patients maintained sinus rhythm at 1 year . Conversion rates were 38/43 ( 88.4 % ) with amiodarone versus 34/44 ( 77.3 % ) with placebo ( p=0.49 ) : corresponding rate for maintaining sinus rhythm was 29/42 ( 69.1 % ) versus 16/44 ( 36.4 % ) , p=0.008 respectively . CONCLUSIONS Maintenance of sinus rhythm appeared to be superior to ventricular rate control in patients with rheumatic atrial fibrillation in terms of an effect on mortality and morbidity . Sinus rhythm could be restored in the majority and amiodarone was superior to placebo in this regard",
"Dofetilide may be advantageous in terminating atrial fibrillation/atrial flutter ( AFl ) when there are contraindications for class I drugs ( left ventricular dysfunction and /or manifest myocardial ischemia ) and beta blockers . In particular , its successful outcome in usually drug-resistant AFl is promising and underscores the importance of selective class III action for terminating AFl",
"Background —Atrial fibrillation ( AF ) has a deleterious impact on health-related quality -of-life ( HRQoL ) , but measuring this outcome is difficult . A comprehensive , vali date d , disease-specific question naire to measure the spectrum of QoL domains affected by AF and its treatment is not available . We developed and vali date d a 20-item question naire , Atrial Fibrillation Effect on QualiTy -of-life ( AFEQT ) , in a 6-center , prospect i ve , observational study . Methods and Results —Factor analyses established 4 conceptual domains ( Symptoms , Daily Activities , Treatment Concern , and Treatment Satisfaction ) from which individual domain and global scores were calculated . Participants from 6 centers completed the AFEQT at baseline , at month 1 , and at month 3 . Psychometric analyses included internal consistency and known-group validity . Test-retest reliability was assessed by comparing 1-month changes in scores among those with no change in therapy . Effect size was used to assess responsiveness after intervention . Among 219 patients age 62±11.9 years , 94 % completed the AFEQT at baseline and 3 months ; 66 % had paroxysmal , 24 % persistent , 5 % longst and ing persistent , and 5 % permanent AF . Internal consistency was > 0.88 for all scales . Lower AFEQT scores were observed with increased AF severity , categorized as asymptomatic , mild , moderate and severe , respectively : 71.2±20.6 , 71.3±19.2 , 57.9±19.0 , and 42.0±21.2 . Intraclass correlations for Overall , Symptoms , Daily Activities , Treatment Concern , and Satisfaction scores were 0.8 , 0.5 , 0.8 , 0.7 , and 0.7 , respectively . Changes in 3-month scores were larger after ablation than with pharmacological adjustments , and both were greater than those observed in stable patients . Conclusions —This initial validation of AFEQT supports its use as an outcome in studies and a means to clinical ly follow patients with AF",
"Background Although previous clinical trials demonstrated the non-inferiority of a rate control to rhythm control strategy for management of atrial fibrillation ( AF ) , the optimal treatment strategy for paroxysmal AF ( PAF ) remains unclear . Methods and Results A r and omized , multicenter comparison of rate control vs rhythm control in Japanese patients with PAF ( the Japanese Rhythm Management Trial for Atrial Fibrillation ( J-RHYTHM ) study ) was conducted . The primary endpoint was a composite of total mortality , symptomatic cerebral infa rct ion , systemic embolism , major bleeding , hospitalization for heart failure , or physical/psychological disability requiring alteration of treatment strategy . In the study , 823 patients with PAF were followed for a mean period of 578 days . The primary endpoint occurred in 64 patients ( 15.3 % ) assigned to rhythm control and in 89 patients ( 22.0 % ) to rate control ( P=0.0128 ) . No significant differences between the treatment strategies were observed in the incidences of death , stroke , bleeding and heart failure . Meanwhile , significantly fewer patients requested changes of assigned treatment strategy in the rhythm control vs the rate control group , which was accompanied by improvement in AF-specific quality of life scores . Conclusion The J-RHYTHM study showed that rhythm control was associated with fewer primary endpoints than rate control . However , mortality and cardiovascular morbidity were not affected by the treatment strategy ( umin-CTR No. C000000106 )",
"Background Rapid conversion of atrial fibrillation ( AF ) to sinus rhythm may be achieved by the administration of class IA , IC and III antiarrhythmic drugs or vernakalant hydrochloride . However , that treatment may be related to potential pro-arrhythmia , lack of efficacy or the exceptionally high cost of a compound used . Antazoline is a first generation antihistaminic agent with chinidin-like properties . When administered intravenously , antazoline exerts a strong antiarrhythmic effect on supraventricular arrhythmia , especially on AF , facilitating rapid conversion to sinus rhythm . Despite a relative lack of published data antazoline has been marketed in Pol and and widely used in cardiology wards and emergency rooms for many years due to its efficacy , safety and rapid onset of action within minutes of administration . Methods / design A r and omized , double blind , placebo-controlled , superiority clinical trial was design ed to assess clinical efficacy of antazoline in rapid conversion of AF to sinus rhythm . Eligible patients will present AF lasting less than 43 hours , will be in stable cardio-pulmonary condition and will have no prior history of advanced heart failure or significant valvular disease . Long-term antiarrhythmic therapy is not considered an exclusion criterion . Subjects who fulfill selection criteria will be r and omly assigned to receive intravenously either antazoline or placebo in divided doses and observed for 1.5 hours after conversion to sinus rhythm or after the last i.v . bolus . Primary end point will be the conversion of AF to sinus rhythm confirmed in an electrocardiogram ( ECG ) during the observation period . Secondary end points will be comprised of time to conversion and return of AF during the observation period . Special consideration will be given to the observation of any adverse events . A sample size of 80 patients was calculated based on the following assumptions : two-tailed test , a type I error of 0.01 , a power of 90 % , efficacy of placebo 5 % , efficacy of antazoline 50 % and 20 % drop-out rate to fulfill the criteria of intention-to-treat analysis . Due to the presumed lack of statistical power , the secondary end points and safety endpoints will be considered exploratory . Clinical trials registry Clinical Trials.gov ,",
"Objective Ibutilide , a class III antiarrhythmic drug , has been shown to convert atrial fibrillation to sinus rhythm more rapidly than procainamide or sotalol . Our objective was to compare the efficacy and safety of ibutilide and amiodarone in patients after cardiac surgery . Design Prospect i ve , r and omized , double-blinded study . Setting Intensive care unit of a university hospital . Patients Forty adults with an onset of atrial fibrillation within 3 hrs after admission . Interventions Before the administration of antiarrhythmic drugs , a 24-hr Holter electrocardiograph was attached . Patients in the ibutilide group received ibutilide 0.008 mg/kg body weight over 10 mins ; treatment was repeated if atrial fibrillation or flutter persisted . If sinus rhythm was not achieved within 4 hrs , amiodarone 5 mg/kg was administered over 30 mins , followed by amiodarone 15 mg/kg over 24 hrs . Patients in the amiodarone group received amiodarone 5 mg/kg over 30 mins , followed by amiodarone 15 mg/kg over 24 hrs if atrial fibrillation or flutter continued . Measurements and Main Results Within the first 4 hrs , atrial fibrillation was converted in nine of 20 patients ( 45 % ) in group ibutilide and in ten of 20 patients ( 50 % ) in group amiodarone ( not significant ) . Mean time for conversion overall was 385 mins in group ibutilide and 495 mins in group amiodarone ( not significant ) . In group amiodarone , the protocol was discontinued in two patients because of severe arterial hypotension . Atrial fibrillation recurred in 11 of 20 patients ( 55 % ) in group ibutilide and in seven of 20 patients ( 35 % ) in group amiodarone ( not significant ) . Ventricular arrhythmia did not occur during the first 24 hrs of the protocol . Conclusions Ibutilide has no significant advantage over amiodarone for the conversion of atrial fibrillation to sinus rhythm in either time to conversion or conversion overall , but severe hypotension was not seen with ibutilide",
"OBJECTIVES This multicenter study compared the efficacy and safety of ibutilide versus procainamide for conversion of recent-onset atrial flutter or fibrillation . BACKGROUND Ibutilide fumarate is an intravenous ( IV ) class III antiarrhythmic agent that has been shown to be significantly more effective than placebo in the pharmacologic conversion of atrial flutter and fibrillation to sinus rhythm . Procainamide is commonly used for conversion of recent-onset atrial fibrillation to normal sinus rhythm . METHODS One hundred twenty-seven patients ( age range 22 to 92 years ) with atrial flutter or fibrillation of 3 h to 90 days ' ( mean 21 days ) duration were r and omized to receive either two 10-min IV infusions of 1 mg of ibutilide fumarate , separated by a 10-min infusion of 5 % dextrose in sterile water , or three successive 10-min IV infusions of 400 mg of procainamide hydrochloride . RESULTS Of the 127 patients , 120 were evaluated for efficacy : 35 ( 58.3 % ) of 60 in the ibutilide group compared with 11 ( 18.3 % ) of 60 in the procainamide group had successful termination within 1.5 h of treatment ( p patients with atrial flutter , ibutilide had a significantly higher success rate than procainamide ( 76 % [ 13 of 17 ] vs. 14 % [ 3 of 22 ] , p=0.001 ) . Similarly , in the atrial fibrillation group , ibutilide had a significantly higher success rate than procainamide ( 51 % [ 22 of 43 ] vs. 21 % [ 8 of 38 ] , p=0.005 ) . One patient who received ibutilide , which was found to be a protocol violation , had sustained polymorphic ventricular tachycardia requiring direct current cardioversion . Seven patients who received procainamide became hypotensive . CONCLUSIONS This study establishes the superior efficacy of ibutilide over procainamide when administered to patients to convert either atrial fibrillation or atrial flutter to sinus rhythm . Hypotension was the major adverse effect seen with procainamide . A low incidence of serious proarrhythmia was seen with the administration of ibutilide occurring at the end of infusion",
"OBJECTIVES This study sought to determine the safety and efficacy of a single bolus of intravenous dofetilide , a pure class III antiarrhythmic agent , for the termination of sustained atrial fibrillation or flutter . BACKGROUND Dofetilide is a highly selective blocker of the rapid component of the delayed rectifier current causing action potential prolongation . These effects , and preliminary clinical data , suggest that it may be effective in the treatment of atrial fibrillation and flutter . METHODS Ninety-one patients with sustained atrial fibrillation ( 75 patients ) or flutter ( 16 patients ) were entered into a double-blind , r and omized multicenter study of one of two doses of dofetilide ( 4 or 8 micrograms/kg body weight ) or placebo . RESULTS Dofetilide effectively terminated the arrhythmia in 31 % of patients receiving 8 micrograms/kg , a statistically significant difference from those receiving 4 micrograms/kg ( conversion rate 12.5 % , p placebo ( no conversion , p Patients with atrial flutter had a greater response to dofetilide ( 54 % conversion rate ) than those with atrial fibrillation ( 14.5 % conversion rate , p dofetilide can convert sustained atrial fibrillation or flutter to sinus rhythm . However , its efficacy is greater in flutter -- a response that contrasts with the poorer response seen with class I agents . This finding potentially represents an important advance in the pharmacologic termination of atrial flutter",
"BACKGROUND Amiodarone is effective in maintaining sinus rhythm in atrial fibrillation but is associated with potentially serious toxic effects . Dronedarone is a new antiarrhythmic agent pharmacologically related to amiodarone but developed to reduce the risk of side effects . METHODS In two identical multicenter , double-blind , r and omized trials , one conducted in Europe ( Clinical Trials.gov number , NCT00259428 [ Clinical Trials.gov ] ) and one conducted in the United States , Canada , Australia , South Africa , and Argentina ( termed the non-European trial , NCT00259376 [ Clinical Trials.gov ] ) , we evaluated the efficacy of dronedarone , with 828 patients receiving 400 mg of the drug twice daily and 409 patients receiving placebo . Rhythm was monitored transtelephonically on days 2 , 3 , and 5 ; at 3 , 5 , 7 , and 10 months ; during recurrence of arrhythmia ; and at nine scheduled visits during a 12-month period . The primary end point was the time to the first recurrence of atrial fibrillation or flutter . RESULTS In the European trial , the median times to the recurrence of arrhythmia were 41 days in the placebo group and 96 days in the dronedarone group ( P=0.01 ) . The corresponding duration s in the non-European trial were 59 and 158 days ( P=0.002 ) . At the recurrence of arrhythmia in the European trial , the mean ( + /-SD ) ventricular rate was 117.5+/-29.1 beats per minute in the placebo group and 102.3+/-24.7 beats per minute in the dronedarone group ( P Rates of pulmonary toxic effects and of thyroid and liver dysfunction were not significantly increased in the dronedarone group . CONCLUSIONS Dronedarone was significantly more effective than placebo in maintaining sinus rhythm and in reducing the ventricular rate during recurrence of arrhythmia",
"Atrial fibrillation ( AF ) is common after coronary artery bypass grafting ( CABG ) and increases the morbidity and cost . Amiodarone reduces AF after CABG . Ranolazine , an antianginal agent , also prolongs atrial refractoriness and inhibits after depolarizations and triggered activity ; effects that could decrease AF after CABG . The present study compared amiodarone versus ranolazine for the prevention of AF after CABG . A retrospective cohort study of patients undergoing CABG at Aspirus Hospital from June 2008 to April 2010 . The patients received either amiodarone ( 400 mg preoperatively followed by 200 mg twice daily for 10 to 14 days ) or ranolazine ( 1,500 mg preoperatively followed by 1,000 mg twice daily for 10 to 14 days ) . The primary end point was any identified AF after CABG . A total of 393 consecutive patients undergoing CABG ( mean age 65 ± 10 years , 72 % men ) received either amiodarone ( n = 211 [ 53.7 % ] ) or ranolazine ( n = 182 [ 46.3 % ] ) . AF occurred in 26.5 % of the amiodarone-treated patients compared to 17.5 % of the ranolazine-treated patient ( p = 0.035 ) . The univariate predictors of AF included amiodarone use , age , chronic lung disease , and congestive heart failure . The multivariate predictors of AF included amiodarone use ( odds ratio 1.7 , 95 % confidence interval 1.01 to 2.91 , p = 0.045 vs ranolazine ) , age ( odds ratio 2.2 per 10 years , 95 % confidence interval 1.63 to 2.95 , p the risk of adverse events between the 2 therapies . In conclusion , ranolazine was independently associated with a significant reduction of AF compared to amiodarone after CABG , with no difference in the incidence of adverse events . R and omized studies should be conducted to confirm these results",
"Ninety-eight patients , who developed atrial fibrillation/flutter after coronary artery bypass grafting within 1 - 6 days after surgery , were included into a double-blind , placebo-controlled , r and omized trial to assess the efficacy and safety of dofetilide . Patients were r and omly allocated to dofetilide 4 micrograms/kg i.v . ( n = 33 ) , dofetilide 8 micrograms/kg i.v . ( n = 32 ) or placebo ( n = 33 ) given intravenously over 15 min at a constant infusion rate . Responders were defined as patients who converted to sinus rhythm at any time during the initial 3 h after the start of the infusion . The conversion rates were 24 % ( 8/33 ) on placebo , 36 % ( 12/33 ) on dofetilide 4 micrograms/kg , and 44 % ( 14/32 ) on dofetilide 8 micrograms/kg . The P-values ( two-tailed ) were 0.27 for dofetilide 4 micrograms/kg vs. placebo , 0.11 for dofetilide 8 micrograms/kg vs. placebo , and 0.10 for dose-response relationship . Short episodes of aberrant ventricular conduction and ventricular tachycardia were seen separately in three subjects after dofetilide 8 micrograms/kg . No episodes of torsades de pointes were noted . No negative inotropic effect was noted . In conclusion , dofetilide was well tolerated , but the effects on atrial fibrillation/flutter did not attain statistical significance , possibly due to the high placebo conversion rate",
"A population of 123 patients with recent-onset ( was r and omly treated with propafenone ( PFN ) intravenously ( i.v . ) ( 2 mg/kg bolus followed by 0.0078 mg/kg/min infusion ) or in a single oral dose ( o.s . ) ( 600 mg ) , or with placebo ( PLA ) ( phase 1 ) . If AF persisted 8 hours later , patients on active drugs received the alternative formulation ( crossover ) , and patients receiving PLA remained on PLA ( phase 2 ) . A 24-hour Holter monitoring was performed and conversion to sinus rhythm ( SR ) at 1 , 4 , and 8 hours of each phase was used as the criterion of efficacy . Conversion to SR occurred within 1 hour in 48 % of patients with i.v.-PFN , 15 % with o.s.-PFN , and in 17 % with PLA ( both P PFN was superior to PLA at 4 hours ( 71 % vs 33 % , P = 0.001 ) and 8 hours ( 78 % vs 48 % , P mean conversion time within 4 hours was shorter with i.v.-PFN ( 25 + /- 15 ' ) than with o.s.-PFN ( 167 + /- 166 ' , P PLA ( 156 + /- 107 ' , P rates of conversion to SR with i.v.-PFN after o.s.-PFN failure were comparable to PLA at any observation time , whereas nonresponders to i.v.-PFN who received o.s.-PFN had significantly higher conversion rates than with placebo at both 4 hours ( 65 % vs 19 % ) and 8 hours ( 76 % vs 24 % ; both P serious adverse effects nor episodes of regular tachycardia with 1:1 AV conduction were noted . PFN administered intravenously or in a single oral loading dose was safe and efficacious in converting recent-onset AF to SR . The rates of conversion were different with different routes of administration : i.v.-PFN was superior to o.s.-PFN over a short observation period , while the overall efficacy of o.s.-PFN was superior at 8 hours",
"AIM The aim of our study was to compare the efficacy and safety of ibutilide and amiodarone ( intravenously ) in converting recent-onset atrial fibrillation ( AF ) and atrial flutter ( Af ) to sinus rhythm ( SR ) . METHODS The study was prospect i ve , r and omized and included 152 ( 103 men and 49 women ) consecutive patients with AF or Af of 3 - 48 h duration . Ibutilide is a selective class III antiarrhythmic agent which when administered intravenously can terminate AF and Af . Amiodarone is also a class III antiarrhythmic agent that when given intravenously or orally has proved to be more effective than other agents in terminating AF and Af [ B.N. Singh , F.V. Mody , B. Lopez , J.S. Sarma . Antiarrhythmic agents for atrial fibrillation : focus on prolonging atrial repolarization . Am J Cardiol 1999 Nov 4 ; 84 : 161R-173R . ] . Seventy-nine patients ( 56 with AF and 23 with Af ) that consisted group A were treated with ibutilide . Seventy-three ( 52 with AF and 21 with Af ) consisted group B and were treated with intravenous infusion of amiodarone . RESULTS The conversion rate of group A ( ibutilide ) was significantly higher than the conversion rate of group B ( amiodarone ) ( 80 % vs. 57 % , p=0.0054 ) . As regards the kind of arrhythmia separately , for AF there was n't significant difference ( 77 % vs. 69 % , p = ns ) whereas for Af ibutilide was superior to amiodarone ( 87 % vs. 29 % , p=0.003 ) . The conversion rates of ibutilide did n't differ for AF and Af ( 77 % vs. 87 % , p = ns ) . CONCLUSIONS Ibutilide is more effective than amiodarone in converting recent-onset Af to SR whereas both drugs are equally effective in converting recent-onset AF to SR",
"STUDY OBJECTIVES To investigate the efficacy and safety of amiodarone administered as the drug of first choice in the conversion of atrial fibrillation , regardless of its duration . DESIGN : Prospect i ve , r and omized , controlled clinical study . SETTING : Tertiary cardiac referral center . PATIENTS Two-hundred eight consecutive patients ( 102 men ; mean [ + /- SD ] age , 65 + /- 10 years ) with atrial fibrillation . INTERVENTIONS One-hundred eight patients received amiodarone , and 100 patients received placebo treatment . Patients r and omized to amiodarone received 300 mg IV for 1 h , and then 20 mg/kg for 24 h. They were also given 600 mg/d orally , divided into three doses , for 1 week , and thereafter 400 mg/d for 3 weeks . Patients r and omized to placebo treatment received an identical amount of saline solution IV over 24 h , and oral placebo treatment for 1 month . MEASUREMENTS AND RESULTS Baseline clinical characteristics were similar in the two groups . Conversion to sinus rhythm was achieved in 87 of 108 patients ( 80.05 % ) who received amiodarone , and in 40 of 100 patients ( 40 % ) in the placebo group ( p duration of the arrhythmia and the size of the left atrium affected both the likelihood of conversion to sinus rhythm and the time to conversion in both groups . No side effects requiring discontinuation of treatment were observed in either group . CONCLUSIONS Amiodarone appears to be safe and effective in the termination of atrial fibrillation . However , extreme cases with a large left atrium and long-lasting arrhythmia need long-term therapy",
"BACKGROUND Dronedarone is a new antiarrhythmic drug that is being developed for the treatment of patients with atrial fibrillation . METHODS We conducted a multicenter trial to evaluate the use of dronedarone in 4628 patients with atrial fibrillation who had additional risk factors for death . Patients were r and omly assigned to receive dronedarone , 400 mg twice a day , or placebo . The primary outcome was the first hospitalization due to cardiovascular events or death . Secondary outcomes were death from any cause , death from cardiovascular causes , and hospitalization due to cardiovascular events . RESULTS The mean follow-up period was 21+/-5 months , with the study drug discontinued prematurely in 696 of the 2301 patients ( 30.2 % ) receiving dronedarone and in 716 of the 2327 patients ( 30.8 % ) receiving placebo , mostly because of adverse events . The primary outcome occurred in 734 patients ( 31.9 % ) in the dronedarone group and in 917 patients ( 39.4 % ) in the placebo group , with a hazard ratio for dronedarone of 0.76 ( 95 % confidence interval [ CI ] , 0.69 to 0.84 ; P deaths ( 5.0 % ) in the dronedarone group and 139 ( 6.0 % ) in the placebo group ( hazard ratio , 0.84 ; 95 % CI , 0.66 to 1.08 ; P=0.18 ) . There were 63 deaths from cardiovascular causes ( 2.7 % ) in the dronedarone group and 90 ( 3.9 % ) in the placebo group ( hazard ratio , 0.71 ; 95 % CI , 0.51 to 0.98 ; P=0.03 ) , largely due to a reduction in the rate of death from arrhythmia with dronedarone . The dronedarone group had higher rates of bradycardia , QT-interval prolongation , nausea , diarrhea , rash , and an increased serum creatinine level than the placebo group . Rates of thyroid- and pulmonary-related adverse events were not significantly different between the two groups . CONCLUSIONS Dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation . ( Clinical Trials.gov number , NCT00174785 .",
"Background —In patients with left ventricular dysfunction , atrial fibrillation and flutter ( AF and AFl , respectively ) are common arrhythmias associated with increased morbidity and mortality . The present study investigated the potential of dofetilide in AF-AFl patients with left ventricular dysfunction to restore and maintain sinus rhythm , which might reduce mortality and hospitalizations . Methods and Results —In the Danish Investigations of Arrhythmia and Mortality ON Dofetilide ( DIAMOND ) studies , 506 patients were in AF-AFl at baseline . Over the course of study , cardioversion occurred in 148 ( 59 % ) dofetilide- and 86 ( 34 % ) placebo-treated patients . In these patients , the probability of maintaining sinus rhythm for 1 year was 79 % with dofetilide versus 42 % with placebo ( P Dofetilide had no effect on all-cause mortality , but restoration and maintenance of sinus rhythm was associated with significant reduction in mortality ( risk ratio [ RR ] , 0.44 ; 95 % CI , 0.30 to 0.64;P dofetilide therapy was associated with a significantly lower risk ratio versus placebo for either all-cause ( RR , 0.70 ; 95 % CI , 0.56 to 0.89;P ≤0.005 ) or congestive heart failure ( RR , 0.69 ; 95 % CI , 0.51 to 0.93;P ≤0.02 ) rehospitalization . Conclusions —Dofetilide is safe and increases the probability of obtaining and maintaining sinus rhythm in patients with structural heart disease . The present study suggests that restoration of sinus rhythm is associated with improved survival",
"Twenty two patients with heart failure were studied in a double blind crossover trial to compare amiodarone ( 200 mg/day ) with placebo . Each agent was given for three months . Extrasystoles and complex ventricular arrhythmias were common during ambulatory electrocardiographic monitoring and during exercise testing at entry to the study . Breathlessness and tiredness as assessed by visual analogue scores and duration of treadmill exercise did not become worse during amiodarone treatment . During the placebo and amiodarone phases of the study left ventricular ejection fraction and cardiac index determined by first pass radionuclide ventriculography were similar , both at rest and during upright bicycle exercise . Exercise induced ventricular tachycardia was abolished and simple and complex ventricular arrhythmias observed on 24 hour ambulatory monitoring were greatly diminished during amiodarone treatment . Three patients died , all suddenly , during the placebo phase . In two patients amiodarone was withdrawn after a further myocardial infa rct ion in one and a worsening of symptoms of ventricular arrhythmia in the other . In contrast with other antiarrhythmic agents amiodarone is effective in suppressing ventricular arrhythmias in heart failure without causing adverse haemodynamic effects . Because frequent ventricular arrhythmias are known to be associated with a poor prognosis in heart failure , these data suggest that amiodarone may improve the poor prognosis in patients with heart failure",
"BACKGROUND Dronedarone is a novel antiarrhythmic drug with electrophysiological properties that are similar to those of amiodarone , but it does not contain iodine and thus does not cause iodine-related adverse reactions . Therefore , it may be of value in the treatment of patients with heart failure . METHODS In a multicenter study with a double-blind design , we planned to r and omly assign 1000 patients who were hospitalized with symptomatic heart failure and severe left ventricular systolic dysfunction to receive 400 mg of dronedarone twice a day or placebo . The primary end point was the composite of death from any cause or hospitalization for heart failure . RESULTS After inclusion of 627 patients ( 310 in the dronedarone group and 317 in the placebo group ) , the trial was prematurely terminated for safety reasons , at the recommendation of the data and safety monitoring board , in accordance with the board 's predefined rules for termination of the study . During a median follow-up of 2 months , 25 patients in the dronedarone group ( 8.1 % ) and 12 patients in the placebo group ( 3.8 % ) died ( hazard ratio in the dronedarone group , 2.13 ; 95 % confidence interval [ CI ] , 1.07 to 4.25 ; P=0.03 ) . The excess mortality was predominantly related to worsening of heart failure--10 deaths in the dronedarone group and 2 in the placebo group . The primary end point did not differ significantly between the two groups ; there were 53 events in the dronedarone group ( 17.1 % ) and 40 events in the placebo group ( 12.6 % ) ( hazard ratio , 1.38 ; 95 % CI , 0.92 to 2.09 ; P=0.12 ) . More increases in the creatinine concentration were reported as serious adverse events in the dronedarone group than in the placebo group . CONCLUSIONS In patients with severe heart failure and left ventricular systolic dysfunction , treatment with dronedarone was associated with increased early mortality related to the worsening of heart failure . ( Clinical Trials.gov number , NCT00543699 .",
"AIMS This study compared the efficacy and safety of intravenous dofetilide with amiodarone and placebo in converting atrial fibrillation or flutter to sinus rhythm . METHODS AND RESULTS One hundred and fifty patients with atrial fibrillation or flutter ( duration range 2 h-6 months ) were given 15-min intravenous infusions of 8 microg . kg(-1)of dofetilide ( n=48 ) , 5 mg . kg(-1)of amiodarone ( n=50 ) , or placebo ( n=52 ) and monitored continuously for 3 h. Sinus rhythm was restored in 35 % , 4 % , and 4 % of patients , respectively ( P dofetilide vs placebo;P = ns , amiodarone versus placebo ) . Dofetilide was more effective in atrial flutter than in atrial fibrillation ( cardioversion rates 75 % and 22 % , respectively;P=0.004 ) . The mean time to conversion with dofetilide was 55+/-15 min . Dofetilide prolonged the QTc interval ( + 16 % at 20 min ) . Amiodarone substantially decreased the ventricular rate in non-converters ( -18 beats . min(-1)at 30 min ) . Two patients given dofetilide ( 4 % ) had non-sustained ventricular tachycardias , and four ( 8 % ) had torsade de pointes , in one case requiring electrical cardioversion . CONCLUSION Intravenous dofetilide is significantly more effective than amiodarone or placebo in restoring sinus rhythm in patients with atrial fibrillation or flutter . However , when infused intravenously at this dose and rate , dofetilide causes a significant incidence of torsade de pointes",
"BACKGROUND Atrial arrhythmias occur commonly after cardiac surgery and are a cause of significant morbidity and increased hospital costs , yet there is no well-studied treatment strategy to deal with them expeditiously . The purpose of this study was to determine the efficacy and safety of ibutilide fumarate , an approved drug for the rapid conversion of atrial fibrillation and flutter , in patients after cardiac surgery . METHODS AND RESULTS Patients with atrial fibrillation or flutter occurring 1 to 7 days after surgery and lasting 1 hour to 3 days were r and omized to receive two 10-minute blinded infusions of placebo or 0.25 , 0.5 , or 1.0 mg of ibutilide fumarate . Treatment was considered successful if sinus rhythm was restored for any period of time by hour 1.5 . A total of 302 patients were r and omized , 201 with fibrillation and 101 with flutter . Treatment with ibutilide result ed in significantly higher conversion rates than placebo , and efficacy was dose related ( placebo 15 % ; ibutilide 0.25 mg 40 % , 0.5 mg 47 % , and 1.0 mg 57 % ) . Conversion rates at all doses were higher for atrial flutter than for atrial fibrillation . Mean time to conversion decreased as the dose was increased . Polymorphic ventricular tachycardia was the most serious adverse effect and occurred in 1.8 % of the ibutilide-treated patients compared with 1.2 % of patients who received placebo . CONCLUSIONS Ibutilide is a useful and safe treatment alternative for the atrial arrhythmias that occur after cardiac surgery",
"OBJECTIVES This study was design ed to determine the efficacy of intravenous amiodarone in the management of recent-onset atrial fibrillation . BACKGROUND The optimal approach for acute atrial fibrillation has not been established . Amiodarone is a unique antiarrhythmic agent with activity in both supraventricular and ventricular tachyarrhythmias , but its value for the restoration of sinus rhythm in patients with recent-onset atrial fibrillation has not been demonstrated . METHODS Sample size was calculated to detect a 25 % increase in reversion rate with amiodarone with a statistical power of 80 % . One hundred consecutive patients with recent-onset ( to receive either intravenous amiodarone , 5 mg/kg body weight in 30 min followed by 1,200 mg over 24 h , or an identical amount of saline . Both groups received intravenous digoxin , 0.5 mg initially , followed by 0.25 mg at 2 h and 0.25 mg every 6 h thereafter , to complete 24 h while the ventricular rate was > 100 beats/min . Amiodarone and digoxin blood levels were determined . Both groups were homogeneous regarding underlying heart disease , time from onset to treatment , initial ventricular rate and left atrial size . RESULTS By the end of the 24-h treatment period , 34 patients ( 68 % , 95 % confidence interval [ CI ] 53 % to 80 % ) in the amiodarone group and 30 ( 60 % , 95 % CI 45 % to 74 % ) in the control group had returned to sinus rhythm ( p = 0.532 ) . Mean times ( + /-SD ) of conversion were 328 + /- 335 and 332 + /- 359 min , respectively ( p = 0.957 ) . Among patients who did not convert to sinus rhythm , treatment with amiodarone was associated with a slower ventricular rate ( 82 + /- 15 beats/min in the amiodarone group vs. 91 + /- 23 beats/min in the control group , p = 0.022 ) . After restoration of sinus rhythm , atrial fibrillation recurred during a 15-day follow-up period in 4 ( 12 % ) of 34 patients ( 95 % CI 3 % to 27 % ) in the amiodarone group and in 3 ( 10 % ) of 30 ( 95 % CI 2 % to 26 % ) in the control group ( p = 0.861 ) . CONCLUSIONS Intravenous amiodarone , at the doses used in this study , produces a modest but not significant benefit in converting acute atrial fibrillation to sinus rhythm",
"AIMS Dronedarone , a benzofurane derivative without iodine substituents , shares the electrophysiologic properties of amiodarone . This study was design ed to determine the most appropriate dose of dronedarone for prevention of atrial fibrillation ( AF ) after cardioversion . METHODS AND RESULTS Patients with persistent AF were r and omly allocated to 800 , 1200 , 1600 mg daily doses of dronedarone or placebo . The main analysis was conducted on 199/270 patients , who entered the maintenance phase following pharmacological cardioversion or , if unsuccessful , DC cardioversion . Within 6-month follow-up , the time to AF relapse increased on dronedarone 800 mg , with a median of 60 days vs 5.3 days in the placebo group ( relative risk reduction 55 % [ 95 % CI , 28 to 72 % ] P=0.001 ) . No significant effect was seen at higher doses . Spontaneous conversion to sinus rhythm on dronedarone occurred in 5.8 to 14.8 % of patients ( P=0.026 ) . There were no proarrhythmic reactions . Drug-induced QT prolongation was only noticed in the 1600 mg group . Premature drug discontinuations affected 22.6 % of subjects given 1600 mg dronedarone versus 3.9 % on 800 mg and were mainly due to gastrointestinal side effects . No evidence of thyroid , ocular or pulmonary toxicity was found . CONCLUSION Dronedarone , at a 800 mg daily dose , appears to be effective and safe for the prevention of AF relapses after cardioversion . The absence of thyroid side effects and of proarrhythmia are important features of the drug . Further studies are needed to better delineate the antiarrhythmic profile of the drug",
"BACKGROUND This study was design ed to assess the efficacy and safety of intravenous dofetilide in acute termination of atrial fibrillation ( AF ) and flutter ( AFL ) . Dofetilide , an investigational class III antiarrhythmic agent , selectively inhibits the rapid component of the delayed rectifier potassium current , thus prolonging the effective refractory period and duration of the action potential . Dofetilide can be administered intravenously and has a rapid onset of electrophysiologic action . METHODS AND RESULTS Ninety-six patients with AF ( n = 79 ) or AFL ( n = 17 ) with a median arrhythmia duration of 62 days ( range 1 to 180 ) were r and omized to placebo ( n = 30 ) or 8 micrograms/kg IV dofetilide ( n = 66 ) over 30 minutes . Conversion was defined as termination of the atrial arrhythmia within 3 hours from the start of infusion . The conversion rate was 30.3 % after dofetilide and 3.3 % after placebo ( P Conversion rate was higher in AFL than in AF : 64 % versus 24 % ( P = . 012 ) . In nonconverters , there was no statistically significant difference between the change in heart rate among the dofetilide-treated compared with the placebo-treated patients ( P = . 42 ) . Torsade de pointes ventricular tachycardia developed in 2 patients ( 3 % ) . In both patients , drug infusion was discontinued before the event because of prolongation of the QT interval . CONCLUSIONS Intravenous dofetilide is effective in acute termination of AF and AFL of medium duration , with a particularly high efficacy rate in AFL . A small but serious risk of proarrhythmia must be anticipated",
"A population of 283 patients with recent onset ( oral dose of propafenone , or digoxin 1 mg , or placebo for conversion to sinus rhythm ( SR ) , was studied to determine whether a routine admission to the hospital for drug administration is justified . Previous bradyarrhythmias or sick sinus syndrome ( SSS ) , and concomitant use of antiarrhythmic drugs were exclusion criteria . None of the 283 patients studied experienced VT or VF and none of them needed implantation of a temporary pacemaker . Periods of atrial tachyarrhythmias with regularization of atrial waves and 1:1 AV conduction were observed in only two cases , both receiving placebo . No predictor of proarrhythmia was found among the clinical variables considered ( age , etiology , arrhythmia duration , atrial dimension , and blood potassium ) . No serious hemodynamic adverse effects were noted in either group . The rates of conversion to SR after 4 hours were : 80 ( 57 % ) of 141 patients who received propafenone and 35 ( 25 % ) of 142 patients who received digoxin or placebo ( P propafenone is simple and effective for the conversion of recent onset AF to SR in patients without clinical signs of heart failure . The routine admission of these patients to the hospital is not necessary . Home-based administration of oral propafenone to a selected group of patients could significantly increase the cost effectiveness of this treatment",
"The efficacy and safety of intravenous flecainide to convert recent-onset atrial fibrillation ( AF ) ( present for greater than or equal to 30 minutes and less than or equal to 72 hours and a ventricular response greater than or equal to 120 beats/min ) was investigated . A total of 102 patients without severe heart or circulatory failure were r and omized to receive either intravenous flecainide ( 2 mg/kg , maximum dose 150 mg ; 51 patients ) or placebo ( 51 patients ) in a double-blind trial . Digoxin ( 500 micrograms intravenously ) was administered to all patients who had not previously been receiving digoxin . The electrocardiogram was monitored continuously during the study . In 29 ( 57 % ) patients stable sinus rhythm was restored within 1 hour after flecainide and in only 7 ( 14 % ) given placebo ( chi square 18.9 ; p = 0.000013 ; odds ratio 8.3 ; 95 % confidence interval 2.9 - 24.8 ) . Reversion to sinus rhythm within 1 hour after starting the trial medication was considered a pretrial end point and likely to be due to a drug effect . At the end of the 6-hour monitoring period , 34 patients ( 67 % ) in the flecainide group were in sinus rhythm whereas only 18 ( 35 % ) in the placebo group had reverted ( chi square 8.83 , p = 0.003 ; odds ratio 3.67 ; 95 % confidence interval 1.5 - 9.1 ) . Significant hypotension , although short lived , was more common in the flecainide group . One patient given flecainide developed torsades de pointes and was successfully electrically cardioverted . Flecainide is useful for the management of recent-onset AF both for control of the ventricular response and conversion to sinus rhythm . ( ABSTRACT TRUNCATED AT 250 WORDS",
"UNLABELLED In a population of 417 hospitalized patients , the efficacy and safety of different drug regimens administered to convert atrial fibrillation ( AF ) of recent onset ( were evaluated . All patients were in NYHA Class They were r and omly allocated to treatment with placebo in 121 patients ; i.v . amiodarone , 5 mg/kg bolus , followed by 1.8 g/24 hours in 51 patients ; i.v . propafenone , 2 mg/kg bolus , followed by 0.0078 mg/kg/min in 57 patients ; p.o . propafenone , 600 mg p.o . in a single dose in 119 patients ; and p.o . flecainide , 300 mg p.o . in a single dose in 69 patients . All patients were continuously monitored by Holter ECG , and the number of conversions to sinus rhythm was measured at 1 , 3 , and 8 hours . RESULTS ( 1 ) I.v . propafenone result ed in a higher conversion rate within 1 hour compared with the oral loading regimens of propafenone or flecainide , but the conversion rates at 3 and 8 hours were comparable , approximately 75 % at 8 hours ; 2 ) i.v . amiodarone was not different from placebo until 8 hours when it was associated with 57 % of conversions ; ( 3 ) conversion to sinus rhythm at 8 hours was observed in 37 % of the placebo treated patients . Serious adverse effects occurred in few patients : two patients treated with flecainide and one treated with i.v . propafenone experienced left ventricular decompensation ; one patient treated with placebo and two treated with flecainide had atrial flutter with rapid ventricular response . In conclusion , single-dose , oral loading with propafenone or flecainide are acceptable alternatives to conventional drug regimens in selected hospitalized patients . In addition , the measure of a placebo effect is m and atory in studies of recent-onset AF",
"Background Atrial fibrillation ( AF ) may arise out of anomalous impulse activity at atrial venous junctions . Triggered activity may be a source of abnormal impulse activity . Ranolazine is an anti-anginal agent , which inhibits normal and abnormal late Na+ channel current in the ventricle and peak Na+ channel current in the atrium . This produces an energy sparing effect and stabilizes cardiac membranes . Ranolazine is a potent inhibitor of triggered activity . The purpose of this report is to describe our initial experience with ranolazine used in patients with resistant AF . Methods Seven patients ( 4 males , 3 females , 67 ± 9 years ) who developed recurrent AF within hours to a few days of restoring sinus rhythm despite AF ablation and /or failing one or more anti-arrhythmic agents were started on ranolazine ( 500 - 1000 mg/twice/day ) after stopping all other anti-arrhythmic therapy . All but one patient had some form of associated structural heart disease . Results Two patients received no apparent benefit from ranolazine developing recurrent AF within 2 days . All other patients derived significant benefit . Four patients have experienced no recurrent AF . The other patient relapsed at 3 months and again at 6 months . The mean time in sinus rhythm to date , or to the first relapse , for the five responders was 27 ± 11 weeks . No clinical ly evident pro-arrhythmic episodes occurred . Conclusion Ranolazine was helpful in maintaining sinus rhythm in the majority of patients in which more established measures had failed . A controlled prospect i ve trial is warranted to further investigate the efficacy of ranolazine in AF",
"BACKGROUND Spontaneous conversion of recent onset paroxysmal atrial fibrillation to normal sinus rhythm occurs commonly and is not affected by low-dose amiodarone treatment . METHODS In a r and omized , placebo-controlled trial of 100 patients with paroxysmal atrial fibrillation of recent onset ( we compared the effects of treatment with continuous intravenous amiodarone 125 mg per hour ( total 3 g ) and intravenous placebo . Patients in the placebo group who did not convert to normal sinus rhythm within 24 h were started on amiodarone therapy . RESULTS Conversion to normal sinus rhythm occurred within 24 h in 32 of 50 patients ( 64 % ) in the placebo group , most of whom converted within 8 h. Lower conversion rates were observed in patients with hypertension , ischaemic heart disease or congestive heart failure and in patients with echocardiographic findings of left atrial diameter above 45 mm , ejection fraction below 45 % or significant mitral regurgitation . However , in most patients these clinical or echocardiographic risk factors of decreases in conversion rate were not present . In such patients the spontaneous conversion rate was approximately 90 % . The conversion rate during 24 h of treatment in the amiodarone group was 92 % ( P=0.0017 , compared to the placebo group ) . In this group , the conversion rate was largely unaffected by baseline characteristics . Of the 18 patients who did not convert with placebo , 15 ( 85 % ) converted after being crossed over to amiodarone . All patients not responding to high-dose amiodarone were in chronic atrial fibrillation within 1 month . In patients still in atrial fibrillation after 8 h of treatment , the pulse rate decreased significantly more in the amiodarone as compared to the placebo group ( 83+/-15 vs 114+/-20 beats . min(-1 ) , P=0.0014 ) . CONCLUSION The spontaneous conversion of recent onset paroxysmal atrial fibrillation is high and approaches 90 % in specific clinical and echocardiographically defined subgroups . Intravenous high-dose amiodarone safely facilitates conversion of paroxysmal atrial fibrillation . However , such treatment should be reserved for patients with unfavourable risk factor profiles , not converting during 8 h of observation or requiring rate control",
"CONTEXT Ranolazine is a novel antianginal agent that reduces ischemia in patients with chronic angina but has not been studied in patients with acute coronary syndromes ( ACS ) . OBJECTIVE To determine the efficacy and safety of ranolazine during long-term treatment of patients with non-ST-elevation ACS . DESIGN , SETTING , AND PATIENTS A r and omized , double-blind , placebo-controlled , multinational clinical trial of 6560 patients within 48 hours of ischemic symptoms who were treated with ranolazine ( initiated intravenously and followed by oral ranolazine extended-release 1000 mg twice daily , n = 3279 ) or matching placebo ( n = 3281 ) , and followed up for a median of 348 days in the Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes (MERLIN)-TIMI 36 trial between October 8 , 2004 , and February 14 , 2007 . MAIN OUTCOME MEASURES The primary efficacy end point was a composite of cardiovascular death , myocardial infa rct ion ( MI ) , or recurrent ischemia through the end of study . The major safety end points were death from any cause and symptomatic documented arrhythmia . RESULTS The primary end point occurred in 696 patients ( 21.8 % ) in the ranolazine group and 753 patients ( 23.5 % ) in the placebo group ( hazard ratio [ HR ] , 0.92 ; 95 % confidence interval [ CI ] , 0.83 - 1.02 ; P = .11 ) . The major secondary end point ( cardiovascular death , MI , or severe recurrent ischemia ) occurred in 602 patients ( 18.7 % ) in the ranolazine group and 625 ( 19.2 % ) in the placebo group ( HR , 0.96 ; 95 % CI , 0.86 - 1.08 ; P = .50 ) . Cardiovascular death or MI occurred in 338 patients ( 10.4 % ) allocated to ranolazine and 343 patients ( 10.5 % ) allocated to placebo ( HR , 0.99 ; 95 % CI , 0.85 - 1.15 ; P = .87 ) . Recurrent ischemia was reduced in the ranolazine group ( 430 [ 13.9 % ] ) compared with the placebo group ( 494 [ 16.1 % ] ; HR , 0.87 ; 95 % CI , 0.76 - 0.99 ; P = .03 ) . QTc prolongation requiring a reduction in the dose of intravenous drug occurred in 31 patients ( 0.9 % ) receiving ranolazine compared with 10 patients ( 0.3 % ) receiving placebo . Symptomatic documented arrhythmias did not differ between the ranolazine ( 99 [ 3.0 % ] ) and placebo ( 102 [ 3.1 % ] ) groups ( P = .84 ) . No difference in total mortality was observed with ranolazine compared with placebo ( 172 vs 175 ; HR , 0.99 ; 95 % CI , 0.80 - 1.22 ; P = .91 ) . CONCLUSIONS The addition of ranolazine to st and ard treatment for ACS was not effective in reducing major cardiovascular events . Ranolazine did not adversely affect the risk of all-cause death or symptomatic documented arrhythmia . Our findings provide support for the safety and efficacy of ranolazine as antianginal therapy . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00099788",
"BACKGROUND Amiodarone , given as intravenous bolus has not yet been studied in patients with atrial fibrillation and a high ventricular rate . METHODS One hundred consecutive patients with atrial fibrillation and a ventricular rate above 135 bpm were r and omized to receive either 450 mg amiodarone or 0.6 mg digoxin given as a single bolus through a peripheral venous access . If the ventricular rate exceeded 100 bpm after 30 min , another 300 mg amiodarone or 0.4 mg digoxin were added . Primary endpoints of the study were the ventricular rate and the occurrence of sinus rhythm after 30 and 60 min . Secondary endpoints were blood pressure during the first hour after drug administration , and safety regarding drug induced hypotension , and phlebitis at the infusion site . RESULTS Baseline heart rate was 144+/-19 in the amiodarone group and 145+/-15 in the digoxin group ( p=0.72 ) . Following amiodarone , heart rate was 104+/-25 after 30 min compared to 116+/-23 in the digoxin group ( p=0.02 ) and 94+/-22 versus 105+/-22 after 60 min ( p=0.03 ) . After 30 min , sinus rhythm was documented in 14 ( 28 % ) patients following amiodarone compared to 3 ( 6 % ) patients in the digoxin group ( p=0.003 ) , and after 60 min in 21 ( 42 % ) versus 9 ( 18 % ) patients ( p=0.012 ) . Asymptomatic hypotension was observed in 4 amiodarone treated patients , and superficial phlebitis in 1 patient . CONCLUSIONS Amiodarone , given as an intravenous bolus is relatively safe and more effective than digoxin for heart rate control and conversion to sinus rhythm in patients with atrial fibrillation and a rapid ventricular rate",
"STUDY OBJECTIVE A prospect i ve , r and omized controlled trial of new-onset atrial fibrillation was conducted to compare the efficacy and safety of sotalol and amiodarone ( active treatment ) with rate control by digoxin alone for successful reversion to sinus rhythm at 48 hours . METHODS We prospect ively r and omly assigned 120 patients with atrial fibrillation of less than 24 hours ' duration to treatment with sotalol , amiodarone , or digoxin using a single intravenous dose followed by 48 hours of oral treatment . Patients had ECG monitoring for 48 hours , and time of reversion , adequacy of rate control , and numbers of adverse events were compared . After 48 hours , those still in atrial fibrillation underwent cardioversion according to a st and ardized protocol . After 48 hours of therapy and attempted cardioversion , the number of patients whose rhythms had successfully reverted were compared . RESULTS There was a significant reduction in the time to reversion with both sotalol ( 13 . 0+/-2.5 hours , P amiodarone ( 18.1+/-2.9 hours , P digoxin only ( 26.9+/-3.4 hours ) . By 48 hours , the active treatment group was significantly more likely to have reverted to sinus rhythm than the rate control group ( 95 % versus 78 % , P ventricular rate control in the sotalol group at both 24 and 48 hours compared with those who received either amiodarone or digoxin . There were also fewer adverse events in the active treatment group compared with the rate control group . CONCLUSION Immediate pharmacologic therapy for new-onset atrial fibrillation with class III antiarrhythmic drugs ( sotalol or amiodarone ) improves complication-free 48-hour reversion rates compared with rate control with digoxin",
"Atrial fibrillation ( AF ) is one of the most frequent dysrhythmias in patients coming to emergency departments ( EDs ) , and pharmacological treatment is frequently performed . The aim of this r and omized placebo-controlled multicenter trial was to compare propafenone ( a class 1C antidysrhythmic agent ) , administered i.v . in the ED , with placebo in the treatment of recent-onset AF ( . We r and omly allocated 156 patients ( 88 males ; 68 females ) from 18 to 80 years old , with recent-onset AF , to receive i.v . propafenone ( 2 mg/kg for 10 min ) or the matching placebo . The patients were followed for 2 h. Exclusion criteria were the presence of one of the following : lack of informed consent , clinical evidence of heart failure , clinical hyperthyroidism , recent acute myocardial infa rct ion , atrioventricular block , cardiac valve dysfunction , a history of bronchial asthma , and current treatment with antidysrhythmic agents including digitalis . The two groups did not differ significantly in terms of sex , age , body weight , or estimated time elapsed since the beginning of atrial fibrillation . Conversion to sinus rhythm occurred in 13 of the 75 patients who received the placebo ( 17.3 % ) and in 57 of the 81 patients who were given propafenone ( 70.3 % ) . In conclusion , intravenous propafenone administration in the ED can be considered a safe and effective approach for converting AF to sinus rhythm",
"OBJECTIVES We compared the effects of five pharmacologic regimens on the circadian rhythm and exercise-induced changes of ventricular rate ( VR ) in patients with chronic atrial fibrillation ( CAF ) . BACKGROUND Systematic comparison of st and ardized drug regimens on 24 h VR control in CAF have not been reported . METHODS In 12 patients ( 11 male , 69+/-6 yr ) with CAF , the effects on VR by 5 st and ardized daily regimens : 1 ) 0.25 mg digoxin , 2 ) 240 mg diltiazem-CD , 3 ) 50 mg atenolol , 4 ) 0.25 mg digoxin + 240 mg diltiazem-CD , and 5 ) 0.25 mg digoxin + 50 mg atenolol ; were studied after 2 week treatment assigned in r and om order . The VR data were analyzed by ANOVA with repeated measures . The circadian phase differences were evaluated by cosinor analysis . RESULTS The 24-h mean ( + /-SD ) values of VR ( bpm ) were - digoxin : 78.9 + /- 16.3 , diltiazem : 80.0+/-15.5 , atenolol : 75.9+/-11.7 , digoxin + diltiazem : 67.3+/-14.1 and digoxin + atenolol : 65.0+/-9.4 . Circadian patterns were significant in each treatment group ( p VR on digoxin + atenolol was significantly lower than that on digoxin ( p diltiazem ( p atenolol ( p time of peak VR on Holter was significantly delayed with regimens 3 and 5 which included atenolol ( p digoxin and digoxin + atenolol treatments result ed in the highest and lowest mean VR respectively . The exercise Time-VR plots of all groups were nearly parallel ( p = ns ) . The exercise duration was similar in all treatment groups ( p = ns ) . CONCLUSIONS This study indicates that digoxin and diltiazem , as single agents at the doses tested , are least effective for controlling ventricular rate in atrial fibrillation during daily activity . Digoxin + atenolol produced the most effective rate control reflecting a synergistic effect on the AV node . The data provides a basis for testing the effects of chronic suppression of diurnal fluctuations of VR on left atrial and ventricular function in CAF",
"Background : Pharmacological conversion of paroxysmal atrial fibrillation is frequently necessary . The aim of this study was to compare intravenous propafenone , a class Ic antiar‐rhythmic agent , with placebo in paroxysmal atrial fibrillation ( AF ) of recent onset ( < 72 h )",
"AIMS To evaluate the efficacy and safety of a single loading oral dose of propafenone in the interruption of recent-onset atrial fibrillation . METHODS After a complete medical history , physical examination , 12-lead ECG , chest X-ray , and routine biochemical laboratory testing , 55 consecutive patients with recent-onset atrial fibrillation were r and omized double-blind in the emergency department for the administration of either a single oral dose ( 450 to 750 mg ) of propafenone ( 29 cases ) or a placebo ( 26 cases ) . After the 24-h observation period , comprehensive echocardiographic examination was performed . RESULTS The groups were homogeneous as regards biological , clinical and echocardiographic characteristics . Two hours after treatment , 12 patients ( 41 % ) on propafenone but only two ( 8 % ) on placebo had converted to sinus rhythm ( P = 0.005 ) . This striking difference was maintained 6 h after treatment ( 65 vs 31 % ; P = 0.015 ) but lessened at 12 h ( 69 % vs 42 % ; P = 0.060 ) and was insignificant at the end of the 24-h treatment period ( 79 % , vs 73 % ; P = 0.752 ) . Apart from hypotension , transient in three cases and sustained in one whose later echocardiographic examination demonstrated left systolic ventricular dysfunction , propafenone was well tolerated . CONCLUSION Although there is no significant difference in the rates of conversion 24 h after treatment , propafenone works faster than placebo in achieving sinus rhythm . This rapid action of oral propafenone can be useful to solve quickly the clinical problems of a high proportion of patients arriving at the emergency department with acute atrial fibrillation",
"STUDY OBJECTIVE To compare placebo vs two different regimens of propafenone administration -- intravenous administration or short-term oral loading -- in converting recent-onset atrial fibrillation to sinus rhythm . DESIGN Single-blind placebo-controlled study . PATIENTS Eighty-seven patients with atrial fibrillation of recent onset ( The patients were assigned r and omly to treatment with intravenous propafenone ( 29 patients ) , oral propafenone ( 29 patients ) , or placebo ( 29 patients ) . INTERVENTIONS Administration of propafenone intravenously ( 2-mg/kg bolus followed by 0.0078 mg/kg/min ) or as short-term oral loading ( 600 mg orally single dose ) . Patients were su bmi tted to Holter monitoring and conversion to sinus rhythm was evaluated at 1 , 3 , and 8 h. RESULTS Conversion to sinus rhythm was obtained within 1 h in 28 % with intravenous propafenone , in 3 % with oral propafenone , and in 3 % with placebo . At 3 h , the efficacy of intravenous propafenone ( 41 % ) and of oral propafenone ( 55 % ) were statistically superior to placebo ( 10 % of conversions ) and at 8 h either intravenous or oral propafenone were effective in almost two thirds of the patients with a statistical difference vs placebo , whose efficacy was 24 % . No major side effects were observed . CONCLUSIONS Propafenone as an oral loading dose is an efficacious and fast way of treating atrial fibrillation of recent onset and due to its simplicity of administration and safety can be preferred to the intravenous route",
"AIMS A r and omized , double-blind study with a high dose of digoxin administered intravenously for conversion of atrial fibrillation ( not due to haemodynamic alternations ) to sinus rhythm , and for rate control in converters and non-converters was set up . Outcome measures were conversion within 12 h ; time to conversion ; early rate control ; and stable slowing within 12 h. METHODS We studied 40 patients with recent onset ( saline intravenously , the other patients digoxin 1.25 mg . RESULTS One patient converted before digoxin administration . Conversion occurred in 9/19 patients on digoxin and in 8/20 on placebo ( ns ) . The mean time to conversion tended to be shorter only for digoxin . Two late conversions on placebo were observed within 24 h. Heart rate during atrial fibrillation decreased after 30 min for converters and non-converters ( P digoxin , heart rate after 30 min was lower compared to baseline ( P placebo ( P Persistent , stable slowing occurred only in 3/10 non-converters on digoxin ( P bradyarrhythmias . QTc was shortened immediately after conversion in all patients . Converters had baseline characteristics similar to those of non-converters . CONCLUSIONS Intravenous digoxin offers no substantial advantages over placebo in recent onset atrial fibrillation with respect to conversion , and provides weak rate control",
"In severe heart failure many deaths are sudden and are presumed to be due to ventricular arrhythmias . The GESICA trial evaluated the effect of low-dose amiodarone on two-year mortality in patients with severe heart failure . Our prospect i ve multicentre trial included 516 patients on optimal st and ard treatment for heart failure . Patients were r and omised to 300 mg/day amiodarone ( 260 ) or to st and ard treatment ( 256 ) . Intention-to-treat analysis showed 87 deaths in the amiodarone group ( 33.5 % ) compared with 106 in the control group ( 41.4 % ) ( risk reduction 28 % ; 95 % CI 4%-45 % ; log rank test p = 0.024 ) . There were reductions in both sudden death ( risk reduction 27 % ; p = 0.16 ) and death due to progressive heart failure ( risk reduction 23 % ; p = 0.16 ) . Fewer patients in the amiodarone group died or were admitted to hospital due to worsening heart failure ( 119 versus 149 in the control group ; risk reduction 31 % ; 95 % CI 13 - 46 % ; p = 0.0024 ) . The decrease in mortality and hospital admission was present in all subgroups examined and independent of the presence of non-sustained ventricular tachycardia . Side-effects were reported in 17 patients ( 6.1 % ) ; amiodarone was withdrawn in 12 . Low-dose amiodarone proved to be an effective and reliable treatment , reducing mortality and hospital admission in patients with severe heart failure independently of the presence of complex ventricular arrhythmias",
"Background — Vernakalant , a relatively atrial-selective antiarrhythmic drug , has previously demonstrated efficacy for the acute conversion of atrial fibrillation ( AF ) to sinus rhythm . This study was design ed to determine the most appropriate oral dose of vernakalant for the prevention of AF recurrence postcardioversion . Methods and Results — Patients with nonpermanent AF were r and omized to 150 , 300 , or 500 mg vernakalant or placebo twice daily for up to 90 days . The efficacy analysis was conducted on 605 of 735 patients who entered the maintenance phase on day 3 after cardioversion . The time to the first recurrence of symptomatic sustained AF was significantly longer in the 500 mg vernakalant group , with a median of > 90 days versus 29 days in the placebo group ( hazard ratio , 0.735 ; P=0.0275 ) . No significant effect was seen at the lower doses . The percent of patients in sinus rhythm at day 90 was 41 % , 39 % , and 49 % in the 150-mg ( n=147 ) , 300-mg ( n=148 ) , and 500-mg ( n=150 ) vernakalant groups , respectively , compared with 36 % in the placebo group ( n=160 ) . There were no vernakalant-related proarrhythmic events . Related serious adverse events occurred in 2 patients in the 150-mg vernakalant group and in 1 patient in each of the other groups . Conclusions — Vernakalant , 500 mg twice daily , appears to be effective and safe for the prevention of AF recurrence after cardioversion . The absence of proarrhythmia and favorable safety profile is an important finding for the drug . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00526136",
"STUDY OBJECTIVES The relative risks and benefits of strategies of rate control vs rhythm control in patients with atrial fibrillation ( AF ) remain to be fully explored . DESIGN The How to Treat Chronic Atrial Fibrillation ( HOT CAFE ) Polish trial was design ed to evaluate in a r and omized , multicenter , and prospect i ve manner the feasibility and long-term outcomes of rate control vs rhythm control strategies in patients with persistent AF . PATIENTS Our study population comprised 205 patients ( 134 men and 71 women ; mean [ + /- SD ] age , 60.8 + /- 11.2 years ) with a mean AF duration of 273.7 + /- 112.4 days . The mean observation period was 1.7 + /- 0.4 years . One hundred one patients were r and omly assigned to the rate control group and received rate-slowing therapy guided by repeated 24-h Holter monitoring . Direct current cardioversion and atrioventricular junctional ablation with pacemaker placement were alternative nonpharmacologic strategies for patients with tachycardia that was resistant to medical therapy . One hundred four patients were r and omized to sinus rhythm restoration and maintenance using serial cardioversion supported by a predefined stepwise antiarrhythmic drug regimen ( ie , disopyramide , propafenone , sotalol , and amiodarone ) . In both groups , thromboembolic prophylaxis followed current guidelines . MEASUREMENTS AND RESULTS At the end of follow-up , 63.5 % of patients in the rhythm control arm remained in sinus rhythm . No significant differences in the composite end point ( ie , all-cause mortality , number of thromboembolic events , or major bleeding ) were found between the rate control group and the rhythm control group ( odds ratio , 1.98 ; 95 % confidence interval , 0.28 to 22.3 ; p > 0.71 ) . The incidence of hospital admissions was much lower in the rate control arm ( 12 % vs 74 % , respectively ; p New York Heart Association functional class improved in both study groups , while mean exercise tolerance , as measured by the maximal treadmill workload , improved only in the rhythm control group ( 5.2 + /- 5.1 vs 7.6 + /- 3.3 metabolic equivalents , respectively ; p mean left ventricular fractional shortening ( 29 + /- 7 % vs 31 + /- 7 % , respectively ; p pulmonary embolism occurred in the rate control group despite oral anticoagulation therapy , while three patients in the rhythm control arm of the study experienced ischemic strokes ( not significant ) . CONCLUSIONS The Polish HOT CAFE study revealed no significant differences in major end points between the rate control group and the rhythm control group",
"The efficacy of amiodarone has been proved in long-term maintenance of sinus rhythm ( SR ) in patients with paroxysmal atrial fibrillation ( AF ) . The present study evaluates the efficacy and safety of a single oral dose of amiodarone in patients with recent-onset AF ( amiodarone or placebo . Conversion to SR was verified by 24-hour Holter monitoring . Ten patients were excluded because of SR in the beginning of monitoring or technical failure during Holter monitoring . The remaining study groups were comparable ( n = 31 for each ) , except that in the placebo group beta blockers were more common . The patients receiving amiodarone converted to SR more effectively than those receiving placebo ( p amiodarone group and 20 % in the placebo group ( Holter successful ) had converted to SR , whereas after 24 hours the corresponding figures were 87 % and 35 % , respectively . The median time for conversion ( 8.7 hours for amiodarone and 7.9 hours for placebo ) did not differ in the groups . Amiodarone was hemodynamically well tolerated , and the number of adverse events in the study groups was similar . Amiodarone as a single oral dose of 30 mg/kg appears to be effective and safe in patients with recent-onset AF",
"The optimal way to convert recent-onset atrial fibrillation to sinus rhythm is a subject of much debate . The effectiveness of intravenous propafenone has been shown [ 1 - 3 ] , but the full antiarrhythmic effect of this regimen depends not only on the parent compound but on its 5-hydroxylated metabolite [ 4 , 5 ] . This dependence provides a strong rationale for the use of oral loading regimens [ 3 ] . Results of previous controlled studies have shown that oral loading of propafenone is highly effective in converting recent-onset atrial fibrillation to sinus rhythm [ 6 , 7 ] . Safety is a major concern with antiarrhythmic therapy . One of the primary proarrhythmic risks of propafenone and flecainide is the transformation of atrial fibrillation to flutter with 1:1 atrioventricular conduction and hemodynamic impairment [ 8 - 10 ] . We sought to determine whether the effectiveness and safety of propafenone differ in patients who have structural heart disease and patients who do not . Methods From June 1990 to June 1994 , consecutive patients with recent-onset atrial fibrillation ( 7 days ) who presented to one of three centers were considered for enrollment . Onset of arrhythmia was documented by electrocardiography or by an abrupt onset of palpitations with subsequent evidence of atrial fibrillation on electrocardiography . Patients were excluded for any of the following reasons : age greater than 80 years , heart failure greater than NYHA ( New York Heart Association ) class II , mean ventricular rate during atrial fibrillation less than 70 beats/min , recent myocardial infa rct ion ( within bifascicular block , the sick sinus syndrome , hypokalemia ( potassium level renal or hepatic failure with severe hypoxia ( Pao 2 metabolic disturbances , or known thyroid dysfunction . Patients who were receiving long-term digoxin therapy or antiarrhythmic drugs or had received such treatments within 8 hours before study entry were also excluded . Patients who had atrial fibrillation that lasted 72 hours or longer were enrolled only if they were receiving long-term warfarin therapy for anticoagulation . Patients provided informed consent . Eligible patients had a 24-hour Holter monitor applied ; after 1 to 2 hours of observation to assess the stability of atrial fibrillation , they were r and omly assigned by center in a single-blind manner to receive propafenone ( 300 mg in two tablets as a single oral dose ) or placebo . All patients received intravenous saline throughout the study period . The electrocardiogram was monitored by telemetry , blood pressure was measured every 2 hours , and 12-lead electrocardiography was done every hour for the first 4 hours and then every 2 hours for the next 4 hours . When patients converted to sinus rhythm , 12-lead electrocardiography was done immediately . Conversion was defined as a stable sinus rhythm that lasted for at least 1 hour . Eight hours after the study drug was administered , physicians could continue treatment with the study drug or switch to a different therapeutic option . Holter monitor tapes were analyzed by two blinded observers using computer scanning systems ( Marquette 8000 , Milwaukee , Wisconsin , and Del Mar Avionics , Irvine , California ) to determine the time of conversion to sinus rhythm and whether an abnormal rhythm was present . Within 24 hours after enrollment , echocardiography was done for each patient and left atrial diameter was measured in the left parasternal long-axis view . On the basis of clinical history and the results of physical examination , echocardiography , and chest radiography , patients were classified as having structural heart disease ( defined as the presence of cardiac abnormalities other than atrial fibrillation ) , hypertension without structural heart disease ( defined as previously recognized systemic hypertension according to the criteria of the World Health Organization ) , or neither . Continuous outcomes and baseline characteristics of the patients were compared by using the chi-square statistic and t-test as appropriate . The rates of conversion to sinus rhythm were assessed at 3 and 8 hours . Odds ratios and corresponding CIs were calculated according to the methods of Gardner and Altman [ 11 ] . We did logistic regression analysis to describe how the interaction of treatment with the presence or absence of heart disease and hypertension affected the probability of conversion to sinus rhythm . Analyses were done using SPS software , version 6.1.3 ( SPS , Inc. , Chicago , Illinois ) . Results Patients During the study period , 407 patients presented to the three centers and were screened for eligibility . Two hundred forty-three patients were eligible , and 240 gave consent . A total of 164 patients were excluded for one or more of the following reasons : age greater than 80 years ( n = 10 ) , heart failure greater than NYHA class II ( n = 33 ) , recent myocardial infa rct ion ( n = 20 ) , bundle-branch block ( n = 24 ) , the sick sinus syndrome ( n = 6 ) , severe hypoxia ( n = 13 ) , thyroid dysfunction ( n = 12 ) , and previous antiarrhythmic treatment ( n = 63 ) . Two hundred forty patients were r and omly assigned to receive propafenone ( n = 119 ) or placebo ( n = 121 ) . The two groups were similar with regard to age , sex , cause of atrial fibrillation , NYHA class , left atrial dimension ( measured by echocardiography ) , structural heart disease , and hypertension ( Table 1 ) . The duration of atrial fibrillation before r and omization ranged from 2.5 to 120 hours and did not differ significantly between the treatment groups . Table 1 . Patient Characteristics Conversion to Sinus Rhythm and Presence of Heart Disease The probability of conversion to sinus rhythm was greater after propafenone than after placebo at 3 and 8 hours ( P Conversion to sinus rhythm within 8 hours in patients receiving propafenone or placebo . At 8 hours , the probability of conversion to sinus rhythm was significantly higher in the propafenone group than in the placebo group for patients who had heart disease ( odds ratio , 21.7 [ CI , 5.9 to 80.1 ] ; P Conversion rates at 8 hours for patients receiving propafenone were similar among the three heart disease subgroups , but conversion rates for patients receiving placebo differed significantly ( 56 % for patients without structural heart disease , 27 % for patients with hypertension , and 17 % patients with structural heart disease [ P = 0.009 by logistic regression model ] ) . At 3 hours , the probability of conversion to sinus rhythm was higher in the propafenone group than in the placebo group for patients who did not have heart disease ( 48 % for propafenone compared with 26 % for placebo ; odds ratio , 2.6 [ CI , 1.2 to 6.0 ] ; P = 0.02 ) , patients who had hypertension ( 41 % for propafenone compared with 16 % for placebo ; odds ratio , 3.5 [ CI , 1.2 to 10.5 ] ; P = 0.02 ) , and patients who had structural heart disease ( 47 % for propafenone compared with 7 % for placebo ; odds ratio , 12.3 [ CI , 2.5 to 60.5 ] ; P Mean time SD for conversion to sinus rhythm within 8 hours was 181 118 minutes for propafenone and 181 112 minutes for placebo ( P > 0.2 ) . Adverse Effects Sustained atrial flutter or tachycardia ( lasting 1 min ) occurred in eight patients ( 7 % ) receiving propafenone and seven patients ( 6 % ) receiving placebo ( P > 0.2 ) , regardless of heart disease status . Among these patients , atrioventricular conduction was 2:1 in two patients receiving propafenone ( heart rate , 115 to 140 beats/min ) and three patients receiving placebo ( heart rate , 120 to 150 beats/min ) , 3:1 in six patients receiving propafenone ( heart rate , 60 to 95 beats/min ) and three patients receiving placebo ( heart rate , 60 to 100 beats/min ) , and 1:1 in one patient receiving placebo ( heart rate , 240 beats/min ) . This patient developed atrial flutter and collapsed . Pauses in ventricular rate lasting longer than 2 seconds were seen in one patient ( 1 % ) receiving propafenone and three patients ( 2 % ) receiving placebo ( P > 0.2 ) . Among patients receiving propafenone , nine ( 8 % ) had the following adverse effects : QRS complexes of the electrocardiogram greater than 120 ms ( n = 3 ) , hypotension ( n = 2 ) , slight hypotension and bradycardia at conversion ( n = 3 ) , and phases of junctional rhythm after conversion ( n = 1 ) . No ventricular proarrhythmic effects occurred . Discussion Oral loading of propafenone was effective for conversion to sinus rhythm in our study , as it has been in smaller studies [ 3 , 6 , 7 , 12 , 13 ] . The recent findings of Wijffels and colleagues [ 14 ] in a model of chronic atrial fibrillation in animals indicate that electrophysiologic remodeling occurs within a few hours of persistent atrial fibrillation and results primarily from changes in atrial refractoriness that enhance the persistence of atrial fibrillation . This observation provides a strong rationale for prompt conversion to sinus rhythm . Therefore , oral loading of propafenone ( which has an effectiveness similar to that of intravenous propafenone [ 3 ] ) offers many advantages over such regimens as oral quinidine and intravenous amiodarone , which require titration of dose or a longer period of time to achieve an effect [ 6 , 13 , 15 ] . In controlled trials , propafenone was shown to be more effective and to take effect more quickly than amiodarone [ 13 ] or digoxin plus quinidine [ 6 ] . Intravenous amiodarone was no more effective than placebo ",
"The fundamental management strategy for atrial fibrillation ( AF ) is still debated . There is no doubt that those patients at risk of thromboembolic events should be offered anticoagulant therapy . However , it is uncertain whether rhythm control ( restoration and maintenance of sinus rhythm ) or rate control ( adjustment to a physiological ventricular rate while allowing AF to continue ) is the preferred primary treatment option for the reduction of symptoms and major cardiovascular ( CV ) outcomes associated with AF . Several well conducted trials comparing the two strategies led to the conclusion that there was little to choose between them . However , guidelines leaned towards recommending rate control as the initial strategy , and reserved rhythm control for those who remained symptomatic . Recently this status quo is being increasingly challenged by the clear demonstration that left atrial catheter ablation is effective at suppressing AF resistant to traditional antiarrhythmic drugs , such as those that failed to demonstrate any superiority when compared with rate control . Also , recently introduced antiarrhythmic therapy may have superior efficacy with regard to reducing unexpected CV hospitalization , CV mortality and stroke . In addition , there is a growing perception that atrial remodelling should be best prevented by early rhythm control rather than delaying until rate control has proven unsatisfactory . For these reasons the results of large r and omised clinical trials , which recruit patients soon after the presentation of AF and compare ' aggressive ' modern rhythm control against the guideline approach of primary rate control , are eagerly awaited . In the meantime the pendulum of clinical opinion has begun to swing towards a rhythm control strategy",
"OBJECTIVES This study was design ed to compare two treatment strategies in patients with atrial fibrillation(AF ) : rhythm-control ( restoration and maintenance of sinus rhythm ) and rate-control ( pharmacologic or invasive rate-control and anticoagulation ) . BACKGROUND Atrial fibrillation is the most common arrhythmia . It is unclear whether a strategy of rhythm- or rate-control is better in terms of mortality , morbidity , and quality of life . METHODS The Strategies of Treatment of Atrial Fibrillation ( STAF ) multicenter pilot trial r and omized 200 patients ( 100 per group ) with persistent AF to rhythm- or rate-control . The combined primary end point was a combination of death , cardiopulmonary resuscitation , cerebrovascular event , and systemic embolism . RESULTS After 19.6 + /- 8.9 months ( range 0 to 36 months ) there was no difference in the primary end point between rhythm-control ( 9/100 ; 5.54%/year ) and rate-control ( 10/100 ; 6.09%/year ; p = 0.99 ) . The percentage of patients in sinus rhythm in the rhythm-control group after up to four cardioversions during the follow-up period ( rate-control group ) was 23 % ( 0 % ) at 36 months . Eighteen primary end points occurred in atrial fibrillation ; only one occurred in sinus rhythm ( p = 0.049 ) . CONCLUSIONS The STAF pilot study showed no differences between the two treatment strategies in all end points except hospitalizations . These data suggest that there was no benefit in attempting rhythm-control in these patients with a high risk of arrhythmia recurrence . It remains unclear whether the results in the rhythm-control group would have been better if sinus rhythm had been maintained in a higher proportion of patients , as all but one end point occurred during AF",
"In recent-onset atrial fibrillation , intravenous propafenone has been shown to effectively restore sinus rhythm , whereas the efficacy of intravenous digoxin has been question ed . We directly compared these 2 drugs and placebo in acute atrial fibrillation . One hundred twenty-three patients with atrial fibrillation lasting were r and omized to a 10-minute intravenous infusion of either propafenone ( 2 mg/kg , 41 patients ) or digoxin ( 0.007 mg/kg , 40 patients ) or placebo ( 42 patients ) . After 1 hour , nonconverted propafenone or digoxin patients were switched to the alternative drug , while nonconverted placebo patients were r and omized to either propafenone or digoxin . The observation time ended 1 hour later . By 1 hour , conversion rates were 49 % in the propafenone group , 32 % in the digoxin group ( p = 0.12 ) , and 14 % in placebo group ( p propafenone , p = 0.08 vs digoxin ) . After crossover , digoxin converted 5 % of propafenone patients , while propafenone converted 48 % of digoxin patients ( p 36 nonconverted placebo patients , sinus rhythm was obtained in 53 % of cases with propafenone , and in 5 % with digoxin ( p 116 patients who received a drug as first treatment , 30 of 60 patients ( 50 % ) were converted by propafenone versus 14 of 56 ( 25 % ) by digoxin ( p ventricular rate reduction was faster ( 15 vs 45 minutes ) and more prominent ( -24 % vs -14 % ) with propafenone than with digoxin . In conclusion , intravenous propafenone terminates atrial fibrillation more effectively than either placebo or intravenous digoxin . In addition , in nonconverted patients , it obtains a more rapid and marked control of the ventricular rate",
"OBJECTIVES The purpose of this study was to determine the efficacy and safety of intravenous RSD1235 in terminating recent onset atrial fibrillation ( AF ) . BACKGROUND Anti-arrhythmic drugs currently available to terminate AF have limited efficacy and safety . RSD1235 is a novel atrial selective anti-arrhythmic drug . METHODS This was a phase II , multi-centered , r and omized , double-blinded , step-dose , placebo-controlled , parallel group study . Fifty-six patients from 15 U.S. and Canadian sites with AF of 3 to 72 h duration were r and omized to one of two RSD1235 dose groups or to placebo . The two RSD1235 groups were RSD-1 ( 0.5 mg/kg followed by 1 mg/kg ) or RSD-2 ( 2 mg/kg followed by 3 mg/kg ) , by intravenous infusion over 10 min ; a second dose was given only if AF was present . The primary end point was termination of AF during infusion or within 30-min after the last infusion . Secondary end points included the number of patients in sinus rhythm at 0.5 , 1 , and 24 h post-last infusion and time to conversion to sinus rhythm . RESULTS The RSD-2 dose showed significant differences over placebo in : 1 ) termination of AF ( 61 % vs. 5 % , p patients in sinus rhythm at 30 min ( 56 % vs. 5 % , p sinus rhythm at 1 h ( 53 % vs. 5 % , p = 0.0014 ) ; and 4 ) median time to conversion to SR ( 14 vs. 162 min , p = 0.016 ) . There were no serious adverse events related to RSD1235 . CONCLUSIONS RSD1235 , a new atrial-selective anti-arrhythmic agent , appears to be efficacious and safe for converting recent onset AF to sinus rhythm",
"In patients with recent-onset atrial fibrillation ( AF ) , restoration of sinus rhythm is considered to be the first-line therapeutic option . Although this conversion might be obtained by direct-current shock or intravenous antiarrhythmic drugs , administration of an oral loading dose of class I or III antiarrhythmic drugs is more simple and convenient . This prospect i ve , r and omized , multicenter study compares the time to conversion to sinus rhythm obtained with an oral loading dose of propafenone or amiodarone . Patients with recent-onset AF ( , were r and omly assigned to be treated with propafenone ( 600 mg for the first 24 hours and if necessary a repeated dose of 300 mg for 24 hours ) or amiodarone ( 30 mg/kg for the first 24 hours and if necessary a repeated dose of 15 mg/kg for 24 hours ) . Exact conversion time during the first 24 hours was determined by Holter monitoring . In each treatment group 43 patients with the same baseline characteristics were included . The median time for restoration of sinus rhythm was shorter ( p = 0.05 ) in the propafenone ( 2.4 hours ) than in the amiodarone ( 6.9 hours ) group . After 24 hours ( 56 % in the propofenone and 47 % in the amiodarone group ) and 48 hours , the same proportion of patients in the 2 groups recovered sinus rhythm ( no serious adverse events were noticed ) . Thus , oral loading dose of propafenone or amiodarone was safe with a similar conversion rate of recent-onset AF . Propafenone had a faster action",
"BACKGROUND Maintenance of sinus rhythm is the main therapeutic goal in patients with atrial fibrillation . However , recurrences of atrial fibrillation and side effects of antiarrhythmic drugs offset the benefits of sinus rhythm . We hypothesized that ventricular rate control is not inferior to the maintenance of sinus rhythm for the treatment of atrial fibrillation . METHODS We r and omly assigned 522 patients who had persistent atrial fibrillation after a previous electrical cardioversion to receive treatment aim ed at rate control or rhythm control . Patients in the rate-control group received oral anticoagulant drugs and rate-slowing medication . Patients in the rhythm-control group underwent serial cardioversions and received antiarrhythmic drugs and oral anticoagulant drugs . The end point was a composite of death from cardiovascular causes , heart failure , thromboembolic complications , bleeding , implantation of a pacemaker , and severe adverse effects of drugs . RESULTS After a mean ( + /-SD ) of 2.3+/-0.6 years , 39 percent of the 266 patients in the rhythm-control group had sinus rhythm , as compared with 10 percent of the 256 patients in the rate-control group . The primary end point occurred in 44 patients ( 17.2 percent ) in the rate-control group and in 60 ( 22.6 percent ) in the rhythm-control group . The 90 percent ( two-sided ) upper boundary of the absolute difference in the primary end point was 0.4 percent ( the prespecified criterion for noninferiority was 10 percent or less ) . The distribution of the various components of the primary end point was similar in the rate-control and rhythm-control groups . CONCLUSIONS Rate control is not inferior to rhythm control for the prevention of death and morbidity from cardiovascular causes and may be appropriate therapy in patients with a recurrence of persistent atrial fibrillation after electrical cardioversion",
"BACKGROUND The authors report their experience in recent-onset atrial fibrillation treated with intravenous flecainide and propafenone , in comparison with the placebo group . METHODS We r and omized 352 ( 138 in the flecainide group , 164 in the propafenone group and 50 in the control group ) consecutive patients ( 167 males , 185 females , mean age 59 + /- 12 years ) with recent-onset atrial fibrillation . The electrocardiogram of all patients was monitored for at least 24 hours . RESULTS The restoration of sinus rhythm occurred in 72.5 , 80.4 , 86.2 and 89.8 % of patients in the flecainide group ; in 54.3 , 68.3 , 75 and 92.1 % in the propafenone group ; in 22.2 , 27.8 , 35.2 and 46.3 % in the control group , at 1 , 3 , 6 and 24 hours respectively . The occurrence of side effects was the same in all treatment groups , and occurred in about 10 % of patients in the flecainide and propafenone groups , and in 4 % in the control group . In our study population the treatment of recent-onset atrial fibrillation with flecainide was faster in converting the arrhythmia to sinus rhythm ( p efficacy of either flecainide or propafenone was the same ( p = NS at 24 hours ) . CONCLUSIONS Side effects were similar in both treatment groups . In particular malignant arrhythmias did not occur in the treatment groups and in the control group",
"OBJECTIVES This r and omized double-blind study compared the efficacy and safety of intravenous vernakalant and amiodarone for the acute conversion of recent-onset atrial fibrillation ( AF ) . BACKGROUND Intravenous vernakalant has effectively converted recent-onset AF and was well tolerated in placebo-controlled studies . METHODS A total of 254 adult patients with AF ( 3 to 48 h duration ) eligible for cardioversion were enrolled in the study . Patients received either a 10-min infusion of vernakalant ( 3 mg/kg ) followed by a 15-min observation period and a second 10-min infusion ( 2 mg/kg ) if still in AF , plus a sham amiodarone infusion , or a 60-min infusion of amiodarone ( 5 mg/kg ) followed by a maintenance infusion ( 50 mg ) over an additional 60 min , plus a sham vernakalant infusion . RESULTS Conversion from AF to sinus rhythm within the first 90 min ( primary end point ) was achieved in 60 of 116 ( 51.7 % ) vernakalant patients compared with 6 of 116 ( 5.2 % ) amiodarone patients ( p rapid conversion ( median time of 11 min in responders ) and was associated with a higher rate of symptom relief compared with amiodarone ( 53.4 % of vernakalant patients reported no AF symptoms at 90 min compared with 32.8 % of amiodarone patients ; p = 0.0012 ) . Serious adverse events or events leading to discontinuation of study drug were uncommon . There were no cases of torsades de pointes , ventricular fibrillation , or polymorphic or sustained ventricular tachycardia . CONCLUSIONS Vernakalant demonstrated efficacy superior to amiodarone for acute conversion of recent-onset AF . Both vernakalant and amiodarone were safe and well tolerated in this study . ( A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation [ AVRO ] ; NCT00668759 )",
"BACKGROUND Uncertainty persists about the safety and efficacy of amiodarone for the management of heart failure . METHODS AND RESULTS We r and omized 3029 patients with chronic heart failure to receive carvedilol or metoprolol and followed patients for a median of 58 months . One hundred fifty-five of 1466 patients in New York Heart Association ( NYHA ) Class II and 209 of 1563 in Class III or IV received amiodarone at baseline . Persistence with amiodarone treatment was high and 66 % received amiodarone after 4 years . During follow-up , 38.7 % and 58.9 % of patients receiving amiodarone in NYHA Classes II and III + IV died versus 26.2 % and 43.3 % not receiving amiodarone ( P increased risk of death due to circulatory failure ( HR 2.4 , CI 1.9 - 3.1 , P amiodarone . Sudden death was not different ( HR 1.07 , CI 0.8 - 1.4 , P = .7 ) . The increased risk was similar across NYHA classes with HR of 1.60 ( CI 1.2 - 2.1 , P amiodarone was associated with an increased risk of death from circulatory failure independent of functional class",
"In a r and omized , double-blind , controlled study of 98 patients with atrial fibrillation ( AF ) ( present for > or = 30 minutes , or = 100 beats/min ) , intravenous flecainide ( 2 mg/kg , maximum 150 mg ) was compared with intravenous amiodarone ( 7 mg/kg ) and placebo . Exclusion criteria included significant left ventricular dysfunction , inotrope dependence , recent antiarrhythmic therapy , hypokalemia , and pacemaker dependence . Reversion to stable sinus rhythm within 2 hours of starting medication was considered likely to be due to drug effect . Twenty of 34 patients ( 59 % ) given flecainide , 11 of 32 ( 34 % ) given amiodarone , and 7 of 32 ( 22 % ) given placebo reverted to stable sinus rhythm in stable rhythm with flecainide than with placebo ( p = 0.005 ; odds ratio 5.1 , 95 % confidence interval 1.54 to 17.5 ) . There was no significant difference between amiodarone and placebo or between flecainide and amiodarone . However , after 8 hours there were no significant differences in reversion between the treatment groups : flecainide ( n = 23 , 68 % ) , amiodarone ( n = 19 , 59 % ) , and placebo ( n = 18 , 56 % ) . Amiodarone promptly reduced the ventricular rate , and this effect was maintained for 8 hours in those whose reversion to stable sinus rhythm was unsuccessful : flecainide was no more effective than placebo in controlling ventricular rate . Adverse effects were not significantly different in the 3 groups . Thus , intravenous flecainide results in earlier reversion of AF than does intravenous amiodarone or placebo . Amiodarone , although less effective in reverting AF , slows the rapid ventricular response . ( ABSTRACT TRUNCATED AT 250 WORDS",
"To evaluate the efficacy of propafenone in converting recent‐onset atrial fibrillation ( AF ) lasting propafenone ( Group 1 , n = 98 ) and with placebo 0.9 % saline solution ( Group 2 , n = 84 ) in a double blind study . The treatment was continued until sinus rhythm ( SR ) was restored , but for no more than 24 h. Eighty‐nine patients treated with propafenone ( 90.8 % ) and 27 patients treated with placebo ( 32.1 % ) responded to the treatment and SR was restored ( p The mean time for SR restoration was 2.51± 2.77 h in Group 1 , and 17.15± 7.8 h in Group 2 ( p larger left atrial size and longer duration of AF than responders at the onset of the arrhythmia . Nonresponders in Group 1 showed a decrease in mean ventricular rate ( MVR ) from 143± 16 to 101± 18 ( p no reduction of MVR was observed . Two patients whose SR was restored with propafenone had sinus st and still lasting 3.4 and 3.8 s , respectively . Propafenone used intravenously is an effective , quick , and safe drug for treating AF . Moreover , it significantly reduces MVR in nonresponders",
"The effects of amiodarone in a low dosage ( 200 mg every 8 h for 2 weeks , then 200 mg/day ) was assessed in a double-blind placebo-controlled trial in 34 patients with a history of severe congestive heart failure but no sustained ventricular arrhythmia . Left ventricular ejection fraction , treadmill exercise tolerance and 48 h electrocardiographic monitoring were assessed before and repeatedly after beginning amiodarone or placebo therapy over 6 months , and side effects were monitored . In patients receiving amiodarone , the ejection fraction increased significantly from 19 + /- 7 to 29 + /- 15 % at 6 months ( p less than 0.01 from baseline ) , but not significantly in 14 placebo-treated patients ( 18 + /- 5 to 22 + /- 9 % ) . Exercise tolerance increased significantly in amiodarone-treated patients ( median 433 s to 907 s , p less than 0.05 ) , but not significantly in placebo-treated patients ( 757 to 918 s ) . Nonsustained ventricular tachycardia was present in 88 % of amiodarone-treated patients before , but in only 21 % of patients after 6 months of treatment ( p = 0.06 ) ; it was seen in 43 % of placebo-treated patients at baseline and in 50 % after 6 months . Fifty percent of amiodarone-treated patients had side effects ( principally nausea ) and the drug was withdrawn in 28 % of cases ; no life-threatening effects were seen . Low dose amiodarone appears to have a multifaceted potential to produce benefits in arrhythmia control , exercise tolerance and ventricular function in patients with a history of severe congestive heart failure , but better control of side effects ( principally nausea ) appears essential . Effects on mortality could not be determined from this study ; such assessment requires a larger cohort of patients",
"Summary : Thirty-four patients with atrial fibrillation complicating suspected acute myocardial infa rct ion were r and omised to treatment with intravenous amiodarone ( n = 18 ) or intravenous digoxin ( n = 16 ) . After 24 h , similar proportions of patients in each group had reverted to sinus rhythm . However , there was a tendency towards earlier reversion with amiodarone . At 4 h , 72 % of the amiodarone group had reverted to sinus rhythm , compared with 31 % of the digoxin group ( p amiodarone 75 % reversion , digoxin 10 % reversion ) . Neither drug had a significant effect on blood pressure . Atrial fibrillation may cause serious haemodynamic deterioration in acute myocardial infa rct ion . In comparison with digoxin , amiodarone offers more rapid control of the ventricular response rate and may , in addition , restore sinus rhythm more rapidly",
"UNLABELLED The efficacy and safety of intravenous propafenone , amiodarone , or placebo were compared in the treatment of atrial fibrillation ( AF ) of recent onset ( duration METHODS 143 patients ( 77 men , mean age 63 + /- 12 years ) were studied , of whom 46 received propafenone ( 2 mg/kg over 15 minutes followed by 10 mg/kg over the next 24 hours ) , 48 received amiodarone ( 300 mg intravenously over 1 hour , followed by 20 mg/kg over the next 24 hours , plus 1,800 mg/day orally , in 3 divided doses ) , and 49 received placebo ( the equivalent amount of saline i.v . over 24 hours ) . Digoxin was administered to all patients who had not previously received it . RESULTS Conversion to normal sinus rhythm occurred in 36 of 46 patients ( 78.2 % ) receiving propafenone , in 40 of 48 patients ( 83.3 % ) receiving amiodarone , and in 27 of the 49 ( 55.10 % ) controls ( P placebo , between drugs NS ) . The mean time to conversion was 2 + /- 3 hours for propafenone , 7 + /- 5 hours for amiodarone , and 13 + /- 9 for placebo ( P smaller atria than those who did not ( diameter : 42.7 + /- 5 vs 47.2 + /- 7 mm , P amiodarone group because of an allergic reaction and in two patients in the propafenone group because of excessive QRS widening . No side effects were observed in the placebo group . CONCLUSIONS Both drugs tested intravenously were equally effective and safe for the rapid conversion of recent-onset atrial fibrillation to sinus rhythm . However , propafenone offered the advantage of more rapid conversion than amiodarone",
"INTRODUCTION Dofetilide , a new class III antiarrhythmic drug , was tested for its ability to reduce mortality and morbidity in patients with congestive heart failure and left ventricular dysfunction . METHODS In 34 Danish centers , 1518 patients with NYHA class III or IV heart failure and wall motion index of the left ventricle to receive dofetilide or placebo in a double blind study . The dose of dofetilide was adjusted to renal function and the QT interval . Patients were monitored continuously with ekg during the first three days in the study . Minimum follow up was one year . RESULTS Dofetilide did not affect mortality . Hospitalizations for worsening of heart failure were reduced significantly , hazard ratio 0.75 ( 0.63 - 0.89 ) Dofetilide effectively converted atrial fibrillation to sinus rhythm . After one year , 61 % of patients with atrial fibrillation had converted on dofetilide and 33 % on placebo ( p Dofetilide can be used to convert atrial fibrillation to sinus rhythm and to maintain sinus rhythm in patients with congestive heart failure and left ventricular dysfunction . Dofetilide does not affect mortality",
"BACKGROUND We sought to assess the association of amiodarone use with mortality during consecutive periods in patients with post-acute myocardial infa rct ion with left ventricular systolic dysfunction and /or HF treated with a contemporary medical regimen . METHODS This study used data from VALIANT , a r and omized comparison of valsartan , captopril , or both in patients with acute myocardial infa rct ion with HF and /or left ventricular systolic dysfunction . We compared baseline characteristics of 825 patients treated with amiodarone at r and omization with 13,875 patients not treated with amiodarone . Using Cox models , we examined the association of amiodarone use with subsequent mortality during consecutive periods after r and omization ( days 1 - 16 , 17 - 45 , 46 - 198 , and 199 - 1096 ) . RESULTS Patients treated with amiodarone were older , had higher Killip class , and were more likely to have a history of diabetes mellitus and hypertension . Adjusting for baseline predictors of mortality , we found that amiodarone use was associated with a significant increase in mortality during 3 of the 4 periods : hazard ratio 1.5 , 95 % CI ( 1.1 - 2.0 ) , P = .02 , for days 1 to 16 ; 2.1 ( 1.5 - 2.9 ) , P amiodarone use was associated with excess early and late all-cause and cardiovascular mortality . These observational findings are in contrast to earlier r and omized trials of amiodarone and need to be vali date d prospect ively",
"Background : Attempts to prolong life with antiarrhythmic drugs in patients at increased risk of sudden cardiac death have so far been disappointing or inconclusive",
"AIMS The DAAF Trial was design ed to investigate whether digoxin , within 16 h of its use , increases the rate of conversion to sinus rhythm in patients with acute atrial fibrillation . METHODS AND RESULTS In a r and omized , double-blind multicentre trial the effects of intravenous digoxin and placebo , ( mean dose 0.88 + /- 0.35 mg and 0.96 + /- 0.37 mg ) were compared in 239 patients with a mean age of 66.2 + /- 13.0 years and atrial fibrillation of , at most , 7 days ' duration . The mean arrhythmia duration was 21.7 + /- 30.4 h and baseline heart rate 122.0 + /- 23.0 beats.min-1 . At 16 h , 46 % of the placebo group and 51 % of the digoxin group had converted to sinus rhythm , ( ns ) . Time to sinus rhythm was shorter in the digoxin group , but the difference was not significant . Digoxin had a pronounced and rapid effect on heart rate , which was already significant at 2 h ; 104.6 + /- 20.9 beats.min-1 vs 116.8 + /- 22.5 beats.min-1 ( P = 0.0001 ) . CONCLUSION Acute intravenous treatment with digoxin does not increase the rate of conversion to sinus rhythm , but has a fast acting and clinical ly significant effect on heart rate and should remain an alternative in haemodynamically stable patients",
"INTRODUCTION . Atrial fibrillation is a frequent cause of worsening of symptoms in patients with congestive heart failure . The drugs currently available for maintenance of sinus rhythm all have major side effects . METHODS . In 34 Danish coronary care units , 1518 patients with congestive heart failure and reduced left ventricular systolic function were r and omized to receive either placebo or a new class III antiarrhythmic drug , dofetilide . The dose of dofetilide was adjusted according to the presence of atrial fibrillation , the length of the QT interval , and renal function . Patients were continuously monitored electrocardiographically for the first 3 days of the study . The primary end point was all-cause mortality and follow-up was for at least 1 year . RESULTS . In the dofetilide/placebo groups , 311/317 patients died ( 41%/42 % ) . The hazard ratio for dofetilide treatment was 0.95 ( 95 % confidence interval , 0.81 - 1.11 ) . Treatment with dofetilide reduced worsening of heart failure significantly ( hazard ratio , 0.75 ; 0.63 - 0.89 ) . After 1 year , 61 % of patients with atrial fibrillation at the start of the study had converted to sinus rhythm on dofetilide , vs. 33 % in the placebo group . After conversion to sinus rhythm , 78%/43 % of patients in the dofetilide/placebo groups remained in sinus rhythm for at least 1 year . There were 25 instances ( 3 % ) of torsade de pointes ventricular tachycardia in the dofetilide group and none in the placebo group . CONCLUSION . In patients with congestive heart failure , dofetilide can effectively convert atrial fibrillation to sinus rhythm and maintain sinus rhythm after conversion . Hospitalization for congestive heart failure is reduced . Dofetilide does not affect mortality . (c)2001 by CHF ,",
"BACKGROUND Currently available antiarrhythmic drugs have limited efficacy for acute termination of atrial fibrillation and flutter , especially if the arrhythmia is not of recent onset . The purpose of this multicenter study was to determine the efficacy and safety of repeated doses of intravenous ibutilide , a class III antiarrhythmic drug , in terminating atrial fibrillation or flutter . METHODS AND RESULTS Two hundred sixty-six patients with sustained atrial fibrillation ( n = 133 ) or flutter ( n = 133 ) , with an arrhythmia duration of 3 hours to 45 days , were r and omized to receive up to two 10-minute infusions , separated by 10 minutes , of ibutilide ( 1.0 and 0.5 mg or 1.0 and 1.0 mg ) or placebo . The conversion rate was 47 % after ibutilide and 2 % after placebo ( P ibutilide dosing regimens did not differ in conversion efficacy ( 44 % versus 49 % ) . Efficacy was higher in atrial flutter than fibrillation ( 63 % versus 31 % , P conversion rates were higher in patients with a shorter arrhythmia duration or a normal left atrial size . Arrhythmia termination occurred a mean of 27 minutes after start of the infusion . Of 180 ibutilide-treated patients , 15 ( 8.3 % ) developed polymorphic ventricular tachycardia during or soon after the infusion . The arrhythmia required cardioversion in 3 patients ( 1.7 % ) and was nonsustained in 12 patients ( 6.7 % ) . CONCLUSIONS Intravenous ibutilide given in repeated doses is effective in rapidly terminating atrial fibrillation and flutter and under monitored conditions is an alternative to current cardioversion options",
"BACKGROUND Amiodarone and sotalol are commonly used for the maintenance of sinus rhythm , but the efficacy of these agents administered as high-dose infusions for rapid conversion of atrial fibrillation is unknown . Use in this context would facilitate drug initiation in patients in whom ongoing prophylactic therapy is indicated . METHODS We assessed the efficacy and safety of rapid high-dose intravenous infusions of amiodarone and sotalol for heart rate control and rapid reversion to sinus rhythm in patients who came to the emergency department with recent-onset symptomatic atrial fibrillation . Patients ( n = 140 ) were r and omized to receive 1.5mg/kg of sotalol infused in 10 minutes , 10mg/kg of amiodarone in 30 minutes , or 500 microg of digoxin in 20 minutes . Electrical cardioversion was attempted for patients not converting to sinus rhythm within 12 hours . RESULTS The rapid infusion of sotalol or amiodarone result ed in more rapid rate control than digoxin . Each of the 3 trial strategies result ed in similar rates of pharmacological conversion to sinus rhythm ( amiodarone , 51 % ; sotalol , 44 % ; digoxin , 50 % ; P = not significant ) . The overall rates of cardioversion after trial drug infusion and defibrillation were high for all groups ( amiodarone , 94 % ; sotalol , 95 % , ; digoxin , 98 % ; P = not significant ) , but there was a trend toward a higher incidence of serious adverse reactions in the amiodarone group . CONCLUSION The rapid infusion of sotalol or amiodarone in patients with symptomatic recent-onset atrial fibrillation results in rapid control of ventricular rate . Even with high-dose rapid infusions , all 3 agents are associated with a poor overall reversion rate within 12 hours . Almost all patients were returned to sinus rhythm with a combination of pharmacological therapy and electrical cardioversion"
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41170190-06ff-11f0-808a-c43d1ab1c353
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AIM The aim of the present meta- analysis was to investigate the long-term effects of glycemic index-related diets in the management of obesity with a special emphasis on the potential benefits of low glycemic index/load ( GI/GL ) in the prevention of obesity-associated risks . DATA SYNTHESIS Electronic search es for r and omized controlled trials ( RCTs ) comparing low glycemic index/load versus high glycemic index/load diets were performed in MEDLINE , EMBASE and the Cochrane Library . Outcome of interest markers included anthropometric data as well as biomarkers of CVD and glycemic control . Study specific weighted mean differences were pooled using a r and om effect model . 14 studies were included in the primary meta- analysis . Weighted mean differences in change of C-reactive protein [ WMD : -0.43 mg/dl , ( 95 % CI -0.78 to -0.09 ) , p = 0.01 ] , and fasting insulin [ WMD : -5.16 pmol/L , ( 95 % CI -8.45 to -1.88 ) , p = 0.002 ] were significantly more pronounced in benefit of low GI/GL diets . However decrease in fat free mass [ WMD : -1.04 kg ( 95 % CI -1.73 to -0.35 ) , p = 0.003 ] was significantly more pronounced following low GI/GL diets as well . No significant changes were observed for blood lipids , anthropometric measures , HbA1c and fasting glucose . Sensitivity analysis was performed for RCTs excluding subjects with type 2 diabetes . Decreases in C-reactive protein and fasting insulin remained statistically significant in the low GI/GL subgroups . CONCLUSIONS The present systematic review provides evidence for beneficial effects of long-term interventions administering a low glycemic index/load diet with respect to fasting insulin and pro-inflammatory markers such as C-reactive protein which might prove to be helpful in the primary prevention of obesity-associated diseases
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"AIMS To compare the effects of lifestyle modification programs that prescribe low-glycemic load ( GL ) vs. low-fat diets in a r and omized trial . METHODS Seventy-nine obese adults with type 2 diabetes received low-fat or low-GL dietary instruction , delivered in 40-week lifestyle modification programs with identical goals for calorie intake and physical activity . Changes in weight , HbA(1c ) , and other metabolic parameters were compared at weeks 20 and 40 . RESULTS Weight loss did not differ between groups at week 20 ( low-fat : -5.7±3.7 % ; low-GL : -6.7±4.4 % , p=.26 ) or week 40 ( low-fat : -4.5±7.5 % ; low-GL : -6.4±8.2 % , p=.28 ) . Adjusting for changes in antidiabetic medications , subjects on the low-GL diet had larger reductions in HbA(1c ) than those on the low-fat diet at week 20 ( low-fat : -0.3±0.6 % ; low-GL : -0.7±0.6 % , p=.01 ) , and week 40 ( low-fat : -0.1±1.2 % ; low-GL : -0.8±1.3 % ; p=.01 ) . Groups did not differ significantly on any other metabolic outcomes ( p≥.06 ) . CONCLUSIONS Results suggest that targeting GL , rather than dietary fat , in a low-calorie diet can significantly enhance the effect of weight loss on HbA(1c ) in patients with type 2 diabetes",
"BACKGROUND AND AIMS Nutrition recommendations for type 2 diabetes ( T2DM ) are partly guided by the postpr and ial responses elicited by diets varying in carbohydrate ( CHO ) . We aim ed to explore whether long-term changes in postpr and ial responses on low-glycemic-index ( GI ) or low-CHO diets were due to acute or chronic effects in T2DM . METHODS AND RESULTS Subjects with diet-alone-treated T2DM were r and omly assigned to high-CHO/high-GI ( H ) , high-CHO/low-GI ( L ) , or low-CHO/high-monounsaturated-fat ( M ) diets for 12-months . At week-0 ( Baseline ) postpr and ial responses after H-meals ( 55 % CHO , GI = 61 ) were measured from 0800 h to 1600 h. After 12 mo subjects were r and omly assigned to H-meals or study diet meals ( L , 57 % CHO , GI = 50 ; M , 44 % CHO , GI = 61 ) . This yielded 5 groups : H diet with H-meals ( HH , n = 34 ) ; L diet with H- ( LH , n = 17 ) or L-meals ( LL , n = 16 ) ; and M diet with H- ( MH , n = 18 ) or M meals ( MM , n = 19 ) . Postpr and ial glucose fluctuations were lower in LL than all other groups ( p Changes in postpr and ial-triglycerides differed among groups ( p fasting- and postpr and ial-triglycerides were similar to Baseline while in MH postpr and ial-triglycerides were significantly higher than at Baseline ( p = 0.028 ) . In LH , triglycerides were consistently ( 0.18 - 0.34 mmol/L ) higher than Baseline throughout the day , while in LL the difference from Baseline varied across the day from 0.04 to 0.36 mmol/L ( p Low-GI and low-CHO diets have both acute and chronic effects on postpr and ial glucose and triglycerides in T2DM subjects . Thus , the composition of the acute test-meal and the habitual diet should be considered when interpreting the nutritional implication s of different postpr and ial responses",
"BACKGROUND Little is known about the effects of the amount and type of carbohydrates on risk of coronary heart disease ( CHD ) . OBJECTIVE The objective of this study was to prospect ively evaluate the relations of the amount and type of carbohydrates with risk of CHD . DESIGN A cohort of 75521 women aged 38 - 63 y with no previous diagnosis of diabetes mellitus , myocardial infa rct ion , angina , stroke , or other cardiovascular diseases in 1984 was followed for 10 y. Each participant 's dietary glycemic load was calculated as a function of glycemic index , carbohydrate content , and frequency of intake of individual foods reported on a vali date d food-frequency question naire at baseline . All dietary variables were up date d in 1986 and 1990 . RESULTS During 10 y of follow-up ( 729472 person-years ) , 761 cases of CHD ( 208 fatal and 553 nonfatal ) were documented . Dietary glycemic load was directly associated with risk of CHD after adjustment for age , smoking status , total energy intake , and other coronary disease risk factors . The relative risks from the lowest to highest quintiles of glycemic load were 1.00 , 1.01 , 1 . 25 , 1.51 , and 1.98 ( 95 % CI : 1.41 , 2.77 for the highest quintile ; P for trend of CHD risk . The association between dietary glycemic load and CHD risk was most evident among women with body weights above average ¿ ie , body mass index ( in kg/m(2 ) ) > /= 23 . CONCLUSION These epidemiologic data suggest that a high dietary glycemic load from refined carbohydrates increases the risk of CHD , independent of known coronary disease risk factors",
"BACKGROUND Lowering the dietary glycemic load and increasing protein intake may be advantageous for weight management . OBJECTIVE This r and omized controlled trial was design ed to evaluate the effects of an ad libitum reduced-glycemic-load ( RGL ) diet on body weight , body composition , and cardiovascular disease ( CVD ) risk markers in overweight and obese adults during an initial weight-loss phase ( 12 wk ) and a weight-loss maintenance phase ( weeks 24 - 36 ) . DESIGN Subjects were assigned to RGL ( n = 43 ) or low-fat , portion-controlled ( control ; n = 43 ) diet groups . The RGL group was instructed to eat until satisfied , maintaining a low carbohydrate intake during weeks 0 - 2 and adding low-glycemic-index carbohydrate thereafter . Control subjects were instructed to reduce fat intake and decrease portion sizes , with a targeted energy deficit of 500 to 800 kcal/d . RESULTS The RGL group had lost significantly more weight than did the control group at week 12 ( -4.9 and -2.5 kg , respectively ; P = 0.002 ) , but the 2 groups did not differ significantly at week 36 ( -4.5 and -2.6 kg , respectively ; P = 0.085 ) . Changes in fat mass differed between the groups at week 12 ( -1.9 and -0.9 kg , respectively ; P = 0.016 ) but not at week 36 ( -2.0 and -1.3 kg , respectively ; P = 0.333 ) . At the end of the study , no differences were found in responses for CVD risk markers except a larger mean change in HDL cholesterol in the RGL group than in the control group ( 3.8 and 1.9 mg/dL , respectively ; P = 0.037 ) . CONCLUSION These findings provide evidence that an ad libitum RGL diet is a reasonable alternative to a low-fat , portion-controlled eating plan for weight management",
"Reducing the dietary glycemic load and the glycemic index was proposed as a novel approach to weight reduction . A parallel- design , r and omized 12-wk controlled feeding trial with a 24-wk follow-up phase was conducted to test the hypothesis that a hypocaloric diet design ed to reduce the glycemic load and the glycemic index would result in greater sustained weight loss than other hypocaloric diets . Obese subjects ( n = 29 ) were r and omly assigned to 1 of 3 diets providing 3138 kJ less than estimated energy needs : high glycemic index ( HGI ) , low glycemic index ( LGI ) , or high fat ( HF ) . For the first 12 wk , all food was provided to subjects ( feeding phase ) . Subjects ( n = 22 ) were instructed to follow the assigned diet for 24 additional weeks ( free-living phase ) . Total body weight was obtained and body composition was assessed by skinfold measurements . Insulin sensitivity was assessed by the homeostasis model ( HOMA ) . At 12 wk , weight changes from baseline were significant in all groups but not different among groups ( -9.3 + /- 1.3 kg for the HGI diet , -9.9 + /- 1.4 kg for the LGI diet , and -8.4 + /- 1.5 kg for the HF diet ) . All groups improved in insulin sensitivity at the end of the feeding phase of the study . During the free-living phase , all groups maintained their initial weight loss and their improved insulin sensitivity . Weight loss and improved insulin sensitivity scores were independent of diet composition . In summary , lowering the glycemic load and glycemic index of weight reduction diets does not provide any added benefit to energy restriction in promoting weight loss in obese subjects",
"BACKGROUND The optimal nutritional approach for the prevention of cardiovascular disease among obese persons remains a topic of intense controversy . Available approaches range from conventional low-fat to very-low-carbohydrate diets . OBJECTIVE The aim of this pilot study was to evaluate the efficacy of an ad libitum low-glycemic load diet , without strict limitation on carbohydrate intake , as an alternative to a conventional low-fat diet . DESIGN A r and omized controlled trial compared 2 dietary treatments in obese young adults ( n = 23 ) over 12 mo . The experimental treatment emphasized ad libitum consumption of low-glycemic-index foods , with 45 - 50 % of energy from carbohydrates and 30 - 35 % from fat . The conventional treatment was restricted in energy ( 250 - 500 kcal/d deficit ) and fat ( We compared changes in study outcomes by repeated- measures analysis of log-transformed data and expressed the results as mean percentage change . RESULTS Body weight decreased significantly over a 6-mo intensive intervention in both the experimental and conventional diet groups ( -8.4 % and -7.8 % , respectively ) and remained below baseline at 12 mo ( -7.8 % and -6.1 % , respectively ) . The experimental diet group showed a significantly greater mean decline in plasma triacylglycerols than did the conventional diet group ( -37.2 % and -19.1 % , respectively ; P = 0.005 ) . Mean plasminogen activator inhibitor 1 concentrations decreased ( -39.0 % ) in the experimental diet group but increased ( 33.1 % ) in the conventional diet group ( P = 0.004 ) . Changes in cholesterol concentrations , blood pressure , and insulin sensitivity did not differ significantly between the groups . CONCLUSION An ad libitum low-glycemic load diet may be more efficacious than a conventional , energy-restricted , low-fat diet in reducing cardiovascular disease risk",
"BACKGROUND Despite interest in the glycemic index diets as an approach to weight control , few long-term evaluations are available . OBJECTIVE The objective was to investigate the long-term effect of a low-glycemic-index ( LGI ) diet compared with that of a high-glycemic-index ( HGI ) diet ; all other dietary components were equal . DESIGN After a 6-wk run-in , we r and omly assigned 203 healthy women [ body mass index ( in kg/m2 ) : 23 - 30 ] aged 25 - 45 y to an LGI or an HGI diet with a small energy restriction . The primary outcome measure was weight change at 18 mo . Secondary outcomes included hunger and fasting insulin and lipids . RESULTS Despite requiring a run-in and the use of multiple incentives , only 60 % of the subjects completed the study . The difference in glycemic index between the diets was approximately 35 - 40 units ( 40 compared with 79 ) during all 18 mo of follow-up , and the carbohydrate intake from energy remained at approximately 60 % in both groups . The LGI group had a slightly greater weight loss in the first 2 mo of follow-up ( -0.72 compared with -0.31 kg ) , but after 12 mo of follow-up both groups began to regain weight . After 18 mo , the weight change was not significantly different ( P = 0.93 ) between groups ( LGI : -0.41 kg ; HGI : -0.26 kg ) . A greater reduction was observed in the LGI diet group for triacylglycerol ( difference = -16.4 mg/dL ; P = 0.11 ) and VLDL cholesterol ( difference = -3.7 mg/dL ; P = 0.03 ) . CONCLUSIONS Long-term weight changes were not significantly different between the HGI and LGI diet groups ; therefore , this study does not support a benefit of an LGI diet for weight control . Favorable changes in lipids confirmed previous results",
"BACKGROUND The optimal source and amount of dietary carbohydrate for managing type 2 diabetes ( T2DM ) are unknown . OBJECTIVE We aim ed to compare the effects of altering the glycemic index or the amount of carbohydrate on glycated hemoglobin ( HbA1c ) , plasma glucose , lipids , and C-reactive protein ( CRP ) in T2DM patients . DESIGN Subjects with T2DM managed by diet alone ( n=162 ) were r and omly assigned to receive high-carbohydrate , high-glycemic-index ( high-GI ) , high-carbohydrate , low-glycemic-index ( low-GI ) , or low-carbohydrate , high-monounsaturated-fat ( low-CHO ) diets for 1 y. RESULTS The high-GI , low-GI , and low-CHO diets contained , respectively , 47 % , 52 % , and 39 % of energy as carbohydrate and 31 % , 27 % , and 40 % of energy as fat ; they had GIs of 63 , 55 , and 59 , respectively . Body weight and HbA1c did not differ significantly between diets . Fasting glucose was higher ( P=0.041 ) , but 2-h postload glucose was lower ( P=0.010 ) after 12 mo of the low-GI diet . With the low-GI diet , overall mean triacylglycerol was 12 % higher and HDL cholesterol 4 % lower than with the low-CHO diet ( P ratio of total to HDL cholesterol disappeared by 6 mo ( time x diet interaction , P=0.044 ) . Overall mean CRP with the low-GI diet , 1.95 mg/L , was 30 % less than that with the high-GI diet , 2.75 mg/L ( P=0.0078 ) ; the concentration with the low-CHO diet , 2.35 mg/L , was intermediate . CONCLUSIONS In subjects with T2DM managed by diet alone with optimal glycemic control , long-term HbA1c was not affected by altering the GI or the amount of dietary carbohydrate . Differences in total : HDL cholesterol among diets had disappeared by 6 mo . However , because of sustained reductions in postpr and ial glucose and CRP , a low-GI diet may be preferred for the dietary management of T2DM",
"The determine the effect of different foods on the blood glucose , 62 commonly eaten foods and sugars were fed individually to groups of 5 to 10 healthy fasting volunteers . Blood glucose levels were measured over 2 h , and expressed as a percentage of the area under the glucose response curve when the same amount of carbohydrate was taken as glucose . The largest rises were seen with vegetables ( 70 + /- 5 % ) , followed by breakfast cereals ( 65 + /- 5 % ) , cereals and biscuits ( 60 + /- 3 % ) , fruit ( 50 + /- 5 % ) , dairy products ( 35 + /- 1 % ) , and dried legumes ( 31 + /- 3 % ) . A significant negative relationship was seen between fat ( p less than 0.01 ) and protein ( p less than 0.001 ) and postpr and ial glucose rise but not with fiber or sugar content",
"OBJECTIVE This study examined the relation between quality of dietary carbohydrate intake , as measured by glycemic index ( GI ) and glycemic load ( GL ) , and serum high-sensitivity C-reactive protein ( hs-CRP ) levels . METHODS During a 1-y observational study , data were collected at baseline and at each quarter thereafter . GI and GL were calculated from multiple 24-h dietary recalls ( 24HRs ) , 3 r and omly selected 24HRs at every quarter , with up to 15 24HRs per participant . The hs-CRP was measured in blood sample s collected at baseline and each of the four quarterly measurement points . Multivariable linear mixed models were used to examine the cross-sectional and longitudinal associations of GI , GL , and hs-CRP . RESULTS Among 582 adult men and women with at least two measurements of diet and hs-CRP , average daily GI score ( white bread = 100 ) was 85 and average GL was 198 , and average hs-CRP was 1.84 mg/L. Overall , there was no association between GI or GL and hs-CRP . Subgroup analyses revealed an inverse association between GL and hs-CRP among obese individuals ( body mass index > or = 30 kg/m(2 ) ) . CONCLUSION Quality of dietary carbohydrates does not appear to be associated with serum hs-CRP levels . Among obese individuals , higher dietary GL appears to be related to lower hs-CRP levels . Due to the limited number of studies on this topic and their conflicting results , further investigation is warranted",
"CONTEXT The results of clinical trials involving diet in the treatment of obesity have been inconsistent , possibly due to inherent physiological differences among study participants . OBJECTIVE To determine whether insulin secretion affects weight loss with 2 popular diets . DESIGN , SETTING , AND PARTICIPANTS R and omized trial of obese young adults ( aged 18 - 35 years ; n = 73 ) conducted from September 2004 to December 2006 in Boston , Mass , and consisting of a 6-month intensive intervention period and a 12-month follow-up period . Serum insulin concentration at 30 minutes after a 75-g dose of oral glucose was determined at baseline as a measure of insulin secretion . Outcomes were assessed at 6 , 12 , and 18 months . Missing data were imputed conservatively . INTERVENTIONS A low-glycemic load ( 40 % carbohydrate and 35 % fat ) vs low-fat ( 55 % carbohydrate and 20 % fat ) diet . MAIN OUTCOME MEASURES Body weight , body fat percentage determined by dual-energy x-ray absorptiometry , and cardiovascular disease risk factors . RESULTS Change in body weight and body fat percentage did not differ between the diet groups overall . However , insulin concentration at 30 minutes after a dose of oral glucose was an effect modifier ( group x time x insulin concentration at 30 minutes : P = .02 for body weight and P = .01 for body fat percentage ) . For those with insulin concentration at 30 minutes above the median ( 57.5 microIU/mL ; n = 28 ) , the low-glycemic load diet produced a greater decrease in weight ( -5.8 vs -1.2 kg ; P = .004 ) and body fat percentage ( -2.6 % vs -0.9 % ; P = .03 ) than the low-fat diet at 18 months . There were no significant differences in these end points between diet groups for those with insulin concentration at 30 minutes below the median level ( n = 28 ) . Insulin concentration at 30 minutes after a dose of oral glucose was not a significant effect modifier for cardiovascular disease risk factors . In the full cohort , plasma high-density lipoprotein cholesterol and triglyceride concentrations improved more on the low-glycemic load diet , whereas low-density lipoprotein cholesterol concentration improved more on the low-fat diet . CONCLUSIONS Variability in dietary weight loss trials may be partially attributable to differences in hormonal response . Reducing glycemic load may be especially important to achieve weight loss among individuals with high insulin secretion . Regardless of insulin secretion , a low-glycemic load diet has beneficial effects on high-density lipoprotein cholesterol and triglyceride concentrations but not on low-density lipoprotein cholesterol concentration . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00130299",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"OBJECTIVE The aim of this study was to compare the effects of different glycemic load diets on biochemical data and body composition , in overweight and obese subjects , during a 6-month period . RESEARCH DESIGN AND METHODS This study was an experimental , r and omized , parallel design . Anthropometric measurements and biochemical data were measured at baseline at 3 and at 6 months . All subjects completed 3-day dietary intake diaries at the baseline period and during the third and the sixth months . At the sixth month , LGL group had a mean intake of 1,360 ± 300 kcal/day and the high glycemic load group ( HGL ) had a mean intake of 1,544 ± 595 kcal/day . RESULTS LGL group obtained a weight reduction of 4.5 % ( p = 0.006 ) and the HGL group of 3.0 % ( p = 0.18 ) . Significant reductions in waist circumference ( 5 % , p = 0.001 ) of the LGL group were observed , 10 % of body fat percentage ( p = 0.001 ) , 4.3 kg ( 13 % ) of body fat ( p = 0.001 ) , 14 % of total cholesterol ( p=0.007 ) , 35 % of high-density lipoproteins ( HDL ) ( p = 0.001 ) , and 10 % of HOMA ( p = 0.009 ) . In the HGL group , reductions of 4.5 % of waist circumference ( p = 0.02 ) , 37 % of HDL ( p = 0.002 ) , and an increase of 8 % of LDL ( p = 0.04 ) were observed . CONCLUSIONS These results suggest that long term LGL diets are more effective for reducing body mass index , body fat , waist circumference and HOMA and , therefore , may contribute in the prevention of diabetes",
"BACKGROUND Insulin sensitivity ( Si ) is improved by weight loss and exercise , but the effects of the replacement of saturated fatty acids ( SFAs ) with monounsaturated fatty acids ( MUFAs ) or carbohydrates of high glycemic index ( HGI ) or low glycemic index ( LGI ) are uncertain . OBJECTIVE We conducted a dietary intervention trial to study these effects in participants at risk of developing metabolic syndrome . DESIGN We conducted a 5-center , parallel design , r and omized controlled trial [ RISCK ( Reading , Imperial , Surrey , Cambridge , and Kings ) ] . The primary and secondary outcomes were changes in Si ( measured by using an intravenous glucose tolerance test ) and cardiovascular risk factors . Measurements were made after 4 wk of a high-SFA and HGI ( HS/HGI ) diet and after a 24-wk intervention with HS/HGI ( reference ) , high-MUFA and HGI ( HM/HGI ) , HM and LGI ( HM/LGI ) , low-fat and HGI ( LF/HGI ) , and LF and LGI ( LF/LGI ) diets . RESULTS We analyzed data for 548 of 720 participants who were r and omly assigned to treatment . The median Si was 2.7 × 10(-4 ) mL · μU(-1 ) · min(-1 ) ( interquartile range : 2.0 , 4.2 × 10(-4 ) mL · μU(-1 ) · min(-1 ) ) , and unadjusted mean percentage changes ( 95 % CIs ) after 24 wk treatment ( P = 0.13 ) were as follows : for the HS/HGI group , -4 % ( -12.7 % , 5.3 % ) ; for the HM/HGI group , 2.1 % ( -5.8 % , 10.7 % ) ; for the HM/LGI group , -3.5 % ( -10.6 % , 4.3 % ) ; for the LF/HGI group , -8.6 % ( -15.4 % , -1.1 % ) ; and for the LF/LGI group , 9.9 % ( 2.4 % , 18.0 % ) . Total cholesterol ( TC ) , LDL cholesterol , and apolipoprotein B concentrations decreased with SFA reduction . Decreases in TC and LDL-cholesterol concentrations were greater with LGI . Fat reduction lowered HDL cholesterol and apolipoprotein A1 and B concentrations . CONCLUSIONS This study did not support the hypothesis that isoenergetic replacement of SFAs with MUFAs or carbohydrates has a favorable effect on Si . Lowering GI enhanced reductions in TC and LDL-cholesterol concentrations in subjects , with tentative evidence of improvements in Si in the LF-treatment group . This trial was registered at clinical trials.gov as IS RCT N29111298",
"OBJECTIVE To examine prospect ively the relationship between glycemic diets , low fiber intake , and risk of non-insulin-dependent diabetes mellitus . DESIGN Cohort study . SETTING In 1986 , a total of 65173 US women 40 to 65 years of age and free from diagnosed cardiovascular disease , cancer , and diabetes completed a detailed dietary question naire from which we calculated usual intake of total and specific sources of dietary fiber , dietary glycemic index , and glycemic load . MAIN OUTCOME MEASURE Non-insulin-dependent diabetes mellitus . RESULTS During 6 years of follow-up , 915 incident cases of diabetes were documented . The dietary glycemic index was positively associated with risk of diabetes after adjustment for age , body mass index , smoking , physical activity , family history of diabetes , alcohol and cereal fiber intake , and total energy intake . Comparing the highest with the lowest quintile , the relative risk ( RR ) of diabetes was 1.37 ( 95 % confidence interval [ CI ] , 1.09 - 1.71 , P trend=.005 ) . The glycemic load ( an indicator of a global dietary insulin dem and ) was also positively associated with diabetes ( RR= 1.47 ; 95 % CI , 1.16 - 1.86 , P trend=.003 ) . Cereal fiber intake was inversely associated with risk of diabetes when comparing the extreme quintiles ( RR=0.72 , 95 % CI , 0.58 - 0.90 , P trend=.001 ) . The combination of a high glycemic load and a low cereal fiber intake further increased the risk of diabetes ( RR=2.50 , 95 % CI , 1.14 - 5.51 ) when compared with a low glycemic load and high cereal fiber intake . CONCLUSIONS Our results support the hypothesis that diets with a high glycemic load and a low cereal fiber content increase risk of diabetes in women . Further , they suggest that grains should be consumed in a minimally refined form to reduce the incidence of diabetes",
"Low-glycemic index diets and exercise independently improve glucose tolerance and reduce diabetes risk . However , the combined effect of a low-glycemic index diet and exercise on inflammation and glucose metabolism is not known . Therefore , we r and omized 28 insulin-resistant adults ( age : 66 ± 1 y ; BMI : 34.2 ± 0.7 kg · m(-2 ) ) to a 12-wk , low ( LGI = 40 ) or high- ( HGI = 80 ) glycemic index diet plus aerobic exercise ( 5 d · wk(-1 ) , 60 min · d(-1 ) , 80 - 85 % heart rate(max ) ) intervention . All food and fluids were provided during the study . Inflammation was assessed from cytokine ( TNFα and IL-6 ) secretion using peripheral blood mononuclear cells ( MNC ) stimulated overnight with LPS . Glycemic response was determined following ingestion of a 75-g glucose solution . Fasting blood sample s were collected for additional cytokine [ TNFα , IL-6 , and monocyte chemoattractant protein 1 ( MCP-1 ) ] analysis . Both interventions decreased BMI ( P ( P = 0.01 ) , and insulin ( P = 0.02 ) . The glycemic response was reduced only in the LGI group ( P = 0.04 ) . Plasma and MNC-derived TNFα secretion were reduced in the LGI group ( P = 0.02 ) but increased in the HGI group ( P = 0.02 ) . Secretion of IL-6 from MNC and plasma IL-6 and MCP-1 concentrations were reduced in the LGI group . The change in MNC-derived TNFα ( r = 0.43 ; P = 0.04 ) and plasma MCP-1 ( r = 0.44 ; P = 0.04 ) correlated with decreases in the glycemic response . These data highlight the importance of diet composition in the treatment and prevention of inflammation and hyperglycemia . A low-glycemic index diet has antiinflammatory and antidiabetogenic effects when combined with exercise in older , obese prediabetics",
"BACKGROUND AND AIM The role of dietary glycemic index ( GI ) and glycemic load ( GL ) in coronary heart disease ( CHD ) is unclear . Our aim was to study the association between the dietary GI and GL and the risk of acute myocardial infa rct ion ( AMI ) . METHODS AND RESULTS The study population consisted of 1981 Finnish men from the prospect i ve population -based Kuopio Ischaemic Heart Disease Risk Factor ( KIHD ) Study , aged 42 - 60 years and free of CHD at baseline . During an average follow-up time of 16.1 years , 376 new AMI events occurred . In multivariable-adjusted Cox proportional hazards models , the relative risk ( RR ) for AMI in the highest quartile of GI was 1.25 ( 95 % CI : 0.92 - 1.69 ; P for trend=0.08 ) and for GL 1.11 ( 95 % CI : 0.79 - 1.57 ; P for trend=0.21 ) when compared with the lowest quartile . For overweight ( BMI ≥ 27.5 kg/m² ) men , the multivariable-adjusted RR for AMI in the highest compared to the lowest tertile of GI and GL were 1.58 ( 95 % CI : 1.03 - 2.43 ; P for trend=0.04 , P for interaction=0.01 ) and 2.05 ( 95 % CI : 1.30 - 3.23 ; P for trend=0.002 , P for interaction=0.002 ) , respectively . For physically less active men ; energy expenditure for leisure-time physical activity the RR for AMI was 1.72 ( 95 % CI : 1.07 - 2.76 ; P for trend=0.04 , P for interaction 0.80 ) with higher GL . CONCLUSIONS Our results suggest that both high dietary GI and GL are associated with increased risk of AMI among overweight and GL possibly among less physically active men",
"OBJECTIVE We compared the effects of a low glycemic index ( GI ) diet with the American Diabetes Association ( ADA ) diet on glycosylated hemoglobin ( HbA1c ) among individuals with type 2 diabetes . METHODS Forty individuals with poorly controlled type 2 diabetes were r and omized to a low-GI or an ADA diet . The intervention , consisting of eight educational sessions ( monthly for the first 6 mo and then at months 8 and 10 ) , focused on a low-GI or an ADA diet . Data on demographics , diet , physical activity , psychosocial factors , and diabetes medication use were assessed at baseline and 6 and 12 mo . Generalized linear mixed models were used to compare the two groups on HbA1c , diabetic medication use , blood lipids , weight , diet , and physical activity . RESULTS Participants ( 53 % female , mean age 53.5 y ) were predominantly white with a mean body mass index of 35.8 kg/m(2 ) . Although both interventions achieved similar reductions in mean HbA1c at 6 mo and 12 mo , the low-GI diet group was less likely to add or increase dosage of diabetic medications ( odds ratio 0.26 , P = 0.01 ) . Improvements in high-density lipoprotein cholesterol , triacylglycerols , and weight loss were similar between groups . CONCLUSION Compared with the ADA diet , the low-GI diet achieved equivalent control of HbA1c using less diabetic medication . Despite its limited size , this trial suggests that a low-GI diet is a viable alternative to the ADA diet . Findings should be evaluated in a larger r and omized controlled trial",
"BACKGROUND To our knowledge , no single investigation concerning the long-term effects of overweight status on the risk for hypertension , hypercholesterolemia , diabetes mellitus , and cardiovascular sequelae has been reported . METHODS Relations between categories of body mass index ( BMI ) , cardiovascular disease risk factors , and vascular disease end points were examined prospect ively in Framingham Heart Study participants aged 35 to 75 years , who were followed up to 44 years . The primary outcome was new cardiovascular disease , which included angina pectoris , myocardial infa rct ion , coronary heart disease , or stroke . Analyses compared overweight ( BMI [ calculated as weight in kilograms divided by the square of height in meters ] , 25.0 - 29.9 ) and obese persons ( BMI > or = 30 ) to a referent group of normal-weight persons ( BMI , 18.5 - 24.9 ) . RESULTS The age-adjusted relative risk ( RR ) for new hypertension was highly associated with overweight status ( men : RR , 1.46 ; women : RR , 1.75 ) . New hypercholesterolemia and diabetes mellitus were less highly associated with excess adiposity . The age-adjusted RR ( confidence interval [ CI ] ) for cardiovascular disease was increased among those who were overweight ( men : 1.21 [ 1.05 - 1.40 ] ; women : 1.20 [ 1.03 - 1.41 ] ) and the obese ( men : 1.46 [ 1.20 - 1.77 ] ; women : 1.64 [ 1.37 - 1.98 ] ) . High population attributable risks were related to excess weight ( BMI > or = 25 ) for the outcomes hypertension ( 26 % men ; 28 % women ) , angina pectoris ( 26 % men ; 22 % women ) , and coronary heart disease ( 23 % men ; 15 % women ) . CONCLUSIONS The overweight category is associated with increased relative and population attributable risk for hypertension and cardiovascular sequelae . Interventions to reduce adiposity and avoid excess weight may have large effects on the development of risk factors and cardiovascular disease at an individual and population level",
"OBJECTIVE Intake of carbohydrates that provide a large glycemic response has been hypothesized to increase the risk of NIDDM , whereas dietary fiber is suspected to reduce incidence . These hypotheses have not been evaluated prospect ively . RESEARCH DESIGN AND METHODS We examined the relationship between diet and risk of NIDDM in a cohort of 42,759 men without NIDDM or cardiovascular disease , who were 40–75 years of age in 1986 . Diet was assessed at baseline by a vali date d semiquantitative food frequency question naire . During 6-years of follow-up , 523 incident cases of NIDDM were documented . RESULTS The dietary glycemic index ( an indicator of carbohydrate 's ability to raise blood glucose levels ) was positively associated with risk of NIDDM after adjustment for age , BMI , smoking , physical activity , family history of diabetes , alcohol consumption , cereal fiber , and total energy intake . Comparing the highest and lowest quintiles , the relative risk ( RR ) of NIDDM was 1.37 ( 95 % CI , 1.02–1.83 , P trend = 0.03 ) . Cereal fiber was inversely associated with risk of NIDDM ( RR = 0.70 ; 95 % CI , 0.51–0.96 , P trend = 0.007 ; for > 8.1 g/day vs. glycemic load and a low cereal fiber intake further increased the risk of NIDDM ( RR = 2.17 , 95 % CI , 1.04–4.54 ) when compared with a low glycemic load and high cereal fiber intake . CONCLUSIONS These findings support the hypothesis that diets with a high glycemic load and a low cereal fiber content increase risk of NIDDM in men . Further , they suggest that grains should be consumed in a minimally refined form to reduce the incidence of NIDDM ",
"Background : Wholegrain intake is inversely related to weight gain over time , but little information is available on the role of pulses in weight control . Objective : To compare weight loss , metabolic outcomes , and nutrient intakes in obese people assigned to a diet rich in pulses and wholegrains or a control diet . Methods : R and omized controlled study of 18 months with 113 volunteers ( body mass index [ BMI ] ≥ 28 kg/m2 ) . Diets were based on guidelines published by the National Heart Foundation of New Zeal and . The intervention group was advised to consume 2 serves of pulses and 4 serves of wholegrain foods per day as substitutions for more refined carbohydrates . Results : Fiber intakes were higher , intakes of several vitamins and minerals were better maintained , and dietary glycemic index was lower in the intervention compared with the control group . Mean ( st and ard error [ SE ] ) weight loss at 6 months was 6.0 ( 0.7 ) kg and 6.3 ( 0.6 ) kg in the control and intervention groups , respectively , and was not different between groups ( p > 0.05 ) . Blood pressure , triglycerides , and glycemic load were lowered in both groups compared with baseline . Waist circumference was decreased at 18 months in the intervention compared with the control group ( −2.8 cm ; 95 % confidence interval [ CI ] : −0.4 , −5.1 ) . Conclusions : Incorporation of pulses and wholegrain foods into a weight loss program result ed in a greater reduction in waist circumference compared with the group consuming a control diet , although no difference in weight loss was noted between groups . Retention of several nutrients was better with the pulse and wholegrain diet ",
" Low-glycemic load ( GL ) diets improve insulin resistance and glucose homeostasis in individuals with diabetes . Less is known about whether low-GL diets , independent of weight loss , improve the health profile for persons without diabetes or other preexisting conditions . We conducted a r and omized , cross-over feeding study testing low- compared to High-GL diets on biomarkers of inflammation and adiposity in healthy adults . Eighty participants ( n = 40 with BMI 18.5 - 24.9 kg/m² ; n = 40 with BMI 28.0 - 40.0 kg/m² ) completed two 28-d feeding periods in r and om order where one period was a high-GL diet ( mean GL/d = 250 ) and the other a low-GL diet ( mean GL/d = 125 ) . Diets were isocaloric with identical macronutrient content ( as percent energy ) . All food was provided and participants maintained weight and usual physical activity . Height , weight , and DXA were measured at study entry and weight assessed again thrice per week . Blood was drawn from fasting participants at the beginning and end of each feeding period and serum concentrations of high-sensitivity CRP , serum amyloid A , IL-6 , leptin , and adiponectin were measured . Linear mixed models tested the intervention effect on the biomarkers ; models were adjusted for baseline biomarker concentrations , diet sequence , feeding period , age , sex , and body fat mass . Among participants with high-body fat mass ( > 32.0 % for males and > 25.0 % for females ) , the low-GL diet reduced CRP ( P = 0.02 ) and marginally increased adiponectin ( P = 0.06 ) . In conclusion , carbohydrate quality , independent of energy , is important . Dietary patterns emphasizing low-GL foods may improve the inflammatory and adipokine profiles of overweight and obese individuals",
"We aim ed to determine whether altering dietary glycemic index ( GI ) in addition to healthy eating and weight loss advice affects arterial compliance and 24-hour blood pressure ( BP ) , both coronary heart disease ( CHD ) risk factors . Middle-aged men with at least 1 CHD risk were r and omized to a 6-month low-GI ( LGI ) or high-GI ( HGI ) diet . All were advised on healthy eating and weight loss . They were seen monthly to assess dietary compliance and anthropometrics . Carotid-femoral pulse wave velocity ( PWV ) , fasting blood lipid profile , and glucose and insulin concentrations were measured at baseline and at months 3 and 6 . Six-hour postpr and ial glucose and insulin responses and 24-hour ambulatory BP were also assessed at baseline and month 6 . Thirty-eight subjects ( HGI group , n = 16 ; LGI group , n = 22 ) completed the study . At month 6 , groups differed in dietary GI , glycemic load , and carbohydrate intake ( P Fasting insulin concentration and insulin resistance ( calculated by homeostatic model assessment ) were lower in the LGI than the HGI group ( P total cholesterol and 24-hour BP was bigger in the LGI than the HGI group ( P PWV , low-density lipoprotein cholesterol , and triacylglycerol concentration . There were no differences in postpr and ial glucose or insulin responses between the groups . The results suggest that an LGI diet may be more beneficial in reducing CHD risk , including PWV and 24-hour BP , even in the setting of healthy eating and weight loss ; and thus , further study is warranted",
"CONTEXT Clinical trials using antihyperglycemic medications to improve glycemic control have not demonstrated the anticipated cardiovascular benefits . Low-glycemic index diets may improve both glycemic control and cardiovascular risk factors for patients with type 2 diabetes but debate over their effectiveness continues due to trial limitations . OBJECTIVE To test the effects of low-glycemic index diets on glycemic control and cardiovascular risk factors in patients with type 2 diabetes . DESIGN , SETTING , AND PARTICIPANTS A r and omized , parallel study design at a Canadian university hospital research center of 210 participants with type 2 diabetes treated with antihyperglycemic medications who were recruited by newspaper advertisement and r and omly assigned to receive 1 of 2 diet treatments each for 6 months between September 16 , 2004 , and May 22 , 2007 . INTERVENTION High-cereal fiber or low-glycemic index dietary advice . MAIN OUTCOME MEASURES Absolute change in glycated hemoglobin A(1c ) ( HbA(1c ) ) , with fasting blood glucose and cardiovascular disease risk factors as secondary measures . RESULTS In the intention-to-treat analysis , HbA(1c ) decreased by -0.18 % absolute HbA(1c ) units ( 95 % confidence interval [ CI ] , -0.29 % to -0.07 % ) in the high-cereal fiber diet compared with -0.50 % absolute HbA(1c ) units ( 95 % CI , -0.61 % to -0.39 % ) in the low-glycemic index diet ( P high-density lipoprotein cholesterol in the low-glycemic index diet by 1.7 mg/dL ( 95 % CI , 0.8 - 2.6 mg/dL ) compared with a decrease of high-density lipoprotein cholesterol by -0.2 mg/dL ( 95 % CI , -0.9 to 0.5 mg/dL ) in the high-cereal fiber diet ( P = .005 ) . The reduction in dietary glycemic index related positively to the reduction in HbA(1c ) concentration ( r = 0.35 , P high-density lipoprotein cholesterol ( r = -0.19 , P = .009 ) . CONCLUSION In patients with type 2 diabetes , 6-month treatment with a low-glycemic index diet result ed in moderately lower HbA(1c ) levels compared with a high-cereal fiber diet . Trial Registration clinical trials.gov identifier : NCT00438698",
"The aim of this article is to evaluate the pros and cons of a specific impact of postpr and ial hyperglycemia and glycemic variability on the — mainly cardiovascular (CV)—complications of diabetes , above and beyond the average blood glucose ( BG ) as measured by HbA1c or fasting plasma glucose ( FPG ) . The strongest arguments in favor of this hypothesis come from impressive pathophysiological studies , also in the human situation . Measures of oxidative stress and endothelial dysfunction seem to be especially closely related to glucose peaks and even more so to fluctuating high and low glucose concentrations and can be restored to normal by preventing those glucose peaks or wide glucose excursions . The epidemiological evidence , which is more or less confined to postpr and ial hyperglycemia and postglucose load glycemia , is also rather compelling in favor of the hypothesis , although certainly not fully conclusive as there are also a number of conflicting results . The strongest cons are seen in the missing evidence as derived from r and omized prospect i ve intervention studies targeting postpr and ial hyperglycemia longer term , i.e. , over several years , and seeking to reduce hard CV end points . In fact , several such intervention studies in men have recently failed to produce the intended beneficial outcome results . As this evidence by intervention is , however , key for the ultimate approval of a treatment concept in patients with diabetes , the current net balance of attained evidence is not in favor of the hypothesis here under debate , i.e. , that we should care about postpr and ial hyperglycemia and glycemic variability . The absence of a uniformly accepted st and ard of how to estimate these parameters adds a further challenge to this whole debate"
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Public health guidelines suggest that physical activity can be accumulated in multiple short bouts dispersed through the day . A synthesis of the evidence for this approach is lacking . Our objective was to undertake a systematic review and meta- analysis to examine if exercise interventions consisting of a single bout of exercise compared with interventions comprising the same total duration , mode , and intensity of exercise accumulated over the course of the day have different effects on health outcomes in adults . Six electronic data bases were search ed ( Jan 1970–29 August 2018 ) . Two authors identified studies that evaluated the effects of a single bout of exercise compared with the same intensity , total duration , and mode of exercise accumulated in multiple bouts over the course of a day , in community-dwelling adults . Risk of bias was assessed using the Cochrane Collaboration tool . Pooled effects were reported as st and ardised mean differences ( MDs ) and 95 % confidence intervals ( CIs ) using a r and om effects model . A total of 19 studies involving 1080 participants met the inclusion criteria . There were no differences between accumulated and continuous groups for any cardiorespiratory fitness or blood pressure outcomes . A difference was found in body mass changes from baseline to post-intervention in favour of accumulated exercise compared with continuous ( MD − 0.92 kg , 95 % CI − 1.59 to − 0.25 , I2 = 0 % ; five studies , 211 participants ) . In subgroup analyses , accumulating > 150 min of weekly exercise in multiple bouts per day result ed in small effects on body fat percentage ( combined post-intervention and change from baseline values : MD − 0.87 % , 95 % CI − 1.71 to − 0.04 , I2 = 0 % ; three studies , 166 participants ) compared with 150 min of exercise amassed via single continuous bouts per day . There was a decrease in low-density lipoprotein ( LDL ) cholesterol with accumulated versus continuous exercise ( MD − 0.39 mmol/l , 95 % CI − 0.73 to − 0.06 , I2 = 23 % ; two studies , 41 participants ) . No differences were observed for any other blood biomarker ( total cholesterol , high-density lipoprotein cholesterol , triglycerides , fasting blood glucose , and fasting insulin ) . There is no difference between continuous and accumulated patterns of exercise in terms of effects on fitness , blood pressure , lipids , insulin and glucose . There is some evidence from a small number of studies that changes in body mass and LDL cholesterol are more favourable following the accumulated condition . Collectively our findings suggest that adults are likely to accrue similar health benefits from exercising in a single bout or accumulating activity from shorter bouts throughout the day . This review will inform public health guidelines for physical activity at the global and national levels ( PROSPERO 2016 CRD42016044122 )
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"BACKGROUND Current ACSM guidelines recommend that adults should exercise for 20 - 60 min on 3 - 5 days.week(-1 ) ( M.L. Pollock , et al. , The recommended quantity and quality of exercise for developing and maintaining cardiorespiratory and muscular fitness , and flexibility in healthy adults . Medicine and Science in Sports and Exercise , 30 ( 6 ) ( 1998 ) 975 - 991 . ) . For individuals constrained by a busy lifestyle , an exercise prescription that delivers benefits with the minimum investment of time is attractive . The purpose of the present study , therefore , was to examine the effect of instructing sedentary individuals to undertake 20 min of brisk walking , in two different patterns , 3 days per week , on fitness and other cardiovascular disease ( CVD ) risk factors . METHODS Forty-eight subjects ( 31 women ) mean ( + /-SD ) age 45.7 + /- 9.4 year were r and omly assigned to either one 20-min walk ( single bout ) , two 10-min walks ( accumulated bouts ) 3 days week(-1 ) for 12-week , or no training ( control ) . Oxygen consumption ( VO2 ) , heart rate ( HR ) , and ratings of perceived exertion ( RPE ) were measured during a 4-stage treadmill test at pre- and post-intervention . Body composition , resting blood pressure and fasting lipoproteins were also assessed . Thirty-two subjects completed the study . RESULTS There was a significant difference between single-bout and accumulated-bout walkers in the reduction of HR at stages 2 and 3 of the treadmill test from pre- to post-intervention ( P VO2 or RPE from pre- to post-intervention . There were also no changes in body mass , adiposity , blood pressure , waist and hip circumferences , or lipid/lipoproteins . CONCLUSION Brisk walking for 20 min on 3 days of the week fails to alter cardiovascular disease risk factors in previously sedentary adults",
"Abstract This study examined the effects of one single bout daily versus triple bouts of resistance exercise for 12 weeks on muscular strength and anaerobic performance of the upper body . Twenty young male adults ( age : 22.0 ± 1.0 years , bench press : 44.0 ± 10.3 kg ) were r and omly assigned to a single bout ( SB ) or triple bouts ( TB ) of resistance exercise group . Maximal strength and anaerobic performance of the upper body using the bench press ( one-repetition maximum ) and the modified 30 s Wingate test were determined before and after the intervention . Additionally , changes in lactate levels before and after the Wingate test were measured . Although the SB and TB groups showed a significant increase in maximal strength ( post-intervention , SB : 67.2 ± 9.2 and TB : 67.6 ± 7.6 kg , respectively ) compared with the values at pre-intervention ( SB : 44.6 ± 11.4 and TB : 43.9 ± 8.7 kg , respectively ) , there was no significant difference for this variable between the two groups post-intervention ( p > 0.05 ) . The anaerobic performance of the upper body in the SB and TB groups also displayed improvements without significant difference between the two groups after the completion of different training regimes . On the basis of the same training volume , multiple bouts of resistance training showed similar improvements in maximal strength and anaerobic performance to one bout of resistance training in young adult men without prior experience in resistance",
"The aim of this study was to determine whether accumulated short bouts of exercise can achieve the same cardiovascular benefits as a single long bout of exercise in sedentary male Japanese workers and to compare the programs ’ relative effects on oxidative stress . Twenty-three sedentary male workers were r and omly assigned into 2 different exercise programs : a Long-bout group , which performed a single period of continuous exercise ( Long-bout group : 30 min × 1 ) 3 d per week , and a Short-bouts group , which performed 3 short bouts of exercise ( Short-bouts group : 10 min × 3 ) 3 d per week . Cardiovascular risk factors , including the plasma thiobarbituric acid-reactive substances ( TBARS ) level , were examined at baseline and after both 10 and 20 wk . In the Long-bout group , waist circumference and maximum oxygen uptake ( VO2max ) significantly improved after 20 wk . The Short-bouts group demonstrated significant increases in VO2max after 10 weeks and in HDL-C after 20 wk . Plasma TBARS significantly decreased after 20 weeks in the Long-bout group and tended to decrease ( but not significantly ) in the Short-bouts group . These results indicate that accumulated short bouts of exercise are an effective option , especially for busy workers , for incorporating exercise into one ’s lifestyle",
"BACKGROUND AND PURPOSE Menopause may induce a phase of rapid decreases in bone mineral density , aerobic fitness , muscle strength , and balance , especially in sedentary women . The purpose of this study was to examine the effects and feasibility of an exercise program of 1 or 2 bouts of walking and resistance training on lower-extremity muscle strength ( the force-generating capacity of muscle ) , balance , and walking performance in women who recently went through menopause . SUBJECTS AND METHODS The subjects were 134 women who recently went through menopause . The study was a 15-week , r and omized , controlled trial with continuous and fractionated exercise groups . The outcomes assessed were lower-extremity muscle strength , balance , and walking time over 2 km . Feasibility was assessed by question naires , interviews , and training logs . RESULTS One hundred twenty-eight women completed the study . Adherence to the study protocol was 92 % . Both continuous and fractionated exercise groups improved equally in lower-extremity muscle strength and walking time but not in balance . Almost 70 % of the subjects considered the program to be feasible . Two daily walking sessions caused fewer lower-extremity problems than did continuous walking . DISCUSSION AND CONCLUSION Brisk walking combined with moderate resistance training is feasible and effective . Fractionating the walking into 2 daily sessions is more feasible than continuous walking",
"Objective : The specific aim of this study was to determine if three 10 minute bouts of exercise per day ( 3 × 10 ) and two 15 minute bouts per day ( 2 × 15 ) were as effective as one 30 minute bout per day ( 1 × 30 ) for improving VO2 max and weight loss . Methods : Overweight , female college students ( body mass index ≥28 kg/m2 ) were recruited and assessed at baseline and post-treatment for aerobic fitness ( Astr and maximal cycle test ) , weight , skinfold thickness ( 7-site ) , and circumference measures ( 4-site ) . Following measurement of resting energy expenditure ( REE ) , subjects were asked to follow a self-monitored calorie restricted diet ( 80 % of REE ) for the twelve week duration of the study and were assigned ( non-r and om ) to one of four treatment groups : 1 ) a nonexercising control group ( control , n = 8) , 2 ) a 30 minutes continuous exercise group ( 1 × 30 , n = 12 ) , 3 ) a 30 minutes accumulated exercise group ( 2 × 15 , n = 10 ) and 4 ) a second 30 minutes accumulated exercise group ( 3 × 10 , n = 8) . The exercising subjects participated in aerobic exercise training at 75 % of heart rate reserve three to five days per week with all exercise monitored . Results : VO2 max increased significantly while weight , body mass index , sum of skinfolds , and sum of circumferences decreased significantly from baseline to post-treatment in the 1 × 30 , 2 × 15 and the 3 × 10 groups , but not in the control group . A tertiary finding was that exercise participation did not differ among the exercising groups with regard to the average number of days per week . Conclusions : These results support the hypothesis that exercise accumulated in several short bouts has similar effects as one continuous bout with regard to aerobic fitness and weight loss during caloric restriction in overweight , young women",
"PURPOSE To compare the effects of different patterns of regular brisk walking on fitness , risk factors for cardiovascular disease , and psychological well-being in previously sedentary adults . METHODS Twenty-one subjects ( 14 women ) , aged 44.5 + /- 6.1 yr ( mean + /- SD ) were r and omly assigned to two different , 6-wk programs of brisk walking in a cross-over design , with an interval of 2 wk . One program comprised one 30-min walk per day , 5 d.wk(-1 ) ( long bout ) and the other three 10-min walks per day , also 5 d.wk(-1 ) ( short bouts ) . All walking was at 70 - 80 % of predicted maximal heart rate . Maximal oxygen uptake ( (.)VO(2max ) ) , body composition , resting arterial blood pressure , fasting plasma lipoprotein variables , and psychological parameters were assessed before and after each program . RESULTS Overall , subjects completed 88.2 + /- 1.1 % and 91.3 + /- 4.1 % of prescribed total walking time in the short- and long-bout programs , respectively . Both programs increased plasma concentrations of high-density lipoprotein cholesterol , and decreased concentrations of triacylglycerol and total cholesterol ( all body mass , but the sum of four skinfolds , waist circumference , and hip circumference were decreased after both walking programs ( all P Predicted (.)VO(2max ) increased with both programs ( P tension/anxiety ( P brisk walking accumulated throughout the day are at least as effective as one continuous bout of equal total duration in reducing cardiovascular risk and improving aspects of mood in previously sedentary individuals",
"BACKGROUND AND PURPOSE The purpose s of this study were : ( 1 ) to assess the effectiveness of a 16-week progressive program of home-based , videotape-based , low-impact aerobic exercise on physical function and signs and symptoms of fibromyalgia in previously sedentary women aged 20 to 55 years and ( 2 ) to compare the effects of 1 long exercise bout versus 2 short exercise bouts per training day ( fractionation ) on physical function , signs and symptoms of fibromyalgia , and exercise adherence . SUBJECTS One hundred forty-three sedentary women were r and omly assigned to 1 of 3 groups : a group who trained using a long bout of exercise ( LBE group , n=51 ) , a group who trained using short bouts of exercise ( SBE group , n=56 ) , and a group who performed no exercise ( NE group , n=36 ) . METHODS The SBE group exercised twice daily , and the LBE group worked out once daily . Both groups progressed in total daily training duration from 10 to 30 minutes , 3 to 5 times a week , for 16 weeks . Physical and psychological well-being , symptoms , and self-efficacy were evaluated using a multivariate analysis of variance . RESULTS Dropout rates for the NE , SBE , and LBE groups were 14 % , 38 % , and 29 % , respectively . The NE group differed from the LBE group in disease severity , self-efficacy , and psychological well-being ( midtest , efficacy analysis ) and from the SBE group in disease severity and self-efficacy ( posttest , efficacy analysis ) . Exercise adherence was greater for the LBE group than for the SBE group between weeks 5 and 8 of the training program . No other differences between exercise groups were found . DISCUSSION AND CONCLUSION Progressive , home-based , low-impact aerobics improved physical function and fibromyalgia symptoms minimally in participants who completed at least two thirds of the recommended exercise . Fractionation of exercise training provided no advantage in terms of exercise adherence , improvements in fibromyalgia symptoms or physical function . High attrition rates and problems with exercise adherence were experienced in both exercise groups",
"This study sought to determine whether a 12-week intermittent ( INT ; 2 3 15 min·d−1 ) exercise program yielded similar improvements in cardiovascular health and fitness , compared with a traditional 12-week , 30-minute continuous ( CON ; 1 X 30 min·d−1 ) exercise program . A second purpose was to determine the effects of switching exercise programs and continuing training for an additional 12 weeks . Twenty women and 17 men , ( age 48.8 ± 9.0 years ) were divided r and omly into 2 groups : INT ( n = 20 ) and CON ( n = 17 ) . Aerobic exercise was performed 4 d·wk−1 for 12 weeks . Subjects then crossed over to the opposite training program for an additional 12 weeks of training . Subjects exercised incrementally for weeks 1–4 and training was conducted at 70–80 % heart rate reserve for weeks 5–24 . Both groups showed comparable exercise adherence , completing 96.6 ± 12.2 % ( CON ) and 96.3 % ± 17.7 % ( INT ) of the prescribed exercise time . The INT walked at a lower percentage of & OV0312;O2max , maximum heart rate , systolic blood pressure , and diastolic blood pressure ( p increased by 4.5 % in CON and by 8.7 % in INT . Following the second 12 weeks , & OV0312;O2max increased by 3.6 and 7.7 % in CON and INT , respectively . Treadmill test time increased by 41 seconds in CON ( p training . High-density lipoproteins significantly increased in the INT group following the first 12 weeks of training . This study suggests that an INT exercise program , which is incremental in nature , provides comparable , and in some cases greater , health and fitness benefits than those expected following traditional CON exercise training",
"We compared the effects of one vs two daily bouts of walking on aerobic fitness and body composition in postmenopausal women . One hundred and thirty-four subjects were r and omized into exercise groups or a control group and 130 completed the study . The subjects walked 5 d/week for 15 weeks at 65 % of their maximal aerobic power expending 300 kcal ( 1255 kJ ) in exercise in one ( Group S1 ) or two daily sessions ( Group S2 ) . VO(2max ) was measured in a direct maximal treadmill test . Body mass index ( BMI ) was calculated and the percentage of body fat ( fat% ) estimated using skinfold measurements . The net change in the VO(2max ) was 2.5 mL min/kg ( 95 % CI 1.5 , 3.5 ) ( 8.7 % ) in Group S1 and 2.5 mL min/kg ( 95 % CI 1.5 , 3.5 ) ( 8.8 % ) in Group S2 . The net change in body mass was -1.2 kg ( 95 % CI-1.9 , -0.5 ) in Group S1 and -1.1 kg ( 95 % CI -1.8 , -0.4 ) in Group S2 . The net fat% change was -2.1 % ( 95 % CI-2.7 , -1.4 ) in Group S1 and -1.7 % ( 95 % CI-2.3 , -1.0 ) in Group S2 . Exercise improved the maximal aerobic power and body composition equally when walking was performed in one or two daily bouts",
"BACKGROUND To compare the ACSM-CDC physical activity accumulation recommendation to the traditional recommendation , for impact on mood and physiological markers of fitness . METHODS R and omized controlled trial with sedentary male ( n = 21 ) and female ( n = 19 ) subjects assigned to walk either long bouts ( LB ; 30 min/day ) , short bouts ( SB ; 3 x 10 min/day ) , or a nonexercise control ( CTL ) group for 8 weeks . Pre- and post- measures were collected for V02max and percent body fat . Pre- , mid- , and post- measures were collected for the Profile of Mood States ( POMS ) . RESULTS VO2max increased in the SB group ( + 7.2 % ) and LB ( + 6.7 % ; P Percent body fat decreased in the LB group ( -6.7 % ; P Total mood disturbance ( TMD ) decreased in the LB and SB groups ( P Tension-anxiety and vigor-activity were altered in the LB group compared to the other two groups ( P Reductions in percent body fat correlated with TMD ( r = 0.38 ; P Tension-anxiety reduction ( r = 0.40 ; P VO2max LB walking was more effective at reducing percent body fat , tension-anxiety and total mood disturbance , and increasing vigor compared to the control group",
"BACKGROUND The accumulation of physical activity ( PA ) throughout the day has been suggested as a means to increase PA behavior . It is not known , however , if accumulated PA results in equivalent increases in PA behavior compared with one continuous session . The purpose of this investigation was to compare changes in PA between participants assigned to walk daily in accumulated shorter bouts vs. one continuous session . METHODS In this 8-week r and omized controlled trial , 60 inactive women were r and omly assigned to one of the following : ( 1 ) control group , ( 2 ) 30 minutes a day of walking 5 days a week in one continuous long bout ( LB ) , or ( 3 ) three short 10-minute bouts ( SB ) of walking a day , all at a prescribed heart rate intensity . Walking was assessed by pedometer and self-reported walking log . Before and after measures were taken of average steps/day , resting systolic and diastolic blood pressure ( SBP , DBP ) , resting heart rate ( RHR ) , six-minute walk test ( 6MWT ) distance , height , weight , body mass index ( BMI ) , and hip and waist circumference . RESULTS Both walking groups significantly increased PA measured as steps/day compared to controls ( p hip circumference and significant increases in 6MWT distance compared to the control group . CONCLUSIONS Both walking groups significantly increased PA participation . LB group participants completed more walking at a higher intensity than the SB and control groups , which result ed in significant increases in health benefits",
"CONTEXT Enhancing participation in long-term exercise may translate into improved long-term weight loss in overweight adults . OBJECTIVES To compare the effects of intermittent with traditional continuous exercise on weight loss , adherence , and fitness , and to examine the effect of combining intermittent exercise with that using home exercise equipment . DESIGN R and omized trial from September 1996 through September 1998 . SETTING AND PARTICIPANTS A total of 148 sedentary , overweight ( mean [ SD ] body mass index , 32.8 [ 4.0 ] kg/m2 ) women ( mean [ SD ] age , 36.7 [ 5.6 ] years ) in a university-based weight control program . INTERVENTIONS Eighteen-month behavioral weight control program with 3 groups : long-bout exercise ( LB ) , multiple short-bout exercise ( SB ) , or multiple short-bout exercise with home exercise equipment ( SBEQ ) using a treadmill . MAIN OUTCOME MEASURES Body weight , body composition , cardiorespiratory fitness , and exercise adherence . RESULTS Of 148 subjects , 115 ( 78 % ) completed the 18-month program . At 18 months , mean ( SD ) weight loss was significantly greater in subjects in the SBEQ group compared with subjects in the SB group ( -7.4 [ 7.8 ] kg vs -3.7 [ 6.6 ] kg ; P Mean ( SD ) weight loss for subjects in the LB group ( -5.8 [ 7.1 ] kg ) was not significantly different than for subjects in the SB or SBEQ groups . Subjects in the SBEQ group maintained a higher level of exercise than subjects in both the SB and LB groups ( P cardiorespiratory fitness from baseline to 18 months , with no difference between groups . Mean ( SD ) weight loss at 18 months was significantly greater in individuals exercising more than 200 min/wk throughout the intervention ( -13.1 [ 8.0 ] kg ) compared with individuals exercising 150 to 200 min/wk ( -8.5 [ 5.8 ] kg ) or less than 150 min/wk ( -3.5 [ 6.5 ] kg ) ( P long-term weight loss , exercise participation , or cardiorespiratory fitness . Access to home exercise equipment facilitated the maintenance of SB , which may improve long-term weight loss . A dose-response relationship exists between amount of exercise and long-term weight loss in overweight adult women ",
"OBJECTIVE To investigate whether prescribing exercise in several short-bouts versus one long-bout per day would enhance exercise adherence , cardiorespiratory fitness , and weight loss in overweight adult females in a behavioral weight control program . DESIGN R and omized controlled trial with subjects r and omized to either a short-bout exercise group ( SB , n = 28 , age = 40.4 + /- 5.9 yrs ) or a long-bout exercise group ( LB , n = 28 , age = 40.9 + /- 7.3 yrs ) , with subjects followed for a period of 20 weeks . Both groups were instructed to exercise 5 days per week with exercise duration progressing from 20 to 40 min per day . The LB group performed one exercise bout per day , whereas the SB group performed multiple 10 min bouts of exercise per day . The recommended caloric intake for all subjects was 5022 - 6277 kJ/day ( 1200 - 1500 kcal/day ) , with fat reduced to 20 % of caloric intake . SUBJECTS Fifty-six obese , sedentary females ( BMI = 33.9 + /- 4.1 kg/m2 ) . MEASUREMENTS Exercise participation was assessed from self-reported diaries and Tri-Trac Accelerometers . Cardiorespiratory fitness was assessed using a submaximal cycle ergometer test . RESULTS Exercising in multiple short-bouts per day improved adherence to exercise : the SB group reported exercising on a greater number of days ( mean + /- s.d . = 87.3 + /- 29.5 days vs 69.1 + /- 28.9 days ; P greater total duration ( 223.8 + /- 69.5 min/week vs 188.2 + /- 58.4 min/week ; P = 0.08 ) than the LB group . Predicted VO2Peak increased by 5.6 % and 5.0 % for the LB and SB groups , respectively ( P weight loss to be greater in the SB group ( -8.9 + /- 5.3 kg ) compared to the LB group ( -6.4 + /- 4.5 kg ; P of exercise may enhance exercise adherence . Short-bouts of exercise may also enhance weight loss and produce similar changes in cardiorespiratory fitness when compared to long-bouts of exercise . Thus , short-bouts of exercise may be preferred when prescribing exercise to obese adults",
"We studied the fractionization of walking training and search ed for the minimum dose to affect coronary risk factors in two r and omized controlled trials . Altogether 134 ( Study I ) and 121 ( Study II ) healthy , sedentary postmenopausal women started the trials , and 130 ( Study I ) and 116 ( Study II ) completed them . In Study I the exercise intensity was 65 % of the maximal aerobic power ( VO2max ) and a total of 300 kcal was expended in one ( Group W1 ) or two ( Group W2 ) daily walking bouts . In Study II the exercise was continuous , and the exercise intensity ( % of VO2max ) and energy expenditure ( kcal session(-1 ) ) were 55 % and 300 kcal ( Group W3 ) , 45 % and 300 kcal ( Group W4 ) , 55 % and 200 kcal ( Group W5 ) and 45 % and 200 kcal ( Group W6 ) . All the subjects walked 5 days a week . The outcome measures were blood pressure , serum lipoproteins and blood glucose and plasma insulin in fasting state and also during 2-h oral glucose tolerance test in Study I. There was no change in diastolic pressure in the original study groups , but in the combined exercise group ( W1+W2 ) in Study I , the mean diastolic pressure declined by -3.0 mmHg ( 95 % con-fidence interval ( CI ) -5.5 to -0.4 ) ( P=0.025 ) in comparison with that of the controls . The mean blood glucose declined by -0.21 mmol L(-1 ) ( CI -0.33 to -0.09 ) in Group W1 and -0.13 mmol L(-1 ) ( CI -0.25 to -0.01 ) in Group W2 compared to controls ( P=0.03 ) . Also the 2-h glucose concentration decreased in Groups W1 and W2 compared to controls . Systolic blood pressure , serum lipoproteins and insulin levels did not change in Study I or Study II . We conclude that our training program with the greatest exercise dose , exercise intensity 65 % of VO2max and weekly expenditure of 1500 kcal had a minimal , positive effect on diastolic pressure and blood glucose , and the effect was similar in one or two daily exercise session groups . This exercise dose is probably close to the minimum to affect coronary risk factors in healthy postmenopausal women . To get a more pronounced and clinical ly relevant effect , a greater exercise dose is needed",
"OBJECTIVE Although several studies have examined the effect of accumulated bouts on health outcomes , the impact of recommending short bouts on activity-related behavior in health promotion efforts has received minimal investigation . METHOD During this 5-week study in 2007 - 2008 , 43 university employees ( 8 male , 35 female ) in the Southeastern United States were r and omly assigned to a group recommended to achieve ( a ) 10,000 steps ( 10 K ) , ( b ) 30-minutes ( 30 min ) of continuous physical activity , or ( c ) 30-minutes of activity in bouts of at least 10 minutes ( bouts ) . RESULTS AND CONCLUSIONS Repeated measures ANOVA revealed that the 10 K group showed the largest increase in step counts whereas the bouts group showed the smallest change over the intervention period , p=0.01 . Condition differences were most pronounced on days in which participants met their activity recommendation . Accelerometer results revealed that the 10 K ( d=1.1 ) and 30 min groups ( d=0.89 ) showed large increases in minutes of moderate to vigorous activity ( MVPA ) , whereas the bouts group showed minimal change ( d=0.11 ) . Although activity recommendations did not differentially affect self-efficacy , participants from all conditions showed decreased self-efficacy across the intervention ( p=0.02 ) , highlighting the need to develop strategies to increase self-efficacy in activity promotion efforts",
"BACKGROUND This study was design ed to test different ways of meeting the new ACSM/CDC recommendations for physical activity stating that all Americans at least 2 years of age should obtain 30 minutes of moderate intensity activity on most days of the week . METHODS Thirty-two sedentary 18- to 55-year-old adults were r and omly assigned to three groups of brisk walking/6 days per week : 30 continuous minutes , three 10-minute bouts , and 30 minutes in any combination of bouts as long as each bout was at least 5 minutes . Aerobic fitness , blood pressure , body composition , and physical activity were assessed at baseline , at end of program ( 16 weeks ) , and at follow-up ( 32 weeks ) . RESULTS All groups significantly ( P aerobic fitness and systolic blood pressure and increased their physical activity at the end of the program . At follow-up all groups maintained these changes , while additionally reducing their percentage body fat and diastolic blood pressure . CONCLUSION These findings demonstrate that a walking prescription of 30 minutes per day on most days of the week with the choice to walk in as little as 5 minute bouts can improve cardiovascular health and body composition , as well as help sedentary people maintain those improvements over time . This is supported by all participants indicating that \" making walking part of my lifestyle \" was the most important factor in maintaining their walking habits",
"This study compared the effects of short and long bouts of brisk walking in sedentary women . Forty seven women aged 44.4 + /- 6.2 yr ( mean + /- SD ) were r and omly assigned to either three 10-min walks per day ( short bouts ) , one 30-min walk per day ( long bouts ) or no training ( control ) . Brisk walking was done on 5 d x wk(-1 ) , at 70 to 80 % of maximal heart rate , typically at speeds between 1.6 and 1.8 m x s(-1 ) ( 3.5 and 4.0 mph ) , for 10 wk . Subjects agreed not to make changes to their diet . Twelve short-bout walkers , 12 long-bout walkers , and 10 controls completed the study . Relative to controls , VO2max ( short-bout , + 2.3 + /- 0.1 mL x kg(-1 ) x min(-1 ) ; long-bout , + 2.4 + /- 0.1 mL x kg(-1 ) x min(-1 ) ; controls , -0.5 + /- 0.1 mL x kg(-1 ) x min[-1 ] ) and the VO2 at a blood lactate concentration of 2 mmol x L(-1 ) increased in walkers ( both P heart rate during st and ard , submaximal exercise nor resting systolic blood pressure changed in a different way in walkers and controls . The sum of four skinfold thicknesses decreased in both walking groups ( P body mass ( short-bout , -1.7 + /- 1.7 kg ; long-bout , -0.9 + /- 2.0 kg ; controls , + 0.6 + /- 0.7 kg ) and waist circumference decreased significantly only in short-bout walkers . Changes in anthropometric variables did not differ between short- and long-bout walkers . Thus short bouts of brisk walking result ed in similar improvements in fitness and were at least as effective in decreasing body fatness as long bouts of the same total duration"
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4117026c-06ff-11f0-808a-c43d1ab1c353
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Background Psychosocial factors are key determinants of health and can influence patient-reported outcomes after rotator cuff tears . However , to our knowledge , a systematic review of published studies has not been conducted to determine the degree of consistency and strength of the relationship between psychosocial factors and patient-reported outcomes in this patient population . Questions / purpose s ( 1 ) Are psychosocial factors associated with patient-reported measures at initial clinical presentation in patients with rotator cuff tears ? ( 2 ) Are psychosocial factors associated with patient-reported outcomes after treatment in patients with rotator cuff tears ? Methods A systematic review of cross-sectional and prospect i ve observational studies was performed in MEDLINE / PubMed , EMBASE , CINAHL , PsycINFO , and Web of Science from each data base ’s inception to June 2016 . We included studies examining associations between psychosocial factors and patient-reported measures in patients with rotator cuff tears . We excluded studies not reporting on this relationship , involving patients with nonspecific shoulder pain , and written in a language other than English . Two independent review ers performed the search , extracted information , and assessed method ological quality . Study quality was assessed using the Method ological Items for Non-R and omized Studies ( MINORS ) criteria . The primary outcomes for the review were associations between each psychosocial factor and patient-reported measures of function or disability , pain , or quality of life . Associations were interpreted based on significance , strength , and direction of the relationship . A total of 10 studies ( five cross-sectional and five prospect i ve ) in 1410 patients ( age range , 46 - 62 years , 60 % [ 571 of 958 ] men ) were included in the review . Pooling of results for meta-analyses was not possible as a result of study heterogeneity . Results Weak to moderate cross-sectional associations were found for emotional or mental health with function or disability and pain in multiple studies . Lower emotional or mental health function was associated with greater pain or disability or lower physical function at initial evaluation . Only one psychosocial factor ( patient expectation ) was weak to moderately associated with patient-reported outcomes after treatment in more than one study . In the two studies that examined expectations , the higher the expectation of benefit , the greater the perceived benefit after surgical intervention . Conclusions At the initial evaluation of patients with rotator cuff tear , there was an association between self-reported function and pain and emotional or mental health . However , these factors were not associated with patient-reported outcomes after intervention . This finding could be attributed to the lack of large prospect i ve studies in this area or complex phenotypes within this patient population . Preoperative patient expectation is an important predictor of patient-reported outcomes in patients after rotator cuff surgery and may be a modifiable target for enhancing recovery . Level of Evidence Level III , therapeutic study
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"Background To specify what patients want and worry preoperatively is important in orthopedic practice . The aim of the current study was to analyze the patient characteristics of rotator cuff disease in Korean population who were willing to undergo arthroscopic surgery , and to evaluate the differences in expectations and concerns by age and gender . Methods We prospect ively enrolled 303 patients who underwent rotator cuff surgery between April 2004 and August 2008 . Three question naires were completed before surgery : the first one addressing preoperative patient 's expectation , the second one focusing on concerns by covering 64 items using a visual analogue scale , and the third one evaluating patient 's demographic characteristics . The characteristics of preoperative expectation , concern , and demographic data were evaluated according to gender and age group . Results Female patients had lower level of sports activity ( p = 0.007 ) and lower levels of information ( p = 0.028 ) . Gender specific worries are about a caregiver during hospital stay , operating on the working side , fear about ugly scars , postoperative pain , applying makeup or combing hair . The older group responded that they ca n't be willing to change activities of daily living ( p = 0.001 ) , are not living with a spouse ( p = 0.002 ) , had previous shoulder operation history ( p = 0.008 ) , and had a lower level of information ( p = 0.007 ) . They especially worried about medical bills , worried about the physician being too young and inexperienced , postoperative pain , loss of arm function , and hospital food . Conclusions Our data showed what Korean patients wanted and were concerned about prior to rotator cuff surgery . This can empower patients to formulate realistic expectations and make informed decisions . We feel that we can achieve higher levels of postoperative satisfaction by analyzing expectations and concerns in depth and addressing these proactively",
"Background Clinical guidelines advocate the routine identification of depressive symptoms for patients with pain in the lumbar or cervical spine , but not for other anatomical regions . Objective The purpose of this study was to investigate the prevalence and impact of depressive symptoms for patients with musculoskeletal pain across different anatomical regions . Design This was a prospect i ve , associational study . Methods Demographic , clinical , depressive symptom ( Symptom Checklist 90–Revised ) , and outcome data were collected by self-report from a convenience sample of 8,304 patients . Frequency of severe depressive symptoms was assessed by chi-square analysis for demographic and clinical variables . An analysis of variance examined the influence of depressive symptoms and anatomical region on intake pain intensity and functional status . Separate hierarchical multiple regression models by anatomical region examined the influence of depressive symptoms on clinical outcomes . Results Prevalence of severe depression was higher in women , in industrial and pain clinics , and in patients who reported chronic pain or prior surgery . Lower prevalence rates were found in patients older than 65 years and those who had upper- or lower-extremity pain . Depressive symptoms had a moderate to large effect on pain ratings ( Cohen d=0.55–0.87 ) and a small to large effect on functional status ( Cohen d=0.28–0.95 ) . In multivariate analysis , depressive symptoms contributed additional variance to pain intensity and functional status for all anatomical locations , except for discharge values for the cervical region . Conclusions Rates of depressive symptoms varied slightly based on anatomical region of musculoskeletal pain . Depressive symptoms had a consistent detrimental influence on outcomes , except on discharge scores for the cervical anatomical region . Exp and ing screening recommendations for depressive symptoms to include more anatomical regions may be indicated in physical therapy setting",
"BACKGROUND To compare risk factors for shoulder pain without and with rotator cuff syndrome ( RCS ) . METHODS A total of 3,710 workers of a French region were r and omly included in the cross-sectional study between 2002 and 2005 . Personal and occupational risk factors were assessed during a physical examination and by a self-administered question naire . Multinomial logistic modeling was used for the following outcomes : no shoulder pain and no RCS ( reference ) , shoulder pain without RCS ( called \" shoulder pain \" ) and RCS , separately for men and women . RESULTS The prevalence rates of \" shoulder pain \" for men and women were 28.0 % and 31.1 % , respectively , and the prevalence rates of RCS were 6.6 % and 8.5 % , respectively . In men , \" shoulder pain \" and RCS were associated with age , high-perceived physical exertion , and arm abduction . Automatic work pace and low supervisor support were associated with \" shoulder pain , \" and high psychological dem and and low skill discretion with RCS . In women , \" shoulder pain \" and RCS were associated with age , repetitiveness of tasks , and low supervisor support . High perceived physical exertion and exposure to cold temperatures were associated with \" shoulder pain . \" CONCLUSIONS Age was more strongly associated with RCS than with shoulder pain without RCS for both genders . Biomechanical and psychosocial factors were associated with \" shoulder pain \" and RCS and differed between genders",
"Background Recently , psychological status , patient-centered outcomes , and health-related quality of life ( HRQoL ) in patients with scheduled or who underwent orthopaedic surgeries have been emphasized . The relationship between preoperative psychological status and postoperative clinical outcome in patients with rotator cuff repair has not yet been investigated . Questions / purpose sThe primary objective of this study was to investigate changes in psychological status ( depression , anxiety , insomnia ) and HRQoL after rotator cuff repair . The secondary objective was to assess whether preoperative depression , anxiety , and insomnia predict clinical outcome after rotator cuff repair . Methods Forty-seven patients who underwent rotator cuff repair prospect ively completed the visual analog scale ( VAS ) pain score , the UCLA Scale , the American Shoulder and Elbow Surgeons ’ Scale ( ASES ) , the Hospital Anxiety and Depression Scale ( HADS ) , the Pittsburgh Sleep Quality Index ( PSQI ) , and the World Health Organization Quality -of-life Scale Abbreviated Version ( WHOQOL-BREF ) before surgery and at 3 , 6 , and 12 months after surgery . Repeated- measures analysis of variance was used to evaluate the serial changes in psychological parameters and outcome measurements . The chi-square test was also used to compare preoperative and postoperative prevalence of depression , anxiety , and insomnia . Finally , multiple regression analysis was applied to determine the relationship between preoperative psychological status and postoperative clinical outcome . Results With surgery , depression , anxiety , and insomnia decreased , whereas quality of life increased . The mean HADS-D and HADS-A scores and the mean PSQI score decreased from 3.7 ± 3.3 , 4.3 ± 4.3 , and 6.6 ± 3.6 , respectively , before surgery to 2.1 ± 2.3 , 1.4 ± 2.4 , and 4.2 ± 3.3 , respectively , at 12 months after surgery ( HADS-D mean difference 1.6 [ 95 % confidence interval { CI } , 0.6–2.6 ] , p = 0.003 ; HADS-A mean difference 2.9 [ 1.5–4.4 ] , p p score increased from 60.4 ± 11.0 before surgery to 67.4 ± 11.8 at 12 months after surgery ( mean difference −7.0 [ 95 % CI , −10.7 to −3.4 ] , p depression ( six of 47 [ 22.8 % ] versus three of 47 [ 6.4 % ] , p = 0.002 ) , anxiety ( 11 of 47 [ 23.4 % ] versus two of 47 [ 4.3 % ] , p = 0.016 ) , and insomnia ( 33 of 47 [ 70.2 % ] versus 20 of 47 [ 42.6 % ] , p = 0.022 ) . Preoperative HADS-depression , HADS-anxiety , and PSQI scores did not correlate with the VAS pain score , UCLA , or ASES scores at 12 months after surgery . Conclusions Psychological status and HRQoL improved with decreasing pain and increasing functional ability from 3 months after surgery . Preoperative depression , anxiety , and insomnia did not predict poor outcome after rotator cuff repair . Our findings suggest that successful rotator cuff repair may improve psychological status and HRQoL.Level of Evidence Level II , prospect i ve study",
"Background Patients with shoulder and rotator cuff pathology who exhibit greater levels of psychological distress report inferior preoperative self- assessment s of pain and function . In several other areas of orthopaedics , higher levels of distress correlate with a higher likelihood of persistent pain and disability after recovery from surgery . To our knowledge , the relationship between psychological distress and outcomes after arthroscopic rotator cuff repair has not been similarly investigated . Questions / purpose s(1 ) Are higher levels of preoperative psychological distress associated with differences in outcome scores ( visual analog scale [ VAS ] for pain , Simple Shoulder Test , and American Shoulder and Elbow Surgeons score ) 1 year after arthroscopic rotator cuff repair ? ( 2 ) Are higher levels of preoperative psychological distress associated with less improvement in outcome scores ( VAS for pain , Simple Shoulder Test , and American Shoulder and Elbow Surgeons score ) 1 year after arthroscopic rotator cuff repair ? ( 3 ) Does the prevalence of psychological distress in a population with full-thickness rotator cuff tears change when assessed preoperatively and 1 year after arthroscopic rotator cuff repair ? Methods Eighty-five patients with full-thickness rotator cuff tears were prospect ively enrolled ; 70 patients ( 82 % ) were assessed at 1-year followup . During the study period , the three participating surgeons performed 269 rotator cuff repairs ; in large part , the low overall rate of enrollment was related to two surgeons enrolling only two patients total in the initial 14 months of the study . Psychological distress was quantified using the Distress Risk Assessment Method question naire , and patients completed self- assessment s including the VAS for pain , the Simple Shoulder Test , and the American Shoulder and Elbow Surgeons score preoperatively and 1 year after arthroscopic rotator cuff repair . Fifty of 85 patients ( 59 % ) had normal levels of distress , 26 of 85 ( 31 % ) had moderate levels of distress , and nine of 85 ( 11 % ) had severe levels of distress . Statistical models were used to assess the effect of psychological distress on patient self- assessment of shoulder pain and function at 1 year after surgery . Results With the numbers available , distressed patients were not different from nondistressed patients in terms of postoperative VAS for pain ( 1.9 [ 95 % confidence interval { CI } , 1.0–2.8 ] versus 1.0 [ 95 % CI , 0.5–1.4 ] , p = 0.10 ) , Simple Shoulder Test ( 9 [ 95 % CI , 8.1–10.4 ] versus 11 [ 95 % CI , 10.0–11.0 ] , p = 0.06 ) , or American Shoulder and Elbow Surgeons scores ( 80 [ 95 % CI , 72–88 ] versus 88 [ 95 % CI , 84–92 ] , p = 0.08 ) 1 year after arthroscopic rotator cuff repair . With the numbers available , distressed patients also were not different from nondistressed patients in terms of the amount of improvement in scores between preoperative assessment and 1-year followup on the VAS for pain ( 3 [ 95 % CI , 2.2–4.1 ] versus 2 [ 95 % CI , 1.4–2.9 ] , p = 0.10 ) , Simple Shoulder Test ( 5.2 [ 95 % CI , 3.7–6.6 ] versus 5.0 [ 95 % CI , 4.2–5.8 ] , p = 0.86 ) , or American Shoulder and Elbow Surgeons scale ( 38 [ 95 % CI , 29–47 ] versus 30 [ 95 % CI , 25–36 ] , p = 0.16 ) . The prevalence of psychological distress in our patient population was lower at 1 year after surgery 14 of 70 ( 20 % ) versus 35 of 85 ( 41 % ) preoperatively ( odds ratio , 0.36 ; 95 % CI , 0.17–0.74 ; p = 0.005 ) . Conclusions Mild to moderate levels of distress did not diminish patient-reported outcomes to a clinical ly important degree in this small series of patients with rotator cuff tears . This contrasts with reports from other areas of orthopaedic surgery and may be related to a more self-limited course of symptoms in patients with rotator cuff disease or possibly to a beneficial effect of rotator cuff repair on sleep quality or other unrecognized determinants of psychosocial status . Level of Evidence Level I , prognostic study",
"OBJECTIVES This study assessed the prevalence , incidence , and persistence of nontraumatic rotator cuff tendinitis and shoulder symptoms over a 1-year period in a working population and the predictive value of symptoms and physical findings . METHODS A 1-year prospect i ve study of 436 active workers was conducted at 12 different worksites . Detailed health interviews , psychosocial question naires , and physical examinations were conducted at baseline and again after 1 year , with shorter evaluations at 4 and 8 months . Individual observed exposure assessment of shoulder posture , arm-h and activity , and h and forces was conducted . RESULTS The prevalence of rotator cuff tendinitis at baseline was 7.6 % [ 95 % confidence interval ( 95 % CI 5.1 - 10.1 % ) ] for the right and 4.8 % ( 95 % CI 3.0 - 7.0 % ) for the left , compared with shoulder symptoms of 18.6 % ( 95 % CI 14.9 - 22.3 % ) ( right ) and 11.2 % ( 95 % CI 8.2 - 14.2 % ) ( left ) . The incidence of rotator cuff tendinitis was 5.5 % ( 95 % CI 2.8 - 6.8 % ) and 2.9 % ( 95 % CI 1.0 - 3.8 % ) , respectively . Higher proportions of participants with current symptoms or physical findings at baseline became clinical cases after 1 year than those without symptoms or findings . The 1-year persistence of clinical case status was 31.3 % ( 95 % CI 26.9 - 35.7 % ) ( right ) and 31.6 % ( 95 % CI 27.2 - 36.0 % ) ( left ) . There were significant differences at baseline between the asymptomatic participants and the clinical cases with respect to physical health on the 12-item Short-form Health Survey ( P=0.0002 ) , the perception of general health ( P=0.0027 ) , and the frequency of high h and force exposure ( P=0.0177 ) . CONCLUSIONS Considerable movement occurs between different stages of shoulder problems . Symptoms and physical findings alone appear to predict clinical case status within 1 year . Frequent follow-up is necessary to capture changes in health and exposure status in prospect i ve studies",
"BACKGROUND Previous studies have demonstrated varying correlations between Workers ' Compensation status and the outcome of rotator cuff repair . However , none of those studies have formally accounted for potential confounding factors with multivariable analysis . We hypothesized that patients with Workers ' Compensation cl aims who undergo rotator cuff repair have worse outcomes , even after controlling for confounding factors . METHODS One hundred and twenty-five patients ( including thirty-nine with Workers ' Compensation cl aims ) who underwent unilateral primary repair of a chronic rotator cuff tear by a single surgeon were studied prospect ively and were evaluated one year postoperatively , prior to the settlement of any cl aims . Outcomes were assessed with the Simple Shoulder Test ( SST ) ; the Disabilities of the Arm , Shoulder and H and ( DASH ) index ; three visual analog scales ( shoulder pain , shoulder function , and quality of life ) ; and the Short Form-36 ( SF-36 ) . RESULTS Patients in the Workers ' Compensation group were significantly younger , had greater work dem and s , and had lower marital rates , education levels , and preoperative expectations for the outcome of treatment as compared with those in the non-Workers ' Compensation group ( p = 0.001 to 0.016 ) . Preoperatively , patients in the Workers ' Compensation group had significantly lower scores on the SST , the SF-36 Physical Function scale , and the SF-36 Social Function scale ( p = 0.01 to 0.038 ) . One year postoperatively , those patients reported worse performance on the SST , the DASH , all three visual analog scales , and the SF-36 ( p = 0.0007 to 0.05 ) and had worse improvement on the DASH , the visual analog scales for shoulder pain and function , and the SF-36 Bodily Pain and Role Emotional scales ( p = 0.0028 to 0.038 ) . Multivariable analysis controlling for age , sex , comorbidities , smoking , marital status , education , duration of symptoms , work dem and s , expectations , and tear size confirmed that Workers ' Compensation status was an independent predictor of worse DASH scores . CONCLUSIONS Patients with Workers ' Compensation cl aims report worse outcomes , even after controlling for confounding factors . The present study provides further evidence that the existence of a Workers ' Compensation cl aim portends a less robust outcome following rotator cuff repair . LEVEL OF EVIDENCE Prognostic Level I. See Instructions to Authors for a complete description of levels of evidence",
"UNLABELLED Pain-related fear and pain catastrophizing are 2 central psychologic factors in fear-avoidance models . Our previous studies in healthy subjects indicated that pain-related fear , but not pain catastrophizing , was associated with cold pressor pain outcomes . The current study extends previous work by investigating pain-related fear and pain catastrophizing in a group of subjects with shoulder pain , and included concurrent measures of experimental and clinical pain . Fifty nine consecutive subjects seeking operative treatment of shoulder pain were enrolled in this study ( 24 women , mean age = 50.4 , SD = 14.9 ) . Subjects completed vali date d measures of pain-related fear , pain catastrophizing , and clinical pain intensity and then underwent a cold pressor task to determine experimental pain sensitivity . Multivariate regression models used sex , age , pain-related fear , and pain catastrophizing to predict experimental pain sensitivity and clinical pain intensity . Results indicated that only pain-related fear uniquely contributed to variance in experimental pain sensitivity ( beta = -.42 , P clinical pain intensity . These data provide additional support for application of fear-avoidance models to subjects with shoulder pain . Our results also suggest that pain-related fear and pain catastrophizing may influence different components of the pain experience , providing preliminary support for recent theoretical conceptualizations of the role of pain catastrophizing . PERSPECTIVE This study provided additional information on how specific psychological variables potentially influence experimental and clinical pain . In this sample of subjects with shoulder pain , we replicated findings from our previous studies involving healthy subjects , as fear of pain was uniquely associated with experimental pain sensitivity . In contrast , pain catastrophizing emerged as the sole psychological variable related to clinical pain intensity ",
"OBJECTIVE To evaluate the relationship between patient expectations of total joint arthroplasty ( TJA ) and health related quality of life plus satisfaction 6 months after surgery . Methods . This prospect i ve cohort study included patients undergoing primary total hip ( THA ) and knee arthroplasty ( TKA ) . Patients were evaluated with self-report question naires prior to surgery and 6 months post-surgery . Medical Outcomes Study Short Form 36 ( SF-36 ) , the Western Ontario McMaster Universities Osteoarthritis Index ( WOMAC ) , and a satisfaction scale were used to evaluate outcomes at final followup . Multivariate regression models were used to evaluate the impact of expectations on outcomes . RESULTS There were 102 patients with THA and 89 with TKA . Mean age was 66 years . All patients achieved significant improvements in their WOMAC and SF-36 scores following surgery . Patient expectations regarding surgery were not associated with their age , gender , index joint of surgery , marital status , or race . Expectations were not correlated with pre-operative functional health status . Expectation of complete pain relief after surgery was an independent predictor of better physical function and improvement in level of pain at 6 months post-surgery . Expectation of low risk of complications from TJA was an independent predictor of greater satisfaction . CONCLUSIONS Patient expectations were important independent predictors of improved functional outcomes and satisfaction following TJA . Greater underst and ing of the relationship between expectations and outcomes may improve the process of care and outcomes of TJA",
"STUDY DESIGN Prospect i ve , multicenter research design . OBJECTIVES To assess functional and health status outcomes in patients following a physical therapy program after rotator cuff repair surgery , and to determine the impact of selected patient medical comorbidities on rehabilitation outcomes . BACKGROUND While authors have studied the influence of multiple factors on patient outcomes after rotator cuff repair surgery , little research has been done on the impact of comorbidities , particularly as it relates to establishing an accurate patient prognosis . eighteen patients who had recently undergone a rotator cuff repair surgical procedure were recruited at 1 of 30 Physiotherapy Associates , Inc outpatient clinics located in 13 states . A rehabilitation protocol was implemented and included the following interventions , as indicated : therapeutic exercise , manual therapy , electrotherapeutic modalities , and physical agents . Patient health history factors were documented during the initial examination , including age , race , body mass index , smoking , rotator cuff tear size , type of surgical procedure , and selected medications and comorbidities . The Disabilities of the Arm , Shoulder , and H and ( DASH ) and the Short-Form-36 ( SF-36 ) were completed prior to rehabilitation , at discharge , and at 6 months postdischarg RESULTS DASH and most SF-36 domain mean scores obtained postrehabilitation were significantly improved from pretherapy scores . Most health status outcomes were maintained at 6-month follow-up , with slight further improvement noted in SF-36 physical dimensions and DASH scores . Having a greater number of comorbidities was associated with worse postrehabilitation SF-36 scores , but not with the DASH shoulder function scores . The mean change scores ( difference between prerehabilitation and postrehabilitation status ) for the DASH and SF-36 were not significantly different for patients with 0 to 1 , 2 , or at least 3 or more comorbidities ( except for emotional role ) . In regression analyses a model with baseline physical function score ( P = .0001 ) , age ( P = .03 ) , and number of comorbidities ( P = .003 ) fitted the data well and explained 38 % of the variance in the physical function score at discharge . CONCLUSIONS A higher number of comorbidities had a negative effect on general health status outcomes but not on shoulder function outcomes at the time of patient discharge following rehabilitation . Despite a negative effect of more comorbidities on health status outcomes , the specific number of medical comorbidities did not affect the overall level of improvement prerehabilitation to postrehabilitation in function and health status . The findings describing the influence of comorbidities on rehabilitation outcomes may assist therapists in establishing accurate patient prognosis",
"Background The role of degenerative changes in rotator cuff musculature with respect to the functional outcomes of rotator cuff repair have only recently been recognized and are still not well understood . In addition , the reversibility of these changes with repair of the tendons is question able . Hypothesis Poorer preoperative muscle quality negatively affects outcome , and a successful outcome ( in terms of a healed repair ) might demonstrate improvements in fatty infiltration and muscle atrophy . Study Design Cohort study ; Level of evidence , 2 . Methods Thirty-eight patients ( mean age , 62 years ) were prospect ively evaluated with preoperative and 1-year postoperative clinical examination and appropriate magnetic resonance image sequencing to determine grade s of muscle atrophy and fatty infiltration of the supraspinatus and infraspinatus muscles . American Shoulder and Elbow Society ( ASES ) , Constant , and pain scores were determined as well as strength measurements . The retear rate and progression of muscle degeneration were also evaluated . Independent predictors of outcome measurements and cuff integrity were determined . Results The overall clinical outcome , including ASES , Constant , and pain scores , improved significantly ( P Strength in forward elevation improved significantly ( P external rotation strength did not . There was a strongly negative correlation between muscle quality and outcome results in most cases . When the results were adjusted for multivariate effect , muscle atrophy and fatty infiltration of the infraspinatus muscle were the only independent predictors of ASES and Constant scores ( P Tear size and rotator cuff healing did not play an independent role . Tear size , however , was the only independent predictor of ultimate cuff integrity ( P = .002 ) . Both atrophy and fatty infiltration progressed significantly over the course of the study . In cases in which the tendon had re-torn , the progression was found to be more significant than when the repair proved successful ( P muscle degeneration and a failed repair result ed in significantly more progression . In general , healed repairs demonstrated minimal progression . These findings suggest that repairs should be performed , if possible , before more significant deterioration in the cuff musculature in order to optimize outcomes , and that underst and ing the degree of muscle atrophy and fatty infiltration before surgery can help guide patient expectations",
"Background : Rotator cuff repair is associated with good short or mid-term results , but to date there have been no long-term functional outcome studies demonstrating durability of results over time . In most long-term studies , the results have been compared with those of historical controls or with those of other , short-term follow-up studies . The purpose of the present prospect i ve study was to evaluate short and long-term shoulder function after surgical repair in a single population of patients in order to follow changes over time . Methods : Thirty-three patients underwent surgery , performed by one surgeon , for the treatment of a chronic , symptomatic , full-thickness rotator cuff defect . Data were obtained from question naires and physical examinations preoperatively , at two years , and at ten years . Identical st and ardized pain and function question naires were used and clinical evaluation was performed in a consistent fashion at all time-periods . The activity level , Constant score , level of disability , shoulder function score , and patient ’s subjective rating of the outcome were determined at the time of the final follow-up and compared with the same parameters at the two-year follow-up examination in order to determine if early results change with time . Results : At the ten-year follow-up examination , there was no change in the raw Constant score determined at the two-year examination . When the Constant score was normalized for expected age-related changes , the percentage of patients who had a satisfactory result at ten years was even greater than the percentage at two years . Activity level decreased significantly over the time-period ( p = 0.005 ) . At the final follow-up examination , twelve patients worked at the same occupation as they had when the two-year examination was performed , two worked at a less strenuous occupation , and the remaining patients were retired . Only two patients retired because of problems related to the shoulder . The level of disability decreased over the study period , and there was a small improvement in the patients ’ self- assessment shoulder function score . The patients ’ subjective assessment of the outcome remained unchanged . Conclusions : The results of open rotator cuff repair for chronic tears do not deteriorate with time ( ten years ) . The level of disability decreases , presumably because of a concurrent decrease in the activity level and in the dem and on the shoulder as the patient ages . It is important to consider age-related changes when assessing the final outcome",
"BACKGROUND Elevated expectations before orthopaedic procedures appear to correlate with inferior preoperative subjective measures . The purpose of this study was to evaluate preoperative patient expectations before arthroscopic shoulder surgery and to correlate them with preoperative subjective measures and patients ' reasons for seeking treatment . METHODS We prospect ively collected and retrospectively analyzed data from patients before elective arthroscopic shoulder surgery for a wide range of pathologic processes . Preoperative subjective data included QuickDASH scores , pain and functional components of the American Shoulder and Elbow Surgeons ( ASES ) score , and mental and physical components of the SF-12 score . Expectations data were collected and grouped on the basis of the reasons for seeking of medical treatment and ranked according to their relative importance . RESULTS The study included 313 shoulders . There were 205 men and 108 women with a mean age at surgery of 48.7 years ( range , 18 - 78 years ) . Overall , the most important expectations were for the \" shoulder to be back to the way it was before the problem started \" and to continue participation in sporting activities . Patients who presented with the \" shoulder coming out \" had fewer important expectations than did those who presented for other reasons . Those patients who indicated a desire to continue participation in sports had significantly less pain ( improved ASES pain scores ) compared with the rest of the population . CONCLUSIONS Although return to sport was the most important expectation overall , the importance of other expectations varied by patients ' reasons for seeking treatment . The current question naire may have limited use in patients with shoulder instability . LEVEL OF EVIDENCE Level III , cross-sectional design , epidemiology",
"Background Open rotator cuff repairs have led to excellent clinical results ; however , several studies have linked postoperative structural integrity to patient outcomes . The purpose of this study is to prospect ively assess postoperative cuff integrity after open rotator cuff repair and assess its relationship to clinical outcome . Hypothesis Preoperative rotator cuff tear size and postoperative rotator cuff integrity are important factors in overall clinical outcomes . Study Design Prospect i ve nonr and omized clinical outcomes study . Methods Forty-seven consecutive patients undergoing repair of full-thickness rotator cuff tears by a single surgeon were enrolled in this prospect i ve study . A st and ardized evaluation was performed preoperatively and postoperatively at annual intervals . All patients underwent postoperative magnetic resonance imaging at least 1 year after surgery . Statistical evaluation was performed using paired and unpaired 2-tailed t tests for comparison . Results Thirty-two patients were available for evaluation . Overall , the patients experienced a significant ( P American Shoulder and Elbow Surgeons survey ( 40 - 85 ) and Constant ( 53 - 80 ) scores . The overall retear rate was 31 % . Although patients with large tears preoperatively and retears postoperatively had lower overall outcomes scores , this was not significant . Conclusion These data support open rotator cuff repair as an effective technique that restores excellent shoulder function . The authors did not find postoperative cuff integrity to have a significant effect on outcomes when compared with those with an intact cuff . In fact , those with a retear still had a significant improvement in all clinical areas assessed , including strength",
"STUDY DESIGN Cross-sectional . OBJECTIVES This study examined the baseline relationship of pain intensity , physical impairment , and pain-related fear to shoulder function . BACKGROUND There is no consensus regarding the influence psychological variable have on function and recovery in individuals with shoulder pathologies . While pain-related fear has been shown to predict disability for patients with low-back and cervical pain , this relationship has not been consistently reported for patients with shoulder pain . METHODS AND MEASURES One hundred forty-two subjects ( 78 male , 64 female ; mean age , 41.4 years ) with nonoperative unilateral shoulder disorders were identified from a clinical data base of impairment and outcome measures .Demographic information , duration of symptoms , mechanism of injury , pain intensity , pain-related fear , and range-of-motion ( ROM ) measures were collected . Self-report of function was measured with the Shoulder Pain and Disability Index ( SPADI ) . Hierarchical regression analysis determined the proportions of explained variance in function . RESULTS Demographic variables ( duration of symptoms , sex , age , and mechanism of injury ) collectively contributed approximately 9 % ( P=.003 ) of the variance in function scores . Average pain intensity and flexion ROM contributed an additional 22 % ( P Tampa Scale of Kinesiophobia ( TSK-11 ) scores contributed an additional 3 % ( P symptoms longer than 3 months ( beta=.23 , P=.003 ) , pain intensity ( beta=.25 , P=.002 ) , shoulder flexion ROM index ( beta=-.35 , P=.001 ) , and kinesiophobia ( beta=.17 , P=.026 ) explained 33 % of the variance in SPADI function score ( P months , average pain intensity , flexion ROM index ( strongest contributor in multivariate model ) , and fear-of-pain scores all contributed to baseline shoulder function . The immediate clinical relevance of these findings is unclear but they do provide direction for prospect i ve studies",
"& NA ; Fear‐avoidance beliefs have been identified as an important psychosocial variable in patients with chronic disability doe to low back pain . The importance of fear‐avoidance beliefs for individuals with acute low back pain has not been explored . Seventy‐eight subjects with work‐related low back pain of less than 3 weeks ' duration were studied . Measurements of pain intensity , physical impairment , disability , nonorganic signs and symptoms , and depression were taken at the initial evaluation . Fear‐avoidance beliefs were measured with the work and physical activity subscales of the Fear‐avoidance Beliefs Question naire . Disability and work status were re‐assessed after 4 weeks of physical therapy . Patterns of correlation between fear‐avoidance beliefs and other concurrently‐measured variables were similar to those reported in patients with chronic low back pain . Fear‐avoidance beliefs did not explain a significant amount of the variability in initial disability levels after controlling for pain intensity and physical impairment . Fear‐avoidance beliefs about work were significant predictors of 4‐week disability and work status even after controlling for initial levels of pain intensity , physical impairment , and disability , and the type of therapy received . Fear‐avoidance beliefs are present in patients with acute low back pain , and may be an important factor in explaining the transition from acute to chronic conditions . Screening for fear‐avoidance beliefs may be useful for identifying patients at risk of prolonged disability and work absence",
"Background Psychological distress may be an important determinant of perceived disability in patients with chronic musculoskeletal disorders . We evaluated the relationship between depressive symptoms and perceived disability in patients with chronic shoulder pain and quantified the contribution made by depression to perceived disability . Methods In this prospect i ve study , 109 patients with chronic shoulder pain caused by degenerative or inflammatory disorders were evaluated using the Disability of Arm , Shoulder and H and ( DASH ) question naire and the Center for Epidemiologic Studies -Depression ( CES-D ) Scale to determine relationships between depressive symptoms and perceived disability in patients with chronic shoulder pain . In addition , pain scores were evaluated using a visual analog scale ( VAS ) during activity , and range of motion ( ROM ) and abduction strength ( strength ) measurements were measured . Multivariate analyses of variance and regression modeling were used to assess the relative contributions made by depressive symptoms ( CES-D ) and other clinical parameters to patient-perceived disability ( DASH ) . Results DASH scores were found to be moderately correlated ( 0.3 ROM , strength , pain VAS and CES-D ; DASH scores were more strongly correlated with CES-D scores than with pain VAS scores or range of motion ( r = 0.58 ; p gender , ROM , pain VAS and CES-D scores independently predicted DASH score and accounted for 43 % of the variance . CES-D score was found to be the strongest predictor of DASH score and accounted for 23 % of the variance . Conclusions Degrees of depressive symptoms were found to be significantly associated with higher symptom scores and greater disability in patients with chronic shoulder pain . Although a large proportion of perceived disability remains unexplained , perceived disability in patients with chronic shoulder pain was found to be strongly influenced by depressive symptoms . Type of study /level of evidence Level 2 , prospect i ve cohort study , prognostic study",
"Background In many areas of orthopaedics , patients with greater levels of psychological distress report inferior self- assessment s of pain and function . This effect can lead to lower-than-expected baseline scores on common patient-reported outcome scales , even those not traditionally considered to have a psychological component . Questions / purpose sThis study attempts to answer the following questions : ( 1 ) Are higher levels of psychological distress associated with clinical ly important differences in baseline scores on the VAS for pain , the Simple Shoulder Test , and the American Shoulder and Elbow Surgeons score in patients undergoing arthroscopic rotator cuff repair ? ( 2 ) Does psychological distress remain a negative predictor of baseline shoulder scores when other clinical variables are controlled ? Methods Eighty-five patients with full-thickness rotator cuff tears were prospect ively enrolled . Psychological distress was quantified using the Distress Risk Assessment Method question naire . Patients completed baseline self- assessment s including the VAS for pain , the Simple Shoulder Test , and the American Shoulder and Elbow Surgeons score . Age , sex , BMI , smoking status , American Society of Anesthesiologists classification , tear size , and tear retraction were recorded for each patient . Bivariate correlations and multivariate regression models were used to assess the effect of psychological distress on patient self- assessment of shoulder pain and function . Results Distressed patients reported higher baseline VAS scores ( 6.7 [ 95 % CI , 4.4–9.0 ] versus 2.9 [ 95 % CI , 2.3–3.6 ] , p = 0.001 ) and lower baseline Simple Shoulder Test ( 3.7 [ 95 % CI , 2.9–4.5 ] versus 5.7 [ 95 % CI 5.0–6.4 ] , p = 0.001 ) and American Shoulder and Elbow Surgeons scores ( 39 [ 95 % CI , 34–45 ] versus 58 [ 95 % CI , 53–63 ] , p higher VAS scores ( p = 0.001 ) and lower Simple Shoulder Test ( p American Shoulder and Elbow Surgeons scores ( p distress on postoperative outcomes after arthroscopic rotator cuff repair . Level of Evidence Level I , prognostic study . See the Instructions for Authors for a complete description of levels of evidence",
"Objectives : Improvement in pain is a major expectation of patients undergoing lumbar spine surgery . Material s and Methods : Among 422 patients , the goal of this prospect i ve study was to measure 2-year postoperative pain and to determine whether this outcome varied according to patient and clinical characteristics , including amount of pain relief expected preoperatively . Before surgery patients completed valid question naires that addressed clinical characteristics and expectations for pain improvement . Two years after surgery patients reported how much pain improvement they actually received . Results : The mean age was 56 years old and 55 % were men . Two years after surgery 11 % of patients reported no improvement in pain , 28 % reported a little to moderate improvement , 44 % reported a lot of improvement , and 17 % reported complete improvement . In multivariable analysis , patients reported less pain improvement if , before surgery , they expected greater pain improvement ( odds ratio [ OR ] 1.4 ) , had a positive screen for depression ( OR 1.7 ) , were having revision surgery ( OR 1.6 ) , had surgery at L4 or L5 ( OR 2.5 ) , had a degenerative diagnosis ( OR 1.6 ) , and if , after surgery , they had another surgery ( OR 2.8 ) and greater back ( OR 1.3 ) and leg ( OR 1.1 ) pain ( all variables P⩽0.05 ) . Conclusions : Pain is not uncommon after lumbar surgery and is associated with a network of clinical , surgical , and psychological variables . This study provides evidence that patients ’ expectations about pain are an independent variable in this network . Because expectations are potentially modifiable this study supports addressing pain-related expectations with patients before surgery through discussion s with surgeons and through formal preoperative patient education",
"BACKGROUND The importance of emotional and psychological factors in treatment of patients with rotator cuff disease has been recently emphasized . Our goal was to establish factors most predictive of poor emotional health in patients with full-thickness rotator cuff tears ( FT RCTs ) . METHODS In 2007 , we began to prospect ively collect data on patients with symptomatic , atraumatic FT RCTs . All patients completed a question naire collecting data on demographics , symptom characteristics , comorbidities , willingness to undergo surgery , and patient-related outcomes ( 12-Item Short Form Health Survey , American Shoulder and Elbow Surgeons score , Western Ontario Rotator Cuff Index [ WORC ] , Single Assessment Numeric Evaluation score , Shoulder Activity Scale ) . Physicians recorded physical examination and imaging data . To evaluate the predictors of lower WORC emotion scores , a linear multiple regression model was fit . RESULTS Baseline data for 452 patients were used for analysis . In patients with symptomatic FT RCTs , the factors most predictive of worse WORC emotion scores were higher levels of pain ( interquartile range odds ratio , -18.9 ; 95 % confidence interval , -20.2 to -11.6 ; P lower Single Assessment Numeric Evaluation scores ( rating of percentage normal that patients perceive their shoulder to be ; interquartile range odds ratio , 6.2 ; 95 % confidence interval , 2.5 - 9.95 ; P = .0012 ) . Higher education ( P = .006 ) and unemployment status ( P = .0025 ) were associated with higher WORC emotion scores . CONCLUSIONS Education level , employment status , pain levels , and patient perception of percentage of shoulder normalcy were most predictive of emotional health in patients with FT RCTs . Structural data , such astendon tear size , were not . Those with poor emotional health may perceive their shoulder to be worse than others and experience more pain . This may allow us to better optimize patient outcomes with nonoperative and operative treatment of rotator cuff tears",
"Abstract Patients have multiple expectations of THA and TKA . We asked whether preoperative educational classes addressing recovery during the first year could modify patients ’ expectations of their 12-month postoperative recovery . Participants were enrolled consecutively in two r and omized , controlled trials , one for THA ( 177 patients ) and one for TKA ( 143 patients ) . Control patients preoperatively received a st and ard THA or TKA class addressing recovery immediately after surgery . Intervention patients preoperatively received the st and ard class plus a joint-specific module addressing recovery during the first 12 months . Before and after the class , patients completed either a hip-specific or knee-specific vali date d expectations survey . The main outcome was the within-patient change in expectation scores ( maximum increase , + 100 ; maximum decrease , −100 ) before and after the class but preoperatively . Mean changes in hip scores were + 3.3 ± 8 for intervention patients ( range , −22–+32 ) and + 4.9 ± 8 for control patients ( range , −13–+29 ) . Mean changes in knee scores were −3.4 ± 10 for intervention patients ( range , −26–+33 ) and + 2.4 ± 10 for control patients ( range , −30–+30 ) . Patients ’ preoperative expectations of their recovery from THA or TKA can be modified by preoperative educational classes . Level of Evidence : Level I , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence",
"OBJECTIVE To examine whether pain sensitivity and pain catastrophizing are associated with persistent pain and disability after lumbar spine surgery . DESIGN Prospect i ve observational cohort study . SETTING Academic medical center . PARTICIPANTS Patients ( N=68 ; mean age , 57.9±13.1y ; 40 women [ 58.8 % ] ) undergoing spine surgery for a degenerative condition from March 1 , 2012 to April 30 , 2013 were assessed 6 weeks , 3 months , and 6 months after surgery . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES The main outcome measures were persistent back pain intensity , pain interference , and disability . Patients with persistent back pain intensity , pain interference , or disability were identified as those patients reporting Brief Pain Inventory scores ≥4 and Oswestry Disability Index scores ≥21 at all postoperative time points . RESULTS From 6 weeks to 6 months after surgery , approximately 12.9 % , 24.2 % , and 46.8 % of patients reported persistent back pain intensity , pain interference , or disability , respectively . Increased pain sensitivity at 6 weeks was associated with having persistent back pain intensity ( odds ratio [ OR ] , 2.0 ; 95 % confidence interval [ CI ] , 1.0 - 4.1 ) after surgery . Increased pain catastrophizing at 6 weeks was associated with having persistent back pain intensity ( OR , 1.1 ; 95 % CI , 1.0 - 1.2 ) , pain interference ( OR , 1.1 ; 95 % CI , 1.0 - 1.2 ) , and disability ( OR , 1.3 ; 95 % CI , 1.1 - 1.4 ) . An interaction effect was not found between pain sensitivity and pain catastrophizing on persistent outcomes ( P>.05 ) . CONCLUSIONS The findings suggest the importance of early postoperative screening for pain sensitivity and pain catastrophizing to identify patients at risk for poor postoperative pain intensity , pain interference , and /or disability outcomes . Future research should consider the benefit of targeted therapeutic strategies for patients with these postoperative prognostic factors",
"BACKGROUND Good clinical results have been reported for both surgical and conservative treatment of rotator cuff tears . The primary aim of this r and omized controlled trial was to compare functional and radiologic improvement after surgical and conservative treatment of degenerative rotator cuff tears . METHODS We conducted a r and omized controlled trial that included 56 patients with a degenerative full-thickness rotator cuff tear between January 2009 and December 2012 ; 31 patients were treated conservatively , and rotator cuff repair was performed in 25 patients . Outcome measures , including the Constant-Murley score ( CMS ) , visual analog scale ( VAS ) pain and VAS disability scores , were assessed preoperatively and after 6 weeks and 3 , 6 , and 12 months . Magnetic resonance imaging was performed preoperatively and at 12 months postoperatively . RESULTS At 12 months postoperatively , the mean CMS was 81.9 ( st and ard deviation [ SD ] , 15.6 ) in the surgery group vs 73.7 ( SD , 18.4 ) in the conservative group ( P = .08 ) . VAS pain ( P = .04 ) and VAS disability ( P = .02 ) were significantly lower in the surgery group at the 12-month follow-up . A subgroup analysis showed postoperative CMS results were significantly better in surgically treated patients without a retear compared with conservatively treated patients ( 88.5 [ SD , 6.2 ] vs 73.7 [ SD , 18.4 ] ) . CONCLUSION In our population of patients with degenerative rotator cuff tears who were r and omly treated by surgery or conservative protocol , we did not observe differences in functional outcome as measured with the CMS 1 year after treatment . However , significant differences in pain and disabilities were observed in favor of surgical treatment . The best outcomes in function and pain were seen in patients with an intact rotator cuff postoperatively",
"BACKGROUND Patient-reported outcome measures have increasingly accompanied objective examination findings in the evaluation of orthopaedic interventions . Our objective was to determine whether a vali date d measure of mental health ( Short Form-36 Mental Component Summary [ SF-36 MCS ] ) or measures of tear severity on magnetic resonance imaging were more strongly associated with self-assessed shoulder pain and function in patients with symptomatic full-thickness rotator cuff tears . METHODS One hundred and sixty-nine patients with full-thickness rotator cuff tears were prospect ively enrolled . Patients completed the Short Form-36 , visual analog scales for shoulder pain and function , the Simple Shoulder Test ( SST ) , and the American Shoulder and Elbow Surgeons ( ASES ) instrument at the time of diagnosis . Shoulder magnetic resonance imaging examinations were review ed to document the number of tendons involved , tear size , tendon retraction , and tear surface area . Age , sex , body mass index , number of medical comorbidities , smoking status , and Workers ' Compensation status were recorded . Bivariate correlations and multivariate regression models were calculated to identify associations with baseline shoulder scores . RESULTS The SF-36 MCS had the strongest correlation with the visual analog scale for shoulder pain ( Pearson correlation coefficient , -0.48 ; p visual analog scale for shoulder function ( Pearson correlation coefficient , -0.33 ; p SST ( Pearson correlation coefficient , 0.37 ; p ASES score ( Pearson correlation coefficient , 0.51 ; p Tear severity only correlated with the visual analog scale for shoulder function ; the Pearson correlation coefficient was 0.19 for tear size ( p = 0.018 ) , 0.18 for tendon retraction ( p = 0.025 ) , 0.18 for tear area ( p = 0.022 ) , and 0.20 for the number of tendons involved ( p = 0.011 ) . Tear severity did not correlate with other scores in bivariate correlations ( all p > 0.05 ) . In all multivariate models , the SF-36 MCS had the strongest association with the visual analog scale for shoulder pain , the visual analog scale for shoulder function , the SST , and the ASES score ( all p in patients with full-thickness rotator cuff tears . Further studies are needed to determine its effect on the outcome of the treatment of rotator cuff disease",
"Background Psychological symptoms are highly prevalent in patients with shoulder complaints . Psychological symptoms in patients with shoulder complaints might play a role in the aetiology , perceived disability and pain and clinical outcome of treatment . The aim of this study was to assess whether preoperative symptoms of distress , depression , anxiety and somatisation were associated with a change in function after shoulder surgery and postoperative patient perceived improvement of pain and function . In addition , the change of psychological symptoms after shoulder surgery was analyzed and the influence of postoperative symptoms of psychological disorders after surgery on the change in function after shoulder surgery and perceived postoperative improvement of pain and function . Methods and Findings A prospect i ve longitudinal cohort study was performed in a general teaching hospital . 315 consecutive patients planned for elective shoulder surgery were included . Outcome measures included change of Disabilities of the Arm , Shoulder and H and ( DASH ) score and anchor questions about improvement in pain and function after surgery . Psychological symptoms were identified before and 12 months after surgery with the vali date d Four-Dimensional Symptom Question naire ( 4DSQ ) . Psychological symptoms were encountered in all the various shoulder diagnoses . Preoperative symptoms of psychological disorders persisted after surgery in 56 % of patients , 10 % of patients with no symptoms of psychological disorders before surgery developed new psychological symptoms . Preoperative symptoms of psychological disorders were not associated with the change of DASH score and perceived improvement of pain and function after shoulder surgery . Patients with symptoms of psychological disorders after surgery were less likely to improve on the DASH score . Postoperative symptoms of distress and depression were associated with worse perceived improvement of pain . Postoperative symptoms of distress , depression and somatisation were associated with worse perceived improvement of function . Conclusions Preoperative symptoms of distress , depression , anxiety and somatisation were not associated with worse clinical outcome 12 months after shoulder surgery . Symptoms of psychological disorders before shoulder surgery persisted in 56 % of patients after surgery . Postoperative symptoms of psychological disorders 12 months after shoulder surgery were strongly associated with worse clinical outcome"
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Importance Hormone therapy ( HT ) has been suggested for protection against age-related muscle weakness in women . However , the potential for HT-associated health risks necessitates a better underst and ing of the direction and magnitude of the association between HT and health outcomes , such as lean body mass ( LBM ) . Objective To determine whether HT was associated with reduced LBM loss compared with not receiving HT among postmenopausal women aged 50 years and older . Data Sources MEDLINE , Embase , AgeLine , CINAHL , and SportD iscus ( search ed from inception until April 25 , 2018 ) . Study Selection For this systematic review and meta- analysis , r and omized clinical trials including postmenopausal women undergoing HT and control groups of women not receiving HT were selected by 2 review ers . Studies were included if LBM or fat-free mass were measured as an outcome . Studies with participants from hospitals , long-term care facilities , or with specific diseases were excluded . Data Extraction and Synthesis Information regarding study characteristics and outcome measures were extracted by 1 review er and verified by another . Risk of bias was evaluated . Quality of evidence was assessed using the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) approach . Preferred Reporting Items for Systematic Review s and Meta-analyses ( PRISMA ) guidelines were used to abstract data and assess data quality /validity . Data were pooled using a fixed-effects model . Main Outcomes and Measures The primary study outcome was the overall absolute change in LBM ( measured in kilograms ) , captured by dual-energy x-ray absorptiometry , dual-photon absorptiometry , or bioelectrical impedance analysis imaging . Results Of 8961 studies that met selection criteria , 12 were included , with a total of 4474 recruited participants . Of the participants , mean ( SD ) age was 59.0 ( 6.1 ) years . Data on ethnicity were collected by 2 of the studies . Of the 22 HT intervention arms , 15 used estrogen-progesterone combination HT and 7 used estrogen-only HT . Control participants were women who received no HT at all or who received placebo . The median follow-up duration was 2 years ( range , 6 months to 6 years ) . Seven treatment arms showed a loss of LBM , and 14 were protective . Overall , HT users lost 0.06 kg ( 95 % CI , -0.05 to 0.18 ) less LBM compared with control participants , but the difference was not statistically significant ( P = .26 ) . The results were unchanged when stratified based on treatment type and dosage , duration of follow-up , time since menopause , study quality , and type of LBM measurement , with HT users losing between 0.06 kg more to 0.20 kg less LBM compared with control participants for all strata . The quality of evidence based on GRADE was low . Conclusions and Relevance This systematic review and meta- analysis did not show a significant beneficial or detrimental association of HT with muscle mass . Although muscle retention in aging women is of crucial importance , these findings suggest that interventions other than HT should be explored
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"Objective To evaluate the efficacy of two ultra-low-dose 17β-estradiol plus norethisterone acetate ( NETA ) treatment regimens for relieving menopausal symptoms . Design A total of 577 postmenopausal women were enrolled , in three treatment groups in a double-blind , r and omized , placebo-controlled study of 0.5 mg 17β-estradiol + 0.1 mg NETA or 0.5 mg 17β-estradiol + 0.25 mg NETA or placebo . Participants returned at weeks 4 , 8 , 12 and 24 for climacteric complaint evaluation based on a daily diary vasomotor symptom record . Patients were assessed by the Greene Climacteric Scale and urogenital symptoms were also evaluated . Results Treatment with ultra-low-dose 0.5 mg 17β-estradiol + 0.1 mg NETA ( 0.1 Group ) or 0.5 mg 17β-estradiol + 0.25 mg NETA ( 0.25 Group ) effectively reduced the severity and number of hot flushes within the initial weeks of therapy . Compared to placebo , a rapid , statistically significant decrease in the frequency and severity of hot flushes was achieved by week 3 , followed by further improvement which continued throughout the study . There were no statistically significant differences between the active treatment arms . Conclusions The data show that both ultra-low-dose regimens are effective in reducing the severity and number of hot flushes compared to placebo , with good safety profiles",
"BACKGROUND It has been suggested that hormone therapy may help counter undesirable changes in body composition in older women . OBJECTIVE This study was design ed to test whether estrogen plus progestin ( E+P ) therapy favorably affects age-related changes in body composition in postmenopausal women . DESIGN The sub study was composed of 835 women from the estrogen plus progestin trial of the Women 's Health Initiative who were r and omly assigned to receive either E+P therapy ( n = 437 ) or placebo ( n = 398 ) . The women had a mean age of 63.1 y and , on average , were 13.8 y past menopause . More than 17 % of the participants were from an ethnic minority . No significant differences in baseline body composition ( measured with dual-energy X-ray absorptiometry ) by intervention assignment were observed . RESULTS After 3 y of intervention , the women who received active E+P therapy lost less lean soft tissue mass ( -0.04 kg ) than did the women who received placebo ( -0.44 kg ; P = 0.001 ) . Additionally , the women in the E+P group had less upper-body fat distribution than did the women in the placebo group ( change in ratio of trunk to leg fat mass : -0.025 for the E+P group and 0.004 for the placebo group ; P = 0.003 ) . A sensitivity analysis , which was conducted on the women who took > or = 80 % of the study medication during the intervention period , corroborated the findings from the intent-to-treat analysis . CONCLUSIONS A 3-y E+P intervention significantly reduced both the loss of lean soft tissue mass and the ratio of trunk to leg fat mass in postmenopausal women . However , the effect sizes were small , and whether these changes in body composition lead to significant health benefits remains to be confirmed",
"BACKGROUND Menopause is associated with decreases in lean mass and increases in fat mass . Serum hormone levels and hormone replacement therapy ( HRT ) may modify the effects of exercise training on body composition in postmenopausal women . METHODS We assessed the changes in total body and regional lean soft tissue and fat mass ( using dual-energy x-ray absorptiometry ) in 94 sedentary postmenopausal women , aged 40 - 65 years , after 12 months of resistance and weight-bearing aerobic exercise training . Women currently on oral HRT ( n = 39 ) and not on HRT ( n = 55 ) were r and omized within groups to exercise and no exercise , result ing in four groups : exercise + HRT ( n = 20 ) , HRT ( n = 22 ) , exercise ( n = 24 ) , and control ( n = 28 ) . Fasting blood sample s were measured for resting serum total levels of estrone , estradiol , cortisol , and rostenedione , growth hormone , and insulin-like growth factor 1 at baseline and 12 months . RESULTS We found significant effects of exercise on increases in total body , arm , and leg lean soft tissue mass , and decreases in leg fat mass and percentage of body fat . There were no interaction effects of exercise and HRT on the changes in muscle strength and body composition . No significant changes in total hormone levels were found after 12 months . CONCLUSIONS Exercise training result ed in significant beneficial changes in lean soft tissue and fat mass in early postmenopausal women . These changes in body composition were neither influenced by prolonged HRT use nor accompanied by changes in total levels of the hormones determined in this study",
"The aim of this study was to study the influence of hormone replacement therapy ( HRT ) on weight changes , body composition , and bone mass in early postmenopausal women in a partly r and omized comprehensive cohort study design . A total of 2016 women ages 45 - 58 years from 3 months to 2 years past last menstrual bleeding were included . One thous and were r and omly assigned to HRT or no HRT in an open trial , whereas the others were allocated according to their preferences . All were followed for 5 years for body weight , bone mass , and body composition measurements . Body weight increased less over the 5 years in women r and omized to HRT ( 1.94 + /- 4.86 kg ) than in women r and omized to no HRT ( 2.57 + /- 4.63 , p = 0.046 ) . A similar pattern was seen in the group receiving HRT or not by their own choice . The smaller weight gain in women on HRT was almost entirely caused by a lesser gain in fat . The main determinant of the weight gain was a decline in physical fitness . Women opting for HRT had a significantly lower body weight at inclusion than the other participants , but the results in the self-selected part of the study followed the pattern found in the r and omized part . The change in fat mass was the strongest predictor of bone changes in untreated women , whereas the change in lean body mass was the strongest predictor when HRT was given . Body weight increases after the menopause . The gain in weight is related to a decrease in working capacity . HRT is associated with a smaller increase in fat mass after menopause . Fat gain protects against bone loss in untreated women but not in HRT-treated women . The data suggest that women 's attitudes to HRT are more positive if they have low body weight , but there is no evidence that the conclusions in this study are skewed by selection bias",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"The independent and combined effects of exercise training and hormone replacement therapy ( HRT ) on body composition , fat distribution , glucose tolerance , and insulin action were studied in postmenopausal women , aged 68 + /- 5 yr , assigned to control ( n = 19 ) , exercise ( n = 18 ) , HRT ( n = 15 ) , and exercise + HRT ( n = 16 ) groups . The exercise consisted of 2 mo of flexibility exercises followed by 9 mo of endurance exercise . HRT was conjugated estrogens 0.625 mg/day and trimonthly medroxyprogesterone acetate 5 mg/day for 13 days . Total and regional body composition were measured by dual-energy X-ray absorptiometry . Serum glucose and insulin responses were measured during a 2-h oral glucose tolerance test . There were significant main effects of exercise on reductions in total and regional ( trunk , arms , legs ) fat mass , increase in leg fat-free mass , and improvements in glucose tolerance and insulin action . There were significant main effects of HRT on the reduction of total fat mass ( HRT , -3.0 + /- 4.0 kg ; no HRT , -1.3 + /- 2.6 kg ) , with a strong trend for reductions in trunk and leg fat mass ( both P = 0.07 ) . There was also a significant improvement in insulin action in response to HRT . These results suggest that there are independent and additive effects of exercise training and HRT on the reduction in fat mass and improvement in insulin action in postmenopausal women ; the effect of HRT on insulin action may be mediated , in part , through changes in central adiposity",
"OBJECTIVE Our purpose was to determine the efficacy of dietary calcium augmentation in the prevention of early postmenopausal bone density loss in comparison with hormonal replacement therapy and placebo . STUDY DESIGN A three-arm parallel r and omized trial comparing the influence of placebo , dietary calcium augmentation , and estrogen-progesterone-calcium in 118 women who were within 6 years of menopause was conducted . Dual photon absorptiometry was performed annually to measure lean and fat mass . In addition , the ratio of fat in the trunk/extremities was measured . RESULTS Body weight increased in each group . The increase was statistically significant in the hormone replacement group ( 0.8 kg/year ) . The percent of body fat increased in each group from baseline measurements , with the greatest increase in the hormonal replacement group . There was a decline in the extremity/trunk ratio in the hormonal replacement group as a result of a relatively greater increase in the trunk fat mass . There was a rapid rate of loss in lean body mass that was equal among groups . CONCLUSIONS Menopause is associated with a gain in fat mass and a loss of lean body mass , but these changes in body composition are not prevented by hormone replacement therapy",
"Summary Sarcopenia may be diagnosed in the clinic using operational definitions based on low muscle mass or function . This prospect i ve , population -based study revealed that sex-specific associations may exist between operational definitions of sarcopenia and falls in community-dwelling middle-aged and older adults . Introduction The objective of this study is to verify associations between sarcopenia and falls risk and to determine changes in sarcopenia prevalence over 5 years in middle-aged and older men and women according to different anthropometric and performance-based operational definitions . Methods N = 681 volunteers ( 48 % female ; mean ± SD age 61.4 ± 7.0 years ) participated in baseline and follow-up assessment s ( mean 5.1 ± 0.5 years later ) . Appendicular lean mass ( ALM ) was assessed by dual-energy X-ray absorptiometry , h and grip ( HGS ) and lower-limb ( LLS ) strength were assessed by dynamometry , and falls risk was determined using the physiological profile assessment . Anthropometric definitions ( ALM/height squared [ ALM – H ] , ALM/weight × 100 and a residuals method [ ALM – R ] ) and performance-based definitions ( HGS , LLS and upper- and lower-limb muscle quality [ LMQ ] ) of sarcopenia were examined . The lowest 20 % of the sex-specific distribution for each definition at baseline was classified as sarcopenia . Results Sarcopenia prevalence increased after 5 years for all operational definitions except ALM – H ( men : −4.0 % ; women : −5.5 % ) . Men classified with sarcopenia according to anthropometric definitions , and women classified with sarcopenia according to performance-based definitions , had significant increases in falls risk over 5 years ( all P ALM-R , LLS and LMQ ( all P Sarcopenia prevalence generally increases at a higher rate when assessed using performance-based definitions . Sarcopenia is associated with increases in falls risk over 5 years in community-dwelling middle-aged and older adults , but sex-specific differences may exist according to different anthropometric or performance-based definitions",
"OBJECTIVES To determine the effects of ultra-low-dose hormone therapy on muscle mass and physical function in community-dwelling women . DESIGN Double-blind , placebo-controlled trial . SETTING Clinical research center in Connecticut . PARTICIPANTS Healthy , community-dwelling women aged 65 and older ( n=167 ) . INTERVENTION Eligible women were r and omly assigned to treatment with 0.25 mg 17-beta estradiol or placebo for 36 months . All women ( estradiol or placebo ) with an intact uterus received micronized progesterone 100 mg/d for 2 weeks every 6 months . All participants received 1,300 mg elemental calcium with 1,000 IU vitamin D per day . MEASUREMENTS Appendicular skeletal muscle mass ( ASM ) , lean body mass ( LBM ) , and percentage body fat were measured using dual x-ray absorptiometry . Sarcopenia was defined as skeletal muscle mass ( ASM/height2 ) 2 st and ard deviations or less than young , healthy reference population mean . Physical activity ( Physical Activity Scale in the Elderly ( PASE ) ) and performance were measured . Serum estrone , estradiol , and sex hormone-binding globulin were measured . RESULTS The prevalence of sarcopenia at baseline was 13 % . There were no baseline differences between groups except for PASE score and chair rise time , in which the estrogen group had better performance . No changes in ASM , LBM , percentage of body fat , or physical performance were found after 3 years of estrogen therapy . CONCLUSION Sarcopenia was present in 13 % of this group of community-dwelling , postmenopausal older women . Ultra-low-dose estrogen therapy neither improves nor harms ASM . Similarly , no changes in body fat or physical performance were detected",
"CONTEXT Despite decades of accumulated observational evidence , the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain . OBJECTIVE To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States . DESIGN Estrogen plus progestin component of the Women 's Health Initiative , a r and omized controlled primary prevention trial ( planned duration , 8.5 years ) in which 16608 postmenopausal women aged 50 - 79 years with an intact uterus at baseline were recruited by 40 US clinical centers in 1993 - 1998 . INTERVENTIONS Participants received conjugated equine estrogens , 0.625 mg/d , plus medroxyprogesterone acetate , 2.5 mg/d , in 1 tablet ( n = 8506 ) or placebo ( n = 8102 ) . MAIN OUTCOMES MEASURES The primary outcome was coronary heart disease ( CHD ) ( nonfatal myocardial infa rct ion and CHD death ) , with invasive breast cancer as the primary adverse outcome . A global index summarizing the balance of risks and benefits included the 2 primary outcomes plus stroke , pulmonary embolism ( PE ) , endometrial cancer , colorectal cancer , hip fracture , and death due to other causes . RESULTS On May 31 , 2002 , after a mean of 5.2 years of follow-up , the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits . This report includes data on the major clinical outcomes through April 30 , 2002 . Estimated hazard ratios ( HRs ) ( nominal 95 % confidence intervals [ CIs ] ) were as follows : CHD , 1.29 ( 1.02 - 1.63 ) with 286 cases ; breast cancer , 1.26 ( 1.00 - 1.59 ) with 290 cases ; stroke , 1.41 ( 1.07 - 1.85 ) with 212 cases ; PE , 2.13 ( 1.39 - 3.25 ) with 101 cases ; colorectal cancer , 0.63 ( 0.43 - 0.92 ) with 112 cases ; endometrial cancer , 0.83 ( 0.47 - 1.47 ) with 47 cases ; hip fracture , 0.66 ( 0.45 - 0.98 ) with 106 cases ; and death due to other causes , 0.92 ( 0.74 - 1.14 ) with 331 cases . Corresponding HRs ( nominal 95 % CIs ) for composite outcomes were 1.22 ( 1.09 - 1.36 ) for total cardiovascular disease ( arterial and venous disease ) , 1.03 ( 0.90 - 1.17 ) for total cancer , 0.76 ( 0.69 - 0.85 ) for combined fractures , 0.98 ( 0.82 - 1.18 ) for total mortality , and 1.15 ( 1.03 - 1.28 ) for the global index . Absolute excess risks per 10 000 person-years attributable to estrogen plus progestin were 7 more CHD events , 8 more strokes , 8 more PEs , and 8 more invasive breast cancers , while absolute risk reductions per 10 000 person-years were 6 fewer colorectal cancers and 5 fewer hip fractures . The absolute excess risk of events included in the global index was 19 per 10 000 person-years . CONCLUSIONS Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal US women . All-cause mortality was not affected during the trial . The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases , and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD",
"The reduction in cardiovascular risk induced by hormone replacement therapy is only partly explained by changes in serum lipids and lipoproteins . As body composition and body fat distribution in particular are independent predictors of cardiovascular disease , we investigated the effect of postmenopausal hormone therapy on body composition parameters directly measured . Sixty-two early postmenopausal women were followed up for 2 years in a prospect i ve , r and omized , placebo-controlled study . We found that combined estrogen-progestogen therapy prevented the increase in abdominal fat after menopause ( P less than .05 ) , and that this effect was independent of the effect on serum lipids and lipoproteins . The therapy reduced postmenopausal bone loss significantly ( P less than .001 ) , whereas it did not have a statistically significant influence on total body fat mass or total lean body mass . The findings of the present study suggest that some of the protective impact of postmenopausal hormone therapy on cardiovascular disease may be explained by the effect on body composition , in particular abdominal fat",
"A Physical Activity Scale for the Elderly ( PASE ) was evaluated in a sample of community-dwelling , older adults . Respondents were r and omly assigned to complete the PASE by mail or telephone before or after a home visit assessment . Item weights for the PASE were derived by regressing a physical activity principal component score on responses to the PASE . The component score was based on 3-day motion sensor counts , a 3-day physical activity dairy and a global activity self- assessment . Test-retest reliability , assessed over a 3 - 7 week interval , was 0.75 ( 95 % CI = 0.69 - 0.80 ) . Reliability for mail administration ( r = 0.84 ) was higher than for telephone administration ( r = 0.68 ) . Construct validity was established by correlating PASE scores with health status and physiologic measures . As hypothesized , PASE scores were positively associated with grip strength ( r = 0.37 ) , static balance ( r = + 0.33 ) , leg strength ( r = 0.25 ) and negatively correlated with resting heart rate ( r = -0.13 ) , age ( r = -0.34 ) and perceived health status ( r = -0.34 ) ; and overall Sickness Impact Profile score ( r = -0.42 ) . The PASE is a brief , easily scored , reliable and valid instrument for the assessment of physical activity in epidemiologic studies of older people",
"The loss of muscle mass and strength with aging is well characterized , but our knowledge of the molecular mechanisms underlying the development of sarcopenia remains incomplete . Although menopause is often accompanied with first signs of age-associated changes in muscle structure and function , the effects of hormone replacement therapy ( HRT ) or menopause-related decline in estrogen production in the muscles of postmenopausal women is not well understood . Furthermore the knowledge of the global transcriptional changes that take place in skeletal muscle in relation to estrogen status has thus far been completely lacking . We used a r and omized double-blinded study design together with an explorative microarray experiment to characterize possible effects of continuous , combined HRT and estrogen deprivation on the skeletal muscle of fifteen women . Here , we report the differential response of both Gene Ontology-annotated biological processes and some individual genes responding differentially to the use or non-use of HRT . Our results revealed transcription level changes in , for example , muscle protein and energy metabolism . In particular , the ubiquitine-proteosome system was found to be effected at several levels . HRT seemed to partially counteract the postmenopause-related transcriptional changes . Our results suggest that during the early postmenopausal years , when there is no counteracting medication available , muscle transcriptome changes notably , whereas HRT appears to slow down this phenomenon and could therefore aid in maintaining proper muscle mass and function after menopause",
"BACKGROUND Sarcopenia is prevalent in older population s with many causes and varying outcomes however information for use in clinical practice is still lacking . AIMS The aim of this report is to identify the clinical determinants and prognostic significance of sarcopenia in a cohort of hospitalized acutely ill older patients . METHODS Four hundred and thirty two r and omly selected patients had their baseline clinical characteristic data assessed within 72 h of admission , at 6 weeks and at 6 months . Nutritional status was assessed from anthropometric and biochemical data . Sarcopenia was diagnosed from low muscle mass and low muscle strength-h and grip using anthropometric measures based on the European Working Group criteria . RESULTS Compared with patients without sarcopenia , those diagnosed with sarcopenia 44 ( 10 % ) were more likely to be older , have more depression symptoms and lower serum albumin concentration . The length of hospital stay ( LOS ) was significantly longer in patients diagnosed with sarcopenia compared with patients without sarcopenia [ mean ( SD ) LOS 13.4 ( 8.8 ) versus 9.4 ( 7 ) days respectively , p = 0.003 ] . The risk of non-elective readmission in the 6 months follow up period was significantly lower in patients without sarcopenia compared with those diagnosed with sarcopenia ( adjusted hazard ratio .53 ( 95 % CI : .32 to .87 , p = 0.013 ) . The death rate was also lower in patients without sarcopenia 38/388 ( 10 % ) , compared with those with sarcopenia 12/44 ( 27 % ) , p-value = .001 . CONCLUSION Older people with sarcopenia have poor clinical outcome following acute illness compared with those without sarcopenia",
"OBJECTIVE To evaluate the effects of combination estrogen/ and rogen therapy on muscle mass , strength and endurance , serum hormone and lipid profiles , and quality of life measures in postmenopausal women . METHODS Prospect i ve , r and omized , placebo-controlled pilot study at a tertiary care medical center . Fifty postmenopausal women were r and omized to a 12-week course of ( 1 ) dehydroepi and rostenedione ( DHEA ) 50 mg daily , ( 2 ) conjugated equine estrogen ( CEE ) 0.625 mg daily , ( 3 ) DHEA 50 mg+CEE 0.625 mg daily , or ( 4 ) placebo . Main outcome measures of lower extremity muscle ( calf ) mass , functional muscle parameters , serum hormone and lipid levels , and quality of life ( QOL ) were obtained at baseline and after treatment . Statistical analysis compared percent change from baseline values and treatment differences among outcomes . RESULTS Significant increases in mean DHEA , DHEA sulfate ( DHEA-S ) , testosterone , and and rostenedione levels were noted with DHEA alone or combined DHEA/CEE treatments when compared with placebo . Compared with no hormone therapy , none of the supplemental hormone groups caused significant changes in muscle mass , muscle strength , muscle endurance , feelings of well-being , sleep , or sexual function . CONCLUSIONS And rogen replacement therapy , with DHEA , to menopausal women increases serum and rogen levels without any appreciable effect on muscle cross-sectional area , muscle strength , muscle function , or improvement in health-related QOL",
"OBJECTIVE Menopause is linked to an increase in fat mass and a decrease in lean mass exceeding age-related changes , possibly related to reduced output of ovarian steroids . In this study we examined the effect of combined postmenopausal hormone replacement therapy ( HRT ) on the total and regional distribution of fat and lean body mass . RESEARCH METHODS AND PROCEDURES Sixteen healthy postmenopausal women ( age : 55 + /- 3 years ) were studied in a placebo-controlled , crossover study and were r and omized to 17beta estradiol plus cyclic norethisterone acetate ( HRT ) or placebo in two 12-week periods separated by a 3-month washout . Total and regional body composition was measured by DXA at baseline and in the 10th treatment week in both periods . Changes were compared by a paired Student 's t test . RESULTS The change in body weight during HRT was equal to the change during placebo ( -24.6 g vs. -164 g , p = 0.42 ) , but relative fat mass was significantly reduced ( -0.5 % vs. + 1.24 % , p HRT , compared with during placebo , lean body mass increased ( + 347 g vs. -996 g , p total fat mass decreased ( -400 g vs. + 836 g , p = 0.06 ) . Total bone mineral content increased ( + 28.9 g vs. -4.4 g , p = 0.04 ) and abdominal fat decreased ( -185 g vs. + 253 g , p = 0.04 ) during HRT compared with placebo . DISCUSSION HRT is linked to the reversal of both menopause-related obesity and loss of lean mass , without overall change in body weight . The increase in lean body mass during HRT is likely explained by muscle anabolism , which in turn , prevents disease in the elderly",
"Objective The impact of hormone replacement therapy ( HRT ) on skeletal muscle mass is still a controversial issue in women 's health . Some authors hypothesize anabolic effects , others catabolic . These hypotheses , however , await confirmation by longitudinal observations based on more direct measurements of muscle mass . The aim of the present preliminary study was to evaluate the effect of a 3-year HRT program on appendicular lean tissue mass ( LTMA ) in early postmenopausal women aged 45–54 years . Design This was a r and omized , double-blind and placebo-controlled trial . Women received HRT with 2 mg estradiol valerate combined either continuously with 1 mg cyproterone acetate ( days 1–28;n = 15 ) or sequentially with 75 & mgr;g levonorgestrel ( days 17–28;n = 15 ) , or placebo ( n = 18 ) . Serum estradiol was measured by radioimmunoassay . LTMA was measured by dual photon absorptiometry ( baseline ) and dual energy X-ray absorptiometry ( years 2 and 3 ) . Results Baseline serum estradiol did not show significant correlation with the respective LTMA ( r = 0.018 , p = 0.88 , n = 75 ) . Cross-sectional analysis found no significant differences between the intervention groups at any time points . The longitudinal changes between years 2 and 3 showed a trend toward decreasing LTMA in those receiving HRT ( −0.08 ± 0.12 kg , n = 30 ) compared to those receiving placebo ( 0.12 ± 0.25 kg , n = 18 , p = 0.44 ) . Conclusions The present preliminary study did not find significant effects on LTMA caused by HRT . The trends toward decreasing LTMA in the HRT groups might suggest catabolic rather than anabolic effects . These trends , however , await confirmation by larger clinical trials",
"BACKGROUND AND AIMS sarcopenia has been indicated as a reliable marker of frailty and poor prognosis among the oldest individuals . We evaluated the impact of sarcopenia on the risk of all-cause death in a population of frail older persons living in community . METHODS we analysed data from the Aging and Longevity Study , a prospect i ve cohort study that collected data on all subjects aged 80 years and older residing in the Sirente geographic area ( n = 364 ) . The present analysis was conducted among those subjects who were between 80 and 85 years of age at the time of the baseline assessment ( n = 197 ) . The main outcome measure was all-cause mortality over 7-year follow-up . According to the European Working Group on Sarcopenia in Older People ( EWGSOP ) criteria , the diagnosis of sarcopenia required the documentation of low muscle mass and the documentation of either low muscle strength or low physical performance . Cox proportional regression models were used to estimate crude and adjusted hazard ratios and 95 % confidence intervals of death by the presence of sarcopenia . RESULTS using the EWGSOP-suggested criteria , 43 subjects with sarcopenia ( 21.8 % ) were identified . During the 7-year follow-up , 29 ( 67.4 % ) participants died among subjects with sarcopenia compared with 63 subjects ( 41.2 % ) without sarcopenia ( P activities of daily living ( ADL ) impairment , body mass index , hypertension , congestive heart failure , chronic obstructive pulmonary disease , number of diseases , TNF-α , participants with sarcopenia had a higher risk of death for all causes compared with non-sarcopenic subjects ( HR : 2.32 , 95 % CI : 1.01 - 5.43 ) . CONCLUSIONS our results obtained from a representative sample of very old and frail subjects show that sarcopenia is associated with mortality , independently of age and other clinical and functional variables",
"The long-term effect of percutaneous and oral estrogen replacement therapy on soft tissue body composition was examined in a two-year , placebo-controlled study with 110 early postmenopausal women . The women were allocated to four treatment groups : ( 1 ) oral cyclical combination of estradiol valerate and cyproterone acetate , ( 2 ) oral placebo , ( 3 ) percutaneous 17 beta-estradiol , supplemented by oral progesterone during the second year , or ( 4 ) percutaneous placebo cream . Total-body lean body mass ( LBM ) and fat mass ( FM ) were measured by dual photon ( 153Gd ) absorptiometry once a year , and the fat layer in the distal forearm ( FATarm ) was measured every 3 months by single photon ( 125I ) absorptiometry . Both hormone therapies prevented an increase in FATarm , as observed in the placebo groups . A similar pattern was seen for FM , body weight , and skin-fold thickness ( measured once a year by mechanical calipers ) , whereas LBM was unaffected by the therapy . Hormonal replacement therapy prevents the age-related increase in body fat observed after the menopause",
"CONTEXT Hormone administration to elderly individuals can increase lean body mass ( LBM ) and decrease fat , but interactive effects of growth hormone ( GH ) and sex steroids and their influence on strength and endurance are unknown . OBJECTIVE To evaluate the effects of recombinant human GH and /or sex steroids on body composition , strength , endurance , and adverse outcomes in aged persons . DESIGN , SETTING , AND PARTICIPANTS A 26-week r and omized , double-blind , placebo-controlled parallel-group trial in healthy , ambulatory , community-dwelling US women ( n = 57 ) and men ( n = 74 ) aged 65 to 88 years recruited between June 1992 and July 1998 . INTERVENTIONS Participants were r and omized to receive GH ( starting dose , 30 micro g/kg , reduced to 20 micro g/kg , subcutaneously 3 times/wk ) + sex steroids ( women : transdermal estradiol , 100 micro g/d , plus oral medroxyprogesterone acetate , 10 mg/d , during the last 10 days of each 28-day cycle [ HRT ] ; men : testosterone enanthate , biweekly intramuscular injections of 100 mg ) ( n = 35 ) ; GH + placebo sex steroid ( n = 30 ) ; sex steroid + placebo GH ( n = 35 ) ; or placebo GH + placebo sex steroid ( n = 31 ) in a 2 x 2 factorial design . MAIN OUTCOME MEASURES Lean body mass , fat mass , muscle strength , maximum oxygen uptake ( VO(2)max ) during treadmill test , and adverse effects . RESULTS In women , LBM increased by 0.4 kg with placebo , 1.2 kg with HRT ( P = .09 ) , 1.0 kg with GH ( P = .001 ) , and 2.1 kg with GH + HRT ( P Fat mass decreased significantly in the GH and GH + HRT groups . In men , LBM increased by 0.1 kg with placebo , 1.4 kg with testosterone ( P = .06 ) , 3.1 kg with GH ( P Fat mass decreased significantly with GH and GH + testosterone . Women 's strength decreased in the placebo group and increased nonsignificantly with HRT ( P = .09 ) , GH ( P = .29 ) , and GH + HRT ( P = .14 ) . Men 's strength also did not increase significantly except for a marginally significant increase of 13.5 kg with GH + testosterone ( P = .05 ) . Women 's VO(2)max declined by 0.4 mL/min/kg in the placebo and HRT groups but increased with GH ( P = .07 ) and GH + HRT ( P = .06 ) . Men 's VO(2)max declined by 1.2 mL/min/kg with placebo and by 0.4 mL/min/kg with testosterone ( P = .49 ) but increased with GH ( P = .11 ) and with GH + testosterone ( P strength ( r = 0.355 ; P VO(2)max ( r = 0.320 ; P = .002 ) were directly related to changes in LBM . Edema was significantly more common in women taking GH ( 39 % vs 0 % ) and GH + HRT ( 38 % vs 0 % ) . Carpal tunnel symptoms were more common in men taking GH + testosterone ( 32 % vs 0 % ) and arthralgias were more common in men taking GH ( 41 % vs 0 % ) . Diabetes or glucose intolerance occurred in 18 GH-treated men vs 7 not receiving GH ( P = .006 ) . CONCLUSIONS In this study , GH with or without sex steroids in healthy , aged women and men increased LBM and decreased fat mass . Sex steroid + GH increased muscle strength marginally and VO ( 2)max in men , but women had no significant change in strength or cardiovascular endurance . Because adverse effects were frequent ( importantly , diabetes and glucose intolerance ) , GH interventions in the elderly should be confined to controlled studies",
"BACKGROUND Maintaining lean body mass ( LBM ) after a severe burn is an essential goal of modern burn treatment . An accurate determination of LBM is necessary for short- and long-term therapeutic decisions . The aim of this study was to compare 2 measurement methods for body composition , whole-body potassium counting ( K count ) and dual x-ray absorptiometry ( DEXA ) , in a large prospect i ve clinical trial in severely burned pediatric patients . METHODS Two-hundred seventy-nine patients admitted with burns covering 40 % of total body surface area ( TBSA ) were enrolled in the study . Patients enrolled were controls or received long-term treatment with recombinant human growth hormone ( rhGH ) . Near-simultaneous measurements of LBM with DEXA and fat-free mass ( FFM ) with K count were performed at hospital discharge and at 6 , 9 , 12 , 18 , and 24 months post injury . Results were correlated using Pearson 's regression analysis . Agreement between the 2 methods was analyzed with the Bl and -Altman method . RESULTS Age , gender distribution , weight , burn size , and admission time from injury were not significantly different between control and treatment groups . rhGH and control patients at all time points postburn showed a good correlation between LBM and FFM measurements ( R(2 ) between 0.9 and 0.95 ) . Bl and -Altman revealed that the mean bias and 95 % limits of agreement depended only on patient weight and not on treatment or time postburn . The 95 % limits ranged from 0.1 + /- 2.9 kg for LBM or FFM in 7- to 18-kg patients to 16.3 + /- 17.8 kg for LBM or FFM in patients > 60 kg . CONCLUSIONS DEXA can provide a sufficiently accurate determination of LBM and changes in body composition , but a correction factor must be included for older children and adolescents with more LBM . DEXA scans are easier , cheaper , and less stressful for the patient , and this method should be used rather than the K count",
"In a controlled single blind study to determine the minimal effective dose of estrogen for protection against bone loss , conjugated equine estrogens in doses of 0.625 and 1.25 mg per day were equally effective in reducing bone loss in postmenopausal and oophorectomized women when bone mass was estimated by single-photon absorptiometry or radiogrammetry . Daily dose levels of less than 0.625 mg were essentially ineffective . Fifty percent response level was calculated to be 0.45 mg per day . Concomitant biochemical effects , reduction in urine calcium and hydroxyproline , were compatible with the observed effects on bone mineral",
"OBJECTIVE The objective of the study was to determine the effects of several doses of conjugated estrogens ( CE ) and CE plus medroxyprogesterone acetate ( MPA ) on body composition ( BC ) . STUDY DESIGN This was a r and omized , double-blind , placebo-controlled sub study of the Women 's Health , Osteoporosis , Progestin , Estrogen ( HOPE ) trial . Healthy women ( n = 822 , 1 - 4 years after menopause ) were r and omly assigned to receive the following treatments daily for 2 years : CE , 0.625 mg ; CE , 0.625 mg , and MPA , 2.5 mg ; CE , 0.45 mg ; CE , 0.45 mg , and MPA , 2.5 mg ; CE , 0.45 mg , and MPA , 1.5 mg ; CE , 0.3 mg ; CE , 0.3 mg , and MPA , 1.5 mg ; or placebo . Body weight ( BW ) was assessed every 3 - 4 cycles and fat body mass ( FBM ) , lean body mass ( LBM ) , and percent body fat ( PBF ) at cycles 6 , 13 , 19 , and 26 . RESULTS In the placebo group , BW , FBM , and PBF increased at each visit during the study . Changes in these parameters were smaller in the active groups . These effects were independent of CE dose and the presence of MPA . Changes in LBM were small and comparable across groups . CONCLUSION Treatment with CE or CE and MPA for up to 2 years does not affect BC"
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41170348-06ff-11f0-808a-c43d1ab1c353
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ABSTRACT Hospitalization may induce a decrease of muscle strength and muscle mass in older patients due to physical inactivity , malnutrition and diseases , negatively affecting health outcome . We aim ed to examine the literature on change in muscle strength and muscle mass in older patients during hospitalization . A literature search was performed in major electronic data bases from inception to March 2016 . Studies including hospitalized patients with a mean age ≥ 65 years , describing change of h and grip strength and /or muscle mass were found eligible . Extracted data were divided in h and grip strength or muscle mass and stratified by elective or acute admission . Meta‐ analysis was conducted using Comprehensive Meta‐ analysis . Twenty‐five studies were included , describing a total of 1789 patients with a mean age range of 65 to 85.8 years and an overall median length of stay of 14.7 days . Pooled h and grip strength and muscle mass were found to significantly decrease in electively admitted older patients during hospitalization ( st and ardized mean difference ( 95 % confidence interval ) : − 0.42 ( − 0.66 , − 0.17 ) and − 0.44 ( − 0.61 , − 0.27 ) ) , but not in acutely admitted older patients ( st and ardized mean difference ( 95 % confidence interval ) : 0.18 ( − 0.02 , 0.37 ) and − 0.25 ( − 0.58 , 0.09 ) ) . In conclusion , decrease in muscle strength and muscle mass in older patients is dependent on the type of admission . HIGHLIGHTSPhysical inactivity during hospitalization is associated with detrimental outcome .Muscle strength and muscle mass decreased in electively admitted older patients .Muscle strength and muscle mass did not change in acutely admitted older patients
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"Background Inflammation is the main cause of disease-associated muscle wasting . In a previous single blind study we have demonstrated improved recovery of muscle endurance following celecoxib treatment in hospitalized geriatric patients with acute infection . Here we further evaluate NSAID treatment with piroxicam in a double blind RCT and investigate the role of cytokines and heat shock proteins ( Hsp ) with respect to muscle performance . We hypothesized that NSAID treatment would preserve muscle performance better than antibiotic treatment alone , by reducing infection-associated inflammation and by increasing expression of cytoprotective Hsp . Methods Consecutive admissions to the geriatric ward were screened . 30 Caucasian patients , median age 84.5 years , with acute infection-induced inflammation and serum levels of CRP > 10 mg/L were included and r and omized to active treatment with 10 mg piroxicam daily or placebo . Assessment comprised general clinical and biochemical parameters , 25 cytokines in serum , intra- and extracellular Hsp27 and Hsp70 , Elderly Mobility Scale ( EMS ) scores , grip strength ( GS ) , fatigue resistance ( FR ) and lean body mass ( LBM ) . Patients were evaluated until discharge with a maximum of 3 weeks after treatment allocation . Results EMS scores , FR and grip work ( GW ) , a measure taking into account GS and FR , significantly improved with piroxicam , but not with placebo . Early decreases in IL-6 serum levels with piroxicam correlated with better muscle performance at week 2 . Basal expression of Hsp27 in monocytes without heat challenge ( WHC ) was positively correlated with FR at baseline and significantly increased by treatment with piroxicam compared to placebo . Profound modifications in the relationships between cytokines or Hsp and changes in muscle parameters were observed in the piroxicam group . Conclusions Piroxicam improves clinical ly relevant measures of muscle performance and mobility in geriatric patients hospitalized with acute infection-induced inflammation . Underlying mechanisms may include modifications in the cytokine network and increases in monocytic expression of cytoprotective Hsp27.Trial registration numberIS RCT N : IS RCT",
"Background / Objectives : This study aims to increase knowledge regarding the association of sarcopenia with hospitalization costs among a wide-ranging sample of adult hospitalized patients .Subjects/ Methods : A prospect i ve study was conducted among hospitalized adult patients . Sarcopenia was identified according to the European Working Group on Sarcopenia in Older People , as low muscle mass , assessed by bioelectrical impedance analysis and low muscle function evaluated by h and grip strength . Hospitalization cost was calculated for each patient based on discharge diagnosis-related group codes and determined on the basis of a relative weight value . Costs were defined as the percentage of deviation from the cost of a patient with a relative weight equal to one . Multivariable linear regression models were performed to identify the factors independently associated with hospitalization costs . Results : A total of 656 hospitalized patients aged ⩾18 years ( 24.2 % sarcopenic ) composed the study sample . Sarcopenia increased hospitalization costs by [ euro ] 1240 ( 95 % confidence interval ( CI ) : [ euro ] 596–1887 ) for patients aged increase in hospitalization costs of [ euro ] 884 ( 95 % CI : [ euro ] 295–1476 ) . Conclusions : Sarcopenia is independently related to hospitalization costs . This condition is estimated to increase hospitalization costs by 58.5 % for patients aged ⩾65 years",
"BACKGROUND Acute inflammation has a negative effect on the muscular system in elderly patients , compromising the outcome of the underlying disease . OBJECTIVE The aim of this study was to evaluate the effect of cyclooxygenase-2 ( COX-2 ) inhibition on muscle performance and mobility in hospitalized elderly patients with acute inflammation of infectious origin . METHODS In this single-blind , controlled trial , consecutively hospitalized elderly patients ( age > or = 70 years ) with inflammation ( C-reactive protein [ CRP ] levels > or = 10 mg/L ) due to acute infection were r and omly assigned to receive 2 weeks of treatment with the COX-2-selective inhibitor celecoxib , acetaminophen , or no supplementary medication ( control ) . The following variables were assessed at baseline and at 1 and 2 weeks ' follow-up : muscle fatigue resistance ( primary outcome measure ) ; grip strength and mobility ( secondary outcome measures ) ; and levels of the acute-phase markers CRP , interleukin (IL)-1beta , IL-6 , IL-10 , tumor necrosis factor-alpha ( TNF-alpha ) , and transforming growth factor-beta ( TGF-beta ) as explanatory variables . RESULTS Forty-three consecutively hospitalized elderly patients ( 31 women , 12 men ; mean [ SD ] age , 84 [ 6 ] years ) were enrolled . Fourteen patients received celecoxib , 14 received acetaminophen , and 15 received no supplementary medication . The change in fatigue resistance was significantly different between groups ( P = 0.021 , Kruskal-Wallis chi-square test ) , with significantly greater improvement in patients receiving celecoxib compared with the acetaminophen and control groups ( 63 % increase from baseline ; P grip strength , mobility , IL-1beta , IL-6 , TNF-alpha , or TGF-beta . The changes in levels of IL-10 differed significantly between groups ( P = 0.020 , Kruskal-Wallis chi-square test ) , with greater improvement in the celecoxib group compared with the acetaminophen group ( P = 0.032 ) . CONCLUSION The results of this study suggest that COX-2-selective inhibition has a beneficial effect on muscle fatigue resistance in hospitalized elderly patients with acute inflammation of infectious origin . However , until further trials are conducted , the use of COX-2-selective inhibitors for this indication is not recommended",
"The aim of this trial was to compare multimodal optimization with conventional perioperative management in a consecutive series of patients undergoing a wide range of colorectal procedures",
"Objective : Postoperatively patients have a reduction in nutritional intake and body weight . We studied the effect of postoperative physical training on nutritional intake and body composition . Methods : Patients ⩾60 y admitted for elective colorectal surgery were r and omised to train muscular strength ( group A ) or to nonstrengthening exercises ( group B ) for 3 months . Fat mass ( FM ) and lean body mass ( LBM ) were assessed with bioimpedance preoperatively , 7 , 30 , and 90 days postoperatively . Nutritional intake was registered in a sub population . Results : Of 119 included patients , 60 were r and omised to group A and 59 to B. The changes in LBM at postoperative day 7 were a mean ( s.d . ) of 0.4 ( 2.1 ) kg in group A compared to −0.7 ( 2.0 ) kg in B. The difference between groups of 1.2 ( 0.5 ) kg at day 7 was statistically significant ( P=0.03 ) . At no other time was observed difference between groups in weight , LBM , or FM . The energy and protein intake rose during postoperative day 1–7 and rose further after discharge . At no time were differences between groups . Conclusion : Physical training had little effect on body composition following abdominal surgery . The nutritional intake in well-nourished patients did not increase by training",
"OBJECTIVES To examine the proportion of time spent in three levels of mobility ( lying , sitting , and st and ing or walking ) by a cohort of hospitalized older veterans as measured by vali date d wireless accelerometers . DESIGN A prospect i ve , observational cohort study . SETTING One hundred fifty-bed Department of Veterans Affairs hospital . PARTICIPANTS Forty-five hospitalized medical patients , aged 65 and older who were not delirious , did not have dementia , and were able to walk in the 2 weeks before admission were eligible . MEASUREMENTS Wireless accelerometers were attached to the thigh and ankle of patients for the first 7 days after admission or until hospital discharge , whichever came first . The mean proportion of time spent lying , sitting , and st and ing or walking was determined for each hour after hospital admission using a previously vali date d algorithm . RESULTS Forty-five male patients ( mean age 74.2 ) with a mean length of stay of 5.1 days generated 2,592 one-hour periods of data . A baseline functional assessment indicated that 35 ( 77.8 % ) study patients were willing and able to walk a short distance independently . No patient remained in bed the entire measured hospital stay , but on average , 83 % of the measured hospital stay was spent lying in bed . The average amount of time that any one individual spent st and ing or walking ranged from a low of 0.2 % to a high of 21 % , with a median of 3 % , or 43 minutes per day . CONCLUSION This is the first study to continuously monitor mobility levels early during a hospital stay . On average , older hospitalized patients spent most of their time lying in bed , despite an ability to walk independently",
"BACKGROUND The aim of this trial was to compare multimodal optimization with conventional perioperative management in a consecutive series of patients undergoing gastrectomy procedures . METHODS According to r and omized controlled studies and conclusions made by meta-analyses in colorectal surgery , optimized perioperative measures were design ed and applied in gastrectomy surgery . Thirty-three patients were r and omized to the optimized group and 30 patients to a control group . Two groups were treated in 1 center by a single surgical team in different wards . Both groups used patient-controlled intravenous analgesia for postoperative analgesia . The primary end point was length of postoperative hospital stay . Secondary outcomes included bowel function recovery after surgery , perioperative changes of inflammatory factors , glucocorticoid , insulin resistance , and body composition . Perioperative complications and adverse events were also recorded . RESULTS The groups were similar in terms of age , sex ratio , and Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity ( POSSUM score ) . The optimized group was associated with a significantly shorter postoperative hospital stay compared with the conventional care group ( P Duration s of urinary catheterization and abdominal drainage were also less ( P well tolerated and was associated with an earlier recovery of gut function ( P Proinflammatory factors were less elevated and body composition was more stable in the optimized group than in controls . There were no differences in morbidity or mortality between the groups . CONCLUSIONS Optimization of care in gastrectomy can shorten postoperative hospital stay and provides multiple beneficial outcomes , including hastening the return of gut function , without increasing morbidity",
"We determined whether essential amino acid and carbohydrate supplementation could offset the catabolic response to prolonged inactivity . Major outcome measures included mixed muscle fractional synthetic rate ( FSR ) , phenylalanine net balance , lean leg mass , and leg extension strength . On d 1 and 28 , vastus lateralis muscle biopsies and femoral arterio-venous blood sample s were obtained during a primed constant infusion of l-[ring-(2)H(5)]phenylalanine . Net balance and FSR were calculated over 16 h , during which the control group ( CON ) received a nutritionally mixed meal every 5 h ( 0830 , 1330 , and 1830 h ) . The experimental group ( EXP ) also consumed 16.5 g essential amino acids and 30 g carbohydrate ( 1100 , 1600 , and 2100 h ) . The dietary regimen was maintained during bedrest . FSR was higher in the EXP group on d 1 ( EXP , 0.099 + /- 0.008%/h ; CON : 0.075 + /- 0.005%/h ) and d 28 ( EXP , 0.093 + /- 0.006%/h ; CON , 0.055 + /- 0.007%/h ) . Lean leg mass was maintained throughout bedrest in the EXP group ( + 0.2 + /- 0.3 kg ) , but fell in the CON group ( -0.4 + /- 0.1 kg ) . Strength loss was more pronounced in the CON group ( EXP , -8.8 + /- 1.4 kg ; CON , -17.8 + /- 4.4 kg ) . Essential amino acid and carbohydrate supplementation may represent a viable intervention for individuals at risk of sarcopenia due to immobility or prolonged bedrest",
"Background Lack of appropriate reporting of method ological details has previously been shown to distort risk of bias assessment s in r and omized controlled trials . The same might be true for observational studies . The goal of this study was to compare the Newcastle-Ottawa Scale ( NOS ) assessment for risk of bias between review ers and authors of cohort studies included in a published systematic review on risk factors for severe outcomes in patients infected with influenza . Methods Cohort studies included in the systematic review and published between 2008–2011 were included . The corresponding or first authors completed a survey covering all NOS items . Results were compared with the NOS assessment applied by review ers of the systematic review . Inter-rater reliability was calculated using kappa ( K ) statistics . Results Authors of 65/182 ( 36 % ) studies completed the survey . The overall NOS score was significantly higher ( p . Inter-rater reliability by item ranged from slight ( K = 0.15 , 95 % confidence interval [ CI ] = −0.19 , 0.48 ) to poor ( K = −0.06 , 95 % CI = −0.22 , 0.10 ) . Reliability for the overall score was poor ( K = −0.004 , 95 % CI = −0.11 , 0.11 ) . Conclusions Differences in assessment and low agreement between review ers and authors suggest the need to contact authors for information not published in studies when applying the NOS in systematic review",
"Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies",
"BACKGROUND & AIMS Previous studies reported a severely impaired energy balance in COPD patients during the first days of an acute exacerbation , mainly due to a decreased energy and protein intake . The aim of the study was to investigate the feasibility and effectiveness of energy- and protein-rich nutritional supplements during hospitalization for an acute exacerbation in nutritionally depleted COPD patients . METHODS In a r and omized double-blind , placebo-controlled two-center trial , 56 COPD patients were r and omized and 47 patients completed the study . Nutritional intervention consisted of 3 x 125 ml ( 2.38 MJ/day ) and the placebo group received similar amounts of a non-caloric fluid . Medical therapy and dietetic consultation were st and ardized and dietary intake was measured daily . Body composition , respiratory and skeletal muscle strength , lung function and symptoms were measured on admission and on days 4 and 8 of hospitalization . RESULTS Forty-seven percent of the patients had experienced recent involuntary weight loss prior to admission . The degree of weight loss was inversely related to resting arterial oxygen tension ( r = 0.31 ; P Nutritional intervention result ed in a significant increase in energy ( 16 % vs. placebo ) and protein intake ( 38 % vs. placebo ) . Mean duration of hospitalization was 9 + /- 2 days . Relative to usual care , no additional improvements in lung function or muscle strength were seen after nutritional intervention . CONCLUSIONS Oral nutritional supplementation during hospitalization for an acute exacerbation is feasible in nutritionally depleted COPD patients and does not interfere with normal dietary intake",
"BACKGROUND Recombinant human growth hormone ( rhGH ) has been shown to have powerful anabolic effects and to reduce or even prevent nitrogen catabolism in stressed patients . The effects of rhGH on functional parameters are less clearly defined . The aim of this study was to assess the effects of perioperative rhGH on nutritional markers , skeletal muscle function , and psychological well-being in patients undergoing infrarenal , abdominal aortic aneurysm repair . METHODS Thirty-three patients undergoing elective infrarenal abdominal aortic aneurysm repair were r and omized to one of three groups : ( 1 ) control ( n = 12 ) : placebo for 6 days before and after surgery ; ( 2 ) preop + postop ( n = 10 ) : rhGH ( Genotropin ; Pharmacia Ltd , Uppsala , Sweden ) 0.3 IU/kg/d for 6 days before and after surgery ; and ( 3 ) postop ( n = 11 ) : placebo for 6 days before and rhGH 0.3 IU/kg/d for 6 days after surgery . Patients were assessed on days -7 and -1 before surgery and days 7 , 14 , and 60 after surgery . RESULTS Administration of rhGH result ed in increased insulin-like growth factor 1 levels , the increase being significantly more marked in the group given rhGH preoperatively . Preoperative and postoperative rhGH reduced the postoperative decrease in both serum transferrin and grip strength at day 7 by 30 % and 70 % , respectively . Postoperative respiratory function and arterial oxygenation also were improved , with significant differences in arterial oxygenation between rhGH-treated and untreated groups . No difference in mood was seen between groups after surgery , nor was there any difference between subjective assessment of fatigue scores between groups . CONCLUSIONS This pilot study indicates that rhGH administered preoperatively has beneficial effects on skeletal muscle and respiratory function and may be more useful than postoperative rhGH administration alone",
"CONTEXT The exact relationship between the bed rest-induced loss of skeletal muscle and reductions in muscle strength and physical performance in the older individuals is still unclear . OBJECTIVE We examined the effect of 10 days of bed rest on changes in regional body composition , muscle strength , and functional status , and the relationship between these variables in older individuals . DESIGN , PARTICIPANTS , AND INTERVENTION Regional body composition was measured using dual energy x-ray absorptiometry . We also determined changes in leg strength and several indices of functional status , including walking speed . RESULTS Body weight , body mass index , and total and lower extremity lean mass decreased with bed rest . There were also significant reductions in knee extension one repetition maximum , isometric knee extension , knee extension 60 ° concentric , stair ascent time , stair ascent power , stair descent time , VO2 max , floor transfer test , 5-minute walk time , and chair st and . The overall change in total and lower extremity lean mass was also directly related to bed rest-induced reductions in one repetition maximum knee extension . CONCLUSIONS Bed rest promoted overall declines in muscle mass , muscle strength , and physical function in older individuals . The changes in lean tissue were closely correlated with the bed rest-induced decline of muscle strength",
"OBJECTIVE To investigate the feasibility and preliminary effectiveness of a home-based intensive exercise program to improve physical health of frail elderly patients scheduled for elective total hip arthroplasty ( THA ) . DESIGN Single-blind pilot r and omized controlled trial . SETTING Patients ' homes and a general hospital in The Netherl and s. PARTICIPANTS Frail patients ( N=30 ) older than 65 years . INTERVENTION A preoperative , home-based program supervised by an experienced physical therapist to train functional activities and walking capacity . The control group received usual care consisting of 1 session of instructions . MAIN OUTCOME MEASURES Feasibility was determined on the basis of adherence to treatment , patient satisfaction , adverse events , walking distance ( measured with a pedometer ) , and intensity of exercise ( evaluated with the Borg scale ) . Preliminary pre- and postoperative effectiveness was determined by the Timed Up & Go ( TUG ) test , 6-minute walk test ( 6MWT ) , Chair Rise Time , and self-reported measures of functions , activities , and participation . RESULTS Patient satisfaction and adherence to the training were good ( median=5 on a 5-point Likert scale ) and no serious adverse events occurred . The Borg score during training was 14 ( range , 13 - 16 ) . Preoperative clinical relevant differences on the TUG test ( 2.9 s ; 95 % confidence interval [ CI ] , -0.9 to 6.6 ) and significant differences on the 6MWT ( 41 m ; 95 % CI , 8 to 74 ) were found between groups . CONCLUSIONS Intensive preoperative training at home is feasible for frail elderly patients waiting for THA and produces relevant changes in functional health . A larger multicenter r and omized controlled trial is in progress to investigate the (cost-)effectiveness of preoperative training",
" Multimodal optimization of surgical care has been associated with reduced hospital stay and improved physical function . The aim of this r and omized trial was to compare multimodal optimization with st and ard care in patients undergoing colonic resection",
"OBJECTIVE To determine the safety and efficacy of the anabolic steroid n and rolone in elderly patients with hip fractures . DESIGN A r and omized double-blind placebo-controlled trial . SETTING The orthopedic ward of a university teaching hospital . PARTICIPANTS 29 frail elderly females with hip fractures . INTERVENTION Subjects received n and rolone 2 mg/kg ( n = 15 ) or placebo ( n = 14 ) by weekly injection for 4 weeks or until discharge . MEASURES Baseline functional status was assessed by the Lawton-Brody ADL and IADL . Hemoglobin , transferrin , thyroid-binding prealbumin , albumin , liver function tests , creatinine , weight , MAMC , bioelectric impedance , st and ard anthropometrics and grip strength were measured at baseline and weekly intervals . Rehabilitation parameters and length of stay were recorded . RESULTS The placebo and n and rolone groups were similar in age , although the control group had slightly higher baseline ADL scores . There was no difference between groups in biochemical parameters , anthropometrics , body composition , grip strength , rehabilitation end points or length of stay . One subject in the n and rolone group had a doubling of AST and was withdrawn from the study . CONCLUSIONS N and rolone can be given safely to frail elderly subjects with hip fractures but is likely to be of minimal benefit at the doses we employed",
"BACKGROUND & AIMS Malnutrition is common in the elderly and increases morbidity and mortality . Most attempts to reverse malnutrition have used liquid supplements , but the findings are inconsistent . This study tests a new approach using a r and omised-controlled design . The aim was to examine whether health care assistants , trained to provide additional support with feeding , can improve acutely ill elderly in- patients ' clinical outcomes . METHODS The study was carried out on three acute medicine for the elderly wards at Hammersmith Hospitals NHS Trust , London . In all , 592 patients , all over 65 years old , were recruited . RESULTS The results showed that the median time patients received feeding support was 16 days , and the assisted group was given less intravenous antibiotics ( P=0.007 ) . However , the groups did not differ in markers of nutritional status , Barthel score , grip strength , length of stay or mortality . CONCLUSION It was concluded that the use of health care assistants in this specialised role , in an acute setting , without change to the food provision or without targeting higher risk patients , reduced the need for intravenous antibiotics . However , the intervention did not improve nutritional status or have an effect on length of stay in the time span studied . The results highlight the difficulties of improving the intake of acutely ill elderly patients during a hospital stay",
"BACKGROUND New evidence indicates that increased dietary protein ingestion promotes health and recovery from illness , and also maintains functionality in older adults . The present study aim ed to investigate whether a novel food service concept with protein-supplementation would increase protein and energy intake in hospitalised patients at nutritional risk . METHODS A single-blinded r and omised controlled trial was conducted . Eighty-four participants at nutritional risk , recruited from the departments of Oncology , Orthopaedics and Urology , were included . The intervention group ( IG ) received the protein-supplemented food service concept . The control group ( CG ) received the st and ard hospital menu . Primary outcome comprised the number of patients achieving ≥75 % of energy and protein requirements . Secondary outcomes comprised mean energy and protein intake , body weight , h and grip strength and length of hospital stay . RESULTS In IG , 76 % versus 70 % CG patients reached ≥75 % of their energy requirements ( P = 0.57 ) ; 66 % IG versus 30 % CG patients reached ≥75 % of their protein requirements ( P = 0.001 ) . The risk ratio for achieving ≥75 % of protein requirements : 2.2 ( 95 % confidence interval = 1.3 - 3.7 ) ; number needed to treat = 3 ( 95 % confidence interval = 2 - 6 ) . IG had a higher mean intake of energy and protein when adjusted for body weight ( CG : 82 kJ kg(-1 ) versus IG : 103 kJ kg(-1 ) , P = 0.013 ; CG : 0.7 g protein kg(-1 ) versus 0.9 g protein kg(-1 ) , P = 0.003 ) . Body weight , h and grip strength and length of hospital stay did not differ between groups . CONCLUSIONS The novel food service concept had a significant positive impact on overall protein intake and on weight-adjusted energy intake in hospitalised patients at nutritional risk",
"OBJECTIVE The objective of this study was to describe postoperative undernutrition in terms of postoperative losses of appendicular skeletal muscle mass ( ASMM ) with respect to complications , quality of life , readmission , and 1-y mortality after cardiac surgery . METHODS Patients undergoing cardiac surgery were prospect ively followed . ASMM was measured 2 wk before and 2 mo after surgery using dual-energy X-ray absorptiometry . ASMM consists of arm skeletal muscle mass ( SMM ) and leg SMM . The association between ≥5 % of ASMM decrease and postoperative outcome was analyzed using the chi-square test . A similar approach was used to analyze arm SMM and leg SMM decreases separately . RESULTS Twenty-nine patients were included ( 23 male , 34.5 % ≥65 y old ) . Postoperatively , seven patients ( 24.1 % ) lost ≥5 % ASMM . When analyzed separately , a ≥5 % decrease in leg SMM was associated with a decrease in experienced vitality ( odds ratio 13.0 , 95 % confidence interval 1.32 - 128.11 , P = 0.03 ) . In contrast , a ≥5 % loss of arm SMM was associated with fewer in-hospital complications ( odds ratio 0.20 , 95 % confidence interval 0.04 - 0.98 , P = 0.04 ) . These patients were characterized by a higher preoperative fat-free mass index ( kilograms per meter squared ; P = 0.01 ) . CONCLUSIONS The results suggest that a preoperatively higher fat-free mass index indicates better ability to cope with operative stress , result ing in fewer complications . In addition , postoperative loss of muscle mass was associated with decreased vitality . We advocate further research investigating the effect of preoperative and postoperative nutritional intervention combined with physical exercise programs to increase lean body mass and thereby improve postoperative recovery after cardiac surgery",
"OBJECTIVES To estimate the prevalence of different levels of mobility in a hospitalized older cohort , to measure the degree and rate of adverse outcomes associated with different mobility levels , and to examine the physician activity orders and documented reasons for bedrest in the lowest mobility group . DESIGN A prospect i ve cohort study . SETTING An 800-bed university teaching hospital . PARTICIPANTS Four hundred ninety-eight hospitalized medical patients , aged 70 and older . MEASUREMENTS Using average mobility level , scored from 0 to 12 , the low-mobility group was defined as having a score of 4 or less , intermediate as a score of higher than 4 to 8 , and high as higher than 8 . Outcomes were functional decline , new institutionalization , death , and death or new institutionalization . RESULTS Low and intermediate levels of mobility were common , accounting for 80 ( 16 % ) and 157 ( 32 % ) study patients , respectively . Overall , any activity of daily living ( ADL ) decline occurred in 29 % , new institutionalization in 13 % , death in 7 % , and death or new institutionalization in 22 % of patients in this cohort . When compared with the high mobility group , the low and intermediate groups were associated with the adverse outcomes in a grade d fashion , even after controlling for multiple confounders . The low-mobility group had an adjusted odds ratio ( OR ) of 5.6 ( 95 % confidence interval (CI)=2.9 - 11.0 ) for ADL decline , 6.0 ( 95 % CI=2.5 - 14.8 ) for new institutionalization , 34.3 ( 95 % CI=6.3 - 185.9 ) for death , and 7.2 ( 95 % CI=3.6 - 14.4 ) for death or new institutionalization . The intermediate group had adjusted ORs of 2.5 ( 95 % CI=1.5 - 4.1 ) , 2.9 ( 95 % CI=1.4 - 6.0 ) , 10.1 ( 95 % CI=1.9 - 52.9 ) , and 3.3 ( 95 % CI=1.8 - 5.9 ) for ADL decline , new institutionalization , death , and death or new institutionalization , respectively . Bedrest was ordered at some point during hospitalization in 165 ( 33 % ) patients . For most patients , mobility was limited involuntarily ( bedrest orders ) , and almost 60 % of bedrest episodes in the lowest mobility group had no documented medical indication . CONCLUSION Low mobility and bedrest are common in hospitalized older patients and are important predictors of adverse outcomes . This study demonstrated that the adverse outcomes associated with low mobility and bedrest may be viewed as iatrogenic events leading to complications , such as functional decline",
"BACKGROUND : Previous work has shown that the administration of oral dietary supplements to patients who have undergone gastrointestinal surgery results in clinical ly significant short term benefits . AIMS : This study aim ed firstly to re-evaluate these short term effects , and secondly to establish whether there are any long term benefits . SUBJECTS : One hundred patients admitted for elective moderate or major gastrointestinal surgery . METHODS : In the inpatient phase , patients were r and omised to receive a normal ward diet postoperatively , or the same diet supplemented with an oral dietary supplement . In the outpatient phase , patients were further r and omised to receive their home diet , or their home diet supplemented with the oral dietary supplement for four months . RESULTS : During the inpatient phase , patients treated with oral supplements had a significantly improved nutritional intake and lost less weight ( 2.2 , 95 % confidence interval ( 95 % CI ) 0.9 kg ) compared with control patients ( 4.2 ( 0.78 ) kg , p h and grip strength whereas control patients showed a significant reduction in grip strength ( p Subjective levels of fatigue increased significantly above preoperative levels in control patients ( p complications compared with four in the supplemented group ( p nutrient intakes but there were no significant differences in indices of nutritional status or wellbeing between the groups . CONCLUSIONS : The prescription of oral dietary supplements to patients who have undergone gastrointestinal surgery results in clinical ly significant benefits . These benefits , however , are restricted to the inpatient phase",
"Objective : To evaluate effects of early intensive physiotherapy during acute illness on post hospitalization activity daily living autonomy ( ADL ) . Design : Prospect i ve r and omized controlled trial of intensive physiotherapy rehabilitation on day 1 to 2 after admission until clinical stability or usual care . Setting : acute care geriatric medicine ward . Patients : A total of 76 acutely ill patients , acutely bedridden or with reduced mobility but who were autonomous for mobility within the previous 3 months . Patients in palliative care or with limiting mobility pathology were excluded . Mean age was 85.4 ( SD 6.6 ) years . Measurements : At admission , at clinical stability and one month later : anthropometry , energy and protein intakes , h and grip strength , ADL scores , and baseline inflammatory parameters . An exploratory principal axis analysis was performed on the baseline characteristics and general linear models were used to explore the course of ADL and nutritional variables . Results : A 4-factor solution was found explaining 71.7 % of variance with a factor “ nutrition ” , a factor “ function ” ( 18.8 % of variance ) for ADL , h and grip strength , bedridden state , energy and protein intakes , serum albumin and C-reactive protein concentrations ; a factor “ strength ” and a fourth factor . During follow-up , dietary intakes , h and grip strength , and ADL scores improved but no changes occurred for anthropometric variables . Intervention was associated only with an increase in protein intake . Better improvement in ADL was found in intervention group when model was adjusted on “ function ” factor items . Conclusion : Physical intervention programs should be proposed according to nutritional intakes with the aim of preventing illness induced disability",
"Background and Aims : Major surgery is often followed by fatigue and reduced physical function . We wished to study if postoperative physical training reduced fatigue and improved physical function . Material and Methods : R and omised , placebo-controlled , single-blinded study . Participants were unselected patients ≥ 60 years undergoing elective colorectal surgery without disseminated cancer or inflammatory bowel disease . Group A trained muscular strength and work capacity . Group B performed relaxation exercises and received hot wrappings and massage . Main outcome measures were : fatigue ( visual analogue scale ) , muscular strength , walking speed , physical performance test , and physical function questions ( SF-36 ) . Results : Preoperatively the two groups were similar except that A was more fatigued than B. By postoperative day seven fatigue had increased compared to preoperatively , more in B than A , but by day 30 and 90 there were no significant differences between groups . All indices of physical function decreased postoperative day seven and were at the preoperative level day 90 with no significant differences between groups in change in function . Day seven the change in knee extension strength tended to be lower in B than A but by day 30 changes were similar in both groups . Conclusion : Postoperative training did not improve physical function , but reduced fatigue in hospital",
"Major surgery is associated with postoperative insulin resistance which is attenuated by preoperative carbohydrate ( CHO ) treatment . The effect of this treatment on clinical outcome after major abdominal surgery has not been assessed in a double‐blind r and omized trial",
"OBJECTIVE A postoperative regimen using a multimodal approach with enforced mobilization and early oral nutrition has been reported to improve convalescence but has not been compared with other postoperative regimens . METHODS Forty patients undergoing elective colorectal surgery were r and omly allocated to an intervention group receiving comprehensive information on the importance of mobilization , balanced anesthesia , and postoperative analgesia including epidural local anesthetics and enforced postoperative mobilization or a control group receiving anesthesia without epidural local anesthetics , postoperative analgesia with epidural morphine , and mobilization without fixed goals . All patients were offered early oral nutrition . The regimens were compared by means of ambulation time and physical activity , voluntary muscle strength , pulmonary function , and body composition . RESULTS The ambulation time improved substantially within 22 h in the intervention group versus 3 h in the control group on day 1 ( P = 0.0004 ) and within 8 h versus 2 h on day 4 ( P = 0.0003 ) . The voluntary strength of the quadriceps muscle decreased by 3 % in the intervention group versus 15 % in the control group on day 7 ( P = 0.04 ) . Two months postoperatively , the difference between groups was the same ( P = 0.02 ) . CONCLUSION This active per- and postoperative regimen based on a multimodal approach improved ambulation time and muscle function during admission and late convalescence",
"OBJECTIVE An acute disease is regularly associated with inflammation , decreased food intake , and low physical activity ; the consequence is loss of muscle mass . However , the restoration of muscle tissue is problematic , especially in older patients . Loss of muscle mass leads to further decrease of physical activity which leads , together with recurring disease , to the progressive muscle mass loss accompanied by loss of self-sufficiency . Early nutrition support and physical activity could reverse this situation . Therefore , the aim of this study was to determine whether an active approach based on early nutritional therapy and exercise would influence the development of sarcopenia and impaired self-sufficiency during acute illness . METHODS Two hundred patients > 78 y were admitted to a hospital internal medicine department and participated in a prospect i ve , r and omized controlled study . The patients were r and omized to a control group receiving st and ard treatment ( n = 100 ) or to an intervention group ( n = 100 ) . The intervention consisted of nutritional supplements ( 600 kcal , 20 g/d protein ) added to a st and ard diet and a simultaneous intensive rehabilitation program . The tolerance of supplements and their influence on spontaneous food intake , self-sufficiency , muscle strength , and body composition were evaluated during the study period . The patients were then regularly monitored for 1 y post-discharge . RESULTS The provision of nutritional supplements together with early rehabilitation led to increased total energy and protein intake while the intake of st and ard hospital food was not reduced . The loss of lean body mass and a decrease in self-sufficiency were apparent at discharge from the hospital and 3 mo thereafter in the control group . Nutritional supplementation and the rehabilitation program in the study group prevented these alterations . A positive effect of nutritional intervention and exercise during the hospital stay was apparent at 6 mo post-discharge . CONCLUSIONS The early nutritional intervention together with early rehabilitation preserves muscle mass and independence in ill older patients hospitalized because of acute disease",
"PURPOSE : This study was design ed to investigate the clinical outcome and recovery before and immediately after implementation of the enhanced recovery after surgery enhanced recovery after surgery protocol in colonic and rectal resection . METHODS : One hundred and sixty-eight consecutive patients in a single center underwent colorectal surgery before ( traditional , n = 69 ) and immediately after implementing enhanced recovery after surgery ( n = 99 ) . Rectal surgery was performed in 77 patients . Postoperative food and fluid intake , mobilization , physiologic function , and clinical outcome were measured prospect ively . RESULTS : Resumption of oral diet was achieved on postoperative day postoperative day 1 in the enhanced recovery after surgery group . In the enhanced recovery after surgery group , mobilization more than 6 hours daily was achieved on postoperative day 2 to 3 and passage of stool occurred on postoperative day 2 vs. postoperative day 5 in the traditional group ( P Muscle strength and lung function were less reduced in the enhanced recovery after surgery group ( P Median hospital stay was reduced by 2 days ( P Readmission rates increased ( 4 percent vs. 15 percent , P total hospital stay was still lower in the enhanced recovery after surgery group ( P colonic resection , postoperative complications decreased in enhanced recovery after surgery ( 37 percent vs. 18 percent , P rectal resection . CONCLUSION : Immediately after implementing enhanced recovery after surgery , recovery was improved and length of hospital stay was reduced . Notably , postoperative morbidity decreased only in patients undergoing colonic resection ",
"IMPORTANCE Major postoperative complications and delirium contribute independently to adverse outcomes and high re source use in patients who undergo major surgery ; however , their interrelationship is not well examined . OBJECTIVE To evaluate the association of major postoperative complications and delirium , alone and combined , with adverse outcomes after surgery . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study in 2 large academic medical centers of 566 patients who were 70 years or older without recognized dementia or a history of delirium and underwent elective major orthopedic , vascular , or abdominal surgical procedures with a minimum 3-day hospitalization between June 18 , 2010 , and August 8 , 2013 . Data analysis took place from December 13 , 2013 , through May 1 , 2015 . MAIN OUTCOMES AND MEASURES Major postoperative complications , defined as life-altering or life-threatening events ( Accordion Severity grade 2 or higher ) , were identified by expert-panel adjudication . Delirium was measured daily with the Confusion Assessment Method and a vali date d medical record review method . The following 4 subgroups were analyzed : ( 1 ) no complications or delirium ; ( 2 ) complications only ; ( 3 ) delirium only ; and ( 4 ) complications and delirium . Adverse outcomes included a length of stay ( LOS ) of more than 5 days , institutional discharge , and rehospitalization within 30 days of discharge . RESULTS In the 566 participants , the mean ( SD ) age was 76.7 ( 5.2 ) years , 236 ( 41.7 % ) were male , and 523 ( 92.4 % ) were white . Forty-seven patients ( 8.3 % ) developed major complications and 135 ( 23.9 % ) developed delirium . Compared with no complications or delirium as the reference group , major complications only contributed to prolonged LOS only ( relative risk [ RR ] , 2.8 ; 95 % CI , 1.9 - 4.0 ) ; by contrast , delirium only significantly increased all adverse outcomes , including prolonged LOS ( RR , 1.9 ; 95 % CI , 1.4 - 2.7 ) , institutional discharge ( RR , 1.5 ; 95 % CI , 1.3 - 1.7 ) , and 30-day readmission ( RR , 2.3 ; 95 % CI , 1.4 - 3.7 ) . The subgroup with complications and delirium had the highest rates of all adverse outcomes , including prolonged LOS ( RR , 3.4 ; 95 % CI , 2.3 - 4.8 ) , institutional discharge ( RR , 1.8 ; 95 % CI , 1.4 - 2.5 ) , and 30-day readmission ( RR , 3.0 ; 95 % CI , 1.3 - 6.8 ) . Delirium exerted the highest attributable risk at the population level ( 5.8 % ; 95 % CI , 4.7 - 6.8 ) compared with all other adverse events ( prolonged LOS , institutional discharge , or readmission ) . CONCLUSIONS AND RELEVANCE Major postoperative complications and delirium are separately associated with adverse events and demonstrate a combined effect . Delirium occurs more frequently and has a greater effect at the population level than other major complications",
"BACKGROUND & AIMS Older individuals are more likely to experience extended hospitalization and become protein malnourished during hospitalization . The concomitant compulsory inactivity results in functional decline . Increasing protein intake in hospitalized patients improves nitrogen balance , but effects on function are unknown . In the present study , we examined the effects of increasing protein intake by essential amino acid ( EAA ) supplementation in older individuals subjected to 10 d bed rest on LBM and muscle function . METHODS Subjects were given a placebo ( n=12 , 68+/-5 ( SD ) yrs , 83+/-19 kg ) or 15 g of EAA ( n=10 , 71+/-6 , 72+/-8 kg ) 3 times per day throughout 10d of bed rest . LBM , muscle protein synthesis , and muscle function were determined before and after bed rest . Due to an imbalance in r and omized gender distribution between groups , gender and beginning functional and LBM measures were utilized for analyses by repeated measures analysis of covariance ( RMANCOVA ) . RESULTS Analyses revealed the potential for the preservation of functional outcomes with EAA supplementation . CONCLUSIONS Increasing protein intake above the RDA may preserve muscle function in the elderly during compulsory inactivity . EAA supplementation is potentially an efficient method of increasing protein intake without affecting satiety"
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BACKGROUND : Telemedicine , the use of telecommunications to deliver health services , expertise and information , is a promising but unproven tool for improving the quality of diabetes care . We summarized the effectiveness of different methods of telemedicine for the management of diabetes compared with usual care . METHODS : We search ed MEDLINE , Embase and the Cochrane Central Register of Controlled Trials data bases ( to November 2015 ) and reference lists of existing systematic review s for r and omized controlled trials ( RCTs ) comparing telemedicine with usual care for adults with diabetes . Two independent review ers selected the studies and assessed risk of bias in the studies . The primary outcome was glycated hemoglobin ( HbA1C ) reported at 3 time points ( ⩽ 3 mo , 4–12 mo and > 12 mo ) . Other outcomes were quality of life , mortality and episodes of hypoglycemia . Trials were pooled using r and omeffects meta- analysis , and heterogeneity was quantified using the I2 statistic . RESULTS : From 3688 citations , we identified 111 eligible RCTs ( n = 23 648 ) . Telemedicine achieved significant but modest reductions in HbA1C in all 3 follow-up periods ( difference in mean at ⩽ 3 mo : −0.57 % , 95 % confidence interval [ CI ] −0.74 % to −0.40 % [ 39 trials ] ; at 4–12 mo : −0.28 % , 95 % CI −0.37 % to −0.20 % [ 87 trials ] ; and at > 12 mo : −0.26 % , 95 % CI −0.46 % to −0.06 % [ 5 trials ] ) . Quantified heterogeneity ( I2 statistic ) was 75 % , 69 % and 58 % , respectively . In meta-regression analyses , the effect of telemedicine on HbA1C appeared greatest in trials with higher HbA1C concentrations at baseline , in trials where providers used Web portals or text messaging to communicate with patients and in trials where telemedicine facilitated medication adjustment . Telemedicine had no convincing effect on quality of life , mortality or hypoglycemia . INTERPRETATION : Compared with usual care , the addition of telemedicine , especially systems that allowed medication adjustments with or without text messaging or a Web portal , improved HbA1C but not other clinical ly relevant outcomes among patients with diabetes
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"OBJECTIVE This study was design ed to evaluate the impact of a teleassistance system on the metabolic control of type 2 diabetes patients . RESEARCH DESIGN AND METHODS We conducted a 1-year controlled parallel-group trial comparing patients r and omized ( 1 ) to an intervention group , assigned to a teleassistance system using real-time transmission of blood glucose results , with immediate reply when necessary , and telephone consultations , or ( 2 ) to a control group , being regularly followed-up at their healthcare center . Study subjects were type 2 diabetes patients > 30 years of age followed in the primary care setting . RESULTS A total of 328 type 2 diabetes patients were recruited from 35 family practice s in the province of Málaga , Spain . There was a reduction in hemoglobin A1c after 12 months from 7.62 + /- 1.60 % to 7.40 + /- 1.43 % ( P = 0.027 ) in the intervention group and from 7.44 + /- 1.31 % to 7.35 + /- 1.38 % ( P = 0.303 ) in the control group . The difference in the change between groups was not statistically significant . There was also a significant decrease in systolic and diastolic blood pressure , total cholesterol , low-density lipoprotein cholesterol , and body mass index in the intervention group . In the control group , the only significant decline was in low-density lipoprotein cholesterol . CONCLUSIONS A teleassistance system using real-time transmission of blood glucose results with an option to make telephone consultations is feasible in the primary care setting as a support tool for family physicians in their follow-up of type 2 diabetes patients",
"Background To determine whether an internet-based mentoring program can improve glycemic control in subjects with type 1 diabetes mellitus ( T1DM ) . Methods Subjects with T1DM on intensive insulin therapy and with hemoglobin A1c ( HbA1c ) ≥8.0 % were r and omized to mentored ( glucometer transmission with feedback from mentors ) or control ( glucometer transmission without feedback ) groups and were examined for 12 weeks . Five mentors were interviewed and selected , of which two were T1DM patients themselves and three were parents with at least one child diagnosed with T1DM since more than 5 years ago . Results A total of 57 T1DM adult subjects with a mean duration after being diagnosed with diabetes of 7.4 years were recruited from Samsung Medical Center . Unfortunately , the mentored group failed to show significant improvements in HbA1c levels or other outcomes , including the quality of life , after completion of the study . However , the mentored group monitored their blood glucose ( 1.41 vs. 0.30 ) and logged into our website ( http://ubisens.co.kr/ ) more frequently ( 20.59 times vs. 5.07 times ) than the control group . Conclusion A 12-week internet-based mentoring program for T1DM patients with inadequate glycemic control did not prove to be superior to the usual follow-up . However , the noted increase in the subjects ' frequency of blood glucose monitoring may lead to clinical benefits",
"Objective To evaluate the impacts of using SMS on improving laboratory test levels and Knowledge , Attitude , Practice ( KAP ) and Self Efficacy ( SE ) of patients with type 2 diabetes mellitus ( DM ) in Iran . Material s and methods In this r and omized controlled trial study , a total of 81 type 2 diabetes patients were r and omly assigned into two groups exp . group ( n = 43 ) and cont . group ( n = 38 ) . Only exp . group received 4 messages weekly consisted of diet , exercise , medication taking and . The research ers provided the intervention for 12 weeks . Data were collected with results of laboratory tests and KAP , SE reliable and valid question naires and demographic characteristics list . Data gathering at the baseline of the study and after 3 months intervention and was analyzed by SPSS11.5 software using descriptive and inferential statistics methods . Results The results of this study showed that exp . group compared with cont . group improved significantly in HbA1C ( p = 0.024 ) , LDL ( p = 0.019 ) , cholesterol ( p = 0.002 ) , BUN ( p ≤ 0.001 ) , micro albumin ( p ≤ 0.001 ) , knowledge ( p ≤ 0.001 ) , practice ( p ≤ 0.001 ) and self efficacy ( p ≤ 0.001 ) . Conclusion The finding of this study demonstrate the effectiveness of intervention using SMS via mobile phone in the management of type 2 diabetes mellitus ( DM ) . Thus , further studies are recommended for wide usage of distance education with mobile phone utilization",
"OBJECTIVE To assess the effects of web-based care management on glucose and blood pressure control over 12 months in patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS For this study , 104 patients with diabetes and HbA(1c ) ( A1C ) > or = 9.0 % who received their care at a Department of Veterans Affairs medical center were recruited . All participants completed a diabetes education class and were r and omized to continue with their usual care ( n = 52 ) or receive web-based care management ( n = 52 ) . The web-based group received a notebook computer , glucose and blood pressure monitoring devices , and access to a care management website . The website provided educational modules , accepted uploads from monitoring devices , and had an internal messaging system for patients to communicate with the care manager . RESULTS Participants receiving web-based care management had lower A1C over 12 months ( P care . Persistent website users had greater improvement in A1C when compared with intermittent users ( -1.9 vs. -1.2 % ; P = 0.051 ) or education and usual care ( -1.4 % ; P website data uploads was associated with a larger decline in A1C ( highest tertile -2.1 % , lowest tertile -1.0 % ; P Hypertensive participants in the web-based group had a greater reduction in systolic blood pressure ( P HDL cholesterol rose and triglycerides fell in the web-based group ( P Web-based care management may be a useful adjunct in the care of patients with poorly controlled diabetes",
"BACKGROUND Diabetic patients taking insulin often have suboptimal glucose control , and st and ard methods of health care delivery are ineffective in improving such control . This study was undertaken to determine if insulin adjustment according to advice provided by telephone by a diabetes nurse educator could lead to better glucose control , as indicated by level of glycated hemoglobin ( HbA1c ) . METHODS The authors conducted a prospect i ve r and omized trial involving 46 insulin-requiring diabetic patients who had poor glucose control ( HbA1c of 0.085 or more ) . Eligible patients were those already taking insulin and receiving endocrinologist-directed care through a diabetes centre and whose most recent HbA1c level was 0.085 or higher . The patients were r and omly assigned to receive st and ard care or to have regular telephone contact with a diabetes nurse educator for advice about adjustment of insulin therapy . RESULTS At baseline there was no statistically significant difference between the 2 groups in terms of HbA1c level ( mean [ and st and ard deviation ] for st and ard-care group 0.094 [ 0.008 ] and for intervention group 0.096 [ 0.010 ] ) , age , sex , type or duration of diabetes , duration of insulin therapy or complications . After 6 months , the mean HbA1c level in the st and ard-care group was 0.089 ( 0.010 ) , which was not significantly different from the mean level at baseline . However , the mean HbA1c level in the intervention group had fallen to 0.078 ( 0.008 ) , which was significantly lower than both the level at baseline for that group ( p Insulin adjustment according to advice from a diabetes nurse educator is an effective method of improving glucose control in insulin-requiring diabetic patients",
"Adults with type 2 diabetes mellitus often struggle with their antihyperglycemic medication regimens . To improve medication management , providers must ensure that their patients underst and potential benefits , harms , and burdens of available options and elicit patients ' preferences and barriers to taking medications . Patients who are actively involved in treatment decision making tend to be more satisfied with their health care , be more adherent to treatment , and have improved clinical outcomes ( 13 ) . Such discussion s , however , can be too time-consuming for clinic visits . For inner-city low-income African American and Latino adults , low health literacy and limited English proficiency are often additional barriers ( 4 ) that reduce the exchange of information and decrease patient participation during primary care visits ( 58 ) . This contributes to less optimal treatment decisions and lower patient satisfaction , leading to poor medication adherence and outcomes ( 3 , 911 ) . There is therefore an urgent need for cost-effective approaches to enable low-re source health systems to help these high-risk population s gain information and decision support so that they can more actively participate in and improve satisfaction with their treatment decision making . Since 2000 , the REACH ( Racial and Ethnic Approaches to Community Health 2010 ) Detroit Partnership , a coalition of community , health system , and academic partners , has used community-based participatory research principles to guide development , implementation , and evaluation of interventions to meet this need among African American and Latino adults with diabetes in Detroit , Michigan . These interventions have built on evidence that community health workers ( CHWs ) are effective in improving diabetes outcomes , particularly among racial and ethnic minority communities ( 12 ) . CHW interventions train community members to work as bridges between their ethnic , cultural , or geographic communities and health care providers ( 13 ) . Two cohorts of participants in our previous CHW-led diabetes self-management support interventions improved hemoglobin A1c ( HbA1c ) levels and diabetes distress compared with usual care ( 14 , 15 ) . An important next step in increasing the potential effect of CHWs and other lay health care workers is to develop and test effective tools they can use to better present evidence -based information to patients and to help patients make better self-management decisions ( 16 ) . Little is known about the effectiveness of different approaches for nontraditional care providers , such as CHWs , to deliver health information to ethnic minority and low-literacy population s ( 17 ) . By definition , CHWs and other lay workers do not have medical expertise and thus rely on effectively sharing printed educational and support material s with patients as part of their coaching and counseling efforts . Decision aids can increase satisfaction with treatment decisions and result in treatments that better reflect patients ' preferences ( 18 , 19 ) . There is also evidence that tailored health messages are more effective than generic group messages ( 20 , 21 ) , including for patients with diabetes ( 22 , 23 ) . Tailoring individualizes information and behavior change strategies to reach each person based on characteristics unique to that person derived from an individual assessment and related to the outcome of interest ( 24 ) . Software programs that are being developed to automatically embed tailored content into portable e-health Web applications show promise in improving health behaviors and outcomes ( 25 , 26 ) . To date , however , most e-health applications have been design ed for use by patients with relatively high literacy and the skills to navigate them ( 27 ) . Do more sophisticated , tailored , interactive e-health tools increase the effectiveness of CHW outreach with underserved patients compared with reliance on printed educational material s alone ? We addressed this question by developing and evaluating a personally tailored , interactive diabetes medication decision aid ( iDecide [ in English ] or iDecido [ in Spanish ] ) design ed for CHWs to deliver on tablet computers with 3 G wireless access to African American and Latino adults with diabetes and low health literacy . We then evaluated the effectiveness of iDecide in improving key diabetes outcomes compared with CHW delivery of the same evidence -based information , without tailoring , through print consumer booklets developed by the Agency for Healthcare Research and Quality ( AHRQ ) . Methods Setting This study was developed and implemented by using community-based participatory research principles ( 28 ) in partnership with the REACH Detroit Partnership and the Community Health and Social Services Center ( CHASS ) , a federally qualified health center in Southwest Detroit serving more than 13000 patients with 47099 visits in 2012 ( 29 ) . The University of Michigan and CHASS institutional review boards approved the study . Content of AHRQ Consumer Guides The AHRQ guides ( Pills for Type 2 Diabetes and Premixed Insulin for Type 2 Diabetes ) ( 30 , 31 ) provide information on diabetes and summarize the effectiveness of currently available medication classes ( oral and insulin ) on HbA1c . They also provide information on administration methods , costs , medication adverse effects , risks for diabetes complications , suggested questions to discuss with health care providers , and prompts to make notes of any questions for the doctor . The booklets include pictures of patients and tables and graphs summarizing information . Content of iDecide The development process and content of the iDecide program have been described in detail elsewhere ( 32 ) . Briefly , we used community-based participatory research and user-centered design ( 33 , 34 ) principles to iteratively develop and refine the iDecide tool . iDecide is available in English and Spanish , can be delivered via tablet computers , and enables navigation by the CHW and participant to selectively explore issues most important to the participant . The iDecide program is organized into 4 main sections and includes the same content as the AHRQ consumer guides . However , its information is presented in a more graphical style suited to patients with low literacy . Table 1 summarizes key differences between the presentation of information in iDecide and the printed material s. The first section illustrates , through animations , how diabetes affects the way glucose is processed in the body and how different medication classes , foods , and physical activity affect blood glucose . The second section includes pictographs showing participants ' own risk for diabetes complications ( tailored according to their baseline HbA1c ) and enabling participants to explore how their risk for different complications changes with their HbA1c levels . In the third section , participants review their current diabetes medications and barriers to taking the medications they had reported on the baseline survey . This section includes an interactive issue card approach to help elicit patient preferences and priorities about different medication characteristics ( for example , cost , adverse effects , effects on weight , and dosing schedules ) ( 22 , 35 ) . The fourth section prompts participants to set goals and develop specific action plans to address identified barriers or other concerns and identify specific questions and concerns to discuss with their doctor about their medications or making lifestyle changes . Personal information from the baseline assessment is interwoven throughout the program ( high-depth tailoring within sentences ) . Motivational interviewingbased , tailored discussion prompts encourage autonomy-supportive CHWpatient interactions at key points with open-ended questions and values exploration to help participants discover their motivation , overcome barriers to change , and develop an action plan ( 36 ) . Table 1 . Comparison of Content and Mode of Delivery Between the iDecide Study Group and the Printed Material s Group Recruitment and R and omization From September 2011 to August 2012 , potentially eligible participants were identified from a computer-generated list of CHASS patients with physician-diagnosed type 2 diabetes . Inclusion criteria required a HbA1c value greater than 7.5 % in the previous 6 months or expressed concerns about current diabetes medications during the screening assessment . Exclusion criteria were age younger than 21 years , terminal health conditions , self-reported alcohol or drug abuse , and conditions ( such as blindness and dementia ) that would impede meaningful participation . Pregnant women and individuals who reported that they could not be contacted by telephone were also excluded . Introductory letters were sent in timed batches . Research staff then telephoned patients and screened them for eligibility . Interested eligible patients met with research staff , who facilitated completion of written informed consent , administered baseline surveys in English or Spanish , and measured HbA1c and blood pressure . Participants received a stipend of $ 20 after each assessment . Within 1 to 14 days , participants were scheduled for a visit with a CHW ( at home , the clinic , or another agreed-upon place ) . At the beginning of the CHW visits , participants were registered into the iDecide program and r and omly assigned by the computer program , through use of a r and om-sequence algorithm , into 1 of 2 study groups . There were no differences between the steps to participate in either study group . Patients , research staff , and CHWs were blinded to r and omization results through completion of all baseline measures up to the start of the intervention . Data assessors remained blinded to group assignment throughout the study . CHW Intervention for Both Study Groups All participants received an initial one-on-one , face-to-face session with a CHW and a copy of the printed material s to take home . The iDecide sessions lasted approximately 2 hours , and the sessions using printed material s lasted",
"BACKGROUND Cardiovascular disease ( CVD ) and diabetes account for one-third of the mortality difference between African American and white patients . We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes . METHODS We r and omized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention . The 12-month intervention provided monthly self-management support and quarterly medication management facilitation . Co primary outcomes were changes in systolic blood pressure ( SBP ) , hemoglobin A1c ( HbA1c ) , and low-density lipoprotein cholesterol ( LDL-C ) over 12 months . We estimated between-intervention group differences over time using linear mixed-effects models . The secondary outcome was self-reported medication adherence . RESULTS The sample was 72 % female ; 49 % had low health literacy , and 37 % had annual income Model-based estimates for mean baseline SBP , HbA1c , and LDL-C were 136.8 mm Hg ( 95 % CI 135.0 - 138.6 ) , 8.0 % ( 95 % CI 7.8 - 8.2 ) , and 99.1 mg/dL ( 95 % CI 94.7 - 103.5 ) , respectively . Intervention patients received 9.9 ( SD 3.0 ) intervention calls on average . Primary providers replied to 76 % of nurse medication management facilitation contacts , 18 % of these result ed in medication changes . There were no between-group differences over time for SBP ( P = .11 ) , HbA1c ( P = .66 ) , or LDL-C ( P = .79 ) . Intervention patients were more likely than those receiving usual care to report improved medication adherence ( odds ratio 4.4 , 95 % CI 1.8 - 10.6 , P = .0008 ) , but adherent patients did not exhibit relative improvement in primary outcomes . CONCLUSIONS This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes . Further research is needed to determine how to maximally impact CVD risk factors in African American patients",
"OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with st and ard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A cluster-r and omized clinical trial , the Mobile Diabetes Intervention Study , r and omly assigned 26 primary care practice s to one of three stepped treatment groups or a control group ( usual care ) . A total of 163 patients were enrolled and included in analysis . The primary outcome was change in glycated hemoglobin levels over a 1-year treatment period . Secondary outcomes were changes in patient-reported diabetes symptoms , diabetes distress , depression , and other clinical ( blood pressure ) and laboratory ( lipid ) values . Maximal treatment was a mobile- and web-based self-management patient coaching system and provider decision support . Patients received automated , real-time educational and behavioral messaging in response to individually analyzed blood glucose values , diabetes medications , and lifestyle behaviors communicated by mobile phone . Providers received quarterly reports summarizing patient ’s glycemic control , diabetes medication management , lifestyle behaviors , and evidence -based treatment options . RESULTS The mean declines in glycated hemoglobin were 1.9 % in the maximal treatment group and 0.7 % in the usual care group , a difference of 1.2 % ( P = 0.001 ) over 12 months . Appreciable differences were not observed between groups for patient-reported diabetes distress , depression , diabetes symptoms , or blood pressure and lipid levels ( all P > 0.05 ) . CONCLUSIONS The combination of behavioral mobile coaching with blood glucose data , lifestyle behaviors , and patient self-management data individually analyzed and presented with evidence -based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year",
"Abstract OBJECTIVE : To examine the impact of a nurse-coordinated intervention delivered to patients with non-insulin-dependent diabetes mellitus between office visits to primary care physicians . DESIGN : R and omized , controlled trial . SETTING : Veterans Affairs general medical clinic . PATIENTS : 275 veterans who had NIDDM and were receiving primary care from general internists . INTERVENTION : Nurse-initiated contacts were made by telephone at least monthly to provide patient education ( with special emphasis on regimens and significant signs and symptoms of hyperglycemia and hypoglycemia ) , reinforce compliance with regimens , monitor patients ’ health status , facilitate resolution of identified problems , and facilitate access to primary care . MEASUREMENTS : Glycemic control was assessed using glycosylated hemoglobin ( GHb ) and fasting blood sugar ( FBS ) levels . Health-related quality of life ( HRQOL ) was measured with the Medical Outcomes Study SF-36 , and diabetes-related symptoms were assessed using patients ’ self-reports of signs and symptoms of hyper- and hypoglycemia during the previous month . MAIN RESULTS : At one year , between-group differences favored intervention patients for FBS ( 174.1 mg/dL vs 193.1 mg/dL , p=0.011 ) and GHb ( 10.5 % vs 11.1 % , p=0.046 ) . Statistically significant differences were not observed for either SF-36 scores ( p=0.66 ) or diabetes-related symptoms ( p=0.23 ) . CONCLUSIONS : The intervention , design ed to be a pragmatic , low-intensity adjunct to care delivered by physicians , modestly improved glycemic control but not HRQOL or diabetes-related symptoms ",
"OBJECTIVE To evaluate whether assessment of barriers to self-care and strategies to cope with these barriers in older adults with diabetes is superior to usual care with attention control . The American Diabetes Association guidelines recommend the assessment of age-specific barriers . However , the effect of such strategy on outcomes is unknown . RESEARCH DESIGN AND METHODS We r and omized 100 subjects aged ≥69 years with poorly controlled diabetes ( A1C > 8 % ) in two groups . A geriatric diabetes team assessed barriers and developed strategies to help patients cope with barriers for an intervention group . The control group received equal amounts of attention time . The active intervention was performed for the first 6 months , followed by a “ no-contact ” period . Outcome measures included A1C , Tinetti test , 6-min walk test ( 6MWT ) , self-care frequency , and diabetes-related distress . RESULTS We assessed 100 patients ( age 75 ± 5 years , duration 21 ± 13 years , 68 % type 2 diabetes , 89 % on insulin ) over 12 months . After the active period , A1C decreased by −0.45 % in the intervention group vs. −0.31 % in the control group . At 12 months , A1C decreased further in the intervention group by −0.21 % vs. 0 % in control group ( linear mixed-model , P scores on measures of self-care ( Self-Care Inventory-R ) , gait and balance ( Tinetti ) , and endurance ( 6MWT ) compared with the control group . Diabetes-related distress improved in both groups . CONCLUSIONS Only attention between clinic visits lowers diabetes-related distress in older adults . However , communication with an educator cognizant of patients ’ barriers improves glycemic control and self-care frequency , maintains functionality , and lowers distress in this population",
"OBJECTIVE To improve quality and efficiency of care for elderly patients with type 2 diabetes , we introduced elderly-friendly strategies to the clinical decision support system (CDSS)-based ubiquitous healthcare ( u-healthcare ) service , which is an individualized health management system using advanced medical information technology . RESEARCH DESIGN AND METHODS We conducted a 6-month r and omized , controlled clinical trial involving 144 patients aged > 60 years . Participants were r and omly assigned to receive routine care ( control , n = 48 ) , to the self-monitored blood glucose ( SMBG , n = 47 ) group , or to the u-healthcare group ( n = 49 ) . The primary end point was the proportion of patients achieving A1C without hypoglycemia at 6 months . U-healthcare system refers to an individualized medical service in which medical instructions are given through the patient ’s mobile phone . Patients receive a glucometer with a public switched telephone network-connected cradle that automatically transfers test results to a hospital-based server . Once the data are transferred to the server , an automated system , the CDSS rule engine , generates and sends patient-specific messages by mobile phone . RESULTS After 6 months of follow-up , the mean A1C level was significantly decreased from 7.8 ± 1.3 % to 7.4 ± 1.0 % ( P proportion of patients with A1C was 30.6 % in the u-healthcare group , 23.4 % in the SMBG group ( 23.4 % ) , and 14.0 % in the control group ( P u-healthcare service achieved better glycemic control with less hypoglycemia than SMBG and routine care and may provide effective and safe diabetes management in the elderly diabetic patients",
"Background Intensive lifestyle intervention trials in type 2 diabetes contribute evidence on what can be achieved under optimal conditions , but are less informative for translation in applied setting s. Purpose Living Well with Diabetes is a telephone-delivered weight loss intervention design ed for real-world delivery . Methods This study is a r and omized controlled trial of telephone counseling ( n = 151 ) versus usual care ( n = 151 ) ; 6-month primary outcomes of weight , physical activity , HbA1c ; secondary diet outcomes ; analysis was by adjusted generalized linear models . Results Relative to usual care , telephone counseling participants had small but significantly better weight loss [ −1.12 % of initial body weight ; 95 % confidence interval ( CI ) −1.92 , −0.33 % ] ; physical activity [ relative rate ( RR ) = 1.30 ; 95 % CI , 1.08 , 1.57 ] ; energy intake reduction ( −0.63 MJ/day ; 95 % CI , −1.01 , −0.25 ) ; and diet quality ( 3.72 points ; 95 % CI , 1.77 , 5.68 ) , with no intervention effect for HbA1c ( RR = 0.99 ; 95 % CI , 0.96 , 1.01 ) . Conclusions Results are discussed in light of challenges to intervention delivery",
"A system has been constructed to evaluate the design , implementation , and analysis of r and omized control trials ( RCT ) . The degree of quadruple blinding ( the r and omization process , the physicians and patients as to therapy , and the physicians as to ongoing results ) is considered to be the most important aspect of any trial . The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies . Description of the patient and treatment material s and the measurement of various controls of quality have less weight . An index of quality of a RCT is proposed with its pros and cons . If published papers were to approximate these principles , there would be a marked improvement in the quality of r and omized control trials . Finally , a reasonable st and ard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials",
"Purpose The purpose of this study was to determine whether “ clinical inertia”—inadequate intensification of therapy by the provider — could contribute to high A1C levels in patients with type 2 diabetes managed in a primary care site . Methods In a prospect i ve observational study , management was compared in the Medical Clinic , a primary care site supervised by general internal medicine faculty , and the Diabetes Clinic , a specialty site supervised by endocrinologists . These municipal hospital clinics serve a common population that is largely African American , poor , and uninsured . Results Four hundred thirty-eight African American patients in the Medical Clinic and 2157 in the Diabetes Clinic were similar in average age , diabetes duration , body mass index , and gender , but A1C averaged 8.6 % in the Medical Clinic versus 7.7 % in the Diabetes Clinic ( P Use of pharmacotherapy was less intensive in the Medical Clinic ( less use of insulin ) , and when patients had elevated glucose levels during clinic visits , therapy was less than half as likely to be advanced in the Medical Clinic compared to the Diabetes Clinic ( P Intensification rates were lower in the Medical Clinic regardless of type of therapy ( P intensification of therapy was independently associated with improvement in A1C ( P Medical Clinic patients had worse glycemic control , were less likely to be treated with insulin , and were less likely to have their therapy intensified if glucose levels were elevated . To improve diabetes management and glycemic control nationwide , physicians in training and generalists must learn to overcome clinical inertia , to intensify therapy when appropriate , and to use insulin when clinical ly indicated",
"Introduction The objective of this pilot 6-month r and omized controlled trial was to determine the effectiveness of an intensive , community-based , group intervention that focused on diet , physical activity , and peer support for reducing weight among urban-dwelling African Americans with comorbid type 2 diabetes and hypertension . Methods Sixty-one participants were r and omized into an intervention or control group . The 6-month intervention consisted of 18 group sessions led by a dietitian in a community setting and weekly telephone calls from a peer supporter . The intervention featured culturally tailored nutrition education , behavioral skills training , and social support focused on changes to diet and physical activity . The control group consisted of two 3-hour group sessions of diabetes self-management education taught by a community health worker . Outcome measures were assessed at baseline and 6 months . The primary outcome was achievement of a 5 % weight reduction at 6 months . A secondary outcome was achievement of a 0.5 percentage-point reduction in hemoglobin A1c ( HbA1c ) . Results Groups did not differ in achievement of the weight-loss goal . Intervention participants lost a mean of 2.8 kg ( P = .01 ) ; control participants did not lose a significant amount of weight . A greater proportion of intervention ( 50.0 % ) than control ( 21.4 % ) participants reduced HbA1c by 0.5 percentage points or more at 6 months ( P = .03 ) . Conclusion The intervention was more effective than usual care ( short-term diabetes education ) at improving glycemic control , but not weight , in low-income African Americans with comorbid diabetes and hypertension . A community-based 6-month group class with culturally tailored education , behavioral skills training , and peer support can lead to a clinical ly significant reduction in HbA1c",
"OBJECTIVE We hypothesized that people with type 2 diabetes in an online diabetes self-management program , compared with usual-care control subjects , would 1 ) demonstrate reduced A1C at 6 and 18 months , 2 ) have fewer symptoms , 3 ) demonstrate increased exercise , and 4 ) have improved self-efficacy and patient activation . In addition , participants r and omized to listserve reinforcement would have better 18-month outcomes than participants receiving no reinforcement . RESEARCH DESIGN AND METHODS A total of 761 participants were r and omized to 1 ) the program , 2 ) the program with e-mail reinforcement , or 3 ) were usual-care control subjects ( no treatment ) . This sample included 110 American Indians/Alaska Natives ( AI/ANs ) . Analyses of covariance models were used at the 6- and 18-month follow-up to compare groups . RESULTS At 6 months , A1C , patient activation , and self-efficacy were improved for program participants compared with usual care control subjects ( P health or behavioral indicators . The AI/AN program participants demonstrated improvements in health distress and activity limitation compared with usual-care control subjects . The subgroup with initial A1C > 7 % demonstrated stronger improvement in A1C ( P = 0.01 ) . At 18 months , self-efficacy and patient activation were improved for program participants . A1C was not measured . Reinforcement showed no improvement . CONCLUSIONS An online diabetes self-management program is acceptable for people with type 2 diabetes . Although the results were mixed they suggest 1 ) that the program may have beneficial effects in reducing A1C , 2 ) AI/AN population s can be engaged in and benefit from online interventions , and 3 ) our follow-up reinforcement appeared to have no value",
"Background Effective self-management of diabetes is essential for the reduction of diabetes-related complications , as global rates of diabetes escalate . Methods R and omised controlled trial . Adults with type 2 diabetes ( n = 120 ) , with HbA1c greater than or equal to 7.5 % , were r and omly allocated ( 4 × 4 block r and omised block design ) to receive an automated , interactive telephone-delivered management intervention or usual routine care . Baseline sociodemographic , behavioural and medical history data were collected by self-administered question naires and biological data were obtained during hospital appointments . Health-related quality of life ( HRQL ) was measured using the SF-36 . Results The mean age of participants was 57.4 ( SD 8.3 ) , 63 % of whom were male . There were no differences in demographic , socioeconomic and behavioural variables between the study arms at baseline . Over the six-month period from baseline , participants receiving the Australian TLC ( Telephone-Linked Care ) Diabetes program showed a 0.8 % decrease in geometric mean HbA1c from 8.7 % to 7.9 % , compared with a 0.2 % HbA1c reduction ( 8.9 % to 8.7 % ) in the usual care arm ( p = 0.002 ) . There was also a significant improvement in mental HRQL , with a mean increase of 1.9 in the intervention arm , while the usual care arm decreased by 0.8 ( p = 0.007 ) . No significant improvements in physical HRQL were observed . Conclusions These analyses indicate the efficacy of the Australian TLC Diabetes program with clinical ly significant post-intervention improvements in both glycaemic control and mental HRQL . These observed improvements , if supported and maintained by an ongoing program such as this , could significantly reduce diabetes-related complications in the longer term . Given the accessibility and feasibility of this kind of program , it has strong potential for providing effective , ongoing support to many individuals with diabetes in the future",
"Background The Whole Systems Demonstrator was a large , pragmatic , cluster r and omised trial that compared telehealth with usual care among 3,230 patients with long-term conditions in three areas of Engl and . Telehealth involved the regular transmission of physiological information such as blood glucose to health professionals working remotely . We examined whether telehealth led to changes in glycosylated haemoglobin ( HbA1c ) among the subset of patients with type 2 diabetes . Methods The general practice electronic medical record was used as the source of information on HbA1c . Effects on HbA1c were assessed using a repeated measures model that included all HbA1c readings recorded during the 12-month trial period , and adjusted for differences in HbA1c readings recorded before recruitment . Secondary analysis averaged multiple HbA1c readings recorded for each individual during the trial period . Results 513 of the 3,230 participants were identified as having type 2 diabetes and thus were included in the study . Telehealth was associated with lower HbA1c than usual care during the trial period ( difference 0.21 % or 2.3 mmol/mol , 95 % CI , 0.04 % to 0.38 % , p = 0.013 ) . Among the 457 patients in the secondary analysis , mean HbA1c showed little change for controls following recruitment , but fell for intervention patients from 8.38 % to 8.15 % ( 68 to 66 mmol/mol ) . A higher proportion of intervention patients than controls had HbA1c below the 7.5 % ( 58 mmol/mol ) threshold that was targeted by general practice s ( 30.4 % vs. 38.0 % ) . This difference , however , did not quite reach statistical significance ( adjusted odds ratio 1.63 , 95 % CI , 0.99 to 2.68 , p = 0.053 ) . Conclusions Telehealth modestly improved glycaemic control in patients with type 2 diabetes over 12 months . The scale of the improvements is consistent with previous meta-analyses , but was relatively modest and seems unlikely to produce significant patient benefit . Trial registration numberInternational St and ard R and omized Controlled Trial Number Register IS RCT N43002091",
"OBJECTIVE —To test Web-based care management of glycemic control using a shared electronic medical record with patients who have type 2 diabetes . RESEARCH DESIGN AND METHODS —We conducted a trial of 83 adults with type 2 diabetes r and omized to receive usual care plus Web-based care management or usual care alone between August 2002 and May 2004 . All patients had GHb ≥7.0 % , had Web access from home , and could use a computer with English language –based programs . Intervention patients received 12 months of Web-based care management . The Web-based program included patient access to electronic medical records , secure e-mail with providers , feedback on blood glucose readings , an educational Web site , and an interactive online diary for entering information about exercise , diet , and medication . The primary outcome was change in GHb . RESULTS —GHb levels declined by 0.7 % ( 95 % CI 0.2−1.3 ) on average among intervention patients compared with usual-care patients . Systolic blood pressure , diastolic blood pressure , total cholesterol levels , and use of in-person health care services did not differ between the two groups . CONCLUSIONS —Care management delivered through secure patient Web communications improved glycemic control in type 2 diabetes",
"Numerous diabetes-management systems and programs for improving glycemic control to meet guideline targets have been proposed , using IT technology . But all of them allow only limited-or no-real-time interaction between patients and the system in terms of system response to patient input ; few studies have effectively assessed the systems ' usability and feasibility to determine how well patients underst and and can adopt the technology involved . DialBetics is composed of 4 modules : ( 1 ) data transmission module , ( 2 ) evaluation module , ( 3 ) communication module , and ( 4 ) dietary evaluation module . A 3-month r and omized study was design ed to assess the safety and usability of a remote health- data monitoring system , and especially its impact on modifying patient lifestyles to improve diabetes self-management and , thus , clinical outcomes . Fifty-four type 2 diabetes patients were r and omly divided into 2 groups , 27 in the DialBetics group and 27 in the non-DialBetics control group . HbA1c and fasting blood sugar ( FBS ) values declined significantly in the DialBetics group : HbA1c decreased an average of 0.4 % ( from 7.1 ± 1.0 % to 6.7 ± 0.7 % ) compared with an average increase of 0.1 % in the non-DialBetics group ( from 7.0 ± 0.9 % to 7.1 ± 1.1 % ) ( P = .015 ) ; The DialBetics group FBS decreased an average of 5.5 mg/dl compared with a non-DialBetics group average increase of 16.9 mg/dl ( P = .019 ) . BMI improvement-although not statistically significant because of the small sample size-was greater in the DialBetics group . DialBetics was shown to be a feasible and an effective tool for improving HbA1c by providing patients with real-time support based on their measurements and inputs",
"OBJECTIVE Widespread use of carbohydrate counting is limited by its complex education . In this study we compared a Diabetes Interactive Diary ( DID ) with st and ard carbohydrate counting in terms of metabolic and weight control , time required for education , quality of life , and treatment satisfaction . RESEARCH DESIGN AND METHODS Adults with type 1 diabetes were r and omly assigned to DID ( group A , n = 67 ) or st and ard education ( group B , n = 63 ) and followed for 6 months . A subgroup also completed the SF-36 Health Survey ( SF-36 ) and World Health Organization-Diabetes Treatment Satisfaction Question naire ( WHO-DTSQ ) at each visit . RESULTS Of 130 patients ( aged 35.7 ± 9.4 years ; diabetes duration 16.5 ± 10.5 years ) , 11 dropped out . Time for education was 6 h ( range 2–15 h ) in group A and 12 h ( 2.5–25 h ) in group B ( P = 0.07 ) . A1C reduction was similar in both groups ( group A from 8.2 ± 0.8 to 7.8 ± 0.8 % and group B from 8.4 ± 0.7 to 7.9 ± 1.1 % ; P = 0.68 ) . Nonsignificant differences in favor of group A were documented for fasting blood glucose and body weight . No severe hypoglycemic episode occurred . WHO-DTSQ scores increased significantly more in group A ( from 26.7 ± 4.4 to 30.3 ± 4.5 ) than in group B ( from 27.5 ± 4.8 to 28.6 ± 5.1 ) ( P = 0.04 ) . Role Physical , General Health , Vitality , and Role Emotional SF-36 scores improved significantly more in group A than in group B. CONCLUSIONS DID is at least as effective as traditional carbohydrate counting education , allowing dietary freedom for a larger proportion of type 1 diabetic patients . DID is safe , requires less time for education , and is associated with lower weight gain . DID significantly improved treatment satisfaction and several quality -of-life dimensions ",
"BACKGROUND We compared telecare and conventional self-monitored blood glucose ( SMBG ) programs for titrating the addition of one bolus injection of insulin glulisine in patients with type 2 diabetes uncontrolled on oral hypoglycemic agents for ≥3 months who were first titrated with basal insulin glargine . METHODS This r and omized , multicenter , parallel-group study included 241 patients ( mean screening glycosylated hemoglobin [ HbA(1c ) ] , 8.8 % [ 73 mmol/mol ] ) . In the run-in phase , any antidiabetes medication , except for metformin , was discontinued . Metformin was then up-titrated to 2 g/day ( 1 g twice daily ) until study completion . Following run-in , all patients started glargine for 8 - 16 weeks , targeting fasting plasma glucose ( FPG ) ≤5.6 mmol/L using conventional SMBG . Patients with FPG ≤7 mmol/L added a glulisine dose at the meal with the highest postpr and ial plasma glucose excursion , titrated to target 2-h postpr and ial plasma glucose level using telecare or SMBG for 24 weeks . Patients with FPG > 7 mmol/L at week 16 were withdrawn from the study . RESULTS After glargine titration , 224 patients achieved FPG ≤7 mmol/L , without any difference between telecare and SBMG groups ( mean±SD , 6.2±0.8 vs. 6.0±0 . 9 mmol/L , respectively ) . HbA(1c ) levels were lower following titration and were similar for telecare and SMBG ( 7.9±0.9 % vs. 7.8±0.9 % [ 63 vs. 62 mmol/mol ] , respectively ) . Adding glulisine further reduced HbA(1c ) in both groups ( -0.7 % vs. -0.7 % ) ; 45.2 % and 54.8 % ( P=0.14 ) , respectively , of patients achieved HbA(1c ) ≤7.0 % ( ≤53 mmol/mol ) . Weight change and hypoglycemia were similar between groups . CONCLUSIONS Patients adding one dose of glulisine at the meal with the highest postpr and ial plasma glucose excursion to titrated basal glargine achieved comparable improvements in glycemic control irrespective of traditional or telecare blood glucose monitoring",
"OBJECTIVE To assess the effect of an Internet-based glucose monitoring system ( IBGMS ) on A1C levels in patients with type 2 diabetes treated with insulin . RESEARCH DESIGN AND METHODS This trial involved 50 patients r and omly assigned to receive either conventional treatment alone or with additional follow-up through an IBGMS for 6 months . Patients r and omized to the intervention group uploaded blood glucose readings every 2 weeks to a secure Web site for review and receipt of feedback from their endocrinologist . A1C and laboratory test results were collected at 0 , 3 , and 6 months . RESULTS The baseline parameters were not significantly different . Over a 6-month follow-up , A1C dropped from 8.8 to 7.6 % ( P IBGMS significantly improved A1C levels in patients with type 2 diabetes treated with insulin",
"OBJECTIVE To assess the efficacy of a lifestyle intervention program that can be readily translated into clinical practice for obese patients with type 2 diabetes . RESEARCH DESIGN AND METHODS The study consisted of a 12-month r and omized controlled trial of 147 health plan members with type 2 diabetes and obesity ( BMI > or=27 kg/m(2 ) ) . Participants were r and omized to lifestyle case management or usual care . Case management entailed individual and group education , support , and referral by registered dietitians ; intervention cost was US dollars 350 per person . Individuals treated with usual care received educational material . Both groups received ongoing primary care . Outcomes were difference between groups for change in weight ( kilograms ) , waist circumference ( centimeters ) , HbA(1c ) , fasting lipid levels , use of prescription medications , and health-related quality of life . RESULTS Case management result ed in greater weight loss ( P reduced waist circumference ( P reduced HbA(1c ) level ( P = 0.02 ) , less use of prescription medications ( P = 0.03 ) , and improved health-related quality of life ( P weight loss and waist circumference was 3.0 kg ( 95 % CI -5.4 to -0.6 ) and -4.2 cm ( -6.8 to -1.6 ) . HbA(1c ) differences were greatest at 4 months ( -0.59 % , P = 0.006 ) but not significant by 12 months ( -0.19 % , P = 0.45 ) . Participants in the case management group lowered their use of medications , primarily diabetes medications , by 0.8 medications per day more than participants treated with usual care ( P = 0.03 ) . In seven of nine quality -of-life domains , the case management group improved compared with usual care ( P health indicators among obese patients with type 2 diabetes",
"OBJECTIVE To compare the effectiveness of a telephonic and a print intervention over 1 year to improve diabetes control in low-income urban adults . RESEARCH DESIGN AND METHODS A r and omized trial in Spanish and English comparing a telephonic intervention implemented by health educators with a print intervention . Participants ( N = 526 ) had an A1C ≥7.5 % and were prescribed one or more oral agents . All were members of a union/employer jointly sponsored health benefit plan . Health coverage included medications . Primary outcomes were A1C and pharmacy cl aims data ; secondary outcomes included self-report of two medication adherence measures and other self-care behaviors . RESULTS Participants were 62 % black and 23 % Hispanic ; 77 % were foreign born , and 42 % had annual family incomes . Baseline median A1C was 8.6 % ( interquartile range 8.0–10.0 ) . Insulin was also prescribed for 24 % of participants . The telephone group had mean ± SE decline in A1C of 0.23 ± 0.11 % over 1 year compared with a rise of 0.13 ± 0.13 % for the print group ( P = 0.04 ) . After adjusting for baseline A1C , sex , age , and insulin use , the difference in A1C was 0.40 % ( 95 % CI 0.10–0.70 , P = 0.009 ) . Change in medication adherence measured by cl aims data , but not by self-report measures , was significantly associated with change in A1C ( P = 0.01 ) . Improvement in medication adherence was associated ( P = 0.005 ) with the telephonic intervention , but only among those not taking insulin . No diabetes self-care activities were significantly correlated with the change in A1C . CONCLUSIONS A 1-year tailored telephonic intervention implemented by health educators was successful in significantly , albeit modestly , improving diabetes control compared with a print intervention in a low-income , insured , minority population",
"Background The aim was to evaluate the effect of a 12-month individualized health coaching intervention by telephony on clinical outcomes . Methods An open-label cluster-r and omized parallel groups trial . Pre- and post-intervention anthropometric and blood pressure measurements by trained nurses , laboratory measures from electronic medical records ( EMR ) . A total of 2594 patients filling inclusion criteria ( age 45 years or older , with type 2 diabetes , coronary artery disease or congestive heart failure , and unmet treatment goals ) were identified from EMRs , and 1535 patients ( 59 % ) gave consent and were r and omized into intervention or control arm . Final analysis included 1221 ( 80 % ) participants with data on primary end-points both at entry and at end . Primary outcomes were systolic and diastolic blood pressure , serum total and LDL cholesterol concentration , waist circumference for all patients , glycated hemoglobin ( HbA1c ) for diabetics and NYHA class in patients with congestive heart failure . The target effect was defined as a 10-percentage point increase in the proportion of patients reaching the treatment goal in the intervention arm . Results The proportion of patients with diastolic blood pressure initially above the target level decreasing to 85 mmHg or lower was 48 % in the intervention arm and 37 % in the control arm ( difference 10.8 % , 95 % confidence interval 1.5–19.7 % ) . No significant differences emerged between the arms in the other primary end-points . However , the target levels of systolic blood pressure and waist circumference were reached non-significantly more frequently in the intervention arm . Conclusions Individualized health coaching by telephony , as implemented in the trial was unable to achieve majority of the disease management clinical measures . To provide substantial benefits , interventions may need to be more intensive , target specific sub-groups , and /or to be fully integrated into local health care . Trial registration Clinical Trials.gov Identifier :",
"OBJECTIVE To conduct a 1-year r and omized clinical trial to evaluate a remote comprehensive diabetes self-management education ( DSME ) intervention , Diabetes TeleCare , administered by a dietitian and nurse/certified diabetes educator ( CDE ) in the setting of a federally qualified health center ( FQHC ) in rural South Carolina . RESEARCH DESIGN AND METHODS Participants were recruited from three member health centers of an FQHC and were r and omized to either Diabetes TeleCare , a 12-month , 13-session curriculum delivered using telehealth strategies , or usual care . RESULTS Mixed linear regression model results for repeated measures showed a significant reduction in glycated hemoglobin ( GHb ) in the Diabetes TeleCare group from baseline to 6 and 12 months ( 9.4 ± 0.3 , 8.3 ± 0.3 , and 8.2 ± 0.4 , respectively ) compared with usual care ( 8.8 ± 0.3 , 8.6 ± 0.3 , and 8.6 ± 0.3 , respectively ) . LDL cholesterol was reduced at 12 months in the Diabetes TeleCare group compared with usual care . Although not part of the original study design , GHb was reduced from baseline to 12 and 24 months in the Diabetes TeleCare group ( 9.2 ± 0.4 , 7.4 ± 0.5 , and 7.6 ± 0.5 , respectively ) compared with usual care ( 8.7 ± 0.4 , 8.1 ± 0.4 , and 8.1 ± 0.5 , respectively ) in a post hoc analysis of a subset of the r and omized sample who completed a 24-month follow-up visit . CONCLUSIONS Telehealth effectively created access to successfully conduct a 1-year remote DSME by a nurse CDE and dietitian that improved metabolic control and reduced cardiovascular risk in an ethnically diverse and rural population",
"Despite the numerous benefits of physical activity for patients with diabetes , most healthcare providers in busy clinical setting s rarely find time to counsel their patients about it . A Web-based program for healthcare providers can be used as an effective counseling tool , when strategies are outlined for specific stages of readiness for physical activity . Seventy-three adults with type 2 diabetes were r and omly assigned to Web-based intervention , printed- material intervention , or usual care . After 12 weeks , the effects of the interventions on physical activity , fasting blood sugar , and glycosylated hemoglobin were evaluated . Both Web-based and printed material intervention , compared with usual care , were effective in increasing physical activity ( P fasting blood sugar ( P glycosylated hemoglobin ( P printed material intervention and usual care , but not between web-based and printed material intervention . The findings of this study support the value of Web-based and printed material interventions in healthcare counseling . With increasing Web access , the effectiveness of Web-based programs offered directly to patients needs to be tested",
"OBJECTIVES To investigate the acceptability and feasibility of using short message services ( SMS ) via cell phones to ensure adherence to management prescriptions by diabetic patients . METHODS Type 2 diabetic patients with 5 or more years of diabetes and having HbA1c between 7.0 % to 10 % were r and omized to the control arm ( n = 105 ) to receive st and ard care and to the intervention arm ( SMS , n = 110 ) . Messages in English on principles of diabetes management were sent once in 3 days , the contents and frequencies varied as per the patients ' preferences . The study duration was 1 year . All participants were advised to report for quarterly clinic visits . A comparative assessment of the clinical , biochemical and anthropometric outcomes was made among the groups at the annual visit . RESULTS Annual review was possible in 71 % of intervention group and 63 % of control group . SMS was acceptable to the patients and the median number requested was 2 per week . HbA1c and plasma lipids improved significantly in the SMS group . CONCLUSIONS The pilot study showed that frequent communication via SMS was acceptable to diabetic patients and it helped to improve the health outcomes",
"BACKGROUND : This study was conducted to evaluate the effect of a clinical pharmacist-led patient education program for type 2 diabetic patients at Isfahan Endocrine & Metabolism Research Center ( IEMRC ) from April 2008 to January 2009 . METHODS : In a r and omized controlled clinical trial , a total of 172 patients with uncontrolled type 2 diabetes were selected and r and omly allocated into control and intervention groups . After taking informed written consent , the intervention group received an educational program about oral anti-hyperglycemic medications , adherence , diabetes dairy log and pill box usage . Patient 's glycemic control in the intervention group was followed for three months through either telephone or face to face interviews with the pharmacist . Fasting blood glucose and HbA1c were measured at the start and end of the pharmacistled drug education program for both intervention and control groups . RESULTS : After a three months follow-up , mean fasting blood glucose and HbA1c of the patients in the intervention group decreased significantly compared to control group ( p diabetes management of type 2 diabetics by involving a pharmacist in the multidisciplinary teams in the outpatient clinics . The results suggest the benefits of adding adherence education to the diabetic education programs",
"AIM To investigate the effectiveness of a nurse short message service ( SMS ) by cellular phone and wire Internet on plasma glucose levels in people with diabetes for six months . BACKGROUND Blood glucose management system using telemedicine approaches may maintain the appropriate blood glucose levels in type-2 diabetic patients . DESIGN A control group pre-test-post-test design was used to assess the effectiveness of nurse 's education . METHODS Twenty-five patients were r and omly assigned to an intervention group and 26 to a control group . The intervention was applied for six months . The goal of the intervention was to keep blood glucose concentrations close to the normal range . Participants were requested to input their blood glucose level , diet and exercise diary everyday in the website by cellular phone or wire Internet . The research er sends optimal recommendations to each patient using SMS by cellular phone and wire Internet weekly . RESULTS Glycosylated hemoglobin ( HbA(1)c ) decreased 1.15 % points at three months and 1.05 % points at six months compared with baseline in the intervention group . Patients in the intervention group had a decrease of two hours post meal glucose ( 2HPMG ) of 85.1 mg/dl at three months and 63.1 mg/dl at six months compared with baseline . CONCLUSION This web-based intervention using SMS of cellular phone improved HbA(1)c and 2HPMG for six months in type-2 diabetic patients . RELEVANCE TO CLINICAL PRACTICE An SMS of cellular phone intervention by a nurse can reduce HbA(1)c and 2HPMG for six months in type-2 diabetic patients",
"OBJECTIVE To evaluate an online disease management system supporting patients with uncontrolled type 2 diabetes . MATERIAL S AND METHODS Engaging and Motivating Patients Online With Enhanced Re sources for Diabetes was a 12-month parallel r and omized controlled trial of 415 patients with type 2 diabetes with baseline glycosylated hemoglobin ( A1C ) values ≥7.5 % from primary care sites sharing an electronic health record . The intervention included : ( 1 ) wirelessly uploaded home glucometer readings with graphical feedback ; ( 2 ) comprehensive patient-specific diabetes summary status report ; ( 3 ) nutrition and exercise logs ; ( 4 ) insulin record ; ( 5 ) online messaging with the patient 's health team ; ( 6 ) nurse care manager and dietitian providing advice and medication management ; and ( 7 ) personalized text and video educational ' nuggets ' dispensed electronically by the care team . A1C was the primary outcome variable . RESULTS Compared with usual care ( UC , n=189 ) , patients in the intervention ( INT , n=193 ) group had significantly reduced A1C at 6 months ( -1.32 % INT vs -0.66 % UC ; p had improved diabetes control ( > 0.5 % reduction in A1C ) than UC patients at 12 months ( 69.9 ( 95 % CI 63.2 to 76.5 ) vs 55.4 ( 95 % CI 48.4 to 62.5 ) ; p=0.006 ) . CONCLUSIONS A nurse-led , multidisciplinary health team can manage a population of diabetic patients in an online disease management program . INT patients achieved greater decreases in A1C at 6 months than UC patients , but the differences were not sustained at 12 months . More INT than UC patients achieved improvement in A1C ( > 0.5 % decrease ) . Trial registered in clinical trials.gov : # NCT00542204",
"OBJECTIVE Despite the importance of self-management support ( SMS ) , few studies have compared SMS interventions , involved diverse population s , or entailed implementation in safety net setting s. We examined the effects of two SMS strategies across outcomes corresponding to the Chronic Care Model . RESEARCH DESIGN AND METHODS A total of 339 out patients with poorly controlled diabetes from county-run clinics were enrolled in a three-arm trial . Participants , more than half of whom spoke limited English , were uninsured , and /or had less than a high school education , were r and omly assigned to usual care , interactive weekly automated telephone self-management support with nurse follow-up ( ATSM ) , or monthly group medical visits with physician and health educator facilitation ( GMV ) . We measured 1-year changes in structure ( Patient Assessment of Chronic Illness Care [ PACIC ] ) , communication processes ( Interpersonal Processes of Care [ IPC ] ) , and outcomes ( behavioral , functional , and metabolic ) . RESULTS Compared with the usual care group , the ATSM and GMV groups showed improvements in PACIC , with effect sizes of 0.48 and 0.50 , respectively ( P improvements in IPC ( effect sizes 0.40 vs. usual care and 0.25 vs. GMV , P improvements in self-management behavior versus the usual care arm ( P fewer bed days per month than the usual care group ( −1.7 days , P = 0.05 ) and the GMV group ( −2.3 days , P less interference with daily activities than the usual care group ( odds ratio 0.37 , P = 0.02 ) . We observed no differences in A1C change . CONCLUSIONS Patient-centered SMS improves certain aspects of diabetes care and positively influences self-management behavior . ATSM seems to be a more effective communication vehicle than GMV in improving behavior and quality of life",
"OBJECTIVE The Internet is used worldwide as a communication tool . To improve the quality of diabetes control , we investigated the effectiveness of an Internet-based blood glucose monitoring system ( IBGMS ) on controlling the changes in HbA(1c ) levels . RESEARCH DESIGN AND METHODS We conducted a r and omized clinical trial involving 110 patients who visited the outpatient clinic at the Kangnam St. Mary 's Hospital for 3 months . The study subjects were treated with IBGMS for 12 weeks , and the control group received the usual outpatient management over the same period . HbA(1c ) and other laboratory tests were performed twice , once at the beginning of the study and again at the end of the study . RESULTS The test results from the beginning of the study established that there were no significant differences between the two groups with respect to age , sex , diabetes duration , BMI , blood pressure , HbA(1c ) , and other laboratory data . On follow-up examination 12 weeks later , HbA(1c ) levels were significantly decreased from 7.59 to 6.94 % within the intervention group ( P HbA(1c ) levels in the intervention group were significantly lower than in the control group after adjusting the baseline HbA(1c ) ( 6.94 vs. 7.62 % ; P HbA(1c ) lower HbA(1c ) than those in the control group ( 6.38 vs. 6.99 % ; P HbA(1c ) > or = 7.0 % , the difference between the two groups appeared more obvious : HbA(1c ) levels at the end of the study were 8.12 % . CONCLUSIONS This new IBGMS result ed in a significant reduction of HbA(1c ) during the study period . We propose that this IBGMS be used as a method for improving diabetes control",
"OBJECTIVE We compared the short-term efficacy of home telemonitoring coupled with active medication management by a nurse practitioner with a monthly care coordination telephone call on glycemic control in veterans with type 2 diabetes and entry A1C ≥7.5 % . RESEARCH DESIGN AND METHODS Veterans who received primary care at the VA Pittsburgh Healthcare System from June 2004 to December 2005 , who were taking oral hypoglycemic agents and /or insulin for ≥1 year , and who had A1C ≥7.5 % at enrollment were r and omly assigned to either active care management with home telemonitoring ( ACM+HT group , n = 73 ) or a monthly care coordination telephone call ( CC group , n = 77 ) . Both groups received monthly calls for diabetes education and self-management review . ACM+HT group participants transmitted blood glucose , blood pressure , and weight to a nurse practitioner using the Viterion 100 TeleHealth Monitor ; the nurse practitioner adjusted medications for glucose , blood pressure , and lipid control based on established American Diabetes Association targets . Measures were obtained at baseline , 3-month , and 6-month visits . RESULTS Baseline characteristics were similar in both groups , with mean A1C of 9.4 % ( CC group ) and 9.6 % ( ACM+HT group ) . Compared with the CC group , the ACM+HT group demonstrated significantly larger decreases in A1C at 3 months ( 1.7 vs. 0.7 % ) and 6 months ( 1.7 vs. 0.8 % ; P ACM+HT group demonstrated significantly greater reductions in A1C by 3 and 6 months . However , both interventions improved glycemic control in primary care patients with previously inadequate control",
"OBJECTIVE We evaluated automated telephone disease management ( ATDM ) with telephone nurse follow-up as a strategy for improving diabetes treatment processes and outcomes in Department of Veterans Affairs ( VA ) clinics . We also compared the results with those of a prior ATDM trial conducted in a county health care system . RESEARCH DESIGN AND METHODS A total of 272 VA patients with diabetes using hypoglycemic medications were r and omized . During the 1-year study period , intervention patients received biweekly ATDM health assessment and self-care education calls , and a nurse educator followed up with patients based on their ATDM assessment reports . Telephone surveys were used to measure patients ' self-care , symptoms , and satisfaction with care . Outpatient service use was evaluated using electronic data bases and self-reports , and glycemic control was measured by HbA1c and serum glucose testing . RESULTS At 12 months , intervention patients reported more frequent glucose self-monitoring and foot inspections than patients receiving usual care and were more likely to be seen in podiatry and diabetes specialty clinics . Intervention patients also were more likely than control patients to have had a cholesterol test . Among patients with baseline HbA1c levels > or = 8 % , mean end-point values were lower among intervention patients than control patients ( 8.7 vs. 9.2 % , respectively ; P = 0.04 ) . Among intervention and control patients with baseline values > or = 9 % , mean end-point values were 9.1 and 10.2 % , respectively ( P = 0.04 ) . At follow-up , intervention patients reported fewer symptoms of poor glycemic control than control patients and greater satisfaction with their health care . CONCLUSIONS This intervention improved the quality of VA diabetes care . Intervention effects for most end points replicated findings from the prior county clinic trial , although intervention-control differences in the current study were smaller because of the relatively good self-care and health status among the current study 's enrollees",
" This article describes the design and implementation of an online diabetes self-management intervention for a sample of inner-city African Americans with diabetes . Study participants were r and omly assigned to the treatment ( 26 ) and control ( 21 ) conditions . The results indicate that treatment group participants were more likely to achieve positive outcomes in terms of lowered hemoglobin A1c and body mass index measurements than were control group members . These findings support the development of telehealth interventions to promote effective chronic disease management in medically underserved communities",
"CONTEXT Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions and lower access to care . OBJECTIVES To examine the effectiveness of a telemedicine intervention to achieve clinical management goals in older , ethnically diverse , medically underserved patients with diabetes . DESIGN , Setting , and Patients A r and omized controlled trial was conducted , comparing telemedicine case management to usual care , with blinded outcome evaluation , in 1,665 Medicare recipients with diabetes , aged > /= 55 years , residing in federally design ated medically underserved areas of New York State . Interventions Home telemedicine unit with nurse case management versus usual care . Main Outcome Measures The primary endpoints assessed over 5 years of follow-up were hemoglobin A1c ( HgbA1c ) , low density lipoprotein ( LDL ) cholesterol , and blood pressure levels . RESULTS Intention-to-treat mixed models showed that telemedicine achieved net overall reductions over five years of follow-up in the primary endpoints ( HgbA1c , p = 0.001 ; LDL , p systolic and diastolic blood pressure , p = 0.024 ; p HgbA1c , 3.84 ( -0.08 , 7.77 ) mg/dL for LDL cholesterol , and 4.32 ( 1.93 , 6.72 ) mm Hg for systolic and 2.64 ( 1.53 , 3.74 ) mm Hg for diastolic blood pressure . There were 176 deaths in the intervention group and 169 in the usual care group ( hazard ratio 1.01 [ 0.82 , 1.24 ] ) . CONCLUSIONS Telemedicine case management result ed in net improvements in HgbA1c , LDL-cholesterol and blood pressure levels over 5 years in medically underserved Medicare beneficiaries . Mortality was not different between the groups , although power was limited . Trial Registration http:// clinical trials.gov Identifier : NCT00271739",
"Background Persistently poor glycemic control in adult type 1 diabetes patients is a common , complex , and serious problem initiating significant damage to the cardiovascular , renal , neural , and visual systems . Currently , there is a plethora of low-cost and free diabetes self-management smartphone applications available in online stores . Objective The aim of this study was to examine the effectiveness of a freely available smartphone application combined with text-message feedback from a certified diabetes educator to improve glycemic control and other diabetes-related outcomes in adult patients with type 1 diabetes in a two-group r and omized controlled trial . Methods Patients were recruited through an online type 1 diabetes support group and letters mailed to adults with type 1 diabetes throughout Australia . In a 6-month intervention , followed by a three-month follow-up , patients ( n=72 ) were r and omized to usual care ( control group ) or usual care and the use of a smartphone application ( Glucose Buddy ) with weekly text-message feedback from a Certified Diabetes Educator ( intervention group ) . All outcome measures were collected at baseline and every three months over the study period . Patients ’ glycosylated hemoglobin levels ( HbA1c ) were measured with a blood test and diabetes-related self-efficacy , self-care activities , and quality of life were measured with online question naires . Results The mean age of patients was 35.20 years ( SD 10.43 ) ( 28 male , 44 female ) , 39 % ( 28/72 ) were male , and patients had been diagnosed with type 1 diabetes for a mean of 18.94 years ( SD 9.66 ) . Of the initial 72 patients , 53 completed the study ( 25 intervention , 28 control group ) . The intervention group significantly improved glycemic control ( HbA1c ) from baseline ( mean 9.08 % , SD 1.18 ) to 9-month follow-up ( mean 7.80 % , SD 0.75 ) , compared to the control group ( baseline : mean 8.47 % , SD 0.86 , follow-up : mean 8.58 % , SD 1.16 ) . No significant change over time was found in either group in relation to self-efficacy , self-care activities , and quality of life . Conclusions In adjunct to usual care , the use of a diabetes-related smartphone application combined with weekly text-message support from a health care professional can significantly improve glycemic control in adults with type 1 diabetes . Trial Registration Australian New Zeal and Clinical Trials Registry : ACTRN12612000132842 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?ACTRN=12612000132842 ( Archived by WebCite at http://www.webcitation.org/6Kl4jqn5u )",
"OBJECTIVE Investigate the effectiveness of an educational intervention that used both the cellular phone with a short messaging service ( SMS ) and the Internet on the glycemic control of the patients with type 2 diabetes mellitus . METHODS Twenty-five patients were r and omly assigned to an intervention group and twenty-six to a control group . The intervention was applied for 12 months . The goal of the intervention was to keep blood glucose concentrations close to the normal range ( HbA(1)c access a website by using a cellular phone or to wiring the Internet and input their blood glucose levels weekly . Participants were sent the optimal recommendations by both cellular phone and the Internet weekly . RESULTS Participants in the intervention group had lower HbA(1)c over 12 months when compared with the control group . At 12 months the change from baseline in HbA(1)c was -1.32 in the intervention group versus + 0.81 in the control group . Two hours post-meal glucose ( 2HPMG ) had a significantly greater decline in the intervention group after 12 months when compared with the control group ( -100.0 versus + 18.1mg/dl ) . CONCLUSION This educational intervention using the Internet and a SMS by cellular phone rapidly improved and stably maintained the glycemic control of the patients with type 2 diabetes mellitus",
"OBJECTIVE —To investigate the long-term effectiveness of the Internet-based glucose monitoring system ( IBGMS ) on glucose control in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS —We conducted a prospect i ve , r and omized , controlled trial in 80 patients with type 2 diabetes for 30 months . The intervention group was treated with the IBGMS , while the control group made conventional office visits only . HbA1c ( A1C ) was performed at 3-month intervals . For measuring of the stability of glucose control , the SD value of A1C levels for each subject was used as the A1C fluctuation index ( HFI ) . RESULTS —The mean A1C and HFI were significantly lower in the intervention group ( n = 40 ) than in the control group ( n = 40 ) . ( A1C [ mean ± SD ] 6.9 ± 0.9 vs. 7.5 ± 1.0 % , P = 0.009 ; HFI 0.47 ± 0.23 vs. 0.78 ± 0.51 , P = 0.001 ; intervention versus control groups , respectively ) . Patients in the intervention group with a basal A1C ≥7 % ( n = 27 ) had markedly lower A1C levels than corresponding patients in the control group during the first 3 months and maintained more stable levels throughout the study ( P = 0.022 ) . Control patients with a basal A1C distribution of A1C levels , whereas the A1C levels in the intervention group remained stable throughout the study with low HFI . CONCLUSIONS —Long-term use of the IBGMS has proven to be superior to conventional diabetes care systems based on office visits for controlling blood glucose and achieving glucose stability ",
"Objective To evaluate the effectiveness of goal focused telephone coaching by practice nurses in improving glycaemic control in patients with type 2 diabetes in Australia . Design Prospect i ve , cluster r and omised controlled trial , with general practice s as the unit of r and omisation . Setting General practice s in Victoria , Australia . Participants 59 of 69 general practice s that agreed to participate recruited sufficient patients and were r and omised . Of 829 patients with type 2 diabetes ( glycated haemoglobin ( HbA1c ) > 7.5 % in the past 12 months ) who were assessed for eligibility , 473 ( 236 from 30 intervention practice s and 237 from 29 control practice s ) agreed to participate . Intervention Practice nurses from intervention practice s received two days of training in a telephone coaching programme , which aim ed to deliver eight telephone and one face to face coaching episodes per patient . Main outcome measures The primary end point was mean absolute change in HbA1c between baseline and 18 months in the intervention group compared with the control group . Results The intervention and control patients were similar at baseline . None of the practice s dropped out over the study period ; however , patient attrition rates were 5 % in each group ( 11/236 and 11/237 in the intervention and control group , respectively ) . The median number of coaching sessions received by the 236 intervention patients was 3 ( interquartile range 1 - 5 ) , of which 25 % ( 58/236 ) did not receive any coaching sessions . At 18 months ’ follow-up the effect on glycaemic control did not differ significantly ( mean difference 0.02 , 95 % confidence interval −0.20 to 0.24 , P=0.84 ) between the intervention and control groups , adjusted for HbA1c measured at baseline and the clustering . Other biochemical and clinical outcomes were similar in both groups . Conclusions A practice nurse led telephone coaching intervention implemented in the real world primary care setting produced comparable outcomes to usual primary care in Australia . The addition of a goal focused coaching role onto the ongoing generalist role of a practice nurse without prescribing rights was found to be ineffective . Trial registration Current Controlled Trials IS RCT N50662837",
"BACKGROUND Previous studies have provided limited guidance regarding the clinical efficacy and cost-effectiveness of interventions using \" telemedicine \" models in the management of diabetes mellitus . We conducted a study to determine if routine clinical assessment s of diabetes patients could be effectively conducted via computer and telephone interaction with patients and still provide clinical results similar to traditional office care . SUBJECTS AND METHODS We enrolled 100 subjects with diabetes in this 12-month , r and omized , controlled , non-inferiority study . Subjects were r and omized ( 1:1 ratio ) to a control group ( CG ) or study group ( SG ) . Baseline characteristics were similar . CG subjects participated in quarterly office visits ; SG subjects participated in two office visits ( months 6 and 12 ) and two telemedicine interactions ( months 3 and 9 ) . Changes in clinical measurements ( hemoglobin A1c [ HbA1c ] , blood pressure , lipids , body mass index [ BMI ] , and body weight ) and clinician time requirements were assessed . RESULTS Seventy subjects completed the study ( CG , n=37 ; SG , n=33 ) . No significant between-group differences in HbA1c , blood pressure , lipids , or BMI were seen at 12 months . SG subjects showed significantly greater reductions in mean ( SD ) body weight compared with CG subjects : -5.2 ( 1.6 ) pounds versus -0.7 ( 1.5 ) pounds , respectively ( P=0.04 ) . Clinician time requirements for SG subjects were reduced by > 40 % . CONCLUSIONS Our study demonstrated that use of a telemedicine-based treatment protocol in diabetes patients is feasible and efficient and yields similar clinical outcomes compared with traditional , clinic-based protocol s. Telemedicine applications of computer software can potentially exp and access to care for patients and may reduce costs for patients , providers , and payers",
"OBJECTIVE To evaluate the effectiveness of a psychological , family-based intervention to improve diabetes-related outcomes in patients with poorly controlled type 2 diabetes . METHODS This study was a r and omized controlled trial of a psychological family-based intervention targeted at individuals with poorly controlled type 2 diabetes . Recruitment and follow-up occurred at specialist diabetes clinics . Patients were r and omly allocated to an intervention group ( n=60 ) or a control group ( n=61 ) . Poor control was defined as at least 2 of the patient 's last 3 glycated hemoglobin ( A1C ) readings at > 8.0 % . The intervention consisted of 2 sessions delivered by a health psychologist to the patient and a family member in the patient 's home , with a third session involving a 15-minute follow-up telephone call . RESULTS At 6-month follow-up , the intervention group reported significantly lower mean A1C levels than the control group ( 8.4 % [ SD=0.99 % ] vs 8.8 % [ SD=1.36 % ] ; P=.04 ) . The intervention was most effective in those with the poorest control at baseline ( A1C>9.5 % ) ( intervention 8.7 % [ SD=1.16 % , n=15 ] vs control 9.9 % [ SD=1.31 % , n=15 ] ; P=.01 ) . The intervention group also reported statistically significant improvements in beliefs about diabetes , psychological well-being , diet , exercise , and family support . CONCLUSIONS After participating in a family-based intervention targeting negative and /or inaccurate illness perceptions , patients with poorly controlled type 2 diabetes showed improvements in A1C levels and other outcomes . Our results suggest that adding a psychological , family-based component to usual diabetes care may help improve diabetes management",
"Background Diabetes outcomes are worse for underserved patients from certain ethnic/racial minority population s. Telephonic disease management is a cost-effective strategy to deliver self-management services and possibly improve diabetes outcomes for such patients . Objective We conducted a trial to test the effectiveness of a supplemental telephonic disease management program compared to usual care alone for patients with diabetes cared for in a community health center . Design R and omized controlled trial . Participants All patients had type 2 diabetes , and the majority was Hispanic or African American . Most were urban-dwelling with low socioeconomic status , and nearly all had Medicaid or were uninsured . Measurements Clinical measures included glycemic control , blood pressure , lipid levels , and body mass index . Vali date d surveys were used to measure dietary habits and physical activity . Results A total of 146 patients were r and omized to the intervention and 149 to the control group . Depressive symptoms were highly prevalent in both groups . Using an intention to treat analysis , there were no significant differences in the primary outcome ( HbA1c ) between the intervention and control groups at 12 months . There were also no significant differences for secondary clinical or behavioral outcome measures including BMI , systolic or diastolic blood pressure , LDL cholesterol , smoking , or intake of fruits and vegetables , or physical activity . Conclusions A clinic-based telephonic disease management support for underserved patients with diabetes did not improve clinical or behavioral outcomes at 1 year as compared to patients receiving usual care alone",
"For physicians , pharmacists , pharmacologists , and others , the medical literature is a key source of information about prescription drugs [ 1 , 2 ] . The medical literature on drugs includes articles from peer- review ed journals , non-peer- review ed ( controlled circulation or throwaway ) journals , and the published proceedings of symposia [ 3 , 4 ] . Symposia are a rapidly growing and potentially major means of disseminating information about drugs . In the clinical journals with the highest circulation rates , the number of symposia published increased from 83 during 1972 - 1977 to 307 during 1984 - 1989 . Approximately half of these symposia were on pharmaceutical topics [ 4 ] . Symposia can be valuable sources of information about drugs , but evidence suggests that they can also be used to market drugs and other interventions , especially if they are industry sponsored . Approximately 70 % of symposia on pharmaceutical topics are sponsored by drug companies [ 3 , 4 ] . Among symposia , sponsorship by a single drug company is associated with promotional characteristics that include a focus on a single drug , misleading titles , use of br and names , and lack of peer review [ 4 ] . Other studies indicate that clinical trials , including those published in symposia , are more likely to favor a new drug therapy if they are funded by the pharmaceutical industry than if they are not [ 5 , 6 ] . Although physicians often report that the peer- review ed literature is one of their main sources of drug information , industry sources of information can sometimes have a stronger influence on prescribing behavior [ 2 ] . Thus , if symposia sponsored by drug companies are a growing source of information about drugs for pharmacists and physicians , assessing the quality of the articles in these symposia is important . We compared the method ologic quality and relevance of drug studies published in symposia sponsored by single drug companies with those of studies that were published in symposia that had other sponsors or in the peer- review ed parent journals . We also assessed whether a methods section was present , because such a section is necessary for evaluating quality . Finally , we tested whether drug industry support of research was associated with study outcome . Methods A symposium is a collection of papers published as a separate issue or as a special section in a regular issue of a medical journal [ 4 ] . We defined original clinical drug articles as articles that 1 ) appeared to present original data from studies done in humans [ that is , articles that had at least one table or figure that was not acknowledged to have been reprinted from another source ] and 2 ) did not specifically state that they were review s [ 4 ] . Selection of Articles We identified original clinical drug articles that had a section describing the study methods , because such a section is needed to assess the quality of an article . Using a computer-generated list of r and om numbers from 1 to 625 , we r and omly selected symposia from 625 symposia that had been identified for a previous study [ 4 ] . We had data on the type of sponsorship of publication for each symposium . From each selected symposium , we r and omly selected one original clinical drug article that had a methods section . We continued selecting symposia until we had enough articles ( n = 127 ) according to the sample size estimates described below . We also calculated the proportion of articles in the selected symposia , overall and by type of sponsorship , that had methods sections . Quality Assessment We compared the quality of original clinical drug articles published in symposia sponsored by single drug companies with that of similar articles published in symposia that had other sponsors and in the peer- review ed parent journals . Sample Size Estimates We estimated the sample size needed to test the association between the independent variable type of sponsorship of publication and the main outcome measure , method ologic quality score . For a three-group comparison , a minimum sample of 108 symposium articles was needed to detect a minimum effect size of 0.10 ( on a scale of 0 to 1 ) , with an value of 0.05 and a value of 0.80 , and st and ard deviation of quality scores of 0.18 based on previous results [ 7 ] . To compare articles from symposia sponsored by single pharmaceutical companies with articles from the peer- review ed parent journals , we estimated that we would need 45 symposia articles and 45 journal articles ; this estimate was the result of sample size calculations done using the variables described above . Because date of publication , journal , and therapeutic class of drug could have confounded the association between source of publication and quality [ 8 - 10 ] , we matched each symposium article to an article from the parent journal by using these characteristics , as described previously [ 7 ] . Our sample of symposium articles contained 50 articles sponsored by single drug companies , but 5 articles published in Transplantation Proceedings were excluded from this analysis because no parent journal is associated with that publication . Instruments We used previously developed instruments to measure the method ologic quality of articles ( defined as the minimization of systematic bias and the consistency of conclusions with results ) and non method ologic indices of quality , such as clinical relevance and generalizability . Both instruments were valid and reliable and have been published elsewhere [ 7 ] . Four review ers independently assessed each article : Two used the method ologic quality instrument , and two used the clinical relevance instrument . We derived method ologic quality and clinical relevance scores for each article by using a previously described scoring system [ 7 ] . Each score was between 0 ( lowest quality ) and 1 ( highest quality ) and was the average of the scores of the two review ers . Two clinical pharmacologists with extensive research experience in the health sciences did the method ologic quality assessment . For the clinical relevance instrument , three pairs of review ers with clinical experience in general internal medicine and research experience in the health sciences each assessed one third of the articles . Each pair of review ers review ed the articles in the same r and omized order . For both instruments , review ers were trained as described previously [ 7 ] . For the quality assessment s , each review er worked independently , was blinded as to whether an article had been published in a symposium , and was given photocopies of articles from which author names , institution names , journal names , date s , and all other reference information had been obliterated . Review ers were unaware of our hypotheses and the purpose of their review ing , and they were paid for their work . None of the review ers were known to us or knew of our previous work before the study . We assessed the inter-rater reliability of quality scores by using the Kendall coefficient of concordance ( W ) with adjustment for tied ranks [ 11 ] and the intraclass correlation ( R ; treating both review ers and articles as r and om effects [ 12 ] ) . Inter-rater reliability of quality scores was high ( for method ologic quality scores : W equals 0.85 , R equals 0.74 [ 95 % CI , 0.67 to 0.80 ] ; for clinical relevance scores : W equals 0.77 , R equals 0.56 [ CI , 0.44 to 0.65 ] ) . Drug Company Support and Study Outcome For each article , one of us determined whether a drug company had supported the research and whether the article 1 ) reported an outcome favorable to the drug of interest , 2 ) did not report an outcome favorable to the drug of interest , or 3 ) did not test a hypothesis . The drug of interest ( as defined from the perspective of the authors , according to Gotzsche [ 13 ] ) was the newest drug if two or more drugs were studied . We defined research as having had drug company support if the article that reported the research acknowledged either that a drug company had provided funding or drugs or that any of the authors were employed by a drug company . We determined drug company support solely on the basis of information in the paper . If an article did not test a hypothesis , it was excluded from this analysis . We classified the remaining articles as favorable or unfavorable using Gotzsche 's definitions [ 13 ] . An article was favorable if the drug that seemed to be of primary interest to the authors had the same effect as the comparison drug or drugs but with less pronounced side effects , had a better effect without more pronounced side effects , or was preferred more often by patients when the effect and side-effect evaluations were combined . All other articles were considered not favorable . The conclusions of the authors were taken at face value , even if they conflicted with the study results . To test inter-rater reliability , the other author independently assessed a subset of the articles ( n = 90 ) . Agreement in classifying articles as favorable or not favorable was 85 % . Statistical Analyses Because method ologic quality and relevance scores were distributed normally ( Shapiro-Wilk test ) , we analyzed differences between groups ( type of sponsorship of publication ) by using parametric one-way analysis of variance followed by the Tukey test for multiple comparisons or two-way analysis of variance ( total error rate , 0.05 ) . We compared matched groups ( symposium articles and peer- review ed parent journal articles ) by using the paired t-test ( two-tailed equals 0.05 ) . To analyze categorical data on the outcome of studies , we tested for differences in proportions between groups by using the chi-square statistic . For tests of significance , we used an value of 0.05 . All hypothesis tests were two-sided . Results Presence of a Method Section To obtain 127 original clinical drug articles for quality assessment , we had to select 213 symposia containing a total of 5041 articles . The proportions of articles that reported original data but contained no methods sections were 4 % overall ( 195 of 5041 ) , 10 % ( 108 of 1064 ) in the symposia sponsored by single drug companies",
"OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity",
"BACKGROUND Type 2 diabetes is an individual health challenge requiring ongoing self-management . Remote patient reporting of relevant health parameters and linked automated feedback via mobile telephone have potential to strengthen self-management and improve outcomes . This research involved development and evaluation of a mobile telephone-based remote patient reporting and automated telephone feedback system , guided by health behavior change theory , aim ed at improving self-management and health status in individuals with type 2 diabetes . SUBJECTS AND METHODS This research comprised a r and omized controlled trial . Inclusion criteria were diagnosis of type 2 diabetes , elevated glycosylated hemoglobin ( HbA1c ) levels ( range , 6.5 - 11 % ) or use of oral diabetes medication , and 30 - 70 years of age . Intervention subjects ( n=24 ) participated in remote patient reporting of health status parameters and linked health behavior change feedback . Control participants ( n=24 ) received st and ard of care including diabetes education and healthcare provider counseling . Patients were followed for approximately 10 months . RESULTS Intervention participants achieved , compared with controls and controlling for baseline , a significantly greater mean reduction in HbA1c of -0.40 % ( 95 % confidence interval [ CI ] -0.67 % to -0.14 % ) versus 0.036 % ( 95 % CI -0.23 % to 0.30 % ) ( P weight reduction of -2.1 kg ( 95 % CI -3.6 to -0.6 kg ) versus 0.4 kg ( 95 % CI -1.1 to 1.9 kg ) . Nonsignificant trends for greater intervention compared with control improvement in systolic and diastolic blood pressure were observed . CONCLUSIONS Sophisticated information technology platforms for remote patient reporting linked with theory-based health behavior change automated feedback have potential to improve patient outcomes in type 2 diabetes and merit scaled-up research efforts",
"Background : Diabetes mellitus is a complex disease with serious complications . Electronic decision support , providing information that is shared and discussed by both patient and physician , encourages timely interventions and may improve the management of this chronic disease . However , it has rarely been tested in community-based primary care . Methods : In this pragmatic r and omized trial , we r and omly assigned adult primary care patients with type 2 diabetes to receive the intervention or usual care . The intervention involved shared access by the primary care provider and the patient to a Web-based , colour-coded diabetes tracker , which provided sequential monitoring values for 13 diabetes risk factors , their respective targets and brief , prioritized messages of advice . The primary outcome measure was a process composite score . Secondary outcomes included clinical composite scores , quality of life , continuity of care and usability . The outcome assessors were blinded to each patient ’s intervention status . Results : We recruited sequentially 46 primary care providers and then 511 of their patients ( mean age 60.7 [ st and ard deviation 12.5 ] years ) . Mean follow-up was 5.9 months . The process composite score was significantly better for patients in the intervention group than for control patients ( difference 1.27 , 95 % confidence interval [ CI ] 0.79–1.75 , p clinical composite score also had significantly more variables with improvement for the intervention group ( 0.59 , 95 % CI 0.09–1.10 , p = 0.02 ) , including significantly greater declines in blood pressure ( −3.95 mm Hg systolic and −2.38 mm Hg diastolic ) and glycated hemoglobin ( −0.2 % ) . Patients in the intervention group reported greater satisfaction with their diabetes care . Interpretation : A shared electronic decision-support system to support the primary care of diabetes improved the process of care and some clinical markers of the quality of diabetes care . ( Clinical Trials.gov trial register no. NCT00813085 .",
"OBJECTIVE To assess whether modem access improves diabetes control in IDDM patients . RESEARCH DESIGN AND METHODS Forty-two patients participated in the study and were followed for 12 wk . The patients were r and omly divided into two groups at baseline , a modem group and a control group . There were no significant differences between HbA1c , r and om blood glucose , and weight between the groups at the beginning of the study . Patients were asked to perform five blood glucose determinations/day ( before breakfast , before lunch , afternoon [ 1500 ] , before dinner , and at bedtime ) twice/week . The modem group transferred their data over the phone once/week . The control group would bring in their results on their regular visits every 6 wk . Patients in the modem group were counseled every week over the telephone after transferring results to adjust insulin and food intake if necessary . RESULTS In the modem group , HbA1c improved from 0.106 to 0.092 ( 13.20 % ) . The control group improved from 0.112 to 0.102 ( 8.9 % ) . There was no significant change in weight , r and om blood glucose , or insulin . CONCLUSIONS The use of telephone modem-based patient-monitoring systems in diabetes clinical research seems to stimulate the patient to keep closer control of blood glucose levels . It might be especially useful in rural setting s , for which this study was design ed",
" A total of 175 patients with Types 1 and 2 diabetes in primary care and university hospital outpatient departments were r and omized into a study group ( n = 101 ) or usual care ( n = 74 ) . The study group used an e-health application with a diabetes management system and a home care link . Usual care did not involve e-health , i.e. the patients made regular general practitioner visits about every three months . After 12 months HbA1c decreased significantly in both groups of patients . The differences were small , but HbA1c was significantly lower in the study group than the controls . Diastolic blood pressure , fasting plasma glucose , serum total cholesterol , serum LDL-cholesterol and serum triglycerides were significantly lower in the study than in the control group . This was achieved with fewer visits by study patients to doctors and nurses . Use of e-health in diabetes care for 12 months was able to provide equivalent diabetic control to usual care , and improved cardiovascular risk factors",
"We conducted a r and omized controlled trial to investigate the efficacy and safety of a system for online glucose monitoring of type 2 diabetes patients . The software automatically filtered the self-monitored blood glucose data to reduce physicians ' time . In the control group , the physicians had to contact the patients manually . We measured the time spent by physicians for online management in a 24-week study . Seventy-nine patients were recruited . The frequency of physicians ' online monitoring of the patients was decreased by 55 % in patients with HbA1c ≤ 6.5 % and by 29 % when HbA1c > 6.5 % ( P 0.01 ) . Physicians ' log-in time was reduced by 67 % and 55 % in patients with HbA1c ≤6.5 % and > 6.5 % , respectively ( P were maintained at showed the efficacy and safety of the software for online communication in diabetes management . The results suggest that it could improve the cost-effectiveness of online communication systems and form the basis of future clinical applications",
"We conducted a six-month prospect i ve interventional crossover study examining a computerized diabetes monitoring system ( DMS ) that conveyed dietary information . The objectives were to compare glycaemic control between intervention and control periods , and to assess patients ' acceptance of the DMS . Nineteen patients were r and omized into two groups , each using the DMS for three months and serving as the control group for another three months . The patients recorded information about their meal portions and blood glucose readings in a h and -held electronic diary . After transmitting the data to the DMS through a telephone modem , the patients received immediate feedback about the carbohydrate , protein and fat content of the meal , as well as the calorie content . A significant improvement in glycaemic control was achieved during intervention compared with control periods ( mean HbA1C reduction of 0.825 % ) . The DMS was also highly acceptable : 95 % patients found it easy to operate while 63 % found it useful . The DMS was thus a feasible model of telemedicine in diabetes care and a larger study is warranted to examine its cost-effectiveness",
"BACKGROUND The emergence of the World Wide Web in the last decade has made it feasible for the Internet to be a vehicle for chronic disease management . METHODS A r and omized controlled trial ( n = 62 ) testing the effects of a 6-month web-based intervention plus usual care , compared with usual care alone , among adults 60 years of age and older with diabetes . The outcomes were hemoglobin A1c ( HbA1c ) , blood pressure , weight , cholesterol , and high-density lipoprotein ( HDL ) levels . RESULTS A multivariate analysis of covariance controlling for all baseline outcome variables , age , gender , and number of years with diabetes showed significant ( P = 0.001 ) reductions in HbA1c , weight , and cholesterol level and significant improvement in HDL levels in the intervention versus the control group . CONCLUSIONS Findings show a web-based intervention was effective in improving HbA1c , weight , cholesterol , and HDL levels at a 6-month follow-up . Future research is needed to investigate the long-term effectiveness of web-based interventions",
"PURPOSE The present study evaluated whether an intervention using the SMS by personal cellular phone and internet would improve the levels of plasma glucose of obese type 2 diabetes at 3 , 6 , 9 , and 12 months . METHODS This is a quasi-experimental design with pre- and follow-up tests . Participants were recruited from the endocrinology outpatient department of tertiary care hospital located in an urban city of South Korea . Eighteen patients were r and omly assigned to an intervention group and 16 to a control group . The goal of the intervention was to decrease body weight and keep blood glucose concentrations close to the normal range . Patients were requested to record their blood glucose level in a weekly diary on the website by personal cellular phones or computer internet . The research er sent optimal recommendations to each patient , by both the cellular phone and the Internet weekly . The intervention was applied for 1 year . RESULTS Glycosylated hemoglobin ( HbA(1)c ) decreased 1.22 percentage points at 3 months , 1.09 percentage points at 6 months , 1.47 percentage points at 9 months , and 1.49 percentage points at 12 months compared with baseline in the intervention group ( all time points , p 2-h post-pr and ial test ( 2HPPT ) of 120.1mg/dl at 3 months , 58.9 mg/dl at 6 months , 62.0mg/dl at 9 months , and 102.9 mg/dl at 12 months compared with baseline ( all time points , p web-based intervention using SMS of personal cellular phone and Internet improved HbA(1)c and 2HPPT at 3 , 6 , 9 , and 12 months in patients with obese type 2 diabetes",
"Introduction Good metabolic control is important in type 2 diabetes mellitus to improve quality of life , work ability and life expectancy , and the use of telemedicine has proved efficient as an add-on to the usual treatment . However , few studies in type 2 diabetes patients have directly compared telemedicine with conventional outpatient treatment , and we wanted to evaluate whether telemedicine , compared with st and ard care , provides equivalent clinical outcomes . Methods Forty patients with type 2 diabetes mellitus allocated from October 2011–July 2012 were r and omized to either treatment at home by video conferences only or st and ard outpatient treatment . Primary outcomes were HbA1c and blood glucose levels and secondary outcomes were 24-hour blood pressure , cholesterol levels and albuminuria . The video-telephone was a broadb and solution installed and serviced by the Danish Telephone Company ( TDC ) . Results The improvements in the two treatments , given as changes in percentage of telemedicine vs st and ard , showed significant differences in HbA1c ( −15 vs −11 % ) , mean blood glucose ( −18 vs −13 % ) and in cholesterol ( −7 vs −6 % ) . No differences in LDL ( −4 vs −6 % ) , weight ( −1 vs 2 % ) , diastolic diurnal blood pressure ( −1 vs −7 % ) , and systolic diurnal blood pressure ( 0 vs −1 % ) were found . Nine consultations were missed in the st and ard outpatient group and none in the telemedicine group . Conclusions In the direct comparison of home video consultations vs st and ard outpatient treatment in type 2 diabetes mellitus , telemedicine was a safe and available option with favourable outcomes after six months treatment",
"OBJECTIVE To determine whether a system of telemedicine support can improve glycemic control in type 1 diabetes . RESEARCH DESIGN AND METHODS A 9-month r and omized trial compared glucose self-monitoring real-time result transmission and feedback of results for the previous 24 h in the control group with real-time graphical phone-based feedback for the previous 2 weeks together with nurse-initiated support using a web-based graphical analysis of glucose self-monitoring results in the intervention group . All patients aged 18 - 30 years with HbA(1c ) ( A1C ) levels of 8 - 11 % were eligible for inclusion . RESULTS A total of 93 patients ( 55 men ) with mean diabetes duration ( means + /- SD ) 12.1 + /- 6.7 years were recruited from a young adult clinic . In total , the intervention and control groups transmitted 29,765 and 21,400 results , respectively . The corresponding median blood glucose levels were 8.9 mmol/l ( interquartile range 5.4 - 13.5 ) and 10.3 mmol/l ( 6.5 - 14.4 ) ( P reduction in A1C in the intervention group after 9 months from 9.2 + /- 1.1 to 8.6 + /- 1.4 % ( difference 0.6 % [ 95 % CI 0.3 - 1.0 ] ) and a reduction in A1C in the control group from 9.3 + /- 1.5 to 8.9 + /- 1.4 % ( difference 0.4 % [ 0.03 - 0.7 ] ) . This difference in change in A1C between groups was not statistically significant ( 0.2 % [ -0.2 to 0.7 , P = 0.3 ) . CONCLUSIONS Real-time telemedicine transmission and feedback of information about blood glucose results with nurse support is feasible and acceptable to patients , but to significantly improve glycemic control , access to real-time decision support for medication dosing and changes in diet and exercise may be required",
"AIMS The rapidly increasing prevalence of chronic diseases is an important challenge to healthcare systems worldwide . To improve the quality and efficiency of chronic disease care , we investigated the effectiveness and applicability of the Ubiquitous Chronic Disease Care ( UCDC ) system using cellular phones and the internet for overweight patients with both Type 2 diabetes and hypertension . METHODS We conducted a r and omized , controlled clinical trial over 3 months that included 123 patients at a university hospital and a community public health centre . RESULTS After 12 weeks , there were significant improvements in HbA(1c ) in the intervention group ( 7.6 + /- 0.9 % to 7.1 + /- 0.8 % , P systolic and diastolic blood pressure , as well as improvements in total cholesterol , low-density lipoprotein-cholesterol and triglyceride levels in the intervention group . Furthermore , there was a significant increase in adiponectin levels in the intervention group compared with the control group , although high-sensitivity C-reactive protein and interleukin-6 levels did not change in either group . CONCLUSIONS The novel UCDC system presented in this paper improved multiple metabolic parameters simultaneously in overweight patients with both Type 2 diabetes and hypertension",
"Abstract Objective : To determine the relation between exposure to glycaemia over time and the risk of macrovascular or microvascular complications in patients with type 2 diabetes . Design : Prospect i ve observational study . Setting : 23 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Participants : 4585 white , Asian Indian , and Afro-Caribbean UKPDS patients , whether r and omised or not to treatment , were included in analyses of incidence ; of these , 3642 were included in analyses of relative risk . Outcome measures : Primary predefined aggregate clinical outcomes : any end point or deaths related to diabetes and all cause mortality . Secondary aggregate outcomes : myocardial infa rct ion , stroke , amputation ( including death from peripheral vascular disease ) , and microvascular disease ( predominantly retinal photo-coagulation ) . Single end points : non-fatal heart failure and cataract extraction . Risk reduction associated with a 1 % reduction in up date d mean HbA1c adjusted for possible confounders at diagnosis of diabetes . Results : The incidence of clinical complications was significantly associated with glycaemia . Each 1 % reduction in up date d mean HbA1c was associated with reductions in risk of 21 % for any end point related to diabetes ( 95 % confidence interval 17 % to 24 % , P deaths related to diabetes ( 15 % to 27 % , P myocardial infa rct ion ( 8 % to 21 % , P microvascular complications ( 33 % to 41 % , P patients with type 2 diabetes the risk of diabetic complications was strongly associated with previous hyperglycaemia . Any reduction in HbA1c is likely to reduce the risk of complications , with the lowest risk being in those with HbA1c values in the normal range ( < 6.0 % )",
"OBJECTIVE To determine the effect of mobile phone intervention on HbA1c in type-2 Diabetes Mellitus ( DM ) patients living in rural areas of Pakistan . STUDY DESIGN R and omized controlled trial . PLACE AND DURATION OF STUDY Department of Endocrinology , Liaquat National Hospital , Karachi , from December 2013 to June 2014 . METHODOLOGY A total of 440 patients in intervention and control groups were enrolled . All patients between 18 - 70 years of age , residing in rural areas of Pakistan , HbA1c ³ 8.0 % and having personal functional mobile phone were included . The intervention group patients were called directly on mobile phone after every 15 days for a period of 4 months . They were asked about the self-monitoring blood glucose , intake of medications , physical activity , healthy eating and were physically examined after 4 months . However , the control group was examined initially and after 4 months physically in the clinic and there were no mobile phone contacts with these patients . RESULTS Patients in intervention group showed improvement ( p 0.001 ) in following diet plan from 17.3 % at baseline to 43.6 % at endline , however , the control group showed insignificant increase ( p=0.522 ) from 13.6 % at baseline to 15.9 % at endline . Intervention group ( RR = 2.71 , 95 % CI = 1.18 - 6.40 ) showed significant positive association with normalization of HbA1c levels . The relationship was adjusted for age , gender , socio-economic status , ethnicity , education , hypertension , medication , BMI , diet , LDL levels and physical activity . Dietary restriction and low LDL levels also showed significant associations with reduced HbA1c levels on multivariate analysis . CONCLUSION Mobile phone technology in rural areas of Pakistan was helpful in lowering HbA1c levels in intervention group through direct communication with the diabetic patients . Lowering LDL and following diabetic diet plan can reduce HbA1c in these patients and help in preventing future complications",
"BACKGROUND Disease management programs that include ongoing telephone support for patients with diabetes have shown promise , but published studies have enrolled few socially and economically disadvantaged patients . METHODS We conducted a r and omized controlled trial with 201 patients with poorly controlled type 2 diabetes mellitus ( 72 % African American or Latino ; 74 % with incomes of ≤$15,000 ) . Participants were r and omized to an intervention package consisting of a 24-minute video behavior support intervention with a workbook and 5 sessions of telephone coaching by a trained diabetes nurse or a 20-page brochure developed by the National Diabetes Education Program . Study measures were completed at baseline , 1 month , and 6 months . Participants ' review of the intervention material s was assessed at 1 month . The primary trial end point was hemoglobin A(1c ) value . Secondary end points included lipid levels , blood pressure , diabetes knowledge , and self-care behaviors . Data were analyzed with repeated measures analysis of variance . RESULTS Most participants in both groups ( 94 % ) review ed the intervention provided , and 73 % of participants assigned to the experimental group completed 5 sessions of telephone coaching . There was a significant overall reduction in mean ( SD ) hemoglobin A(1c ) value from baseline ( 9.6 % [ 2.0 % ] ) to 6 months ( 9.1 % [ 1.9 % ] ) ( P on other clinical measures ( lipid levels and blood pressure ) and measures of diabetes knowledge and self-care behaviors were also nonsignificant . CONCLUSIONS There was no significant effect of the experimental intervention compared with the control condition . The dose of intervention provided was less than in previously published studies . More intensive interventions may be necessary for the most disadvantaged patients . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00668590",
"Background : Telehealth-supported clinical interventions may improve diabetes self-management . We explored the feasibility of stepwise self-titration of oral glucose-lowering medication guided by a mobile telephone-based telehealth platform for improving glycemic control in type 2 diabetes . Methods : We recruited 14 type 2 diabetes patients to a one-year feasibility study with 1:1 r and omization . Intervention group patients followed a stepwise treatment plan for titration of oral glucose-lowering medication with self-monitoring of glycemia using real-time graphical feedback on a mobile telephone and remote nurse monitoring using a Web-based tool . We carried out an interim analysis at 6 months . Results : We screened 3476 type 2 diabetes patients ; 94 % of the ineligible did not meet the eligibility criteria for hemoglobin A1c ( HbA1c ) or current treatment . Mean ( st and ard deviation ) patient age at baseline was 58 ( 11 ) years , HbA1c was 65 ( 12 ) mmol/mol ( 8.1 % [ 1.1 % ] ) , body mass index was 32.9 ( 6.4 ) kg/m2 , median [ interquartile range ( IQR ) ] diabetes duration was 2.6 ( 0.6 to 4.7 ) years , and 10 ( 71 % ) were men . The median ( IQR ) change in HbA1c from baseline to six months was −10 ( −21 to 3 ) mmol/mol ( −0.9 % [ -1.9 % to 0 % ] ) in the intervention group and −5 ( −13 to 6 ) mmol/mol ( −0.5 % [ -1.2 % to 0.6 % ] ) in the control group . Six out of seven intervention group patients and four out of seven control group patients changed their oral glucose-lowering medication ( p = .24 ) . Conclusions : Self-titration of oral glucose-lowering medication in type 2 diabetes with self-monitoring and remote monitoring of glycemia is feasible , and further studies using adapted recruitment strategies are required to evaluate whether it improves clinical outcomes ",
"Background : This study examined whether mobile phone-based , one-way video messages about diabetes self-care improve hemoglobin A1c ( A1C ) and self-monitoring of blood glucose ( SMBG ) . Methods : This was a 1-year prospect i ve r and omized trial with two groups . The active intervention lasted 6 months . The study enrolled 65 people with A1C > 8.0 % who were established ( > 6 months ) patients in the endocrinology clinics of the Walter Reed Health Care System . Participants were r and omized to receive “ usual care ” or self-care video messages from their diabetes nurse practitioner . Video messages were sent daily to cell phones of study participants . Hemoglobin A1c and SMBG data were collected at 0 , 3 , 6 , 9 , and 12 months . Results : Participants who received the messages had a larger rate of decline in A1C than people who received usual care ( 0.2 % difference over 12 months , adjusting for covariates ; p = .002 and p = .004 for the interaction between time and group and for the quadratic effect of time by group , respectively ) . Hemoglobin A1c decline was greatest among participants who received video messages and viewed > 10 a month ( 0.6 % difference over 12 months , adjusting for covariates ; p Self-monitoring of blood glucose metrics were not related to the intervention . Conclusions : A one-way intervention using mobile phone-based video messages about diabetes self-care can improve A1C . Engagement with the technology is an important predictor of its success . This intervention is simple to implement and sustain",
"AIM Conventional follow-up of type 1 diabetic patients treated with continuous subcutaneous insulin infusion ( CSII ) was compared with intensive coaching using the Web and the cellular phone network for retrospective data transmission and short message service ( SMS ) . METHODS Thirty poorly controlled patients ( HbA1c 7.5 - 10 % ) were enrolled in a bicenter , open-label , r and omized , 12-month , two-period , crossover study . After a 1-month run-in period , 15 patients were r and omly assigned to receive weekly medical support through SMS based upon weekly review of glucose values , while 15 patients continued to download self-monitored blood glucose ( SMBG ) values on a weekly basis without receiving SMS . After 6 months , patients crossed over to the alternate sequence for 6 additional months . Visits at the clinic were maintained every 3 months . RESULTS Patients with long-st and ing inadequately controlled diabetes ( 24 + /- 13 years ) were included . A non-significant trend to reduction in HbA(1c ) ( -0.25+/-0.94 % , P mean glucose values ( -9.2+/-25 mg/dl , P=0.06 ) during the 6-month SMS sequence was observed as compared with the no-SMS period . No safety issue ( hypoglycemia , glucose variability ) was reported . Adherence to SMBG was not affected by the trial . Quality of life analysis suggests a significant improvement in DQOL global score , as well as the DQOL satisfaction with life subscale , during the SMS sequence . CONCLUSIONS Long-term telemedical follow-up of insulin pump-treated patients using a cellular phone- , SMS- and Web-based platform is feasible , safe , does not alter quality of life and associated with a trend toward improved metabolic control",
"OBJECTIVE There is a well-documented gap between diabetes care guidelines and the services received by patients in most health care setting s. This report presents 12-month follow-up results from a computer-assisted , patient-centered intervention to improve the level of recommended services patients received from a variety of primary care setting s. RESEARCH DESIGN AND METHODS A total of 886 patients with type 2 diabetes under the care of 52 primary care physicians participated in the Diabetes Priority Program . Physicians were stratified and r and omized to intervention or control conditions and evaluated on two primary outcomes : number of recommended laboratory screenings and recommended patient-centered care activities completed from the National Committee on Quality Assurance/American Diabetes Association Provider Recognition Program ( PRP ) . Secondary outcomes were evaluated using the Problem Areas in Diabetes 2 quality of life scale , lipid and HbA1c levels , and the Patient Health Question naire-9 depression scale . RESULTS The program was well implemented and significantly improved both the number of laboratory assays and patient-centered aspects of diabetes care patients received compared with those in the control condition . There was overall improvement on secondary outcomes of lipids , HbA1c , quality of life , and depression scores ; between-condition differences were not significant . CONCLUSIONS Staff in small , mixed-payer primary care offices can consistently implement a patient-centered intervention to improve PRP measures of quality of diabetes care . Alternative explanations for why these process improvements did not lead to improved outcomes , and suggested directions for future research are discussed",
"PURPOSE We sought to evaluate the effect of automated telephone assessment and self-care education calls with nurse follow-up on the management of diabetes . SUBJECTS AND METHODS We enrolled 280 English- or Spanish-speaking adults with diabetes who were using hypoglycemic medications and who were treated in a county health care system . Patients were r and omly assigned to usual care or to receive an intervention that consisted of usual care plus bi-weekly automated assessment and self-care education calls with telephone follow-up by a nurse educator . Outcomes measured at 12 months included survey-reported self-care , perceived glycemic control , and symptoms , as well as glycosylated hemoglobin ( Hb A1c ) and serum glucose levels . RESULTS We collected follow-up data for 89 % of enrollees ( 248 patients ) . Compared with usual care patients , intervention patients reported more frequent glucose monitoring , foot inspection , and weight monitoring , and fewer problems with medication adherence ( all P -0.03 ) . Follow-up Hb A , , levels were 0.3 % lower in the intervention group ( P = 0.1 ) , and about twice as many intervention patients had Hb A1c levels within the normal range ( P = 0.04 ) . Serum glucose levels were 41 mg/dL lower among intervention patients than usual care patients ( P = 0.002 ) . Intervention patients also reported better glycemic control ( P = 0.005 ) and fewer diabetic symptoms ( P symptoms of hyperglycemia and hypoglycemia . CONCLUSIONS Automated calls with telephone nurse follow-up may be an effective strategy for improving self-care behavior and glycemic control , and for decreasing symptoms among vulnerable patients with diabetes",
"Background : Training and continuous dynamic communication between patients and health professionals in chronic diseases like diabetes , is important . The aim of this study is to evaluate the effects of diabetes self-care group education and nurse- telephone follow-up on glycemic control and compliance with treatment orders in patients with type 2 diabetes attending to diabetes clinic in khomein . Methods : In this clinical trial , 62 patients with type 2 diabetes who attending to the diabetes clinic selected and were r and omly assigned to experiment and control groups . Self-care group education was applied for case group ( n = 31 ) and they were followed up using telephone calls for 12 weeks by a nurse . The control group ( n = 31 ) received the conventional management . Demographic characteristics , compliance with treatment recommendations ( diet , drug use , exercise ) and blood glucose control indices were recorded before and after interventions . Data were analyzed by SPSS software version 16 using independent t-test , paired t-test , Chi-square test , non-parametric tests , mixed model ( ANOVA + repeated measure ) and ANCOVA . Results : The mean age of intervention and control groups was 50.9 ± 7.3 and 55.1 ± 10.1 years , respectively . Blood glucose indices ( FBS , 2 hpp BS , Hb A1C ) were improved in both case and control group after intervention but it was only statistically significant in case group P > 0.0001 . During study , percentage of patients with very good compliance in control group decrease from 12.5 % to zero ( 0 % ) , whereas in experiment group these amounts increase from 6.5 % to 90.3 % P > 0.0001 . Conclusions : According to the results of the current study self-care group education and 12 weeks follow-up by a nurse using telephone causes significant improvement in metabolic parameters and adherence to treatment recommendations in diabetic patients",
"BACKGROUND Re source barriers complicate diabetes care management . Support from peers may help patients manage their diabetes . OBJECTIVE To compare a reciprocal peer-support ( RPS ) program with nurse care management ( NCM ) . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00320112 ) SETTING 2 U.S. Department of Veterans Affairs health care facilities . PATIENTS 244 men with hemoglobin A(1c ) ( HbA(1c ) ) levels greater than 7.5 % during the previous 6 months . MEASUREMENTS The primary outcome was 6-month change in HbA(1c ) level . Secondary outcomes were changes in insulin therapy ; blood pressure ; and patient reports of medication adherence , diabetes-related support , and emotional distress . INTERVENTION Patients in the RPS group attended an initial group session to set diabetes-related behavioral goals , receive peer communication skills training , and be paired with another age-matched peer patient . Peers were encouraged to talk weekly using a telephone platform that recorded call occurrence and provided reminders to promote peer contact . These patients could also participate in optional group sessions at 1 , 3 , and 6 months . Patients in the NCM group attended a 1.5-hour educational session and were assigned to a nurse care manager . RESULTS Of the 244 patients enrolled , 216 ( 89 % ) completed the HbA(1c ) assessment s and 231 ( 95 % ) completed the survey assessment s at 6 months . Mean HbA(1c ) level decreased from 8.02 % to 7.73 % ( change , -0.29 % ) in the RPS group and increased from 7.93 % to 8.22 % ( change , 0.29 % ) in the NCM group . The difference in HbA(1c ) change between groups was 0.58 % ( P = 0.004 ) . Among patients with a baseline HbA(1c ) level greater than 8.0 % , those in the RPS group had a mean decrease of 0.88 % , compared with a 0.07 % decrease among those in the NCM group ( between-group difference , 0.81 % ; P insulin therapy , compared with 1 patient in the NCM group ( P = 0.020 ) . Groups did not differ in blood pressure , self-reported medication adherence , or diabetes-specific distress , but the RPS group reported improvement in diabetes social support . LIMITATION The study included only male veterans and lasted only 6 months . CONCLUSION Reciprocal peer support holds promise as a method for diabetes care management",
"AIM To determine whether a nurse telephone follow-up service could improve the level of adherence to a diabetes therapeutic regimen for patients with type 2 diabetes . METHODS A total of 61 patients attended a 3 day diabetes self-care program at the Iranian Diabetes Society . They were r and omly assigned to one of the experimental or control groups . A telephone follow-up program was applied to the experimental group for 3 months , twice per week for the first month and weekly for the second and third months . The data - collection instruments included a data sheet to record the glycosylated hemoglobin ( HbA1c ) level and a question naire . The data were collected at baseline and after 12 weeks . RESULTS There were significant differences between the control and the experimental groups in their adherence to a diabetic diet , exercise , foot care , blood glucose monitoring , and medication-taking . Also , the HbA1c levels differed significantly between the two groups after 3 months . CONCLUSION A nurse-led telephone follow-up was effective in enhancing the level of adherence to a diabetes therapeutic regimen , such that the HbA1c level decreased",
"BACKGROUND Increased emphasis is being placed on the critical need to control hypertension ( HTN ) in patients with diabetes . OBJECTIVE The objective of this study was to evaluate the efficacy of a nurse-managed home telehealth intervention to improve outcomes in veterans with comorbid diabetes and HTN . DESIGN A single-center , r and omized , controlled clinical trial design comparing two remote monitoring intensity levels and usual care in patients with type 2 diabetes and HTN being treated in primary care was used . MEASUREMENTS Primary outcomes were hemoglobin A1c and systolic blood pressure ( SBP ) ; secondary outcome was adherence . RESULTS Intervention subjects experienced decreased A1c during the 6-month intervention period compared with the control group , but 6 months after the intervention was withdrawn , the intervention groups were comparable with the control group . For SBP , the high-intensity subjects had a significant decrease in SBP compared with the other groups at 6 months and this pattern was maintained at 12 months . Adherence improved over time for all groups , but there were no differences among the three groups . LIMITATIONS Subjects had relatively good baseline control for A1c and SBP ; minorities and women were underrepresented . CONCLUSIONS Home telehealth provides an innovative and pragmatic approach to enhance earlier detection of key clinical symptoms requiring intervention . Transmission of education and advice to the patient on an ongoing basis with close surveillance by nurses can improve clinical outcomes in patients with comorbid chronic illness",
"The objective of this study was to evaluate the value of an intensive telephone follow-up as an additional component of a diabetes disease management program already shown to be effective in improving glycemic control , adherence with American Diabetes Association ( ADA ) st and ards of care , and health-related quality of life ( HRQOL ) . The study involved a r and omized controlled trial . The intervention group received a series of 12 weekly phone calls reinforcing base education and self-management skills . Five hundred and seven consenting patients , age 18 years or older , with type 1 or type 2 diabetes mellitus referred to the hospital- based disease management program who had telephones and were able to complete surveys in English or Spanish were enrolled . Outcomes were evaluated at 3 and 12 months follow- up . Adherence to ADA st and ards of care , specifically annual eye exams , physician foot exams , foot self-exams , and pneumonia vaccination were significantly better with the added telephone intervention , but there were no differences between the groups on glycemic control , HRQOL , or patient satisfaction . The effectiveness of the disease management program was replicated with sustained improvement in glycemic control , HRQOL , and adherence to ADA st and ards . The additional telephone intervention further improved adherence to ADA guidelines for self-care and medical care but did not affect glycemic control or HRQOL",
"BACKGROUND Failure to achieve treatment targets is common among people with type 2 diabetes . Cost-effective treatments are required to delay the onset and slow the progression of diabetes-related complications . AIMS This study aim ed to measure the effect of a 6-month telephone coaching intervention on glycaemic control , risk factor status and adherence to diabetes management practice s at the intervention 's conclusion ( 6 months ) and at 12 months . METHOD This r and omised controlled trial recruited 94 adults with type 2 diabetes and an HbA1C > 7 % from the Diabetes Clinic of St Vincent 's Hospital Melbourne . People who were non-English speaking , cognitively impaired , severely hearing impaired or without telephone access were excluded . Participants were r and omised to receive usual care plus 6 months of telephone coaching focusing on achieving treatment targets and complication screening , or usual care only . The primary outcome was HbA1C at 6 months ; secondary outcomes included other physiological and monitoring measures . RESULTS Significant interaction effects were observed between group and time at 6 months , demonstrating improvement in HbA1C , fasting glucose , diastolic blood pressure and physical activity . The intervention 's effect on these parameters was not sustained at 12 months . Intervention group participants also improved compliance with foot examinations and pneumococcal vaccination by 6 months and retinal screening by 12 months . CONCLUSIONS Telephone coaching improved glycaemic control and adherence to complication screening in people with type 2 diabetes , for the duration of its delivery , but these effects were not maintained on withdrawal of the intervention . Strategies that assist patients to sustain these benefits are required",
"BACKGROUND Patients with insulin dependent diabetes require frequent advice if their metabolic control is not optimal . This study focuses on the fiscal and administrative aspects of telemanagement , which was used to establish a supervised autonomy of patients on intensified insulin therapy . METHODS A prospect i ve , r and omised trial with 43 patients on intensified insulin therapy was conducted . Travelling distance to the diabetes centre was 50 min one way ; all patients had undergone a diabetes education course with lessons in dose adaptation . Patients were r and omly assigned to telecare ( n=27 ) or conventional care ( n=16 ) . They used BG-meters with a storage capacity of 120 values ( Precision QID Abbott/Medisense ) and transmitted their data over a combined modem/interface via telephone line to the diabetes centre . Data were displayed and stored by a customised software ( Precision Link Plus , Abbott/Medisense ) . Advice for proper dose adjustment was given by telephone . RESULTS Average time needed for instruction in the telemedical system was 15 min . Data were transmitted every 1 - 3 weeks and a teleconsultation was performed by phone every 2 - 4 weeks , depending on the extent of specific problems . On average , personal visits in the control group were performed once a month . Physician 's time expenditure for telemanagement , compared to conventional advice was moderately higher ( 50 vs. 42 min per month ) . A substantial amount of time on the patients side could be saved through replacing personal communications by telephone contacts and data transmission reduction ( 96 vs. 163 min/month including data transmission time ) . Setting up an optimal telemanagement scenario , a cost analysis was carried out yielding savings of approximately 650 euro per year per patient . HbA(1c ) dropped significantly from 8.2 to 7.0 % after 8 months of observation , but there was no significant difference between the intervention and control groups . Major technical problems with the telematic system did not occur during the study . CONCLUSIONS Telemanagement of insulin-requiring diabetic patients is a cost and time saving procedure for the patients and results in metabolic control comparable to conventional outpatient management",
"IMPORTANCE In type 2 diabetes mellitus ( T2DM ) , team management using protocol s with regular feedback improves clinical outcomes , although suboptimal self-management and psychological distress remain significant challenges . OBJECTIVE To investigate if frequent contacts through a telephone-based peer support program ( Peer Support , Empowerment , and Remote Communication Linked by Information Technology [ PEARL ] ) would improve cardiometabolic risk and health outcomes by enhancing psychological well-being and self-care in patients receiving integrated care implemented through a web-based multicomponent quality improvement program ( JADE [ Joint Asia Diabetes Evaluation ] ) . DESIGN , SETTING , AND PARTICIPANTS Between 2009 and 2010 , 628 of 2766 Hong Kong Chinese patients with T2DM from 3 publicly funded hospital-based diabetes centers were r and omized to the JADE + PEARL ( n = 312 ) or JADE ( n = 316 ) groups , with comprehensive assessment at 0 and 12 months . INTERVENTIONS Thirty-three motivated patients with well-controlled T2DM received 32 hours of training ( four 8-hour workshops ) to become peer supporters , with 10 patients assigned to each . Peer supporters called their peers at least 12 times , guided by a checklist . MAIN OUTCOMES AND MEASURES Changes in hemoglobin A(1c ) ( HbA(1c ) ) level ( primary ) , proportions of patients with attained treatment targets ( HbA(1c ) blood pressure mm Hg ; low-density lipoprotein cholesterol mmol/L [ to convert to milligrams per deciliter , divide by 0.0256 ] ) ( secondary ) , and other health outcomes at month 12 . RESULTS Both groups had similar baseline characteristics ( mean [ SD ] age , 54.7 [ 9.3 ] years ; 57 % men ; disease duration , 9.4 [ 7.7 ] years ; HbA(1c ) level , 8.2 % [ 1.6 % ] ; systolic blood pressure , 136 [ 19 ] mm Hg ; low-density lipoprotein cholesterol level , 2.89 [ 0.82 ] mmol/L ; 17.4 % cardiovascular-renal complications ; and 34.9 % insulin treated ) . After a mean ( SD ) follow-up period of 414 ( 55 ) days , 5 patients had died , 144 had at least 1 hospitalization , and 586 had repeated comprehensive assessment s. On intention-to-treat analysis , both groups had similar reductions in HbA(1c ) ( JADE + PEARL , 0.30 % [ 95 % CI , 0.12%-0.47 % ] , vs JADE , 0.29 % [ 95 % CI , 0.12%-0.47 % ] [ P = .97 ] ) and improvements in treatment targets and psychological-behavioral measures . In the JADE + PEARL group , 90 % of patients maintained contacts with their peer supporters , with a median of 20 calls per patient . Most of the discussion items were related to self-management . CONCLUSIONS AND RELEVANCE In patients with T2DM receiving integrated care , peer support did not improve cardiometabolic risks or psychological well-being . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00950716",
"BACKGROUND Diabetes education can improve the quality of care of people with diabetes , but many organizations are not equipped to manage its implementation . Involving people with diabetes in the education process can overcome the problem . Thus , we compared clinical , metabolic and psychological outcomes in people with type 2 diabetes 1 year after attending a structured diabetes education programme implemented by professional educators versus the same programme implemented by trained peers with diabetes that also provided ongoing peer support . METHODS People with type 2 diabetes ( 25 - 75 years ) were r and omly assigned to attend a 4-week structured diabetes education course delivered by professional educators ( control ) or previously trained peers ( peer ) . Peers also received continuing psychological support , including examples on how to apply diabetes knowledge in daily life via weekly peer cellular phone calls and bimonthly face-to-face interviews in small groups ( ten patients ) , using a structured question naire related to the patient 's clinical , metabolic and psychological progress . Identical outcome data from both groups were used for follow-up . RESULTS Both groups had a comparable positive effect on clinical , metabolic and psychological indicators immediately following the programme . Over the following year , peer-educated subjects had lower A(1C ) and systolic blood pressure and showed higher adherence to physical activity and better control of hypoglycaemic episodes . CONCLUSION The non-inferiority of the peer outcomes and the mentioned improvements in this group suggest that volunteer trained peer educators and ongoing support can be successful . This approach provides an effective alternative method of education , especially in areas with limited availability of professionals and economic re sources",
"Objectives This r and omized controlled trial investigated whether a patient-centered supportive counseling intervention comprising monthly telephone-based counseling sessions by practice nurses over 12 months improved diabetes-related medical and psycho-social outcomes above usual care in type 2 diabetes patients with poor glycemic control at baseline ( HbA1c > 7.5 % ) in a primary care setting . Research Design Patients were individually r and omized into intervention ( n = 103 ) and usual care group ( n = 101 ) . The primary outcome was change in HbA1c-concentration after 12 and 18 months . Secondary outcomes were lipid levels , blood pressure , health-related quality of life and symptoms of depression . Follow-up- measurements were carried out after 6 , 12 and 18 months to assess potential immediate and maintained effects of the intervention . For the multivariate analysis , hierarchical linear models were computed for each outcome to assess within-group changes in outcomes over time and between-group differences in patterns of change . Results HbA1c ( in % ) decreased significantly from baseline to 12-month follow-up measurement both in the intervention ( −0.44 ) and the usual care group ( −0.51 ) , but there was no significant between-group intervention effect . Significant improvements in the intervention group along with significant between-group differences were seen for health-related quality of life and , transiently , for systolic blood pressure and depression . Conclusions Although we found no beneficial effect of the supportive telephone counseling in terms of a reduction of HbA1c above usual care , our findings suggest some beneficial effects on cardiovascular risk factors , quality of life and depression . Continuous efforts might be needed to sustain improvements in patient outcomes . Trial Registration Clinical Trials.gov",
"AIMS To estimate the efficacy of a self-monitoring-based disease management strategy in patients with Type 2 diabetes treated with oral agent monotherapy . METHODS This was an open-label , r and omized , pilot study , primarily led by diabetes nurses . Patients were r and omly allocated to either a self-monitoring-based disease management strategy or usual care ( ratio 3:1 ) and followed up for 6 months . Education was centred on how to modify lifestyle according self-monitoring readings . Self-monitoring of blood glucose results were discussed during monthly telephone contact . The primary endpoint was mean change in HbA(1c ) levels , estimated with an ANOVA for repeated measures . All analyses were intention to treat . RESULTS Three diabetic clinics recruited 62 patients , of whom five were lost to follow-up . At baseline , both groups had a mean HbA(1c ) value of 7.9 % ± 0.6 % ( 63 ± 6 mmol/mol ) . After 6 months , mean HbA(1c ) reduction was 1.2 ± 0.1 % ( -13 ± 1 mmol/mol ) in the intervention group and 0.7 ± 0.2 (-8 ± 2 mmol/mol ) in the control group , with an absolute mean difference between groups of -0.5 % ( 95 % CI -0.9 to -0.0 % ; P = 0.04 ) ( -5 mmol/mol , 95 % CI -10 to 0 ) . At study end , 61.9 % of patients in the intervention group and 20.0 % in the control group reached the target level of HbA(1c ) ( P = 0.005 ) . Body weight reduction was significantly greater in the intervention group than in the control group ( between-group absolute mean difference : -3.99 kg ; 95 % CI -7.26 to -0.73 ; P = 0.02 ) . Therapy changes were more frequent in the control group . CONCLUSIONS A self-monitoring disease management strategy , primarily led by diabetes nurses and allowing a timely and efficient use of self-monitoring readings , is able to improve metabolic control , primarily through lifestyle modifications leading to weight loss",
"BACKGROUND Glycemic goals ( hemoglobin A1c patients with type 2 diabetes despite the availability of many effective treatments and the documented benefits of glycemic control in the reduction of long-term microvascular and macrovascular complications . Several studies have established the important positive effects of pharmacist-led management on achieving glycemic control and other clinical outcomes in patients with diabetes . Diabetes prevalence and mortality are increasing rapidly in Jordan . Nevertheless , clinical pharmacists in Jordan do not typically provide pharmaceutical care ; instead , the principal responsibilities of pharmacists in Jordan are dispensing and marketing of medical products to physicians . OBJECTIVE To assess the primary clinical outcome of glycemic control ( A1c ) and secondary outcomes , including blood pressure , lipid values , self-reported medication adherence , and self-care activities for patients with type 2 diabetes in an outpatient diabetes clinic r and omly assigned to either usual care or a pharmacist-led pharmaceutical care intervention program . METHODS Patients with type 2 diabetes attending an outpatient diabetes clinic of a large teaching hospital were recruited over a 4-month period from January through April 2011 and r and omly assigned to intervention and usual care groups using the Minim software technique . The intervention group at baseline received face-to-face objective -directed education from a clinical pharmacist about type 2 diabetes , prescription medications , and necessary lifestyle changes , followed by 8 weekly telephone follow-up calls to discuss and review the prescribed treatment plan and to resolve any patient concerns . The primary outcome measure was glycemic control ( A1c ) , and secondary measures included systolic and diastolic blood pressure , complete lipid profile ( i.e. , total cholesterol , low-density lipoprotein cholesterol [ LDL-C ] , high-density lipoprotein cholesterol [ HDL-C ] , serum triglycerides ) , and self-reported medication adherence ( 4-item Morisky Scale ) and self-care activities ( Summary of Diabetes Self-Care Activities question naire ) . Data were collected at baseline and at 6 months follow-up . Changes from baseline to follow-up were calculated for biomarker values , and between-group differences in the change amounts were tested using the t test for independent sample s. A P value of usual care had baseline and 6-month follow-up values . Compared with baseline values , patients in the intervention group had a mean reduction of 0.8 % in A1c versus a mean increase of 0.1 % from baseline in the usual care group ( P = 0.019 ) . The intervention group compared with the usual care group had small but statistically significant improvements in the secondary measures of fasting blood glucose , systolic and diastolic blood pressure , total cholesterol , LDL-C , serum triglycerides , self-reported medication adherence , and self-care activities . Between-group differences in changes in the secondary measures of HDL-C and body mass index were not significant . CONCLUSIONS Patients with type 2 diabetes who received pharmacist-led pharmaceutical care in an outpatient diabetes clinic experienced reduction in A1c at 6 months compared with essentially no change in the usual care group . Six of 8 secondary biomarkers were improved in the intervention group compared with usual care",
"Effective control of diabetes is known to delay or prevent the end-organ complications of this disease . Can telemedicine improve a patient 's ability to self-manage diabetes ? Twenty-eight patients entered a study comparing home telemedicine consultation with st and ard outpatient care . A nurse case manager contacted the telemedicine group once a week under the direction of a primary care physician , who contacted the telemedicine group once a month . Laboratory studies and total body weight were measured at the beginning and at the end of the 3-month study . The hemoglobin A1c ( HbA1c ) and total body weight improved significantly in the intervention ( telemedicine ) group , as shown by a 16 % reduction in mean HbA1c level ( from 9.5 to 8.2 % ) and a 4 % mean weight reduction ( from 214.3 to 206.7 pounds ) . Based on our experience , we present a functionally based telemedicine classification system to improve the application of electronic medicine in future studies",
"AIMS To evaluate the feasibility and effectiveness of a telemedicine system based on internet in the follow-up of patients with type 2 diabetes mellitus ( T2DM ) . METHODS A prospect i ve r and omized telemedicine study with two parallel groups was design ed . 114 patients diagnosed T2DM were r and omly divided into telemedicine group and traditional face-to-face visit group as control . 57 cases were included for each group . 108 patients completed the trial , in which 53 cases in telemedicine group and 55 cases in control group . Patients in telemedicine group were taught to use telemedicine software to upload their blood glucose and other metabolic information at home at least every 2 weeks , and the research ers gave proper advices according to patients ' key behaviors . The telemedicine interval is 3 months . RESULTS Compared to control group , telemedicine group exhibited better HbA1c and fasting blood glucose controlling ( P decreased hypoglycemia risk ( P = 0.044 ) , and contributed to levels of HbA1c less than 7 % which is the target of our study ( P = 0.049 ) . CONCLUSIONS Telemedicine system can provide a tighter glycemic control for the treatment of T2DM patients , especially in cases with difficulties to access to the medical centre",
"BACKGROUND We design ed a system for diabetes patients treated with glargine , a long-acting insulin , to make an automatic adjustment of insulin dose based on glucose level data and to provide the patients with the needed insulin dose by using a short message service ( SMS ) . We also compared diabetes patients who used our system with patients who received the conventional titration scheme . METHODS Included were 100 type 2 diabetes patients whose blood glucose was suboptimally controlled on their previous antidiabetes treatment . Each participant was assigned to either the intervention or control group , each with 50 patients , using adaptive r and omization . We applied our system to the intervention group for 12 weeks , whereas the control group received a conventional titration scheme , seeking a target fasting blood glucose of 120 mg/dL. RESULTS The fasting and postpr and ial glucose levels of the intervention group declined earlier than those of the control group . Lastly , a greater ( P = 0.023 ) reduction in hemoglobin A(1C ) from baseline to the end point was observed in the intervention group ( from 9.8 + /- 1.3 % to 7.4 + /- 0.7 % ) than in the control group ( from 9.8 + /- 1.2 % to 7.8 + /- 0.8 % ) . The incidence of symptomatic , asymptomatic , and nocturnal hypoglycemia was similar in both groups . There was a small increase in body weight from baseline to the end point with both the intervention ( 2.4 + /- 3.0 kg ) and control ( 2.2 + /- 2.8 kg ) groups . CONCLUSIONS This study demonstrated that SMS based on our specialized Internet-supported system is an effective and safe approach to long-acting insulin dose adjustments in patients with type 2 diabetes",
"Background : In the United States , Spanish-speaking patients with diabetes often receive inadequate dietary counseling . Providing language and culture-concordant dietary counseling on an ongoing basis is critical to diabetes self-care . Objective : To determine if automated telephone nutrition support ( ATNS ) counseling could help patients improve glycemic control by duplicating a successful pilot in Mexico in a Spanish-speaking population in Oakl and , California . Design : A prospect i ve r and omized open-label trial with blinded endpoint assessment ( PROBE ) was performed . Participants : The participants were seventy-five adult patients with diabetes receiving care at a federally qualified health center in Oakl and , California . Interventions : ATNS , a computerized system that dialed patients on their phones , prompted them in Spanish to enter ( via keypad ) portions consumed in the prior 24 hours of various cultural-specific dietary items , and then provided dietary feedback based on proportion of high versus low glycemic index foods consumed . The control group received the same ATNS phone calls 14 weeks after enrollment . Main Measures : The primary outcome was hemoglobin A1c % ( A1c ) 12 weeks following enrollment . Key Results : Participants had no significant improvement in A1c ( –0.3 % in the control arm , –0.1 % in the intervention arm , P = .41 for any difference ) or any secondary parameters . Conclusions : In our study , an ATNS system did not improve diabetes control in a Spanish-speaking population in Oakl and",
"OBJECTIVE To determine whether Pro-Active Call Center Treatment Support ( PACCTS ) , using trained nonmedical telephonists supported by specially design ed software and a diabetes nurse , can effectively improve glycemic control in type 2 diabetes . RESEARCH DESIGN AND METHODS A r and omized controlled implementation trial of 1-year duration was conducted in Salford , U.K. The trial comprised 591 r and omly selected individuals with type 2 diabetes . By r and om allocation , 197 individuals were assigned to the usual care ( control ) group and 394 to the PACCTS ( intervention ) group . Lifestyle advice and drug treatment in both groups followed local guidelines . PACCTS patients were telephoned according to a protocol with the frequency of calls proportional to the last HbA(1c ) level . The primary outcome was absolute reduction in HbA(1c ) , and the secondary outcome was the proportion of patients reducing HbA(1c ) by at least 1 % . RESULTS A total of 332 patients ( 84 % ) in the PACCTS group and 176 patients ( 89 % ) in the control group completed the study . Final HbA(1c ) values were available in 374 patients ( 95 % ) in the PACCTS group and 180 patients ( 92 % ) in the usual care group . Compared with usual care , HbA(1c ) improved by 0.31 % ( 95 % CI 0.11 - 0.52 , P = 0.003 ) overall in the PACCTS patients . For patients with baseline HbA(1c ) > 7 % , the improvement increased to 0.49 % ( 0.21 - 0.77 , P achieving a > /=1 % reduction in HbA(1c ) significantly favored the PACCTS intervention : 10 % ( 4 - 16 , P 7 % . CONCLUSIONS In an urban Caucasian trial population with blood glucose HbA(1c ) > 7 % , PACCTS facilitated significant improvement in glycemic control . Further research should extend the validity of findings to rural communities and other ethnic groups , as well as to smoking and lipid and blood pressure control",
"BACKGROUND Less than 63 % of individuals with diabetes meet professional guidelines target of hemoglobin A1c A1c of a cell phone-based diabetes management software system used with web-based data analytics and therapy optimization tools . Secondary aims examined health care provider ( HCP ) adherence to prescribing guidelines and assessed HCPs ' adoption of the technology . METHODS Thirty patients with type 2 diabetes were recruited from three community physician practice s for a 3-month study and evenly r and omized . The intervention group received cell phone-based software design ed by endocrinologists and CDEs ( WellDoc Communications , Inc. , Baltimore , MD ) . The software provided real-time feedback on patients ' blood glucose levels , displayed patients ' medication regimens , incorporated hypo- and hyperglycemia treatment algorithms , and requested additional data needed to evaluate diabetes management . Patient data captured and transferred to secure servers were analyzed by proprietary statistical algorithms . The system sent computer-generated logbooks ( with suggested treatment plans ) to intervention patients ' HCPs . RESULTS The average decrease in A1c for intervention patients was 2.03 % , compared to 0.68 % ( P medications titrated or changed by their HCP compared to controls ( 23 % , P = 0.002 ) . Intervention patients ' HCPs reported the system facilitated treatment decisions , provided organized data , and reduced logbook review time . CONCLUSIONS Adults with type 2 diabetes using WellDoc 's software achieved statistically significant improvements in A1c . HCP and patient satisfaction with the system was clinical ly and statistically significant",
"BACKGROUND To determine whether a Web-based diabetes case management program based in an electronic medical record can improve glycemic control ( primary outcome ) and diabetes-specific self-efficacy ( secondary outcome ) in adults with type 1 diabetes , a pilot r and omized controlled trial was conducted . METHODS A 12-month r and omized trial tested a Web-based case management program in a diabetes specialty clinic . Patients 21 - 49 years old with type 1 diabetes receiving multiple daily injections with insulin glargine and rapid-acting analogs who had a recent A1C > 7.0 % were eligible for inclusion . Participants were r and omized to receive either ( 1 ) usual care plus the nurse-practitioner-aided Web-based case management program ( intervention ) or ( 2 ) usual clinic care alone ( control ) . We compared patients in the two study arms for changes in A1C and self-efficacy measured with the Diabetes Empowerment Scale . RESULTS A total of 77 patients were recruited from the diabetes clinic and enrolled in the trial . The mean baseline A1C among study participants was 8.0 % . We observed a nonsignificant decrease in average A1C ( -0.48 ; 95 % confidence interval -1.22 to 0.27 ; P = 0.160 ) in the intervention group compared to the usual care group . The intervention group had a significant increase in diabetes-related self-efficacy compared to usual care ( group difference of 0.30 ; 95 % confidence interval 0.01 to 0.59 ; P = 0.04 ) . CONCLUSIONS Use of a Web-based case management program was associated with a beneficial treatment effect on self-efficacy , but change in glycemic control did not reach statistical significance in this trial of patients with moderately poorly controlled type 1 diabetes . Larger studies may be necessary to further clarify the intervention 's impact on health outcomes",
"BACKGROUND Type 2 diabetes mellitus is increasing in incidence and research has shown that normalization of blood glucose levels can moderate the risk of microvascular and neurological complications . AIM The purpose of this study was to investigate the effect of nurse telephone calls on glycosylated haemoglobin ( HbA1c ) levels and adherence to diabetes control recommendations . METHODS A r and omized design with control and experimental groups being assessed pre- and post intervention was used to assess the effectiveness of nurse telephone calls . Twenty patients were r and omly assigned to an intervention group and 16 to a control group . The goal of the intervention was to keep blood glucose concentrations close to the normal range ( HbA1c continued education and reinforcement of diet , exercise , medication adjustment recommendations , as well as frequent self-monitoring of blood glucose levels . Telephone intervention was performed twice per week for the first month and then weekly for the second and third month . Participants were requested to write self-management logs including blood glucose levels , diet and an exercise diary . A dietitian analysed the diet diaries and participants were informed about their results by telephone or mail . All medication adjustments were communicated to participants ' doctors . The HbA1c and diabetes adherence were measured before and after the intervention . RESULTS Patients in the intervention group had a mean decrease of 1.2 % in HbA1c levels and those in the control group had a mean increase of 0.6 % in HbA1c levels . The intervention group had greater diet and blood glucose testing adherence than the control group . CONCLUSION These findings indicate that a nurse telephone intervention can improve HbA1c , and diet and blood glucose testing adherence",
"AIMS The aim of this study was to test the feasibility and impact of an intervention consisting of self-monitored blood pressure , medicine review , a Digital Versatile Disc , and motivational interviewing telephone calls to help people with diabetes and kidney disease improve their blood pressure control and adherence to prescribed medications . BACKGROUND People with co-existing diabetes , kidney disease and hypertension require multiple medications to manage their health . About 50 % of people are non-adherent to their prescribed medications with non-adherence increasing in the presence of chronic conditions . DESIGN R and omized controlled trial . METHODS Patients aged ≥18 years with diabetes , chronic kidney disease and systolic hypertension were recruited from nephrology and diabetes out patients ' clinics of an Australian metropolitan hospital between 2008 - 2009 . Participants were r and omly allocated on a 1:1 basis to one of two groups in a r and omized controlled trial : the intervention delivered over 3 months ( n = 39 ) and usual care ( n = 41 ) , with follow-up at 3 , 6 and 9 months postintervention . People collecting data and assessing outcomes were blinded to group assignment . RESULTS Seventy-five participants completed the study . The intervention was acceptable and feasible for this cohort . There were no statistically significant differences between groups , although the mean systolic blood pressure reduction in the intervention group ( n = 36 ) was -6·9 mmHg 95 % CI ( -13·8 , -0·02 ) at 9 months postintervention . CONCLUSION The study was feasible and statistically significant differences may be determinable in a larger sample to overcome the variability between groups , paying attention to recommendations for further research . TRIAL REGISTRATION The trial was prospect ively registered with the Australian and New Zeal and Clinical Trials Register ( ACTRN12607000044426 )",
"A r and omized controlled trial was conducted to evaluate the impact of an automated telephone intervention on glycemic control in patients with type 2 diabetes . One hundred twenty participants were r and omly assigned to a treatment group that received a daily , automated telephone message regarding diabetes or to a control group that received usual care . The treatment group demonstrated a significant improvement in the frequency of self-monitoring of blood glucose levels compared with the control group ( P positive attitudes toward diabetes and a reduction in perceived monitoring and exercise barriers were seen in the intervention group compared with the control group",
"STUDY OBJECTIVE Increasingly , low-income inner-city patients with diabetes utilize emergency departments ( EDs ) for acute and chronic care . We seek to determine whether a scalable , low-cost , unidirectional , text message-based mobile health intervention ( TExT-MED ) improves clinical outcomes , increases healthy behaviors , and decreases ED utilization in a safety net population . METHODS We conducted an r and omized controlled trial of 128 adult patients with poorly controlled diabetes ( glycosylated hemoglobin [ Hb A1C ] level ≥8 % ) in an urban , public ED . The TExT-MED group received 2 daily text messages for 6 months in English or Spanish . The primary outcome was change in Hb A1C level . Secondary outcomes included changes in medication adherence , self-efficacy , performance of self-care tasks , quality of life , diabetes-specific knowledge , ED utilization , and patient satisfaction . RESULTS Hb A1C level decreased by 1.05 % in the TExT-MED group compared with 0.60 % in the controls ( Δ0.45 ; 95 % confidence interval [ CI ] -0.27 to 1.17 ) at 6 months . Secondary outcomes favored the TExT-MED group , with the most sizable change observed in self-reported medication adherence ( as measured by the Morisky Medication Adherence Scale , an 8-point vali date d scale with higher scores representing better adherence ) , which improved from 4.5 to 5.4 in the TExT-MED group compared with a net decrease of -0.1 in the controls ( Δ1.1 [ 95 % CI 0.1 to 2.1 ] ) . Effects were larger among Spanish speakers for both medication adherence ( 1.1 versus -0.3 ; Δ1.4 ; 95 % CI 0.2 to 2.7 ) and Hb A1C ( -1.2 % versus -0.4 % ) in the TExT-MED group . The proportion of patients who used emergency services trended lower in the TExT-MED group ( 35.9 % versus 51.6 % ; Δ15.7 % ; 95 % CI 9.4 % to 22 % ) . Overall , 93.6 % of respondents enjoyed TExT-MED and 100 % would recommend it to family/friends . CONCLUSION The TExT-MED program did not result in a statistically significant improvement in Hb A1C . However , trends toward improvement in the primary outcome of Hb A1C and other secondary outcomes , including quality of life , were observed , the most pronounced being improved medication adherence . TExT-MED also decreased ED utilization . These findings were magnified in the Spanish-speaking subgroup . Technologies such as TExT-MED represent highly scalable , low-cost , and widely accessible solutions for safety-net ED population",
"PURPOSE The use of technology to implement cost-effective health care management on a large scale may be an alternative for diabetes management but needs to be evaluated in controlled trials . This study assessed the utility and cost-effectiveness of an automated Diabetes Remote Monitoring and Management System ( DRMS ) in glycemic control versus usual care . METHODS In this r and omized , controlled study , patients with uncontrolled diabetes on insulin were r and omized to use of the DRMS or usual care . Participants in both groups were followed up for 6 months and had 3 clinic visits at 0 , 3 , and 6 months . The DRMS used text messages or phone calls to remind patients to test their blood glucose and to report results via an automated system , with no human interaction unless a patient had severely high or low blood glucose . The DRMS made adjustments to insulin dose(s ) based on vali date d algorithms . Participants reported medication adherence through the Morisky Medication Adherence Scale-8 , and diabetes-specific quality of life through the diabetes Daily Quality of Life question naire . A cost-effectiveness analysis was conducted based on the estimated overall costs of DRMS and usual care . FINDINGS A total of 98 patients were enrolled ( 59 [ 60 % ] female ; mean age , 59 years ) ; 87 participants ( 89 % ) completed follow-up . HbA1c was similar between the DRMS and control groups at 3 months ( 7.60 % vs 8.10 % ) and at 6 months ( 8.10 % vs 7.90 % ) . Changes from baseline to 6 months were not statistically significant for self-reported medication adherence and diabetes-specific quality of life , with the exception of the Daily Quality of Life-Social/Vocational Concerns subscale score ( P = 0.04 ) . IMPLICATION S An automated system like the DRMS may improve glycemic control to the same degree as usual clinic care and may significantly improve the social/vocational aspects of quality of life . Cost-effectiveness analysis found DRMS to be cost-effective when compared to usual care and suggests DRMS has a good scale of economy for program scale up . Further research is needed to determine how to sustain the benefits seen with the automated system over longer periods",
"We conducted a r and omized controlled trial using mobile health technology in an ethnically diverse sample of 137 patients with complicated diabetes . Patients in the intervention group ( n = 72 ) were trained to measure their blood glucose with a sensor which transmitted the readings to a mobile phone via a Bluetooth wireless link . Clinicians were then able to examine and respond to the readings which were viewed with a web-based application . Patients in the control arm of the study ( n = 65 ) did not transmit their readings and received care with their usual doctor in the outpatient and /or primary care setting . The mean follow-up period was 9 months in each group . The default rate was higher in the patients in the intervention arm due to technical problems . In an intention-to-treat analysis there were no differences in HbA1c between the intervention and control groups . In a sub-group analysis of the patients who completed the study , the telemonitoring group had a lower HbA1c than those in the control group : 7.76 % and 8.40 % , respectively ( P = 0.06 )",
"OBJECTIVE To test trial design issues related to measuring the effectiveness of a peer telephone intervention to enhance self-efficacy in type 2 diabetes ; evaluate the impact on self-efficacy and clinical outcome ; and describe patient and peer experience . METHODS Eligible patients had raised HbA1c ( initial threshold > 8 % , reduced to > 7.4 % mid-way through trial ) . Patients were recruited from 40 general practice s and r and omised ( 40:40:20 ratio ) to receive routine care alone or , in addition , motivational telephone support from a peer supporter or a diabetes specialist nurse ( 9 peers and 12 DSNs ) for a period of up to 6 months . The primary outcome measure was self-efficacy score , and secondary outcome measures included HbA1c . Patient and telecare supporter satisfaction and experience were evaluated . RESULTS In all , 231 patients participated . At 6 months there were no statistically significant differences in self-efficacy scores ( p=0.68 ) , HbA1c ( p=0.87 ) or other secondary outcome measures . There was evidence of a high level of acceptability , but peer telecare support was less highly valued than that from a DSN . Some patients stated that they would have valued more information and advice . CONCLUSIONS Further consideration needs to be given to the targeting of the telecare peer support , its intensity , the training and ongoing supervision of peer supporters , and the extent to which information and advice should be incorporated . PRACTICE IMPLICATION S While some patients with poorly controlled type 2 diabetes value peer telephone support , this approach appears not to suit all patients . Further intervention development and evaluation is required before widespread adoption can be recommended",
"PURPOSE Depression commonly accompanies diabetes , result ing in reduced adherence to medications and increased risk for morbidity and mortality . The objective of this study was to examine whether a simple , brief integrated approach to depression and type 2 diabetes mellitus ( type 2 diabetes ) treatment improved adherence to oral hypoglycemic agents and antidepressant medications , glycemic control , and depression among primary care patients . METHODS We undertook a r and omized controlled trial conducted from April 2010 through April 2011 of 180 patients prescribed pharmacotherapy for type 2 diabetes and depression in primary care . Patients were r and omly assigned to an integrated care intervention or usual care . Integrated care managers collaborated with physicians to offer education and guideline -based treatment recommendations and to monitor adherence and clinical status . Adherence was assessed using the Medication Event Monitoring System ( MEMS ) . We used glycated hemoglobin ( HbA1c ) assays to measure glycemic control and the 9-item Patient Health Question naire ( PHQ-9 ) to assess depression . RESULTS Intervention and usual care groups did not differ statistically on baseline measures . Patients who received the intervention were more likely to achieve HbA1c levels of less than 7 % ( intervention 60.9 % vs usual care 35.7 % ; P remission of depression ( PHQ-9 score of less than 5 : intervention 58.7 % vs usual care 30.7 % ; P primary care . An integrated approach to depression and type 2 diabetes treatment may facilitate its deployment in real-world practice s with competing dem and s for limited re sources",
"OBJECTIVE To demonstrate that Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support significantly improves HbA1c in poorly controlled type 1 diabetic patients . RESEARCH DESIGN AND METHODS In a six-month open-label parallel-group , multicenter study , adult patients ( n = 180 ) with type 1 diabetes ( > 1 year ) , on a basal-bolus insulin regimen ( > 6 months ) , with HbA1c ≥8 % , were r and omized to usual quarterly follow-up ( G1 ) , home use of a smartphone recommending insulin doses with quarterly visits ( G2 ) , or use of the smartphone with short teleconsultations every 2 weeks but no visit until point end ( G3 ) . RESULTS Six-month mean HbA1c in G3 ( 8.41 ± 1.04 % ) was lower than in G1 ( 9.10 ± 1.16 % ; P = 0.0019 ) . G2 displayed intermediate results ( 8.63 ± 1.07 % ) . The Diabeo system gave a 0.91 % ( 0.60 ; 1.21 ) improvement in HbA1c over controls and a 0.67 % ( 0.35 ; 0.99 ) reduction when used without teleconsultation . There was no difference in the frequency of hypoglycemic episodes or in medical time spent for hospital or telephone consultations . However , patients in G1 and G2 spent nearly 5 h more than G3 patients attending hospital visits . CONCLUSIONS The Diabeo system gives a substantial improvement to metabolic control in chronic , poorly controlled type 1 diabetic patients without requiring more medical time and at a lower overall cost for the patient than usual care"
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41170406-06ff-11f0-808a-c43d1ab1c353
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Introduction Appendectomy has long been the mainstay of intervention for acute appendicitis , aim ing at preventing perforation , peritonitis , abscess formation and recurrence . With better underst and ing of the disease process , non-operative management ( NOM ) with antibiotics alone has been proved a feasible treatment for uncomplicated appendicitis . This article aim ed at systematic ally review ing the available literature s and discussing the question whether NOM should replace appendectomy as the st and ard first-line treatment for uncomplicated appendicitis . Method A search of the Embase , Pubmed and Cochrane Library was performed using the keywords ‘ acute appendicitis ’ and ‘ antibiotic therapy ’ . Meta- analysis with inverse variance model for continuous variable and Mantel Haenzel Model for dichotomous variable was performed to evaluate the one year treatment efficacy , morbidities rate , sick leave duration and length of hospital stay associated with emergency appendectomy and NOM . Results Six r and omized control trials were identified out of 1943 publications . NOM had a significant lower treatment efficacy rate at one year , 0.10 ( 95 % CI 0.03–0.36 , p appendectomy . The morbidities rate was comparable between the two interventions . The length of hospital stay was longer , with a mean difference of 1.08 days ( 95 % CI 0.09–2.07 , p = 0.03 ) , and the sick leave duration was shorter , a mean difference of 3.37 days ( 95 % CI -5.90 to −0.85 days , p appendectomy is the gold st and ard of treatment for uncomplicated appendicitis , given its higher efficacy rate when compared to NOM
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"Background Case control studies that r and omly assign patients with diagnosis of acute appendicitis to either surgical or non-surgical treatment yield a relapse rate of approximately 14 % at one year . It would be useful to know the relapse rate of patients who have , instead , been selected for a given treatment based on a thorough clinical evaluation , including physical examination and laboratory results ( Alvarado Score ) as well as radiological exams if needed or deemed helpful . If this clinical evaluation is useful , the investigators would expect patient selection to be better than chance , and relapse rate to be lower than 14 % . Once the investigators have established the utility of this evaluation , the investigators can begin to identify those components that have predictive value ( such as blood analysis , or US/CT findings ) . This is the first step toward developing an accurate diagnostic-therapeutic algorithm which will avoid risks and costs of needless surgery . Methods / design This will be a single-cohort prospect i ve observational study . It will not interfere with the usual pathway , consisting of clinical examination in the Emergency Department ( ED ) and execution of the following exams at the physician 's discretion : full blood count with differential , C reactive protein , abdominal ultrasound , abdominal CT . Patients admitted to an ED with lower abdominal pain and suspicion of acute appendicitis and not needing immediate surgery , are requested by informed consent to undergo observation and non operative treatment with antibiotic therapy ( Amoxicillin and Clavulanic Acid ) . The patients by protocol should not have received any previous antibiotic treatment during the same clinical episode . Patients not undergoing surgery will be physically examined 5 days later . Further follow-up will be conducted at 7 , 15 days , 6 months and 12 months . The study will conform to clinical practice guidelines and will follow the recommendations of the Declaration of Helsinki . The protocol was approved on November 2009 by Maggiore Hospital Ethical Review Board ( ID CE09079 ) . Trial Registration Clinical Trials.gov identifier : NCT01096927",
"Objective : To compare length of hospital stay , in-hospital complications , in-hospital mortality , and rate of routine discharge between laparoscopic and open appendectomy based on a representative , nationwide data base . Summary Background Data : Numerous single-institutional r and omized clinical trials have assessed the efficacy of laparoscopic and open appendectomy . The results , however , are conflicting , and a consensus concerning the relative advantages of each procedure has not yet been reached . Methods : Patients with primary ICD-9 procedure codes for laparoscopic and open appendectomy were selected from the 1997 Nationwide Inpatient Sample , a data base that approximates 20 % of all US community hospital discharges . Multiple linear and logistic regression analyses were used to assess the risk-adjusted endpoints . Results : Discharge abstract s of 43,757 patients were used for our analyses . 7618 patients ( 17.4 % ) underwent laparoscopic and 36,139 patients ( 82.6 % ) open appendectomy . Patients had an average age of 30.7 years and were predominantly white ( 58.1 % ) and male ( 58.6 % ) . After adjusting for other covariates , laparoscopic appendectomy was associated with shorter median hospital stay ( laparoscopic appendectomy : 2.06 days , open appendectomy : 2.88 days , P lower rate of infections ( odds ratio [ OR ] = 0.5 [ 0.38 , 0.66 ] , P decreased gastrointestinal complications ( OR = 0.8 [ 0.68 , 0.96 ] , P = 0.02 ) , lower overall complications ( OR = 0.84 [ 0.75 , 0.94 ] , P = 0.002 ) , and higher rate of routine discharge ( OR = 3.22 [ 2.47 , 4.46 ] , P Laparoscopic appendectomy has significant advantages over open appendectomy with respect to length of hospital stay , rate of routine discharge , and postoperative in-hospital morbidity",
"Background Appendectomy has been the treatment for acute appendicitis for over 120 years . Antibiotic treatment has occasionally been used in small uncontrolled studies , instead of operation , but this alternative has never before been tried in a multicenter r and omized trial . Patients and Methods Male patients , 18–50 years of age , admitted to six different hospitals in Sweden between 1996 and 1999 were enrolled in the study . No women were enrolled by decision of the local ethics committee . If appendectomy was planned , patients were asked to participate , and those who agreed were r and omized either to surgery or to antibiotic therapy . Patients r and omized to surgery were operated on with open surgery or laparoscopically . Those r and omized to antibiotic therapy were treated intravenously for 2 days , followed by oral treatment for 10 days . If symptoms did not resolve within 24 hours , an appendectomy was performed . Participants were monitored at the end of 1 week , 6 weeks , and 1 year . Results During the study period 252 men participated , 124 in the surgery group and 128 in the antibiotic group . The frequency of appendicitis was 97 % in the surgery group and 5 % had a perforated appendix . The complication rate was 14 % in the surgery group . In the antibiotic group 86 % improved without surgery ; 18 patients were operated on within 24 hours , and the diagnosis of acute appendicitis was confirmed in all but one patient , and he was suffering from terminal ileitis . There were seven patients ( 5 % ) with a perforated appendix in this group . The rate of recurrence of symptoms of appendicitis among the 111 patients treated with antibiotics was 14 % during the 1-year follow-up . Conclusions Acute nonperforated appendicitis can be treated successfully with antibiotics . However , there is a risk of recurrence in cases of acute appendicitis , and this risk should be compared with the risk of complications after appendectomy",
"IMPORTANCE An increasing amount of evidence supports the use of antibiotics instead of surgery for treating patients with uncomplicated acute appendicitis . OBJECTIVE To compare antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis confirmed by computed tomography ( CT ) . DESIGN , SETTING , AND PARTICIPANTS The Appendicitis Acuta ( APPAC ) multicenter , open-label , noninferiority r and omized clinical trial was conducted from November 2009 until June 2012 in Finl and . The trial enrolled 530 patients aged 18 to 60 years with uncomplicated acute appendicitis confirmed by a CT scan . Patients were r and omly assigned to early appendectomy or antibiotic treatment with a 1-year follow-up period . INTERVENTIONS Patients r and omized to antibiotic therapy received intravenous ertapenem ( 1 g/d ) for 3 days followed by 7 days of oral levofloxacin ( 500 mg once daily ) and metronidazole ( 500 mg 3 times per day ) . Patients r and omized to the surgical treatment group were assigned to undergo st and ard open appendectomy . MAIN OUTCOMES AND MEASURES The primary end point for the surgical intervention was the successful completion of an appendectomy . The primary end point for antibiotic-treated patients was discharge from the hospital without the need for surgery and no recurrent appendicitis during a 1-year follow-up period . RESULTS There were 273 patients in the surgical group and 257 in the antibiotic group . Of 273 patients in the surgical group , all but 1 underwent successful appendectomy , result ing in a success rate of 99.6 % ( 95 % CI , 98.0 % to 100.0 % ) . In the antibiotic group , 70 patients ( 27.3 % ; 95 % CI , 22.0 % to 33.2 % ) underwent appendectomy within 1 year of initial presentation for appendicitis . Of the 256 patients available for follow-up in the antibiotic group , 186 ( 72.7 % ; 95 % CI , 66.8 % to 78.0 % ) did not require surgery . The intention-to-treat analysis yielded a difference in treatment efficacy between groups of -27.0 % ( 95 % CI , -31.6 % to ∞ ) ( P = .89 ) . Given the prespecified noninferiority margin of 24 % , we were unable to demonstrate noninferiority of antibiotic treatment relative to surgery . Of the 70 patients r and omized to antibiotic treatment who subsequently underwent appendectomy , 58 ( 82.9 % ; 95 % CI , 72.0 % to 90.8 % ) had uncomplicated appendicitis , 7 ( 10.0 % ; 95 % CI , 4.1 % to 19.5 % ) had complicated acute appendicitis , and 5 ( 7.1 % ; 95 % CI , 2.4 % to 15.9 % ) did not have appendicitis but received appendectomy for suspected recurrence . There were no intra-abdominal abscesses or other major complications associated with delayed appendectomy in patients r and omized to antibiotic treatment . CONCLUSIONS AND RELEVANCE Among patients with CT-proven , uncomplicated appendicitis , antibiotic treatment did not meet the prespecified criterion for noninferiority compared with appendectomy . Most patients r and omized to antibiotic treatment for uncomplicated appendicitis did not require appendectomy during the 1-year follow-up period , and those who required appendectomy did not experience significant complications . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01022567",
"BACKGROUND Research ers have suggested that antibiotics could cure acute appendicitis . We assessed the efficacy of amoxicillin plus clavulanic acid by comparison with emergency appendicectomy for treatment of patients with uncomplicated acute appendicitis . METHODS In this open-label , non-inferiority , r and omised trial , adult patients ( aged 18 - 68 years ) with uncomplicated acute appendicitis , as assessed by CT scan , were enrolled at six university hospitals in France . A computer-generated r and omisation sequence was used to allocate patients r and omly in a 1:1 ratio to receive amoxicillin plus clavulanic acid ( 3 g per day ) for 8 - 15 days or emergency appendicectomy . The primary endpoint was occurrence of postintervention peritonitis within 30 days of treatment initiation . Non-inferiority was shown if the upper limit of the two-sided 95 % CI for the difference in rates was lower than 10 percentage points . Both intention-to-treat and per- protocol analyses were done . This trial is registered with Clinical Trials.gov , number NCT00135603 . FINDINGS Of 243 patients r and omised , 123 were allocated to the antibiotic group and 120 to the appendicectomy group . Four were excluded from analysis because of early dropout before receiving the intervention , leaving 239 ( antibiotic group , 120 ; appendicectomy group , 119 ) patients for intention-to-treat analysis . 30-day postintervention peritonitis was significantly more frequent in the antibiotic group ( 8 % , n=9 ) than in the appendicectomy group ( 2 % , n=2 ; treatment difference 5·8 ; 95 % CI 0·3 - 12·1 ) . In the appendicectomy group , despite CT-scan assessment , 21 ( 18 % ) of 119 patients were unexpectedly identified at surgery to have complicated appendicitis with peritonitis . In the antibiotic group , 14 ( 12 % [ 7·1 - 18·6 ] ) of 120 underwent an appendicectomy during the first 30 days and 30 ( 29 % [ 21·4 - 38·9 ] ) of 102 underwent appendicectomy between 1 month and 1 year , 26 of whom had acute appendicitis ( recurrence rate 26 % ; 18·0 - 34·7 ) . INTERPRETATION Amoxicillin plus clavulanic acid was not non-inferior to emergency appendicectomy for treatment of acute appendicitis . Identification of predictive markers on CT scans might enable improved targeting of antibiotic treatment . FUNDING French Ministry of Health , Programme Hospitalier de Recherche Clinique 2002",
"BACKGROUND In this prospect i ve study , operative and nonoperative management of acute appendicitis were evaluated regarding their safety and cost effectiveness . METHODS Two hundred ninety patients presenting to our Emergency Department between March 2005 and March 2006 with acute appendicitis were included in this prospect i ve study . Nonoperative medical therapy was performed in 107 patients ( Group 1 ) , and 183 patients were treated surgically ( Group 2 ) . Routine follow-up controls were done on the 10th day , at the 3rd and 6th months and at the first year after discharge in Group 1 . Both groups were compared regarding age , gender , mean hospital stay , modified Alvarado score , morbidity , mortality , and cost effectiveness . RESULTS The male/female ratio of Groups 1 and 2 were 65/42 ( mean age : 30.98+/-1.30 ) and 125/58 ( mean age : 26.25+/-0.79 ) , respectively . In Group 1 , 19 patients were operated . Operation indications were resistance to therapy , patient 's request , and operation in another hospital . Although the mean hospital stay of Group 1 was statistically significantly longer than Group 2 , the mean cost of the therapy was $ 559 in Group 2 and $ 433 in Group 1 . Morbidity rates were similar , with no mortality in either group . CONCLUSION With its high success rate and cost effectiveness , medical treatment seems to be a good alternative to the gold st and ard therapy of surgery in management of acute appendicitis",
"BACKGROUND Emerging literature has supported the safety of nonoperative management of uncomplicated appendicitis . STUDY DESIGN Patients with emergent , uncomplicated appendicitis were identified by appropriate ICD-9 diagnosis codes in the California Office of Statewide Health Planning and Development data base from 1997 to 2008 . Rates of treatment failure , recurrence , and perforation after nonsurgical management were calculated . Factors associated with treatment failure , recurrence , and perforation were identified using multivariable logistic regression . Mortality , length of stay , and total charges were compared between treatment cohorts using matched propensity score analysis . RESULTS Of 231,678 patients with uncomplicated appendicitis , the majority ( 98.5 % ) were managed operatively . Of the 3,236 nonsurgically managed patients who survived to discharge without an interval appendectomy , 5.9 % and 4.4 % experienced treatment failure or recurrence , respectively , during a median follow-up of more than 7 years . There were no mortalities associated with treatment failure or recurrence . The risk of perforation after discharge was approximately 3 % . Using multivariable analysis , race and age were significantly associated with the odds of treatment failure . Sex , age , and hospital teaching status were significantly associated with the odds of recurrence . Age and hospital teaching status were significantly associated with the odds of perforation . Matched propensity score analysis indicated that after risk adjustment , mortality rates ( 0.1 % vs 0.3 % ; p = 0.65 ) and total charges ( $ 23,243 vs $ 24,793 ; p = 0.70 ) were not statistically different between operative and nonoperative patients ; however , length of stay was significantly longer in the nonoperative treatment group ( 2.1 days vs 3.2 days ; p nonoperative management of uncomplicated appendicitis can be safe and prompts additional investigations . Comparative effectiveness research using prospect i ve r and omized studies can be particularly useful"
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41170456-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES The primary objective of the review was to describe change that occurs in skeletal muscle during periods of unplanned hospitalisation in adult patients . The secondary objective was to examine the relationship between both physical activity and inflammation with the change in skeletal muscle . A further objective was to investigate the effect of interventions on change in skeletal muscle during periods of unplanned hospitalisation . DESIGN A systematic review and meta-analyses . Embase , MEDLINE , CINAHL , AMED , PEDro and the Cochrane Library were search ed for studies that included any measures of skeletal muscle ( excluding pulmonary function ) at two time points during unplanned hospitalisation . Studies that were set in critical care , or included patients with acute or progressive neurological illness , were excluded . RESULTS Our search returned 27,809 unique articles , of which 35 met the inclusion criteria . Meta-analyses of change between baseline and follow-up in r and om effects models suggested that grip strength had an average increase : st and ardised mean difference ( SMD ) = 0.10 ( 95 % CI : 0.03 ; 0.16 ) ; knee extension strength had an average reduction : SMD = -0.24 ( 95 % CI : -0.33 ; -0.14 ) ; and mid-arm muscle circumference had an average reduction : SMD = -0.17 ( 95 % CI : -0.22 ; -0.11 ) . Inflammation appeared to be associated with greater loss of muscle strength . There was inconclusive evidence that the level of physical activity affects change in skeletal muscle . In regard to the effect of interventions , only exercise interventions were consistently associated with improved skeletal muscle outcomes . CONCLUSIONS Adult patients who undergo an unplanned hospital admission may experience a small reduction in knee extension strength and mid-arm muscle mass . Prospect i ve research is needed to clarify the contribution of confounding factors underlying the observations made in this review , with particular attention to levels of physical activity , and possible contributions from environmental factors and processes of hospital care
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"Background Inflammation is the main cause of disease-associated muscle wasting . In a previous single blind study we have demonstrated improved recovery of muscle endurance following celecoxib treatment in hospitalized geriatric patients with acute infection . Here we further evaluate NSAID treatment with piroxicam in a double blind RCT and investigate the role of cytokines and heat shock proteins ( Hsp ) with respect to muscle performance . We hypothesized that NSAID treatment would preserve muscle performance better than antibiotic treatment alone , by reducing infection-associated inflammation and by increasing expression of cytoprotective Hsp . Methods Consecutive admissions to the geriatric ward were screened . 30 Caucasian patients , median age 84.5 years , with acute infection-induced inflammation and serum levels of CRP > 10 mg/L were included and r and omized to active treatment with 10 mg piroxicam daily or placebo . Assessment comprised general clinical and biochemical parameters , 25 cytokines in serum , intra- and extracellular Hsp27 and Hsp70 , Elderly Mobility Scale ( EMS ) scores , grip strength ( GS ) , fatigue resistance ( FR ) and lean body mass ( LBM ) . Patients were evaluated until discharge with a maximum of 3 weeks after treatment allocation . Results EMS scores , FR and grip work ( GW ) , a measure taking into account GS and FR , significantly improved with piroxicam , but not with placebo . Early decreases in IL-6 serum levels with piroxicam correlated with better muscle performance at week 2 . Basal expression of Hsp27 in monocytes without heat challenge ( WHC ) was positively correlated with FR at baseline and significantly increased by treatment with piroxicam compared to placebo . Profound modifications in the relationships between cytokines or Hsp and changes in muscle parameters were observed in the piroxicam group . Conclusions Piroxicam improves clinical ly relevant measures of muscle performance and mobility in geriatric patients hospitalized with acute infection-induced inflammation . Underlying mechanisms may include modifications in the cytokine network and increases in monocytic expression of cytoprotective Hsp27.Trial registration numberIS RCT N : IS RCT",
"OBJECTIVES To investigate whether systemic inflammation in acutely admitted older medical patients ( age > 65 years ) is associated with physical performance and organ dysfunction . Organ dysfunction´s association with physical performance , and whether these associations are mediated by systemic inflammation , was also investigated . METHODS A cross-sectional study in an Emergency Department . Physical performance was assessed by h and grip strength and de Morton Mobility Index ( DEMMI ) , and organ dysfunction by FI-OutRef , the number of st and ard blood tests outside the reference range . Systemic inflammation was assessed by suPAR , TNFα , and IL-6 . Associations were investigated by regression analyses adjusted for age , sex , cognitive impairment , CRP , and VitalPAC Modified Early Warning Score . RESULTS A total of 369 patients were evaluated . In adjusted analyses , suPAR and TNFα was associated with both physical performance measures ( p and IL-6 with h and grip strength ( p=0.007 ) . All inflammation biomarkers were associated with FI-OutRef ( p with physical performance ( all p ; suPAR being the inflammatory biomarker with the highest impact when adjusting for inflammation . CONCLUSION Inflammatory biomarkers are potentially feasible for systematic assessment of vulnerability . Moreover , suPAR may be an important mediator between organ dysfunction and physical performance",
"BACKGROUND Acute inflammation has a negative effect on the muscular system in elderly patients , compromising the outcome of the underlying disease . OBJECTIVE The aim of this study was to evaluate the effect of cyclooxygenase-2 ( COX-2 ) inhibition on muscle performance and mobility in hospitalized elderly patients with acute inflammation of infectious origin . METHODS In this single-blind , controlled trial , consecutively hospitalized elderly patients ( age > or = 70 years ) with inflammation ( C-reactive protein [ CRP ] levels > or = 10 mg/L ) due to acute infection were r and omly assigned to receive 2 weeks of treatment with the COX-2-selective inhibitor celecoxib , acetaminophen , or no supplementary medication ( control ) . The following variables were assessed at baseline and at 1 and 2 weeks ' follow-up : muscle fatigue resistance ( primary outcome measure ) ; grip strength and mobility ( secondary outcome measures ) ; and levels of the acute-phase markers CRP , interleukin (IL)-1beta , IL-6 , IL-10 , tumor necrosis factor-alpha ( TNF-alpha ) , and transforming growth factor-beta ( TGF-beta ) as explanatory variables . RESULTS Forty-three consecutively hospitalized elderly patients ( 31 women , 12 men ; mean [ SD ] age , 84 [ 6 ] years ) were enrolled . Fourteen patients received celecoxib , 14 received acetaminophen , and 15 received no supplementary medication . The change in fatigue resistance was significantly different between groups ( P = 0.021 , Kruskal-Wallis chi-square test ) , with significantly greater improvement in patients receiving celecoxib compared with the acetaminophen and control groups ( 63 % increase from baseline ; P grip strength , mobility , IL-1beta , IL-6 , TNF-alpha , or TGF-beta . The changes in levels of IL-10 differed significantly between groups ( P = 0.020 , Kruskal-Wallis chi-square test ) , with greater improvement in the celecoxib group compared with the acetaminophen group ( P = 0.032 ) . CONCLUSION The results of this study suggest that COX-2-selective inhibition has a beneficial effect on muscle fatigue resistance in hospitalized elderly patients with acute inflammation of infectious origin . However , until further trials are conducted , the use of COX-2-selective inhibitors for this indication is not recommended",
"QUESTION Among people who are hospitalised for community-acquired pneumonia , does an inpatient exercise-based rehabilitation program improve functional outcomes , symptoms , quality of life and length of hospital stay more than a respiratory physiotherapy regimen ? DESIGN R and omised trial with concealed allocation , intention-to-treat analysis and blinding of some outcomes . PARTICIPANTS Forty-nine adults hospitalised for community-acquired pneumonia . INTERVENTION The experimental group ( n=32 ) underwent a physical training program that included warm-up , stretching , peripheral muscle strength training and walking at a controlled speed for 15 minutes . The control group ( n=17 ) underwent a respiratory physiotherapy regimen that included percussion , vibrocompression , respiratory exercises and free walking . The intervention regimens lasted 8 days . OUTCOME MEASURES The primary outcome was the Glittre Activities of Daily Living test , which assesses the time taken to complete a series of functional tasks ( eg , rising from a chair , walking , stairs , lifting and bending ) . Secondary outcomes were distance walked in the incremental shuttle walk test , peripheral muscle strength , quality of life , dyspnoea , lung function , C-reactive protein and length of hospital stay . Measures were taken 1 day before and 1 day after the intervention period . RESULTS There was greater improvement in the experimental group than in the control group on the Glittre Activities of Daily Living test ( mean between-group difference 39 seconds , 95 % CI 20 to 59 ) and the incremental shuttle walk test ( mean between-group difference 130 m , 95 % CI 77 to 182 ) . There were also significantly greater improvements in quality of life , dyspnoea and peripheral muscle strength in the experimental group than in the control group . There were no between-group differences in lung function , C-reactive protein or length of hospital stay . CONCLUSION The improvement in functional outcomes after an inpatient rehabilitation program was greater than the improvement after st and ard respiratory physiotherapy . The exercise training program led to greater benefits in functional capacity , peripheral muscle strength , dyspnoea and quality of life . REGISTRATION Clinical Trials.gov , NCT02103400",
"OBJECTIVES To investigate the combined contribution of processes of hospitalization and preadmission individual risk factors in explaining functional decline at discharge and at 1-month follow-up in older adults with nondisabling conditions . DESIGN Prospect i ve cohort study . SETTING Internal medicine wards in two Israeli medical centers . PARTICIPANTS Six hundred eighty-four individuals aged 70 and older admitted for a nondisabling problem . MEASUREMENTS Functional decline was measured according to change in modified Barthel Index from premorbid to discharge and from premorbid to 1 month after discharge . In-hospital mobility , continence care , sleep medication consumption , satisfaction with hospital environment , and nutrition intake were assessed using previously tested self-report instruments . RESULTS Two hundred eighty-two participants ( 41.2 % ) reported functional decline at discharge and 317 ( 46.3 % ) at 1 month after discharge . Path analysis indicated that in-hospital mobility ( st and ardized maximum likelihood estimate ( SMLE ) = -0.48 , P continence care ( SMLE = -0.12 , P length of stay ( LOS ) ( SMLE = 0.06 , P In-hospital mobility , continence care , and LOS were indirectly related to functional decline at 1 month after discharge through functional decline at discharge ( SMLE = 0.45 , P Nutrition consumption ( SMLE = -0.07 , P functional decline at 1 month after discharge , explaining , together with other risk factors , 32 % of variance . CONCLUSION In-hospital low mobility , suboptimal continence care , and poor nutrition account for immediate and 1-month posthospitalization functional decline . These are potentially modifiable hospitalization risk factors for which practice and policy should be targeted in efforts to curb the posthospitalization functional decline trajectory",
"The impact of oral nutritional supplementation during an acute exacerbation of COPD on functional status was assessed through measuring change in lung function , strength testing , and general well-being . Subjects hospitalized for an acute exacerbation of COPD ( n = 33 ) were r and omized to extra nutritional support or the regular hospital care . They consumed an additional 10 kcal/kg/d . Outcome measures were measured at 2 wk as change scores . Forced vital capacity ( % predicted ) improved in the treatment group as compared with the control group ( + 8.7 % versus -3.5 % , p = 0.015 ) , and change in FEV1 was in the same direction but not significantly different ( p = 0.099 ) . There were no changes in h and grip strength or respiratory muscle strength , but there was a trend towards more improvement in the general well-being score ( + 11.96 versus -10.25 , p = 0.066 ) . Almost all subjects were in negative nitrogen balance , indicating muscle wasting . The degree of muscle wasting was strongly correlated with the dose of corticosteroids ( r = 0.73 , p muscle wasting in patients with COPD treated with corticosteroids , but some small gains were observed with increased dietary intake",
"Objective The aim of this work was to evaluate the time course of changes in strength and functional performance in elderly hospitalized medical patients . Design This was a prospect i ve observational study in elderly medical patients of age 65 years or older at a geriatric department . Measurements were obtained on days 2 to 4 , day 5 to 8 , and days 9 to 13 . Functional performance was measured with De Morton Mobility Index ( DEMMI ) test and a 30-second chair st and test ( 30-s CST ) . Muscular strength was measured with h and grip strength . Activity level was determined with accelerometry ( ActivPAL ) . Results Results in DEMMI and 30-s CST gradually improved ( P h and grip strength remained unchanged ( P > 0.05 ) . Larger functional improvements were observed in patients with “ high ” compared to “ low ” and “ moderate ” activity level ( P Changes in DEMMI score correlated with changes in 30-s CST ( P changes in DEMMI score and 30-s CST were more likely to occur in patients with a low versus high functional level , respectively . Conclusions Functional performance of the lower extremities in geriatric patients improves moderately over the time of a hospital stay of less than 14 days , with larger improvements in patients with high activity level . The DEMMI test and the 30-s CST seem to be complementary to each other when evaluating functional changes in a geriatric hospital population . To Cl aim CME Credits Complete the self- assessment activity and evaluation online at http://www.physiatry.org/JournalCME CME Objectives Upon completion of this article , the reader should be able to ( 1 ) describe changes in mobility and muscle strength of geriatric patients during a hospital stay of less than 14 days , ( 2 ) underst and the significance of physical activity during hospital admission in geriatric patients , and ( 3 ) discuss the potential limitations of measures for assessing mobility and lower extremity strength status and change during a hospital admission . Level Advanced Accreditation The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians . The Association of Academic Physiatrists design ates this activity for a maximum of 1.5 AMA PRA Category 1 Credit(s) ™ . Physicians should only cl aim credit commensurate with the extent of their participation in the activity",
"OBJECTIVES To examine the proportion of time spent in three levels of mobility ( lying , sitting , and st and ing or walking ) by a cohort of hospitalized older veterans as measured by vali date d wireless accelerometers . DESIGN A prospect i ve , observational cohort study . SETTING One hundred fifty-bed Department of Veterans Affairs hospital . PARTICIPANTS Forty-five hospitalized medical patients , aged 65 and older who were not delirious , did not have dementia , and were able to walk in the 2 weeks before admission were eligible . MEASUREMENTS Wireless accelerometers were attached to the thigh and ankle of patients for the first 7 days after admission or until hospital discharge , whichever came first . The mean proportion of time spent lying , sitting , and st and ing or walking was determined for each hour after hospital admission using a previously vali date d algorithm . RESULTS Forty-five male patients ( mean age 74.2 ) with a mean length of stay of 5.1 days generated 2,592 one-hour periods of data . A baseline functional assessment indicated that 35 ( 77.8 % ) study patients were willing and able to walk a short distance independently . No patient remained in bed the entire measured hospital stay , but on average , 83 % of the measured hospital stay was spent lying in bed . The average amount of time that any one individual spent st and ing or walking ranged from a low of 0.2 % to a high of 21 % , with a median of 3 % , or 43 minutes per day . CONCLUSION This is the first study to continuously monitor mobility levels early during a hospital stay . On average , older hospitalized patients spent most of their time lying in bed , despite an ability to walk independently",
"BACKGROUND Older adults live with multimorbidity including frailty and cognitive impairment often requiring hospitalization . While physical activity interventions ( PAIs ) are a normal rehabilitative treatment , their clinical effect in hospitalized older adults is uncertain . OBJECTIVE To observe PAI dosing characteristics and determine their impact on clinical performance parameters . DESIGN A single-site prospect i ve observational cohort study in an older persons ' unit . SUBJECTS Seventy-five older persons ' unit patients ≥65 years . INTERVENTION PAI ; therapeutic contact between physiotherapy clinician and patient . MEASUREMENTS Parameters included changes in activities-of-daily-living ( Barthel Index ) , h and grip strength , balance confidence , and gait velocity , measured between admission and discharge ( episode ) . Dosing characteristics were PAI temporal initiation , frequency , and duration . Frailty/cognition status was dichotomized independently per participant yielding 4 subgroups : frail/nonfrail and cognitively-impaired/cognitively-unimpaired . RESULTS Median ( interquartile range ) PAI initiation occurred after 2 days ( 1 - 4 ) , frequency was 0.4 PAIs per day ( 0.3 - 0.5 ) , and PAI duration per episode was 3.75 hours ( 1.8 - 7.2 ) . All clinical parameters improved significantly across episodes : grip strength median ( interquartile range ) change , 2.0 kg ( 0.0 - 2.3 ) ( P ) ; Barthel Index , 5 ( 3 - 8 ) ( P ) ; gait velocity , 0.06 m.∙s-1 ( 0.06 - 0.16 ) ( P ) ; and balance confidence , -3 ( -6 to -1 ) ( P . Physical activity intervention dosing remained consistent within subgroups . While several moderate to large associations between amount of PAIs and change in clinical parameters were observed , most were within unimpaired subgroups . CONCLUSIONS PAI dosing is consistent . However , while clinical changes during hospital episodes are positive , more favourable responses to PAIs occur if patients are nonfrail/cognitively-unimpaired . Therefore , to deliver a personalized rehabilitation approach , adaptation of PAI dose based on patient presentation is desirable",
"Purpose : Hospital‐associated deconditioning due to a combination of illness and inactivity is a serious problem for elderly adults . Here we investigate whether persistence in inflammatory status affects changes in physical function during short‐term hospitalization . Methods : This was a prospect i ve observational study in elderly medical patients at a geriatric department . Measurements were obtained at admission and one week after admission and included de Morton Mobility Index ( DEMMI ) test , 30‐second chair st and test ( 30‐s CST ) , 4‐m gait speed ( 4‐m GST ) test , h and grip strength , activity levels determined with ActivPALs , and concentrations of circulating C‐reactive protein ( CRP ) from blood sample s. Only patients with inflammation ( C‐reactive protein levels ≥ 10 mg·L− 1 ) at admission were included in this study . They were divided into those with continued inflammation ( CI : CRP remained ≥ 10 mg·L− 1 ) and those that became non‐inflammatory ( BN : CRP decreased to On admission 214 patients ( 67 % female ) with a median ( IQR ) age of 86 ( 81–91 ) years were categorized as inflammatory . There were no baseline differences in physical function between CI ( n = 138 , 67 % female ) and BN ( n = 76 , 68 % female ) . DEMMI‐score increased similarly in both groups ( P changes in h and grip strength were significantly different between the CI‐ and BN‐group ( − 0.05 [ − 0.27–0.28 ] vs. 0.16 [ − 0.10–0.41 ] kg·day− 1 , respectively , P between changes in CRP and length of hospital stay ( rs = 0.30 , P Hospitalized geriatric patients admitted with inflammation showed only moderate improvement of general mobility during hospital stay , regardless of changes in their inflammatory status . However , h and grip strength increased only in those patients who became non‐inflammatory during hospitalization . HighlightsHospital‐associated deconditioning is a serious problem for elderly adults . We examined changes in physical function and inflammation in geriatric patients .We included 214 patients with inflammation on admission . H and grip strength improved only in the patients that became non‐inflammatory . Continuous inflammation may attenuate recovery of muscle strength",
"BACKGROUND & AIMS Previous studies reported a severely impaired energy balance in COPD patients during the first days of an acute exacerbation , mainly due to a decreased energy and protein intake . The aim of the study was to investigate the feasibility and effectiveness of energy- and protein-rich nutritional supplements during hospitalization for an acute exacerbation in nutritionally depleted COPD patients . METHODS In a r and omized double-blind , placebo-controlled two-center trial , 56 COPD patients were r and omized and 47 patients completed the study . Nutritional intervention consisted of 3 x 125 ml ( 2.38 MJ/day ) and the placebo group received similar amounts of a non-caloric fluid . Medical therapy and dietetic consultation were st and ardized and dietary intake was measured daily . Body composition , respiratory and skeletal muscle strength , lung function and symptoms were measured on admission and on days 4 and 8 of hospitalization . RESULTS Forty-seven percent of the patients had experienced recent involuntary weight loss prior to admission . The degree of weight loss was inversely related to resting arterial oxygen tension ( r = 0.31 ; P Nutritional intervention result ed in a significant increase in energy ( 16 % vs. placebo ) and protein intake ( 38 % vs. placebo ) . Mean duration of hospitalization was 9 + /- 2 days . Relative to usual care , no additional improvements in lung function or muscle strength were seen after nutritional intervention . CONCLUSIONS Oral nutritional supplementation during hospitalization for an acute exacerbation is feasible in nutritionally depleted COPD patients and does not interfere with normal dietary intake",
"ABSTRACT The objective of this study was to determine whether an exercise intervention using a pedal exerciser is able to reduce disability in frail older patients with chronic obstructive pulmonary disease ( COPD ) during hospitalization due to an acute exacerbation . This study was a r and omized , single-blind clinical trial . Fifty-eight frail older patients admitted to hospital due to an acute exacerbation of COPD ( AE COPD ) were included in this study . All patients received st and ard medical and pharmacological care . Patients assigned to the intervention group also received an exercise intervention . The main outcome measures were balance , muscle strength , and exercise capacity . Significant between-group differences were found in muscle strength ( p = 0.028 ) and balance ( p = 0.013 ) after the intervention . All the variables improved significantly ( p mean difference in muscle strength between baseline and discharge was 10.47 N. Balance also improved , showing a mean difference of 7.56 seconds on the right leg and 6.57 seconds on the left leg . Exercise capacity improved as well , with a difference of 4.97 st and s between baseline and discharge . All the variables showed impairment in the control group . In conclusion , an exercise intervention using a pedal exerciser during the hospital stay of frail elderly patients with an AE COPD improves muscle strength , balance , and exercise capacity",
"OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity",
"BACKGROUND Inactivity during hospitalization in older medical patients may lead to functional decline . This study quantified 24-hour mobility , vali date d the accelerometers used , and assessed the daily level of basic mobility in acutely admitted older medical patients during their hospitalization . METHODS This is a prospect i ve cohort study in older medical patients able to walk independently ( ambulatory patients ) and those not able to walk independently ( nonambulatory patients ) on admission . The 24-hour mobility level during hospitalization was assessed by measuring the time in lying , sitting , and st and ing and /or walking , by two accelerometers . Basic mobility was quantified within 48 hours of admission and repeated daily throughout hospitalization . RESULTS Forty-three ambulatory patients and six nonambulatory patients were included . The ambulatory patients tended to be hospitalized for fewer days than the nonambulatory patients ( 7 vs 16 , p = .13 ) . The ambulatory patients were lying median 17 hours , ( interquartile range [ IQR ] : 14.4 - 19.1 ) , sitting 5.1 hours ( IQR : 2.9 - 7.1 ) , and st and ing and /or walking 1.1 hours ( IQR : 0.6 - 1.7 ) per day . On days with independency in basic mobility , the ambulatory patients were lying 4.1 hours less compared with days with dependency in basic mobility ( p lying , sitting , and st and ing and /or walking of the accelerometers , corresponded by 89%-100 % with positions performed by older medical patients . CONCLUSIONS Older acutely hospitalized medical patients with walking ability spent 17h/d of their in-hospital time in bed , and the level of in-hospital mobility seemed to depend on the patients ' level of basic mobility . The accelerometers were valid in assessing mobility in older medical patients",
"RATIONALE Exacerbations of chronic obstructive pulmonary disease ( COPD ) acutely reduce skeletal muscle strength and result in long-term loss of functional capacity . OBJECTIVES To investigate whether resistance training is feasible and safe and can prevent deteriorating muscle function during exacerbations of COPD . METHODS Forty patients ( FEV(1 ) 49 + /- 17 % predicted ) hospitalized with a severe COPD exacerbation were r and omized to receive usual care or an additional resistance training program during the hospital admission . Patients were followed up for 1 month after discharge . Primary outcomes were quadriceps force and systemic inflammation . A muscle biopsy was taken in a subgroup of patients to assess anabolic and catabolic pathways . MEASUREMENTS AND MAIN RESULTS Resistance training did not yield higher systemic inflammation as indicated by C-reactive protein levels and could be completed uneventfully . Enhanced quadriceps force was seen at discharge ( + 9.7 + /- 16 % in the training group ; -1 + /- 13 % in control subjects ; P = 0.05 ) and at 1 month follow-up in the patients who trained . The 6-minute walking distance improved after discharge only in the group who received resistance training ( median 34 ; interquartile range , 14 - 61 m ; P = 0.002 ) . In a subgroup of patients a muscle biopsy showed a more anabolic status of skeletal muscle in patients who followed training . Myostatin was lower ( P = 0.03 ) and the myogenin/MyoD ratio tended to be higher ( P = 0.08 ) in the training group compared with control subjects . CONCLUSIONS Resistance training is safe , successfully counteracts skeletal muscle dysfunction during acute exacerbations of COPD , and may up-regulate the anabolic milieu in the skeletal muscle . Clinical trial registered with www . clinical trials.gov ( NCT00877084 )",
"PURPOSE Although it is well known that immobilization causes muscle atrophy , most immobilization models have examined lower limbs , and little is known about the forearm . The purpose of this study was to determine whether forearm immobilization produces changes in muscle morphology and function . METHODS Six healthy males ( age : 21.5 + /- 1.4 , mean + /- SD ) participated in this study . The nondominant arm was immobilized with a cast ( CAST ) for 21 d , and the dominant arm was measured as the control ( CONT ) . The forearm cross-sectional area ( CSA ) and circumference were measured as muscle morphology . Maximum grip strength , forearm muscle oxidative capacity , and dynamic grip endurance were measured as muscle function . Magnetic resonance ( MR ) imaging was used to measure CSA , and 31phosphorus MR spectroscopy was used to measure time constant ( Tc ) for phosphocreatine ( PCr ) recovery after submaximal exercise ( PCr-Tc ) . Grip endurance was expressed by the number of h and grip contractions at 30 % maximum grip strength load . All measurements were taken before and after the immobilization . RESULTS After the 21-d forearm immobilization , no changes were seen for each measurement in CONT . CSA and the circumference showed no significant changes in CAST . However , maximum grip strength decreased by 18 % ( P PCr-Tc was prolonged by 45 % ( P grip endurance at the absolute load was reduced by 19 % ( P CAST . CONCLUSION In this model , 21-d forearm immobilization caused no significant changes in forearm muscle morphology , but the muscle function showed remarkable deterioration ranging from 18 to 45 %",
"OBJECTIVE To determine the safety and efficacy of the anabolic steroid n and rolone in elderly patients with hip fractures . DESIGN A r and omized double-blind placebo-controlled trial . SETTING The orthopedic ward of a university teaching hospital . PARTICIPANTS 29 frail elderly females with hip fractures . INTERVENTION Subjects received n and rolone 2 mg/kg ( n = 15 ) or placebo ( n = 14 ) by weekly injection for 4 weeks or until discharge . MEASURES Baseline functional status was assessed by the Lawton-Brody ADL and IADL . Hemoglobin , transferrin , thyroid-binding prealbumin , albumin , liver function tests , creatinine , weight , MAMC , bioelectric impedance , st and ard anthropometrics and grip strength were measured at baseline and weekly intervals . Rehabilitation parameters and length of stay were recorded . RESULTS The placebo and n and rolone groups were similar in age , although the control group had slightly higher baseline ADL scores . There was no difference between groups in biochemical parameters , anthropometrics , body composition , grip strength , rehabilitation end points or length of stay . One subject in the n and rolone group had a doubling of AST and was withdrawn from the study . CONCLUSIONS N and rolone can be given safely to frail elderly subjects with hip fractures but is likely to be of minimal benefit at the doses we employed",
"OBJECTIVE To evaluate the effects of whole-body resistance training on exercise capacity , health-related quality of life ( HRQOL ) , and muscle strength in patients hospitalized for exacerbation of chronic obstructive pulmonary disease . DESIGN R and omized controlled trial . SETTING University hospital . PARTICIPANTS Patients ( N=46 ) were r and omized to either a control group ( CG ) or training group ( TG ) , and 29 patients completed the study . INTERVENTION Training consisted of weight-lifting exercises for 6 muscle groups in the upper and lower limbs ( 2 sets of 8 repetitions each ) , and the initial load was set at 80 % of the 1-repetition maximum load . MAIN OUTCOME MEASURES Patients were evaluated on the second day of hospitalization , at hospital discharge , and 30 days postdischarge . Patients were evaluated on the basis of the 6-minute walking distance ( 6MWD ) , HRQOL , muscle strength , systemic inflammatory markers , and level of physical activity in daily life ( PADL ) . RESULTS The CG showed a reduction in the strength of lower-limb muscles ( P 6MWD ( P>.05 ) . In contrast , patients from the TG improved strength in the lower-limb muscles and 6MWD during and 30 days after hospitalization ( P impact domain in HRQOL after hospitalization . No improvement in PADL was observed in the TG . Finally , a reduction in the blood levels of inflammatory markers was observed only in the TG after hospitalization . CONCLUSIONS Our results suggest that resistance training during hospitalization improves the 6MWD , HRQOL , and lower-limb muscle strength , without altering the levels of systemic inflammation . However , future research should explore this intervention in larger r and omized trials",
"The objective of this study was to analyze the results of a multimodal therapeutic program during hospitalization in obese AE COPD patients . This was a r and omized , single-blind clinical trial conducted at two university hospitals in Granada , Spain . Forty-nine patients hospitalized due to AE COPD were r and omly allocated to a control group ( CG ) , in which patients received st and ard care , or to an intervention group ( IG ) , in which patients were included in a multimodal therapeutic program , added to the st and ard care . The main outcome measures were pulmonary , physical ( strength and exercise capacity ) and perceived ( dyspnea , quality of life and psychological distress ) variables . Within-group significant improvements ( p and perceived variables in the IG after the treatment . In the CG , a significant decrease was found in lower limb strength and a significant improvement in dyspnea and in three subscales of the EuroQol-5D question naire . The between-groups analysis showed significant differences after the treatment on lower limb strength and exercise capacity values ( p three of the EuroQol-5D subscales , and in the total score and the depression subscale of the Hospital Anxiety and Depression Scale . A multimodal therapeutic program has a beneficial effect on physical functioning and perceived variables in hospitalized obese patients with AE COPD",
"BACKGROUND : COPD exacerbations are frequent events that have a negative impact on the lives of patients . The aims of this study were to analyze physical and functional impairment during hospital stay in subjects hospitalized due to COPD exacerbation and to assess the physical and functional impact of hospitalization at a 1-month follow-up in patients with severe COPD . METHODS : This was a prospect i ve observational study on a sample of 52 subjects hospitalized due to COPD exacerbation . The assessment s were performed at baseline , discharge , and 1-month follow-up . The outcome measures were dyspnea , muscle strength , functional capacity , and postural steadiness . RESULTS : Quadriceps strength [ 1.036 ( P = .043 ) kg mean difference ] and the one-leg stance test [ 1.04 ( P = .02 ) and 0.73 ( P = .032 ) s mean difference right and left leg ] showed significant impairment during hospitalization . Dyspnea perception improved significantly ( P = .004 ) during hospitalization . Additionally , strength in the upper and lower limbs [ 4.04 ( P = .002 ) and 1.23 ( P = .038 ) kg mean difference ] , functional capacity [ 3.0 number of steps mean difference ( P = .032 ) ] , and the one-leg stance test [ 2.12 ( P = .006 ) and 0.53 ( P = .047 ) s mean difference right and left leg ] showed significant impairment 1-month follow-up . CONCLUSIONS : Hospitalization due to COPD exacerbation leads to physical and functional impairment in patients ; impairment is greater at 1-month follow-up . It would be interesting to conduct physical therapy interventions to prevent the impairment"
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INTRODUCTION Chronic depression represents a substantial portion of depressive disorders and is associated with severe consequences . This review examined the efficacy and acceptability of selective serotonin reuptake inhibitors ( SSRIs ) and tricyclic antidepressants ( TCAs ) in the treatment of chronic depression . Additionally , the comparative effectiveness of the two types of antidepressants has been examined . METHODS A systematic search was conducted in the following data bases : CENTRAL , MEDLINE , EMBASE , ISI Web of Science , BIOSIS , PsycINFO , and CINAHL . Primary efficacy outcome was a response to treatment ; primary acceptance outcome was dropping out of the study . Only r and omized controlled trials were considered . RESULTS We identified 20 studies with 22 relevant comparisons . 19 studies focused on sample s with a majority of dysthymic patients . Both SSRIs and TCAs are efficacious in terms of response rates when compared to placebo ( Benefit Ratio [BR]=1.49 ; p placebo in terms of dropout rates could be found . No differences in effectiveness were found between SSRIs and TCAs in terms of response rates ( BR=1.01 ; p=0.91 ) , yet , SSRIs showed statistically better acceptability in terms of dropout rates than TCAs ( Odds Ratio [OR]=0.41 ; p=0.02 ) . LIMITATIONS The method ological quality of the primary studies was evaluated as unclear in many cases and more evidence is needed to assess the efficacy of SSRIs and TCAs in patients suffering from chronic forms of depression other than dysthymia . CONCLUSIONS This systematic review provides evidence for the efficacy of both SSRIs and TCAs in the treatment of chronic depression and showed a better acceptability of SSRIs
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"1 . There is increasing evidence that many patients with major depression also have coexisting dysthymia , and that antidepressant treatment may alleviate both conditions . 2 . Open-label study of fluoxetine and trazodone for 18 patients meeting DSM-III-R criteria for concurrent dysthymia and major depression . 3 . Fourteen patients completed three-month medication trials , and seven ( 50 % ) of completers ) responded to treatment . At five months , eight ( 57.1 % ) were in remission . Fluoxetine was significantly better tolerated than trazodone , with respective dropout rates of 7.7 % and 80 % . 4 . Findings are consistent with efficacy of serotonergic agents in this condition",
"BACKGROUND Despite the high prevalence of dysthymia and its associated morbidity , few controlled trials have evaluated the efficacy of antidepressant medication for this disorder . A 12-week , double-blind , placebo-controlled , r and omized , multicenter trial was performed to evaluate the safety and efficacy of sertraline hydrochloride and imipramine hydrochloride in treating dysthymia . METHODS A total of 416 out patients ( 271 women and 145 men ) aged 25 to 65 years with DSM-III-R-defined , early-onset , primary dysthymia without concurrent major depression were r and omized to 12 weeks of treatment with sertraline , imipramine , or placebo . RESULTS Both active treatments result ed in significantly reduced scores on the 17-item Hamilton Rating Scale for Depression ( P = .04 and P = .01 for sertraline and imipramine vs placebo , respectively ) , the Montgomery-Asberg Depression Rating Scale ( P = .01 and P = .003 vs placebo , respectively ) , Hopkins Symptom Checklist ( P self-rated version of the Inventory of Depressive Symptoms ( P Clinical Global impressions improvement score of 1 or 2 ( very much or much improved ) to define response , response rates were 59 % for sertraline , 64 % for imipramine , and 44 % for placebo ( P = .02 for sertraline vs placebo and P imipramine vs placebo ) . A significantly greater proportion of patients receiving imipramine than those receiving sertraline or placebo discontinued treatment because of adverse events ( P = .001 and P dysthymia in patients suffering from this chronic affective disorder , with both sertraline and imipramine being more effective than placebo . The greater tolerability of sertraline is an important consideration because of the chronicity of dysthymia , which may require prolonged treatment with antidepressant medication ",
"BACKGROUND There have been very few controlled studies of antidepressants in dysthymia , particularly in sample s diagnosed reliably and with an adequate length of follow-up . In this investigation , we measured the long-term outcome in a large group of patients meeting DSM-III-R criteria for dysthymia . This study was design ed to investigate whether fluoxetine is effective in the treatment of dysthymia . METHOD This r and omised study including 140 patients , compared fluoxetine ( 91 patients ) and placebo ( 49 patients ) on a double-blind basis in two distinct phases : a short-term end-point ( 3 months with 20 mg/day fluoxetine ) and a medium-term end-point ( 6 months ) where the initial responders continued double-blind treatment unchanged and non-responders received an additional treatment of 20 mg/day fluoxetine . RESULTS After three months of treatment , response was seen more frequently in the fluoxetine group ( 42/72 ) than in the placebo group ( 14/39 , P fluoxetine was increased to 40 mg daily . CONCLUSIONS This study showed the significant and persistent action of fluoxetine on dysthymia . The finding that 50 % of the non-responders at 3 months were improved at 6 months , after fluoxetine dosage was increased to 40 mg daily , argues in favour of treating dysthymic patients for at least 6 months , and with a higher dosage if the initial doses are ineffective",
"BACKGROUND Over the past decade , studies of the effectiveness of pharmacological treatment for depression have often been based on research design s intended to measure efficacy , and for this reason the results are of limited generalizability . Research is needed comparing the clinical and economic outcomes of antidepressants in day-to-day clinical practice . METHODS A six-month r and omised prospect i ve naturalistic study comparing fluoxetine to imipramine carried out in three primary care health centres . Outcome measures were the Montgomery Asberg Depression Rating Scale ( MADRS ) , direct costs , indirect costs and total costs . Subjects were evaluated at the beginning of treatment and at one , three and six months thereafter . RESULTS Of the 103 patients , 38.8 % ( n = 40 ) were diagnosed with major depressive disorder , 14.6 % ( n = 15 ) with dysthymic disorder , and 46.6 % ( n = 48 ) with depressive disorder not otherwise specified . Patients with major depressive disorder or dysthymic disorder achieved similar clinical improvement in both treatment groups ( mean MADRS ratings decrease in major depressive disorder from baseline to 6 months of 18.3 for imipramine and 18.8 for fluoxetine ) . For patients with major depressive disorder and dysthymic disorder , the imipramine group had fewer treatment-associated costs ( imipramine 469.66 Euro versus fluoxetine 1,585.93 Euro in major depressive disorder , p group with depressive disorder not otherwise specified did not experience statistically significant differences in clinical and costs outcomes between treatment groups . LIMITATIONS Exclusion criteria , participating physicians may not represent GPs . CONCLUSIONS In a primary care context , imipramine may represent a more cost-effective treatment option than fluoxetine for treating major depressive disorder or dysthymic disorder . There were no differences in cost-effectiveness in the treatment of depressive disorder not otherwise specified",
"CONTEXT Insufficient evidence exists for recommendation of specific effective treatments for older primary care patients with minor depression or dysthymia . OBJECTIVE To compare the effectiveness of pharmacotherapy and psychotherapy in primary care setting s among older persons with minor depression or dysthymia . DESIGN R and omized , placebo-controlled trial ( November 1995-August 1998 ) . SETTING Four geographically and clinical ly diverse primary care practice s. PARTICIPANTS A total of 415 primary care patients ( mean age , 71 years ) with minor depression ( n = 204 ) or dysthymia ( n = 211 ) and a Hamilton Depression Rating Scale ( HDRS ) score of at least 10 were r and omized ; 311 ( 74.9 % ) completed all study visits . INTERVENTIONS Patients were r and omly assigned to receive paroxetine ( n = 137 ) or placebo ( n = 140 ) , starting at 10 mg/d and titrated to a maximum of 40 mg/d , or problem-solving treatment- primary care ( PST-PC ; n = 138 ) . For the paroxetine and placebo groups , the 6 visits over 11 weeks included general support and symptom and adverse effects monitoring ; for the PST-PC group , visits were for psychotherapy . MAIN OUTCOME MEASURES Depressive symptoms , by the 20-item Hopkins Symptom Checklist Depression Scale ( HSCL-D-20 ) and the HDRS ; and functional status , by the Medical Outcomes Study Short-Form 36 ( SF-36 ) physical and mental components . RESULTS Paroxetine patients showed greater ( difference in mean [ SE ] 11-week change in HSCL-D-20 scores , 0.21 [ 0 . 07 ] ; P = .004 ) symptom resolution than placebo patients . Patients treated with PST-PC did not show more improvement than placebo ( difference in mean [ SE ] change in HSCL-D-20 scores , 0.11 [ 0.13 ] ; P = .13 ) , but their symptoms improved more rapidly than those of placebo patients during the latter treatment weeks ( P = .01 ) . For dysthymia , paroxetine improved mental health functioning vs placebo among patients whose baseline functioning was high ( difference in mean [ SE ] change in SF-36 mental component scores , 5.8 [ 2.02 ] ; P = . 01 ) or intermediate ( difference in mean [ SE ] change in SF-36 mental component scores , 4.4 [ 1.74 ] ; P = .03 ) . Mental health functioning in dysthymia patients was not significantly improved by PST-PC compared with placebo ( P>/=.12 for low- , intermediate- , and high-functioning groups ) . For minor depression , both paroxetine and PST-PC improved mental health functioning in patients in the lowest tertile of baseline functioning ( difference vs placebo in mean [ SE ] change in SF-36 mental component scores , 4.7 [ 2.03 ] for those taking paroxetine ; 4.7 [ 1.96 ] for the PST-PC treatment ; P = .02 vs placebo ) . CONCLUSIONS Paroxetine showed moderate benefit for depressive symptoms and mental health function in elderly patients with dysthymia and more severely impaired elderly patients with minor depression . The benefits of PST-PC were smaller , had slower onset , and were more subject to site differences than those of paroxetine",
"OBJECTIVE Chronic depression starts at an early age for many individuals and could affect their accumulation of \" human capital \" ( i.e. , education , higher amounts of which can broaden occupational choice and increase earnings potential ) . The authors examined the impact , by gender , of early- ( before age 22 ) versus late-onset major depressive disorder on educational attainment . They also determined whether the efficacy and sustainability of antidepressant treatments and psychosocial outcomes vary by age at onset and quantified the impact of early- versus late-onset , as well as never-occurring , major depressive disorder on expected lifetime earnings . METHOD The authors used logistic and multivariate regression methods to analyze data from a three-phase , multicenter , double-blind , r and omized trial that compared sertraline and imipramine treatment of 531 patients with chronic depression aged 30 years and older . These data were integrated with U.S. Census Bureau data on 1995 earnings by age , educational attainment , and gender . RESULTS Early-onset major depressive disorder adversely affected the educational attainment of women but not of men . No significant difference in treatment responsiveness by age at onset was observed after 12 weeks of acute treatment or , for subjects rated as having responded , after 76 weeks of maintenance treatment . A r and omly selected 21-year-old woman with early-onset major depressive disorder in 1995 could expect future annual earnings that were 12%-18 % lower than those of a r and omly selected 21-year-old woman whose onset of major depressive disorder occurred after age 21 or not at all . CONCLUSIONS Early-onset major depressive disorder causes substantial human capital loss , particularly for women . Detection and effective treatment of early-onset major depressive disorder may have substantial economic benefits",
"BACKGROUND Chronic depressions are common , disabling , and undertreated , and prior chronicity predicts future chronicity . However , few studies directly inform the acute or maintenance phase treatments of chronic depressions and even less is known about the effects of treatment on psychosocial functioning . METHOD We describe the design and rationale for 2 parallel double-blind , r and omized , multicenter acute and maintenance phase treatment trials . One focused on DSM-III-R major depression currently in a chronic ( > or = 2 years ) major depressive episode , the other on DSM-III-R major depression with concurrent DSM-III-R dysthymia ( \" double depression \" ) . RESULTS Considering the critical knowledge deficits , we design ed a 12-week acute phase safety and efficacy trial of sertraline versus imipramine , followed by a 16-week continuation treatment phase for subjects with a satisfactory therapeutic response . Patients receiving sertraline who successfully completed the continuation phase entered a 76-week maintenance trial to compare sertraline with placebo ; those taking imipramine continued without a placebo substitution . As part of the acute trial , subjects completing but failing to respond to the initial 12-week acute phase medication were crossed over ( double-blind ) to the alternative medication for a 12-week acute phase trial . We obtained naturalistic follow-up data ( up to 18 months ) for subjects exiting the protocol at any time . CONCLUSION Multiphase protocol s for chronic depression can test efficacy by r and omized contrasts as well as shed light on key clinical issues such as the degree of response or attrition expected at particular times in a trial or the preferred medication sequence in a potential multistep treatment program",
"OBJECTIVE The purpose of this study was to assess the efficacy of fluoxetine , a selective serotonergic antidepressant , in the treatment of dysthymia . METHOD Thirty-five patients who met criteria for dysthymia , but not major depression , began r and omized , double-blind 8-week trials of fluoxetine or placebo . RESULTS Of 32 patients who completed the study , 10 ( 62.5 % ) of the 16 patients given fluoxetine and three ( 18.8 % ) of the 16 given placebo responded to treatment . Response was defined as 1 ) 50 % or greater decrease in Hamilton Rating Scale for Depression score and 2 ) a score of 1 or 2 on the Clinical Global Impression ( CGI ) improvement subscale . Fluoxetine subjects showed significantly greater improvement at week 8 than placebo subjects on the Hamilton depression and CGI scales , but not on the Hopkins Symptom Check-list ( 58-item ) or the Cornell Dysthymia Rating Scale . CONCLUSIONS When compared to placebo , fluoxetine showed short-term effectiveness in treating dysthymic symptoms",
"OBJECTIVE The research ers evaluated the effectiveness of paroxetine and Problem-Solving Treatment for Primary Care ( PST-PC ) for patients with minor depression or dysthymia . STUDY DESIGN This was an 11-week r and omized placebo-controlled trial conducted in primary care practice s in 2 communities ( Lebanon , NH , and Seattle , Wash ) . Paroxetine ( n=80 ) or placebo ( n=81 ) therapy was started at 10 mg per day and increased to a maximum 40 mg per day , or PST-PC was provided ( n=80 ) . There were 6 scheduled visits for all treatment conditions . POPULATION A total of 241 primary care patients with minor depression ( n=114 ) or dysthymia ( n=127 ) were included . Of these , 191 patients ( 79.3 % ) completed all treatment visits . OUTCOMES Depressive symptoms were measured using the 20-item Hopkins Depression Scale ( HSCL-D-20 ) . Remission was scored on the Hamilton Depression Rating Scale ( HDRS ) as less than or equal to 6 at 11 weeks . Functional status was measured with the physical health component ( PHC ) and mental health component ( MHC ) of the 36-item Medical Outcomes Study Short Form . RESULTS All treatment conditions showed a significant decline in depressive symptoms over the 11-week period . There were no significant differences between the interventions or by diagnosis . For dysthymia the remission rate for paroxetine ( 80 % ) and PST-PC ( 57 % ) was significantly higher than for placebo ( 44 % , P=.008 ) . The remission rate was high for minor depression ( 64 % ) and similar for each treatment group . For the MHC there were significant outcome differences related to baseline level for paroxetine compared with placebo . For the PHC there were no significant differences between the treatment groups . CONCLUSIONS For dysthymia , paroxetine and PST-PC improved remission compared with placebo plus nonspecific clinical management . Results varied for the other outcomes measured . For minor depression , the 3 interventions were equally effective ; general clinical management ( watchful waiting ) is an appropriate treatment option",
"OBJECTIVE This study assessed the efficacy of antidepressant treatment ( sertraline ) and group cognitive behavior therapy , alone or in combination , in primary dysthymia . The clinical features of dysthymia , as well as the functional impairments associated with the illness ( e.g. , quality of life , stress perception , coping styles ) , were evaluated . METHOD Patients ( N = 97 ) diagnosed with primary dysthymia , but no other current comorbid disorder , received either sertraline or placebo in a double-blind design over 12 weeks . In addition , a subgroup of the patients ( N = 49 ) received a structured , weekly group cognitive behavior therapy intervention . RESULTS Treatment with sertraline , with or without group cognitive behavior therapy , reduced the functional impairment of depression . The reductions were similar in the drug-cognitive therapy group and in subjects who received the drug alone . Furthermore , while group cognitive behavior therapy alone reduced the depression scores , this effect was not significantly greater than the effect of the placebo . The drug treatment also induced pronounced improvement in the functional measures , and in some respects these effects were augmented by group cognitive behavior therapy . Among patients who responded favorably to cognitive behavior therapy , the improvements in the functional measures were similar to those who responded to drug treatment , whereas such functional changes were not seen among patients who responded to placebo . CONCLUSIONS Sertraline treatment effectively reduces the clinical symptoms and functional impairments associated with dysthymia . Although the group cognitive behavior therapy intervention was less effective in alleviating clinical symptoms , it augmented the effects of sertraline with respect to some functional changes , and in a subgroup of patients it attenuated the functional impairments characteristic of dysthymia",
"BACKGROUND The selective serotonin reuptake inhibitor sertraline has been shown to be efficacious and well tolerated for the treatment of major depressive disorder . Relatively few trials , however , have examined the role of pharmacotherapy in dysthymia without concurrent major depression . The current investigation focuses on the use of sertraline for the treatment of dysthymia . METHOD In this 12-week , multicenter , double-blind study , 310 patients with a DSM-III-R diagnosis of dysthymic disorder without concurrent major depression were r and omly assigned to receive either sertraline ( N = 158 ) or placebo ( N = 152 ) . Sertraline was initiated at a dose of 50 mg daily , with titration permitted to a maximum of 200 mg daily . The primary evaluation criteria were the Structured Interview Guide for the Hamilton Depression Rating Scale , Seasonal Affective Disorder Version ( SIGH-SAD ) , the Montgomery-Asberg Depression Rating Scale ( MADRS ) , and the Clinical Global Impressions-Severity of Illness ( CGI-S ) and -Improvement ( CGI-I ) scales . RESULTS Mean percentage reductions for the intent-to-treat population in SIGH-SAD scores were 44.6 % for the sertraline-treated group and 33.2 % for the placebo-treated group ( p = .03 ) ; MADRS scores , 43.6 % and 33.0 % ( p = .02 ) ; and CGI-S scores , 32.8 % and 22.8 % ( p = .02 ) . A significantly greater proportion of the sertraline-treated group was classified as responders ( defined for HAM-D and MADRS scores as a 50 % score reduction and for CGI-I as a score of 1 or 2 by the final visit ) and remitters ( SIGH-SAD score sertraline-treated patients experienced greater improvements in all 9 domains of the Battelle Quality of Life Question naire than placebo-treated patients did , with a significant difference observed in favor of sertraline in 8 of the 9 domains . The life satisfaction and social interaction quality of life domains showed significantly greater response in sertraline responders compared with placebo SIGH-SAD responders . Sertraline was well tolerated . Thirteen percent of the sertraline-treated group versus 8 % of the placebo-treated group withdrew from therapy owing to adverse events ( p = .14 ) . CONCLUSION Sertraline is efficacious and well tolerated in the short-term treatment of dysthymia without concurrent major depression",
"Numerous studies have assessed the acute efficacy of antidepressants , including selective serotonin reuptake inhibitors , in treating dysthymic disorder ; however , escitalopram , the S-enantiomer of citalopram , has not been studied . Thirty-six out patients with Structured Clinical Interview for DSM-III-R-diagnosed dysthymic disorder , aged 23–65 years ( mean±SD=44.7±11 years ) , were r and omly assigned to double-blind escitalopram ( maximum dose 20 mg/day ) versus placebo for 12 weeks . Inclusion criteria included age 18–65 years and Hamilton Depression Rating Scale ( HDRS ) score ≥12 . We hypothesized that escitalopram would be superior to placebo in the HDRS-24 item total score at week 12 . We also hypothesized the superiority of escitalopram over placebo for secondary measures , including the percentage of participants classified as responders and remitters , as well as social functioning ( Social Adjustment Scale ) , clinical global impression-improvement , Global Assessment of Functioning Scale . Participants ' baseline HDRS-24 averaged 23.4±5.9 . Final HDRS-24 scores at last observation carried forward did not differ significantly between escitalopram-treated ( mean±SD=10.88±5.83 ) and placebo-treated individuals ( mean±SD=16.4±6.34 ) ( F=2.82 , degrees of freedom=1,32 , P=0.10 ) . Significant differences favoring active medication were found on the Social Adjustment Scale and the Clinical Global Impression Severity and Global Assessment of Functioning Scale , but not in the percentages of responders or remitters . A larger study sample or higher escitalopram dose may show more significant placebo – medication differences",
"BACKGROUND Chronic depression appears to be a common , frequently disabling illness that is often inadequately treated . Unlike episodic depressions with shorter illness duration , neither acute nor long-term treatment approaches for chronic depression have been well studied . METHOD 635 out patients at 12 sites who met DSM-III-R criteria for chronic major depression or double depression were r and omly assigned to 12 weeks of double-blind treatment with either sertraline ( in daily doses of 50 - 200 mg ) or imipramine ( in daily doses of 50 - 300 mg ) . Efficacy and safety were assessed either weekly or every 2 weeks during the 12 weeks of acute treatment . RESULTS Despite high rates of chronicity ( mean duration of major depression = 8.9+/-9.1 years ; mean duration of dysthymia = 23+/-13 years ) and high rates of comorbidity , 52 % of patients achieved a satisfactory therapeutic response to sertraline or imipramine ( by a conservative , intent-to-treat analysis ) . Approximately 21 % of the patients who had achieved a therapeutic response at week 12 had not done so at week 8 , confirming the longer time to response in depressions with high chronicity . Patients treated with sertraline reported significantly fewer adverse events and were significantly less likely to discontinue treatment due to side effects than imipramine-treated patients ( 6.3 % vs. 12.0 % ) . CONCLUSION These results indicate that patients suffering from depression with high chronicity can achieve a good therapeutic response to acute treatment with either sertraline or imipramine , although sertraline is better tolerated",
"The authors compared the effects of 6 weeks of imipramine treatment with 6 weeks of placebo treatment on social and vocational impairment in chronic depression . Imipramine was associated with significantly greater pre- to posttreatment improvement of social-vocational impairments in chronic depression , suggesting that these impairments may have represented affective symptoms rather than characterologic deficits",
"An algorithm for transcribing Research Diagnostic Criteria diagnoses for depressive disorders to similar categories in the DSM-III was applied to 103 depressed out patients previously diagnosed by Research Diagnostic Criteria . All had Hamilton Depression Rating Scale scores of 18 or less . Among 64 patients completing a six-week , double-blind study comparing desipramine hydrochloride with placebo , desipramine was significantly more effective than placebo in patients with DSM-III major depression but not in those with dysthymic disorder . Among patients with major depression , a significant drug-placebo response difference was demonstrated even in those without melancholia . These findings support the clinical usefulness of the DSM-III in the treatment of depressed out patients . Independent of DSM-III diagnosis , however , evidence of panic attacks seemed to identify patients who benefited from desipramine therapy . This suggests that the DSM-III hierarchy , which excludes consideration of panic in patients with major depression , may require revision",
"BACKGROUND Like major depression , dysthymia has been associated with elevated production of interleukin-1 ( IL-1 beta ) in mitogen-stimulated lymphocytes . In the present investigation , we assessed whether the elevated IL-1 beta production in dysthymic patients would normalize following treatment with sertraline . METHODS The production of IL-1 beta was determined in dysthymic patients and in nondepressed control subjects . Patients then received 12 weeks of doses of either sertraline or placebo in a double-blind trial , after which cytokine production was again determined . RESULTS Basal IL-1 beta was elevated in dysthymic patients relative to control subjects . Cytokine production was modestly correlated with the severity of symptoms and with the age of illness onset . Relative to placebo treatment , sertraline attenuated the symptoms of depression ; however , this was not accompanied by normalization of IL-1 beta production . CONCLUSIONS While dysthymia is associated with elevated IL-1 beta production , the failure for the cytokine to normalize following symptom alleviation suggests that either the IL-1 beta may be a trait marker of the illness , or that more sustained treatment is necessary to reduce cytokine production . Given the neuroendocrine and central neurochemical consequences of exogenously administered IL-1 beta , the possibility ought to be explored that increased IL-1 beta production may play a role in the pathophysiology of dysthymia",
"The acute treatment efficacy , tolerability , and effects on health-related quality of life of sertraline ( 50 - 200 mg/day ) versus imipramine ( 75 - 225 mg/day ) were compared in out patients with non-melancholic depression . The study employed an open-label , parallel-group design . One hundred and sixteen patients were r and omized to receive sertraline and 123 to receive imipramine for 8 weeks . In the intent-to-treat ( ITT ) , last-observation-carried-forward ( LOCF ) analysis , sertraline produced statistically significantly greater improvements in depressive ( 21-item Hamilton Depression Rating Scale [ HAM-D(21 ) ] scores of 24.9 and 24.4 were reduced to 10.3 and 13.1 at endpoint , P anxiety symptoms ( Hamilton Anxiety Rating Scale [ HAM-A ] scores of 21.8 and 21.9 were reduced to 9.5 and 13.9 , P remission rates ( 51.3 % versus 38.0 % at endpoint , P=.041 ) from week 4 onwards compared with imipramine . The proportion of patients who were ' very much improved ' or ' much improved ' ( Clinical Global Impressions Scale of Improvement [ CGI-I ] score of 1 or 2 ) was significantly higher at endpoint in the sertraline group ( 76.1 % ) than in the imipramine group ( 62.8 % ) ( P=.028 ) . At week 8 , patients in both treatment groups showed clear improvements in quality of life , although nonstatistically significant differences were evident in the quality of life of sertraline- versus imipramine-treated patients . Sertraline was significantly superior in tolerability with less discontinuations due to adverse events ( 10.3 % ) compared with the imipramine group ( 24.4 % ) ( P=.004 ) . It was concluded that sertraline is more effective than imipramine in the acute treatment of depressive and anxiety symptoms in patients with non-melancholic depression",
"Fifty out patients with dysthymic disorder ( DSM-III ) were divided by double-blind r and omized assignment into three groups given ritanserin , imipramine , and placebo , respectively . The trial was of 7 weeks ' duration ; by week 6 , imipramine was clearly superior to placebo , whereas by week 7 , both drugs caused significantly more improvement than the placebo . Although imipramine had slightly greater efficacy than ritanserin , it also had significantly more side effects . This was particularly evident in the higher dropout rate with imipramine . The efficacy and side effect profile of ritanserin makes it well tolerated and acceptable with dysthymic patients who , although they do not respond as quickly as patients with major depressive disorder , do show significant improvement , given sufficient time",
"An international , multicenter , placebo-controlled study was undertaken to determine the safety and antidepressant efficacy of moclobemide , a new reversible inhibitor of monoamine oxidase A , and imipramine in the treatment of dysthymia ( DSM-III R ) . A total of 315 patients were enrolled and r and omly assigned to an 8-week treatment in one of three groups ( moclobemide . imipramine and placebo ) . Patients were male or female out patients aged between 18 and 65 years meeting DSM-III-R criteria for dysthymia , primary type , with late or early onset . Of the patients in each group 85 % completed the 8-week treatment period . The percentage of patients who no longer fulfilled DSM-III-R symptom criteria at treatment end-point was significantly higher in the moclobemide ( 60 % ) and imipramine ( 49 % ) treatment groups than in the placebo group ( 22 % ) . Differences to placebo were also statistically significant both for moclobemide and for imipramine on the other efficacy variables ( i.e. Hamilton Rating Scale for Depression , final overall efficacy assessment , Clinical ( Global Impression and symptom check list self rating ) , A significant superiority of moclobemide and imipramine over placebo was found in pure dysthymia and in double-depression , as well as in early and late onset subgroups . In early onset cases , moclobemide was significantly more effective than was imipramine on the Ramilton Rating Scale for Depression . Anticholinergic symptoms and sleepiness were significantly more frequent side effects on imipramine than on moclobemide or on placebo , and the investigators ' final overall assessment of tolerability significantly favoured mociohemide over imipramine . This study demonstrates the efficacy of high dose moclobemide ( mean dose 675mg/day ) and high dose imipramine ( 220 mg/day ) against placebo in the treatment of dysthymia . Moclobemide was better tolerated than was imipramine",
"OBJECTIVE The authors compared the efficacy and side effects of fluoxetine and placebo in elderly out patients with dysthymic disorder . METHODS Patients were r and omly assigned to fluoxetine ( 20 mg-60 mg/day ) or placebo for 12 weeks in a double-blind trial . RESULTS Of 90 r and omized patients , 71 completed the trial . In the intent-to-treat sample , r and om regression analyses of the Hamilton Rating Scale for Depression ( Ham-D ; 24-item ) and Cornell Dysthymia Rating Scale ( CDRS ) scores at each visit produced significant time x treatment group interactions favoring the fluoxetine group . Analysis of percentage change in Ham-D scores yielded no effect for treatment group , but a similar analysis of percentage change in CDRS scores yielded a main effect for treatment group , favoring fluoxetine over placebo . In the intent-to-treat sample , response rates were 27.3 % for fluoxetine and 19.6 % for placebo . In the completer sample , response rates were 37.5 % for fluoxetine and 23.1 % for placebo . CONCLUSION Fluoxetine had limited efficacy in elderly dysthymic patients . The clinical features of elderly dysthymic patients are typically distinct from those of dysthymic disorder in young adults , and the findings suggest that treatments effective for young adult dysthymic patients may not be as useful in elderly dysthymic patients . Further research is needed to identify efficacious treatments for elderly patients with dysthymic disorder , and investigative tools such as electronic/computerized brain scans and neuropsychological testing may help identify the factors that moderate antidepressant treatment response and resistance",
" 210 psychiatric out patients with generalised anxiety disorder ( 71 ) , or panic disorder ( 74 ) , or dysthymic disorder ( 65 ) diagnosed by an interview schedule for DSM-III were allocated by constrained r and omisation to one of five treatments : diazepam ( 28 ) , dothiepin ( 28 ) , placebo ( 28 ) , cognitive and behaviour therapy ( 84 ) , and a self-help treatment programme ( 42 ) . All treatments were given for 6 weeks and then withdrawn by 10 weeks . Ratings of psychopathology were made by psychiatric assessors blind to both treatment and diagnosis before treatment and at 2 , 4 , 6 , and 10 weeks after r and omisation . 18 patients had insufficient data for analysis because of early drop-out . There were no important differences in treatment response between the diagnostic groups , but diazepam was less effective than dothiepin , cognitive and behaviour therapy , or self-help , these three treatments being of similar efficacy . Significantly more patients in the placebo group took additional psychotropic drugs in the 10 week period , and those allocated to dothiepin and cognitive and behaviour therapy took the least"
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41170596-06ff-11f0-808a-c43d1ab1c353
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Adipose tissue is considered as an endocrine organ , which is developed in specific depots , distinguished either as subcutaneous or visceral . Lipectomy , by means of liposuction or abdominoplasty , is a common plastic surgery procedure , which can remove substantial amounts of subcutaneous fat . This systematic review aims to evaluate the impact of surgical removal of abdominal subcutaneous adipose tissue on body weight and fat mass in females in the short- and long-term . A systematic review was conducted using a predetermined protocol established according to the Cochrane H and book ’s recommendations . PubMed , Scopus , CENTRAL , and the Cochrane Library were search ed from inception to December 2014 . Eligible studies were prospect i ve studies with ≥1 month of follow-up that included female only individuals who underwent lipectomy of the abdominal region and reported on body weight , body mass index ( BMI ) , or fat mass . Ten studies were included in this systematic review with a total of 231 individuals . A significant weight loss and BMI improvement were reported in 4 out of 5 studies with a mean follow-up of 1–2 months , but in none of the 5 studies with a longer follow-up ( 3–20 months ) . Fat mass showed a similar to weight change . The risk of bias was low for the two clinical trials but high for the observational studies included in the review . This systematic review revealed only a transient effect of abdominal lipectomy in body fat and weight in women , which fades a few months after the operation . These results corroborate the evidence from experimental and clinical studies , which support fat redistribution and compensatory fat growth , as a result of feedback mechanisms , triggered by fat removal . Additional clinical studies , with adequate follow-up , may further eluci date the long-term effects of abdominal lipectomy in body weight and composition . Systematic review registration PROSPERO CRD42015017564 ( www.crd.york.ac.uk/ PROSPERO
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"OBJECTIVES In animal models , fat removal results in compensatory weight gain . No study has reported measurement of weight following lipectomy in humans . We have examined changes in weight in patients who underwent lipectomy . METHODS In a retrospective analysis , 16 patients who had abdominoplasty and 17 patients who underwent bilateral breast reduction were compared with 16 patients who had carpal tunnel syndrome release . Following this , a prospect i ve study was carried out on 7 subjects awaiting abdominoplasty and 12 subjects awaiting bilateral breast reduction surgery . RESULTS In the retrospective study , all three patient groups gained weight following surgery . The abdominoplasty group was heavier before surgery and showed greatest weight gain but there was no statistically significant difference in weight gain between the groups . In the prospect i ve study , the abdominoplasty group had a mean fat removal of 1.77 kg and breast reduction group had a mean of 3.22 kg . Eighteen months following surgery the abdominoplasty group showed a significant mean increase in body weight ( mean increase : 4.82 kg ) and body mass index ( BMI ) ( mean increase : 1.66 kg/m(2 ) ) . In the bilateral breast reduction group , there was a non-significant mean gain in weight ( mean increase : 0.67 kg ) and BMI ( mean increase : 0.21 kg/m(2 ) ) . CONCLUSIONS Patients undergoing lipectomy during abdominoplasty and bilateral breast reduction will gain weight in the long term . This weight gain probably reflects the expected gain in weight without surgery as a similar finding is observed in patients who have undergone surgery without lipectomy . These results highlight the limitation of lipectomy as a weight control measure",
"Objective Obesity is a major risk factor for coronary heart disease , and surgical treatment of obese patients as part of a multidisciplinary approach seems to provide faster results than diet therapy . The aim of this study was to evaluate the effect of dermolipectomy on insulin action and inflammatory markers in 20 obese women",
"Background : There are no published studies of liposuction or abdominoplasty in a large number of patients using measurements of body dimensions . In the absence of rigorous data , some investigators have proposed that fat returns after liposuction . Methods : A prospect i ve study was undertaken among predominantly nonobese consecutive patients undergoing 301 liposuction and abdominoplasty procedures meeting the study criteria ( inclusion rate , 70.7 percent ) . Lower body dimensions were measured using st and ardized photographs taken before and at least 3 months after surgery . Upper body measurements were compared between women who underwent simultaneous cosmetic breast surgery ( n = 67 ) and a group of women who had breast surgery alone ( n = 78 ) to investigate the possibility of fat redistribution . Results : The average weight change was a loss of 2.2 lbs after lower body liposuction ( p abdominoplasty ( p Liposuction significantly reduced abdominal , thigh , knee , and arm width ( p Midabdominal and hip width were more effectively reduced by lipoabdominoplasty than liposuction alone ( p upper body measurements when comparing patients who had simultaneous liposuction and /or abdominoplasty with patients who had cosmetic breast surgery alone . Measurements in patients with at least 1 year of follow-up ( n = 46 ) showed no evidence of fat reaccumulation . Conclusions : Both liposuction and abdominoplasty are valid techniques for long-term fat reduction and improvement of body proportions . There is no evidence of fat regrowth . CLINICAL QUESTION /LEVEL OF EVIDENCE : Therapeutic , III",
"CONTEXT Liposuction is suggested to result in long-term body fat regain that could lead to increased cardiometabolic risk . We hypothesized that physical activity could prevent this effect . OBJECTIVE Our objective was to investigate the effects of liposuction on body fat distribution and cardiometabolic risk factors in women who were either exercise trained or not after surgery . DESIGN , SETTING , AND PARTICIPANTS Thirty-six healthy normal-weight women participated in this 6-month r and omized controlled trial at the University of Sao Paulo , Sao Paulo , Brazil . INTERVENTIONS Patients underwent a small-volume abdominal liposuction . Two months after surgery , the subjects were r and omly allocated into two groups : trained ( TR , n = 18 , 4-month exercise program ) and nontrained ( NT , n = 18 ) . MAIN OUTCOME MEASURES Body fat distribution ( assessed by computed tomography ) was assessed before the intervention ( PRE ) and 2 months ( POST2 ) , and 6 months ( POST6 ) after surgery . Secondary outcome measures included body composition , metabolic parameters and dietary intake , assessed at PRE , POST2 , and POST6 , and total energy expenditure , physical capacity , and sc adipocyte size and lipid metabolism-related gene expression , assessed at PRE and POST6 . RESULTS Liposuction was effective in reducing sc abdominal fat ( PRE vs. POST2 , P = 0.0001 ) . Despite the sustained sc abdominal fat decrement at POST6 ( P = 0.0001 ) , the NT group showed a significant 10 % increase in visceral fat from PRE to POST6 ( P = 0.04 ; effect size = -0.72 ) and decreased energy expenditure ( P = 0.01 ; effect size = 0.95 ) when compared with TR . Dietary intake , adipocyte size , and gene expression were unchanged over time . CONCLUSION Abdominal liposuction does not induce regrowth of fat , but it does trigger a compensatory increase of visceral fat , which is effectively counteracted by physical activity",
"Background Abdominal skin overhang is not unusual after massive weight loss induced by antiobesity interventions , and poor quality of life should be feared in such circumstances , especially in women . However , long-term results of quality of life have not been often documented in this setting . With the purpose of addressing this question , a prospect i ve study was design ed . Methods Patients ( n = 16 , 100 % females , age 40.1 ± 8.0 years ) su bmi tted to st and ard or combined circumferential abdominoplasty were recruited for this study . All had undergone open Roux-en-Y gastric bypass between 24 and 48 months earlier with stable weight in the last 12 months . Quality of life was assessed by a trained psychologist employing of a semistructured interview , the Adaptative Operationalized Diagnostic Scale ( AODS ) , covering affectivity/personal relations , productivity , social/cultural performance , and organic/somatic health . Results Circumferential abdominoplasty was followed by few problems ( serous fluid collection s in 18.8 % , anemia because of blood loss in 6.3 % ) . The best overall response to the AODS question naire corresponded to the social and cultural domain where 81.3 % of the patients had excellent adaptation ( level 1 ) . For the other three domains , results were remarkably similar with 62.5 % of the tests displaying the highest value of adaptation and rare total failures . Conclusions ( 1 ) The current operation corresponded to the expectations of the patients with few complications and favorable body contouring result . ( 2 ) Quality of life , quantified by means of adaptation and social adjustment scores , was adequate in most circumstances . ( 3 ) Outst and ing responses for social/cultural performance were registered with encouraging findings for affectivity/personal relations , productivity , and organic/somatic health as well",
"In a prospect i ve study , indices of glucose homeostasis , lipid profile , and systemic inflammation were monitored after an aesthetic abdominoplasty , aim ing to scrutinize the possible metabolic benefits for abdominal fat removal . Premenopausal females with substantial weight loss ( N = 40 ) undergoing circumferential abdominoplasty ( index group , n = 20 ) or augmentation mammoplasty with mastopexy ( controls , n = 20 ) were recruited . All of them originally underwent Roux-en-Y gastric bypass . Variables included BMI , white blood cell count , C-reactive protein , hemoglobin , total cholesterol and fractions , triglycerides , glucose , and HbA1c . Follow-up reached 20.3 ± 13.6 months for index cases and 29.5 ± 17.4 months for controls . The metabolic and inflammatory indices improved after the bariatric surgery . Subsequent monitoring indicated a stable body weight and biochemical profile in both groups . The exceptions were HDL cholesterol and C-reactive protein , which respectively increased and diminished after the abdominoplasty , consistent with an inflammatory and metabolic advantage for this operation . This is the first long-term study in a weight-stable population to point out such a pattern after abdominoplasty",
"The aim of this study was to identify the effect of surgically removing subcutaneous fat by abdominoplasty on leptin concentrations and insulin sensitivity . An open clinical trial with a noninterventional parallel group was carried out in 12 obese women . After r and omization , 6 volunteers were selected for abdominoplasty , and the other 6 women were considered as the noninterventional group . A metabolic profile , including leptin concentrations , and insulin tolerance test to assess insulin sensitivity were performed on all volunteers before intervention or nonintervention and 40–50 days afterward . A significant reduction in body mass index ( 30.7 ± 0.9 versus 29.6 ± 0.7 kg/m2 ; P = 0.02 ) and in leptin concentrations ( 41.3 ± 10.6 versus 32.0 ± 10.2 ng/mL ; P = 0.02 ) was observed after abdominoplasty . Insulin sensitivity did not change after intervention . In conclusion , surgically removing subcutaneous fat by abdominoplasty decreased leptin concentrations , with no change in insulin sensitivity ",
"No r and omized studies in humans have examined whether fat returns after removal or where it returns . We undertook a prospect i ve , r and omized-controlled trial of suction lipectomy in nonobese women to determine if adipose tissue ( AT ) is defended and if so , the anatomic pattern of redistribution . Healthy women with disproportionate AT depots ( lower abdomen , hips , or thighs ) were enrolled . Baseline body composition measurements included dual-energy X-ray absorptiometry ( DXA ) ( a priori primary outcome ) , abdominal/limb circumferences , subcutaneous skinfold thickness , and magnetic resonance imaging ( MRI ) ( torso/thighs ) . Participants ( n = 32 ; 36 ± 1 year ) were r and omized to small-volume liposuction ( n = 14 , mean BMI : 24 ± 2 kg/m(2 ) ) or control ( n=18 , mean BMI : 25 ± 2 ) following baseline . Surgery group participants underwent liposuction within 2 - 4 weeks . Identical measurements were repeated at 6 weeks , 6 months , and 1 year later . Participants agreed not to make lifestyle changes while enrolled . Between-group differences were adjusted for baseline level of the outcome variable . After 6 weeks , percent body fat ( % BF ) by DXA was decreased by 2.1 % in the lipectomy group and by 0.28 % in the control group ( adjusted difference ( AD ) : -1.82 % ; 95 % confidence interval ( CI ) : -2.79 % to -0.85 % ; P = 0.0002 ) . This difference was smaller at 6 months , and by 1 year was no longer significant ( 0.59 % ( control ) vs. -0.41 % ( lipectomy ) ; AD : -1.00 % ; CI : -2.65 to 0.64 ; P = 0.23 ) . AT reaccumulated differently across various sites . After 1 year the thigh region remained reduced ( 0.77 % ( control ) vs. -1.83 % ( lipectomy ) ; AD : -2.59 % ; CI : -3.91 to -1.28 ; P = 0.0001 ) , but AT reaccumulated in the abdominal region ( 0.64 % ( control ) vs. 0.42 % ( lipectomy ) ; AD : -0.22 ; CI : -2.35 to 1.91 ; P = 0.84 ) . Following suction lipectomy , BF was restored and redistributed from the thigh to the abdomen",
"Background : Triglyceride levels of 150 mg/dL or greater are known to be associated with an increased cardiovascular risk and metabolic syndrome . This study investigated the effect of liposuction and abdominoplasty on lipid levels , complete blood count , and other parameters . Methods : A prospect i ve study was undertaken among 322 consecutive patients ( 270 women and 52 men ) who presented for liposuction ( n = 229 ) , abdominoplasty with liposuction ( n = 87 ) , and abdominoplasty without liposuction ( n = 6 ) . The mean body mass index was 26.6 kg/m2 ( range , 18.6 to 44.1 kg/m2 ) . Ultrasonic liposuction using a superwet infusion technique was used in all cases , usually treating the lower body in women ( 64.4 percent ) and the trunk in men ( 86.5 percent ) . Results : Mean weight loss 3 months after liposuction was 2.2 lbs for liposuction alone ( p Mean fasting triglyceride level decreased 25.7 percent after liposuction ( p triglyceride level decreased 43.0 percent ( n = 56 , p white cell count after both liposuction and liposuction/abdominoplasty ( p total , low-density lipoprotein , or high-density lipoprotein cholesterol . Fasting glucose was unchanged . Conclusions : A significant ( p triglyceride level in patients with elevated preoperative levels and a significant decrease in leukocyte count ( p liposuction/abdominoplasty . Cholesterol levels are unaffected . CLINICAL QUESTION /LEVEL OF EVIDENCE : Therapeutic , IV"
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41170604-06ff-11f0-808a-c43d1ab1c353
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Background Osteoarthritis ( OA ) is the most common musculoskeletal disease in the world . OA is the result of an inflammatory and degenerative process affecting the entire joint . Osteoarthritis , especially involving the knee , has a relevant socioeconomic impact in terms of drugs , hospital admissions , work absences , and temporary or permanent invalidity . Therapy of knee osteoarthritis is based on pharmacological and nonpharmacological measures . Methods We conducted a systematic review of the studies published between 2002 and 2017 on spa therapy , mud-pack therapy , balneotherapy , and mud-bath therapy in the treatment of knee osteoarthritis in order to investigate the evidence of the efficacy of such treatment on pain , functional limitation , drug use , and quality of life . Overall , 35 studies were examined among which 12 were selected and included in the review if they are trial comparative . We have been able to illustrate the main results obtained in the individual studies and to elaborate these results in order to allow as much a unitary presentation as possible and hence an overall judgment . Results Because the studies we review ed differed markedly from one another in terms of the methods used , we were unable to conduct a quantitative analysis ( meta- analysis ) of pooled data from the 12 studies . For the purpose s of the present review , we reevaluated the results of the different studies using the same statistical method , Student 's t-test , which is used to compare the means of two frequency distributions . Among all the studies , the most relevant indexes used to measure effectiveness of spa therapy were improved including VAS , Lequesne , and WOMAC Score . Conclusions The mud-pack therapy , balneotherapy , mud-bath therapy , and spa therapy have proved to be effective in the treatment and in the secondary prevention of knee osteoarthritis , by reducing pain , nonsteroidal anti-inflammatory drug consumption , and functional limitation and improving quality of life of affected patients
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"Several authors have demonstrated the pivotal role of proinflammatory cytokines in inducing progressive cartilage degradation and secondary inflammation of the synovial membrane in osteoarthritis ( OA ) . It has recently been established that tumor necrosis factor (TNF)-alpha plays a well-defined role in the pathophysiology of inflammatory joint diseases and that binding to circulating soluble TNF-alpha receptors can inactivate it . We investigated the influence of mud pack treatment , which is able to diminish TNF-alpha serum values , on specific TNF receptor ( sTNF-R ) levels . Thirty-six patients with OA were enrolled and r and omized into two groups . Group A underwent mud pack treatment and group B underwent thermal bath treatment . A group of 20 healthy untreated subjects was used as a control . Blood sample s were collected at baseline and after treatment , and assays of sTNF-R55 and sTNF-R75 were performed in both groups . We found small changes in sTNF-Rs serum values but these were not statistically significant . sTNF-R55 serum values decreased by 0.4 % after the therapy in group A , while in group B the decrease was -17.7 % . sTNF-R75 was reduced by -21.17 % in group A and by -10.6 % in group B. In conclusion , through its thermic and ant/inflammatory activity mud pack treatment shows complex interaction with the most common factors of inflammatory and cartilage degradation . Our results suggest that the thermic component of this natural treatment is mainly involved in modulating inflammatory reaction and cartilage damage through binding of the circulating TNF , which controls the activation of the cells responsible for the production of proinflammatory cytokines",
"The purpose of the present investigation was to evaluate whether an anti-inflammatory effect together with an improvement of the regulation of the interaction between the inflammatory and stress responses underlies the clinical benefits of pelotherapy in osteoarthritis ( OA ) patients . This study evaluated the effects of a 10-day cycle of pelotherapy at the spa centre ‘ El Raposo ’ ( Spain ) in a group of 21 OA patients diagnosed with primary knee OA . Clinical assessment s included pain intensity using a visual analog scale ; pain , stiffness and physical function using the Western Ontario and McMaster Universities Arthritis Index ; and health-related quality of life using the EuroQol-5D question naire . Serum inflammatory cytokine levels ( IL-1β , TNF-α , IL-8 , IL-6 , IL-10 and TGF-β ) were evaluated using the Bio-Plex ® Luminex ® system . Circulating neuroendocrine-stress biomarkers , such as cortisol and extracellular 72 kDa heat shock protein ( eHsp72 ) , were measured by ELISA . After the cycle of mud therapy , OA patients improved the knee flexion angle and OA-related pain , stiffness and physical function , and they reported a better health-related quality of life . Serum concentrations of IL-1β , TNF-α , IL-8 , IL-6 and TGF-β , as well as eHsp72 , were markedly decreased . Besides , systemic levels of cortisol increased significantly . These results confirm that the clinical benefits of mud therapy may well be mediated , at least in part , by its systemic anti-inflammatory effects and neuroendocrine-immune regulation in OA patients . Thus , mud therapy could be an effective alternative treatment in the management of OA",
"Mud-bath therapy plays a primary role in the treatment and prevention of osteoarthritis that has been recognised since antiquity . Numerous studies have demonstrated its clinical benefits and its effects on inflammatory mediators ( interleukins ) , the immune system , cenesthesic factors ( endorphins ) , and the diencephalic – pituitary – adrenal axis . This study was conducted to assess the efficacy of mud-bath therapy with mineral water from the Sillene Spring at Italy ’s Chianciano Spa in patients with osteoarthritis of the knee . Patients ( n = 61 ) were divided into two groups . Group A underwent three cycles of mud-based spa therapy over a year ’s time , whereas group B did not . Clinical conditions , visual analogue scale pain ratings , and Lequesne indexes of the two groups were compared . We also compared these same parameters in the patients of the two groups that were following the therapy with drugs and in the patients of the group A before and after spa treatment . The percentage of patients with no symptoms or mild symptoms was higher in group A than in group B. Within group A , this percentage was higher after treatment than before spa therapy . Even in the comparison between the patients of the two groups that were following the therapy with drug , the results was that in group A the percentage of patients with no symptoms or mild symptoms was higher than in group B. Statistical analyses based on various tests revealed that almost all these differences were highly significant . No adverse effects were observed in any of the patients in group A. In conclusion , the mud-bath therapy performed at Chianciano Spa with Sillene Spring water remarkably improved the clinical conditions of patients with knee arthritis and significantly reduces the frequency and severity of symptoms and the disability they cause",
"Mud pack therapy is an alternative mode of treatment for rheumatic diseases . It is based on the application of heated mud packs to the entire body or to specific areas , such as over joints . The aim of the current study was to evaluate the efficacy of treatment with mud compresses at patients ’ homes for osteoarthritis of the knee . Fifty-eight patients with osteoarthritis of the knee were enrolled in a prospect i ve , double-blinded , controlled study . Forty patients were treated with natural mineral-rich mud compresses and 18 patients were treated with mineral-depleted mud compresses . Mud compresses were applied 5 times each week during 3 weeks for a total of 15 treatments . Patients were assessed at baseline , at completion of the 3-week treatment period , and twice after the conclusion of the treatment period — after 1 month and after 3 months . The main outcome measures were the Lequesne Index of severity of knee osteoarthritis , patient self- assessment of pain , and severity of knee pain on a visual analog scale . A reduction of 20 % or more in the pain scores was considered clinical ly significant . In the group treated with natural mud compresses , a significant reduction in knee pain was observed at all assessment s. Similarly , improvement in the Lequesne Index was seen at the end of therapy and a month after treatment . In the control group , given mineral-depleted mud compresses , no significant change in knee pain was seen at any assessment . Improvement in the Lequesne Index was seen 1 and 3 months after completion of the therapy , but not at the end of therapy . Seventy-two percent of the patients in the treatment group had an improvement of > 20 % in self- assessment of knee pain , compared with 33 % in the control group ( p = 0.005).The data suggest that treatment with mud compresses , but only in their natural form , temporarily relieves pain in patients with osteoarthritis of the knees . We believe that treatment with mud compresses might augment conventional medical therapy in these patients",
" Effects of balneotherapy on gait properties of patients with osteoarthritis of the knee were investigated prospect ively . A total of 30 patients with knee osteoarthritis received balneotherapy consisting of two daily thermomineral water baths for 2 weeks . Patients were evaluated using gait analysis and clinical scores , both within 2 weeks , before and after spa treatment . Patients were walking faster in their control analyses ( 0.81 ± 0.21 to 0.89 ± 0.19 m/s ; P = 0.017 ) , with a shorter mean stance time ( 63.0 ± 3.3 to 61.8 ± 2.5 % stride ; P = 0.007 ) , an increased cadence ( 96 ± 13.1 to 100 ± 11.9 steps/min ; P = 0.094 ) and stride length ( 996 ± 174 to 1,058 ± 142 mm ; P = 0.017 ) . Balneotherapy also result ed in a significant decrease in Lequesne knee osteoarthritis index ( 12.1 ± 3.7 to 10.0 ± 3.3 points ; P = 0.003 ) , VAS for pain ( 58 ± 25 to 33 ± 15 ; P = 0.0001 ) , VAS for patients ’ ( 56 ± 24 to 29 ± 19 ; P assessment ( 55 ± 20 to 26 ± 15 ; P WOMAC score ( 2.1 ± 0.7 to 1.6 ± 0.8 ; P = 0.0004 ) . Balneotherapy has positive effects on gait properties and clinical health quality parameters of patients with knee osteoarthritis in short-term evaluations",
"Objective To determine whether spa therapy , plus home exercises and usual medical treatment provides any benefit over exercises and usual treatment , in the management of knee osteoarthritis . Methods Large multicentre r and omised prospect i ve clinical trial of patients with knee osteoarthritis according to the American College of Rheumatology criteria , attending French spa resorts as out patients between June 2006 and April 2007 . Zelen r and omisation was used so patients were ignorant of the other group and spa personnel were not told which patients were participating . The main endpoint criteria were patient self-assessed . All patients continued usual treatments and performed daily st and ardised home exercises . The spa therapy group also received 18 days of spa therapy ( massages , showers , mud and pool sessions ) . Main Endpoint The number of patients achieving minimal clinical ly important improvement ( MCII ) at 6 months , defined as ≥19.9 mm on the visual analogue pain scale and /or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery . Results The intention to treat analysis included 187 controls and 195 spa therapy patients . At 6 months , 99/195 ( 50.8 % ) spa group patients had MCII and 68/187 ( 36.4 % ) controls ( χ2=8.05 ; df=1 ; p=0.005 ) . However , no improvement in quality of life ( Short Form 36 ) or patient acceptable symptom state was observed at 6 months . Conclusion For patients with knee osteoarthritis a 3-week course of spa therapy together with home exercises and usual pharmacological treatments offers benefit after 6 months compared with exercises and usual treatment alone , and is well tolerated . Trial registration number NCT00348777",
"BACKGROUND Osteoarthritis is a degenerative disease associated with pain , reduced range of motion , and impaired function . Balneotherapy or bathing in thermal or mineral waters is used as a non-invasive treatment for various rheumatic diseases . AIM To evaluate the effectiveness of hot sulfurous and non-sulfurous waters in the treatment of knee osteoarthritis . DESIGN A r and omized , assessor-blind , controlled trial . SETTING A spa resort . POPULATION One hundred and forty patients of both genders , mean age of 64.8±8.9 years , with knee osteoarthritis and chronic knee pain . METHODS Patients were r and omized into three groups : the sulfurous water ( SW ) group ( N.=47 ) , non-sulfurous water ( NSW ) group ( N.=50 ) , or control group ( N.=43 ) who received no treatment . Patients were not blinded to treatment allocation . Treatment groups received 30 individual thermal baths ( three 20-minute baths a week for 10 weeks ) at 37 - 39 ° C . The outcome measures were pain ( visual analog scale , VAS ) , physical function ( Western Ontario and McMaster Universities Osteoarthritis Index , WOMAC ; Lequesne Algofunctional Index , LAFI ; Stanford Health Assessment Question naire , HAQ ) , and use of pain medication . Patients were assessed before treatment ( T1 ) , at treatment endpoint ( T2 ) , and two months post-intervention ( T3 ) . Intra- and intergroup comparisons were performed at a significance level of 0.05 ( P decrease in VAS pain scores ( pain during movement , at rest , and at night ) and use of pain medication , and improvement in WOMAC , LAFI and HAQ scores were observed from baseline to T2 and T3 within treatment groups ( P less pain and better functional status than those in the NSW group at T3 , showing a lasting effect of sulfurous water baths . CONCLUSIONS Both therapeutic methods were effective in the treatment of knee osteoarthritis ; however , sulfurous baths yielded longer-lasting effects than non-sulfurous water baths . CLINICAL REHABILITATION IMPACT Baths in thermal waters , especially those in sulfurous waters , are effective in reducing pain and improving physical function in patients with knee osteoarthritis",
"BACKGROUND Balneotherapy is an established treatment modality for musculoskeletal disease , but few studies have examined the efficacy of spa therapy in elderly patients with degenerative spine and joint diseases . OBJECTIVES To assess the effects of balneotherapy on chronic musculoskeletal pain , functional capacity , and quality of life in elderly patients with osteoarthritis of the knee or with chronic low back pain . METHODS The 81 patients in the study group underwent a 1 day course of 30 minute daily baths in mineral water . Changes were evaluated in the following parameters : pain intensity , functional capacity , quality of life , use of non-steroidal anti-inflammatory or analgesic drugs , subjective disease severity perceived by the patients , investigator-rated disease severity , and severity of pain perceived by the patients . We analyzed the results of 76 subjects as 5 did not complete the study . RESULTS Compared to baseline , all monitored parameters were significantly improved by balneotherapy in both investigated groups . Moreover , the favorable effect was prolonged for 3 months after treatment . CONCLUSIONS This study showed that balneotherapy is an effective treatment modality in elderly patients with osteoarthritis of the knee or with chronic low back pain , and its benefits last for at least 3 months after treatment",
"Nitric oxide ( NO ) has recently been proposed as an important mediator in inflammatory phases and in loss of cartilage . In inflammatory arthritis NO levels are correlated with disease activity and articular cartilage is able to produce large amounts of NO with the appropriate inducing factors such as cytokines and /or endotoxin . Neutrophils also play an important role in inflammatory reactions and the level of myeloperoxidase , a constituent of neutrophil granules , is related to the intensity of the inflammation . Because there is evidence that suggests that mud packs influence the main cytokines involved in cartilage damage , we tried to determine whether NO and myeloperoxidase are involved in the mechanisms of action of mud bath treatment . We enrolled 37 subjects and r and omly assigned them to two groups : 19 patients underwent mud bath treatment ( group A ) while 18 patients underwent bath treatment alone . Blood sample s were obtained before and after the treatment cycles to assay serum levels of NO , myeloperoxidase ( MPO ) and glutathione (GSH)-peroxidase . The results showed a statistically significant decrease in NO and myeloperoxidase serum values in groups A and B , while GSH-peroxidase was not significantly increase in either of the groups ; no correlation was found between NO , myeloperoxidase and GSH-peroxidase serum values . Mud bath treatment can exert beneficial effects on cartilage homeostasis and inflammatory reactions , influencing NO and decreasing myeloperoxidase serum values . The increase in GSH-peroxidase was not correlated with the reduction of other biochemical markers , suggesting that mud bath treatment has different mechanisms of action",
"Spa therapy and short wave therapy are two of the most commonly used non-pharmacological approaches for osteoarthritis . The aim of this study was to assess their efficacy in comparison to conventional therapy in patients with osteoarthritis of the knee in a single blind , r and omized , controlled trial . Seventy-four out patients were enrolled ; 30 patients were treated with a combination of daily local mud packs and arsenical ferruginous mineral bath water from the thermal resort of Levico Terme ( Trento , Italy ) for 3 weeks ; 24 patients were treated with short wave therapy for the same period and 20 patients continued regular , routine ambulatory care . Patients were assessed at baseline , upon completion of the 3-week treatment period , and 12 weeks later . Spa therapy and short wave therapy both demonstrated effective symptomatic treatment in osteoarthritis of the knee at the end of the treatment , but only the spa therapy was shown to have efficacy persistent over time . Our study demonstrated the superiority of arsenical ferruginous spa therapy compared to short wave therapy in the treatment of osteoarthritis of the knee , probably in relationship to the specific effects of the minerals in this water",
"BACKGROUND Osteoarthritis is the most frequent joint disease and is a leading cause of pain and locomotor disability in elderly people . The treatment of osteoarthritis includes non-pharmacological , pharmacological , and surgical therapies . Silver level evidence has been found concerning balneotherapy in osteoarthritis . AIM OF THE STUDY The aim of this study was to evaluate how Lake Hévíz thermal mineral water therapy influences pain , knee function , and quality of life in patients with knee osteoarthritis , compared to the control group . STUDY DESIGN r and omized , controlled , single-blind , follow-up study . SETTING Spa Hévíz and St. And rew Hospital for Rheumatic Diseases POPULATION This study included 77 out patients between 45 and 75 years of age with mild to moderate osteoarthritis of the knee meeting the American College of Rheumatology classification criteria . METHODS Patients were r and omized into two groups . In group I ( n = 38 ) , subjects bathed in Lake Hévíz and in group II ( N.=39 ) , patients were treated in a pool full of tap water . Water temperature was 34 ° C for both groups . Participants underwent 30-minute therapy sessions , five times a week for three weeks . Outcome measures were pain visual analogue scale scores , active flexion degree , knee circumference , stair-climb time , Western Ontario and McMaster Universities osteoarthritis index ( WOMAC ) , and EuroQoL Group 5-Dimension Self-Report Question naire score ( EQ-5D ) . Study parameters were recorded at baseline , immediately after treatment , and after 15 weeks . RESULTS Comparison of the two groups revealed a statistically significant difference in pain visual analogue scale scores ( P active flexion degree ( P ) , physical function components of WOMAC ( P , and EQ-5D scores ( P CONCLUSIONS Balneotherapy improved pain , function as well as the quality of life in patients with knee osteoarthritis . CLINICAL REHABILITATION IMPACT Balneotherapy is a potentially useful treatment modality for patients with knee osteoarthritis",
"Abstract . The effects of thermal water from Cserkeszölö in Hungary were appraised in a r and omised , double blind study conducted on 58 patients with osteoarthritis of the knee . Balneotherapy was delivered as a 15-day course of 30-min daily sessions performed with thermal water ( active treatment ) or tap water of similar colour and odour ( placebo treatment ) . The musculoskeletal status of participants was evaluated at baseline , at the end of the balneotherapy course , and 3 months later . Study endpoints ( initial pain , range of motion , tenderness on palpation , stair climbing , physicians ' opinion and subjective rating by patients , and ambulation ) were assessed using visual analogue scales and symptom scores . Both groups improved ; however , the magnitude of improvement was significantly greater in patients treated with thermal water from Cserkeszölö",
"BACKGROUND In clinical trials , at the group level , results are usually reported as mean and st and ard deviation of the change in score , which is not meaningful for most readers . OBJECTIVE To determine the minimal clinical ly important improvement ( MCII ) of pain , patient 's global assessment of disease activity , and functional impairment in patients with knee and hip osteoarthritis ( OA ) . METHODS A prospect i ve multicentre 4 week cohort study involving 1362 out patients with knee or hip OA was carried out . Data on assessment of pain and patient 's global assessment , measured on visual analogue scales , and functional impairment , measured on the Western Ontario McMaster Universities Osteoarthritis Index ( WOMAC ) function subscale , were collected at baseline and final visits . Patients assessed their response to treatment on a five point Likert scale at the final visit . An anchoring method based on the patient 's opinion was used . The MCII was estimated in a subgroup of 814 patients ( 603 with knee OA , 211 with hip OA ) . RESULTS For knee and hip OA , MCII for absolute ( and relative ) changes were , respectively , ( a ) -19.9 mm ( -40.8 % ) and -15.3 mm ( -32.0 % ) for pain ; ( b ) -18.3 mm ( -39.0 % ) and -15.2 mm ( -32.6 % ) for patient 's global assessment ; ( c ) -9.1 ( -26.0 % ) and -7.9 ( -21.1 % ) for WOMAC function subscale score . The MCII is affected by the initial degree of severity of the symptoms but not by age , disease duration , or sex . CONCLUSION Using criteria such as MCII in clinical trials would provide meaningful information which would help in interpreting the results by expressing them as a proportion of improved patients",
"Osteoarthritis is an important rheumatic condition characterized by the progressive destruction of cartilage . The pathophysiologic phenomena leading to the pathologic changes in the joint appear to result from biomechanical factors and activation of final common pathways of tissue damage influencing chondrocyte homeostasis and a functional program . Several cytokines and growth factors are reported to be responsible for inflammation and cartilage degradation . Among these , IL-1 and TNF alpha have been suggested as important in promoting cartilage inflammation and tissue destruction , while IGF I has a protective influence on cartilage structure . Chondrocytes and their metabolism have gained interest as targets of drug intervention ; the results of this study confirm that mud bath therapy is also able to influence chondrocyte activities . Our data suggest that mud bath therapy influences cytokines related to osteoarthrosis pathomechanism and maintenance , and encourage further investigations to evaluate possible synergism between pharmacological treatment and mud bath therapy",
"The objective of this study was to test if spa therapy can play a role in the management of severe knee osteoarthritis ( OA ) . Twenty patients with radiologically and clinical ly severe knee OA were r and omly assigned into spa and drug therapy groups . Spa group ( n = 10 ) traveled to a spa town and stayed at a hotel for a 10-day spa therapy course . They followed a balneotherapy regimen including thermal pool baths at 37 ° C for 20 min two times daily . Drug therapy group ( n = 10 ) stayed at home and followed their individually prescribed drug therapy ( NSAIDs and paracetamol ) . Patients were assessed at baseline ( week 0 ) , after spa therapy at 2 weeks ( week 2 ) and during follow-up period at 12 ( week 12 ) and 24 ( week 24 ) weeks by a blinded investigator . Patients assessed with Lequesne algofunctional index ( LAFI ) , pain ( visual analogue scale , VAS ) , patient ’s and investigator ’s global evaluation ( VAS ) , ten-stairs stepping up and down time , 15 m walking time and three times squatting up and down time . Significant improvement in pain and LAFI scores were found at week 2 , week 12 and week 24 in the spa therapy group compared to baseline . Comparing the two group differences , spa therapy was superior to drug therapy in pain reduction and in physician ’s global assessment at all time points . This superiority was also found in LAFI scores and patients ’ global assessment s at week 12 and week 24 . A 10-day course of spa therapy may be beneficial in short- and medium-term up to 24 weeks by reducing pain and improving functional status and overall well-being in patients with severe knee OA and may be considered as an effective therapeutic tool for such patients in countries like Turkey where it is widely available and ( at least partly ) reimbursed",
"Fioravanti A , Iacoponi F , Bellisai B , Cantarini L , Galeazzi M : Short- and long-term effects of spa therapy in knee osteoarthritis . Objective : To assess both the short- and long-term effectiveness of spa therapy in patients with primary knee osteoarthritis in a prospect i ve , r and omized , single-blinded , controlled trial . Design : Eighty out patients were enrolled in this study ; 40 patients were treated with a combination of daily local mud packs and bicarbonate-sulfate mineral bath water from the spa center of Rapolano Terme ( Siena , Italy ) for 2 wks , and 40 patients continued regular , routine ambulatory care . Patients were assessed at baseline time ; after 2 wks ; after 3 , 6 , and 9 mos after the beginning of the study and were evaluated by Visual Analog Scale for spontaneous pain , Lequesne index , Western Ontario and McMaster Universities Index for gonarthrosis , Arthritis Impact Measurement Scale-1 , and symptomatic drug consumption . Results : We observed a significant improvement of all evaluated parameters at the end of the cycle of spa therapy , which persisted throughout the whole of the follow-up period , whereas in the control group no significant differences were noted . This symptomatic effect was confirmed by the significant reduction of symptomatic drug consumption . Tolerability of spa therapy seemed to be good , with light and transitory side effects . Conclusions : The results from our study confirm that the beneficial effects of spa therapy in patients with knee osteoarthritis lasts over time , with positive effects on the painful symptomatology and a significant improvement on functional capacities . Spa therapy can represent a useful backup to pharmacologic treatment of knee osteoarthritis or a valid alternative for patients who do not tolerate pharmacologic treatments",
"Adipocytokines , including adiponectin , resistin , and visfatin may play an important role in the pathophysiology of osteoarthritis ( OA ) . Spa therapy is one of the most commonly used non-pharmacological approaches for OA , but its mechanisms of action are not completely known . The aim of the present study was to assess whether a cycle of mud-bath therapy ( MBT ) influences the serum levels of adiponectin , resistin , and visfatin in patients with knee OA . As part of a prospect i ve r and omized , single blind-controlled trial evaluating the efficacy of MBT in knee OA , we included in this study 95 out patients . One group ( n = 49 ) received a cycle of MBT at the spa center of Chianciano Terme ( Italy ) in addition to the usual treatment , and one group ( control group ; n = 46 ) continued their regular care routine alone . Patients were assessed at basal time and at the end of the study ( 15 days ) for clinical and biochemical parameters . Clinical assessment s included spontaneous pain on a visual analog scale ( VAS ) score and the Western Ontario and McMaster Universities index ( WOMAC ) subscores for knee OA evaluated as total pain score ( W-TPS ) , total stiffness score ( W-TSS ) , and total physical function score ( W-TPFS ) . Adiponectin , resistin and visfatin serum levels were assessed by enzyme immunoassay methods . At the end of the mud-bath therapy , serum adiponectin levels showed a significant decrease ( p Serum resistin showed a significant decrease ( p MBT group at the end of the study and a significant increase in the control patients ( p visfatin were found in MBT . Furthermore , we tested the relationships between demographic and clinical parameters and adipocytokine concentrations measured in the MBT group at basal and at the end of the study . In conclusion , the present study shows that a cycle of MBT can modify serum levels of adiponectin and resistin but not the circulating levels of visfatin . In view of the recent evidence s about the involvement of adiponectin and resistin in the pathogenesis and progression of OA , the decrease of these adipokines after mud-bath therapy may play a protective role in the course of the disease . However , it remains to be clarified which of the mechanisms of action of MBT may have determined the changes in serum levels of adiponectin and resistin that we observed"
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41170672-06ff-11f0-808a-c43d1ab1c353
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Background Electrically assisted bicycles ( e-bikes ) have been highlighted as a method of active travel that could overcome some of the commonly reported barriers to cycle commuting . The objective of this systematic review was to assess the health benefits associated with e-cycling . Method A systematic literature review of studies examining physical activity , cardiorespiratory , metabolic and psychological outcomes associated with e-cycling . Where possible these outcomes were compared to those from conventional cycling and walking . Seven electronic data bases , clinical trial registers , grey literature and reference lists were search ed up to November 2017 . H and search ing occurred until June 2018 . Experimental or observational studies examining the impact of e-cycling on physical activity and /or health outcomes of interest were included . E-bikes used must have pedals and require pedalling for electric assistance to be provided . Results Seventeen studies ( 11 acute experiments , 6 longitudinal interventions ) were identified involving a total of 300 participants . There was moderate evidence that e-cycling provided physical activity of at least moderate intensity , which was lower than the intensity elicited during conventional cycling , but higher than that during walking . There was also moderate evidence that e-cycling can improve cardiorespiratory fitness in physically inactive individuals . Evidence of the impact of e-cycling on metabolic and psychological health outcomes was inconclusive . Longitudinal evidence was compromised by weak study design and quality . Conclusion E-cycling can contribute to meeting physical activity recommendations and increasing physical fitness . As such , e-bikes offer a potential alternative to conventional cycling . Future research should examine the long-term health impacts of e-cycling using rigorous research design
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[
"Objective : To assess if active commuting with an electrically assisted bicycle ( e-bike ) during a 4-week period can induce increases in cardiorespiratory fitness measured as peak oxygen uptake ( V[Combining Dot Above]O2peak ) in untrained , overweight individuals , and if these changes are comparable with those induced by a conventional bicycle . Design : Four-week r and omized pilot study . Setting : Controlled laboratory . Participants : Thirty-two volunteers ( 28 men ) participated . Seventeen { median age 37 years [ interquartile range ( IQR ) 34 , 45 ] , median body mass index [ BMI ] 29 kg/m2 [ IQR 27 , 31 ] } were r and omized to the E-Bike group and 15 [ median age 43 years ( IQR 38 , 45 ) , median BMI 28 kg/m2 ( IQR 26 , 29 ) ] to the Bike group . Interventions : Participants in both groups were instructed to use the bicycle allocated to them ( e-bike or conventional bicycle ) for an active commute to work in the Basel ( Switzerl and ) area at a self-chosen speed on at least 3 days per week during the 4-week intervention period . Main Outcome Measures : V[Combining Dot Above]O2peak was assessed before and after the intervention in an all-out exercise test on a bicycle ergometer . Results : V[Combining Dot Above]O2peak increased by an average of 3.6 mL/(kg·min ) [ SD 3.6 mL/(kg·min ) ] in the E-Bike group and by 2.2 mL/(kg·min ) [ SD 3.5 mL/(kg·min ) ] in the Bike group , with an adjusted difference between the 2 groups of 1.4 mL/(kg·min ) [ 95 % confidence interval , −1.4 - 4.1 ; P = 0.327 ] . Conclusions : E-bikes may have the potential to improve cardiorespiratory fitness similar to conventional bicycles despite the available power assist , as they enable higher biking speeds and greater elevation gain",
"Introduction Pedelecs are bicycles that provide electric assistance only when a rider is pedaling and have become increasingly popular . Purpose Our purpose was to quantify usage patterns over 4 weeks of real-world commuting with a pedelec and to determine if pedelec use would improve cardiometabolic risk factors . Methods Twenty sedentary commuters visited the laboratory for baseline physiological measurements [ body composition , maximum oxygen consumption ( $ $ \\dot{V}{\\text{O } } _ { 2 } { \\hbox{max } } $ $ V˙O2max ) , mean arterial blood pressure ( MAP ) , blood lipid profile , and 2-h oral glucose tolerance test ( OGTT ) ] . The following 4 weeks , participants were instructed to commute using a pedelec at least 3 days week−1 for 40 min day−1 while wearing a heart rate monitor and a GPS device . Metabolic equivalents ( METS ) were estimated from heart rate data . Following the intervention , we repeated the physiological measurements . Results Average total distance and time were 317.9 ± 113.8 km and 15.9 ± 3.4 h , respectively . Participants averaged 4.9 ± 1.2 METS when riding . Four weeks of pedelec commuting significantly improved 2-h post-OGTT glucose ( 5.53 ± 1.18–5.03 ± 0.91 mmol L−1 , p { 2 } { \\hbox{max } } $ $ V˙O2max ( 2.21 ± 0.48–2.39 ± 0.52 L min−1 , p V˙O2max test power output ( 165.1 ± 37.1–189.3 ± 38.2 W , p improvements in MAP ( 84.6 ± 10.5–83.2 ± 9.4 mmHg , p = 0.15 ) and fat mass ( 28.6 ± 11.3–28.2 ± 11.4 kg , p = 0.07 ) . Conclusion Participants rode a pedelec in the real world at a self-selected moderate intensity , which helped them meet physical activity recommendations . Pedelec commuting also result ed in significant improvements in 2-h post-OGTT glucose , $ $ \\dot{V}{\\text{O } } _ { 2 } { \\hbox{max } } $ $ V˙O2max , and power output . Pedelecs are an effective form of active transportation that can improve some cardiometabolic risk factors within only 4 weeks",
"BACKGROUND A single bout of exercise improves postpr and ial glycemia and insulin sensitivity in prediabetic patients ; however , the impact of exercise intensity is not well understood . The present study compared the effects of acute isocaloric moderate ( MIE ) and high-intensity ( HIE ) exercise on glucose disposal and insulin sensitivity in prediabetic adults . METHODS Subjects ( n=18 ; age 49±14 y ; fasting glucose 105±11 mg/dL ; 2 h glucose 170±32 mg/dL ) completed a peak O2 consumption/lactate threshold ( LT ) protocol plus three r and omly assigned conditions : 1 ) control , 1 hour of seated rest , 2 ) MIE ( at LT ) , and 3 ) HIE ( 75 % of difference between LT and peak O2 consumption ) . One hour after exercise , subjects received an oral glucose tolerance test ( OGTT ) . Plasma glucose , insulin , and C-peptide concentrations were sample d at 5- to 10-minute intervals at baseline , during exercise , after exercise , and for 3 hours after glucose ingestion . Total , early-phase , and late-phase area under the glucose and insulin response curves were compared between conditions . Indices of insulin sensitivity ( SI ) were derived from OGTT data using the oral minimal model . RESULTS Compared with control , SI improved by 51 % ( P=.02 ) and 85 % ( P differences in SI were observed between the exercise conditions ( P=.62 ) . Improvements in SI corresponded to significant reductions in the glucose , insulin , and C-peptide area under the curve values during the late phase of the OGTT after HIE ( P prediabetic adults , acute exercise has an immediate and intensity-dependent effect on improving postpr and ial glycemia and insulin sensitivity ",
"Objective To investigate the association between active commuting and incident cardiovascular disease ( CVD ) , cancer , and all cause mortality . Design Prospect i ve population based study . Setting UK Biobank . Participants 263 450 participants ( 106 674 ( 52 % ) women ; mean age 52.6 ) , recruited from 22 sites across the UK . The exposure variable was the mode of transport used ( walking , cycling , mixed mode v non-active ( car or public transport ) ) to commute to and from work on a typical day . Main outcome measures Incident ( fatal and non-fatal ) CVD and cancer , and deaths from CVD , cancer , or any causes . Results 2430 participants died ( 496 were related to CVD and 1126 to cancer ) over a median of 5.0 years ( interquartile range 4.3 - 5.5 ) follow-up . There were 3748 cancer and 1110 CVD events . In maximally adjusted models , commuting by cycle and by mixed mode including cycling were associated with lower risk of all cause mortality ( cycling hazard ratio 0.59 , 95 % confidence interval 0.42 to 0.83 , P=0.002 ; mixed mode cycling 0.76 , 0.58 to 1.00 , P cancer incidence ( cycling 0.55 , 0.44 to 0.69 , P cancer mortality ( cycling 0.60 , 0.40 to 0.90 , P=0.01 ; mixed mode cycling 0.68 , 0.57 to 0.81 , P Commuting by cycling and walking were associated with a lower risk of CVD incidence ( cycling 0.54 , 0.33 to 0.88 , P=0.01 ; walking 0.73 , 0.54 to 0.99 , P=0.04 ) and CVD mortality ( cycling 0.48 , 0.25 to 0.92 , P=0.03 ; walking 0.64 , 0.45 to 0.91 , P=0.01 ) . No statistically significant associations were observed for walking commuting and all cause mortality or cancer outcomes . Mixed mode commuting including walking was not noticeably associated with any of the measured outcomes . Conclusions Cycle commuting was associated with a lower risk of CVD , cancer , and all cause mortality . Walking commuting was associated with a lower risk of CVD independent of major measured confounding factors . Initiatives to encourage and support active commuting could reduce risk of death and the burden of important chronic conditions",
"The American College of Sports Medicine ( ACSM ) recommends adults participate in weekly aerobic activity for a minimum of 30 minutes moderate intensity exercise 5 days per week or 20 minutes of vigorous activity 3 days per week . The electrically assisted bicycle may help individuals achieve the ACSM ’s aerobic recommendations and introduce inactive individuals to physical activity . To compare the physiological requirements of riding a bicycle with electric pedal assist versus non-assist among healthy active young adults . 6 males and 6 females completed two r and omized cycling trials using electric pedal assist ( PAB ) and non-assist ( NON ) . Cycling trials were completed over a 3.54 km course with varying terrain . Time to completion was faster in the PAB ( 12.5 ± 0.3 min ) than the NON ( 13.8 ± 0.3 min , p=0.01 ) . Rating of Perceived Exertion ( RPE ) was lower in the PAB ( 12.0 ± 0.4 ) than the NON ( 14.8 ± 0.5 , p difference in mean VO2 between PAB ( 2.3 ± 0.1 L·min−1 ) and NON ( 2.5 ± 0.1 L·min−1 , p=0.45 ) . There was no difference in mean power output when comparing PAB ( 115 ± 11 Watts ) to NON ( 128 ± 11 Watts , p=0.38 ) . There was no difference in heart rate between PAB ( 147 ± 5 bpm ) and NON ( 149 ± 5 bpm , p=0.77 ) . Recreationally active younger ( college age ) individuals may self-select a similar physiological intensity of physical activity regardless of mechanical assistance , result ing in quicker completion of a commuting task with PAB . Both the PAB and NON exercise bouts met ACSM criteria for vigorous exercise",
"The purpose of this study was to examine the impact of acute high-intensity interval training ( HIIT ) compared with continuous moderate-intensity ( CMI ) exercise on postpr and ial hyperglycemia in overweight or obese adults . Ten inactive , overweight or obese adults ( 41 ± 11 yrs , BMI = 36 ± 7 kg/m(2 ) ) performed an acute bout of HIIT ( 10 × 1 min at approximately 90 % peak heart rate ( HRpeak ) with 1-min recovery periods ) or matched work CMI ( 30 min at approximately 65 % HRpeak ) in a r and omized , counterbalanced fashion . Exercise was performed 2 h after breakfast , and glucose control was assessed by continuous glucose monitoring under st and ardized dietary conditions over 24 h. Postpr and ial glucose ( PPG ) responses to lunch , dinner , and the following day 's breakfast were analyzed and compared with a no-exercise control day . Exercise did not affect the PPG responses to lunch , but performing both HIIT and CMI in the morning significantly reduced the PPG incremental area under the curve ( AUC ) following dinner when compared with control ( HIIT = 110 ± 35 , CMI = 125 ± 34 , control = 162 ± 46 mmol/L × 2 h , p ( HIIT = 125 ± 53 , CMI = 186 ± 55 , control = 194 ± 96 mmol/L × 2 h ) and the PPG spike ( HIIT = Δ2.1 ± 0.9 , CMI = Δ3.0 ± 0.9 , control = Δ3.0 ± 1.5 mmol/l ) following breakfast on the following day were significantly lower following HIIT compared with both CMI and control ( p spikes were not different between HIIT , CMI , or control for any meal ( p > 0.05 for all ) . We conclude that a single session of HIIT has greater and more lasting effects on reducing incremental PPG when compared with CMI"
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411706cc-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND No cure for rheumatoid arthritis ( RA ) is known at present , so treatment often focuses on management of symptoms such as pain , stiffness and mobility . Treatment options include pharmacological interventions , physical therapy treatments and balneotherapy . Balneotherapy is defined as bathing in natural mineral or thermal waters ( e.g. mineral baths , sulphur baths , Dead Sea baths ) , using mudpacks or doing both . Despite its popularity , reported scientific evidence for the effectiveness or efficacy of balneotherapy is sparse . This review , which evaluates the effects of balneotherapy in patients with RA , is an up date of a Cochrane review first published in 2003 and up date d in 2008 . OBJECTIVES To perform a systematic review on the benefits and harms of balneotherapy in patients with RA in terms of pain , improvement , disability , tender joints , swollen joints and adverse events . SEARCH METHODS We search ed the Cochrane ' Rehabilitation and Related Therapies ' Field Register ( to December 2014 ) , the Cochrane Central Register of Controlled Trials ( 2014 , Issue 1 ) , MEDLIINE ( 1950 to December 2014 ) , EMBASE ( 1988 to December 2014 ) , the Cumulative Index to Nursing and Allied Health Literature ( CINAHL ) ( 1982 to December 2014 ) , the Allied and Complementary Medicine Data base ( AMED ) ( 1985 to December 2014 ) , PsycINFO ( 1806 to December 2014 ) and the Physiotherapy Evidence Data base ( PEDro ) . We applied no language restrictions ; however , studies not reported in English , Dutch , Danish , Swedish , Norwegian , German or French are awaiting assessment . We also search ed the World Health Organization ( WHO ) International Clinical Trials Registry Platform for ongoing and recently completed trials . SELECTION CRITERIA Studies were eligible if they were r and omised controlled trials ( RCTs ) consisting of participants with definitive or classical RA as defined by the American Rheumatism Association ( ARA ) criteria of 1958 , the ARA/American College of Rheumatology ( ACR ) criteria of 1988 or the ACR/European League Against Rheumatism ( EULAR ) criteria of 2010 , or by studies using the criteria of Steinbrocker . Balneotherapy had to be the intervention under study , and had to be compared with another intervention or with no intervention . The World Health Organization ( WHO ) and the International League Against Rheumatism ( ILAR ) determined in 1992 a core set of eight endpoints in clinical trials concerning patients with RA . We considered pain , improvement , disability , tender joints , swollen joints and adverse events among the main outcome measures . We excluded studies when only laboratory variables were reported as outcome measures . DATA COLLECTION AND ANALYSIS Two review authors independently selected trials , performed data extraction and assessed risk of bias . We resolved disagreements by consensus and , if necessary , by third party adjudication . MAIN RESULTS This review includes two new studies and a total of nine studies involving 579 participants . Unfortunately , most studies showed an unclear risk of bias in most domains . Four out of nine studies did not contribute to the analysis , as they presented no data .One study involving 45 participants with h and RA compared mudpacks versus placebo . We found no statistically significant differences in terms of pain on a 0 to 100-mm visual analogue scale ( VAS ) ( mean difference ( MD ) 0.50 , 95 % confidence interval ( CI ) -0.84 to 1.84 ) , improvement ( risk ratio ( RR ) 0.96 , 95 % CI 0.54 to 1.70 ) or number of swollen joints on a scale from 0 to 28 ( MD 0.60 , 95 % CI -0.90 to 2.10 ) ( very low level of evidence ) . We found a very low level of evidence of reduction in the number of tender joints on a scale from 0 to 28 ( MD -4.60 , 95 % CI -8.72 to -0.48 ; 16 % absolute difference ) . We reported no physical disability and presented no data on withdrawals due to adverse events or on serious adverse events . Two studies involving 194 participants with RA evaluated the effectiveness of additional radon in carbon dioxide baths . We found no statistically significant differences between groups for all outcomes at three-month follow-up ( low to moderate level of evidence ) . We noted some benefit of additional radon at six months in terms of pain frequency ( RR 0.6 , 95 % CI 0.4 to 0.9 ; 31 % reduction ; improvement in one or more points ( categories ) on a 4-point scale ; moderate level of evidence ) and 9.6 % reduction in pain intensity on a 0 to 100-mm VAS ( MD 9.6 mm , 95 % CI 1.6 to 17.6 ; moderate level of evidence ) . We also observed some benefit in one study including 60 participants in terms of improvement in one or more categories based on a 4-point scale ( RR 2.3 , 95 % CI 1.1 to 4.7 ; 30 % absolute difference ; low level of evidence ) . Study authors did not report physical disability , tender joints , swollen joints , withdrawals due to adverse events or serious adverse events . One study involving 148 participants with RA compared balneotherapy ( seated immersion ) versus hydrotherapy ( exercises in water ) , l and exercises or relaxation therapy . We found no statistically significant differences in pain on the McGill Question naire or in physical disability ( very low level of evidence ) between balneotherapy and the other interventions . No data on improvement , tender joints , swollen joints , withdrawals due to adverse events or serious adverse events were presented . One study involving 57 participants with RA evaluated the effectiveness of mineral baths ( balneotherapy ) versus Cyclosporin A. We found no statistically significant differences in pain intensity on a 0 to 100-mm VAS ( MD 9.64 , 95 % CI -1.66 to 20.94 ; low level of evidence ) at 8 weeks ( absolute difference 10 % ) . We found some benefit of balneotherapy in overall improvement on a 5-point scale at eight weeks of 54 % ( RR 2.35 , 95 % CI 1.44 to 3.83 ) . We found no statistically significant differences ( low level of evidence ) in the number of swollen joints , but some benefit of Cyclosporin A in the number of tender joints ( MD 8.9 , 95 % CI 3.8 to 14 ; very low level of evidence ) . Physical disability , withdrawals due to adverse events and serious adverse events were not reported . AUTHORS ' CONCLUSIONS Overall evidence is insufficient to show that balneotherapy is more effective than no treatment , that one type of bath is more effective than another or that one type of bath is more effective than mudpacks , exercise or relaxation therapy
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"OBJECTIVE To conduct a preliminary investigation of the effects on floatation spa therapy on quality of life in patients with osteoarthritis to see if controlled trials are warranted . DESIGN Uncontrolled clinical trial . SETTING Private floatation spa therapy centre . PATIENTS Fourteen patients with chronic osteoarthritis of the weight-bearing joints , of whom four dropped out . INTERVENTION Six weekly sessions of floatation spa therapy . OUTCOME MEASURES SF36 , AIMS 2 and MYMOP quality -of-life question naires . MAIN RESULTS All patients improved . Differences between baseline and discharge scores showed statistically significant improvement for MYMOP , but not AIMS 2 or SF-36 . CONCLUSIONS Controlled trials of floatation spa therapy for patients with osteoarthritis are warranted",
"Forty patients with classical or definite rheumatoid arthritis in a stage of active disease were treated for two weeks at a spa hotel . The patients were divided into four groups of 10 . Group I was treated with daily mud packs , group II with daily hot sulphur baths , group III with a combination of mud packs and hot sulphur baths , and group IV served as a control group . The patients were assessed by a rheumatologist who was blinded to the treatment modalities . Statistically significant improvement for a period of up to three months was observed in the three treatment groups in most of the clinical indices . Improvement in the control group was minor in comparison and not statistically significant . No significant improvement was observed in any of the laboratory variables measured . Except for three mild cases of thermal reaction there were no side effects",
"Thirty patients with classical or definite rheumatoid arthritis were r and omly divided into two groups of fifteen patients each of similar age , sex , duration and severity of disease , and medical treatment . All patients were treated once a day with bath salts heated to 35 degrees C for twenty minutes . Group I received Dead Sea bath salts and Group II , the control group , received sodium chloride ( NaCl ) . The study was double-blind and of two weeks ' duration . All patients were evaluated by one rheumatologist both before treatment , and two weeks later at the end of the treatment period . Follow-up evaluations were made one and three months after conclusion of the treatments . The clinical parameters evaluated included duration of morning stiffness , fifteen meter walk time , h and -grip strength , activities of daily living , circumference of proximal interphalangeal joints , number of active joints , Ritchie index and the patient 's own assessment of disease activity . The laboratory parameters evaluated included erythrocyte sedimentation rate and serum levels of amyloid A , rheumatoid factor , sodium , potassium , calcium and magnesium . A statistically significant improvement ( p less than 0.01 or p less than 0.05 ) was observed in Group I only , in most of the clinical parameters assessed . Maximal therapeutic effect was obtained at the end of the treatment and lasted up to one month",
"Abstract The purpose of this study was to evaluate the immediate and delayed effects of balneotherapy at the Dead Sea on patients with psoriatic arthritis ( PsA ) . A total of 42 patients with PsA were treated at the Dead Sea for 4 weeks . Patients were r and omly allocated into two groups : group 1 ( 23 patients ) and group 2 ( 19 patients ) . Both groups received daily exposure to sun ultraviolet rays and regular bathing at the Dead Sea . Group 1 was also treated with mud packs and sulfur baths . Patients were assessed by a dermatologist and a rheumatologist 3 days before arrival , at the end of treatment , and at weeks 8 , 16 , and 28 from the start of treatment . The clinical indices assessed were morning stiffness , right and left h and grip , number of tender joints , number of swollen joints , Schober test , distance from finger to floor when bending forward , patient 's self- assessment of disease severity , inflammatory neck and back pain and psoriasis area and severity index ( PASI ) score . Comparison between groups disclosed a similar statistically significant improvement for variables such as PASI , morning stiffness , patient self- assessment , right and left grip , Schober test and distance from finger to floor when bending forward . For variables such as tender and swollen joints , and inflammatory neck and back pain , improvement over time was statistically significant in group 1 . Addition of mud packs and sulfur baths to sun ultraviolet exposure and Dead Sea baths seems to prolong beneficial effects and improves inflammatory back pain",
"In chronic rheumatic diseases , recent treatment regimens comprise multimodal concepts including pharmacologic , physical/exercise , occupational and psychological therapies . Rehabilitation programmes are used for long-term management of disease . Spa therapy is often integrated in various middle and south European and Asian countries . Here , we investigated radon spa therapy as applied in health resorts compared to a control intervention in rheumatic out- patients . R and omised , blinded trial enroling 681 patients [ mean age 58.3 ( st and ard deviation 11.1 ) ; female 59.7 % ] in 7 health resorts in Germany and Austria with chronic back pain ( n1 = 437 ) , osteoarthritis ( OA ) ( n2 = 230 ) , rheumatoid arthritis ( n3 = 98 ) , and /or ankylosing spondylitis ( n4 = 39 ) ; multiple nominations in 146 cases ) . Outcomes were pain ( primary ) , quality of life , functional capacity , and medication measured before start , after end of treatment , and 3 times thereafter in 3 monthly intervals . Adverse events were documented . To analyse between-group differences , repeated- measures analysis of covariance was performed in metric endpoints and Fisher ’s exact test in rates . Two-sided significance level of 5 % was chosen . Until end of follow-up , superiority of radon therapy was found regarding pain relief ( p = 0.032 ) and analgesic drug consumption ( p = 0.007 ) , but not regarding quality of life . Functional capacity was assessed specific to the underlying indication . Significant benefits were found in radon-treated OA patients until 6-month follow-up ( p = 0.05 ) , but not until end of study ( p = 0.096 ) . Neither the back pain sub- population nor the two smaller patient population s with inflammatory indications benefited significantly in functional capacity . Results suggest beneficial analgesic effects of radon spa therapy in rheumatic diseases until 9 months post-intervention",
"BACKGROUND A beneficial effect was observed in patients with psoriasis vulgaris following balneotherapy with Dead Sea bath salt . OBJECTIVES To evaluate the possible role of trace elements in the effectiveness of balneotherapy . METHODS Serum levels of 11 trace elements were analyzed in 23 patients with psoriasis vulgaris who participated in a double-blind controlled study of balneotherapy with either Dead Sea bath salt ( 12 patients ) or common salt ( 11 patients ) . Thirteen healthy volunteers served as controls . RESULTS The mean pre-treatment serum levels of boron , cadmium , lithium and rubidium were significantly lower in patients compared to controls , whereas the mean pre-treatment serum level of manganese was significantly higher in patients compared to controls . Balneotherapy with Dead Sea bath salt result ed in a significant decrease ( P = 0.0051 ) in the mean serum level of manganese from 0.10 + /- 0.05 mol/L to 0.05 + /- 0.02 mumol/L. The mean reduction in the serum level of manganese differed significantly ( P = 0.002 ) between responders ( % Psoriasis Area and Severity Index score reduction > or = 25 ) and non-responders ( % PASI score reduction balneotherapy with Dead Sea bath salt the mean serum level of lithium decreased in responders by 0.01 + /- 0.02 mumol/L , whereas its level in non-responders increased by 0.03 + /- 0.03 mumol/L. ( P = 0.015 ) . CONCLUSIONS Manganese and lithium may play a role in the effectiveness of balneotherapy with Dead Sea bath salt for psoriasis",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"OBJECTIVE To determine the efficacy of combined spa-exercise therapy in addition to st and ard treatment with drugs and weekly group physical therapy in patients with ankylosing spondylitis ( AS ) . METHODS A total of 120 Dutch out patients with AS were r and omly allocated into 3 groups of 40 patients each . Group 1 ( mean age 48 + /- 10 years ; male : female ratio 25:15 ) was treated in a spa resort in Bad Hofgastein , Austria ; group 2 ( mean age 49 + /- 9 years ; male : female ratio 28:12 ) in a spa resort in Arcen , The Netherl and s. The control group ( mean age 48 + /- 10 years ; male : female ratio 34:6 ) stayed at home and continued their usual drug treatment and weekly group physical therapy during the intervention weeks . St and ardized spa-exercise therapy of 3 weeks duration consisted of group physical exercises , walking , correction therapy ( lying supine on a bed ) , hydrotherapy , sports , and visits to either the Gasteiner Heilstollen ( Austria ) or sauna ( Netherl and s ) . After spa-exercise therapy all patients followed weekly group physical therapy for another 37 weeks . Primary outcomes were functional ability , patient 's global well-being , pain , and duration of morning stiffness , aggregated in a pooled index of change ( PIC ) . RESULTS Analysis of variance showed a statistically significant time-effect ( P spa-exercise therapy , the mean difference in PIC between group 1 and controls was 0.49 ( 95 % confidence interval [ CI ] 0.16 - 0.82 , P = 0.004 ) and between group 2 and controls was 0.46 ( 95 % CI 0.15 - 0.78 , P = 0.005 ) . At 16 weeks , the difference between group 1 and controls was 0.63 ( 95 % CI 0.23 - 1.02 , P = 0.002 ) and between group 2 and controls was 0.34 ( 95 % CI--0.05 - 0.73 ; P = 0.086 ) . At 28 and 40 weeks , more improvement was found for group 1 compared with controls ( P = 0.012 and P = 0.062 , respectively ) but not for group 2 compared with controls . CONCLUSION In patients with AS , a 3-week course of combined spa-exercise therapy , in addition to drug treatment and weekly group physical therapy alone , provides beneficial effects . These beneficial effects may last for at least 40 weeks",
"The objective of this study was to evaluate the effect of spa therapy on clinical parameters of patients with gonarthrosis . Patients with gonarthrosis ( n=33 ) underwent a 2-week spa therapy using three treatment regimes and a 20-week follow-up as follows : group I ( n=11 ) had mineral water baths and hot native mineral mud packs , group II ( n=12 ) had mineral water baths and rinsed mineral-free mud packs and group III ( n=10 ) had tap water baths and mineral-free mud packs . The patients and the assessing rheumatologist were blinded to the difference in the treatment protocol s. A significant improvement in the index of severity of the knee ( ISK ) , as well as night pain scores , was achieved in group I. Improvement in physical findings and a reduction in pain ratings on a visual analogue scale ( VAS ) did not reach statistical significance . Analgesic consumption was significantly decreased in both groups I and III for up to 12 weeks . Global improvement assessed by patients and physician was observed in all three groups up to 16 weeks but persisted to the end of the follow-up period in group I only . Patients with gonarthrosis seemed to benefit from spa therapy under all three regimes . However , for two parameters ( night pain and ISK ) the combination of mineral water baths and mud packs ( group I ) appeared to be superior",
"The effect of \" Kangal Hot Spring with Fish \" in the treatment of psoriasis is investigated . The study was carried out on 87 patients with psoriasis vulgaris and the patients were evaluated by a dermatologist for 21 days . The evaluation of the disease was performed using PASI ( Psoriasis Area and Severity Index ) scores . Recurrences were investigated in the patient population , who had been previously treated in the same hot spring . The first examination scores were significantly higher than the scores of the 3 , 6 , 9 , 12 , 15 and 21 days after treatment ( p Longer remission periods , when compared to the topical corticosteroid treatment , expressed by the 35 patients previously treated in hot spring ( p < 0.01 ) . Spa therapy under observation of a dermatologist may be effective and useful for psoriasis vulgaris patients",
"This study investigates the effects of radon ( plus CO2 ) baths on RA in contrast to artificial CO2 baths in RA rehabilitation using a double-blinded trial enrolling 134 r and omised patients of an in-patient rehabilitative programme ( further 73 consecutive non-r and omised patients are not reported here ) . The outcomes were limitations in occupational context /daily living ( main outcome ) , pain , medication and further quantities . These were measured before the start , after the end of treatment and quarterly in the year thereafter . Repeated- measures analysis of covariance ( RM-ANCOVA ) of the intent-to-treat population was performed with group main effects ( GME ) and group × course interactions ( G × C ) reported . Hierarchically ordered hypotheses ensured the adherence of the nominal significance level . The superiority of the radon treatment was found regarding the main outcome ( RM-ANCOVA until 12 months : pGME = 0.15 , pGxC = 0.033 ) . Consumption of steroids ( pGME = 0.064 , pG × C = 0.025 ) and NSAIDs ( pGME = 0.035 , pG × C = 0.008 ) were significantly reduced . The results suggest beneficial long-term effects of radon baths as adjunct to a multimodal rehabilitative treatment of RA",
"Abstract . The aim of this study was to evaluate the effectiveness of balneotherapy on patients with fibromyalgia ( FM ) at the Dead Sea . Forty-eight patients with FM were r and omly assigned to a treatment group receiving sulfur baths and a control group . All participants stayed for 10 days at a Dead Sea spa . Physical functioning , FM-related symptoms , and tenderness measurements ( point count and dolorimetry ) were assessed at four time points : prior to arrival at the Dead Sea , after 10 days of treatment , and 1 and 3 months after leaving the spa . Physical functioning and tenderness moderately improved in both groups . With the exception of tenderness threshold , the improvement was especially notable in the treatment group and it persisted even after 3 months . Relief in the severity of FM-related symptoms ( pain , fatigue , stiffness , and anxiety ) and reduced frequency of symptoms ( headache , sleep problems , and subjective joint swelling ) were reported in both groups but lasted longer in the treatment group . In conclusion , treatment of FM at the Dead Sea is effective and safe and may become an additional therapeutic modality in FM . Future studies should address the outcome and possible mechanisms of this treatment in FM patients",
"Objective : The present exploratory study sought to examine the changes of well-being associated with 3 weeks of resort based spa therapy . This is a traditional form of health enhancement incorporating balneotherapy , physical therapies , and health education in an inpatient setting . Patients and Method : Subjects were spa patients ( n = 153 , mean age 58 years ) with chronic pain and other age related complaints of moderately higher than normal prevalence . The well-being variables were vegetative complaints , pain , fatigue , positive and negative mood , and health satisfaction assessed at the beginning and end of spa treatment as well as 5 weeks and 12 months thereafter . Results : Well-being improved significantly in all variables during spa therapy , the improvement continuing with a slight deterioration at 5 weeks after the stay . After 12 months , vegetative complaints and fatigue had again reached pre-spa levels , whereas pain , positive and negative mood as well as health satisfaction remained improved . Both patients with high and low levels of pain increase their well-being , although pain patients showed greater improvements in some of the measures . Subjects not responding to spa therapy were older and showed less health satisfaction . Conclusions : The results suggest that spa therapy may be a powerful tool in enhancing well-being in progressed middle aged adults with common health impairments",
"Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists",
"Abstract : Fibromyalgia ( FS ) is an idiopathic chronic pain syndrome defined by widespread non-articular musculoskeletal pain and generalised tender points . As there is no effective treatment , patients with this condition have impaired quality of life ( QoL ) . The aim of this study was to assess the possible effect of balneotherapy at the Dead Sea area on the QoL of patients with FS . Forty-eight subjects participated in the study ; half of them received balneotherapy , and half did not . Their QoL ( using SF-36 ) , psychological well-being and FS-related symptoms were assessed prior to arrival at the spa hotel in the Dead Sea area , at the end of the 10-day stay , and 1 and 3 months later . A significant improvement was reported on most subscales of the SF-36 and on most symptoms . The improvement in physical aspects of QoL lasted usually 3 months , but on psychological measures the improvement was shorter . Subjects in the balneotherapy group reported higher and longer-lasting improvement than subjects in the control group . In conclusion , staying at the Dead Sea spa , in addition to balneotherapy , can transiently improve the QoL of patients with FS . Other studies with longer follow-up are needed to support our findings",
"OBJECTIVE To quantify the efficacy of a series of baths containing natural radon and carbon dioxide ( 1.3 kBq/l , 1.6 g carbon dioxide/l on average ) versus artificial carbon dioxide baths alone in patients with rheumatoid arthritis . SUBJECTS Sixty patients participating in an in-patient rehabilitation programme including a series of 15 baths were r and omly assigned to two groups . DESIGN Pain intensity ( 100 mm visual analogue scale ) and functional restrictions [ Keitel functional test , Arthritis Impact Measurement Scales ( AIMS question naire ) ] were measured at baseline , after completion of treatment and 3 and 6 months thereafter . To investigate whether the overall value of the outcomes was the same in both groups , the overall mean was analysed by Student 's t-test for independent sample s. RESULTS The two groups showed a similar baseline situation . After completion of treatment , relevant clinical improvements were observed in both groups , with no notable group differences . However , the follow-up revealed sustained effects in the radon arm , and a return to baseline levels in the sham arm . After 6 months , marked between-group differences were found for both end-points ( pain intensity : -16.9 % , 95 % confidence interval -27.6 to -6.2 % ; AIMS score : 0.57 , 95 % confidence interval 0.16 to 0.98 ) . The between-group differences were statistically significant for both overall means ( pain intensity , P : = 0.04 ; AIMS , P : = 0.01 ) . CONCLUSION Marked short-term improvements in both groups at the end of treatment may have masked potential specific therapeutic effects of radon baths . However , after 6 months of follow-up the effects were lasting only in patients of the radon arm . This suggests that this component of the rehabilitative intervention can induce beneficial long-term effects",
"OBJECTIVE The aim of this study was to evaluate the therapeutic effects of hydrotherapy which combines elements of warm water immersion and exercise . It was predicted that hydrotherapy would result in a greater therapeutic benefit than either of these components separately . METHODS One hundred thirty-nine patients with chronic rheumatoid arthritis were r and omly assigned to hydrotherapy , seated immersion , l and exercise , or progressive relaxation . Patients attended 30-minute sessions twice weekly for 4 weeks . Physical and psychological measures were completed before and after intervention , and at a 3-month followup . RESULTS All patients improved physically and emotionally , as assessed by the Arthritis Impact Measurement Scales 2 question naire . Belief that pain was controlled by chance happenings decreased , signifying improvement . In addition , hydrotherapy patients showed significantly greater improvement in joint tenderness and in knee range of movement ( women only ) . At followup , hydrotherapy patients maintained the improvement in emotional and psychological state . CONCLUSIONS Although all patients experienced some benefit , hydrotherapy produced the greatest improvements . This study , therefore , provides some justification for the continued use of hydrotherapy",
"Spa therapy is frequently used in daily rheumatological practice , but its benefit remains to be evaluated . A prospect i ve r and omized controlled study was conducted in 1993 in patients with osteoarthritis of the hip , knee or lumbar spine . Treatment was either spa therapy at Vichy ( France ) of 3 weeks duration ( spa group ) or usual therapy ( control group ) . Assessment criteria were pain ( visual analogue scale ) , functional impairment ( Lequesne 's index for hip or knee disease , Main and Waddell 's for lumbar spinal diseases ) , quality of life index [ revised Arthritis Impact Measurement Scale ( AIMS 2 ) ] , and analgesic and /or non-steroidal anti-inflammatory drug ( NSAID ) consumption . Patients were included by r and omization into one of the two arms ( spa or control ) and assessment criteria were collected before spa therapy or the control period , and 3 and 24 weeks thereafter . A total of 188 patients ( lumbar spine 95 , knee 64 , hip 29 ) were included in the study ( spa group 91 , control group 97 ) . Changes in the assessment criteria after a 6 month follow-up period showed improvement in terms of pain , functional impairment and quality of life , with a reduced intake of symptomatic drugs ( NSAID and analgesic drugs ) in the spa group . This study suggests that spa therapy of 3 weeks duration has a prolonged , beneficial , symptomatic effect in osteoarthritis",
"A quantitative systematic review , or meta- analysis , uses statistical methods to combine the results of multiple studies . Meta-analyses have been done for systematic review s of therapeutic trials , diagnostic test evaluations , and epidemiologic studies . Although the statistical methods involved may at first appear to be mathematically complex , their purpose is simple : They are trying to answer four basic questions . Are the results of the different studies similar ? To the extent that they are similar , what is the best overall estimate ? How precise and robust is this estimate ? Finally , can dissimilarities be explained ? This article provides some guidance in underst and ing the key technical aspects of the quantitative approach to these questions . We have avoided using equations and statistical notations ; interested readers will find implementations of the described methods in the listed references . We focus here on the quantitative synthesis of reports of r and omized , controlled , therapeutic trials because far more meta-analyses on therapeutic studies than on other types of studies have been published . For practical reasons , we present a stepwise description of the tasks that are performed when statistical methods are used to combine data . These tasks are 1 ) deciding whether to combine data and defining what to combine , 2 ) evaluating the statistical heterogeneity of the data , 3 ) estimating a common effect , 4 ) exploring and explaining heterogeneity , 5 ) assessing the potential for bias , and 6 ) presenting the results . Deciding Whether To Combine Data and Defining What To Combine By the time one performs a quantitative synthesis , certain decisions should already have been made about the formulation of the question and the selection of included studies . These topics were discussed in two previous articles in this series [ 1 , 2 ] . Statistical tests can not compensate for lack of common sense , clinical acumen , and biological plausibility in the design of the protocol of a meta- analysis . Thus , a reader of a systematic review should always address these issues before evaluating the statistical methods that have been used and the results that have been generated . Combining poor- quality data , overly biased data , or data that do not make sense can easily produce unreliable results . The data to be combined in a meta- analysis are usually either binary or continuous . Binary data involve a yes/no categorization ( for example , death or survival ) . Continuous data take a range of values ( for example , change in diastolic blood pressure after antihypertensive treatment , measured in mm Hg ) . When one is comparing groups of patients , binary data can be summarized by using several measures of treatment effect that were discussed earlier in this series [ 3 ] . These measures include the risk ratio ; the odds ratio ; the risk difference ; and , when study duration is important , the incidence rate . Another useful clinical measure , the number needed to treat ( NNT ) , is derived from the inverse of the risk difference [ 3 ] . Treatment effect measures , such as the risk ratio and the odds ratio , provide an estimate of the relative efficacy of an intervention , whereas the risk difference describes the intervention 's absolute benefit . The various measures of treatment effect offer complementary information , and all should be examined [ 4 ] . Continuous data can be summarized by the raw mean difference between the treatment and control groups when the treatment effect is measured on the same scale ( for example , diastolic blood pressure in mm Hg ) , by the st and ardized mean difference when different scales are used to measure the same treatment effect ( for example , different pain scales being combined ) , or by the correlation coefficients between two continuous variables [ 5 ] . The st and ardized mean difference , also called the effect size , is obtained by dividing the difference between the mean in the treatment group and the mean in the control group by the SD in the control group . Evaluating the Statistical Heterogeneity of the Data This step is intended to answer the question , Are the results of the different studies similar ( homogeneous ) ? It is important to answer this question before combining any data . To do this , one must calculate the magnitude of the statistical diversity ( heterogeneity ) of the treatment effect that exists among the different sets of data . Statistical diversity can be thought of as attributable to one or both of two causes . First , study results can differ because of r and om sampling error . Even if the true effect is the same in each study , the results of different studies would be expected to vary r and omly around the true common fixed effect . This diversity is called the within- study variance . Second , each study may have been drawn from a different population , depending on the particular patients chosen and the interventions and conditions unique to the study . Therefore , even if each study enrolled a large patient sample , the treatment effect would be expected to differ . These differences , called r and om effects , describe the between- study variation with regard to an overall mean of the effects of all of the studies that could be undertaken . The test most commonly used to assess the statistical significance of between- study heterogeneity is based on the chi-square distribution [ 6 ] . It provides a measure of the sum of the squared differences between the results observed and the results expected in each study , under the assumption that each study estimates the same common treatment effect . A large total deviation indicates that a single common treatment effect is unlikely . Any pooled estimate calculated must account for the between- study heterogeneity . In practice , this test has low sensitivity for detecting heterogeneity , and it has been suggested that a liberal significance level , such as 0.1 , should be used [ 6 ] . Estimating a Common Effect The questions that this step tries to answers are , 1 ) To the extent that data are similar , what is their best common point estimate of a therapeutic effect , and 2 ) how precise is this estimate ? The mathematical process involved in this step generally involves combining ( pooling ) the results of different studies into an overall estimate . Compared with the results of individual studies , pooled results can increase statistical power and lead to more precise estimates of treatment effect . Each study is given a weight according to the precision of its results . The rationale is that studies with narrow CIs should be weighted more heavily than studies with greater uncertainty . The precision is generally expressed by the inverse of the variance of the estimate of each study . The variance has two components : the variance of the individual study and the variance between different studies . When the between- study variance is found to be or assumed to be zero , each study is simply weighted by the inverse of its own variance , which is a function of the study size and the number of events in the study . This approach characterizes a fixed-effects model , as exemplified by the Mantel-Haenszel method [ 7 , 8 ] or the Peto method [ 9 ] for dichotomous data . The Peto method has been particularly popular in the past . It has the advantage of simple calculation ; however , although it is appropriate in most cases , it may introduce large biases if the data are unbalanced [ 10 , 11 ] . On the other h and , r and om-effects models also add the between- study variance to the within- study variance of each individual study when the pooled mean of the r and om effects is calculated . The r and om-effects model most commonly used for dichotomous data is the DerSimonian and Laird estimate of the between- study variance [ 12 ] . Fixed- and r and om-effects models for continuous data have also been described [ 13 ] . Pooled results are generally reported as a point estimate and CI , typically a 95 % CI . Other quantitative techniques for combining data , such as the Confidence Profile Method [ 14 ] , use Bayesian methods to calculate posterior probability distributions for effects of interest . Bayesian statistics are based on the principle that each observation or set of observations should be viewed in conjunction with a prior probability describing the prior knowledge about the phenomenon of interest [ 15 ] . The new observations alter this prior probability to generate a posterior probability . Traditional meta- analysis assumes that nothing is known about the magnitude of the treatment effect before r and omized trials are performed . In Bayesian terms , the prior probability distribution is noninformative . Bayesian approaches may also allow the incorporation of indirect evidence in generating prior distributions [ 14 ] and may be particularly helpful in situations in which few data from r and omized studies exist [ 16 ] . Bayesian analyses may also be used to account for the uncertainty introduced by estimating the between- study variance in the r and om-effects model , leading to more appropriate estimates and predictions of treatment efficacy [ 17 ] . Exploring and Explaining Heterogeneity The next important issue is whether the common estimate obtained in the previous step is robust . Sensitivity analyses determine whether the common estimate is influenced by changes in the assumptions and in the protocol for combining the data . A comparison of the results of fixed- and r and om-effects models is one such sensitivity analysis [ 18 ] . Generally , the r and om-effects model produces wider CIs than does the fixed-effects model , and the level of statistical significance may therefore be different depending on the model used . The pooled point estimate per se is less likely to be affected , although exceptions are possible [ 19 ] . Other sensitivity analyses may include the examination of the residuals and the chi-square components [ 13 ] and assessment of the effect of deleting each study in turn . Statistically significant results that depend on a single study may require further exploration . Cumulative Meta- Analysis",
"This paper provides the first data on the incidence of RA based on a prospect i ve population -based register . All new cases of inflammatory polyarthritis in the Norwich Health Authority are notified by general practitioners to the Norfolk Arthritis Register . The patients are then clinical ly evaluated by metrologists and blood taken for RF estimation . Cases of RA were defined as all those notified with an onset of symptoms in 1990 ; who presented by 31 December 1991 ; and who satisfied the 1987 ARA criteria for RA at the time of presentation . Two hundred and ten patients were notified in the defined time-frame , of whom 104 were classified as having RA . The annual incidence rate was 36/100,000 for women and 14/100,000 for men . RA was rare in men aged under 45 yr . The incidence in men rose steeply with age . The incidence in women rose up to age 45 yr , plateaued to age 75 yr , and fell in the very elderly",
"Objective The aim of this study was to evaluate the efficacy of home treatment with mud compresses for the h and s of patients with rheumatoid arthritis ( RA ) . Methods Forty-five patients suffering from RA were enrolled in a double-blind , r and omized , controlled study . Twenty-two were treated with true mud compresses ( treatment group ) and 23 were treated with attenuated mud compresses ( control group ) . The compresses were applied in the patients ’ homes five times a week during a 3-week period . Patients were assessed four times : at baseline , upon completion of the 3-week treatment period , 1 month after the treatment , and 3 months after conclusion of the treatment period . Positive response was defined as reductions of 30 % or more in the number of tender and swollen joints , 20 % or more in physician global assessment of disease activity , and 20 % or more in patient global assessment of the severity of joint pain . Results In the treatment group , significant reductions in the number of swollen and tender joints and patients ’ global assessment s of pain severity was observed at all post-treatment assessment s. Significant improvement in the scores of physician global assessment was seen at the end of therapy and 1 month later . In the control group , no improvement in the number of swollen and tender joints or physician global assessment was found in any post-treatment evaluation . However , a significant reduction in patient global assessment of joint pain severity was reported at the end of therapy and 3 months after concluding treatment . Conclusion Treatment with mud compresses relieves pain affecting the h and s and reduces the number of swollen and tender joints in the h and s of patients suffering from RA . This treatment can augment conventional medical therapy in these patients",
"Forty-one patients with rheumatoid arthritis were treated for 2 weeks at a Tiberias spa hotel . R and omized into 2 groups , Group 1 received a combination of mineral baths and mud packs , and Group 2 had tap water baths only . Both groups had a significant but temporary improvement in Ritchie index . Group 1 showed a significant improvement in grip strength . No improvement was noticed in morning stiffness , 15 meter walk time and laboratory variables of disease activity in either group . Twelve patients with osteoarthritis ( OA ) received 2 weeks of treatment with mineral baths and mud packs . Statistically significant improvement for a period of 6 months was noticed in night pain , pain on passive motion , tenderness on palpation and in the index of severity of OA of the knee",
"OBJECTIVES Several studies suggest a beneficial overall effect of spa therapy in chronic musculoskeletal diseases . The present open controlled study investigated the effects of spa therapy at Bourbonne-Les-Bains , France , in patients with hip or knee osteoarthritis or low back pain . PATIENTS AND METHODS In 1998 , 102 men and women older than 50 years were included in the study . All had low back pain or lower limb osteoarthritis , and none had contraindications to spa therapy . Quality of life was assessed three times at intervals of 4 weeks , twice before and once immediately after 3 weeks of spa therapy , using the Duke Health Profile ( five dimensions and five dysfunctions ) . RESULTS Mean age was 66.4 years , and 67 % of the patients were women . Quality of life was markedly decreased as compared to the population at large ( 1996 , CFES ) . The two pretreatment evaluations produced similar quality -of-life scores . Spa therapy was associated with significant improvements in overall quality of life ( P=0.004 ) , self-esteem ( P=0.009 ) , and pain ( P=0.01 ) . CONCLUSION These findings support those of other studies conducted in France and in other European countries . They indicate that patients report meaningful improvements in their quality of life after spa therapy",
"Hydrotherapy for OA of the hip has rarely been evaluated in controlled studies . Forty-seven patients with OA of the hip were followed for 18 weeks . Patients were r and omly allocated either to a regimen of home exercises or to twice weekly hydrotherapy for 6 weeks in addition to home exercises . There was an improvement seen in both subjective and objective measures in both groups with treatment . There was no significant difference between the two groups . Response to treatment appeared independent of age , sex and radiological severity . We conclude that for most patients , a carefully grade d and supervised regimen of home exercises is beneficial and there is little benefit in adding hydrotherapy to this regimen",
"To treat cases of psoriasis , various modifications of the original Ingram method were tested for increased effectiveness and minimized side reactions . Our modified method consists of 0.1 - 0.5 % anthralin ointment application and selective UVB phototherapy with adjunctive warm water bath and the application of emollients . The object of this study was to evaluate the effectiveness and duration of remission in response to our modified Ingram method and compare the data with the severity of psoriasis . The clearing rate was higher and the failure rate was lower in the moderate group . The number of occasions on which therapy was used and the duration of this therapy were greater in the severe group , but there were no significant differences except for the number of occasions of therapy to the trunk . Fifty-eight percent of the moderate group did not relapse in more than one year , but 63 % of the severe group relapsed within six months . The results of this study showed that the modified Ingram regimen is an effective therapeutic modality in psoriasis , especially in the moderate group",
"BACKGROUND / PURPOSE Apart from climatotherapy and spa therapy , combined treatment with salt water baths and artificial UV radiation ( balneophototherapy ) has been advocated for the treatment of psoriasis . As there is a lack of controlled studies on balneophototherapy ( BPT ) , we conducted a r and omized , one-blind , right/left comparison with salt water versus tap water in order to investigate the significance of the salt concentration in the efficacy of BPT . METHODS Ten psoriasis patients with chronic plaques on the elbows were included in the study . One elbow was soaked in 24 % NaCl solution and the other in tap water . Subsequently , broadb and UVB irradiation was administered . BPT was performed 4 times weekly with a total of 30 treatments . RESULTS A highly significant ( P clinical baseline score was observed after 30 treatments ; however , there was no significant ( P>0.5 ) difference in clearance of the psoriatic lesions between the sites soaked in salt water and tap water . CONCLUSION Our results suggest that any additional benefit of soaking in salt water and tap water in BPT are unlikely to be due to the salinity of the liquids",
"BACKGROUND Balneotherapy has been successfully used to treat various rheumatic diseases , but has only recently been evaluated for the treatment of fibromyalgia . Since no effective treatment exists for this common rheumatic disease , complementary methods of treatment have been attempted . OBJECTIVES To assess the effectiveness of balneotherapy at the Dead Sea area in the treatment of patients suffering from both fibromyalgia and psoriatic arthritis . METHODS Twenty-eight patients with psoriatic arthritis and fibromyalgia were treated with various modalities of balneotherapy at the Dead Sea area . Clinical indices assessed were duration of morning stiffness , number of active joints , a point count of 18 fibrositic tender points , and determination of the threshold of tenderness in nine fibrositic and in four control points using a dolorimeter . RESULTS The number of active joints was reduced from 18.4 + /- 10.9 to 9 + /- 8.2 ( P number of tender points was reduced from 12.6 + /- 2 to 7.1 + /- 5 in men ( P dolorimetric threshold readings after the treatment period in women ( P number of active joints and the reduction in the number of tender points in the same patients ( r = 0.2 ) . CONCLUSIONS Balneotherapy at the Dead Sea area appears to produce a statistically significant substantial improvement in the number of active joints and tender points in both male and female patients with fibromyalgia and psoriatic arthritis . Further research is needed to eluci date the distinction between the benefits of staying at the Dead Sea area without balneotherapy and the effects of balneotherapy in the study population",
"THE AUTHORS examined the effectiveness of the thermal water of Puspokladany on 62 patients suffering from osteoarthritis of the knee in a double-blind , placebo controlled study . Thermal water decreased pain in movement and tenderness of the knee significantly compared to that of the control group . Bath-reaction ( increase of ESR , leukocyte number and spontaneous pain ) was observed only in the group treated with thermal water . The results indi cate , that the thermal water of Puspokladany is suitable for treating patients suffering from degenerative arthopathies . In a previous announcement , Varga and his colleagues had established that a 20-days bath treat ment in the thermal water of Puspokladany signifi cantly reduced the pain of spondylosis patients when the treatment was applied in the undiluted thermal water . Bath reaction was shown on the patients who were treated in the undiluted thermal water , which was proved by the significant increase of the leucocyte number . The present paper deals with the study and tests we conducted to establish the effect of Puspokla dany 's thermal water on patients with osteoarthritis of the knee"
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